{ "reviewed_at": "2026-10-10", "from": "2024-10-10", "through": "2026-10-10", "record_count": 89, "scope": "Fixed cohort of 89 selected matter records with recent activity, not an exhaustive count of lawsuits, sellers or enforcement actions. The larger registry contains 145 historical records.", "counting_method": "One record per compound per comparison cell. A multi-compound record appears in several rows. Sales, supply or testing includes alleged or reported marketing, orders, importation, supply, seized inventory and attributed testing, not only adjudicated completed sales. All-role association also includes settlement scope, background and unclear relationships. Original product names and exact source roles remain visible in each case.", "limitations": [ "No denominator of sellers, sales or exposure by compound. Counts cannot estimate relative enforcement probability or show that an absent compound is unpursued.", "Searches began with GLP-1 disputes and accessible English-language sources. Publication, archive and selection bias affect comparisons.", "FDA letters, criminal cases, private civil disputes and overseas actions are not interchangeable units of enforcement severity.", "Some rows group related defendants or coordinated actions. Initial investigation dates and later dispositions are often unknown.", "New leads found while coding are stored separately from this fixed cohort; see follow-up-leads.json." ], "normalization": { "mappings": { "2-methoxyestradiol": { "names": [ "2-methoxyestradiol" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "kind": "compound" }, "5-AMINO-IMQ": { "names": [ "5-AMINO-IMQ" ], "basis": "Preserve Health Canada’s exact label spelling. The reviewed advisory does not explicitly establish equivalence to 5-amino-1MQ or another similarly written molecule.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "unresolved_product" }, "AOD-9604": { "names": [ "AOD-9604" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious", "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "kind": "compound" }, "ARA-290": { "names": [ "ARA-290" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "BPC-157": { "names": [ "BPC-157" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "CJC-1295": { "names": [ "CJC-1295" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "compound" }, "CJC1295": { "names": [ "CJC-1295" ], "basis": "Punctuation/spacing normalization only. DOJ renders the alleged order as CJC 1295; Health Canada uses CJC-1295. Do not infer DAC status, modified GRF identity or actual vial composition.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "Cag (1 mg) Tirz (10 mg) blend": { "names": [ "Cag (1 mg) Tirz (10 mg) blend" ], "basis": "Keep the partly coded blend unresolved. FDA’s quotation explicitly names cagrilintide but refers to the other component as GLP-2-T. Cagrilintide already has a separate product entry in this case; do not infer tirzepatide or double-count cagrilintide.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ], "kind": "unresolved_product" }, "DHEA": { "names": [ "DHEA" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "compound" }, "DSIP": { "names": [ "DSIP" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "compound" }, "Dihexa": { "names": [ "Dihexa" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "kind": "compound" }, "FGL acetate": { "names": [ "FGL acetate" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Preserve the explicitly named salt/ester/acid form; no active-moiety or family aggregation is used.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "kind": "compound" }, "GE Labs Ykarine": { "names": [ "GE Labs Ykarine" ], "basis": "Preserve the brand/product name. The separate tested_contents entry identifies undeclared trendione; a trade name alone is not an additional chemical identification.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ], "kind": "unresolved_product" }, "GHK": { "names": [ "GHK" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Keep distinct from related full-length peptides, fragments, copper complexes, modified peptides and incompletely specified labels. A source’s loose alternate-label usage is not applied globally as chemical equivalence.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "kind": "compound" }, "GHK-Cu": { "names": [ "GHK-Cu" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Keep distinct from related full-length peptides, fragments, copper complexes, modified peptides and incompletely specified labels. A source’s loose alternate-label usage is not applied globally as chemical equivalence.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "compound" }, "GHRP-2": { "names": [ "GHRP-2" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "kind": "compound" }, "GHRP-6": { "names": [ "GHRP-6" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "kind": "compound" }, "GLP-1 (7-37)": { "names": [ "GLP-1 (7-37)" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Keep distinct from related full-length peptides, fragments, copper complexes, modified peptides and incompletely specified labels. A source’s loose alternate-label usage is not applied globally as chemical equivalence.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "GLP-1 drugs": { "names": [ "GLP-1 drugs" ], "basis": "Drug-class description, not a named molecule; do not turn this into semaglutide, tirzepatide or GLP-1 (7-37).", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state" ], "kind": "class" }, "GLP1S": { "names": [ "GLP1S" ], "basis": "Preserve the PekCura coded product label. Trial references are not an explicit generic-name identification in the FDA letter; do not infer semaglutide.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ], "kind": "unresolved_product" }, "GLP2 Tirz": { "names": [ "GLP2 Tirz" ], "basis": "Preserve the coded Nuscience offer. The reviewed passage does not explicitly supply a generic-name identification.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ], "kind": "unresolved_product" }, "GLP2T": { "names": [ "GLP2T" ], "basis": "Preserve the PekCura coded product label. The FDA letter does not explicitly decode it to tirzepatide.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ], "kind": "unresolved_product" }, "GLP3R": { "names": [ "GLP3R" ], "basis": "Preserve the PekCura coded product label. Do not transfer the explicit GLP3 (R) mapping from a different seller’s complaint to this product.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ], "kind": "unresolved_product" }, "HGH fragment": { "names": [ "HGH fragment" ], "basis": "Fragment identity is not specified. Do not merge with human growth hormone, somatropin, AOD-9604 or a particular numbered growth-hormone fragment.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "unresolved_product" }, "KCF-18": { "names": [ "KCF-18" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "KK-23": { "names": [ "KK-23" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "KPV": { "names": [ "KPV" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "compound" }, "LGD-4033": { "names": [ "LGD-4033" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ], "kind": "compound" }, "LL-37": { "names": [ "LL-37" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "MOTS-C": { "names": [ "MOTS-C" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "compound" }, "NAD+": { "names": [ "NAD+" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf", "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "kind": "compound" }, "NR-7": { "names": [ "NR-7" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "PNC-27": { "names": [ "PNC-27" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "PTD-DBM": { "names": [ "PTD-DBM" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "Pal-GHK": { "names": [ "Pal-GHK" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Keep distinct from related full-length peptides, fragments, copper complexes, modified peptides and incompletely specified labels. A source’s loose alternate-label usage is not applied globally as chemical equivalence.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "QS-13": { "names": [ "QS-13" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "RAD-140": { "names": [ "RAD-140" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ], "kind": "compound" }, "RETRA": { "names": [ "RETRA" ], "basis": "Preserve the affected-product label; Health Canada does not explicitly identify it as retatrutide in the reviewed advisory.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "kind": "unresolved_product" }, "S-23": { "names": [ "S-23" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ], "kind": "compound" }, "SARMs, individual compounds unspecified": { "names": [ "unspecified SARMs" ], "basis": "Equivalent class-only wording; no constituent molecule is inferred.", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances", "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ], "kind": "class" }, "SERMs, individual compounds unspecified": { "names": [ "unspecified SERMs" ], "basis": "Class-only description; no constituent molecule is inferred.", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ], "kind": "class" }, "SLU-PP-332": { "names": [ "SLU-PP-332" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "compound" }, "TB-500": { "names": [ "TB-500" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Keep distinct from related full-length peptides, fragments, copper complexes, modified peptides and incompletely specified labels. A source’s loose alternate-label usage is not applied globally as chemical equivalence.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious", "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ], "kind": "compound" }, "TB500": { "names": [ "TB-500" ], "basis": "Hyphenation normalization of the same numeric label. DOJ uses TB500 and the cited seizure advisory uses TB-500. No global equivalence with full-length thymosin beta-4 or its fragments is imposed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "kind": "compound" }, "Tianeptine Ultimate": { "names": [ "Tianeptine Ultimate" ], "basis": "FDA calls this a tianeptine product but does not specify its chemical form or full composition. Preserve the product label rather than assign it to a particular salt or ester.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ], "kind": "unresolved_product" }, "VIP": { "names": [ "VIP" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "YK-11": { "names": [ "YK-11" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health", "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "kind": "compound" }, "albuterol": { "names": [ "albuterol" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ], "kind": "compound" }, "andarine": { "names": [ "andarine" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "kind": "compound" }, "bacteriostatic water": { "names": [ "bacteriostatic water" ], "basis": "Drug preparation with unspecified preservative/formulation in the normalized name; retain as a preparation class, not a peptide or a verified single-compound ingredient.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ], "kind": "class" }, "bremelanotide": { "names": [ "bremelanotide" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "kind": "compound" }, "bronchogen": { "names": [ "bronchogen" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "buserelin acetate": { "names": [ "buserelin acetate" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Preserve the explicitly named salt/ester/acid form; no active-moiety or family aggregation is used.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "kind": "compound" }, "cagrilintide": { "names": [ "cagrilintide" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ], "kind": "compound" }, "cagrilintide (rendered Cagrilinitide in DOJ release)": { "names": [ "cagrilintide" ], "basis": "Remove the supplied analysis label’s editorial parenthesis from the canonical display. DOJ and the indictment actually spell the item Cagrilinitide; retain that verbatim spelling and the correction caveat in the original product record. This rule does not independently verify chemical identity or silently correct other unknown labels.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china", "https://www.safemedicines.org/wp-content/uploads/2026/04/Justin-Bradley-Watkins-Indictment-1.pdf" ], "kind": "compound" }, "cagrilintide acetate": { "names": [ "cagrilintide acetate" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Preserve the explicitly named salt/ester/acid form; no active-moiety or family aggregation is used.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "kind": "compound" }, "cardarine": { "names": [ "cardarine" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health", "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "kind": "compound" }, "cortagen": { "names": [ "cortagen" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "cyanocobalamin": { "names": [ "cyanocobalamin" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ], "kind": "compound" }, "dapoxetine hydrochloride": { "names": [ "dapoxetine hydrochloride" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Preserve the explicitly named salt/ester/acid form; no active-moiety or family aggregation is used.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "kind": "compound" }, "elamipretide": { "names": [ "elamipretide" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "kind": "compound" }, "elamipretide acetate": { "names": [ "elamipretide acetate" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Preserve the explicitly named salt/ester/acid form; no active-moiety or family aggregation is used.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "kind": "compound" }, "epitalon": { "names": [ "epitalon" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "epithalon": { "names": [ "epitalon" ], "basis": "FDA Substance Registration System explicitly lists EPITHALON as a synonym under preferred name EPITALON, UNII O65P17785G. Do not extend this rule to epithalamin or acetylated/salt forms.", "sources": [ "https://precision.fda.gov/uniisearch/srs/unii/O65P17785G", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "compound" }, "glutathione": { "names": [ "glutathione" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "kind": "compound" }, "gonadorelin": { "names": [ "gonadorelin" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "hexarelin": { "names": [ "hexarelin" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "human chorionic gonadotropin": { "names": [ "human chorionic gonadotropin" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health", "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "kind": "compound" }, "human chorionic gonadotropin / hCG": { "names": [ "human chorionic gonadotropin" ], "basis": "Remove the explicit abbreviation from the canonical display name. The information and DOJ account identify hCG as human chorionic gonadotropin. No urinary/recombinant form or product composition is inferred.", "sources": [ "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa", "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Kawa-Paradigm-Peptides-Judgment.pdf" ], "kind": "compound" }, "human growth hormone": { "names": [ "human growth hormone (form unspecified)" ], "basis": "The advisory uses HGH without a product-specific molecular/form designation. Retain an unspecified hormone category rather than merge with the separately named somatropin.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "class" }, "humanin HNG": { "names": [ "humanin HNG" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Keep distinct from related full-length peptides, fragments, copper complexes, modified peptides and incompletely specified labels. A source’s loose alternate-label usage is not applied globally as chemical equivalence.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "humanine": { "names": [ "humanine" ], "basis": "Preserve the advisory spelling. The source does not establish that it denotes humanin HNG, and that modified peptide must not be inferred from a similar name.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "unresolved_product" }, "ibutamoren": { "names": [ "ibutamoren" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "kind": "compound" }, "ibutamoren / MK-677": { "names": [ "ibutamoren" ], "basis": "Collapse explicit synonym pair. FDA lists MK-677 under ibutamoren. This neither classifies ibutamoren as a SARM nor collapses a separately specified salt.", "sources": [ "https://www.fda.gov/food/dietary-supplements/information-select-dietary-supplement-ingredients-and-other-substances", "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ], "kind": "compound" }, "ipamorelin": { "names": [ "ipamorelin" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "kind": "compound" }, "ipamoreline": { "names": [ "ipamorelin" ], "basis": "Health Canada reproduces Ipamoreline; the NIH PubChem record for ipamorelin explicitly lists Ipamoreline as a synonym. This is a spelling normalization and does not imply the product contains the named substance or identify a salt.", "sources": [ "https://pubchem.ncbi.nlm.nih.gov/compound/9831659", "https://precision.fda.gov/uniisearch/srs/unii/Y9M3S784Z6", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "ivermectin": { "names": [ "ivermectin" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ], "kind": "compound" }, "kisspeptin": { "names": [ "kisspeptin (fragment unspecified)" ], "basis": "Fragment/length is unspecified. Keep separate from the explicitly named kisspeptin-10.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "class" }, "kisspeptin-10": { "names": [ "kisspeptin-10" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Keep distinct from related full-length peptides, fragments, copper complexes, modified peptides and incompletely specified labels. A source’s loose alternate-label usage is not applied globally as chemical equivalence.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "larazotide acetate": { "names": [ "larazotide acetate" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Preserve the explicitly named salt/ester/acid form; no active-moiety or family aggregation is used.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "kind": "compound" }, "ligandrol": { "names": [ "LGD-4033" ], "basis": "FDA lists Ligandrol as a synonym for LGD-4033. A ligandrol label therefore counts under LGD-4033, but the Warrior Labz assay finding that the sample lacked ligandrol remains unchanged.", "sources": [ "https://www.fda.gov/food/dietary-supplements/information-select-dietary-supplement-ingredients-and-other-substances", "https://precision.fda.gov/ginas/app/ui/browse-substance?search=root_codes_comments%3A%22Ligandrol%22", "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "kind": "compound" }, "liraglutide": { "names": [ "liraglutide" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094" ], "kind": "compound" }, "livagen": { "names": [ "livagen" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "mazdutide": { "names": [ "mazdutide" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ], "kind": "compound" }, "melanotan": { "names": [ "melanotan (type unspecified)" ], "basis": "The source does not specify type I or II; do not merge with either named compound.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "kind": "class" }, "melanotan I": { "names": [ "melanotan I" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "melanotan II": { "names": [ "melanotan II" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "compound" }, "niacinamide": { "names": [ "niacinamide" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ], "kind": "compound" }, "ostarine": { "names": [ "ostarine" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "kind": "compound" }, "ostarine / MK-2866": { "names": [ "ostarine" ], "basis": "Collapse explicit synonym pair. FDA lists MK-2866 under ostarine. Product-label identity and any contrary assay result remain separate source roles.", "sources": [ "https://www.fda.gov/food/dietary-supplements/information-select-dietary-supplement-ingredients-and-other-substances", "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ], "kind": "compound" }, "ostarine and clomiphene": { "names": [ "ostarine", "clomiphene" ], "basis": "Split two explicitly identified assay components, not synonyms. FDA’s debarment notice says both tested products contained ostarine and undeclared clomiphene. Each resulting association retains tested_contents; clomiphene must not become an advertised ingredient or confirmed offered product.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "kind": "compound" }, "other peptides, unspecified": { "names": [ "unspecified peptides" ], "basis": "Equivalent unspecified-peptide class description; no individual compound is inferred.", "sources": [ "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR" ], "kind": "class" }, "ovagen": { "names": [ "ovagen" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "pinealon": { "names": [ "pinealon" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "pramipexole": { "names": [ "pramipexole" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ], "kind": "compound" }, "prescription medicines and medical devices": { "names": [ "prescription medicines", "medical devices" ], "basis": "Split two explicitly named administrative-restriction classes, not chemical ingredients; preserve background role.", "sources": [ "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf" ], "kind": "class" }, "prostaglandin E1": { "names": [ "prostaglandin E1" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ], "kind": "compound" }, "prostamax": { "names": [ "prostamax" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "raloxifene": { "names": [ "raloxifene" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ], "kind": "compound" }, "retatrutide": { "names": [ "retatrutide" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://docketnexus.com/document/489631293/", "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf", "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ], "kind": "compound" }, "selank": { "names": [ "selank" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "kind": "compound" }, "semaglutide": { "names": [ "semaglutide" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf", "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "https://docketnexus.com/document/489631293/" ], "kind": "compound" }, "semax": { "names": [ "semax" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "sermorelin": { "names": [ "sermorelin" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "compound" }, "sildenafil": { "names": [ "sildenafil" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "kind": "compound" }, "somatropin": { "names": [ "somatropin" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Keep distinct from related full-length peptides, fragments, copper complexes, modified peptides and incompletely specified labels. A source’s loose alternate-label usage is not applied globally as chemical equivalence.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "compound" }, "survodutide": { "names": [ "survodutide" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ], "kind": "compound" }, "tadalafil": { "names": [ "tadalafil" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "kind": "compound" }, "tamoxifen": { "names": [ "tamoxifen" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ], "kind": "compound" }, "tesamorelin": { "names": [ "tesamorelin" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ], "kind": "compound" }, "tesofensine": { "names": [ "tesofensine" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "kind": "compound" }, "testosterone": { "names": [ "testosterone" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-US-sentencing-memo.pdf" ], "kind": "compound" }, "testosterone cypionate": { "names": [ "testosterone cypionate" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Preserve the explicitly named salt/ester/acid form; no active-moiety or family aggregation is used.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "kind": "compound" }, "thymogen": { "names": [ "thymogen" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "kind": "compound" }, "thymosin alpha": { "names": [ "thymosin alpha (subtype unspecified)" ], "basis": "Health Canada’s affected-product list says only thymosin alpha. It does not establish alpha-1, so that subtype is not inferred.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "kind": "class" }, "thymosin alpha-1": { "names": [ "thymosin alpha-1" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious", "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf" ], "kind": "compound" }, "thymosin beta-4": { "names": [ "thymosin beta-4" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Keep distinct from related full-length peptides, fragments, copper complexes, modified peptides and incompletely specified labels. A source’s loose alternate-label usage is not applied globally as chemical equivalence.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "kind": "compound" }, "thymosin beta-4 fragment 17-23": { "names": [ "thymosin beta-4 fragment 17-23" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Keep distinct from related full-length peptides, fragments, copper complexes, modified peptides and incompletely specified labels. A source’s loose alternate-label usage is not applied globally as chemical equivalence.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "thymulin": { "names": [ "thymulin" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "tianeptine ethyl ester sulfate": { "names": [ "tianeptine ethyl ester sulfate" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Preserve the explicitly named salt/ester/acid form; no active-moiety or family aggregation is used.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ], "kind": "compound" }, "tianeptine free acid": { "names": [ "tianeptine free acid" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Preserve the explicitly named salt/ester/acid form; no active-moiety or family aggregation is used.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ], "kind": "compound" }, "tianeptine sodium": { "names": [ "tianeptine sodium" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Preserve the explicitly named salt/ester/acid form; no active-moiety or family aggregation is used.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ], "kind": "compound" }, "tianeptine sulfate": { "names": [ "tianeptine sulfate" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization. Preserve the explicitly named salt/ester/acid form; no active-moiety or family aggregation is used.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ], "kind": "compound" }, "tirzepatide": { "names": [ "tirzepatide" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf", "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ], "kind": "compound" }, "tirzepatide and products purporting to contain tirzepatide": { "names": [ "tirzepatide" ], "basis": "Normalize the USITC investigation-scope phrase to its expressly named compound. Purported content remains attributed; neither the mapping nor the investigation scope verifies every product’s contents.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf", "https://www.usitc.gov/press_room/news_release/2023/er1121_64592.htm" ], "kind": "compound" }, "trendione": { "names": [ "trendione" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ], "kind": "compound" }, "unspecified SARMs": { "names": [ "unspecified SARMs" ], "basis": "Retain the class-only description; no constituent molecule is inferred.", "sources": [ "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements", "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "kind": "class" }, "unspecified anabolic steroids": { "names": [ "unspecified anabolic steroids" ], "basis": "Retain the narrower anabolic-steroid class; do not merge all steroids into this category.", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ], "kind": "class" }, "unspecified bodybuilding drugs": { "names": [ "unspecified bodybuilding drugs" ], "basis": "Indeterminate product class, not a named substance or proof of a particular peptide.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health" ], "kind": "class" }, "unspecified injectable peptides": { "names": [ "unspecified injectable peptides" ], "basis": "Retain the explicitly injectable product class without inventing a molecule.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health", "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ], "kind": "class" }, "unspecified other peptides": { "names": [ "unspecified peptides" ], "basis": "Equivalent unspecified-peptide class description; no individual compound is inferred.", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ], "kind": "class" }, "unspecified steroids": { "names": [ "unspecified steroids" ], "basis": "Retain the broader steroid class without assuming anabolic identity.", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ], "kind": "class" }, "vesugen": { "names": [ "vesugen" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" }, "vilon": { "names": [ "vilon" ], "basis": "Retain the explicitly named substance as recorded in the cited primary source. No salt, ester, fragment, formulation, product-content finding or pharmacological class is inferred from this display normalization.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "kind": "compound" } }, "notes": [ "Mapping covers every raw product name in the reviewed 89-record case-analysis snapshot. Original product names, roles, source bases and case IDs remain unchanged.", "Count at most one occurrence per normalized compound per record per comparison column. Multiple products, synonyms or evidence roles in one matter must not inflate a case count.", "Sales, supply or testing includes alleged_offered, documented_offered and tested_contents. Keep narrower marketing/supply counts and any-role association counts separately. Normalization does not upgrade allegations or seller labels into analytical findings.", "An explicit assay mixture is split into components while its tested_contents role remains attached to each. The absence of an ingredient in a sample does not erase a documented advertised-label association.", "Salts, esters, modified peptides and numbered fragments remain separate. No molecule-family grouping is implemented. If a family view is later added, label it as a family and preserve each original form visibly.", "Unresolved coded labels, ambiguous spellings and classes are not named-compound rankings. They remain visible as unresolved product/class records; counts are not evidence of complete market coverage.", "Bare thymosin alpha is not silently converted to thymosin alpha-1. TB-500 is not globally equated with thymosin beta-4 or its 17-23 fragment, even though one advisory lists those market labels together.", "The DOJ Cagrilinitide spelling is an explicit editorial caveat in the supplied raw analysis; the display mapper removes its parenthetical note but does not independently resolve chemistry. Preserve the note in every case display." ] }, "missingness": { "no_exact_timing_pair": 57, "no_sales_supply_or_testing_attribution": 3, "records_with_registry_only_source_review": 18 }, "counts_by_category": { "state_enforcement": 4, "trade": 1, "civil": 37, "warning_letter": 25, "foreign_enforcement": 13, "criminal": 9 }, "counts_by_outcome": { "settlement": 4, "administrative_action": 3, "pending_or_unknown": 14, "procedural_order": 11, "dismissal": 10, "mixed": 9, "warning_letter": 25, "seizure_or_investigation": 9, "guilty_plea": 2, "conviction_or_sentence": 2 }, "compound_comparison": [ { "compound": "semaglutide", "associated_records": 44, "marketing_or_supply_records": 41, "sales_supply_or_testing_records": 42, "associated_by_category": { "state_enforcement": 4, "civil": 17, "warning_letter": 16, "foreign_enforcement": 3, "criminal": 4 }, "marketing_or_supply_by_category": { "state_enforcement": 4, "civil": 14, "warning_letter": 16, "foreign_enforcement": 3, "criminal": 4 }, "sales_supply_or_testing_by_category": { "state_enforcement": 4, "civil": 15, "warning_letter": 16, "foreign_enforcement": 3, "criminal": 4 }, "record_ids": [ "al-aurora-2026", "ct-triggered-brand-2025", "lilly-aesthetic-2026", "lilly-pivotal-2024", "lilly-livewell-2026", "fda-711330", "fda-738238", "fda-723330", "fda-733652", "fda-735127", "fda-721817", "fda-735063", "fda-695156", "fda-723704", "fda-734884", "fda-695607", "fda-695663", "fda-735067", "fda-696885", "fda-694608", "fda-715878", "ca-maple-ridge-2025", "ca-rize-fitness-2025", "nj-john-mcgee-2025", "uk-novo-isp-blocking-2025", "novo-aios-2025", "novo-amble-2025", "novo-doceremedical-2025", "novo-dripdrop-2024", "novo-hims-patent-2026", "novo-ivharmony-2024", "novo-liferxmd-2024", "novo-brooksville-2023", "novo-dunklau-2024", "novo-trulife-2023", "novo-medioak-2024", "novo-wellhealth-2023", "novo-wells-2023", "oh-medspa-warning-letters-2025", "strive-antitrust-2026", "us-v-brandon-piper-milestonepurity", "us-v-jeremy-brown-warrior-labz", "us-v-justin-watkins", "us-v-matthew-lewis-semaglutide" ], "marketing_or_supply_record_ids": [ "al-aurora-2026", "ct-triggered-brand-2025", "lilly-livewell-2026", "fda-711330", "fda-738238", "fda-723330", "fda-733652", "fda-735127", "fda-721817", "fda-735063", "fda-695156", "fda-723704", "fda-734884", "fda-695607", "fda-695663", "fda-735067", "fda-696885", "fda-694608", "fda-715878", "ca-maple-ridge-2025", "ca-rize-fitness-2025", "nj-john-mcgee-2025", "uk-novo-isp-blocking-2025", "novo-aios-2025", "novo-amble-2025", "novo-doceremedical-2025", "novo-dripdrop-2024", "novo-hims-patent-2026", "novo-ivharmony-2024", "novo-liferxmd-2024", "novo-brooksville-2023", "novo-dunklau-2024", "novo-trulife-2023", "novo-wellhealth-2023", "novo-wells-2023", "oh-medspa-warning-letters-2025", "strive-antitrust-2026", "us-v-brandon-piper-milestonepurity", "us-v-jeremy-brown-warrior-labz", "us-v-justin-watkins", "us-v-matthew-lewis-semaglutide" ], 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Owners Amanda and Chris Medders were barred from the specified direct-patient-care work, and Amanda surrendered her nursing license. The announced monetary terms distinguish consumer damages from penalties and fees.", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ] }, "products": [ { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "The attorney general alleges administration of research-grade preparations marketed as pharmaceutical grade.", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "The attorney general alleges administration of research-grade preparations marketed as pharmaceutical grade.", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The release references complaining consumers and agency cooperation, but does not establish which complaint or event began the investigation.", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ] }, "challenged_conduct": [ { "text": "The state alleged deceptive presentation and administration of drugs labeled by their manufacturer for research use, rather than authorized human treatment.", "attribution": "allegation", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ] } ], "outcome": { "class": "settlement", "text": "The announced settlement permanently closed the clinic, restricted the owners’ healthcare work, and required $17,267.50 in consumer damages plus $7,000 in penalties/fees. The reviewed release is not the underlying consent judgment.", "as_of": "2026-01-12", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ] }, "timeline": [ { "date": "2025-11", "event": "A temporary restraining order had been announced after the state filed suit.", "kind": "order", "date_basis": "reported_period", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ] }, { "date": "2026-01-12", "event": "The attorney general announced the settlement.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain the filed settlement/order and monitor compliance or enforcement of its restrictions.", "basis": "inference", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ] }, "unknowns": [ "Exact complaint/TRO dates, initial trigger, full settlement language and payment completion were not independently established." ], "source_review": [ { "url": "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf", "review_basis": "archived_full_text", "locator": "One-page attorney-general release, settlement terms and investigation background" } ] }, "compounds": [ "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide", "tirzepatide" ], "latest_documented_date": "2026-01-12", "sources": [ { "url": "https://www.alabamaag.gov/attorney-general-marshall-settles-lawsuit-with-cullman-clinic-for-administering-dangerous-unapproved-weight-loss-drugs/", "title": "Alabama AG announces Aurora settlement", "source_type": "official_agency", "document_type": "press_release", "supports": "Settlement terms and agency account of underlying conduct." }, { "url": "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf", "title": "Aurora settlement announcement PDF", "source_type": "official_agency", "document_type": "press_release_pdf", "supports": "Same official settlement announcement in downloadable format." } ], "business_profile": { "id": "al-aurora-2026", "display_name": "Aurora IV and Wellness", "identities": [ { "name": "Aurora IV and Wellness", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ] }, { "name": "Amanda Medders", "kind": "operator", "basis": "Alabama identifies the Medderses as the owners of the Cullman clinic.", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ] }, { "name": "Chris Medders", "kind": "operator", "basis": "Alabama identifies the Medderses as the owners of the Cullman clinic.", "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ] } ], "activity": { "summary": "Alabama describes prior administration of research-grade semaglutide and tirzepatide, a restraining order announced in November 2025, and a January 12, 2026 settlement announcement requiring permanent closure. The clinic launch and exact final treatment date are not given.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf" ], "limits": [ "January 12, 2026 is the settlement announcement date, not a verified last day of treatment.", "The reviewed source does not establish a continuous operating period or exact date of the earlier restraining order." ] }, "source_review": [ { "url": "https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf", "locator": "One-page January 12, 2026 release: first paragraph (clinic/owners and relief), third paragraph (November restraining order and investigation)" } ] } }, { "id": "itc-tirzepatide-1377", "case_name": "Certain Products Containing Tirzepatide and Products Purporting to Contain Tirzepatide", "category": "trade", "court_or_agency": "U.S. International Trade Commission", "docket_number": "337-TA-1377", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Arctic Peptides", "Strate Labs", "The Triggered Brand", "AustroPeptide", "GenX Peptides", "Paradigm Peptides" ], "parties": [ "Eli Lilly and Company", "Arctic Peptides LLC", "Strate Labs LLC", "Triggered Supplements LLC", "Super Human Store", "Xiamen Austronext Trading Co. Ltd.", "Audrey Beauty Co.", "Biolabshop Limited", "Mew Mews Company Limited", "Steroide Kaufen", "Supopeptide", "Unewlife", "Fibonacci Sequence LLC", "Paradigm RE LLC", "Total Compounding Pharmaceuticals" ], "filed_date": "2023-10-19", "status_date": "2025-04-09", "analysis": { "id": "itc-tirzepatide-1377", "summary": { "text": "This was Lilly’s Section 337 trade proceeding over tirzepatide and purported tirzepatide imports, not a criminal prosecution or an FDA approval decision. Lilly filed its complaint on October 19, 2023 and supplemented it on November 10. The ITC announced institution on November 21; the final notice identifies November 27 as the formal institution date. The starting mechanism is therefore known—a private complainant brought an import case—but the reviewed notices do not explain how Lilly first identified each seller. Partial summary determinations resolved specified trademark, false-origin and false-advertising allegations; the results varied by respondent and claim. On April 9, 2025 the Commission issued import-exclusion remedies and cease-and-desist orders, then terminated the investigation. The general exclusion order applies to covered goods that infringe a specified trademark or are falsely designated as to origin. A separate limited order addresses false advertising by named respondents. Remaining allegations against several respondents were withdrawn earlier, which must not be presented as adjudicated liability on those withdrawn claims. The proceeding supplies evidence about import restrictions and marketing representations. It does not establish a blanket prohibition covering every tirzepatide product, every peptide, or retatrutide.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf", "https://www.usitc.gov/press_room/news_release/2023/er1121_64592.htm" ] }, "products": [ { "name": "tirzepatide and products purporting to contain tirzepatide", "role": "reported_marketing_or_supply", "basis": "Express investigation scope; purported contents were not uniformly established by laboratory analysis.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf", "https://www.usitc.gov/press_room/news_release/2023/er1121_64592.htm" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": true, "text": "Lilly filed the complaint that initiated this trade investigation on October 19, 2023. The reviewed institutional and final notices do not establish the underlying vendor-discovery process or each product test.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf", "https://www.usitc.gov/press_room/news_release/2023/er1121_64592.htm" ] }, "challenged_conduct": [ { "text": "Specified respondents were found in violation on trademark infringement, false designation of origin and/or false advertising claims through partial summary determinations; the finding was respondent- and claim-specific.", "attribution": "judicial_finding", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "text": "Certain remaining allegations were withdrawn; withdrawal should not be described as a merits determination against those respondents.", "attribution": "mixed", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] } ], "outcome": { "class": "administrative_action", "text": "Commission issued a general exclusion order for covered trademark-infringing or falsely designated imports; a limited exclusion order for falsely advertised products imported for Super Human Store, Austro Peptide and Arctic Peptides; and cease-and-desist orders against Arctic Peptides, Triggered Brand and Strate Labs. Investigation terminated.", "as_of": "2025-04-09", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, "timeline": [ { "date": "2023-10-19", "event": "Lilly filed complaint.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf", "https://www.usitc.gov/press_room/news_release/2023/er1121_64592.htm" ] }, { "date": "2023-11-10", "event": "Lilly supplemented complaint.", "kind": "other", "date_basis": "filing", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf", "https://www.usitc.gov/press_room/news_release/2023/er1121_64592.htm" ] }, { "date": "2023-11-21", "event": "ITC announced institution vote.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.usitc.gov/press_room/news_release/2023/er1121_64592.htm" ] }, { "date": "2023-11-27", "event": "Formal institution date identified in final notice.", "kind": "order", "date_basis": "event", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "date": "2024-12-06", "event": "Order 26 partial summary determination issued.", "kind": "order", "date_basis": "event", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "date": "2025-01-10", "event": "Order 29 granted withdrawal of specified remaining allegations.", "kind": "order", "date_basis": "event", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "date": "2025-04-09", "event": "Commission issued final remedies and terminated investigation.", "kind": "order", "date_basis": "event", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] } ], "timing_pairs": [ { "label": "Complaint filing to final Commission remedies", "start": "2023-10-19", "end": "2025-04-09", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ], "days": 538 }, { "label": "Partial summary determination to final remedies", "start": "2024-12-06", "end": "2025-04-09", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ], "days": 124 } ], "next_watch": { "text": "Monitor CBP implementation, any Commission enforcement or modification proceeding and any appeal; no later result was established in this review.", "basis": "inference", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, "unknowns": [ "No retatrutide scope established.", "Individual test results and initial identification of each respondent were not supplied by the reviewed notices.", "Later review, appeal and actual import-enforcement outcomes remain unverified." ], "source_review": [ { "url": "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf", "review_basis": "court_pdf", "locator": "Final notice, April 9, 2025, pages 1–4; local usitc-337-ta-1377-final-notice-2025-04-09.pdf" }, { "url": "https://www.usitc.gov/press_room/news_release/2023/er1121_64592.htm", "review_basis": "official_web_full_text", "locator": "Institution press release, November 21, 2023" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2025-04-09", "sources": [ { "url": "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf", "title": "Certain Products Containing Tirzepatide and Products Purporting to Contain Tirzepatide — final determination", "source_type": "official_agency", "document_type": "final_determination", "supports": "Commission issued general and limited exclusion orders and cease-and-desist orders; investigation terminated. Remedies concern specified trademark infringement, false designation of origin and falsely advertised products, not every tirzepatide product." }, { "url": "https://www.usitc.gov/press_room/news_release/2023/er1121_64592.htm", "title": "USITC institution announcement", "source_type": "official_agency", "document_type": "institution_notice", "supports": "Complaint October 19, 2023; announcement of institution November 21, 2023; original respondents." } ], "business_profile": { "id": "itc-tirzepatide-1377", "display_name": "ITC 337-TA-1377 / multiple independent respondents", "identities": [ { "name": "Arctic Peptides LLC", "kind": "legal_entity", "basis": "Named respondent in the Commission’s final notice, p. 2; an independent entity, not an alias of the other respondents.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Audrey Beauty Co.", "kind": "legal_entity", "basis": "Named respondent in the Commission’s final notice, p. 2; an independent entity, not an alias of the other respondents.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Biolabshop Limited", "kind": "legal_entity", "basis": "Named respondent in the Commission’s final notice, p. 2; an independent entity, not an alias of the other respondents.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Mew Mews Company Limited", "kind": "legal_entity", "basis": "Named respondent in the Commission’s final notice, p. 2; an independent entity, not an alias of the other respondents.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Strate Labs LLC", "kind": "legal_entity", "basis": "Named respondent in the Commission’s final notice, p. 2; an independent entity, not an alias of the other respondents.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Triggered Supplements LLC", "kind": "legal_entity", "basis": "Named respondent in the Commission’s final notice, p. 2; an independent entity, not an alias of the other respondents.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Xiamen Austronext Trading Co., Ltd.", "kind": "legal_entity", "basis": "Named respondent in the Commission’s final notice, p. 2; an independent entity, not an alias of the other respondents.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Singularity Marketing Limited", "kind": "legal_entity", "basis": "Named respondent in the Commission’s final notice, p. 2; an independent entity, not an alias of the other respondents.", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Arctic Peptides", "kind": "trading_name", "basis": "Short form of Arctic Peptides LLC (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Strate Labs", "kind": "trading_name", "basis": "Short form of Strate Labs LLC (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "The Triggered Brand", "kind": "trading_name", "basis": "Express d/b/a of Triggered Supplements LLC (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "AustroPeptide", "kind": "trading_name", "basis": "Express d/b/a of Xiamen Austronext Trading Co., Ltd. (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Swiss Chems", "kind": "trading_name", "basis": "Express d/b/a of Singularity Marketing Limited (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Super Human Store", "kind": "trading_name", "basis": "Named respondent; legal entity form not supplied (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Steroide Kaufen", "kind": "trading_name", "basis": "Named respondent; legal entity form not supplied (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Supopeptide", "kind": "trading_name", "basis": "Named respondent; legal entity form not supplied (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Unewlife", "kind": "trading_name", "basis": "Named respondent; legal entity form not supplied (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Total Compounding Pharmaceuticals", "kind": "trading_name", "basis": "Named respondent; legal entity form not supplied (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "GenX Peptides", "kind": "trading_name", "basis": "Named in the summary-determination/withdrawal discussion; no corporate mapping inferred (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] }, { "name": "Paradigm Peptides", "kind": "trading_name", "basis": "Named in the summary-determination/withdrawal discussion (final notice p. 2).", "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ] } ], "activity": { "summary": "This record groups independent businesses and claim-specific trade proceedings. The reviewed Commission notices identify respondents and procedural events but do not establish a common or complete operating period for their shops.", "kind": "mixed_entities", "start": null, "end": null, "sources": [ "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf" ], "limits": [ "Complaint, institution, default and remedy dates are procedural events, not shop launch/closure dates.", "Names in this record must not be collapsed into aliases of one seller.", "Respondents had different dispositions; being named is not proof of an adverse merits finding on every allegation.", "Historical domains and individual operators are not established for all respondents by the reviewed notices." ] }, "source_review": [ { "url": "https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1377_notice04092025sgl.pdf", "locator": "April 9, 2025 final notice, p. 2: respondent names and express d/b/a mappings; pp. 2–3: partial findings and withdrawn allegations" } ] } }, { "id": "ct-triggered-brand-2025", "case_name": "Connecticut v. Triggered Brand (enforcement announcement)", "category": "state_enforcement", "court_or_agency": "Connecticut Attorney General", "docket_number": null, "jurisdiction": "United States — Connecticut", "record_scope": "matter_record", "brands": [ "Triggered Brand" ], "parties": [ "Triggered Brand" ], "filed_date": null, "status_date": "2025-08-05", "analysis": { "id": "ct-triggered-brand-2025", "summary": { "text": "Connecticut sued Triggered Brand over direct-to-consumer research-grade semaglutide and tirzepatide sales, then announced a settlement. The state alleged weight-loss marketing without the required prescribing and pharmacy safeguards. The settlement imposed a sales stop and a $300,000 judgment, suspended after an $18,500 payment, with the larger obligation relevant to a breach. The announcement does not independently establish payment completion.", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state" ] }, "products": [ { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "The attorney general’s lawsuit announcement alleges direct-to-consumer offers of research-grade weight-loss drugs.", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "The attorney general’s lawsuit announcement alleges direct-to-consumer offers of research-grade weight-loss drugs.", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand" ], "normalized_names": [ "tirzepatide" ] }, { "name": "GLP-1 drugs", "role": "settlement_scope", "basis": "The settlement announcement describes the required cessation of GLP-1 drug sales.", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state" ], "normalized_names": [ "GLP-1 drugs" ] } ], "discovery": { "known": false, "text": "Website and social-media marketing were evidence in the allegations. The source does not establish the original complaint or tip that triggered the inquiry.", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state" ] }, "challenged_conduct": [ { "text": "The state alleged unlawful and misleading marketing of research-grade drugs for human weight loss, including unlicensed pharmacy activity and sales without appropriate prescription oversight.", "attribution": "allegation", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state" ] } ], "outcome": { "class": "settlement", "text": "The company and CEO Sam Stolt agreed to the announced restrictions and financial terms. The release does not say $300,000 was paid or establish a criminal conviction.", "as_of": "2025-08-05", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state" ] }, "timeline": [ { "date": "2025-05-21", "event": "The attorney general announced the lawsuit.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand" ] }, { "date": "2025-08-05", "event": "The attorney general announced the settlement.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state" ] } ], "timing_pairs": [], "next_watch": { "text": "Watch for compliance or breach proceedings, rather than treating the settlement as a laboratory finding or a criminal verdict.", "basis": "inference", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state" ] }, "unknowns": [ "The underlying docket/consent judgment and initial discovery trigger were not reviewed. Separate investigations mentioned in the lawsuit release are not part of this defendant’s settlement." ], "source_review": [ { "url": "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" }, { "url": "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" } ] }, "compounds": [ "GLP-1 drugs", "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide", "tirzepatide" ], "latest_documented_date": "2025-08-05", "sources": [ { "url": "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "title": "Attorney General Tong Sues GLP-1 Weight Loss Drug Distributor Triggered Brand", "source_type": "official_agency", "document_type": "press_release", "supports": "Existence and allegations of state lawsuit, requested penalties." }, { "url": "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state", "title": "Bootleg GLP-1 Weight Loss Drug Distributor to Cease Unlawful Sales in Settlement with State", "source_type": "official_agency", "document_type": "settlement_press_release", "supports": "Announced settlement and monetary terms." } ], "business_profile": { "id": "ct-triggered-brand-2025", "display_name": "Triggered Brand", "identities": [ { "name": "Triggered Brand", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state" ] }, { "name": "Sam Stolt", "kind": "operator", "basis": "Connecticut identifies Stolt as the company CEO in its settlement announcement.", "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state" ] } ], "activity": { "summary": "The May 21, 2025 lawsuit announcement describes direct-to-consumer research-grade GLP-1 sales. On August 5, 2025, the state announced an agreement to stop those sales. Neither release provides a first-sale date, a full trading period, or proof of the exact last transaction.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state" ], "limits": [ "No start/end dates inferred from the lawsuit or settlement announcement.", "A sales restriction is not proof the whole company ceased operating.", "The $300,000 judgment was suspended after an $18,500 payment under the announced terms; payment completion and the underlying signed judgment were not verified." ] }, "source_review": [ { "url": "https://portal.ct.gov/ag/press-releases/2025-press-releases/attorney-general-tong-sues-glp-1-weight-loss-drug-distributor-triggered-brand", "locator": "May 21 release: company identity and complaint allegations; August 5 release: first two settlement paragraphs and CEO identification" }, { "url": "https://portal.ct.gov/ag/press-releases/2025-press-releases/bootleg-weight-loss-drug-distributor-to-cease-unlawful-sales-in-settlement-with-state", "locator": "May 21 release: company identity and complaint allegations; August 5 release: first two settlement paragraphs and CEO identification" } ] } }, { "id": "day-openloop-2025", "case_name": "Darby Day v. OpenLoop Health Inc. et al.", "category": "civil", "court_or_agency": "U.S. District Court, D. Delaware", "docket_number": "1:25-cv-01418", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "OpenLoop", "Triad Rx" ], "parties": [ "Darby Day", "OpenLoop Health Inc.", "Triad Rx Buyer LLC", "Triad Rx Inc." ], "filed_date": "2025-11-20", "status_date": "2025-11-20", "analysis": { "id": "day-openloop-2025", "summary": { "text": "Darby Day’s proposed class action is a consumer suit, unlike the manufacturer-led cases surrounding it. Day alleges he bought oral tirzepatide through MEDVi for $279.99, received Triad Rx packaging, experienced none of the effects he expected after prior injectable GLP-1 use, and cancelled. The complaint links OpenLoop and Triad entities through billing, packaging and service relationships and alleges a broader deceptive-sales scheme. These details document a consumer’s asserted experience, not proof that every oral formulation was ineffective. The requested nationwide and state classes were proposed; no class-certification order is established.", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] }, "products": [ { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "Complaint paragraphs 82–92 describe oral tablets allegedly containing tirzepatide with L-carnitine and vitamin B12; no independent composition test is attached in the reviewed account.", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The plaintiff’s purchase, packaging and lack of expected effect are described. How counsel first identified or began investigating the wider alleged scheme is not established.", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] }, "challenged_conduct": [ { "text": "The consumer alleges false efficacy claims, inadequate clinical interaction and a coordinated sales operation, asserting civil RICO and consumer-law theories.", "attribution": "allegation", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] } ], "outcome": { "class": "pending_or_unknown", "text": "The November 20, 2025 complaint is the latest verified event here. No certified class, liability finding, settlement or consumer recovery is established.", "as_of": "2025-11-20", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] }, "timeline": [ { "date": "2025-11-20", "event": "Consumer alleges oral tirzepatide products were ineffective and deceptively marketed; pleads RICO/state-law theories and seeks class certification. No certified class or merits outcome verified.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] } ], "timing_pairs": [], "next_watch": { "text": "Watch for dismissal and class-certification decisions and evidence connecting each defendant to the representations and purchased product.", "basis": "inference", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] }, "unknowns": [ "Purchase date is stated as on or about October 18, so it is not used as an exact elapsed-time anchor." ], "source_review": [ { "url": "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf", "review_basis": "archived_full_text", "locator": "Complaint paragraphs 82–98, pp. 39–44, and proposed class definitions" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2025-11-20", "sources": [ { "url": "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf", "title": "Darby Day v. OpenLoop Health Inc. et al. — putative class complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Consumer alleges oral tirzepatide products were ineffective and deceptively marketed; pleads RICO/state-law theories and seeks class certification. No certified class or merits outcome verified." } ], "business_profile": { "id": "day-openloop-2025", "display_name": "OpenLoop / Triad Rx", "identities": [ { "name": "OpenLoop Health Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] }, { "name": "Triad Rx Buyer LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] }, { "name": "Triad Rx Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] }, { "name": "OpenLoop", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] }, { "name": "Triad Rx", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] }, { "name": "Jon Lensing", "kind": "operator", "basis": "Complaint paragraph 10 identifies OpenLoop co-founder and CEO. This does not mean he personally supplied the plaintiff's product.", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] }, { "name": "openloophealth.com", "kind": "historical_domain", "basis": "Complaint identifies OpenLoop's business website; separate marketing storefronts are not collapsed into this entity.", "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ] } ], "activity": { "summary": "The consumer alleges a purchase from the separate Medvi storefront on or about October 18, 2025, fulfilled through the alleged OpenLoop/Triad arrangement. Triad Rx Buyer's December 13, 2024 incorporation is a separate entity-history allegation.", "kind": "mixed_entities", "start": null, "end": null, "sources": [ "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf" ], "limits": [ "A single alleged transaction is not the operating period of OpenLoop, Triad or Medvi.", "The approximate purchase date is not represented as an exact-day start.", "Medvi is a separate named storefront in the allegations, not established as an alias of OpenLoop or Triad." ] }, "source_review": [ { "url": "https://chimicles.com/wp-content/uploads/2026/01/OT-Complaint-1.pdf", "locator": "Complaint paragraphs 82–98, pp. 39–44, and proposed class definitions" } ] } }, { "id": "lilly-adonis-2025", "case_name": "Eli Lilly and Company v. Adonis Health Inc.", "category": "civil", "court_or_agency": "U.S. District Court, N.D. California", "docket_number": "4:25-cv-03536", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Henry Meds" ], "parties": [ "Eli Lilly and Company", "Adonis Health Inc." ], "filed_date": "2025-04-23", "status_date": "2025-09-24", "analysis": { "id": "lilly-adonis-2025", "summary": { "text": "Lilly’s Henry Meds case, filed against Adonis Health, concerns both compounded injectable tirzepatide and an oral tirzepatide offering. The September 2025 decision makes a useful claim-level distinction: challenges to safety-and-efficacy statements were dismissed, while claims about personalized treatment survived. The court treated Lilly and Henry as competing for the same tirzepatide customers at the pleading stage and found the alleged diversion sufficient to proceed on the surviving theory. That is not a trial finding that every treatment was standardized or that the oral product had a demonstrated therapeutic effect.", "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/", "https://dockets.justia.com/docket/california/candce/4%3A2025cv03536/448397" ] }, "products": [ { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "The opinion identifies compounded injectable and oral tirzepatide and describes Henry’s advertising.", "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "Website screenshots and cited marketing are documented evidence sources. The court’s discussion does not establish the initial lead, investigation date or product testing.", "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/", "https://dockets.justia.com/docket/california/candce/4%3A2025cv03536/448397" ] }, "challenged_conduct": [ { "text": "Lilly alleged misleading safety/effectiveness and patient-specific treatment claims; the court distinguished those theories rather than accepting or rejecting the complaint wholesale.", "attribution": "allegation", "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/", "https://dockets.justia.com/docket/california/candce/4%3A2025cv03536/448397" ] } ], "outcome": { "class": "procedural_order", "text": "September 24, 2025 partial dismissal removed safety-and-efficacy advertising theories and allowed personalization theories to proceed, with an amendment deadline. No final liability or damages determination was verified.", "as_of": "2025-09-24", "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/", "https://dockets.justia.com/docket/california/candce/4%3A2025cv03536/448397" ] }, "timeline": [ { "date": "2025-04-23", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/", "https://dockets.justia.com/docket/california/candce/4%3A2025cv03536/448397" ] }, { "date": "2025-09-24", "event": "Court granted in part and denied in part the motion to dismiss and set an October 15 amendment deadline. No final disposition verified.", "kind": "order", "date_basis": "event", "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/" ] } ], "timing_pairs": [ { "label": "Complaint filing to partial dismissal", "start": "2025-04-23", "end": "2025-09-24", "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/" ], "days": 154 } ], "next_watch": { "text": "Retrieve the amended complaint and later ruling on whether the promised personalization matched actual care.", "basis": "inference", "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/", "https://dockets.justia.com/docket/california/candce/4%3A2025cv03536/448397" ] }, "unknowns": [ "Later disposition and independent evidence of product contents or effectiveness are missing." ], "source_review": [ { "url": "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/", "review_basis": "court_pdf", "locator": "Document 62, downloaded to civil-source-review/adonis.pdf; background and conclusion" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2025-09-24", "sources": [ { "url": "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/", "title": "Eli Lilly and Company v. Adonis Health Inc. — partial dismissal", "source_type": "court_document", "document_type": "order", "supports": "Court granted in part and denied in part the motion to dismiss and set an October 15 amendment deadline. No final disposition verified." }, { "url": "https://dockets.justia.com/docket/california/candce/4%3A2025cv03536/448397", "title": "Adonis docket mirror", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Caption, docket and filing date." } ], "business_profile": { "id": "lilly-adonis-2025", "display_name": "Henry Meds", "identities": [ { "name": "Adonis Health Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/" ] }, { "name": "Henry Meds", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://law.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv03536/448397/62/", "locator": "Document 62, downloaded to civil-source-review/adonis.pdf; background and conclusion" } ] } }, { "id": "lilly-aesthetic-2026", "case_name": "Eli Lilly and Company v. Aesthetic Envy Cosmetic Centers LLC", "category": "civil", "court_or_agency": "U.S. District Court, E.D. California", "docket_number": "2:26-cv-02764-TLN-SCR", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Aesthetic Envy" ], "parties": [ "Eli Lilly and Company", "Aesthetic Envy Cosmetic Centers LLC" ], "filed_date": "2026-08-12", "status_date": "2026-09-11", "analysis": { "id": "lilly-aesthetic-2026", "summary": { "text": "Aesthetic Envy is a med-spa retatrutide case with a particularly short documented court timeline. Lilly’s complaint alleged the business promoted purported retatrutide as a wellness treatment and used clinical-trial comparisons to suggest it outperformed semaglutide and tirzepatide. Those comparison drugs are background to the challenged advertisement, not proof that Aesthetic sold them in this matter. Thirty days after filing, Lilly voluntarily dismissed the whole action with prejudice. The notice says nothing about a settlement, changed business practices or why Lilly chose dismissal, so none of those explanations can be asserted.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf", "https://docketnexus.com/document/489631293/" ] }, "products": [ { "name": "retatrutide", "role": "alleged_marketing_or_supply", "basis": "Complaint describes a retatrutide wellness offering and challenged efficacy comparisons; actual contents are not verified.", "sources": [ "https://docketnexus.com/document/489631293/" ], "normalized_names": [ "retatrutide" ] }, { "name": "semaglutide", "role": "background", "basis": "Used as a comparator in the challenged retatrutide advertisement, not established here as a defendant product.", "sources": [ "https://docketnexus.com/document/489631293/" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "background", "basis": "Lilly’s products and comparative trial claims provide background; no defendant tirzepatide sale is inferred.", "sources": [ "https://docketnexus.com/document/489631293/" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The complaint cites the clinic’s retatrutide webpage. It does not disclose the first lead or establish a test purchase or inspection.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf", "https://docketnexus.com/document/489631293/" ] }, "challenged_conduct": [ { "text": "Lilly alleged misleading trial-based superiority and regulatory-status representations for purported retatrutide.", "attribution": "allegation", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf", "https://docketnexus.com/document/489631293/" ] } ], "outcome": { "class": "dismissal", "text": "The September 11, 2026 notice voluntarily dismissed all claims with prejudice before an answer or summary-judgment motion. It is a dismissal notice, not a merits finding or an explained settlement.", "as_of": "2026-09-11", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf", "https://docketnexus.com/document/489631293/" ] }, "timeline": [ { "date": "2026-08-12", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf", "https://docketnexus.com/document/489631293/" ] }, { "date": "2026-09-11", "event": "Lilly voluntarily dismissed the entire action with prejudice before an answer or summary-judgment motion. No reason or settlement is stated.", "kind": "dismissal", "date_basis": "event", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf" ] } ], "timing_pairs": [ { "label": "Complaint filing to voluntary dismissal with prejudice", "start": "2026-08-12", "end": "2026-09-11", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf", "https://docketnexus.com/document/489631293/" ], "days": 30 } ], "next_watch": { "text": "Any public settlement or compliance document would add context, but no further obligation is inferred from the notice alone.", "basis": "inference", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf", "https://docketnexus.com/document/489631293/" ] }, "unknowns": [ "Reason for dismissal, any confidential agreement and post-dismissal sales conduct remain unknown. Actual venue was E.D. California." ], "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf", "review_basis": "archived_full_text", "locator": "September 11, 2026 voluntary-dismissal notice" }, { "url": "https://docketnexus.com/document/489631293/", "review_basis": "official_web_full_text", "locator": "Original complaint text reproduced by DocketNexus, introduction and seller-specific claims" } ] }, "compounds": [ "retatrutide", "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "retatrutide" ], "tested_compounds": [], "direct_compounds": [ "retatrutide" ], "latest_documented_date": "2026-09-11", "sources": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf", "title": "Eli Lilly and Company v. Aesthetic Envy Cosmetic Centers LLC — voluntary dismissal", "source_type": "court_document", "document_type": "dismissal_notice", "supports": "Lilly voluntarily dismissed the entire action with prejudice before an answer or summary-judgment motion. No reason or settlement is stated." }, { "url": "https://docketnexus.com/document/489631293/", "title": "Eli Lilly and Company v. Aesthetic Envy Cosmetic Centers LLC — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Original filing and allegation context; allegations are not findings." }, { "url": "https://investor.lilly.com/node/54816/pdf", "title": "Lilly announces six retatrutide suits", "source_type": "party_statement", "document_type": "press_release", "supports": "Plaintiff announcement links defendants, brands and alleged retatrutide sales. Actual court controls where announcement court designation differs." } ], "business_profile": { "id": "lilly-aesthetic-2026", "display_name": "Aesthetic Envy", "identities": [ { "name": "Aesthetic Envy Cosmetic Centers LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf" ] }, { "name": "Aesthetic Envy", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf" ] }, { "name": "Darsh Gosal, DO", "kind": "operator", "basis": "Complaint paragraph 13 identifies the medical director. This role is not proof of equity ownership or personal responsibility for each allegation.", "sources": [ "https://docketnexus.com/document/489631293/" ] }, { "name": "aestheticenvy.com", "kind": "historical_domain", "basis": "Complaint paragraph 13 and footnote 4 identify the medical-spa website and retatrutide service page.", "sources": [ "https://docketnexus.com/document/489631293/" ] } ], "activity": { "summary": "Complaint cites the spa website as observed August 6, 2026, identifies Sacramento-area locations and alleges Triple G retatrutide offerings. The September 11 dismissal supplies no business closure date.", "kind": "dated_observation", "start": "2026-08-06", "end": "2026-08-06", "sources": [ "https://docketnexus.com/document/489631293/", "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf" ], "limits": [ "One dated website observation does not establish a full operating period.", "Medical-director identification is not an ownership finding; a registered agent is not presumed to be an operator.", "A dismissal date is not a sales-stop or business-closure date." ] }, "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.caed.497764/gov.uscourts.caed.497764.6.0.pdf", "locator": "September 11, 2026 voluntary-dismissal notice" }, { "url": "https://docketnexus.com/document/489631293/", "locator": "Original complaint text reproduced by DocketNexus, introduction and seller-specific claims" }, { "url": "https://docketnexus.com/document/489631293/", "locator": "Complaint text mirror, paragraph 13 and footnote 4; original PDF was unavailable locally. Identity/activity information remains pleading-attributed." } ] } }, { "id": "lilly-aios-2025", "case_name": "Eli Lilly and Company v. Aios Inc. et al.", "category": "civil", "court_or_agency": "U.S. District Court, N.D. California", "docket_number": "4:25-cv-03535", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Fella Health" ], "parties": [ "Eli Lilly and Company", "Aios Inc." ], "filed_date": "2025-04-23", "status_date": "2026-03-26", "analysis": { "id": "lilly-aios-2025", "summary": { "text": "Lilly’s separate Aios/Fella case addresses compounded tirzepatide and how allegedly standardized treatment was represented as personalized. The March 2026 opinion divides the theories carefully. Lilly had not adequately connected alleged corporate practice of medicine to its own injury, but its unfair-competition theory and false-personalization advertising claims could proceed, along with civil conspiracy. The survival of these claims means they were plausibly pleaded, not that a court found every patient received identical treatment. This is distinct from Novo’s later suit against related Fella entities and should retain its own docket and claim history.", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ] }, "products": [ { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "The opinion describes compounded tirzepatide, including challenged formulations and treatment-plan claims; no independent assay is reported.", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "Marketing and alleged company-level prescription changes support the pleading. The initial lead and any investigative start date are not established.", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ] }, "challenged_conduct": [ { "text": "Lilly alleged false personalization, misleading promotion and corporate interference in care. Only specified theories survived the pleading challenge.", "attribution": "allegation", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ] } ], "outcome": { "class": "procedural_order", "text": "March 26, 2026 partial dismissal rejected the corporate-practice standing theory, allowed unfair competition, limited surviving false advertising to personalization, and allowed conspiracy, with leave to amend.", "as_of": "2026-03-26", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ] }, "timeline": [ { "date": "2025-04-23", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ] }, { "date": "2026-03-26", "event": "Mixed pleading ruling: corporate-practice UCL theory lacked adequately pleaded standing; false-advertising/personalization and related conspiracy theories survived. Leave to amend granted.", "kind": "order", "date_basis": "event", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ] } ], "timing_pairs": [ { "label": "Complaint filing to partial dismissal", "start": "2025-04-23", "end": "2026-03-26", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ], "days": 337 } ], "next_watch": { "text": "Read the amended pleading and later evidentiary rulings on whether actual prescribing matched the personalization claims.", "basis": "inference", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ] }, "unknowns": [ "Final liability, damages and the post-amendment claim set are unverified." ], "source_review": [ { "url": "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf", "review_basis": "archived_full_text", "locator": "Document 88, pp. 11–12 and 18–19, claims and conclusion" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2026-03-26", "sources": [ { "url": "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf", "title": "Eli Lilly and Company v. Aios Inc. et al. — partial dismissal", "source_type": "court_document", "document_type": "order", "supports": "Mixed pleading ruling: corporate-practice UCL theory lacked adequately pleaded standing; false-advertising/personalization and related conspiracy theories survived. Leave to amend granted." } ], "business_profile": { "id": "lilly-aios-2025", "display_name": "Fella Health", "identities": [ { "name": "Aios Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ] }, { "name": "Fella Health", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_25-cv-03535/pdf/USCOURTS-cand-4_25-cv-03535-9.pdf", "locator": "Document 88, pp. 11–12 and 18–19, claims and conclusion" } ] } }, { "id": "lilly-american-2026", "case_name": "Eli Lilly and Company v. American Peptides LLC", "category": "civil", "court_or_agency": "U.S. District Court, W.D. Louisiana", "docket_number": "5:26-cv-04146", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "American Peptides" ], "parties": [ "Eli Lilly and Company", "American Peptides LLC" ], "filed_date": "2026-10-08", "status_date": "2026-10-08", "analysis": { "id": "lilly-american-2026", "summary": { "text": "The American Peptides proceeding is verified at docket level, but its October 2026 complaint was not obtained for this analysis. Contemporaneous Bloomberg reporting expressly includes American Peptides among vendors sued over purported retatrutide. That supports a carefully attributed connection to the retatrutide litigation wave, not a reconstruction of its advertisements, products or evidence. The collection cannot establish whether Lilly relied on a website, customer complaint, sample purchase or laboratory test in this particular case. It also cannot transfer detailed allegations from the simultaneously filed LiveWell complaint to this defendant.", "sources": [ "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "products": [ { "name": "retatrutide", "role": "unclear", "basis": "Contemporaneous reporting identifies this suit as concerning purported retatrutide; the original complaint is missing, so offering details and primary attribution remain unverified.", "sources": [ "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ], "normalized_names": [ "retatrutide" ] } ], "discovery": { "known": false, "text": "Not established. No original complaint or investigation account is available to identify an initial lead or supporting evidence-gathering method.", "sources": [ "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "challenged_conduct": [ { "text": "Secondary reporting describes allegations of unlawful sale and promotion of purported retatrutide. Exact counts, representations and defendant-specific evidence remain unknown.", "attribution": "allegation", "sources": [ "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] } ], "outcome": { "class": "pending_or_unknown", "text": "The docket records an October 8, 2026 filing in W.D. Louisiana. No later result or finding is established by the October 10 collection cutoff.", "as_of": "2026-10-08", "sources": [ "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "timeline": [ { "date": "2026-10-08", "event": "Docket records complaint filing; contemporaneous reporting links it to alleged retatrutide sales. Complaint text not obtained.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain docket document 1 and any exhibits before making product-specific or discovery-method claims.", "basis": "inference", "sources": [ "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "unknowns": [ "Original complaint, exact product aliases, quantities, testing and response are missing. This is a private Lilly suit, not an agency enforcement finding." ], "source_review": [ { "url": "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926", "review_basis": "registry_support_only", "locator": "Docket filing metadata" }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs", "review_basis": "archived_full_text", "locator": "Accessible Bloomberg report excerpt naming defendants and retatrutide" } ] }, "compounds": [ "retatrutide" ], "marketing_or_supply_compounds": [], "tested_compounds": [], "direct_compounds": [], "latest_documented_date": "2026-10-08", "sources": [ { "url": "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926", "title": "Eli Lilly and Company v. American Peptides LLC — complaint", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Docket records complaint filing; contemporaneous reporting links it to alleged retatrutide sales. Complaint text not obtained." }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs", "title": "Bloomberg Law report on five October 8 suits", "source_type": "secondary", "document_type": "news_report", "supports": "Contemporaneous reported retatrutide scope and brand mapping; no adjudication." } ], "business_profile": { "id": "lilly-american-2026", "display_name": "American Peptides", "identities": [ { "name": "American Peptides LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926" ] }, { "name": "American Peptides", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://dockets.justia.com/docket/louisiana/lawdce/5%3A2026cv04146/223926", "locator": "Docket filing metadata" }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs", "locator": "Accessible Bloomberg report excerpt naming defendants and retatrutide" } ] } }, { "id": "lilly-astra-2026", "case_name": "Eli Lilly and Company v. Astra LLC", "category": "civil", "court_or_agency": "U.S. District Court, W.D. Texas", "docket_number": "5:26-cv-05147", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Astra Peptides" ], "parties": [ "Eli Lilly and Company", "Astra LLC" ], "filed_date": "2026-08-12", "status_date": "2026-08-12", "analysis": { "id": "lilly-astra-2026", "summary": { "text": "Lilly’s original Astra complaint expressly targets purported retatrutide, rather than merely mentioning it as background. It cites a product page discussing appetite and metabolic effects and a Trustpilot review describing personal weight loss, arguing that research-only labeling did not match the intended consumer use. Those exhibits show how Lilly assembled its allegations; they do not prove the vial contents or establish when Lilly first became aware of the seller. Later reports about a wrongly identified Astra entity or dismissal remain unresolved in the collected primary record, making defendant identity and procedural status unusually important gaps.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf" ] }, "products": [ { "name": "retatrutide", "role": "alleged_marketing_or_supply", "basis": "Complaint paragraphs 44–46 cite the retatrutide product page and a consumer review; composition was not independently established.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf" ], "normalized_names": [ "retatrutide" ] } ], "discovery": { "known": false, "text": "Website and review-platform research are documented methods of gathering supporting evidence. The initial lead and start date are not disclosed.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf" ] }, "challenged_conduct": [ { "text": "Lilly alleges research-only disclaimers masked consumer retatrutide sales and that metabolic-benefit marketing diverted patients from approved medicines.", "attribution": "allegation", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf" ] } ], "outcome": { "class": "pending_or_unknown", "text": "The August 12, 2026 original complaint is verified. Conflicting later identity and disposition reports are unresolved; neither pending nor closed is asserted as current status.", "as_of": "2026-08-12", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf" ] }, "timeline": [ { "date": "2026-08-12", "event": "Original complaint alleges deceptive marketing or sale of purported retatrutide. Later party-identification and dismissal reports remain unresolved; do not label case pending or closed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf" ] } ], "timing_pairs": [], "next_watch": { "text": "Prioritize the amended complaint, party-correction papers and any dismissal before drawing conclusions about who was sued or how the case ended.", "basis": "inference", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf" ] }, "unknowns": [ "Legal-entity attribution and later disposition unresolved. General online adverse-event examples are not Astra-specific adjudicated injuries." ], "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf", "review_basis": "archived_full_text", "locator": "Complaint pp. 13–14 and 19–21, especially paragraphs 44–46" } ] }, "compounds": [ "retatrutide" ], "marketing_or_supply_compounds": [ "retatrutide" ], "tested_compounds": [], "direct_compounds": [ "retatrutide" ], "latest_documented_date": "2026-08-12", "sources": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf", "title": "Eli Lilly and Company v. Astra LLC — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Original complaint alleges deceptive marketing or sale of purported retatrutide. Later party-identification and dismissal reports remain unresolved; do not label case pending or closed." }, { "url": "https://investor.lilly.com/node/54816/pdf", "title": "Lilly announces six retatrutide suits", "source_type": "party_statement", "document_type": "press_release", "supports": "Plaintiff announcement links defendants, brands and alleged retatrutide sales. Actual court controls where announcement court designation differs." } ], "business_profile": { "id": "lilly-astra-2026", "display_name": "Astra Peptides", "identities": [ { "name": "Astra LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status. Original complaint attribution; later identity dispute is unresolved in this collection.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf" ] }, { "name": "Astra Peptides", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification. Original complaint attribution; later identity dispute is unresolved in this collection.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf" ] }, { "name": "astrapeptides.com", "kind": "historical_domain", "basis": "Named in the reviewed complaint as a business website; current control and availability not checked. Original complaint attribution; later identity dispute is unresolved in this collection.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf" ] } ], "activity": { "summary": "Original complaint cites Astra Peptides website observations dated August 6, 2026. The identity mapping and any later dismissal remain unresolved.", "kind": "dated_observation", "start": "2026-08-06", "end": "2026-08-06", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations.", "The original complaint links Astra LLC to Astra Peptides, but later party-identification/dismissal reports remain unresolved. Treat that legal-entity-to-brand attribution as a disputed lead, not verified ownership.", "Observation endpoints do not establish uninterrupted trading or business start/end." ] }, "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926918/gov.uscourts.txwd.1172926918.1.0.pdf", "locator": "Complaint pp. 13–14 and 19–21, especially paragraphs 44–46" } ] } }, { "id": "lilly-cenexa-2026", "case_name": "Eli Lilly and Company v. Cenexa Labs LLC", "category": "civil", "court_or_agency": "U.S. District Court, S.D. Texas", "docket_number": "4:26-cv-08806", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Cenexa Labs" ], "parties": [ "Eli Lilly and Company", "Cenexa Labs LLC" ], "filed_date": "2026-10-08", "status_date": "2026-10-08", "analysis": { "id": "lilly-cenexa-2026", "summary": { "text": "Cenexa Labs is another October 2026 Lilly defendant whose full pleading remains missing from the archive. The docket-index source identifies a Southern District of Texas proceeding, while contemporaneous reporting links Cenexa to allegations involving purported retatrutide. That evidence is enough to retain the proceeding in the historical collection with a visible limitation, but not to claim a particular vial was tested or a named advertisement was unlawful. No allegations from Striker, Lone Star or LiveWell should be silently borrowed to fill this record. The source gap is material to any compound-by-outcome comparison.", "sources": [ "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "products": [ { "name": "retatrutide", "role": "unclear", "basis": "Named as a retatrutide-related defendant in contemporaneous reporting; no reviewed original pleading establishes the precise offering or alias.", "sources": [ "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ], "normalized_names": [ "retatrutide" ] } ], "discovery": { "known": false, "text": "Not established. The collected metadata does not identify a tip, website review, purchase, test, inspection or discovery date.", "sources": [ "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "challenged_conduct": [ { "text": "Secondary reporting attributes purported-retatrutide sale and promotion allegations to Lilly; specific state claims and evidence are unverified.", "attribution": "allegation", "sources": [ "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] } ], "outcome": { "class": "pending_or_unknown", "text": "An October 8, 2026 complaint filing is recorded under 4:26-cv-08806. No substantive order, settlement or adjudicated violation is established.", "as_of": "2026-10-08", "sources": [ "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "timeline": [ { "date": "2026-10-08", "event": "Docket records complaint filing; contemporaneous reporting links it to alleged retatrutide sales. Complaint text not obtained.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC" ] } ], "timing_pairs": [], "next_watch": { "text": "Retrieve the original complaint and confirm entity and product attribution before adding detailed conduct analysis.", "basis": "inference", "sources": [ "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "unknowns": [ "Docket index is sparse; complaint, exhibits, response and current posture are missing. No government action is inferred." ], "source_review": [ { "url": "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC", "review_basis": "registry_support_only", "locator": "Sparse docket-index record; archived response is not a complete docket" }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs", "review_basis": "archived_full_text", "locator": "Accessible Bloomberg report excerpt naming Cenexa and retatrutide" } ] }, "compounds": [ "retatrutide" ], "marketing_or_supply_compounds": [], "tested_compounds": [], "direct_compounds": [], "latest_documented_date": "2026-10-08", "sources": [ { "url": "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC", "title": "Eli Lilly and Company v. Cenexa Labs LLC — complaint", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Docket records complaint filing; contemporaneous reporting links it to alleged retatrutide sales. Complaint text not obtained." }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs", "title": "Bloomberg Law report on five October 8 suits", "source_type": "secondary", "document_type": "news_report", "supports": "Contemporaneous reported retatrutide scope and brand mapping; no adjudication." } ], "business_profile": { "id": "lilly-cenexa-2026", "display_name": "Cenexa Labs", "identities": [ { "name": "Cenexa Labs LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC" ] }, { "name": "Cenexa Labs", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://cdn.pacermonitor.com/public/case/67240960/Eli_Lilly_and_Company_v_Cenexa_Labs_LLC", "locator": "Sparse docket-index record; archived response is not a complete docket" }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs", "locator": "Accessible Bloomberg report excerpt naming Cenexa and retatrutide" } ] } }, { "id": "lilly-empower-tx-2025", "case_name": "Eli Lilly and Company v. Empower Clinic Services LLC", "category": "civil", "court_or_agency": "U.S. District Court, S.D. Texas", "docket_number": "4:25-cv-03464", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Empower Pharmacy" ], "parties": [ "Eli Lilly and Company", "Empower Clinic Services LLC" ], "filed_date": "2025-07-25", "status_date": "2026-04-29", "analysis": { "id": "lilly-empower-tx-2025", "summary": { "text": "Lilly’s Texas Empower action concerns oral-disintegrating tirzepatide tablets and injectable tirzepatide/niacinamide, with advertising and unfair-competition theories under several jurisdictions’ laws. The April 2026 decision produced a mixed result: federal Lanham Act and Texas common-law claims were dismissed, while claims under eight other states’ laws survived. The court also treated compliance with compounding exceptions as an issue that could not simply be resolved against the plaintiff on the pleadings. None of this establishes a failed batch or a completed government enforcement action. The related New Jersey case should remain linked rather than counted as unrelated seller conduct.", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf", "https://docketnexus.com/document/447001450/" ] }, "products": [ { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "The opinion describes Empower’s oral-disintegrating tablets and tirzepatide/niacinamide injections as the challenged products.", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The reviewed opinion identifies product marketing and formulations but not the initial lead, a dated test purchase or a laboratory finding.", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf", "https://docketnexus.com/document/447001450/" ] }, "challenged_conduct": [ { "text": "Lilly challenged efficacy, clinical-support and customization representations and asserted state unfair-competition theories concerning the compounded products.", "attribution": "allegation", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf", "https://docketnexus.com/document/447001450/" ] } ], "outcome": { "class": "procedural_order", "text": "April 29, 2026 dismissal removed Lanham Act and Texas common-law claims; Alaska, Colorado, Connecticut, Hawaii, North Carolina, South Carolina, Tennessee and Washington claims survived.", "as_of": "2026-04-29", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf", "https://docketnexus.com/document/447001450/" ] }, "timeline": [ { "date": "2025-07-25", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf", "https://docketnexus.com/document/447001450/" ] }, { "date": "2026-04-29", "event": "Lanham Act and Texas common-law claims dismissed; Alaska, Colorado, Connecticut, Hawaii, North Carolina, South Carolina, Tennessee and Washington claims survived.", "kind": "order", "date_basis": "event", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf" ] } ], "timing_pairs": [ { "label": "Texas complaint filing to partial dismissal", "start": "2025-07-25", "end": "2026-04-29", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf", "https://docketnexus.com/document/447001450/" ], "days": 278 } ], "next_watch": { "text": "Follow evidence-stage rulings on compounding exceptions and the remaining state claims, and reconcile procedural overlap with New Jersey.", "basis": "inference", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf", "https://docketnexus.com/document/447001450/" ] }, "unknowns": [ "No final outcome or finding of actual product composition established." ], "source_review": [ { "url": "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf", "review_basis": "archived_full_text", "locator": "April 29, 2026 memorandum opinion, product background and disposition" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2026-04-29", "sources": [ { "url": "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf", "title": "Eli Lilly and Company v. Empower Clinic Services LLC — partial dismissal", "source_type": "court_document", "document_type": "order", "supports": "Lanham Act and Texas common-law claims dismissed; Alaska, Colorado, Connecticut, Hawaii, North Carolina, South Carolina, Tennessee and Washington claims survived." }, { "url": "https://docketnexus.com/document/447001450/", "title": "Eli Lilly and Company v. Empower Clinic Services LLC — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Original filing and allegation context; allegations are not findings." } ], "business_profile": { "id": "lilly-empower-tx-2025", "display_name": "Empower Pharmacy", "identities": [ { "name": "Empower Clinic Services LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf" ] }, { "name": "Empower Pharmacy", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://www.govinfo.gov/content/pkg/USCOURTS-txsd-4_25-cv-03464/pdf/USCOURTS-txsd-4_25-cv-03464-0.pdf", "locator": "April 29, 2026 memorandum opinion, product background and disposition" } ] } }, { "id": "lilly-empower-nj-2025", "case_name": "Eli Lilly and Company v. Empower Clinic Services LLC et al.", "category": "civil", "court_or_agency": "U.S. District Court, D. New Jersey", "docket_number": "2:25-cv-02183", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Empower Pharmacy", "Empower Pharma" ], "parties": [ "Eli Lilly and Company", "Empower Clinic Services LLC", "Empower Clinic Services New Jersey LLC" ], "filed_date": "2025-04-01", "status_date": "2025-04-01", "analysis": { "id": "lilly-empower-nj-2025", "summary": { "text": "Lilly’s New Jersey complaint attacks two specific Empower offerings: orally disintegrating tirzepatide tablets and injectable tirzepatide combined with niacinamide. Its private advertising case alleges that evidence for Lilly’s approved injectable medicines was used to promote materially different compounded products, and that customization and regulatory-quality language overstated what Empower supplied. The complaint asks for sales restrictions and corrective advertising. Those requested remedies are not orders already entered. A later Texas Empower proceeding is separately docketed but related; the two matters should not be counted as two independent episodes of product harm.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ] }, "products": [ { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "Complaint identifies oral-disintegrating tablets and tirzepatide/niacinamide injections; this establishes allegations about formulation, not independently measured contents.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The complaint relies on product and marketing representations. It does not establish the first lead, a dated initial investigation, or a seller-specific laboratory finding.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ] }, "challenged_conduct": [ { "text": "Lilly alleges misleading efficacy, clinical-support, personalization and regulatory-standard claims for the oral and injectable formulations.", "attribution": "allegation", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ] } ], "outcome": { "class": "pending_or_unknown", "text": "The April 1, 2025 complaint is the latest verified New Jersey event in the collected sources. No New Jersey merits outcome or operative injunction is established.", "as_of": "2025-04-01", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ] }, "timeline": [ { "date": "2025-04-01", "event": "Complaint alleges misleading advertising and sale of compounded tirzepatide. Later disposition not verified.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ] } ], "timing_pairs": [], "next_watch": { "text": "Retrieve the New Jersey docket and compare any transfer, dismissal or amended pleading with the related Texas action.", "basis": "inference", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ] }, "unknowns": [ "Current New Jersey disposition and precise procedural relationship to Texas need verification." ], "source_review": [ { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf", "review_basis": "archived_full_text", "locator": "Complaint, product allegations and prayer for relief, pp. 38–40" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2025-04-01", "sources": [ { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf", "title": "Eli Lilly and Company v. Empower Clinic Services LLC et al. — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Complaint alleges misleading advertising and sale of compounded tirzepatide. Later disposition not verified." } ], "business_profile": { "id": "lilly-empower-nj-2025", "display_name": "Empower Pharmacy / Empower Pharma", "identities": [ { "name": "Empower Clinic Services LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ] }, { "name": "Empower Clinic Services New Jersey LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ] }, { "name": "Empower Pharmacy", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ] }, { "name": "Empower Pharma", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ] }, { "name": "empowerpharmacy.com", "kind": "historical_domain", "basis": "Named in the reviewed complaint as a business website; current control and availability not checked.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/LIlly-Empower.pdf", "locator": "Complaint, product allegations and prayer for relief, pp. 38–40" } ] } }, { "id": "lilly-genesis-2024", "case_name": "Eli Lilly and Company v. Genesis Lifestyle Medicine of Nevada LLC", "category": "civil", "court_or_agency": "U.S. District Court, S.D. Indiana", "docket_number": "1:24-cv-01862", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Genesis Lifestyle Medicine" ], "parties": [ "Eli Lilly and Company", "Genesis Lifestyle Medicine of Nevada LLC" ], "filed_date": "2024-10-21", "status_date": "2026-06-18", "analysis": { "id": "lilly-genesis-2024", "summary": { "text": "Lilly’s Genesis litigation concerns compounded tirzepatide promotion and use of Lilly’s branding across several Genesis-related businesses. By May 2026 the parties represented that they had signed a confidential settlement and asked for a consent judgment and permanent injunction. The June order refused that request because the settlement was not supplied and the proposed judicial relief did not satisfy the applicable requirements. A private settlement and a court-enforceable injunction are different outcomes. The reviewed order documents the former’s reported existence while expressly declining to enter the latter.", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf" ] }, "products": [ { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "The complaint and later proposed-injunction discussion identify compounded tirzepatide; no retatrutide sale is established.", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "Advertising and trademark representations are documented evidence sources. The initial discovery route and any test purchase or laboratory result are not established.", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf" ] }, "challenged_conduct": [ { "text": "Lilly alleged misleading promotion and trademark-related confusion. Defendants denied the allegations, and the order did not resolve their truth.", "attribution": "allegation", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf" ] } ], "outcome": { "class": "mixed", "text": "June 18, 2026 order denied approval of the proposed consent judgment and injunction. Parties could renew with adequate materials or dismiss; no later accepted injunction or dismissal is verified.", "as_of": "2026-06-18", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf" ] }, "timeline": [ { "date": "2024-10-21", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf" ] }, { "date": "2026-05-19", "event": "Parties filed a joint motion stating they had executed a confidential settlement and requesting judicial approval.", "kind": "other", "date_basis": "filing", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf" ] }, { "date": "2026-06-18", "event": "Court denied joint motion to approve consent judgment/permanent injunction because the confidential settlement was not supplied and Rule 65 requirements were not met. Parties could renew or dismiss.", "kind": "order", "date_basis": "event", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf" ] } ], "timing_pairs": [ { "label": "Complaint filing to refusal of proposed consent judgment", "start": "2024-10-21", "end": "2026-06-18", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf" ], "days": 605 } ], "next_watch": { "text": "Find the renewed motion or dismissal to determine how the settlement was ultimately implemented.", "basis": "inference", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf" ] }, "unknowns": [ "Confidential settlement terms and final docket outcome are missing; proposed restrictions must not be presented as an entered injunction." ], "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf", "review_basis": "archived_full_text", "locator": "June 18, 2026 order, background and reasons for denying consent judgment" }, { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf", "review_basis": "archived_full_text", "locator": "Complaint, compounded tirzepatide advertising claims" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2026-06-18", "sources": [ { "url": "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf", "title": "Eli Lilly and Company v. Genesis Lifestyle Medicine of Nevada LLC — consent judgment denied", "source_type": "court_document", "document_type": "order", "supports": "Court denied joint motion to approve consent judgment/permanent injunction because the confidential settlement was not supplied and Rule 65 requirements were not met. Parties could renew or dismiss." }, { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf", "title": "Eli Lilly and Company v. Genesis Lifestyle Medicine of Nevada LLC — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Original filing and allegation context; allegations are not findings." } ], "business_profile": { "id": "lilly-genesis-2024", "display_name": "Genesis Lifestyle Medicine", "identities": [ { "name": "Genesis Lifestyle Medicine of Nevada LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf" ] }, { "name": "Genesis Lifestyle Medicine", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf" ] }, { "name": "genesislifestylemedicine.com", "kind": "historical_domain", "basis": "Named in the reviewed complaint as a business website; current control and availability not checked.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf" ] }, { "name": "Genesis Mothership LLC", "kind": "legal_entity", "basis": "Separately named defendant in the June 18, 2026 order caption; not merged into one legal company.", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf" ] }, { "name": "Genesis Lifestyle Medicine of Indianapolis LLC", "kind": "legal_entity", "basis": "Separately named defendant in the June 18, 2026 order caption; not merged into one legal company.", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf" ] }, { "name": "Summit Lifestyle Medicine LLC", "kind": "legal_entity", "basis": "Separately named defendant in the June 18, 2026 order caption; not merged into one legal company.", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf" ] }, { "name": "Rejuvenate Medspa LLC", "kind": "legal_entity", "basis": "Separately named defendant in the June 18, 2026 order caption; not merged into one legal company.", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf" ] }, { "name": "Genesis Lifestyle Medicine of Greenwood", "kind": "trading_name", "basis": "June 18, 2026 order caption identifies this as Summit Lifestyle Medicine LLC's d/b/a.", "sources": [ "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf" ] } ], "activity": { "summary": "The case involves several separate Genesis-related entities and locations. The collected complaint and consent-motion order do not establish a single group-wide operating period.", "kind": "mixed_entities", "start": null, "end": null, "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf", "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf" ], "limits": [ "Do not treat the filing or settlement-motion date as the start or end of the medical-spa businesses.", "Entity and location histories may differ." ] }, "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/indiana/insdce/1%3A2024cv01862/217718/79/0.pdf", "locator": "June 18, 2026 order, background and reasons for denying consent judgment" }, { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/Genesis.pdf", "locator": "Complaint, compounded tirzepatide advertising claims" } ] } }, { "id": "lilly-legendary-2026", "case_name": "Eli Lilly and Company v. Legendary Peptides LLC", "category": "civil", "court_or_agency": "U.S. District Court, E.D. Texas", "docket_number": "1:26-cv-00347", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Legendary Peptides" ], "parties": [ "Eli Lilly and Company", "Legendary Peptides LLC" ], "filed_date": "2026-08-12", "status_date": "2026-09-10", "analysis": { "id": "lilly-legendary-2026", "summary": { "text": "Lilly’s Legendary Peptides complaint explicitly identifies GLP3 (R) as purported retatrutide and cites a consumer review accompanied by a vial photograph, plus a co-founder’s TikTok promotion of retatrutide kits. It also uses a separate social post about the co-founder’s NAD+ self-use as context for intended human use across the business. That NAD+ anecdote is not a retatrutide adverse event. The September 2026 court order only adjusts briefing time if a dismissal motion is filed; it neither accepts the allegations nor prohibits sales. The seller-specific material is distinct from the complaint’s general Reddit examples of market-wide retatrutide harms.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf", "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ] }, "products": [ { "name": "retatrutide", "role": "alleged_marketing_or_supply", "basis": "Complaint paragraphs 42–49, including OCR of pp. 14–17, explicitly identify GLP3 (R) as purported retatrutide and describe a seller video and customer-vial photograph.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ], "normalized_names": [ "retatrutide" ] }, { "name": "NAD+", "role": "background", "basis": "Paragraph 46 describes a co-founder’s NAD+ self-use social post as supporting human-use context; it is not a retatrutide injury or independent verification of a sold product. NAD+ is not classified here as a peptide.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ], "normalized_names": [ "NAD+" ] } ], "discovery": { "known": false, "text": "The documented supporting sources are website and social-media materials. The initial lead, test-purchase route and beginning of an investigation are not established.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf", "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ] }, "challenged_conduct": [ { "text": "Lilly alleges retatrutide marketing and sales for human use under research-only presentation, causing consumer and competitive harm.", "attribution": "allegation", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf", "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ] } ], "outcome": { "class": "procedural_order", "text": "A September 10, 2026 order extended potential dismissal briefing. No merits ruling, settlement or injunction is established in the reviewed record.", "as_of": "2026-09-10", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf", "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ] }, "timeline": [ { "date": "2026-08-12", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf", "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ] }, { "date": "2026-09-10", "event": "Court extended briefing time in the event of a motion to dismiss; no merits determination.", "kind": "order", "date_basis": "event", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf" ] } ], "timing_pairs": [ { "label": "Complaint filing to briefing-extension order", "start": "2026-08-12", "end": "2026-09-10", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf", "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ], "days": 29 } ], "next_watch": { "text": "Retrieve any motion to dismiss and response, then the ruling that resolves those arguments.", "basis": "inference", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf", "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ] }, "unknowns": [ "Product contents, seller-specific injury and ultimate disposition are unverified. Briefing relief is not a finding against the defendant." ], "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf", "review_basis": "archived_full_text", "locator": "September 10, 2026 briefing order" }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf", "review_basis": "archived_full_text", "locator": "Complaint paragraphs 42–51; image-heavy pp. 13–19 reviewed through OCR saved as civil-source-review/legendary-ocr.txt" } ] }, "compounds": [ "NAD+", "retatrutide" ], "marketing_or_supply_compounds": [ "retatrutide" ], "tested_compounds": [], "direct_compounds": [ "retatrutide" ], "latest_documented_date": "2026-09-10", "sources": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf", "title": "Eli Lilly and Company v. Legendary Peptides LLC — procedural order", "source_type": "court_document", "document_type": "order", "supports": "Court extended briefing time in the event of a motion to dismiss; no merits determination." }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf", "title": "Eli Lilly and Company v. Legendary Peptides LLC — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Original filing and allegation context; allegations are not findings." }, { "url": "https://investor.lilly.com/node/54816/pdf", "title": "Lilly announces six retatrutide suits", "source_type": "party_statement", "document_type": "press_release", "supports": "Plaintiff announcement links defendants, brands and alleged retatrutide sales. Actual court controls where announcement court designation differs." } ], "business_profile": { "id": "lilly-legendary-2026", "display_name": "Legendary Peptides", "identities": [ { "name": "Legendary Peptides LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf" ] }, { "name": "Legendary Peptides", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf" ] }, { "name": "legendarypeptides.com", "kind": "historical_domain", "basis": "Named in the reviewed complaint as a business website; current control and availability not checked.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ] }, { "name": "Brian Milner", "kind": "operator", "basis": "Complaint paragraph 46 and footnote 19 identify a co-founder; the original page is image-based and was reviewed via OCR and embedded screenshot.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ] } ], "activity": { "summary": "Complaint reproduces December 31, 2025 and January 7, 2026 company social posts, a June 13, 2026 retatrutide video and website observations dated August 6. The older posts concern general peptide marketing/NAD+, not proof of retatrutide sales throughout the interval.", "kind": "dated_observation", "start": "2025-12-31", "end": "2026-08-06", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations.", "Observation endpoints do not establish uninterrupted trading or business start/end." ] }, "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.11.0.pdf", "locator": "September 10, 2026 briefing order" }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txed.248221/gov.uscourts.txed.248221.1.0.pdf", "locator": "Complaint paragraphs 42–51; image-heavy pp. 13–19 reviewed through OCR saved as civil-source-review/legendary-ocr.txt" } ] } }, { "id": "lilly-lonestar-2026", "case_name": "Eli Lilly and Company v. Lone Star Peptide Co. LLC", "category": "civil", "court_or_agency": "U.S. District Court, S.D. Texas", "docket_number": "4:26-cv-06562", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Lone Star Peptide" ], "parties": [ "Eli Lilly and Company", "Lone Star Peptide Co. LLC" ], "filed_date": "2026-08-12", "status_date": "2026-08-12", "analysis": { "id": "lilly-lonestar-2026", "summary": { "text": "The Lone Star Peptide complaint documents a direct connection between educational-looking GLP-1 comparisons and a retatrutide purchase link. Lilly cites a page describing weight-loss trial results and alleged superiority over other GLP-1 drugs, alongside consumer-facing marketing and a founder-associated social account. Its theory is that those materials established intended human use despite research-only disclaimers. The complaint is a private competition suit, not an FDA seizure. General reports about black-market retatrutide harms and other sellers appear as background and should not be converted into Lone Star laboratory findings or confirmed customer injuries.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ] }, "products": [ { "name": "retatrutide", "role": "alleged_marketing_or_supply", "basis": "Complaint paragraphs 48–50 connect retatrutide comparison claims with a purchase link and research-only disclaimer.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ], "normalized_names": [ "retatrutide" ] } ], "discovery": { "known": false, "text": "Lilly’s cited website pages and social posts document evidence gathering. The complaint does not identify the first lead, a test purchase or an initial investigation date.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ] }, "challenged_conduct": [ { "text": "Lilly alleges purported retatrutide was promoted for consumer weight management and that trial comparisons misleadingly supported the seller’s own product.", "attribution": "allegation", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ] } ], "outcome": { "class": "pending_or_unknown", "text": "The August 12, 2026 complaint is the latest verified substantive event here. No answer, judgment, settlement, seizure or criminal charge is established.", "as_of": "2026-08-12", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ] }, "timeline": [ { "date": "2026-08-12", "event": "Complaint alleges deceptive research-only marketing and retatrutide sales. Later disposition not verified.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain the response and any ruling on intended use, commercial injury and the relationship between trial claims and the product offered.", "basis": "inference", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ] }, "unknowns": [ "Actual composition, sales volume, supplier identity and later court disposition remain unverified." ], "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf", "review_basis": "archived_full_text", "locator": "Complaint, seller-specific website and social-marketing allegations, pp. 13–16" } ] }, "compounds": [ "retatrutide" ], "marketing_or_supply_compounds": [ "retatrutide" ], "tested_compounds": [], "direct_compounds": [ "retatrutide" ], "latest_documented_date": "2026-08-12", "sources": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf", "title": "Eli Lilly and Company v. Lone Star Peptide Co. LLC — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Complaint alleges deceptive research-only marketing and retatrutide sales. Later disposition not verified." }, { "url": "https://investor.lilly.com/node/54816/pdf", "title": "Lilly announces six retatrutide suits", "source_type": "party_statement", "document_type": "press_release", "supports": "Plaintiff announcement links defendants, brands and alleged retatrutide sales. Actual court controls where announcement court designation differs." } ], "business_profile": { "id": "lilly-lonestar-2026", "display_name": "Lone Star Peptide", "identities": [ { "name": "Lone Star Peptide Co. LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ] }, { "name": "Lone Star Peptide", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ] }, { "name": "lonestarpeptideco.com", "kind": "historical_domain", "basis": "Named in the reviewed complaint as a business website; current control and availability not checked.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ] }, { "name": "Adam Landa", "kind": "operator", "basis": "Complaint paragraph 11 alleges sole member and registered agent; paragraph 57 calls him owner.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ] } ], "activity": { "summary": "Complaint cites May 20, 2026 retatrutide social promotion and website observations dated August 6, 2026. No founding or closure date is established.", "kind": "dated_observation", "start": "2026-05-20", "end": "2026-08-06", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations.", "Observation endpoints do not establish uninterrupted trading or business start/end." ] }, "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103003/gov.uscourts.txsd.2103003.1.0.pdf", "locator": "Complaint, seller-specific website and social-marketing allegations, pp. 13–16" } ] } }, { "id": "lilly-mango-2024", "case_name": "Eli Lilly and Company v. Mangoceuticals Inc.", "category": "civil", "court_or_agency": "U.S. District Court, N.D. Texas", "docket_number": "3:24-cv-02634", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "MangoRx", "TRIM" ], "parties": [ "Eli Lilly and Company", "Mangoceuticals Inc." ], "filed_date": "2024-10-21", "status_date": "2025-06-23", "analysis": { "id": "lilly-mango-2024", "summary": { "text": "Lilly’s Mangoceuticals dispute concerned its MangoRx TRIM tirzepatide offering and challenged marketing. The strongest recorded outcome comes from Mangoceuticals’ own securities filing, which reports a June 2025 confidential settlement and mutual release, a $20,000 payment, and an agreement to stop the TRIM tirzepatide offering. A corporate filing is useful primary evidence of what the company reported, but it is not the missing court dismissal or the complete settlement. The amount should therefore be described as a reported settlement payment rather than a court-assessed penalty or damages verdict.", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-wellness-groups-over-knockoff-weight-loss-drugs" ] }, "products": [ { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "Mangoceuticals’ filing describes ending its TRIM tirzepatide offering as part of settlement.", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The first lead and any test purchase are not established. The available material identifies the product and dispute, not how Lilly originally discovered it.", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-wellness-groups-over-knockoff-weight-loss-drugs" ] }, "challenged_conduct": [ { "text": "Lilly challenged the marketing of the TRIM tirzepatide product; the full operative complaint and adjudicated factual findings have not been reviewed.", "attribution": "allegation", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-wellness-groups-over-knockoff-weight-loss-drugs" ] } ], "outcome": { "class": "settlement", "text": "The company reports a June 23, 2025 settlement and a $20,000 payment on June 27. The original dismissal order and full confidential terms were not obtained.", "as_of": "2025-06-23", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-wellness-groups-over-knockoff-weight-loss-drugs" ] }, "timeline": [ { "date": "2024-10-21", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-wellness-groups-over-knockoff-weight-loss-drugs" ] }, { "date": "2025-06-23", "event": "Mangoceuticals securities filing reports settlement and mutual release, a $20,000 payment and agreement to stop its TRIM tirzepatide offering. Original court dismissal not obtained.", "kind": "announcement", "date_basis": "event", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989" ] }, { "date": "2025-06-27", "event": "Mangoceuticals reports paying the $20,000 settlement amount.", "kind": "other", "date_basis": "event", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989" ] } ], "timing_pairs": [ { "label": "Complaint filing to company-reported settlement", "start": "2024-10-21", "end": "2025-06-23", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-wellness-groups-over-knockoff-weight-loss-drugs" ], "days": 245 } ], "next_watch": { "text": "Obtain the docket dismissal and any public settlement terms to confirm release scope and continuing obligations.", "basis": "inference", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-wellness-groups-over-knockoff-weight-loss-drugs" ] }, "unknowns": [ "Outcome is company-reported; no independent laboratory result or contested liability finding is established." ], "source_review": [ { "url": "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989", "review_basis": "registry_support_only", "locator": "Previously collected securities-filing settlement disclosure" }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-wellness-groups-over-knockoff-weight-loss-drugs", "review_basis": "registry_support_only", "locator": "Secondary report used only for filing context" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2025-06-27", "sources": [ { "url": "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989", "title": "Eli Lilly and Company v. Mangoceuticals Inc. — party reported settlement", "source_type": "party_statement", "document_type": "securities_filing", "supports": "Mangoceuticals securities filing reports settlement and mutual release, a $20,000 payment and agreement to stop its TRIM tirzepatide offering. Original court dismissal not obtained." }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-wellness-groups-over-knockoff-weight-loss-drugs", "title": "Bloomberg Law October 2024 suits", "source_type": "secondary", "document_type": "news_report", "supports": "Mango filing date, docket and allegation context." } ], "business_profile": { "id": "lilly-mango-2024", "display_name": "MangoRx", "identities": [ { "name": "Mangoceuticals Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989" ] }, { "name": "MangoRx", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://www.otcmarkets.com/filing/conv_pdf?guid=y6M-kaSFt2Vbdth&id=18698989", "locator": "Previously collected securities-filing settlement disclosure" }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-wellness-groups-over-knockoff-weight-loss-drugs", "locator": "Secondary report used only for filing context" } ] } }, { "id": "lilly-medshape-2026", "case_name": "Eli Lilly and Company v. MedShape Weight Loss Clinic LLC", "category": "civil", "court_or_agency": "U.S. District Court, D. Arizona", "docket_number": "2:26-cv-07361", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "MedShape Weight Loss Clinic" ], "parties": [ "Eli Lilly and Company", "MedShape Weight Loss Clinic LLC" ], "filed_date": "2026-10-08", "status_date": "2026-10-08", "analysis": { "id": "lilly-medshape-2026", "summary": { "text": "The MedShape Weight Loss Clinic case expands the October 2026 retatrutide wave beyond research-peptide storefronts to a clinic defendant. However, that connection presently rests on a court-docket entry and contemporaneous reporting, not the original complaint. The reviewed evidence does not establish the clinic’s precise formulation, whether it dispensed or administered a product, or which representations Lilly challenged. Those distinctions are essential before comparing a clinical treatment business with an online research seller. The same reporting also names Medrein, a different business; the names should not be merged or treated as aliases.", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "products": [ { "name": "retatrutide", "role": "unclear", "basis": "Contemporaneous reporting links MedShape to purported-retatrutide allegations; original pleading and exact product role remain unreviewed.", "sources": [ "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ], "normalized_names": [ "retatrutide" ] } ], "discovery": { "known": false, "text": "Not established. No reviewed primary narrative identifies the first lead, a patient report, purchase, inspection or testing method.", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "challenged_conduct": [ { "text": "Secondary reporting says Lilly alleged unlawful sale and promotion of purported retatrutide. Specific clinic conduct and statutory claims cannot be reconstructed from the docket title.", "attribution": "allegation", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] } ], "outcome": { "class": "pending_or_unknown", "text": "The docket identifies an October 8, 2026 Arizona complaint, 2:26-cv-07361. No subsequent merits event or government sanction is established.", "as_of": "2026-10-08", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "timeline": [ { "date": "2026-10-08", "event": "Docket records complaint filing; contemporaneous reporting links it to alleged retatrutide sales. Complaint text not obtained.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain the complaint and exhibits to distinguish product administration, sale, advertising and any independently documented medical-practice issue.", "basis": "inference", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789", "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs" ] }, "unknowns": [ "Original complaint, product contents, business-specific evidence and later outcome remain missing." ], "source_review": [ { "url": "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789", "review_basis": "registry_support_only", "locator": "Docket filing metadata" }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs", "review_basis": "archived_full_text", "locator": "Accessible Bloomberg report excerpt identifying MedShape and retatrutide" } ] }, "compounds": [ "retatrutide" ], "marketing_or_supply_compounds": [], "tested_compounds": [], "direct_compounds": [], "latest_documented_date": "2026-10-08", "sources": [ { "url": "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789", "title": "Eli Lilly and Company v. MedShape Weight Loss Clinic LLC — complaint", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Docket records complaint filing; contemporaneous reporting links it to alleged retatrutide sales. Complaint text not obtained." }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs", "title": "Bloomberg Law report on five October 8 suits", "source_type": "secondary", "document_type": "news_report", "supports": "Contemporaneous reported retatrutide scope and brand mapping; no adjudication." } ], "business_profile": { "id": "lilly-medshape-2026", "display_name": "MedShape Weight Loss Clinic", "identities": [ { "name": "MedShape Weight Loss Clinic LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789" ] }, { "name": "MedShape Weight Loss Clinic", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://dockets.justia.com/docket/arizona/azdce/2%3A2026cv07361/1523789", "locator": "Docket filing metadata" }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs", "locator": "Accessible Bloomberg report excerpt identifying MedShape and retatrutide" } ] } }, { "id": "lilly-mochi-2025", "case_name": "Eli Lilly and Company v. Mochi Health Corp. et al.", "category": "civil", "court_or_agency": "U.S. District Court, N.D. California", "docket_number": "3:25-cv-03534", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Mochi Health", "Aequita" ], "parties": [ "Eli Lilly and Company", "Mochi Health Corp.", "Mochi Medical CA PC", "Mochi Medical PA", "Aequita Pharmacy LLC" ], "filed_date": "2025-04-23", "status_date": "2026-04-20", "analysis": { "id": "lilly-mochi-2025", "summary": { "text": "Lilly’s Mochi litigation challenges connected telehealth, medical-group and pharmacy businesses over compounded tirzepatide. Its complaint identifies formulations with glycine, niacinamide or pyridoxine and alleges broad prescription changes contradicted personalization claims. After an April pleading ruling, a September 2026 order split the amended conspiracy theories: UCL conspiracy against Aequita could proceed, but Lanham Act conspiracy against Mochi Medical and Aequita was dismissed. The court found knowledge of advertising alone insufficient without an alleged act advancing the false-advertising scheme. These are pleading decisions, not proven conspiracy, product contamination or clinical-harm findings.", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf", "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf", "https://docs.justia.com/cases/federal/district-courts/california/candce/3%3A2025cv03534/448395/146/0.pdf" ] }, "products": [ { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "Complaint paragraphs 3 and 8 identify tirzepatide products with glycine, niacinamide and pyridoxine; ingredients are alleged formulations, not independently assayed contents.", "sources": [ "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The complaint cites promotional materials and reported group-wide prescription changes. The initial lead, sample purchase and laboratory investigation are not established.", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf", "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf", "https://docs.justia.com/cases/federal/district-courts/california/candce/3%3A2025cv03534/448395/146/0.pdf" ] }, "challenged_conduct": [ { "text": "Lilly alleged misleading personalization, unlicensed corporate influence and advertising of compounded products unsupported by the cited branded-drug evidence.", "attribution": "allegation", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf", "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf", "https://docs.justia.com/cases/federal/district-courts/california/candce/3%3A2025cv03534/448395/146/0.pdf" ] } ], "outcome": { "class": "procedural_order", "text": "September 8, 2026 order allowed UCL conspiracy against Aequita and dismissed Lanham Act conspiracy against Mochi Medical/Aequita without leave to amend, while allowing a later amendment motion if new supporting facts emerge. Other surviving claims were not finally adjudicated.", "as_of": "2026-09-08", "sources": [ "https://docs.justia.com/cases/federal/district-courts/california/candce/3%3A2025cv03534/448395/146/0.pdf" ] }, "timeline": [ { "date": "2025-04-23", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf", "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf", "https://docs.justia.com/cases/federal/district-courts/california/candce/3%3A2025cv03534/448395/146/0.pdf" ] }, { "date": "2026-04-20", "event": "Court allowed UCL and Lanham Act claims to proceed and dismissed the conspiracy theory with leave to amend; a subsequent September 8 ruling addresses the amended conspiracy theories.", "kind": "order", "date_basis": "event", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf" ] }, { "date": "2026-09-08", "event": "Court partly granted dismissal of the second amended complaint: Lanham Act conspiracy against Mochi Medical/Aequita dismissed; UCL conspiracy against Aequita survives.", "kind": "order", "date_basis": "filing", "sources": [ "https://docs.justia.com/cases/federal/district-courts/california/candce/3%3A2025cv03534/448395/146/0.pdf" ] } ], "timing_pairs": [ { "label": "Complaint filing to reviewed partial-dismissal order", "start": "2025-04-23", "end": "2026-04-20", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf", "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf" ], "days": 362 }, { "label": "Complaint filing to second-amended-complaint ruling", "start": "2025-04-23", "end": "2026-09-08", "sources": [ "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf", "https://docs.justia.com/cases/federal/district-courts/california/candce/3%3A2025cv03534/448395/146/0.pdf" ], "days": 503 } ], "next_watch": { "text": "The May schedule sets a case-management statement for October 28 and conference for November 4, 2026, and trial for January 2028. Check for subsequent schedule changes.", "basis": "scheduled_event", "sources": [ "https://cases.justia.com/federal/district-courts/california/candce/3%3A2025cv03534/448395/132/0.pdf" ] }, "unknowns": [ "Final liability, damages and later schedule changes are unverified. September conspiracy dismissal does not dispose of every claim." ], "source_review": [ { "url": "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf", "review_basis": "archived_full_text", "locator": "April 20, 2026 pleading order, claim analysis and conclusion" }, { "url": "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf", "review_basis": "archived_full_text", "locator": "Complaint paragraphs 3–10 and entity-role allegations" }, { "url": "https://docs.justia.com/cases/federal/district-courts/california/candce/3%3A2025cv03534/448395/146/0.pdf", "review_basis": "court_pdf", "locator": "Document 146, pp. 4–7; civil-source-review/mochi-september.pdf" }, { "url": "https://cases.justia.com/federal/district-courts/california/candce/3%3A2025cv03534/448395/132/0.pdf", "review_basis": "court_pdf", "locator": "Document 132, pp. 1–2; civil-source-review/mochi-schedule.pdf" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2026-09-08", "sources": [ { "url": "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf", "title": "Eli Lilly and Company v. Mochi Health Corp. et al. — partial dismissal", "source_type": "court_document", "document_type": "order", "supports": "Court allowed UCL and Lanham Act claims to proceed and dismissed the conspiracy theory with leave to amend. Later September 2026 developments identified as leads but their order was not obtained." }, { "url": "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf", "title": "Eli Lilly and Company v. Mochi Health Corp. et al. — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Original filing and allegation context; allegations are not findings." } ], "business_profile": { "id": "lilly-mochi-2025", "display_name": "Mochi Health / Aequita", "identities": [ { "name": "Mochi Health Corp.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf" ] }, { "name": "Mochi Medical CA PC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf" ] }, { "name": "Mochi Medical PA", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf" ] }, { "name": "Aequita Pharmacy LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf" ] }, { "name": "Mochi Health", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf" ] }, { "name": "Aequita", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf" ] }, { "name": "joinmochi.com", "kind": "historical_domain", "basis": "Named in the reviewed complaint as a business website; current control and availability not checked.", "sources": [ "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf" ] }, { "name": "Myra Ahmad", "kind": "operator", "basis": "Complaint paragraphs 4-5 and 49 identify founder/co-founder and CEO; ownership/control assertions are allegations.", "sources": [ "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf" ] }, { "name": "Abraham Chaibi", "kind": "operator", "basis": "Complaint paragraphs 4-5 and 49 identify an owner and describe links to Aequita entities; ownership/control assertions are allegations.", "sources": [ "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf" ] }, { "name": "Aequita Corporation", "kind": "legal_entity", "basis": "Named defendant in the original complaint and September 2026 order; separate from Aequita Pharmacy LLC.", "sources": [ "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf" ] } ], "activity": { "summary": "The record concerns a telehealth company, two medical practices and separate Aequita pharmacy/corporate entities. It does not establish a single opening-to-closure period for this network.", "kind": "mixed_entities", "start": null, "end": null, "sources": [ "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf" ], "limits": [ "An event involving one pharmacy entity is not the end of Mochi's whole business.", "The complaint's ownership/control allegations are not independent corporate-registry verification." ] }, "source_review": [ { "url": "https://www.courthousenews.com/wp-content/uploads/2026/04/eli-lilly-vs-mochi-health-order.pdf", "locator": "April 20, 2026 pleading order, claim analysis and conclusion" }, { "url": "https://www.statnews.com/wp-content/uploads/2025/04/lilly-vs-mochi.pdf", "locator": "Complaint paragraphs 3–10 and entity-role allegations" }, { "url": "https://docs.justia.com/cases/federal/district-courts/california/candce/3%3A2025cv03534/448395/146/0.pdf", "locator": "Document 146, pp. 4–7; civil-source-review/mochi-september.pdf" } ] } }, { "id": "lilly-pivotal-2024", "case_name": "Eli Lilly and Company v. Pivotal Peptides LLC", "category": "civil", "court_or_agency": "U.S. District Court, W.D. Washington", "docket_number": "2:24-cv-01719", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Pivotal Peptides" ], "parties": [ "Eli Lilly and Company", "Pivotal Peptides LLC" ], "filed_date": "2024-10-21", "status_date": "2025-05-20", "analysis": { "id": "lilly-pivotal-2024", "summary": { "text": "Pivotal is the clearest bridge between a research-peptide complaint and a documented negotiated outcome. Lilly’s original complaint concerned tirzepatide, including pharmaceutical-grade, purity and regulatory representations and sales without prescriptions. The approved settlement contains Pivotal’s admissions about those tirzepatide practices and commits it to stop tirzepatide sales. It also prohibits products involving semaglutide or retatrutide. Those additional restrictions establish settlement scope; they do not establish that Pivotal previously sold either compound. The May 2025 dismissal was with prejudice, and the court retained jurisdiction to enforce the settlement.", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf", "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ] }, "products": [ { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "The settlement stipulation admits specified tirzepatide sales and marketing practices.", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf" ], "normalized_names": [ "tirzepatide" ] }, { "name": "semaglutide", "role": "settlement_scope", "basis": "Included in the forward-looking settlement restriction, not established as an original complaint product.", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf" ], "normalized_names": [ "semaglutide" ] }, { "name": "retatrutide", "role": "settlement_scope", "basis": "Named only in the reviewed settlement restriction; no prior sale is inferred.", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf" ], "normalized_names": [ "retatrutide" ] } ], "discovery": { "known": false, "text": "The complaint documents Lilly’s July 12, 2024 cease-and-desist letter and a later seller communication. It does not establish when or how Lilly first discovered the conduct.", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf", "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ] }, "challenged_conduct": [ { "text": "Pivotal admitted that nonprescription tirzepatide sales and marketing research-grade material as pharmaceutical grade violated Washington law and endangered patient safety.", "attribution": "admission", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf", "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ] } ], "outcome": { "class": "settlement", "text": "The court approved the stipulation May 20, 2025, dismissed with prejudice and retained enforcement jurisdiction. This is a settlement with express admissions, not a contested trial.", "as_of": "2025-05-20", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf", "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ] }, "timeline": [ { "date": "2024-07-12", "event": "Lilly sent a private cease-and-desist letter, according to the complaint.", "kind": "other", "date_basis": "event", "sources": [ "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ] }, { "date": "2024-10-21", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf", "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ] }, { "date": "2025-05-20", "event": "Court approved stipulated settlement and dismissed with prejudice, retaining enforcement jurisdiction. Stipulation includes admissions and an agreement to stop selling tirzepatide, semaglutide and retatrutide products.", "kind": "settlement", "date_basis": "event", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf" ] } ], "timing_pairs": [ { "label": "Private cease-and-desist letter to complaint filing", "start": "2024-07-12", "end": "2024-10-21", "sources": [ "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ], "days": 101 }, { "label": "Complaint filing to settlement approval", "start": "2024-10-21", "end": "2025-05-20", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf", "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ], "days": 211 } ], "next_watch": { "text": "Any later enforcement motion would show whether disputes arose over compliance; none is established here.", "basis": "inference", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf", "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ] }, "unknowns": [ "Initial detection date and prior semaglutide/retatrutide sales are not established." ], "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf", "review_basis": "archived_full_text", "locator": "Stipulation pp. 1–2 and signed approval order" }, { "url": "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf", "review_basis": "archived_full_text", "locator": "Complaint, marketing allegations and July 2024 correspondence" } ] }, "compounds": [ "retatrutide", "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2025-05-20", "sources": [ { "url": "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf", "title": "Eli Lilly and Company v. Pivotal Peptides LLC — settlement dismissal", "source_type": "court_document", "document_type": "order", "supports": "Court approved stipulated settlement and dismissed with prejudice, retaining enforcement jurisdiction. Stipulation includes admissions and an agreement to stop selling tirzepatide, semaglutide and retatrutide products." }, { "url": "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf", "title": "Eli Lilly and Company v. Pivotal Peptides LLC — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Original filing and allegation context; allegations are not findings." } ], "business_profile": { "id": "lilly-pivotal-2024", "display_name": "Pivotal Peptides", "identities": [ { "name": "Pivotal Peptides LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf" ] }, { "name": "Pivotal Peptides", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf" ] }, { "name": "Elizabeth Gately", "kind": "operator", "basis": "Complaint paragraph 5 alleges she is one of the LLC's two members; paragraphs 42-46 attribute customer correspondence to Gately.", "sources": [ "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ] }, { "name": "Hannah Swayne", "kind": "operator", "basis": "Complaint paragraph 5 alleges she is one of the LLC's two members; the reviewed record does not assign her every action attributed to the company.", "sources": [ "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ] }, { "name": "pivotalpeptides.com", "kind": "historical_domain", "basis": "Complaint paragraphs 40-43 identify the former website and July 2024 customer notice that it was no longer active.", "sources": [ "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf" ] } ], "activity": { "summary": "Complaint describes marketing discovered earlier in 2024, Lilly's July 12, 2024 letter, and a customer email dated on or around July 22 saying the business continued after its website went inactive. The May 20, 2025 settlement later restricted three compounds.", "kind": "dated_observation", "start": "2024", "end": "2024-07", "sources": [ "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf", "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf" ], "limits": [ "2024 and July 2024 are source-precision observations, not establishment/closure dates.", "Website inactivity did not establish business closure; Lilly alleged continued sales.", "Settlement restrictions are not proof of company dissolution or prior sales of every restricted compound." ] }, "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/washington/wawdce/2%3A2024cv01719/340620/39/0.pdf", "locator": "Stipulation pp. 1–2 and signed approval order" }, { "url": "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf", "locator": "Complaint, marketing allegations and July 2024 correspondence" }, { "url": "https://cdn.arstechnica.net/wp-content/uploads/2024/10/0001.00_2024-10-21-Complaint-for-False-Advertising-and-Promotion-Pivotal-1.pdf", "locator": "Complaint PDF p. 2, paragraph 5; p. 5, paragraph 18; pp. 9-12, paragraphs 37-46." } ] } }, { "id": "lilly-revive-2023", "case_name": "Eli Lilly and Company v. Revive RX LLC", "category": "civil", "court_or_agency": "U.S. District Court, S.D. Texas", "docket_number": "4:23-cv-03521", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Revive RX" ], "parties": [ "Eli Lilly and Company", "Revive RX LLC" ], "filed_date": "2023-09-19", "status_date": "2026-08-04", "analysis": { "id": "lilly-revive-2023", "summary": { "text": "Lilly’s long-running Revive RX case concerns compounded tirzepatide and state unfair-competition theories. The August 2026 opinion analyzes whether compounded preparations can fall within state new-drug laws and rejects a categorical argument that pharmacy compounding is outside those provisions. It also emphasizes that plaintiffs still must prove their claims and that legitimate patient-specific compounding may raise different causation and safe-harbor issues. This is a pleading-stage legal decision, not a finding that all compounding is unlawful. Revive RX should not be confused with similarly named clinics or sellers in other records.", "sources": [ "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/" ] }, "products": [ { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "The opinion identifies compounded tirzepatide, including a tirzepatide/vitamin-B6 combination discussed in the allegations.", "sources": [ "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The opinion recites product and sales allegations, but it does not establish how Lilly first identified the conduct or document a test purchase.", "sources": [ "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/" ] }, "challenged_conduct": [ { "text": "Lilly alleged unfair competition through challenged compounded-drug sales. Revive argued that compounding was categorically outside the new-drug provisions; the court rejected that pleading defense.", "attribution": "allegation", "sources": [ "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/" ] } ], "outcome": { "class": "procedural_order", "text": "The August 4, 2026 order denied judgment on the pleadings. Earlier Texas claims had been dismissed with prejudice and Hawaii claims without prejudice; other state theories remained in the reviewed record.", "as_of": "2026-08-04", "sources": [ "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/" ] }, "timeline": [ { "date": "2023-09-19", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/" ] }, { "date": "2026-08-04", "event": "Court denied judgment on the pleadings. Earlier rulings dismissed Texas claims with prejudice and Hawaii claims without prejudice; other state claims continued.", "kind": "order", "date_basis": "event", "sources": [ "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/" ] } ], "timing_pairs": [], "next_watch": { "text": "Monitor summary judgment or trial evidence concerning actual formulations, statutory exceptions, competitive harm and the surviving state claims.", "basis": "inference", "sources": [ "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/" ] }, "unknowns": [ "Final liability and damages are not established; this ruling is not an agency inspection or prosecution." ], "source_review": [ { "url": "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/", "review_basis": "court_pdf", "locator": "Document 155, downloaded to civil-source-review/revive.pdf; new-drug analysis and conclusion" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2026-08-04", "sources": [ { "url": "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/", "title": "Eli Lilly and Company v. Revive RX LLC — pleadings order", "source_type": "court_document", "document_type": "order", "supports": "Court denied judgment on the pleadings. Earlier rulings dismissed Texas claims with prejudice and Hawaii claims without prejudice; other state claims continued." } ], "business_profile": { "id": "lilly-revive-2023", "display_name": "Revive RX", "identities": [ { "name": "Revive RX LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/" ] }, { "name": "Revive RX", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://law.justia.com/cases/federal/district-courts/texas/txsdce/4%3A2023cv03521/1935108/155/", "locator": "Document 155, downloaded to civil-source-review/revive.pdf; new-drug analysis and conclusion" } ] } }, { "id": "lilly-striker-2026", "case_name": "Eli Lilly and Company v. Striker Pharmacy LLC", "category": "civil", "court_or_agency": "U.S. District Court, S.D. Texas", "docket_number": "4:26-cv-06563", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Striker Pharmacy" ], "parties": [ "Eli Lilly and Company", "Striker Pharmacy LLC" ], "filed_date": "2026-08-12", "status_date": "2026-08-12", "analysis": { "id": "lilly-striker-2026", "summary": { "text": "Striker differs from research storefront defendants because Lilly describes a compounding pharmacy supplying medical practices and shipping to consumers. The complaint cites vial images, a price list and customer reviews to support its allegation that Striker offered purported retatrutide. It also compares archived versions of the website with later product-page availability and challenges language about ingredients from FDA-registered facilities. These are specified sources of Lilly’s evidence, not proof of an FDA inspection or an admission by Striker. Website changes alone do not establish why material changed or prove concealment.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ] }, "products": [ { "name": "retatrutide", "role": "alleged_marketing_or_supply", "basis": "Complaint paragraphs 49–56 cite alleged vial/price-list evidence and customer reviews; no independently verified assay establishes contents.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ], "normalized_names": [ "retatrutide" ] } ], "discovery": { "known": false, "text": "Lilly documents website-archive comparisons, product imagery and review evidence. None establishes the initial tip or whether a purchase initiated the investigation.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ] }, "challenged_conduct": [ { "text": "Lilly alleges unauthorized retatrutide compounding and sales, and misleading implications of regulatory legitimacy from FDA-registration language.", "attribution": "allegation", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ] } ], "outcome": { "class": "pending_or_unknown", "text": "The August 12, 2026 private complaint is verified. No reviewed ruling determines liability, orders the pharmacy closed or establishes a regulatory sanction.", "as_of": "2026-08-12", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ] }, "timeline": [ { "date": "2026-08-12", "event": "Complaint alleges improper compounding and sale of retatrutide. Later disposition not verified.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ] } ], "timing_pairs": [], "next_watch": { "text": "Seek authenticated product records and the defendant’s response, then distinguish any separate pharmacy-board or FDA action from this suit.", "basis": "inference", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ] }, "unknowns": [ "Actual formulation, source of the depicted samples and later disposition remain unknown. Broader GLP-1 adverse-event statistics are not Striker-specific findings." ], "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf", "review_basis": "archived_full_text", "locator": "Complaint paragraphs 49–56, pp. 18–22, and cited website archives" } ] }, "compounds": [ "retatrutide" ], "marketing_or_supply_compounds": [ "retatrutide" ], "tested_compounds": [], "direct_compounds": [ "retatrutide" ], "latest_documented_date": "2026-08-12", "sources": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf", "title": "Eli Lilly and Company v. Striker Pharmacy LLC — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Complaint alleges improper compounding and sale of retatrutide. Later disposition not verified." }, { "url": "https://investor.lilly.com/node/54816/pdf", "title": "Lilly announces six retatrutide suits", "source_type": "party_statement", "document_type": "press_release", "supports": "Plaintiff announcement links defendants, brands and alleged retatrutide sales. Actual court controls where announcement court designation differs." } ], "business_profile": { "id": "lilly-striker-2026", "display_name": "Striker Pharmacy", "identities": [ { "name": "Striker Pharmacy LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ] }, { "name": "Striker Pharmacy", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ] }, { "name": "Philip Brown III", "kind": "operator", "basis": "Complaint paragraph 13 identifies the managing member and alleges he is the sole member on information and belief.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ] }, { "name": "strikerrx.com", "kind": "historical_domain", "basis": "Complaint paragraph 13 identifies the pharmacy website, last visited August 6, 2026.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ] } ], "activity": { "summary": "Complaint cites a March 13, 2026 archived weight-management webpage, May 2, 2026 customer review and August 6, 2026 website observations. It separately reports incorporation on June 13, 2018 and interstate registrations in early 2026.", "kind": "dated_observation", "start": "2026-03-13", "end": "2026-08-06", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf" ], "limits": [ "The endpoints are cited observations, not business opening/closure or a continuous retatrutide-sales period.", "June 13, 2018 is the alleged incorporation date, not the start of compounding or retatrutide sales.", "Photographed product labels and customer accounts are plaintiff-submitted evidence, not laboratory-confirmed contents." ] }, "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf", "locator": "Complaint paragraphs 49–56, pp. 18–22, and cited website archives" }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txsd.2103004/gov.uscourts.txsd.2103004.1.0.pdf", "locator": "Complaint PDF pp. 5-6, paragraph 13; pp. 18-22, paragraphs 49-55 and dated footnotes." } ] } }, { "id": "lilly-strive-de-2025", "case_name": "Eli Lilly and Company v. Strive Pharmacy LLC et al.", "category": "civil", "court_or_agency": "U.S. District Court, D. Delaware", "docket_number": "1:25-cv-00401", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Strive Pharmacy" ], "parties": [ "Eli Lilly and Company", "Strive Pharmacy LLC", "Strive Specialties Inc." ], "filed_date": "2025-04-01", "status_date": "2025-10-08", "analysis": { "id": "lilly-strive-de-2025", "summary": { "text": "Lilly sued Strive Pharmacy and Strive Specialties in Delaware over advertising of compounded tirzepatide, including representations about personalization. The court dismissed the action without prejudice for lack of personal jurisdiction in October 2025. That means the selected forum could not adjudicate the dispute on the showing made; it does not mean the underlying advertising allegations were disproved. Lilly filed an Arizona action two weeks later. The Delaware and Arizona dockets are distinct proceedings, but reporting them as two unrelated seller incidents would exaggerate the conduct covered by the collection.", "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf" ] }, "products": [ { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "The complaint identifies compounded tirzepatide products and challenged personalization claims.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The complaint cites marketing representations; neither it nor the jurisdiction ruling establishes the initial lead or a dated discovery event.", "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf" ] }, "challenged_conduct": [ { "text": "Lilly alleged false or misleading promotion of compounded tirzepatide as personalized. The reviewed ruling addressed jurisdiction rather than advertising truth.", "attribution": "allegation", "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf" ] } ], "outcome": { "class": "dismissal", "text": "Dismissed without prejudice October 8, 2025 for lack of personal jurisdiction. The subsequent Arizona action is linked history, not a merits reversal.", "as_of": "2025-10-08", "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf" ] }, "timeline": [ { "date": "2025-04-01", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf" ] }, { "date": "2025-10-08", "event": "Dismissed without prejudice for lack of personal jurisdiction. Lilly could plead additional jurisdictional facts or sue in Arizona. No merits decision.", "kind": "dismissal", "date_basis": "event", "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf" ] } ], "timing_pairs": [ { "label": "Complaint filing to jurisdictional dismissal", "start": "2025-04-01", "end": "2025-10-08", "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf" ], "days": 190 } ], "next_watch": { "text": "Follow the Arizona docket for resolution of the substantive claims and identify any materially different amended allegations.", "basis": "inference", "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf", "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf" ] }, "unknowns": [ "No Delaware merits decision; refiling should not be counted as a new episode of harmful conduct." ], "source_review": [ { "url": "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf", "review_basis": "archived_full_text", "locator": "October 8, 2025 memorandum opinion, personal-jurisdiction analysis" }, { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf", "review_basis": "archived_full_text", "locator": "Complaint, product and advertising allegations" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2025-10-08", "sources": [ { "url": "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf", "title": "Eli Lilly and Company v. Strive Pharmacy LLC et al. — jurisdictional dismissal", "source_type": "court_document", "document_type": "order", "supports": "Dismissed without prejudice for lack of personal jurisdiction. Lilly could plead additional jurisdictional facts or sue in Arizona. No merits decision." }, { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf", "title": "Eli Lilly and Company v. Strive Pharmacy LLC et al. — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Original filing and allegation context; allegations are not findings." } ], "business_profile": { "id": "lilly-strive-de-2025", "display_name": "Strive Pharmacy", "identities": [ { "name": "Strive Pharmacy LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf" ] }, { "name": "Strive Specialties Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf" ] }, { "name": "Strive Pharmacy", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf" ] }, { "name": "strivepharmacy.com", "kind": "historical_domain", "basis": "Named in the reviewed complaint as a business website; current control and availability not checked.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://www.ded.uscourts.gov/sites/ded/files/opinions/25-401.pdf", "locator": "October 8, 2025 memorandum opinion, personal-jurisdiction analysis" }, { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf", "locator": "Complaint, product and advertising allegations" } ] } }, { "id": "lilly-strive-az-2025", "case_name": "Eli Lilly and Company v. Strive Pharmacy LLC et al.", "category": "civil", "court_or_agency": "U.S. District Court, D. Arizona", "docket_number": "2:25-cv-03942", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Strive Pharmacy" ], "parties": [ "Eli Lilly and Company", "Strive Pharmacy LLC", "Strive Specialties Inc." ], "filed_date": "2025-10-22", "status_date": "2026-03-13", "analysis": { "id": "lilly-strive-az-2025", "summary": { "text": "The Arizona Strive action followed dismissal of Lilly’s Delaware suit for lack of personal jurisdiction. It is a separate docket concerning related compounded-tirzepatide advertising allegations, not evidence of a newly discovered seller or an additional proven episode of harm. The collected Arizona sources establish the October 2025 filing and later case-management activity, but the complete operative pleading and subsequent merits rulings have not been fully reviewed. Any product or claim comparison with Delaware must therefore preserve that source limitation instead of assuming every paragraph and defendant role remained identical.", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2025cv03942/1464343", "https://docketnexus.com/document/456509829/" ] }, "products": [ { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "Collected complaint metadata identifies compounded tirzepatide as the related Arizona dispute’s subject; full Arizona allegations need review.", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2025cv03942/1464343", "https://docketnexus.com/document/456509829/" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The documented path into Arizona is procedural refiling after Delaware’s jurisdictional dismissal. That is not the original detection of the challenged conduct.", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2025cv03942/1464343", "https://docketnexus.com/document/456509829/" ] }, "challenged_conduct": [ { "text": "Lilly pursued related advertising claims concerning compounded tirzepatide. Precise amendments and differences from Delaware are not established in this review.", "attribution": "allegation", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2025cv03942/1464343", "https://docketnexus.com/document/456509829/" ] } ], "outcome": { "class": "pending_or_unknown", "text": "The latest collected Arizona event is a March 13, 2026 case-management report. It does not establish a final result or prove that the case remains pending today.", "as_of": "2026-03-13", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2025cv03942/1464343", "https://docketnexus.com/document/456509829/" ] }, "timeline": [ { "date": "2025-10-22", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2025cv03942/1464343", "https://docketnexus.com/document/456509829/" ] }, { "date": "2026-03-13", "event": "Arizona action followed Delaware jurisdictional dismissal. Latest collected docket event is a case-management report, not a final disposition.", "kind": "other", "date_basis": "filing", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2025cv03942/1464343" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain the current docket and operative complaint, then link any merits disposition to both procedural records.", "basis": "inference", "sources": [ "https://dockets.justia.com/docket/arizona/azdce/2%3A2025cv03942/1464343", "https://docketnexus.com/document/456509829/" ] }, "unknowns": [ "Full operative complaint and latest status are missing; this refiling should not inflate distinct-conduct counts." ], "source_review": [ { "url": "https://dockets.justia.com/docket/arizona/azdce/2%3A2025cv03942/1464343", "review_basis": "registry_support_only", "locator": "Collected docket and case-management entries" }, { "url": "https://docketnexus.com/document/456509829/", "review_basis": "registry_support_only", "locator": "Complaint metadata only" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2026-03-13", "sources": [ { "url": "https://dockets.justia.com/docket/arizona/azdce/2%3A2025cv03942/1464343", "title": "Eli Lilly and Company v. Strive Pharmacy LLC et al. — case management", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Arizona action followed Delaware jurisdictional dismissal. Latest collected docket event is a case-management report, not a final disposition." }, { "url": "https://docketnexus.com/document/456509829/", "title": "Eli Lilly and Company v. Strive Pharmacy LLC et al. — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Original filing and allegation context; allegations are not findings." } ], "business_profile": { "id": "lilly-strive-az-2025", "display_name": "Strive Pharmacy", "identities": [ { "name": "Strive Pharmacy LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://docketnexus.com/document/456509829/" ] }, { "name": "Strive Specialties Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://docketnexus.com/document/456509829/" ] }, { "name": "Strive Pharmacy", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://docketnexus.com/document/456509829/" ] }, { "name": "strivepharmacy.com", "kind": "historical_domain", "basis": "Related Delaware complaint identifies Strive's business website; reused only for identity, not proof of operation on this proceeding's dates.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://docketnexus.com/document/456509829/" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations.", "Related Strive proceedings should not be presented as additional distinct shops or inferred operating periods." ] }, "source_review": [ { "url": "https://dockets.justia.com/docket/arizona/azdce/2%3A2025cv03942/1464343", "locator": "Collected docket and case-management entries" }, { "url": "https://docketnexus.com/document/456509829/", "locator": "Complaint metadata only" } ] } }, { "id": "lilly-texas-2026", "case_name": "Eli Lilly and Company v. Texas Peptides Inc.", "category": "civil", "court_or_agency": "U.S. District Court, W.D. Texas", "docket_number": "5:26-cv-05146", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Texas Peptides" ], "parties": [ "Eli Lilly and Company", "Texas Peptides Inc." ], "filed_date": "2026-08-12", "status_date": "2026-08-12", "analysis": { "id": "lilly-texas-2026", "summary": { "text": "Lilly’s Texas Peptides complaint expressly identifies the seller’s Reta GLP-3 product as purported retatrutide, allowing that particular alias to be normalized without guesswork. A cited January 2026 social post links the offering to weight loss, blood-sugar and other health-related benefits, and references trial results. Lilly argues these representations showed intended human use despite research-only language elsewhere. The post is evidence of a dated public representation, not the start of sales or Lilly’s detection date. The complaint’s broader reports of retatrutide adverse events do not establish a Texas Peptides-specific injury.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ] }, "products": [ { "name": "retatrutide", "role": "alleged_marketing_or_supply", "basis": "Complaint paragraphs 42–44 explicitly connect Reta GLP-3 to retatrutide and cite seller-specific marketing.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ], "normalized_names": [ "retatrutide" ] } ], "discovery": { "known": false, "text": "The complaint cites website and social-media evidence, including a January 20, 2026 post. It does not disclose how or when Lilly first found the business.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ] }, "challenged_conduct": [ { "text": "Lilly alleges purported retatrutide was sold for human use using metabolic and clinical-result claims despite research-only disclaimers.", "attribution": "allegation", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ] } ], "outcome": { "class": "pending_or_unknown", "text": "The August 12, 2026 complaint is verified. No later disposition, assay result, government penalty or customer-injury finding is established.", "as_of": "2026-08-12", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ] }, "timeline": [ { "date": "2026-01-20", "event": "Complaint cites a Texas Peptides social post linking Reta GLP-3 to weight-loss and other health claims.", "kind": "other", "date_basis": "event", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ] }, { "date": "2026-08-12", "event": "Complaint alleges deceptive research-only marketing and retatrutide sales. Later disposition not verified.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ] } ], "timing_pairs": [], "next_watch": { "text": "Watch for the response and rulings addressing product identity, intended use and the alleged diversion of customers.", "basis": "inference", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ] }, "unknowns": [ "Exact sales start, actual contents and latest case status are unknown. The dated post is not an exact discovery anchor." ], "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf", "review_basis": "archived_full_text", "locator": "Complaint pp. 13–17, especially paragraphs 42–44 and footnotes 19–22" } ] }, "compounds": [ "retatrutide" ], "marketing_or_supply_compounds": [ "retatrutide" ], "tested_compounds": [], "direct_compounds": [ "retatrutide" ], "latest_documented_date": "2026-08-12", "sources": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf", "title": "Eli Lilly and Company v. Texas Peptides Inc. — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Complaint alleges deceptive research-only marketing and retatrutide sales. Later disposition not verified." }, { "url": "https://investor.lilly.com/node/54816/pdf", "title": "Lilly announces six retatrutide suits", "source_type": "party_statement", "document_type": "press_release", "supports": "Plaintiff announcement links defendants, brands and alleged retatrutide sales. Actual court controls where announcement court designation differs." } ], "business_profile": { "id": "lilly-texas-2026", "display_name": "Texas Peptides", "identities": [ { "name": "Texas Peptides Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ] }, { "name": "Texas Peptides", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ] }, { "name": "Richard Moke", "kind": "operator", "basis": "Complaint paragraph 11 identifies him as co-founder and Director of Sales and Business Development based on a cited professional profile; not alleged to be the only owner.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ] }, { "name": "texaspeptidesinc.com", "kind": "historical_domain", "basis": "Complaint paragraph 11 and footnotes 5-6 identify the website.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ] } ], "activity": { "summary": "Complaint cites a January 20, 2026 social-media advertisement for RETA GLP-3 and product/about pages observed August 6, 2026. These are the documented marketing observations, not a verified full operating history.", "kind": "dated_observation", "start": "2026-01-20", "end": "2026-08-06", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf" ], "limits": [ "Opening, incorporation and closure dates were not established.", "The complaint describes a Wyoming corporation with Texas operations; the trading name alone does not establish incorporation in Texas.", "No verified later disposition establishes that business stopped." ] }, "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf", "locator": "Complaint pp. 13–17, especially paragraphs 42–44 and footnotes 19–22" }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txwd.1172926917/gov.uscourts.txwd.1172926917.1.0.pdf", "locator": "Complaint PDF pp. 4-5, paragraph 11; pp. 14-15, paragraphs 44-45 and footnotes 19-22." } ] } }, { "id": "lilly-livewell-2026", "case_name": "Eli Lilly and Company v. William Ian Brown dba LiveWell Peptides", "category": "civil", "court_or_agency": "U.S. District Court, N.D. Texas", "docket_number": "3:26-cv-03514", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "LiveWell Peptides" ], "parties": [ "Eli Lilly and Company", "William Ian Brown" ], "filed_date": "2026-10-08", "status_date": "2026-10-08", "analysis": { "id": "lilly-livewell-2026", "summary": { "text": "Lilly’s LiveWell complaint names William Ian Brown doing business as LiveWell Peptides and focuses on purported retatrutide. It combines a product page, clinical-trial references, consumer-oriented supplies and influencer promotions to argue that research-only labeling contradicted the business’s intended human use. The complaint explicitly connects the GLP-1-R listing with retatrutide, so that alias is supported in this record. It also cites semaglutide and tirzepatide product pages, but those are supporting catalog evidence; retatrutide remains the central challenged product. General Reddit adverse-event stories and third-party testing reports do not prove contamination or injury from LiveWell’s own vials.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ] }, "products": [ { "name": "retatrutide", "role": "alleged_marketing_or_supply", "basis": "Complaint paragraphs 42–51 and cited GLP-1-R page expressly identify purported retatrutide marketed by LiveWell.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ], "normalized_names": [ "retatrutide" ] }, { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "Footnote 43 cites a LiveWell semaglutide product page as supporting catalog evidence; this is not the core retatrutide allegation.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "Footnote 43 cites a LiveWell tirzepatide listing; no sale volume or verified composition is established.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "Website, social posts and affiliate material document evidence gathering. The initial lead, investigation start and any LiveWell test purchase remain undisclosed.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ] }, "challenged_conduct": [ { "text": "Lilly alleges research-only branding masked human-use retatrutide sales and that consumer endorsements and clinical references conveyed misleading legitimacy.", "attribution": "allegation", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ] } ], "outcome": { "class": "pending_or_unknown", "text": "The October 8, 2026 complaint is verified. No answer, liability ruling, seizure or settlement is established by the collection cutoff.", "as_of": "2026-10-08", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ] }, "timeline": [ { "date": "2026-10-08", "event": "Lilly alleges research-only labeling is a pretext for retatrutide sales for human use. No later disposition verified.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ] } ], "timing_pairs": [], "next_watch": { "text": "Monitor the response, any injunction request and evidence tying particular promotions or samples to the named defendant.", "basis": "inference", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ] }, "unknowns": [ "Actual vial composition and seller-specific injury are unproved; this defendant is distinct from TruLife/Live Well Drugstore." ], "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf", "review_basis": "archived_full_text", "locator": "Complaint pp. 15–19, paragraphs 42–51 and footnote 43; broader harm discussion distinguished" } ] }, "compounds": [ "retatrutide", "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "retatrutide", "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "retatrutide", "semaglutide", "tirzepatide" ], "latest_documented_date": "2026-10-08", "sources": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf", "title": "Eli Lilly and Company v. William Ian Brown dba LiveWell Peptides — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Lilly alleges research-only labeling is a pretext for retatrutide sales for human use. No later disposition verified." }, { "url": "https://news.bloomberglaw.com/litigation/eli-lilly-sues-more-vendors-selling-illicit-weight-loss-drugs", "title": "Bloomberg Law report on five October 8 suits", "source_type": "secondary", "document_type": "news_report", "supports": "Contemporaneous reported retatrutide scope and brand mapping; no adjudication." } ], "business_profile": { "id": "lilly-livewell-2026", "display_name": "LiveWell Peptides", "identities": [ { "name": "LiveWell Peptides", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ] }, { "name": "William Ian Brown (identified as William “Ian” Brown)", "kind": "operator", "basis": "Named individual defendant doing business as LiveWell Peptides; complaint paragraphs 1 and 11 describe a sole proprietorship. This is the pleading's attribution.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ] }, { "name": "livewellpeptides.com", "kind": "historical_domain", "basis": "Complaint paragraphs 11 and 42 identify the storefront domain; cited pages were last visited September 30, 2026.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ] } ], "activity": { "summary": "Lilly's complaint says LiveWell was founded in 2023 and cites a profile describing Ian Brown's ownership from June 2024. It documents website observations on September 30, 2026 and social posts from 2025. No first retatrutide sale or closure date is established.", "kind": "documented_period", "start": "2023", "end": null, "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf" ], "limits": [ "2023 is a founding claim in the complaint, not independently verified launch or first-sale evidence.", "June 2024 refers to the cited ownership profile, not the establishment date.", "September 30, 2026 is an observation date, not an operating end date.", "Do not conflate this business with Live Well Drugstore LLC / TruLife Pharmacy." ] }, "source_review": [ { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf", "locator": "Complaint pp. 15–19, paragraphs 42–51 and footnote 43; broader harm discussion distinguished" }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.txnd.428372/gov.uscourts.txnd.428372.1.0.pdf", "locator": "Complaint PDF pp. 4-5, paragraph 11 and footnotes 4-9; pp. 15-19, paragraphs 42-51." } ] } }, { "id": "lilly-willow-2025", "case_name": "Eli Lilly and Company v. Willow Health Services Inc.", "category": "civil", "court_or_agency": "U.S. District Court, C.D. California", "docket_number": "2:25-cv-03570", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Willow" ], "parties": [ "Eli Lilly and Company", "Willow Health Services Inc." ], "filed_date": "2025-04-23", "status_date": "2026-08-12", "analysis": { "id": "lilly-willow-2025", "summary": { "text": "Lilly’s case against Willow Health Services challenged marketing of compounded tirzepatide, including personalization claims. The February 2026 ruling dismissed the first amended complaint with prejudice and without further leave to amend because Lilly had not adequately pleaded its own injury and causal connection under constitutional and Lanham Act standards. The truth of every advertisement was not adjudicated. Willow is consequently a clear example of why a dismissal should be described by its grounds. It is also not a closed historical endpoint: Lilly’s Ninth Circuit appeal is documented and had later briefing activity.", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf", "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317" ] }, "products": [ { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "The dismissal opinion describes Willow’s compounded-tirzepatide marketing and the challenged personalization representations.", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The reviewed record concerns marketing and pleading allegations. It does not establish the initial lead, a test purchase or the start of a government investigation.", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf", "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317" ] }, "challenged_conduct": [ { "text": "Lilly alleged deceptive compounded-tirzepatide promotion; the court found its pleaded commercial injury and causal theory insufficient.", "attribution": "allegation", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf", "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317" ] } ], "outcome": { "class": "dismissal", "text": "Dismissed with prejudice February 3, 2026. Appeal 26-1317 opened March 5; an August 12 order extended the answering-brief deadline to October 23, 2026. No appellate merits outcome is verified.", "as_of": "2026-08-12", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf", "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317" ] }, "timeline": [ { "date": "2025-04-23", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf", "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317" ] }, { "date": "2026-02-03", "event": "First amended complaint dismissed with prejudice without leave to amend for inadequate Article III and Lanham Act standing; court requested proposed judgment. Advertising truth was not adjudicated.", "kind": "dismissal", "date_basis": "event", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf" ] }, { "date": "2026-03-05", "event": "Ninth Circuit appeal 26-1317 opened from 2:25-cv-03570.", "kind": "appeal", "date_basis": "event", "sources": [ "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317" ] }, { "date": "2026-08-12", "event": "Court extended answering-brief deadline to October 23, 2026.", "kind": "appeal", "date_basis": "event", "sources": [ "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317" ] } ], "timing_pairs": [ { "label": "Complaint filing to district-court dismissal", "start": "2025-04-23", "end": "2026-02-03", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf" ], "days": 286 }, { "label": "District-court dismissal to appeal opening", "start": "2026-02-03", "end": "2026-03-05", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf", "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317" ], "days": 30 } ], "next_watch": { "text": "The recorded October 23, 2026 answering-brief deadline is the next scheduled appellate milestone, subject to later docket changes.", "basis": "scheduled_event", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf", "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317" ] }, "unknowns": [ "Appellate outcome unknown; dismissal does not certify product safety or advertising accuracy." ], "source_review": [ { "url": "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf", "review_basis": "archived_full_text", "locator": "February 3, 2026 dismissal opinion, standing analysis and conclusion" }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317", "review_basis": "registry_support_only", "locator": "Collected Ninth Circuit docket events" } ] }, "compounds": [ "tirzepatide" ], "marketing_or_supply_compounds": [ "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2026-08-12", "sources": [ { "url": "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf", "title": "Eli Lilly and Company v. Willow Health Services Inc. — dismissal", "source_type": "court_document", "document_type": "order", "supports": "First amended complaint dismissed with prejudice without leave to amend for inadequate Article III and Lanham Act standing; court requested proposed judgment. Advertising truth was not adjudicated." }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317", "title": "Willow Ninth Circuit appeal docket", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Case identity and the described procedural event." } ], "business_profile": { "id": "lilly-willow-2025", "display_name": "Willow", "identities": [ { "name": "Willow Health Services Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf" ] }, { "name": "Willow", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://a4pc.org/hubfs/CompConnex/2026-02_Lilly-v-Willow-Dismissed.pdf", "locator": "February 3, 2026 dismissal opinion, standing analysis and conclusion" }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca9/26-1317", "locator": "Collected Ninth Circuit docket events" } ] } }, { "id": "fda-719111", "case_name": "FDA warning letter: Atomix LLC", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 719111", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Atomix Research" ], "parties": [ "Atomix LLC" ], "filed_date": null, "status_date": "2025-12-12", "analysis": { "id": "fda-719111", "summary": { "text": "Atomix’s letter concerned MK2866, expressly identified as ostarine/enobosarm, and RAD140, identified as testolone. FDA cited website and social-media claims about muscle, bone and disease-related effects. The named products were advertised as research chemicals, but the agency assessed their surrounding promotional claims as establishing drug intent.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ] }, "products": [ { "name": "ostarine", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ], "normalized_names": [ "ostarine" ] }, { "name": "RAD-140", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ], "normalized_names": [ "RAD-140" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ] }, "challenged_conduct": [ { "text": "FDA assessed the offers as unapproved new drugs based on claims affecting human structure or function and treating disease, notwithstanding research disclaimers.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2025-12-12", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ] }, "timeline": [ { "date": "2025-03-04", "event": "FDA cited dated social-media material supporting its intended-use assessment.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ] }, { "date": "2025-11", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ] }, { "date": "2025-12-12", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "ostarine", "RAD-140" ], "marketing_or_supply_compounds": [ "ostarine", "RAD-140" ], "tested_compounds": [], "direct_compounds": [ "ostarine", "RAD-140" ], "latest_documented_date": "2025-12-12", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025", "title": "Atomix LLC — FDA warning letter 719111 — 2025-12-12", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-719111", "display_name": "Atomix LLC / Atomix Research", "identities": [ { "name": "Atomix LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ] }, { "name": "Atomix Research", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ] }, { "name": "atomixresearch.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ] } ], "activity": { "summary": "FDA cites March 4, 2025 social-media material and a November 2025 website review. The endpoints are evidence observations, not a proven continuous trading period.", "kind": "dated_observation", "start": "2025-03-04", "end": "2025-11", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked.", "The letter names Andrew Pierce as its recipient without an explicit ownership/executive title; that person is not promoted into a verified operator identity here." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/atomix-llc-719111-12122025", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-711330", "case_name": "FDA warning letter: Chengdu Brilliant Biopharmaceutical Co., Ltd.", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration, CDER", "docket_number": "MARCS-CMS 711330", "jurisdiction": "United States — FDA action concerning China-based manufacturer", "record_scope": "regulatory_action", "brands": [], "parties": [ "Chengdu Brilliant Biopharmaceutical Co., Ltd." ], "filed_date": null, "status_date": "2025-09-11", "analysis": { "id": "fda-711330", "summary": { "text": "Chengdu Brilliant was an upstream semaglutide active-ingredient manufacturer in this record, not simply a research-peptide storefront. FDA reviewed requested manufacturing records and identified missing process validation and incoming-material identity testing. The case concerns the quality system behind an ingredient supply, not just how a finished vial was advertised.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "The letter identifies semaglutide API manufacturing and supply; it does not report a patient-dose assay.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "The documented evidence-gathering step was FDA’s March 12 records request. Why FDA initiated that request is not established.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ] }, "challenged_conduct": [ { "text": "FDA assessed manufacturing controls as inconsistent with current good manufacturing practice, including failure to establish process reliability and verify incoming raw-material identity or the reliability of supplier certificates.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ] } ], "outcome": { "class": "warning_letter", "text": "FDA imposed an import-alert listing and subsequently issued the warning. The reviewed letter does not establish final remediation or removal from the alert.", "as_of": "2025-09-11", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ] }, "timeline": [ { "date": "2025-03-12", "event": "FDA requested manufacturing records under its statutory records authority.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ] }, { "date": "2025-07-09", "event": "FDA placed the firm on Import Alert 66-40.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ] }, { "date": "2025-09-11", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ] } ], "timing_pairs": [ { "label": "Documented records request to warning letter", "start": "2025-03-12", "end": "2025-09-11", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ], "days": 183 } ], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ] }, "unknowns": [ "The initial selection trigger, later corrective-action acceptance and current import-alert status were not established." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025", "review_basis": "official_web_full_text", "locator": "Records-request description, manufacturing deficiencies and import-alert paragraph" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2025-09-11", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025", "title": "Chengdu Brilliant Biopharmaceutical Co., Ltd. — 711330 — 2025-09-11", "source_type": "official_agency", "document_type": "warning_letter", "supports": "FDA cited lack of semaglutide API process validation and incoming-material identity testing; letter reports Import Alert 66-40 placement." } ], "business_profile": { "id": "fda-711330", "display_name": "Chengdu Brilliant Biopharmaceutical Co., Ltd.", "identities": [ { "name": "Chengdu Brilliant Biopharmaceutical Co., Ltd.", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ] }, { "name": "Zeng Dong", "kind": "operator", "basis": "FDA identifies this person as General Manager; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ] } ], "activity": { "summary": "FDA describes API manufacturing records reviewed after a March 12, 2025 records request. The request and September warning dates do not establish when manufacturing or semaglutide supply began or ended.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025" ], "limits": [ "The reviewed source does not establish the business launch, continuous operating period, or current trading status." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025", "locator": "Recipient identity/title block; inspection/records-review opening and operational findings" } ] } }, { "id": "fda-716152", "case_name": "FDA warning letter: Darmerica, LLC", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 716152", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Darmerica" ], "parties": [ "Darmerica, LLC" ], "filed_date": null, "status_date": "2025-12-08", "analysis": { "id": "fda-716152", "summary": { "text": "Darmerica supplied and repackaged active pharmaceutical ingredients. FDA’s inspection raised supplier, traceability and quality-control issues and separately challenged distribution of ingredients ineligible for the cited compounding pathway. Crucially, the letter records that Darmerica stopped retatrutide and cagrilintide distribution; FDA regarded those particular corrections as adequate while retaining other concerns.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] }, "products": [ { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "FDA identifies receipt/distribution of these bulk ingredients; this is supply-chain evidence, not proof of a particular finished-dose composition.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "normalized_names": [ "retatrutide" ] }, { "name": "cagrilintide acetate", "role": "reported_marketing_or_supply", "basis": "FDA identifies receipt/distribution of these bulk ingredients; this is supply-chain evidence, not proof of a particular finished-dose composition.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "normalized_names": [ "cagrilintide acetate" ] }, { "name": "dapoxetine hydrochloride", "role": "reported_marketing_or_supply", "basis": "FDA identifies receipt/distribution of these bulk ingredients; this is supply-chain evidence, not proof of a particular finished-dose composition.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "normalized_names": [ "dapoxetine hydrochloride" ] }, { "name": "2-methoxyestradiol", "role": "reported_marketing_or_supply", "basis": "FDA identifies receipt/distribution of these bulk ingredients; this is supply-chain evidence, not proof of a particular finished-dose composition.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "normalized_names": [ "2-methoxyestradiol" ] }, { "name": "tesofensine", "role": "reported_marketing_or_supply", "basis": "FDA identifies receipt/distribution of these bulk ingredients; this is supply-chain evidence, not proof of a particular finished-dose composition.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "normalized_names": [ "tesofensine" ] }, { "name": "FGL acetate", "role": "reported_marketing_or_supply", "basis": "FDA identifies receipt/distribution of these bulk ingredients; this is supply-chain evidence, not proof of a particular finished-dose composition.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "normalized_names": [ "FGL acetate" ] }, { "name": "thymogen", "role": "reported_marketing_or_supply", "basis": "FDA identifies receipt/distribution of these bulk ingredients; this is supply-chain evidence, not proof of a particular finished-dose composition.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "normalized_names": [ "thymogen" ] }, { "name": "buserelin acetate", "role": "reported_marketing_or_supply", "basis": "FDA identifies receipt/distribution of these bulk ingredients; this is supply-chain evidence, not proof of a particular finished-dose composition.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "normalized_names": [ "buserelin acetate" ] }, { "name": "elamipretide acetate", "role": "reported_marketing_or_supply", "basis": "FDA identifies receipt/distribution of these bulk ingredients; this is supply-chain evidence, not proof of a particular finished-dose composition.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "normalized_names": [ "elamipretide acetate" ] }, { "name": "larazotide acetate", "role": "reported_marketing_or_supply", "basis": "FDA identifies receipt/distribution of these bulk ingredients; this is supply-chain evidence, not proof of a particular finished-dose composition.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "normalized_names": [ "larazotide acetate" ] } ], "discovery": { "known": false, "text": "FDA’s onsite inspection is documented, but the initiating trigger is not. Earlier particle complaints form part of the evidence and are not established as the original reason for inspection.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] }, "challenged_conduct": [ { "text": "FDA identified deficient supplier qualification, complaint handling and release controls. It also assessed specified bulk substances distributed to pharmacies as ineligible for the claimed compounding exemptions. Particle complaints concerned redacted ingredients and cannot be assigned to retatrutide.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] } ], "outcome": { "class": "warning_letter", "text": "FDA’s warning acknowledged the retatrutide and cagrilintide corrective steps as apparently adequate. That limited acknowledgement is neither a blanket clearance nor evidence that those sales continued after the reported stop.", "as_of": "2025-12-08", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] }, "timeline": [ { "date": "2025-03-03", "event": "FDA began its inspection.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] }, { "date": "2025-03-19", "event": "The inspection ended.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] }, { "date": "2025-04-07", "event": "Darmerica submitted an inspection response.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] }, { "date": "2025-05-01", "event": "The firm reported ending retatrutide import/distribution and stopping cagrilintide distribution, with listing corrections.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] }, { "date": "2025-12-08", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] } ], "timing_pairs": [ { "label": "Inspection end to warning letter", "start": "2025-03-19", "end": "2025-12-08", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "days": 264 } ], "next_watch": { "text": "Look for resolution of the remaining quality-system findings and any independently documented changes in ingredient distribution.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] }, "unknowns": [ "Identity of ingredients in redacted particle complaints and the final disposition of other deficiencies are unknown." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025", "review_basis": "official_web_full_text", "locator": "Inspection history, quality-unit findings and distribution of ineligible bulk substances" } ] }, "compounds": [ "2-methoxyestradiol", "buserelin acetate", "cagrilintide acetate", "dapoxetine hydrochloride", "elamipretide acetate", "FGL acetate", "larazotide acetate", "retatrutide", "tesofensine", "thymogen" ], "marketing_or_supply_compounds": [ "2-methoxyestradiol", "buserelin acetate", "cagrilintide acetate", "dapoxetine hydrochloride", "elamipretide acetate", "FGL acetate", "larazotide acetate", "retatrutide", "tesofensine", "thymogen" ], "tested_compounds": [], "direct_compounds": [ "2-methoxyestradiol", "buserelin acetate", "cagrilintide acetate", "dapoxetine hydrochloride", "elamipretide acetate", "FGL acetate", "larazotide acetate", "retatrutide", "tesofensine", "thymogen" ], "latest_documented_date": "2025-12-08", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025", "title": "Darmerica, LLC — FDA warning letter 716152 — 2025-12-08", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-716152", "display_name": "Darmerica, LLC", "identities": [ { "name": "Darmerica, LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] }, { "name": "Kyle Hamza", "kind": "operator", "basis": "FDA identifies this person as Vice President; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ] } ], "activity": { "summary": "FDA reports GLP-1 API shipments to Darmerica since March 2022 and inspected its Davie facility March 3–19, 2025. A May 1, 2025 company response reported that retatrutide import/distribution and cagrilintide distribution had stopped. These are supply/inspection observations and a reported product-specific stop, not the company lifespan.", "kind": "dated_observation", "start": "2022-03", "end": "2025-03-19", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025" ], "limits": [ "The March 2022 date applies to GLP-1 API shipments generally; it does not establish the start of retatrutide sales.", "The precise last retatrutide or cagrilintide transaction is not given.", "FDA found those product-specific corrections apparently adequate; other findings remained. No overall closure or current operating status is established." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025", "locator": "Recipient block; inspection opening; Misbranded Drugs paragraphs beginning You received retatrutide, We have reviewed your May 1, 2025 email, and Since March 2022" } ] } }, { "id": "fda-738238", "case_name": "FDA warning letter: Empower Clinic Services, LLC dba Empower Pharmacy", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration, CDER", "docket_number": "MARCS-CMS 738238", "jurisdiction": "United States", "record_scope": "regulatory_action", "brands": [ "Empower Pharmacy" ], "parties": [ "Empower Clinic Services, LLC dba Empower Pharmacy" ], "filed_date": null, "status_date": "2026-09-18", "analysis": { "id": "fda-738238", "summary": { "text": "Empower Pharmacy’s letter follows an inspection of sterile compounding and records for semaglutide/cyanocobalamin and tirzepatide/niacinamide preparations. FDA questioned whether high-volume compounded products satisfied patient-specific significant-difference conditions and also raised aseptic-control concerns. It acknowledged some corrective work while finding other responses inadequate or insufficiently documented; this is not a final compliance clearance.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, "products": [ { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "FDA identifies compounded tirzepatide/niacinamide and semaglutide/cyanocobalamin preparations in inspected production records.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ], "normalized_names": [ "tirzepatide" ] }, { "name": "niacinamide", "role": "reported_marketing_or_supply", "basis": "FDA identifies compounded tirzepatide/niacinamide and semaglutide/cyanocobalamin preparations in inspected production records.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ], "normalized_names": [ "niacinamide" ] }, { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA identifies compounded tirzepatide/niacinamide and semaglutide/cyanocobalamin preparations in inspected production records.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ], "normalized_names": [ "semaglutide" ] }, { "name": "cyanocobalamin", "role": "reported_marketing_or_supply", "basis": "FDA identifies compounded tirzepatide/niacinamide and semaglutide/cyanocobalamin preparations in inspected production records.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ], "normalized_names": [ "cyanocobalamin" ] } ], "discovery": { "known": false, "text": "The inspection and production-record review are documented evidence-gathering steps. The source does not identify the initial trigger for inspecting Empower.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, "challenged_conduct": [ { "text": "FDA assessed certain preparations as essentially copies outside the claimed compounding exemption, questioning repeated or absent prescriber determinations. It separately identified insanitary conditions and manufacturing-control deficiencies. Those are agency assessments, not a court finding that every prescription was improper.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued the warning after multiple responses, accepting some corrective elements but retaining unresolved concerns. A later closeout or adjudicated final outcome is not established.", "as_of": "2026-09-18", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, "timeline": [ { "date": "2025-07", "event": "The reviewed production period began in July and continued through October.", "kind": "other", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, { "date": "2025-11-03", "event": "FDA began the inspection.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, { "date": "2025-11-14", "event": "Inspection ended and observations were issued.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, { "date": "2025-12-08", "event": "The firm submitted an initial response.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, { "date": "2026-03-18", "event": "The firm submitted a further response.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, { "date": "2026-04-30", "event": "FDA identified an additional response.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, { "date": "2026-09-18", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] } ], "timing_pairs": [ { "label": "Inspection end to warning letter", "start": "2025-11-14", "end": "2026-09-18", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ], "days": 308 } ], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, "unknowns": [ "Later correction acceptance, current production status and patient-level outcomes are not established." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026", "review_basis": "official_web_full_text", "locator": "Inspection history, section 503A discussion, Insanitary Conditions and Corrective Actions" } ] }, "compounds": [ "cyanocobalamin", "niacinamide", "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "cyanocobalamin", "niacinamide", "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "cyanocobalamin", "niacinamide", "semaglutide", "tirzepatide" ], "latest_documented_date": "2026-09-18", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026", "title": "Empower Clinic Services, LLC dba Empower Pharmacy — 738238 — 2026-09-18", "source_type": "official_agency", "document_type": "warning_letter", "supports": "FDA cited apparent routine/inordinate copying of marketed drugs, questioned individualized significant-difference determinations, and cited insanitary conditions." } ], "business_profile": { "id": "fda-738238", "display_name": "Empower Pharmacy / Empower Clinic Services, LLC", "identities": [ { "name": "Empower Clinic Services, LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, { "name": "Empower Pharmacy", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] }, { "name": "Arta Shaun Noorian", "kind": "operator", "basis": "FDA identifies this person as Founder and Chief Executive Officer; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ] } ], "activity": { "summary": "FDA describes the reviewed drug-production period as July–October 2025 and a later inspection November 3–14, 2025. The production period concerns the preparations examined in this letter, not the founding or full lifespan of Empower Pharmacy.", "kind": "documented_period", "start": "2025-07", "end": "2025-10", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026" ], "limits": [ "This is a source-described production period, not the complete trading history.", "The letter and corrective responses do not establish business closure or a final compliance closeout." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026", "locator": "Recipient identity/title block; inspection/records-review opening and operational findings" } ] } }, { "id": "fda-723330", "case_name": "FDA warning letter: Harbin Jixianglong Biotech Co., Ltd.", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 723330", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [], "parties": [ "Harbin Jixianglong Biotech Co., Ltd." ], "filed_date": null, "status_date": "2026-05-01", "analysis": { "id": "fda-723330", "summary": { "text": "Harbin Jixianglong’s letter concerns semaglutide and tirzepatide active ingredients. FDA found major manufacturing and supplier-control deficiencies, including relabeling externally sourced semaglutide as the firm’s own manufacture. The letter records a voluntary two-batch semaglutide recall and an import restriction before the warning. These are upstream ingredient events, not proof of contamination in every finished injection.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "Both APIs are identified in the manufacturing inspection; semaglutide batches were specifically distributed and recalled.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "Both APIs are identified in the manufacturing inspection; semaglutide batches were specifically distributed and recalled.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "FDA’s inspection and subsequent records/response review are documented. The reason for initiating the inspection is not established.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] }, "challenged_conduct": [ { "text": "FDA assessed supplier qualification, process/method and cleaning validation, water controls, traceability and batch dating as deficient. It challenged unsupported attribution of semaglutide manufacture and dating changes.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] } ], "outcome": { "class": "warning_letter", "text": "A voluntary recall and import restrictions preceded the warning. FDA did not regard the documented responses as resolving all concerns; no later closeout was located in the reviewed sources.", "as_of": "2026-05-01", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] }, "timeline": [ { "date": "2025-08-23", "event": "One semaglutide batch distribution date is identified in the letter.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] }, { "date": "2025-10-03", "event": "A further semaglutide batch distribution date is identified.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] }, { "date": "2025-11-03", "event": "FDA began the inspection.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] }, { "date": "2025-11-07", "event": "The inspection ended.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] }, { "date": "2026-02-19", "event": "The firm initiated a voluntary recall of two semaglutide batches.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] }, { "date": "2026-02-27", "event": "FDA added an Import Alert 66-40 restriction and removed the firm from the identified green list.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] }, { "date": "2026-05-01", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] } ], "timing_pairs": [ { "label": "Inspection end to voluntary recall", "start": "2025-11-07", "end": "2026-02-19", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ], "days": 104 } ], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] }, "unknowns": [ "Current import-alert status, final remediation and any finished-product patient exposure or injury are not established." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026", "review_basis": "official_web_full_text", "locator": "Inspection opening, supplier and manufacturing findings, recall and import-alert discussion" } ] }, "compounds": [ "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide", "tirzepatide" ], "latest_documented_date": "2026-05-01", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026", "title": "Harbin Jixianglong Biotech Co., Ltd. — FDA warning letter 723330 — 2026-05-01", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-723330", "display_name": "Harbin Jixianglong Biotech Co., Ltd.", "identities": [ { "name": "Harbin Jixianglong Biotech Co., Ltd.", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] }, { "name": "Guo Qing Leng", "kind": "operator", "basis": "FDA identifies this person as President and General Manager; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ] } ], "activity": { "summary": "The letter identifies semaglutide batch distributions on August 23 and October 3, 2025, followed by a November 3–7, 2025 inspection. These dated transactions and inspection do not establish the entire business operating period.", "kind": "dated_observation", "start": "2025-08-23", "end": "2025-11-07", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026" ], "limits": [ "No launch or closure date established.", "The February 19, 2026 voluntary recall is an action date, not an operating endpoint." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026", "locator": "Recipient identity/title block; inspection/records-review opening and operational findings" } ] } }, { "id": "fda-721088", "case_name": "FDA warning letter: Lovega LLC dba Pink Pony Peptides", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration, CDER", "docket_number": "MARCS-CMS 721088", "jurisdiction": "United States", "record_scope": "regulatory_action", "brands": [ "Pink Pony Peptides" ], "parties": [ "Lovega LLC dba Pink Pony Peptides" ], "filed_date": null, "status_date": "2026-03-31", "analysis": { "id": "fda-721088", "summary": { "text": "Pink Pony Peptides’ warning expressly identified GLP2TZ as tirzepatide and GLP3RT as retatrutide. FDA cited metabolic and weight-loss claims together with the marketed reconstitution water. The explicit identifications matter: these compounds can be compared by name here without guessing from a product code.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ] }, "products": [ { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ], "normalized_names": [ "tirzepatide" ] }, { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ], "normalized_names": [ "retatrutide" ] }, { "name": "bacteriostatic water", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ], "normalized_names": [ "bacteriostatic water" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ] }, "challenged_conduct": [ { "text": "FDA assessed the peptide offers and bacteriostatic water as unapproved new drugs. It considered the claims and injection-related context evidence of human-use intent despite research-only statements.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2026-03-31", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ] }, "timeline": [ { "date": "2025-12", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ] }, { "date": "2026-03-31", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "bacteriostatic water", "retatrutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "bacteriostatic water", "retatrutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "bacteriostatic water", "retatrutide", "tirzepatide" ], "latest_documented_date": "2026-03-31", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026", "title": "Lovega LLC dba Pink Pony Peptides — 721088 — 2026-03-31", "source_type": "official_agency", "document_type": "warning_letter", "supports": "FDA cited unapproved-new-drug sales, finding human-use intent despite research-only labeling; cited paired sale of bacteriostatic water." } ], "business_profile": { "id": "fda-721088", "display_name": "Pink Pony Peptides / Lovega LLC", "identities": [ { "name": "Lovega LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ] }, { "name": "Pink Pony Peptides", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ] }, { "name": "pinkponypeptides.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2025-12. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2025-12", "end": "2025-12", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked.", "The letter names Susan Vega as its recipient without an explicit ownership/executive title; that person is not promoted into a verified operator identity here." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovega-llc-dba-pink-pony-peptides-721088-03312026", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-719339", "case_name": "FDA warning letter: Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 719339", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Monster King", "GE Labs" ], "parties": [ "Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS" ], "filed_date": null, "status_date": "2025-12-12", "analysis": { "id": "fda-719339", "summary": { "text": "Musclepower’s MONSTER KING and GE LABS matter includes an actual product test. FDA bought samples in March 2025 and found undeclared trendione in GE Labs Ykarine. The letter also concerned an MK677/ibutamoren offer. Ykarine is retained as a product name: the reviewed letter does not establish that it should simply be normalized to YK-11.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] }, "products": [ { "name": "GE Labs Ykarine", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ], "normalized_names": [ "GE Labs Ykarine" ] }, { "name": "ibutamoren", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ], "normalized_names": [ "ibutamoren" ] }, { "name": "trendione", "role": "tested_contents", "basis": "FDA analysis of a purchased Ykarine sample detected undeclared trendione.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ], "normalized_names": [ "trendione" ] } ], "discovery": { "known": false, "text": "The agency reports sample purchases and website review during March–November 2025. It does not disclose the initial reason for selecting the seller. Sample acquisition is evidence gathering, not necessarily the first detection.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] }, "challenged_conduct": [ { "text": "FDA challenged unapproved drug claims, supplement classification and misbranding involving the undeclared steroid trendione. Ibutamoren’s legal exclusion from the dietary-supplement definition was separately discussed.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and noted that the two products appeared no longer available for U.S. sale through monsterking.eu as of the letter. That observation does not establish worldwide cessation or a formal closeout.", "as_of": "2025-12-12", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] }, "timeline": [ { "date": "2025-03", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] }, { "date": "2025-03", "event": "FDA purchased product samples subsequently analyzed; website review continued through November.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] }, { "date": "2025-12-12", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] }, "unknowns": [ "Ykarine’s complete composition, the original inquiry trigger and later disposition are unknown. The observed U.S. availability change is limited to the identified website." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025", "review_basis": "official_web_full_text", "locator": "Website review and sampling paragraphs, unapproved drugs, misbranding and footnote 6" } ] }, "compounds": [ "GE Labs Ykarine", "ibutamoren", "trendione" ], "marketing_or_supply_compounds": [ "GE Labs Ykarine", "ibutamoren" ], "tested_compounds": [ "trendione" ], "direct_compounds": [ "GE Labs Ykarine", "ibutamoren", "trendione" ], "latest_documented_date": "2025-12-12", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025", "title": "Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS — FDA warning letter 719339 — 2025-12-12", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-719339", "display_name": "MONSTER KING and GE LABS / Musclepower Enterprise Ltd.", "identities": [ { "name": "Musclepower Enterprise Ltd.", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] }, { "name": "MONSTER KING", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] }, { "name": "GE LABS", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] }, { "name": "monsterking.eu", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] }, { "name": "gelabsonline.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ] } ], "activity": { "summary": "FDA purchased product samples in March 2025 and reviewed the two websites between March and November 2025. It separately reported that the two products appeared unavailable for U.S. sale through monsterking.eu by the letter date; that is not worldwide closure. The endpoints are evidence observations, not a proven continuous trading period.", "kind": "dated_observation", "start": "2025-03", "end": "2025-11", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-733652", "case_name": "FDA warning letter: NuScience Peptides LLC", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 733652", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "NuScience Peptides" ], "parties": [ "NuScience Peptides LLC" ], "filed_date": null, "status_date": "2026-08-24", "analysis": { "id": "fda-733652", "summary": { "text": "NuScience’s warning covered multiple peptide offers and bacteriostatic water. The letter expressly names retatrutide and links other product discussions to semaglutide, survodutide, mazdutide, bremelanotide, tesamorelin and ipamorelin. Its GLP2 Tirz product is retained as coded where the reproduced text does not supply the full generic identity. Advertised mechanisms are not demonstrated product benefits.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ], "normalized_names": [ "semaglutide" ] }, { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ], "normalized_names": [ "retatrutide" ] }, { "name": "survodutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ], "normalized_names": [ "survodutide" ] }, { "name": "mazdutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ], "normalized_names": [ "mazdutide" ] }, { "name": "bremelanotide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ], "normalized_names": [ "bremelanotide" ] }, { "name": "tesamorelin", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ], "normalized_names": [ "tesamorelin" ] }, { "name": "ipamorelin", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ], "normalized_names": [ "ipamorelin" ] }, { "name": "bacteriostatic water", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ], "normalized_names": [ "bacteriostatic water" ] }, { "name": "GLP2 Tirz", "role": "unclear", "basis": "The coded offer is reproduced; a full generic-name mapping is not established in the reviewed passage.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ], "normalized_names": [ "GLP2 Tirz" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] }, "challenged_conduct": [ { "text": "FDA assessed metabolic, disease, sexual-function and other human-use claims, plus reconstitution context, as supporting unapproved-new-drug findings despite research labeling.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2026-08-24", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] }, "timeline": [ { "date": "2026-07", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] }, { "date": "2026-08-24", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] }, "unknowns": [ "Full generic identity of GLP2 Tirz, actual batch contents, initial trigger and later response or closeout are not established." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "bacteriostatic water", "bremelanotide", "GLP2 Tirz", "ipamorelin", "mazdutide", "retatrutide", "semaglutide", "survodutide", "tesamorelin" ], "marketing_or_supply_compounds": [ "bacteriostatic water", "bremelanotide", "ipamorelin", "mazdutide", "retatrutide", "semaglutide", "survodutide", "tesamorelin" ], "tested_compounds": [], "direct_compounds": [ "bacteriostatic water", "bremelanotide", "ipamorelin", "mazdutide", "retatrutide", "semaglutide", "survodutide", "tesamorelin" ], "latest_documented_date": "2026-08-24", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026", "title": "NuScience Peptides LLC — FDA warning letter 733652 — 2026-08-24", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-733652", "display_name": "NuScience Peptides LLC", "identities": [ { "name": "NuScience Peptides LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] }, { "name": "NuScience Peptides", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] }, { "name": "nusciencepeptides.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] }, { "name": "Joseph DeRosa", "kind": "operator", "basis": "FDA identifies this person as Manager; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] }, { "name": "Ratsamy DeRosa", "kind": "operator", "basis": "FDA identifies this person as Manager; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2026-07. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2026-07", "end": "2026-07", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-735127", "case_name": "FDA warning letter: Peak Performance Peptides", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 735127", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Peak Performance Peptides", "pppepz.com" ], "parties": [ "Peak Performance Peptides" ], "filed_date": null, "status_date": "2026-08-24", "analysis": { "id": "fda-735127", "summary": { "text": "Peak Performance Peptides’ warning expressly identifies GLP3R as retatrutide and connects SS31 with elamipretide. It also names semaglutide, PT141, tesamorelin and bacteriostatic water. The PT141 generic-name mapping in the product list is separately sourced, rather than inferred from this letter alone. Clinical and mechanistic claims are marketing evidence, not proven effects of the products.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ] }, "products": [ { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ], "normalized_names": [ "retatrutide" ] }, { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ], "normalized_names": [ "semaglutide" ] }, { "name": "elamipretide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ], "normalized_names": [ "elamipretide" ] }, { "name": "bremelanotide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents. The source label is PT-141; generic-name mapping uses the separately cited FDA Royal Peptides letter, which explicitly supplies this alias. Neither source proves batch contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "normalized_names": [ "bremelanotide" ] }, { "name": "tesamorelin", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ], "normalized_names": [ "tesamorelin" ] }, { "name": "bacteriostatic water", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ], "normalized_names": [ "bacteriostatic water" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ] }, "challenged_conduct": [ { "text": "FDA assessed the offered products as unapproved new drugs based on human-use claims and reconstitution context despite research disclaimers.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2026-08-24", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ] }, "timeline": [ { "date": "2026-07", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ] }, { "date": "2026-08-24", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" }, { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026", "review_basis": "official_web_full_text", "locator": "SS-31 (Elamipretide) heading and PT-141/Bremelanotide product discussion; used only for explicit alias support" } ] }, "compounds": [ "bacteriostatic water", "bremelanotide", "elamipretide", "retatrutide", "semaglutide", "tesamorelin" ], "marketing_or_supply_compounds": [ "bacteriostatic water", "bremelanotide", "elamipretide", "retatrutide", "semaglutide", "tesamorelin" ], "tested_compounds": [], "direct_compounds": [ "bacteriostatic water", "bremelanotide", "elamipretide", "retatrutide", "semaglutide", "tesamorelin" ], "latest_documented_date": "2026-08-24", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026", "title": "Peak Performance Peptides — FDA warning letter 735127 — 2026-08-24", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-735127", "display_name": "Peak Performance Peptides", "identities": [ { "name": "Peak Performance Peptides", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ] }, { "name": "pppepz.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ] }, { "name": "Jeffrey Deng", "kind": "operator", "basis": "FDA identifies this person as Founder; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2026-07. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2026-07", "end": "2026-07", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-721817", "case_name": "FDA warning letter: Peaks Curative, LLC dba Peaks", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration, CDER", "docket_number": "MARCS-CMS 721817", "jurisdiction": "United States", "record_scope": "regulatory_action", "brands": [ "Peaks", "Peak Now" ], "parties": [ "Peaks Curative, LLC dba Peaks" ], "filed_date": null, "status_date": "2026-02-20", "analysis": { "id": "fda-721817", "summary": { "text": "Peaks Curative’s warning concerned compounded semaglutide marketing. FDA objected to statements about approval, safety and effectiveness and to a pictured PeakNow label suggesting that Peaks was the compounder. The problem identified was the promotional representation and attribution of compounding, not an assay showing that the preparation contained a different active ingredient.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ] }, "challenged_conduct": [ { "text": "FDA assessed the marketing and label depiction as false or misleading and requested identification of the actual compounders and associated labels.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2026-02-20", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ] }, "timeline": [ { "date": "2025-12", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ] }, { "date": "2026-02-20", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ] }, "unknowns": [ "The initial trigger, independently verified manufacturing arrangements, later label changes and final regulatory disposition are not established." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2026-02-20", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026", "title": "Peaks Curative, LLC dba Peaks — 721817 — 2026-02-20", "source_type": "official_agency", "document_type": "warning_letter", "supports": "FDA cited misleading compounded-drug advertising, including implied FDA approval and identification of Peak Now as compounder when FDA said it was not." } ], "business_profile": { "id": "fda-721817", "display_name": "Peaks / Peaks Curative, LLC", "identities": [ { "name": "Peaks Curative, LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ] }, { "name": "Peaks", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ] }, { "name": "peakscurative.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2025-12. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2025-12", "end": "2025-12", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peaks-curative-llc-dba-peaks-721817-02202026", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-721709", "case_name": "FDA warning letter: PekCura Labs", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration, CDER", "docket_number": "MARCS-CMS 721709", "jurisdiction": "United States", "record_scope": "regulatory_action", "brands": [ "PekCura Labs" ], "parties": [ "PekCura Labs" ], "filed_date": null, "status_date": "2026-03-31", "analysis": { "id": "fda-721709", "summary": { "text": "PekCura Labs was warned over coded peptide offers, a combination product and reconstitution water. The letter reproduces GLP1S, GLP2T and GLP3R names, but does not expressly translate all of those codes into generic ingredients. Cagrilintide is identified in discussion of the blend. The analysis therefore preserves the coded identities rather than silently counting GLP3R as retatrutide.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ] }, "products": [ { "name": "GLP1S", "role": "unclear", "basis": "Product offers are documented, but generic identities are not fully decoded by this letter.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ], "normalized_names": [ "GLP1S" ] }, { "name": "GLP2T", "role": "unclear", "basis": "Product offers are documented, but generic identities are not fully decoded by this letter.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ], "normalized_names": [ "GLP2T" ] }, { "name": "GLP3R", "role": "unclear", "basis": "Product offers are documented, but generic identities are not fully decoded by this letter.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ], "normalized_names": [ "GLP3R" ] }, { "name": "Cag (1 mg) Tirz (10 mg) blend", "role": "unclear", "basis": "Product offers are documented, but generic identities are not fully decoded by this letter.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ], "normalized_names": [ "Cag (1 mg) Tirz (10 mg) blend" ] }, { "name": "cagrilintide", "role": "reported_marketing_or_supply", "basis": "The reproduced blend discussion explicitly names cagrilintide.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ], "normalized_names": [ "cagrilintide" ] }, { "name": "bacteriostatic water", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ], "normalized_names": [ "bacteriostatic water" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ] }, "challenged_conduct": [ { "text": "FDA assessed disease and body-function claims, clinical-study discussion and injection-related supplies as establishing unapproved drug uses despite research disclaimers.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2026-03-31", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ] }, "timeline": [ { "date": "2026-01", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ] }, { "date": "2026-03-31", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ] }, "unknowns": [ "Generic identity of the coded products, actual contents, initial trigger and subsequent corrective-action status remain unresolved." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "bacteriostatic water", "Cag (1 mg) Tirz (10 mg) blend", "cagrilintide", "GLP1S", "GLP2T", "GLP3R" ], "marketing_or_supply_compounds": [ "bacteriostatic water", "cagrilintide" ], "tested_compounds": [], "direct_compounds": [ "bacteriostatic water", "cagrilintide" ], "latest_documented_date": "2026-03-31", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026", "title": "PekCura Labs — 721709 — 2026-03-31", "source_type": "official_agency", "document_type": "warning_letter", "supports": "FDA cited unapproved-new-drug sales and human-use evidence for coded GLP products and bacteriostatic water; also cited Cag/Tirz blend claims." } ], "business_profile": { "id": "fda-721709", "display_name": "PekCura Labs", "identities": [ { "name": "PekCura Labs", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ] }, { "name": "pekcuralabs.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ] }, { "name": "Jonathan Snider", "kind": "operator", "basis": "FDA identifies this person as Owner; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ] }, { "name": "Jonathan Speck", "kind": "operator", "basis": "FDA identifies this person as Owner; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2026-01. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2026-01", "end": "2026-01", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pekcura-labs-721709-03312026", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-735063", "case_name": "FDA warning letter: Peptide Partners LLC", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 735063", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Peptide Partners" ], "parties": [ "Peptide Partners LLC" ], "filed_date": null, "status_date": "2026-08-24", "analysis": { "id": "fda-735063", "summary": { "text": "Peptide Partners’ warning explicitly maps its GLP1S, GLP2T and GLP3Reta labels to generic ingredients. FDA also names SS31/elamipretide, Tesa/tesamorelin and PT141/bremelanotide. The letter cites study summaries and disease-related statements associated with sales pages, together with bacteriostatic reconstitution solution. Those mappings support compound comparison without inferring identity from abbreviated branding alone.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ], "normalized_names": [ "tirzepatide" ] }, { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ], "normalized_names": [ "retatrutide" ] }, { "name": "elamipretide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ], "normalized_names": [ "elamipretide" ] }, { "name": "tesamorelin", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ], "normalized_names": [ "tesamorelin" ] }, { "name": "bremelanotide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ], "normalized_names": [ "bremelanotide" ] }, { "name": "bacteriostatic water", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ], "normalized_names": [ "bacteriostatic water" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ] }, "challenged_conduct": [ { "text": "FDA assessed the offers as unapproved new drugs, relying on promoted metabolic, kidney, liver, retinal and other disease/function uses. The warning does not validate the cited benefits or analytically establish the shipped products.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2026-08-24", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ] }, "timeline": [ { "date": "2026-07", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ] }, { "date": "2026-08-24", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "bacteriostatic water", "bremelanotide", "elamipretide", "retatrutide", "semaglutide", "tesamorelin", "tirzepatide" ], "marketing_or_supply_compounds": [ "bacteriostatic water", "bremelanotide", "elamipretide", "retatrutide", "semaglutide", "tesamorelin", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "bacteriostatic water", "bremelanotide", "elamipretide", "retatrutide", "semaglutide", "tesamorelin", "tirzepatide" ], "latest_documented_date": "2026-08-24", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026", "title": "Peptide Partners LLC — FDA warning letter 735063 — 2026-08-24", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-735063", "display_name": "Peptide Partners LLC", "identities": [ { "name": "Peptide Partners LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ] }, { "name": "Peptide Partners", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ] }, { "name": "peptide.partners", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2026-07. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2026-07", "end": "2026-07", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked.", "The letter names Zachary David Hoff as its recipient without an explicit ownership/executive title; that person is not promoted into a verified operator identity here." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-719337", "case_name": "FDA warning letter: Pinnacle Professional Research dba Pinnacle Peptides", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 719337", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Pinnacle Peptides" ], "parties": [ "Pinnacle Professional Research dba Pinnacle Peptides" ], "filed_date": null, "status_date": "2025-12-12", "analysis": { "id": "fda-719337", "summary": { "text": "Pinnacle Professional Research, trading as Pinnacle Peptides, was warned about three named SARM products. FDA expressly linked Andarine S4, LGD4033/Ligandrol and MK2866/ostarine to the offers. Cancer, osteoporosis, muscle and insulin-sensitivity claims formed part of the evidence. The business name alone does not make this a peptide-specific action.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ] }, "products": [ { "name": "andarine", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ], "normalized_names": [ "andarine" ] }, { "name": "LGD-4033", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ], "normalized_names": [ "LGD-4033" ] }, { "name": "ostarine", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ], "normalized_names": [ "ostarine" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ] }, "challenged_conduct": [ { "text": "FDA assessed the advertised products as unapproved new drugs. The letter relies on intended-use claims and does not report laboratory confirmation of the contents or a final adjudication.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2025-12-12", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ] }, "timeline": [ { "date": "2025-11", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ] }, { "date": "2025-12-12", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "andarine", "LGD-4033", "ostarine" ], "marketing_or_supply_compounds": [ "andarine", "LGD-4033", "ostarine" ], "tested_compounds": [], "direct_compounds": [ "andarine", "LGD-4033", "ostarine" ], "latest_documented_date": "2025-12-12", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025", "title": "Pinnacle Professional Research dba Pinnacle Peptides — FDA warning letter 719337 — 2025-12-12", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-719337", "display_name": "Pinnacle Peptides / Pinnacle Professional Research", "identities": [ { "name": "Pinnacle Professional Research", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ] }, { "name": "Pinnacle Peptides", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ] }, { "name": "pinnaclepeptides.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2025-11. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2025-11", "end": "2025-11", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-719433", "case_name": "FDA warning letter: Prime Sports Nutrition", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 719433", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Prime Sports Nutrition" ], "parties": [ "Prime Sports Nutrition" ], "filed_date": null, "status_date": "2025-12-12", "analysis": { "id": "fda-719433", "summary": { "text": "Prime Sports Nutrition received a warning over products advertised for sports performance, body composition and other human effects. The letter named LGD4033, RAD140, ibutamoren/MK677 and S23. Ibutamoren is listed by its name rather than automatically classified as a pharmacological SARM simply because the marketing grouped it with SARMs.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ] }, "products": [ { "name": "LGD-4033", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ], "normalized_names": [ "LGD-4033" ] }, { "name": "RAD-140", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ], "normalized_names": [ "RAD-140" ] }, { "name": "ibutamoren", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ], "normalized_names": [ "ibutamoren" ] }, { "name": "S-23", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ], "normalized_names": [ "S-23" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ] }, "challenged_conduct": [ { "text": "FDA assessed the offers as unapproved new drugs, citing muscle and body-function claims alongside disease-related and sexual-function statements. A research-compound disclaimer did not resolve the intended-use findings.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2025-12-12", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ] }, "timeline": [ { "date": "2025-11", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ] }, { "date": "2025-12-12", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "ibutamoren", "LGD-4033", "RAD-140", "S-23" ], "marketing_or_supply_compounds": [ "ibutamoren", "LGD-4033", "RAD-140", "S-23" ], "tested_compounds": [], "direct_compounds": [ "ibutamoren", "LGD-4033", "RAD-140", "S-23" ], "latest_documented_date": "2025-12-12", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025", "title": "Prime Sports Nutrition — FDA warning letter 719433 — 2025-12-12", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-719433", "display_name": "Prime Sports Nutrition", "identities": [ { "name": "Prime Sports Nutrition", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ] }, { "name": "primesportsnutrition.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ] }, { "name": "Fernando Arias", "kind": "operator", "basis": "FDA identifies this person as Owner; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2025-11. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2025-11", "end": "2025-11", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sports-nutrition-719433-12122025", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-695156", "case_name": "FDA warning letter: Prime Vitality, Inc. dba Prime Peptides", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 695156", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Prime Peptides" ], "parties": [ "Prime Vitality, Inc. dba Prime Peptides" ], "filed_date": null, "status_date": "2024-12-10", "analysis": { "id": "fda-695156", "summary": { "text": "Prime Vitality, trading as Prime Peptides, was warned about semaglutide and retatrutide offers supported by website and social-media claims. FDA cited weight-loss, diabetes and liver-fat material, including consumer-facing promotional content. Tirzepatide appeared in the surrounding blog/video discussion, but the letter’s two challenged offered products were semaglutide and retatrutide.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ], "normalized_names": [ "semaglutide" ] }, { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ], "normalized_names": [ "retatrutide" ] }, { "name": "tirzepatide", "role": "background", "basis": "Mentioned in cited educational/promotional material; not one of the two offered products identified for this warning.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ] }, "challenged_conduct": [ { "text": "FDA assessed the two products as unapproved new drugs. It treated the surrounding health claims and testimonials as evidence of intended human use notwithstanding the seller’s research disclaimer.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2024-12-10", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ] }, "timeline": [ { "date": "2024-06-23", "event": "One retatrutide social-media post later cited by FDA was dated this day.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ] }, { "date": "2024-10", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ] }, { "date": "2024-12-10", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "retatrutide", "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "retatrutide", "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "retatrutide", "semaglutide" ], "latest_documented_date": "2024-12-10", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024", "title": "Prime Vitality, Inc. dba Prime Peptides — FDA warning letter 695156 — 2024-12-10", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-695156", "display_name": "Prime Peptides / Prime Vitality, Inc.", "identities": [ { "name": "Prime Vitality, Inc.", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ] }, { "name": "Prime Peptides", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ] }, { "name": "primepeptides.co", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ] } ], "activity": { "summary": "FDA cites a June 23, 2024 retatrutide promotion and an October 2024 website review. The endpoints are evidence observations, not a proven continuous trading period.", "kind": "dated_observation", "start": "2024-06-23", "end": "2024-10", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked.", "The letter names Curtis Miller as its recipient without an explicit ownership/executive title; that person is not promoted into a verified operator identity here." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-vitality-inc-dba-prime-peptides-695156-12102024", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-723704", "case_name": "FDA warning letter: ProRx LLC", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration, CDER", "docket_number": "MARCS-CMS 723704", "jurisdiction": "United States", "record_scope": "regulatory_action", "brands": [ "ProRx" ], "parties": [ "ProRx LLC" ], "filed_date": null, "status_date": "2026-04-07", "analysis": { "id": "fda-723704", "summary": { "text": "ProRx’s outsourcing-facility inspection led to a warning over sterile-drug production, compounding conditions and other compliance issues. The letter records an October 2025 voluntary recall of specified tirzepatide and semaglutide lots for insufficient sterility assurance. It also acknowledges corrective responses. Insufficient assurance is not proof that every recalled vial was contaminated.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] }, "products": [ { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ], "normalized_names": [ "tirzepatide" ] }, { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "An onsite inspection supplied the evidence. The source does not explain the initial reason FDA selected this facility for inspection.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] }, "challenged_conduct": [ { "text": "FDA identified inadequate aseptic controls and investigations, including microbial findings, plus failures to satisfy relevant outsourcing-facility conditions. It also challenged tirzepatide production from bulk substance outside the applicable list/shortage conditions.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] } ], "outcome": { "class": "warning_letter", "text": "The firm recalled affected lots and reported pausing aseptic compounding pending cleanroom certification. FDA accepted some corrective elements but considered others inadequate or insufficiently documented. The warning is not a final closeout.", "as_of": "2026-04-07", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] }, "timeline": [ { "date": "2025-09-09", "event": "FDA began the facility inspection.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] }, { "date": "2025-09-19", "event": "Inspection ended and FDA issued inspection observations.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] }, { "date": "2025-10-10", "event": "FDA amended the inspection observations.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] }, { "date": "2025-10-15", "event": "The firm voluntarily recalled specified tirzepatide and semaglutide lots.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] }, { "date": "2025-10-24", "event": "The firm submitted a response; subsequent correspondence continued.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] }, { "date": "2026-02-13", "event": "The letter identifies further correspondence from the firm.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] }, { "date": "2026-04-07", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] } ], "timing_pairs": [ { "label": "Inspection end to warning letter", "start": "2025-09-19", "end": "2026-04-07", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ], "days": 200 } ], "next_watch": { "text": "Monitor a closeout, recall updates and documented restoration of compliant sterile operations, without assuming either continuing failure or completed remediation.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] }, "unknowns": [ "Later resumption of aseptic operations, current recall completion and final FDA disposition are not established. Other non-peptide products also appear in the letter; this product list focuses on the GLP-1 preparations." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026", "review_basis": "official_web_full_text", "locator": "Inspection history, recall paragraph, Unapproved New Drug Products, Insanitary Conditions and Corrective Actions" } ] }, "compounds": [ "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide", "tirzepatide" ], "latest_documented_date": "2026-04-07", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026", "title": "ProRx LLC — 723704 — 2026-04-07", "source_type": "official_agency", "document_type": "warning_letter", "supports": "FDA cited 503B eligibility failures and sterile-manufacturing deficiencies; acknowledged October 2025 recall and some corrective actions." } ], "business_profile": { "id": "fda-723704", "display_name": "ProRx LLC", "identities": [ { "name": "ProRx LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] }, { "name": "ProRx", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ] } ], "activity": { "summary": "FDA inspected the producing facility September 9–19, 2025. The letter separately records outsourcing-facility registration on April 27, 2022 and February 20, 2026, and an October 15, 2025 voluntary lot recall. Registration dates are not proof of first sales or uninterrupted operation.", "kind": "dated_observation", "start": "2025-09-09", "end": "2025-09-19", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026" ], "limits": [ "Inspection endpoints date observations, not the business lifespan.", "Reported pause in aseptic compounding does not establish permanent closure or later resumption." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026", "locator": "Recipient identity/title block; inspection/records-review opening and operational findings" } ] } }, { "id": "fda-715218", "case_name": "FDA warning letter: PureRawz", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 715218", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "PureRawz" ], "parties": [ "PureRawz" ], "filed_date": null, "status_date": "2025-09-08", "analysis": { "id": "fda-715218", "summary": { "text": "PureRawz’s warning in this collection concerned tianeptine products, including several chemical forms and an Ultimate-branded offering. FDA cited mood, depression and anxiety marketing across the website and social channels. It should not be counted as a retatrutide or peptide warning simply because the business may be associated with a broader research-chemical market.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ] }, "products": [ { "name": "tianeptine ethyl ester sulfate", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ], "normalized_names": [ "tianeptine ethyl ester sulfate" ] }, { "name": "tianeptine free acid", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ], "normalized_names": [ "tianeptine free acid" ] }, { "name": "tianeptine sodium", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ], "normalized_names": [ "tianeptine sodium" ] }, { "name": "tianeptine sulfate", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ], "normalized_names": [ "tianeptine sulfate" ] }, { "name": "Tianeptine Ultimate", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ], "normalized_names": [ "Tianeptine Ultimate" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ] }, "challenged_conduct": [ { "text": "FDA assessed the advertised tianeptine products as unapproved new drugs based on therapeutic and body-function claims despite research-only language.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2025-09-08", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ] }, "timeline": [ { "date": "2025-03-12", "event": "A social-media post later cited by FDA promoted tianeptine.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ] }, { "date": "2025-08", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ] }, { "date": "2025-09-08", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "tianeptine ethyl ester sulfate", "tianeptine free acid", "tianeptine sodium", "tianeptine sulfate", "Tianeptine Ultimate" ], "marketing_or_supply_compounds": [ "tianeptine ethyl ester sulfate", "tianeptine free acid", "tianeptine sodium", "tianeptine sulfate", "Tianeptine Ultimate" ], "tested_compounds": [], "direct_compounds": [ "tianeptine ethyl ester sulfate", "tianeptine free acid", "tianeptine sodium", "tianeptine sulfate", "Tianeptine Ultimate" ], "latest_documented_date": "2025-09-08", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025", "title": "PureRawz — FDA warning letter 715218 — 2025-09-08", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-715218", "display_name": "PureRawz", "identities": [ { "name": "PureRawz", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ] }, { "name": "purerawz.co", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ] } ], "activity": { "summary": "FDA cites a March 12, 2025 social-media promotion and an August 2025 website review. The endpoints are evidence observations, not a proven continuous trading period.", "kind": "dated_observation", "start": "2025-03-12", "end": "2025-08", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked.", "The letter names Seann Gloss as its recipient without an explicit ownership/executive title; that person is not promoted into a verified operator identity here." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purerawz-715218-09082025", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-734884", "case_name": "FDA warning letter: Royal Peptides LLC", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 734884", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Royal Peptides" ], "parties": [ "Royal Peptides LLC" ], "filed_date": null, "status_date": "2026-08-24", "analysis": { "id": "fda-734884", "summary": { "text": "Royal Peptides’ warning combined GLP-1-related offers with other peptide products. The letter expressly identifies the retatrutide/tirzepatide mix pack and the tesamorelin–ipamorelin BIMORELIN blend, alongside other named compounds. FDA used metabolic, mitochondrial, sexual-function and growth-related claims to assess intended human drug use, rather than accepting the research disclaimer in isolation.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] }, "products": [ { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "normalized_names": [ "tirzepatide" ] }, { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "normalized_names": [ "semaglutide" ] }, { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "normalized_names": [ "retatrutide" ] }, { "name": "elamipretide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "normalized_names": [ "elamipretide" ] }, { "name": "bremelanotide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "normalized_names": [ "bremelanotide" ] }, { "name": "tesamorelin", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "normalized_names": [ "tesamorelin" ] }, { "name": "ipamorelin", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "normalized_names": [ "ipamorelin" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] }, "challenged_conduct": [ { "text": "FDA assessed the listed products as unapproved new drugs based on therapeutic and body-function promotion. Scientific references in the offer pages were part of the agency’s evidence, not agency endorsement of efficacy.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2026-08-24", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] }, "timeline": [ { "date": "2026-07", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] }, { "date": "2026-08-24", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "bremelanotide", "elamipretide", "ipamorelin", "retatrutide", "semaglutide", "tesamorelin", "tirzepatide" ], "marketing_or_supply_compounds": [ "bremelanotide", "elamipretide", "ipamorelin", "retatrutide", "semaglutide", "tesamorelin", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "bremelanotide", "elamipretide", "ipamorelin", "retatrutide", "semaglutide", "tesamorelin", "tirzepatide" ], "latest_documented_date": "2026-08-24", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026", "title": "Royal Peptides LLC — FDA warning letter 734884 — 2026-08-24", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-734884", "display_name": "Royal Peptides LLC", "identities": [ { "name": "Royal Peptides LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] }, { "name": "Royal Peptides", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] }, { "name": "royal-peptides.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] }, { "name": "Rocco Abate", "kind": "operator", "basis": "FDA identifies this person as Manager; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] }, { "name": "Michael Fraunfelter", "kind": "operator", "basis": "FDA identifies this person as Manager; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2026-07. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2026-07", "end": "2026-07", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-695607", "case_name": "FDA warning letter: Summit Research Peptides", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 695607", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Summit Research Peptides" ], "parties": [ "Summit Research Peptides" ], "filed_date": null, "status_date": "2024-12-10", "analysis": { "id": "fda-695607", "summary": { "text": "Summit Research Peptides was warned after FDA reviewed its website and Facebook marketing. The letter expressly decoded Sema, Reta and Tirz, avoiding reliance on inferred aliases. It cited metabolic and weight-loss claims, including discussion of combinations, as evidence that these ostensibly research products were offered for human drug uses.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ], "normalized_names": [ "semaglutide" ] }, { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ], "normalized_names": [ "retatrutide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ], "normalized_names": [ "tirzepatide" ] }, { "name": "cagrilintide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ], "normalized_names": [ "cagrilintide" ] }, { "name": "mazdutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ], "normalized_names": [ "mazdutide" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ] }, "challenged_conduct": [ { "text": "FDA assessed the offers as unapproved new drugs. Its findings concerned claims establishing intended use, rather than a finding that particular purchasers suffered injury or that tested batches failed purity specifications.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2024-12-10", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ] }, "timeline": [ { "date": "2024-05-18", "event": "A Facebook post later cited in the warning promoted weight-loss combinations.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ] }, { "date": "2024-10", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ] }, { "date": "2024-12-10", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "cagrilintide", "mazdutide", "retatrutide", "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "cagrilintide", "mazdutide", "retatrutide", "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "cagrilintide", "mazdutide", "retatrutide", "semaglutide", "tirzepatide" ], "latest_documented_date": "2024-12-10", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024", "title": "Summit Research Peptides — FDA warning letter 695607 — 2024-12-10", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-695607", "display_name": "Summit Research Peptides", "identities": [ { "name": "Summit Research Peptides", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ] }, { "name": "summitpeptides.shop", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ] } ], "activity": { "summary": "FDA cites a May 18, 2024 Facebook promotion and an October 2024 website review. The endpoints are evidence observations, not a proven continuous trading period.", "kind": "dated_observation", "start": "2024-05-18", "end": "2024-10", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-695663", "case_name": "FDA warning letter: Swisschems", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 695663", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Swisschems" ], "parties": [ "Swisschems" ], "filed_date": null, "status_date": "2024-12-10", "analysis": { "id": "fda-695663", "summary": { "text": "Swisschems received a warning concerning semaglutide and retatrutide marketed on its website and social channels. FDA connected scientific-study discussion, metabolic claims and product promotion to the offered drugs. This record illustrates that scientific framing in sales material can contribute to an intended-use assessment; it does not establish the advertised clinical benefits as true.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ], "normalized_names": [ "semaglutide" ] }, { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ], "normalized_names": [ "retatrutide" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ] }, "challenged_conduct": [ { "text": "FDA assessed the two products as unapproved new drugs, citing disease and body-function claims despite research-only language. No product-specific assay or criminal determination is reported in this letter.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2024-12-10", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ] }, "timeline": [ { "date": "2024-09-18", "event": "FDA cited a dated social-media promotion relating to the products.", "kind": "other", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ] }, { "date": "2024-10", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ] }, { "date": "2024-12-10", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "retatrutide", "semaglutide" ], "marketing_or_supply_compounds": [ "retatrutide", "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "retatrutide", "semaglutide" ], "latest_documented_date": "2024-12-10", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024", "title": "Swisschems — FDA warning letter 695663 — 2024-12-10", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-695663", "display_name": "Swisschems", "identities": [ { "name": "Swisschems", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ] }, { "name": "swisschems.is", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ] } ], "activity": { "summary": "FDA cites a September 18, 2024 promotion and an October 2024 website review. The endpoints are evidence observations, not a proven continuous trading period.", "kind": "dated_observation", "start": "2024-09-18", "end": "2024-10", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swisschems-695663-12102024", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-719645", "case_name": "FDA warning letter: TITAN SARMS LLC", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 719645", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Titan SARMS" ], "parties": [ "TITAN SARMS LLC" ], "filed_date": null, "status_date": "2025-12-12", "analysis": { "id": "fda-719645", "summary": { "text": "TITAN SARMS was warned after FDA reviewed its online offers for four named compounds. The cited evidence included exercise imagery and claims about muscle, bone and recovery. FDA treated the overall presentation as drug marketing despite research-grade labeling. The letter does not establish the identity or purity of every product shipped under these names.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ] }, "products": [ { "name": "LGD-4033", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ], "normalized_names": [ "LGD-4033" ] }, { "name": "RAD-140", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ], "normalized_names": [ "RAD-140" ] }, { "name": "andarine", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ], "normalized_names": [ "andarine" ] }, { "name": "YK-11", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ], "normalized_names": [ "YK-11" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ] }, "challenged_conduct": [ { "text": "FDA assessed LGD4033, RAD140, Andarine S4 and YK11 as unapproved new drugs based on their promoted human structure/function and therapeutic uses.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2025-12-12", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ] }, "timeline": [ { "date": "2025-11", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ] }, { "date": "2025-12-12", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "andarine", "LGD-4033", "RAD-140", "YK-11" ], "marketing_or_supply_compounds": [ "andarine", "LGD-4033", "RAD-140", "YK-11" ], "tested_compounds": [], "direct_compounds": [ "andarine", "LGD-4033", "RAD-140", "YK-11" ], "latest_documented_date": "2025-12-12", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025", "title": "TITAN SARMS LLC — FDA warning letter 719645 — 2025-12-12", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-719645", "display_name": "TITAN SARMS LLC", "identities": [ { "name": "TITAN SARMS LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ] }, { "name": "Titan SARMS", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ] }, { "name": "titansarms.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2025-11. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2025-11", "end": "2025-11", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/titan-sarms-llc-719645-12122025", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-735067", "case_name": "FDA warning letter: TXP Innovations LLC dba Tex Peptides", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 735067", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Tex Peptides" ], "parties": [ "TXP Innovations LLC dba Tex Peptides" ], "filed_date": null, "status_date": "2026-08-24", "analysis": { "id": "fda-735067", "summary": { "text": "Tex Peptides’ warning covers considerably more than tesamorelin. FDA expressly names semaglutide, tirzepatide and retatrutide, together with elamipretide, bremelanotide and reconstitution water. The narrower compound list in the initial catalogue therefore understates this letter. The reviewed primary source supports treating retatrutide as an advertised product here, while leaving actual vial contents unverified.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ], "normalized_names": [ "tirzepatide" ] }, { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ], "normalized_names": [ "retatrutide" ] }, { "name": "elamipretide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ], "normalized_names": [ "elamipretide" ] }, { "name": "bremelanotide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ], "normalized_names": [ "bremelanotide" ] }, { "name": "tesamorelin", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ], "normalized_names": [ "tesamorelin" ] }, { "name": "bacteriostatic water", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ], "normalized_names": [ "bacteriostatic water" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ] }, "challenged_conduct": [ { "text": "FDA assessed the disease, metabolic, mitochondrial, sexual-function and other human-use claims as establishing unapproved drug uses despite research-only labeling.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2026-08-24", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ] }, "timeline": [ { "date": "2026-07", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ] }, { "date": "2026-08-24", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "bacteriostatic water", "bremelanotide", "elamipretide", "retatrutide", "semaglutide", "tesamorelin", "tirzepatide" ], "marketing_or_supply_compounds": [ "bacteriostatic water", "bremelanotide", "elamipretide", "retatrutide", "semaglutide", "tesamorelin", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "bacteriostatic water", "bremelanotide", "elamipretide", "retatrutide", "semaglutide", "tesamorelin", "tirzepatide" ], "latest_documented_date": "2026-08-24", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026", "title": "TXP Innovations LLC dba Tex Peptides — FDA warning letter 735067 — 2026-08-24", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-735067", "display_name": "Tex Peptides / TXP Innovations LLC", "identities": [ { "name": "TXP Innovations LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ] }, { "name": "Tex Peptides", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ] }, { "name": "texpeptide.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ] }, { "name": "Felicia Romero", "kind": "operator", "basis": "FDA identifies this person as CEO; the title is source-specific, not a finding of individual liability or beneficial ownership.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2026-07. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2026-07", "end": "2026-07", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-696885", "case_name": "FDA warning letter: USApeptide.com", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 696885", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "USApeptide.com" ], "parties": [ "USApeptide.com" ], "filed_date": null, "status_date": "2025-02-26", "analysis": { "id": "fda-696885", "summary": { "text": "USApeptide.com was warned over injectable semaglutide and tirzepatide offers to U.S. consumers. FDA cited several vial strengths, comparisons with branded medicines, and access without a prescription. The site’s accompanying injection supplies helped explain the human-use context, but should not be mistaken for laboratory evidence about the peptide vials.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The letter reports a recent website review without a precise review date. It does not identify an initial complaint, interception or other trigger.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025" ] }, "challenged_conduct": [ { "text": "FDA assessed the products as unapproved new drugs and misbranded drugs, including prescription-drug offers without a prescription and inadequate directions for safe lay use.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025" ] } ], "outcome": { "class": "warning_letter", "text": "FDA requested cessation of violative U.S. offers and corrective action. The warning does not establish that sales stopped or that a later enforcement case or closeout occurred.", "as_of": "2025-02-26", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025" ] }, "timeline": [ { "date": "2025-02-26", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide", "tirzepatide" ], "latest_documented_date": "2025-02-26", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025", "title": "USApeptide.com — FDA warning letter 696885 — 2025-02-26", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-696885", "display_name": "USApeptide.com", "identities": [ { "name": "USApeptide.com", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025" ] }, { "name": "usapeptide.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025" ] } ], "activity": { "summary": "FDA describes a recent review of usapeptide.com before its February 26, 2025 letter, without dating the review. Actual operating start and end are unknown.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025" ], "limits": [ "The reviewed source does not establish the business launch, continuous operating period, or current trading status." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025", "locator": "Recipient identity/title block; inspection/records-review opening and operational findings" } ] } }, { "id": "fda-694608", "case_name": "FDA warning letter: Xcel Research LLC", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration", "docket_number": "MARCS-CMS 694608", "jurisdiction": "United States (federal)", "record_scope": "regulatory_action", "brands": [ "Xcel Peptides" ], "parties": [ "Xcel Research LLC" ], "filed_date": null, "status_date": "2024-12-10", "analysis": { "id": "fda-694608", "summary": { "text": "Xcel Research received a warning over online peptide offers. FDA explicitly linked RETA to retatrutide and CagriLean to a cagrilintide–semaglutide combination. Its assessment rested on metabolic, cardiovascular and other human-use claims accompanying the offers, despite research-only labeling. The record documents marketing, rather than a laboratory determination that the vials contained those ingredients.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ] }, "products": [ { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ], "normalized_names": [ "retatrutide" ] }, { "name": "cagrilintide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ], "normalized_names": [ "cagrilintide" ] }, { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ], "normalized_names": [ "semaglutide" ] }, { "name": "mazdutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ], "normalized_names": [ "mazdutide" ] }, { "name": "survodutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ], "normalized_names": [ "survodutide" ] }, { "name": "sermorelin", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ], "normalized_names": [ "sermorelin" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ] }, "challenged_conduct": [ { "text": "FDA assessed the named products as unapproved new drugs because their advertised purposes included treating disease or affecting human body structure or function. Research-only disclaimers did not overcome that stated intended use.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2024-12-10", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ] }, "timeline": [ { "date": "2024-10", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ] }, { "date": "2024-12-10", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ] }, "unknowns": [ "Initial investigation trigger, actual product contents and any later response or closeout are not established by the reviewed letter." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "cagrilintide", "mazdutide", "retatrutide", "semaglutide", "sermorelin", "survodutide" ], "marketing_or_supply_compounds": [ "cagrilintide", "mazdutide", "retatrutide", "semaglutide", "sermorelin", "survodutide" ], "tested_compounds": [], "direct_compounds": [ "cagrilintide", "mazdutide", "retatrutide", "semaglutide", "sermorelin", "survodutide" ], "latest_documented_date": "2024-12-10", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024", "title": "Xcel Research LLC — FDA warning letter 694608 — 2024-12-10", "source_type": "official_agency", "document_type": "warning_letter", "supports": "Recipient, letter date, reference number, products and FDA position described in the letter." } ], "business_profile": { "id": "fda-694608", "display_name": "Xcel Peptides / Xcel Research LLC", "identities": [ { "name": "Xcel Research LLC", "kind": "legal_entity", "basis": "Entity/firm named in the FDA letter recipient block; no separate corporate-registry ownership audit was performed.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ] }, { "name": "Xcel Peptides", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ] }, { "name": "xcelpeptides.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2024-10. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2024-10", "end": "2024-10", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked.", "The letter names Andrew Pierce as its recipient without an explicit ownership/executive title; that person is not promoted into a verified operator identity here." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "fda-715878", "case_name": "FDA warning letter: ybycmeds", "category": "warning_letter", "court_or_agency": "U.S. Food and Drug Administration, CDER", "docket_number": "MARCS-CMS 715878", "jurisdiction": "United States", "record_scope": "regulatory_action", "brands": [ "ybycmeds" ], "parties": [ "ybycmeds" ], "filed_date": null, "status_date": "2025-09-09", "analysis": { "id": "fda-715878", "summary": { "text": "The ybycmeds warning addressed marketing of compounded semaglutide and tirzepatide in vials and prefilled syringes. FDA challenged the impression that these products were equivalent to approved branded drugs. This was a compounding-marketing case, rather than a finding that a research-only retailer’s products contained an undisclosed chemical.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "FDA reproduced the seller’s product offers or marketing; this establishes the advertised identity, not analytically verified vial contents.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The initial tip or reason FDA selected this business is not established. The letter identifies an online review as its evidence basis; that does not establish how the inquiry first began.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ] }, "challenged_conduct": [ { "text": "FDA assessed the promotional comparisons with Ozempic, Wegovy, Mounjaro and Zepbound as false or misleading and identified misbranding under the provisions discussed in the letter.", "attribution": "agency_assessment", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ] } ], "outcome": { "class": "warning_letter", "text": "FDA issued a warning and requested corrective action. The reviewed record does not establish a subsequent closeout, injunction, criminal charge or final compliance determination.", "as_of": "2025-09-09", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ] }, "timeline": [ { "date": "2025-08", "event": "FDA reviewed the website or online marketing described in the letter.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ] }, { "date": "2025-09-09", "event": "FDA issued this warning letter.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a company response, FDA closeout or a separately documented follow-up action; the warning alone does not establish continuing noncompliance.", "basis": "inference", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ] }, "unknowns": [ "Initial review trigger, actual compounder details, product assay results and later corrective-action disposition are not established by this source." ], "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025", "review_basis": "official_web_full_text", "locator": "Opening review description, product-specific findings and Conclusion" } ] }, "compounds": [ "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide", "tirzepatide" ], "latest_documented_date": "2025-09-09", "sources": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025", "title": "ybycmeds — 715878 — 2025-09-09", "source_type": "official_agency", "document_type": "warning_letter", "supports": "FDA warned concerning false or misleading marketing of compounded semaglutide and tirzepatide." } ], "business_profile": { "id": "fda-715878", "display_name": "ybycmeds", "identities": [ { "name": "ybycmeds", "kind": "trading_name", "basis": "Business or trading name identified in the FDA letter and its description of the reviewed storefront.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ] }, { "name": "ybycmeds.com", "kind": "historical_domain", "basis": "Website FDA attributed to the recipient during its review; this does not verify current ownership or availability.", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ] } ], "activity": { "summary": "FDA records a website/marketing observation in 2025-08. This dates the reviewed offers, not the start or end of the business.", "kind": "dated_observation", "start": "2025-08", "end": "2025-08", "sources": [ "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025" ], "limits": [ "Observation dates do not establish uninterrupted sales or business launch/closure.", "The warning-letter issue date is not used as an operating date. Current trading status was not checked." ] }, "source_review": [ { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ybycmeds-715878-09092025", "locator": "Recipient identity/title block and opening website-review paragraph; dated examples where noted" } ] } }, { "id": "ca-canada-peptide-2025", "case_name": "Health Canada action: Canada Peptide", "category": "foreign_enforcement", "court_or_agency": "Health Canada", "docket_number": null, "jurisdiction": "Canada", "record_scope": "matter_record", "brands": [ "Canada Peptide" ], "parties": [ "Canada Peptide" ], "filed_date": null, "status_date": "2025-08-01", "analysis": { "id": "ca-canada-peptide-2025", "summary": { "text": "Health Canada reported seizing unauthorized injectable peptide drugs associated with Canada Peptide while warning about online sales. The affected list explicitly includes retatrutide and tirzepatide alongside growth-hormone, repair-peptide and other labels. These names establish advertised or labeled products in an enforcement record, not independent confirmation of their chemical identity or concentration.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ] }, "products": [ { "name": "AOD-9604", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "AOD-9604" ] }, { "name": "ARA-290", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "ARA-290" ] }, { "name": "bremelanotide", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "bremelanotide" ] }, { "name": "bronchogen", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "bronchogen" ] }, { "name": "BPC-157", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "BPC-157" ] }, { "name": "CJC-1295", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "CJC-1295" ] }, { "name": "cortagen", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "cortagen" ] }, { "name": "DSIP", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "DSIP" ] }, { "name": "epitalon", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "epitalon" ] }, { "name": "GHK", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "GHK" ] }, { "name": "GHK-Cu", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "GHK-Cu" ] }, { "name": "GHRP-2", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "GHRP-2" ] }, { "name": "GHRP-6", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "GHRP-6" ] }, { "name": "GLP-1 (7-37)", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "GLP-1 (7-37)" ] }, { "name": "gonadorelin", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "gonadorelin" ] }, { "name": "hexarelin", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "hexarelin" ] }, { "name": "human growth hormone", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "human growth hormone (form unspecified)" ] }, { "name": "HGH fragment", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "HGH fragment" ] }, { "name": "humanine", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "humanine" ] }, { "name": "ipamoreline", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "ipamorelin" ] }, { "name": "kisspeptin", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "kisspeptin (fragment unspecified)" ] }, { "name": "KK-23", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "KK-23" ] }, { "name": "livagen", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "livagen" ] }, { "name": "LL-37", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "LL-37" ] }, { "name": "melanotan I", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "melanotan I" ] }, { "name": "melanotan II", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "melanotan II" ] }, { "name": "NR-7", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "NR-7" ] }, { "name": "ovagen", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "ovagen" ] }, { "name": "Pal-GHK", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "Pal-GHK" ] }, { "name": "pinealon", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "pinealon" ] }, { "name": "PNC-27", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "PNC-27" ] }, { "name": "prostamax", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "prostamax" ] }, { "name": "QS-13", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "QS-13" ] }, { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "retatrutide" ] }, { "name": "selank", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "selank" ] }, { "name": "semax", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "semax" ] }, { "name": "sermorelin", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "sermorelin" ] }, { "name": "elamipretide", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable. The source label is SS-31; generic-name mapping uses the separately cited FDA Royal Peptides letter, which explicitly supplies this alias. Neither source proves batch contents.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "normalized_names": [ "elamipretide" ] }, { "name": "tesamorelin", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "tesamorelin" ] }, { "name": "thymosin alpha", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "thymosin alpha (subtype unspecified)" ] }, { "name": "thymosin beta-4", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "thymosin beta-4" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "tirzepatide" ] }, { "name": "vilon", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "vilon" ] }, { "name": "VIP", "role": "reported_marketing_or_supply", "basis": "Named in Health Canada’s affected-product list; spelling and incompletely specified identities are retained where applicable.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "normalized_names": [ "VIP" ] } ], "discovery": { "known": false, "text": "The announcement identifies a seizure and online offers but does not disclose the original tip or reason the agency began looking at this seller.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ] }, "challenged_conduct": [ { "text": "Health Canada assessed the listed injectable drugs as unauthorized and not evaluated for the required safety, efficacy and quality assurances.", "attribution": "agency_assessment", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ] } ], "outcome": { "class": "seizure_or_investigation", "text": "A seizure and public advisory were reported. The reviewed source does not announce a conviction or establish the seller’s eventual compliance status.", "as_of": "2025-08-01", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ] }, "timeline": [ { "date": "2025-08-01", "event": "Health Canada announced the seizure and online-sales warning.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for a revised affected-product list or a separate enforcement disposition, keeping authorization findings separate from laboratory findings.", "basis": "inference", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ] }, "unknowns": [ "Exact seizure date, initiating trigger, verified batch composition and later disposition are not established." ], "source_review": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" }, { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026", "review_basis": "official_web_full_text", "locator": "SS-31 (Elamipretide) heading and PT-141/Bremelanotide product discussion; used only for explicit alias support" } ] }, "compounds": [ "AOD-9604", "ARA-290", "BPC-157", "bremelanotide", "bronchogen", "CJC-1295", "cortagen", "DSIP", "elamipretide", "epitalon", "GHK", "GHK-Cu", "GHRP-2", "GHRP-6", "GLP-1 (7-37)", "gonadorelin", "hexarelin", "HGH fragment", "human growth hormone (form unspecified)", "humanine", "ipamorelin", "kisspeptin (fragment unspecified)", "KK-23", "livagen", "LL-37", "melanotan I", "melanotan II", "NR-7", "ovagen", "Pal-GHK", "pinealon", "PNC-27", "prostamax", "QS-13", "retatrutide", "selank", "semax", "sermorelin", "tesamorelin", "thymosin alpha (subtype unspecified)", "thymosin beta-4", "tirzepatide", "vilon", "VIP" ], "marketing_or_supply_compounds": [ "AOD-9604", "ARA-290", "BPC-157", "bremelanotide", "bronchogen", "CJC-1295", "cortagen", "DSIP", "elamipretide", "epitalon", "GHK", "GHK-Cu", "GHRP-2", "GHRP-6", "GLP-1 (7-37)", "gonadorelin", "hexarelin", "HGH fragment", "human growth hormone (form unspecified)", "humanine", "ipamorelin", "kisspeptin (fragment unspecified)", "KK-23", "livagen", "LL-37", "melanotan I", "melanotan II", "NR-7", "ovagen", "Pal-GHK", "pinealon", "PNC-27", "prostamax", "QS-13", "retatrutide", "selank", "semax", "sermorelin", "tesamorelin", "thymosin alpha (subtype unspecified)", "thymosin beta-4", "tirzepatide", "vilon", "VIP" ], "tested_compounds": [], "direct_compounds": [ "AOD-9604", "ARA-290", "BPC-157", "bremelanotide", "bronchogen", "CJC-1295", "cortagen", "DSIP", "elamipretide", "epitalon", "GHK", "GHK-Cu", "GHRP-2", "GHRP-6", "GLP-1 (7-37)", "gonadorelin", "hexarelin", "HGH fragment", "human growth hormone (form unspecified)", "humanine", "ipamorelin", "kisspeptin (fragment unspecified)", "KK-23", "livagen", "LL-37", "melanotan I", "melanotan II", "NR-7", "ovagen", "Pal-GHK", "pinealon", "PNC-27", "prostamax", "QS-13", "retatrutide", "selank", "semax", "sermorelin", "tesamorelin", "thymosin alpha (subtype unspecified)", "thymosin beta-4", "tirzepatide", "vilon", "VIP" ], "latest_documented_date": "2025-08-01", "sources": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "title": "Health Canada advisory: Canada Peptide", "source_type": "official_agency", "document_type": "public_advisory", "supports": "Named seller, seizure and any cessation explicitly reported by agency." } ], "business_profile": { "id": "ca-canada-peptide-2025", "display_name": "Canada Peptide", "identities": [ { "name": "Canada Peptide", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ] } ], "activity": { "summary": "Health Canada’s August 1, 2025 advisory describes seized injectable peptides and sales through the company website, without giving the seizure date or first/last sale dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious" ], "limits": [ "The reviewed source does not establish the business launch, continuous operating period, or current trading status." ] }, "source_review": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious", "locator": "Issue section and original publication/update fields; Rize online-sales and cessation paragraph where applicable" } ] } }, { "id": "ca-maple-ridge-2025", "case_name": "Health Canada action: Maxximus Supplements and Cutting Edge Nutrition", "category": "foreign_enforcement", "court_or_agency": "Health Canada", "docket_number": null, "jurisdiction": "Canada", "record_scope": "matter_record", "brands": [ "Maxximus Supplements", "Cutting Edge Nutrition" ], "parties": [ "Maxximus Supplements and Cutting Edge Nutrition" ], "filed_date": null, "status_date": "2025-12-24", "analysis": { "id": "ca-maple-ridge-2025", "summary": { "text": "Health Canada seized unauthorized products at Maxximus Supplements and Cutting Edge Nutrition in Maple Ridge. The mixed inventory included peptide, SARM, steroid and other prescription-drug labels; the list explicitly includes semaglutide and tirzepatide. A product labeled RETRA is not expressly identified as retatrutide in the advisory and is therefore left unresolved.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "tirzepatide" ] }, { "name": "BPC-157", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "BPC-157" ] }, { "name": "TB-500", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "TB-500" ] }, { "name": "ipamorelin", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "ipamorelin" ] }, { "name": "melanotan", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "melanotan (type unspecified)" ] }, { "name": "human chorionic gonadotropin", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "human chorionic gonadotropin" ] }, { "name": "somatropin", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "somatropin" ] }, { "name": "ostarine", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "ostarine" ] }, { "name": "RAD-140", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "RAD-140" ] }, { "name": "andarine", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "andarine" ] }, { "name": "LGD-4033", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "LGD-4033" ] }, { "name": "YK-11", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "YK-11" ] }, { "name": "ibutamoren", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "ibutamoren" ] }, { "name": "cardarine", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "cardarine" ] }, { "name": "testosterone", "role": "reported_marketing_or_supply", "basis": "Named on affected-product labels in a two-store seizure advisory; this does not assign every product to both stores or verify vial chemistry.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "testosterone" ] }, { "name": "RETRA", "role": "unclear", "basis": "The advisory reproduces RETRA labeling without an explicit retatrutide identification.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "normalized_names": [ "RETRA" ] } ], "discovery": { "known": false, "text": "The source reports seizures at the two stores. It does not establish the initial referral or inspection trigger.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ] }, "challenged_conduct": [ { "text": "Health Canada assessed the products as unauthorized and reported that some carried misleading drug-identification numbers. The advisory does not establish that every listed item carried such a number.", "attribution": "agency_assessment", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ] } ], "outcome": { "class": "seizure_or_investigation", "text": "Products were seized and a public advisory was issued; no court conviction or final business-wide disposition is established.", "as_of": "2025-12-24", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ] }, "timeline": [ { "date": "2025-12-24", "event": "Health Canada published the two-store seizure advisory.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ] } ], "timing_pairs": [], "next_watch": { "text": "Monitor corrected product identities and subsequent licensing or court records before changing the compound attribution.", "basis": "inference", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ] }, "unknowns": [ "Exact seizure date, RETRA identity and later court outcome are unknown. This peptide/SARM-focused product list is not the full mixed inventory of other prescription drugs." ], "source_review": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" } ] }, "compounds": [ "andarine", "BPC-157", "cardarine", "human chorionic gonadotropin", "ibutamoren", "ipamorelin", "LGD-4033", "melanotan (type unspecified)", "ostarine", "RAD-140", "RETRA", "semaglutide", "somatropin", "TB-500", "testosterone", "tirzepatide", "YK-11" ], "marketing_or_supply_compounds": [ "andarine", "BPC-157", "cardarine", "human chorionic gonadotropin", "ibutamoren", "ipamorelin", "LGD-4033", "melanotan (type unspecified)", "ostarine", "RAD-140", "semaglutide", "somatropin", "TB-500", "testosterone", "tirzepatide", "YK-11" ], "tested_compounds": [], "direct_compounds": [ "andarine", "BPC-157", "cardarine", "human chorionic gonadotropin", "ibutamoren", "ipamorelin", "LGD-4033", "melanotan (type unspecified)", "ostarine", "RAD-140", "semaglutide", "somatropin", "TB-500", "testosterone", "tirzepatide", "YK-11" ], "latest_documented_date": "2025-12-24", "sources": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health", "title": "Health Canada advisory: Maxximus Supplements and Cutting Edge Nutrition", "source_type": "official_agency", "document_type": "public_advisory", "supports": "Named seller, seizure and any cessation explicitly reported by agency." } ], "business_profile": { "id": "ca-maple-ridge-2025", "display_name": "Maxximus Supplements and Cutting Edge Nutrition (two shops)", "identities": [ { "name": "Maxximus Supplements", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ] }, { "name": "Cutting Edge Nutrition", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ] } ], "activity": { "summary": "Health Canada’s December 24, 2025 advisory reports seizures at two named Maple Ridge retail locations. It gives no individual shop operating periods or precise seizure date.", "kind": "mixed_entities", "start": null, "end": null, "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health" ], "limits": [ "Two separate named retail locations; no shared ownership is inferred.", "Product-label brands in the seized inventory are not treated as aliases of the shops.", "Seizure inventory is not proof of a completed sale of every product." ] }, "source_review": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-seized-two-stores-maple-ridge-bc-may-pose-serious-health", "locator": "Issue section naming two shops and affected-products table associating inventory with each location" } ] } }, { "id": "ca-optimum-wellness-2025", "case_name": "Health Canada action: Optimum Wellness Centre, Calgary", "category": "foreign_enforcement", "court_or_agency": "Health Canada", "docket_number": null, "jurisdiction": "Canada", "record_scope": "matter_record", "brands": [ "Optimum Wellness Centre" ], "parties": [ "Optimum Wellness Centre, Calgary" ], "filed_date": null, "status_date": "2025-04-02", "analysis": { "id": "ca-optimum-wellness-2025", "summary": { "text": "Health Canada seized unauthorized injectable peptide products at Optimum Wellness Centre in Calgary. Its advisory initially appeared April 1 and was corrected April 2 to amend product names. The list spans numerous peptide labels but does not identify retatrutide, semaglutide or tirzepatide. The agency’s authorization concerns are distinct from a batch assay establishing adulteration.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ] }, "products": [ { "name": "ARA-290", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "ARA-290" ] }, { "name": "BPC-157", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "BPC-157" ] }, { "name": "CJC-1295", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "CJC-1295" ] }, { "name": "DSIP", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "DSIP" ] }, { "name": "epitalon", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "epitalon" ] }, { "name": "thymosin beta-4 fragment 17-23", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "thymosin beta-4 fragment 17-23" ] }, { "name": "GHK-Cu", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "GHK-Cu" ] }, { "name": "humanin HNG", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "humanin HNG" ] }, { "name": "ipamorelin", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "ipamorelin" ] }, { "name": "KCF-18", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "KCF-18" ] }, { "name": "kisspeptin-10", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "kisspeptin-10" ] }, { "name": "KPV", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "KPV" ] }, { "name": "melanotan II", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "melanotan II" ] }, { "name": "MOTS-C", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "MOTS-C" ] }, { "name": "pinealon", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "pinealon" ] }, { "name": "PNC-27", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "PNC-27" ] }, { "name": "bremelanotide", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source. The source label is PT-141; generic-name mapping uses the separately cited FDA Royal Peptides letter, which explicitly supplies this alias. Neither source proves batch contents.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "normalized_names": [ "bremelanotide" ] }, { "name": "PTD-DBM", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "PTD-DBM" ] }, { "name": "selank", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "selank" ] }, { "name": "thymosin alpha-1", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "thymosin alpha-1" ] }, { "name": "thymosin beta-4", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "thymosin beta-4" ] }, { "name": "thymulin", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "thymulin" ] }, { "name": "vesugen", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "vesugen" ] }, { "name": "vilon", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "vilon" ] }, { "name": "VIP", "role": "reported_marketing_or_supply", "basis": "Listed as affected product labels in Health Canada’s seizure advisory; identity is not analytically verified in that source.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "normalized_names": [ "VIP" ] } ], "discovery": { "known": false, "text": "The seizure is documented, but the initial complaint, tip or inspection-selection reason is not disclosed.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ] }, "challenged_conduct": [ { "text": "Health Canada assessed these as unauthorized injectable drug products sold without the required authorization and seized them. General risk warnings are not findings of injury from a particular vial.", "attribution": "agency_assessment", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ] } ], "outcome": { "class": "seizure_or_investigation", "text": "Products were seized. The reviewed advisory does not establish a prosecution, conviction or final business-wide compliance disposition.", "as_of": "2025-04-02", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ] }, "timeline": [ { "date": "2025-04-01", "event": "Health Canada published the original seizure advisory.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ] }, { "date": "2025-04-02", "event": "The advisory was updated to correct product names.", "kind": "other", "date_basis": "announcement", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ] } ], "timing_pairs": [], "next_watch": { "text": "Monitor advisory corrections and any separately documented licensing or court action.", "basis": "inference", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ] }, "unknowns": [ "Exact seizure date, initial trigger, actual contents and any later prosecution are not established." ], "source_review": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" }, { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026", "review_basis": "official_web_full_text", "locator": "SS-31 (Elamipretide) heading and PT-141/Bremelanotide product discussion; used only for explicit alias support" } ] }, "compounds": [ "ARA-290", "BPC-157", "bremelanotide", "CJC-1295", "DSIP", "epitalon", "GHK-Cu", "humanin HNG", "ipamorelin", "KCF-18", "kisspeptin-10", "KPV", "melanotan II", "MOTS-C", "pinealon", "PNC-27", "PTD-DBM", "selank", "thymosin alpha-1", "thymosin beta-4", "thymosin beta-4 fragment 17-23", "thymulin", "vesugen", "vilon", "VIP" ], "marketing_or_supply_compounds": [ "ARA-290", "BPC-157", "bremelanotide", "CJC-1295", "DSIP", "epitalon", "GHK-Cu", "humanin HNG", "ipamorelin", "KCF-18", "kisspeptin-10", "KPV", "melanotan II", "MOTS-C", "pinealon", "PNC-27", "PTD-DBM", "selank", "thymosin alpha-1", "thymosin beta-4", "thymosin beta-4 fragment 17-23", "thymulin", "vesugen", "vilon", "VIP" ], "tested_compounds": [], "direct_compounds": [ "ARA-290", "BPC-157", "bremelanotide", "CJC-1295", "DSIP", "epitalon", "GHK-Cu", "humanin HNG", "ipamorelin", "KCF-18", "kisspeptin-10", "KPV", "melanotan II", "MOTS-C", "pinealon", "PNC-27", "PTD-DBM", "selank", "thymosin alpha-1", "thymosin beta-4", "thymosin beta-4 fragment 17-23", "thymulin", "vesugen", "vilon", "VIP" ], "latest_documented_date": "2025-04-02", "sources": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "title": "Health Canada advisory: Optimum Wellness Centre, Calgary", "source_type": "official_agency", "document_type": "public_advisory", "supports": "Named seller, seizure and any cessation explicitly reported by agency." } ], "business_profile": { "id": "ca-optimum-wellness-2025", "display_name": "Optimum Wellness Centre (Southport Road, Calgary)", "identities": [ { "name": "Optimum Wellness Centre", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ] } ], "activity": { "summary": "Health Canada’s April 1, 2025 advisory, updated April 2, reports seizure at the Southport Road centre. It does not establish the treatment/sales period or the exact seizure date.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta" ], "limits": [ "The reviewed source does not establish the business launch, continuous operating period, or current trading status." ] }, "source_review": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta", "locator": "Issue section and original publication/update fields; Rize online-sales and cessation paragraph where applicable" } ] } }, { "id": "ca-prime-research-2025", "case_name": "Health Canada action: Prime Research, Sherbrooke", "category": "foreign_enforcement", "court_or_agency": "Health Canada", "docket_number": null, "jurisdiction": "Canada", "record_scope": "matter_record", "brands": [ "Prime Research" ], "parties": [ "Prime Research, Sherbrooke" ], "filed_date": null, "status_date": "2025-04-14", "analysis": { "id": "ca-prime-research-2025", "summary": { "text": "Health Canada reported seizing unauthorized injectable peptides and bodybuilding drugs connected with Prime Research in Sherbrooke. The company also stopped advertising and selling the products and removed its website at the agency’s request. The source does not name individual active ingredients, so this action cannot support a retatrutide-specific count.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health" ] }, "products": [ { "name": "unspecified injectable peptides", "role": "reported_marketing_or_supply", "basis": "Health Canada describes the seized and online-sold product classes without naming individual molecules.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health" ], "normalized_names": [ "unspecified injectable peptides" ] }, { "name": "unspecified bodybuilding drugs", "role": "reported_marketing_or_supply", "basis": "Health Canada describes the seized and online-sold product classes without naming individual molecules.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health" ], "normalized_names": [ "unspecified bodybuilding drugs" ] } ], "discovery": { "known": false, "text": "The initial trigger is not established. The advisory reports a seizure and subsequent company actions, rather than explaining the first detection.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health" ] }, "challenged_conduct": [ { "text": "Health Canada assessed the products as unauthorized drugs; no approved safety, efficacy or quality assessment was established for the offers described.", "attribution": "agency_assessment", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health" ] } ], "outcome": { "class": "seizure_or_investigation", "text": "The agency reported seizure, cessation of the identified advertising/sales and website removal. It did not announce a conviction or comprehensive final clearance.", "as_of": "2025-04-14", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health" ] }, "timeline": [ { "date": "2025-04-14", "event": "Health Canada announced the seizure and reported cessation/removal steps.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health" ] } ], "timing_pairs": [], "next_watch": { "text": "Watch for an updated advisory or court record; preserve the reported cessation rather than assuming continued sales.", "basis": "inference", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health" ] }, "unknowns": [ "Individual compounds, exact seizure and cessation dates, initial trigger and any later court proceedings are unknown." ], "source_review": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" } ] }, "compounds": [ "unspecified bodybuilding drugs", "unspecified injectable peptides" ], "marketing_or_supply_compounds": [ "unspecified bodybuilding drugs", "unspecified injectable peptides" ], "tested_compounds": [], "direct_compounds": [ "unspecified bodybuilding drugs", "unspecified injectable peptides" ], "latest_documented_date": "2025-04-14", "sources": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health", "title": "Health Canada advisory: Prime Research, Sherbrooke", "source_type": "official_agency", "document_type": "public_advisory", "supports": "Named seller, seizure and any cessation explicitly reported by agency." } ], "business_profile": { "id": "ca-prime-research-2025", "display_name": "Prime Research (Sherbrooke)", "identities": [ { "name": "Prime Research", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health" ] } ], "activity": { "summary": "The April 14, 2025 advisory reports prior online sales, seizure, cessation of unauthorized-product advertising/sales and website removal. The dates of first sale, seizure and final sale are not specified.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health" ], "limits": [ "The reviewed source does not establish the business launch, continuous operating period, or current trading status." ] }, "source_review": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-sold-prime-research-may-pose-serious-health", "locator": "Issue section and original publication/update fields; Rize online-sales and cessation paragraph where applicable" } ] } }, { "id": "ca-rize-fitness-2025", "case_name": "Health Canada action: Rize Fitness, Vancouver", "category": "foreign_enforcement", "court_or_agency": "Health Canada", "docket_number": null, "jurisdiction": "Canada", "record_scope": "matter_record", "brands": [ "Rize Fitness", "PHX Labs" ], "parties": [ "Rize Fitness, Vancouver" ], "filed_date": null, "status_date": "2025-12-24", "analysis": { "id": "ca-rize-fitness-2025", "summary": { "text": "Health Canada’s Rize Fitness advisory explicitly lists retatrutide 5 mg among PHX Labs products, alongside semaglutide and other peptides. Products were seized in Vancouver and had been sold through phxlab.net. The agency reported that the company stopped advertising and selling the unauthorized products and removed its website at its request.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ] }, "products": [ { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "retatrutide" ] }, { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "semaglutide" ] }, { "name": "AOD-9604", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "AOD-9604" ] }, { "name": "CJC-1295", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "CJC-1295" ] }, { "name": "epithalon", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "epitalon" ] }, { "name": "GHK-Cu", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "GHK-Cu" ] }, { "name": "BPC-157", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "BPC-157" ] }, { "name": "TB-500", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "TB-500" ] }, { "name": "KPV", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "KPV" ] }, { "name": "ipamorelin", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "ipamorelin" ] }, { "name": "kisspeptin", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "kisspeptin (fragment unspecified)" ] }, { "name": "MOTS-C", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "MOTS-C" ] }, { "name": "elamipretide", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity. The source label is SS-31; generic-name mapping uses the separately cited FDA Royal Peptides letter, which explicitly supplies this alias. Neither source proves batch contents.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious", "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026" ], "normalized_names": [ "elamipretide" ] }, { "name": "tesamorelin", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "tesamorelin" ] }, { "name": "thymosin alpha-1", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "thymosin alpha-1" ] }, { "name": "melanotan II", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "melanotan II" ] }, { "name": "DSIP", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "DSIP" ] }, { "name": "5-AMINO-IMQ", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "5-AMINO-IMQ" ] }, { "name": "SLU-PP-332", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "SLU-PP-332" ] }, { "name": "somatropin", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "somatropin" ] }, { "name": "testosterone cypionate", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "testosterone cypionate" ] }, { "name": "DHEA", "role": "reported_marketing_or_supply", "basis": "Named on affected labels, including blend components, in Health Canada’s advisory; not reported assay results. The advisory spelling 5-AMINO-IMQ is retained without inferring a different chemical identity.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "normalized_names": [ "DHEA" ] } ], "discovery": { "known": false, "text": "The first investigative trigger is not disclosed. The source reports the seizure, website sales and resulting company response.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ] }, "challenged_conduct": [ { "text": "Health Canada assessed the seized and advertised products as unauthorized drugs and required the identified advertising and sales to stop.", "attribution": "agency_assessment", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ] } ], "outcome": { "class": "seizure_or_investigation", "text": "The agency reported seizure plus cessation of the identified sales/advertising and website removal. This is not a criminal conviction or proof that all related operations permanently ceased.", "as_of": "2025-12-24", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ] }, "timeline": [ { "date": "2025-12-24", "event": "Health Canada announced the seizure and reported company cessation/removal actions.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ] } ], "timing_pairs": [], "next_watch": { "text": "Watch for an updated advisory or subsequent disposition, retaining the documented company response in any summary.", "basis": "inference", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ] }, "unknowns": [ "Exact seizure and cessation dates, actual contents and later proceedings are unknown. The selected product list excludes ordinary vitamin entries from the broader advisory." ], "source_review": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" }, { "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026", "review_basis": "official_web_full_text", "locator": "SS-31 (Elamipretide) heading and PT-141/Bremelanotide product discussion; used only for explicit alias support" } ] }, "compounds": [ "5-AMINO-IMQ", "AOD-9604", "BPC-157", "CJC-1295", "DHEA", "DSIP", "elamipretide", "epitalon", "GHK-Cu", "ipamorelin", "kisspeptin (fragment unspecified)", "KPV", "melanotan II", "MOTS-C", "retatrutide", "semaglutide", "SLU-PP-332", "somatropin", "TB-500", "tesamorelin", "testosterone cypionate", "thymosin alpha-1" ], "marketing_or_supply_compounds": [ "5-AMINO-IMQ", "AOD-9604", "BPC-157", "CJC-1295", "DHEA", "DSIP", "elamipretide", "epitalon", "GHK-Cu", "ipamorelin", "kisspeptin (fragment unspecified)", "KPV", "melanotan II", "MOTS-C", "retatrutide", "semaglutide", "SLU-PP-332", "somatropin", "TB-500", "tesamorelin", "testosterone cypionate", "thymosin alpha-1" ], "tested_compounds": [], "direct_compounds": [ "5-AMINO-IMQ", "AOD-9604", "BPC-157", "CJC-1295", "DHEA", "DSIP", "elamipretide", "epitalon", "GHK-Cu", "ipamorelin", "kisspeptin (fragment unspecified)", "KPV", "melanotan II", "MOTS-C", "retatrutide", "semaglutide", "SLU-PP-332", "somatropin", "TB-500", "tesamorelin", "testosterone cypionate", "thymosin alpha-1" ], "latest_documented_date": "2025-12-24", "sources": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious", "title": "Health Canada advisory: Rize Fitness, Vancouver", "source_type": "official_agency", "document_type": "public_advisory", "supports": "Named seller, seizure and any cessation explicitly reported by agency." } ], "business_profile": { "id": "ca-rize-fitness-2025", "display_name": "Rize Fitness / phxlab.net", "identities": [ { "name": "Rize Fitness", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ] }, { "name": "phxlab.net", "kind": "historical_domain", "basis": "Health Canada explicitly links the seized products and online sales to this website; current ownership was not checked.", "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ] } ], "activity": { "summary": "The December 24, 2025 advisory reports products seized at Rize Fitness in Vancouver and sold through phxlab.net. It also reports sales/advertising cessation and website removal, without exact transaction or closure dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious" ], "limits": [ "The reviewed source does not establish the business launch, continuous operating period, or current trading status." ] }, "source_review": [ { "url": "https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-health-products-sold-online-and-seized-rize-fitness-may-pose-serious", "locator": "Issue section and original publication/update fields; Rize online-sales and cessation paragraph where applicable" } ] } }, { "id": "nj-john-mcgee-2025", "case_name": "New Jersey permanent medical-license revocation: John R. McGee", "category": "state_enforcement", "court_or_agency": "New Jersey State Board of Medical Examiners; Office of the Attorney General", "docket_number": null, "jurisdiction": "United States — New Jersey", "record_scope": "regulatory_action", "brands": [], "parties": [ "John R. McGee" ], "filed_date": null, "status_date": "2025-09-09", "analysis": { "id": "nj-john-mcgee-2025", "summary": { "text": "New Jersey permanently revoked John R. McGee’s medical license through a final consent order. The announced allegations included indiscriminate semaglutide prescribing and compounding, alongside unrelated professional misconduct. This is a physician-discipline matter; the source does not support describing the revocation as a judgment solely about peptide sales.", "sources": [ "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/" ] }, "products": [ { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "The agency announcement alleges indiscriminate prescribing and compounding, rather than identifying a retail product or tested preparation.", "sources": [ "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "The announcement identifies state investigators but not the complaint or event that first triggered their inquiry.", "sources": [ "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/" ] }, "challenged_conduct": [ { "text": "Allegations included improper prescribing/compounding, failures in medical-spa care, misuse of other physicians’ prescription pads and an inappropriate patient relationship.", "attribution": "allegation", "sources": [ "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/" ] } ], "outcome": { "class": "administrative_action", "text": "The board permanently revoked the license and barred McGee from managing, supervising or influencing medical practice in New Jersey. This was announced as a consent-order outcome, not a criminal conviction.", "as_of": "2025-09-15", "sources": [ "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/" ] }, "timeline": [ { "date": "2025-09-09", "event": "The final consent order was filed, according to the agency.", "kind": "order", "date_basis": "filing", "sources": [ "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/" ] }, { "date": "2025-09-15", "event": "The attorney general announced the permanent revocation.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain the consent order for precise findings/admissions before attributing further legal conclusions.", "basis": "inference", "sources": [ "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/" ] }, "unknowns": [ "Direct agency pages were inaccessible; official indexed announcement text was reviewed. The underlying consent order, full evidentiary record and initial trigger were not obtained." ], "source_review": [ { "url": "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/", "review_basis": "registry_support_only", "locator": "Agency announcement text retrieved in the search index; direct page and underlying consent order unavailable" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2025-09-15", "sources": [ { "url": "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/", "title": "Medical License of New Jersey Doctor Permanently Revoked Following Misconduct Allegations", "source_type": "official_agency", "document_type": "agency_consent_order_announcement", "supports": "September 9 consent order, permanent revocation, alleged semaglutide misconduct and broader disciplinary basis." }, { "url": "https://www.njconsumeraffairs.gov/News/Pages/09152025.aspx", "title": "New Jersey Division of Consumer Affairs — September 15, 2025 press release", "source_type": "official_agency", "document_type": "agency_consent_order_announcement", "supports": "Official parallel copy of announcement." } ], "business_profile": { "id": "nj-john-mcgee-2025", "display_name": "John R. McGee (physician discipline)", "identities": [ { "name": "John R. McGee", "kind": "operator", "basis": "The agency identifies the disciplined physician, not an independently identified research-peptide shop.", "sources": [ "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/" ] } ], "activity": { "summary": "The reviewed agency announcement concerns prescribing/compounding allegations and a September 2025 permanent medical-license revocation. A named shop and the dates of semaglutide activity are not established.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/" ], "limits": [ "Underlying consent order was unavailable in the existing corpus; previous review used official indexed agency text.", "The revocation date is not used as a business end date.", "No peptide-store ownership or continuous sales period inferred." ] }, "source_review": [ { "url": "https://www.njoag.gov/medical-license-of-new-jersey-doctor-permanently-revoked-following-misconduct-allegations/", "locator": "Official agency indexed announcement: John R. McGee, semaglutide allegations and final consent order" } ] } }, { "id": "uk-northampton-sleaford-manufacturing-2025", "case_name": "Northampton warehouse and Sleaford/Grantham unlicensed peptide manufacturing investigation", "category": "foreign_enforcement", "court_or_agency": "Medicines and Healthcare products Regulatory Agency; Northamptonshire Police; Lincolnshire Police", "docket_number": null, "jurisdiction": "United Kingdom — England and Wales", "record_scope": "matter_record", "brands": [], "parties": [], "filed_date": null, "status_date": "2026-02-25", "analysis": { "id": "uk-northampton-sleaford-manufacturing-2025", "summary": { "text": "MHRA reported disrupting an unlicensed weight-loss medicine production operation in Northampton and later a linked facility near Sleaford, with associated action in Grantham. The announcements described retatrutide and tirzepatide products, large quantities of pens or doses and production materials. They represent connected investigative events, not two convictions or necessarily distinct seller enterprises.", "sources": [ "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure", "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne" ] }, "products": [ { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "MHRA identifies these as products in the suspected manufacture/seizure operation; the releases do not supply batch assay results.", "sources": [ "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure", "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne" ], "normalized_names": [ "retatrutide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "MHRA identifies these as products in the suspected manufacture/seizure operation; the releases do not supply batch assay results.", "sources": [ "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure", "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "Warrants and seizures are described, but the original tip, intelligence source or first detection is not disclosed.", "sources": [ "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure", "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne" ] }, "challenged_conduct": [ { "text": "MHRA suspected unlawful manufacture and supply of unlicensed weight-loss medicines. The later operation was expressly linked to the earlier investigation.", "attribution": "allegation", "sources": [ "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure", "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne" ] } ], "outcome": { "class": "seizure_or_investigation", "text": "The agency reported seizures and an ongoing connected investigation. The reviewed announcements do not establish named defendants’ convictions or a final court outcome.", "as_of": "2026-02-25", "sources": [ "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure", "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne" ] }, "timeline": [ { "date": "2025-10-24", "event": "MHRA announced the Northampton operation.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure" ] }, { "date": "2026-02-25", "event": "MHRA announced a linked Sleaford/Grantham operation.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for charges, court records and explicit links across operations before counting unique sellers or defendants.", "basis": "inference", "sources": [ "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure", "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne" ] }, "unknowns": [ "Exact raid dates, original trigger and final prosecutions are not established. Possible overlap with the later Northamptonshire-estate record is unresolved." ], "source_review": [ { "url": "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" }, { "url": "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" } ] }, "compounds": [ "retatrutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "retatrutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "retatrutide", "tirzepatide" ], "latest_documented_date": "2026-02-25", "sources": [ { "url": "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure", "title": "MHRA smashes major illicit weight loss medicine production facility in record seizure", "source_type": "official_agency", "document_type": "enforcement_press_release", "supports": "October Northampton seizure, compounds, quantities and manufacturing equipment." }, { "url": "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne", "title": "MHRA disrupts second manufacturing facility suspected to be involved in the manufacture of illegal weight loss medicines in latest blow to criminal network", "source_type": "official_agency", "document_type": "enforcement_press_release", "supports": "February raids, locations, compounds, quantities and linkage to earlier enforcement." } ], "business_profile": { "id": "uk-northampton-sleaford-manufacturing-2025", "display_name": "Unnamed Northampton / Sleaford–Grantham manufacturing operation", "identities": [], "activity": { "summary": "The October 24, 2025 and February 25, 2026 MHRA accounts describe suspected production/distribution premises and stock awaiting dispatch. They do not identify one named shop, individual operator or continuous operating period.", "kind": "mixed_entities", "start": null, "end": null, "sources": [ "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure", "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne" ], "limits": [ "No shop/operator identity inferred from geographic premises.", "Related raids may concern the same network; they are not independently proven sellers.", "Announcement dates and seizures do not establish the start/end of manufacturing." ] }, "source_review": [ { "url": "https://www.gov.uk/government/news/mhra-smashes-majorillicitweight-loss-medicine-production-facility-in-record-seizure", "locator": "Both MHRA releases: premises, stock awaiting dispatch and description of linked investigation" }, { "url": "https://www.gov.uk/government/news/mhra-disrupts-second-manufacturing-facility-suspected-to-be-involved-in-the-manufacture-of-illegal-weight-loss-medicines-in-latest-blow-to-criminal-ne", "locator": "Both MHRA releases: premises, stock awaiting dispatch and description of linked investigation" } ] } }, { "id": "uk-northamptonshire-estate-2026", "case_name": "Northamptonshire estate unlicensed peptide manufacturing seizure and arrests", "category": "foreign_enforcement", "court_or_agency": "Medicines and Healthcare products Regulatory Agency; Northamptonshire Police", "docket_number": null, "jurisdiction": "United Kingdom — England and Wales", "record_scope": "matter_record", "brands": [], "parties": [], "filed_date": "2026-05-28", "status_date": "2026-05-29", "analysis": { "id": "uk-northamptonshire-estate-2026", "summary": { "text": "MHRA reported a Northamptonshire-estate raid involving about 12,000 doses of unlicensed weight-loss medicines and other peptide-related materials. Retatrutide and tirzepatide were named. Two 29-year-old men were arrested on suspicion of medicines offences. Arrest and seizure establish an investigation, not guilt or the final identity and concentration of every seized product.", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ] }, "products": [ { "name": "retatrutide", "role": "reported_marketing_or_supply", "basis": "MHRA describes products and materials in the seizure; no batch-level assay is supplied in the release.", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ], "normalized_names": [ "retatrutide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "MHRA describes products and materials in the seizure; no batch-level assay is supplied in the release.", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ], "normalized_names": [ "tirzepatide" ] }, { "name": "unspecified other peptides", "role": "reported_marketing_or_supply", "basis": "MHRA describes products and materials in the seizure; no batch-level assay is supplied in the release.", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ], "normalized_names": [ "unspecified peptides" ] } ], "discovery": { "known": false, "text": "The raid is documented, but the first intelligence, complaint or interception that led to it is not disclosed.", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ] }, "challenged_conduct": [ { "text": "The agency suspected unlawful manufacturing and supply activity under the medicines framework. These remain allegations at the stage reported.", "attribution": "allegation", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ] } ], "outcome": { "class": "seizure_or_investigation", "text": "The agency reported seizures, two arrests and an ongoing investigation. A charge, conviction or sentence is not established by this announcement.", "as_of": "2026-05-29", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ] }, "timeline": [ { "date": "2026-05-28", "event": "MHRA carried out the raid and arrests.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ] }, { "date": "2026-05-29", "event": "MHRA announced the operation.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ] } ], "timing_pairs": [], "next_watch": { "text": "Look for charge announcements and court records linking or separating the investigations.", "basis": "inference", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ] }, "unknowns": [ "Initial trigger, identities/final outcomes and any overlap with the Northampton/Sleaford network are unresolved; the records cannot safely be added as unique enterprises." ], "source_review": [ { "url": "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" } ] }, "compounds": [ "retatrutide", "tirzepatide", "unspecified peptides" ], "marketing_or_supply_compounds": [ "retatrutide", "tirzepatide", "unspecified peptides" ], "tested_compounds": [], "direct_compounds": [ "retatrutide", "tirzepatide", "unspecified peptides" ], "latest_documented_date": "2026-05-29", "sources": [ { "url": "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines", "title": "Two arrested during the MHRA’s largest ever seizure of unlicensed weight loss medicines", "source_type": "official_agency", "document_type": "enforcement_press_release", "supports": "Exact raid date, two arrests, suspected manufacturing, named compounds and ongoing enquiries." } ], "business_profile": { "id": "uk-northamptonshire-estate-2026", "display_name": "Unnamed Northamptonshire estate operation", "identities": [], "activity": { "summary": "MHRA observed suspected production/distribution stock at a May 28, 2026 raid and arrested two unnamed men. No named shop, company or period of operation is established.", "kind": "dated_observation", "start": "2026-05-28", "end": "2026-05-28", "sources": [ "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines" ], "limits": [ "A seizure observation is not a confirmed retail transaction or a complete operating period.", "No identity or independence from earlier related investigations inferred.", "Arrests are not convictions." ] }, "source_review": [ { "url": "https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines", "locator": "May 29 MHRA release: operation carried out last night (28 May 2026), unnamed suspects and premises description" } ] } }, { "id": "uk-novo-isp-blocking-2025", "case_name": "Novo Nordisk A/S and Novo Nordisk Limited v British Telecommunications PLC and five other ISPs", "category": "foreign_enforcement", "court_or_agency": "High Court of Justice, Business and Property Courts of England and Wales, Intellectual Property List (Chancery Division)", "docket_number": "IL-2025-000131", "jurisdiction": "United Kingdom — England and Wales", "record_scope": "matter_record", "brands": [ "Viogen Pharma", "Pharma-Labs", "Leo Labs", "The Steroid Supplier", "Ozempic", "Wegovy", "Rybelsus", "Victoza", "Saxenda" ], "parties": [ "Novo Nordisk A/S", "Novo Nordisk Limited", "British Telecommunications PLC", "EE Limited", "Plusnet PLC", "Sky UK Limited", "TalkTalk Telecom Limited", "Virgin Media Limited" ], "filed_date": null, "status_date": "2026-06-23", "analysis": { "id": "uk-novo-isp-blocking-2025", "summary": { "text": "Novo Nordisk obtained website-blocking relief against six internet service providers acting as intermediaries, not accused peptide sellers. The original order concerned four websites and was later extended. This is private civil litigation supported by medicines-regulator evidence. Judicial findings about unlawful online offers do not amount to criminal convictions of the sites’ operators.", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "The judgment describes website offers; product attribution varies by site. The liraglutide discussion distinguishes legitimate generics from the counterfeit branded offers at issue.", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094" ], "normalized_names": [ "semaglutide" ] }, { "name": "liraglutide", "role": "reported_marketing_or_supply", "basis": "The judgment describes website offers; product attribution varies by site. The liraglutide discussion distinguishes legitimate generics from the counterfeit branded offers at issue.", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094" ], "normalized_names": [ "liraglutide" ] }, { "name": "cagrilintide", "role": "reported_marketing_or_supply", "basis": "The judgment describes website offers; product attribution varies by site. The liraglutide discussion distinguishes legitimate generics from the counterfeit branded offers at issue.", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094" ], "normalized_names": [ "cagrilintide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "The judgment describes website offers; product attribution varies by site. The liraglutide discussion distinguishes legitimate generics from the counterfeit branded offers at issue.", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The judgment describes unsuccessful MHRA action against a domain in February 2025 and a request for Novo’s help that prompted the application. How the sites were first identified is not established. Online investigation and purchases were subsequent evidence gathering.", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ] }, "challenged_conduct": [ { "text": "The court assessed unlawful online medicine offers, including unlicensed products and particular counterfeit-branded products, as supporting intermediary blocking relief. Legitimate generic liraglutide also existed; not all liraglutide offers were inherently unlawful.", "attribution": "judicial_finding", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ] } ], "outcome": { "class": "procedural_order", "text": "The court granted the initial blocking order on October 2, 2025. Published reasons followed May 13, 2026; a June 23 extension added seven sites and further updating provisions.", "as_of": "2026-06-23", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ] }, "timeline": [ { "date": "2025-02", "event": "MHRA sought action against a domain and subsequently asked Novo for assistance.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094" ] }, { "date": "2025-10-02", "event": "The court granted the initial four-site blocking order.", "kind": "order", "date_basis": "event", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094" ] }, { "date": "2026-05-13", "event": "The court published reasons for the earlier order.", "kind": "order", "date_basis": "announcement", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094" ] }, { "date": "2026-06-23", "event": "The court issued further blocking relief.", "kind": "order", "date_basis": "event", "sources": [ "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ] } ], "timing_pairs": [ { "label": "Initial blocking order to further order", "start": "2025-10-02", "end": "2026-06-23", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ], "days": 264 } ], "next_watch": { "text": "Watch for variations, challenges and further published judgments defining the scope and duration of blocking relief.", "basis": "inference", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ] }, "unknowns": [ "Initial identification of the sites and ultimate proceedings against each seller are not established. ISP defendants should not be counted as sellers." ], "source_review": [ { "url": "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "review_basis": "archived_full_text", "locator": "[2026] EWHC 1094 (Ch), product and regulatory history; order dated October 2, 2025" }, { "url": "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf", "review_basis": "court_pdf", "locator": "[2026] EWHC 1535 (Ch), six-page judgment on extension of relief" } ] }, "compounds": [ "cagrilintide", "liraglutide", "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "cagrilintide", "liraglutide", "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "cagrilintide", "liraglutide", "semaglutide", "tirzepatide" ], "latest_documented_date": "2026-06-23", "sources": [ { "url": "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "title": "Novo Nordisk A/S & Anor v British Telecommunications & Ors [2026] EWHC 1094 (Ch)", "source_type": "court_document", "document_type": "approved_judgment", "supports": "Parties, claim number, four target sites, compounds, original order and reasons." }, { "url": "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf", "title": "Novo Nordisk A/S & Anor v British Telecommunications Plc & Ors [2026] EWHC 1535 (Ch)", "source_type": "court_document", "document_type": "approved_judgment_pdf", "supports": "Six-page approved judgment: original order date, seven additional targets and dynamic blocking relief. Copy hosted by claimant counsel chambers." }, { "url": "https://8newsquare.co.uk/case/novo-nordisk-v-various-isps-2026-ewhc-1535-ch/", "title": "Novo Nordisk v Various ISPs [2026] EWHC 1535 (Ch)", "source_type": "party_statement", "document_type": "counsel_case_notice", "supports": "Provenance of linked approved judgment and counsel involvement." } ], "business_profile": { "id": "uk-novo-isp-blocking-2025", "display_name": "Viogen Pharma, Pharma-Labs, Leo Labs and The Steroid Supplier (blocking targets)", "identities": [ { "name": "Viogen Pharma", "kind": "trading_name", "basis": "The High Court identifies these as target websites; their anonymous operators are not the named ISP defendants.", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ] }, { "name": "Pharma-Labs", "kind": "trading_name", "basis": "The High Court identifies these as target websites; their anonymous operators are not the named ISP defendants.", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ] }, { "name": "Leo Labs", "kind": "trading_name", "basis": "The High Court identifies these as target websites; their anonymous operators are not the named ISP defendants.", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ] }, { "name": "The Steroid Supplier", "kind": "trading_name", "basis": "The High Court identifies these as target websites; their anonymous operators are not the named ISP defendants.", "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ] } ], "activity": { "summary": "The judgment records a February 2025 attempt to suspend Viogen, regulator communications in June/July 2025, and four target websites considered for the October 2, 2025 blocking order. It establishes no shared first/last trading dates for the four sites.", "kind": "mixed_entities", "start": null, "end": null, "sources": [ "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf" ], "limits": [ "ISPs and Novo Nordisk are not coded as peptide-shop operators.", "The target websites operated anonymously; names are not verified legal entities.", "Blocking dates do not establish worldwide cessation, and mirror/successor sites were contemplated." ] }, "source_review": [ { "url": "https://caselaw.nationalarchives.gov.uk/ewhc/ch/2026/1094", "locator": "[2026] EWHC 1094 (Ch): opening target-site list; MHRA February/June/July 2025 history; anonymous operation and mirror-site discussion" }, { "url": "https://8newsquare.co.uk/wp-content/uploads/Approved-Judgment.pdf", "locator": "[2026] EWHC 1094 (Ch): opening target-site list; MHRA February/June/July 2025 history; anonymous operation and mirror-site discussion" } ] } }, { "id": "novo-aios-2025", "case_name": "Novo Nordisk A/S et al. v. Aios Inc. et al.", "category": "civil", "court_or_agency": "U.S. District Court, Northern District of California", "docket_number": "4:25-cv-06560", "jurisdiction": "United States", "record_scope": "seller_marketing_and_compounding", "brands": [ "Fella Health", "Delilah" ], "parties": [ "Novo Nordisk A/S", "Novo Nordisk Inc.", "Aios Inc.", "Fella Medical Group PA", "Fella Medical Group PC" ], "filed_date": "2025-08-04", "status_date": "2026-09-23", "analysis": { "id": "novo-aios-2025", "summary": { "text": "Novo’s suit against Aios, Fella Health, Delilah and the associated Fella Medical Groups challenges how compounded weight-loss medicines were marketed and prescribed. The complaint identifies semaglutide and tirzepatide, alleging that company-wide formulation changes and nonphysician influence undermined claims of individualized care. Those are Novo’s allegations, not findings that every prescription lacked a medical reason. The latest original reviewed here is a September 2026 discovery order about confidential information and expert access. It shows active evidence disputes at that point, without deciding the truth of the advertising or the safety of any formulation.", "sources": [ "https://docketnexus.com/document/448057500/", "https://dockets.justia.com/docket/california/candce/4%3A2025cv06560/453982", "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/76/0.pdf", "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/78" ] }, "products": [ { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "Complaint introduction paragraph 12 identifies purported semaglutide products promoted as personalized.", "sources": [ "https://docketnexus.com/document/448057500/" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "The same paragraph expressly identifies purported tirzepatide products; it is not an inferred GLP-1 alias.", "sources": [ "https://docketnexus.com/document/448057500/" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The complaint draws on marketing and alleged prescribing practices. The initial discovery route and whether Novo made a test purchase are not established.", "sources": [ "https://docketnexus.com/document/448057500/", "https://dockets.justia.com/docket/california/candce/4%3A2025cv06560/453982", "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/76/0.pdf", "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/78" ] }, "challenged_conduct": [ { "text": "Novo alleges false personalization claims and unlawful corporate influence over medical decisions, including broad prescription changes presented as individualized care.", "attribution": "allegation", "sources": [ "https://docketnexus.com/document/448057500/", "https://dockets.justia.com/docket/california/candce/4%3A2025cv06560/453982", "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/76/0.pdf", "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/78" ] } ], "outcome": { "class": "procedural_order", "text": "September 15, 2026 discovery rulings adopted safeguards for counsel and expert access; a protective order followed September 23. These orders impose information-handling rules, not liability findings.", "as_of": "2026-09-23", "sources": [ "https://docketnexus.com/document/448057500/", "https://dockets.justia.com/docket/california/candce/4%3A2025cv06560/453982", "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/76/0.pdf", "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/78" ] }, "timeline": [ { "date": "2025-08-04", "event": "Novo alleged false advertising and unfair competition in the promotion of compounded weight-loss drugs through Fella Health and Delilah.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://docketnexus.com/document/448057500/" ] }, { "date": "2026-09-15", "event": "Court resolved access-to-confidential-information disputes and directed a proposed protective order.", "kind": "order", "date_basis": "event", "sources": [ "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/76/0.pdf" ] }, { "date": "2026-09-23", "event": "Court granted the stipulated protective order; this is a discovery ruling, not a liability determination.", "kind": "order", "date_basis": "event", "sources": [ "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/78" ] } ], "timing_pairs": [], "next_watch": { "text": "Review dispositive rulings and evidence on who made prescribing decisions, while keeping protected patient information out of public reporting.", "basis": "inference", "sources": [ "https://docketnexus.com/document/448057500/", "https://dockets.justia.com/docket/california/candce/4%3A2025cv06560/453982", "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/76/0.pdf", "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/78" ] }, "unknowns": [ "No final outcome or seller-specific laboratory result verified. A March 2026 dismissal ruling is referenced in Lilly’s related case and should be obtained for complete claim history." ], "source_review": [ { "url": "https://docketnexus.com/document/448057500/", "review_basis": "court_pdf", "locator": "Original complaint available at https://docketnexus.com/doc/448057500.pdf, introduction and corporate-practice allegations" }, { "url": "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/76/0.pdf", "review_basis": "archived_full_text", "locator": "September 15, 2026 discovery order, pp. 1–2" }, { "url": "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/78", "review_basis": "registry_support_only", "locator": "September 23, 2026 protective-order entry" } ] }, "compounds": [ "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide", "tirzepatide" ], "latest_documented_date": "2026-09-23", "sources": [ { "url": "https://docketnexus.com/document/448057500/", "title": "Novo v. Aios complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Case identity and the described procedural event." }, { "url": "https://dockets.justia.com/docket/california/candce/4%3A2025cv06560/453982", "title": "Novo v. Aios docket", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Case identity and the described procedural event." }, { "url": "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/76/0.pdf", "title": "September 15 discovery opinion", "source_type": "court_document", "document_type": "order", "supports": "Case identity and the described procedural event." }, { "url": "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/78", "title": "September 23 protective order", "source_type": "court_document", "document_type": "order", "supports": "Case identity and the described procedural event." } ], "business_profile": { "id": "novo-aios-2025", "display_name": "Fella Health / Delilah", "identities": [ { "name": "Aios Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://docketnexus.com/document/448057500/" ] }, { "name": "Fella Medical Group PA", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://docketnexus.com/document/448057500/" ] }, { "name": "Fella Medical Group PC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://docketnexus.com/document/448057500/" ] }, { "name": "Fella Health", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://docketnexus.com/document/448057500/" ] }, { "name": "Delilah", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://docketnexus.com/document/448057500/" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://docketnexus.com/document/448057500/" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://docketnexus.com/document/448057500/", "locator": "Original complaint available at https://docketnexus.com/doc/448057500.pdf, introduction and corporate-practice allegations" }, { "url": "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/76/0.pdf", "locator": "September 15, 2026 discovery order, pp. 1–2" }, { "url": "https://docs.justia.com/cases/federal/district-courts/california/candce/4%3A2025cv06560/453982/78", "locator": "September 23, 2026 protective-order entry" } ] } }, { "id": "novo-amble-2025", "case_name": "Novo Nordisk A/S et al. v. Amble Health Inc.", "category": "civil", "court_or_agency": "U.S. District Court, Northern District of Ohio", "docket_number": "4:25-cv-01048", "jurisdiction": "United States", "record_scope": "seller_marketing_and_compounding", "brands": [ "Amble Health" ], "parties": [ "Novo Nordisk A/S", "Novo Nordisk Inc.", "Amble Health Inc." ], "filed_date": "2025-05-21", "status_date": "2026-03-19", "analysis": { "id": "novo-amble-2025", "summary": { "text": "Novo challenged Amble’s promotion of personalized compounded semaglutide, but the reviewed dismissal focused on Novo’s ability to connect that advertising to its own injury. The March 2026 opinion found the pleaded chain of causation inadequate, including the role of independent prescription decisions, and addressed both constitutional standing and Lanham Act proximate causation. This is a useful counterweight to accounts that treat every drug-company suit as a successful enforcement action. The court did not establish the truth of all Amble advertisements, validate a batch, or authorize a compounded product.", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/4%3A2025cv01048/317467", "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf" ] }, "products": [ { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "The opinion describes challenged marketing of purportedly personalized compounded semaglutide.", "sources": [ "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "Advertising is the documented source of the challenged representations. The first lead, investigation start and any test purchase are not established.", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/4%3A2025cv01048/317467", "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf" ] }, "challenged_conduct": [ { "text": "Novo alleged misleading personalization and related compounded-semaglutide promotion; Amble contested whether those allegations established injury traceable to its conduct.", "attribution": "allegation", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/4%3A2025cv01048/317467", "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf" ] } ], "outcome": { "class": "dismissal", "text": "The order was signed March 17 and filed March 19, 2026. Dismissal rested on inadequately pleaded standing/causation; no advertising-truth or product-quality judgment was entered.", "as_of": "2026-03-19", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/4%3A2025cv01048/317467", "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf" ] }, "timeline": [ { "date": "2025-05-21", "event": "Complaint challenges advertising of personalized compounded semaglutide.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/4%3A2025cv01048/317467" ] }, { "date": "2026-03-19", "event": "Order signed March 17 and filed March 19 dismissed the complaint for lack of standing/jurisdiction, finding inadequate causal connection between the challenged advertising and Novo’s claimed harm.", "kind": "dismissal", "date_basis": "filing", "sources": [ "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf" ] } ], "timing_pairs": [ { "label": "Complaint filing to dismissal order filing", "start": "2025-05-21", "end": "2026-03-19", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/4%3A2025cv01048/317467", "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf" ], "days": 302 } ], "next_watch": { "text": "Check any amended proceeding or appeal and whether later allegations supply the missing causal link.", "basis": "inference", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/4%3A2025cv01048/317467", "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf" ] }, "unknowns": [ "Post-dismissal appellate or refiling history is not verified." ], "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf", "review_basis": "archived_full_text", "locator": "March 2026 dismissal opinion, standing and proximate-causation analysis" }, { "url": "https://dockets.justia.com/docket/ohio/ohndce/4%3A2025cv01048/317467", "review_basis": "registry_support_only", "locator": "Filing metadata" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2026-03-19", "sources": [ { "url": "https://dockets.justia.com/docket/ohio/ohndce/4%3A2025cv01048/317467", "title": "Amble docket", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Case identity, allegations and procedural event described in this record." }, { "url": "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf", "title": "Amble dismissal opinion", "source_type": "court_document", "document_type": "order", "supports": "Case identity, allegations and procedural event described in this record." } ], "business_profile": { "id": "novo-amble-2025", "display_name": "Amble Health", "identities": [ { "name": "Amble Health Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf" ] }, { "name": "Amble Health", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/ohio/ohndce/4%3A2025cv01048/317467/41/0.pdf", "locator": "March 2026 dismissal opinion, standing and proximate-causation analysis" }, { "url": "https://dockets.justia.com/docket/ohio/ohndce/4%3A2025cv01048/317467", "locator": "Filing metadata" } ] } }, { "id": "novo-doceremedical-2025", "case_name": "Novo Nordisk A/S et al. v. Docere Medical Spa and Laser Center Inc.", "category": "civil", "court_or_agency": "U.S. District Court, Northern District of Ohio", "docket_number": "1:25-cv-01236", "jurisdiction": "United States", "record_scope": "seller_marketing_and_compounding", "brands": [ "Docere Medical Spa and Laser Center" ], "parties": [ "Novo Nordisk A/S", "Novo Nordisk Inc.", "Docere Medical Spa and Laser Center Inc." ], "filed_date": "2025-06-12", "status_date": "2025-09-23", "analysis": { "id": "novo-doceremedical-2025", "summary": { "text": "Novo’s case against Docere Medical remains thinly documented in this collection. The docket identifies a June 2025 complaint and exhibits concerning semaglutide qualification, benefits and aftercare. Those exhibit titles support the connection to semaglutide promotion, but cannot substitute for reading the advertisements and complete pleading. The most useful procedural distinction is that the clerk entered default in September and the defendant then answered and sought to set that default aside. A clerk’s default is not a default judgment and does not establish a damages award or permanent injunction.", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ] }, "products": [ { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "Docket-listed complaint exhibits concern semaglutide promotion; the underlying documents were not obtained.", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "The initial lead and any evidence-gathering method are not established. Exhibit titles alone do not show a test purchase, inspection or consumer complaint.", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ] }, "challenged_conduct": [ { "text": "The docket indicates an advertising dispute involving semaglutide; specific misrepresentations and statutory counts cannot be confidently reconstructed from metadata.", "attribution": "unknown", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ] } ], "outcome": { "class": "procedural_order", "text": "The clerk entered default September 5, 2025; Docere filed an answer and motion to set it aside September 23. No resolution of that request is verified.", "as_of": "2025-09-23", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ] }, "timeline": [ { "date": "2025-06-12", "event": "Docket records complaint and exhibits concerning semaglutide qualification, benefits and aftercare advertising.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ] }, { "date": "2025-09-05", "event": "Clerk entered default; this was not a default judgment.", "kind": "other", "date_basis": "event", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ] }, { "date": "2025-09-23", "event": "After clerk’s September 5 entry of default, defendant filed an answer and motion to set aside default. No disposition of that motion verified.", "kind": "other", "date_basis": "filing", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ] } ], "timing_pairs": [], "next_watch": { "text": "Retrieve the complaint and ruling on the default challenge before assigning a liability outcome.", "basis": "inference", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ] }, "unknowns": [ "Full complaint, advertisements and later disposition missing. A related Docere Holdings filing may be an entity correction/refiling and is not counted here as separate conduct." ], "source_review": [ { "url": "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269", "review_basis": "registry_support_only", "locator": "Collected docket entries and exhibit titles only" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2025-09-23", "sources": [ { "url": "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269", "title": "Docere Medical docket", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Caption, complaint exhibits, filing date, clerk’s default and response/motion dates." } ], "business_profile": { "id": "novo-doceremedical-2025", "display_name": "Docere Medical Spa and Laser Center", "identities": [ { "name": "Docere Medical Spa and Laser Center Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ] }, { "name": "Docere Medical Spa and Laser Center", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://dockets.justia.com/docket/ohio/ohndce/1%3A2025cv01236/318269", "locator": "Collected docket entries and exhibit titles only" } ] } }, { "id": "novo-dripdrop-2024", "case_name": "Novo Nordisk A/S et al. v. Drip Drop Hydration Station LLC", "category": "civil", "court_or_agency": "U.S. District Court, Southern District of Ohio", "docket_number": "1:24-cv-00640", "jurisdiction": "United States", "record_scope": "seller_marketing_and_compounding", "brands": [ "Bedside Manner Telehealth" ], "parties": [ "Novo Nordisk A/S", "Novo Nordisk Inc.", "Drip Drop Hydration Station LLC" ], "filed_date": "2024-11-08", "status_date": "2025-12-11", "analysis": { "id": "novo-dripdrop-2024", "summary": { "text": "Novo’s lawsuit against Drip Drop Hydration Station, operating as Bedside Manner Telehealth, produced an actual default judgment concerning semaglutide advertising. The December 2025 order found trademark, false-origin, false-advertising and Ohio consumer-law violations after the defendant defaulted. Its injunction restricts Ozempic and Wegovy branding and representations that compounded products are FDA-approved or equivalent to those medicines. It also requires disclosure that the compounded offerings lack FDA approval. This is stronger outcome evidence than an unanswered complaint, while remaining a default proceeding rather than a contested trial of laboratory quality.", "sources": [ "https://dockets.justia.com/docket/ohio/ohsdce/1%3A2024cv00640/298155", "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "The default judgment addresses the defendant’s compounded semaglutide marketing and prescribes corrective disclosures.", "sources": [ "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "The initial identification route is not established. The judgment concerns advertising evidence, not a reported undercover purchase or agency investigation.", "sources": [ "https://dockets.justia.com/docket/ohio/ohsdce/1%3A2024cv00640/298155", "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf" ] }, "challenged_conduct": [ { "text": "The court declared willful trademark and false-advertising violations on default and required changes to branding, approval claims and disclosures.", "attribution": "judicial_finding", "sources": [ "https://dockets.justia.com/docket/ohio/ohsdce/1%3A2024cv00640/298155", "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf" ] } ], "outcome": { "class": "mixed", "text": "Default judgment and permanent advertising injunction entered December 11, 2025. Sales accounting was ordered; profit disgorgement was deferred pending that accounting, and fee entitlement did not establish a final dollar award.", "as_of": "2025-12-11", "sources": [ "https://dockets.justia.com/docket/ohio/ohsdce/1%3A2024cv00640/298155", "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf" ] }, "timeline": [ { "date": "2024-11-08", "event": "Novo filed trademark and advertising claims against Bedside Manner Telehealth.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://dockets.justia.com/docket/ohio/ohsdce/1%3A2024cv00640/298155" ] }, { "date": "2025-12-11", "event": "Court granted default judgment, declared willful trademark/false-advertising violations, issued permanent advertising restrictions and disclosure requirements, ordered sales accounting, and deferred profit disgorgement pending further proceedings.", "kind": "order", "date_basis": "event", "sources": [ "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf" ] } ], "timing_pairs": [ { "label": "Complaint filing to default judgment", "start": "2024-11-08", "end": "2025-12-11", "sources": [ "https://dockets.justia.com/docket/ohio/ohsdce/1%3A2024cv00640/298155", "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf" ], "days": 398 } ], "next_watch": { "text": "Check the ordered accounting and later damages or fee rulings before reporting money recovered.", "basis": "inference", "sources": [ "https://dockets.justia.com/docket/ohio/ohsdce/1%3A2024cv00640/298155", "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf" ] }, "unknowns": [ "No contested product-quality finding or final disgorgement amount is established." ], "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf", "review_basis": "archived_full_text", "locator": "December 11, 2025 default judgment and permanent injunction" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2025-12-11", "sources": [ { "url": "https://dockets.justia.com/docket/ohio/ohsdce/1%3A2024cv00640/298155", "title": "Drip Drop docket", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Case identity and the described procedural event." }, { "url": "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf", "title": "Drip Drop default judgment and injunction", "source_type": "court_document", "document_type": "order", "supports": "Case identity and the described procedural event." } ], "business_profile": { "id": "novo-dripdrop-2024", "display_name": "Bedside Manner Telehealth", "identities": [ { "name": "Drip Drop Hydration Station LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf" ] }, { "name": "Bedside Manner Telehealth", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/ohio/ohsdce/1%3A2024cv00640/298155/21/0.pdf", "locator": "December 11, 2025 default judgment and permanent injunction" } ] } }, { "id": "novo-hims-patent-2026", "case_name": "Novo Nordisk A/S et al. v. Hims & Hers Health Inc. et al.", "category": "civil", "court_or_agency": "U.S. District Court, District of Delaware", "docket_number": "1:26-cv-00143", "jurisdiction": "United States", "record_scope": "seller_patent_litigation", "brands": [ "Hims & Hers" ], "parties": [ "Novo Nordisk A/S", "Novo Nordisk Inc.", "Hims & Hers Health Inc.", "Hims Inc." ], "filed_date": "2026-02-09", "status_date": "2026-03-09", "analysis": { "id": "novo-hims-patent-2026", "summary": { "text": "Novo’s Hims & Hers action is a patent dispute over compounded semaglutide, rather than a finding of contamination or false research-only labeling. Hims’ SEC filing says Novo asserted U.S. Patent 8,129,343, sought damages and an injunction, then voluntarily dismissed all claims without prejudice in March 2026. The same filing acknowledges semaglutide products were available by prescription through its platform. This establishes the company’s own account of the offering and case history. It does not establish infringement, invalidate the patent, or explain every term behind the dismissal.", "sources": [ "https://dockets.justia.com/docket/delaware/dedce/1%3A2026cv00143/91967", "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm", "https://www.novomedlink.com/content/dam/novomedlink/semaglutide/02-09-2026-company-statement.pdf" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "Hims’ SEC legal-proceedings disclosure acknowledges compounded semaglutide products available through its prescription platform.", "sources": [ "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "The corporate statement and securities filing identify the challenged business but do not establish the initial discovery route or any product-testing investigation.", "sources": [ "https://dockets.justia.com/docket/delaware/dedce/1%3A2026cv00143/91967", "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm", "https://www.novomedlink.com/content/dam/novomedlink/semaglutide/02-09-2026-company-statement.pdf" ] }, "challenged_conduct": [ { "text": "Novo alleged patent infringement, including willful infringement, in connection with compounded semaglutide. Those claims were withdrawn without a merits adjudication.", "attribution": "allegation", "sources": [ "https://dockets.justia.com/docket/delaware/dedce/1%3A2026cv00143/91967", "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm", "https://www.novomedlink.com/content/dam/novomedlink/semaglutide/02-09-2026-company-statement.pdf" ] } ], "outcome": { "class": "dismissal", "text": "Novo voluntarily dismissed without prejudice March 9, 2026, and the case closed. Hims reports Novo reserved the right to refile; no patent-liability judgment resulted.", "as_of": "2026-03-09", "sources": [ "https://dockets.justia.com/docket/delaware/dedce/1%3A2026cv00143/91967", "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm", "https://www.novomedlink.com/content/dam/novomedlink/semaglutide/02-09-2026-company-statement.pdf" ] }, "timeline": [ { "date": "2026-02-09", "event": "Novo filed patent-infringement claims concerning compounded semaglutide and U.S. Patent 8,129,343.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://dockets.justia.com/docket/delaware/dedce/1%3A2026cv00143/91967" ] }, { "date": "2026-03-09", "event": "Docket records voluntary dismissal and case closure. Hims securities filing states all claims were dismissed without prejudice.", "kind": "dismissal", "date_basis": "event", "sources": [ "https://dockets.justia.com/docket/delaware/dedce/1%3A2026cv00143/91967" ] } ], "timing_pairs": [ { "label": "Patent complaint filing to voluntary dismissal", "start": "2026-02-09", "end": "2026-03-09", "sources": [ "https://dockets.justia.com/docket/delaware/dedce/1%3A2026cv00143/91967", "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm" ], "days": 28 } ], "next_watch": { "text": "Monitor any renewed patent action or public agreement clarifying the commercial arrangement and scope of permitted activity.", "basis": "inference", "sources": [ "https://dockets.justia.com/docket/delaware/dedce/1%3A2026cv00143/91967", "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm", "https://www.novomedlink.com/content/dam/novomedlink/semaglutide/02-09-2026-company-statement.pdf" ] }, "unknowns": [ "Full settlement or commercial terms are not established by the reviewed litigation disclosure." ], "source_review": [ { "url": "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm", "review_basis": "archived_full_text", "locator": "Hims June 30, 2026 Form 10-Q, legal-proceedings discussion" }, { "url": "https://www.novomedlink.com/content/dam/novomedlink/semaglutide/02-09-2026-company-statement.pdf", "review_basis": "archived_full_text", "locator": "Novo February 9, 2026 company statement" }, { "url": "https://dockets.justia.com/docket/delaware/dedce/1%3A2026cv00143/91967", "review_basis": "registry_support_only", "locator": "Dismissal docket metadata" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2026-03-09", "sources": [ { "url": "https://dockets.justia.com/docket/delaware/dedce/1%3A2026cv00143/91967", "title": "Hims patent docket", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Case identity, allegations and procedural event described in this record." }, { "url": "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm", "title": "Hims second-quarter 2026 securities filing", "source_type": "party_statement", "document_type": "securities_filing", "supports": "Company reports March 9 dismissal without prejudice." }, { "url": "https://www.novomedlink.com/content/dam/novomedlink/semaglutide/02-09-2026-company-statement.pdf", "title": "Novo announcement of patent suit", "source_type": "party_statement", "document_type": "press_release", "supports": "Case identity, allegations and procedural event described in this record." } ], "business_profile": { "id": "novo-hims-patent-2026", "display_name": "Hims & Hers", "identities": [ { "name": "Hims & Hers Health Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm" ] }, { "name": "Hims Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm" ] }, { "name": "Hims & Hers", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm" ] } ], "activity": { "summary": "Hims & Hers reported beginning certain compounded GLP-1 offerings in May 2024 in its second-quarter 2026 filing. This dates that product line, not the company's establishment or a verified period of all semaglutide formulations.", "kind": "documented_period", "start": "2024-05", "end": null, "sources": [ "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm" ], "limits": [ "Company-reported product-line start, not a founding date.", "No operating end date is established by the patent case dismissal." ] }, "source_review": [ { "url": "https://www.sec.gov/Archives/edgar/data/1773751/000177375126000163/hims-20260630.htm", "locator": "Hims June 30, 2026 Form 10-Q, legal-proceedings discussion" }, { "url": "https://www.novomedlink.com/content/dam/novomedlink/semaglutide/02-09-2026-company-statement.pdf", "locator": "Novo February 9, 2026 company statement" }, { "url": "https://dockets.justia.com/docket/delaware/dedce/1%3A2026cv00143/91967", "locator": "Dismissal docket metadata" } ] } }, { "id": "novo-ivharmony-2024", "case_name": "Novo Nordisk A/S et al. v. IV Harmony Clinic LLC", "category": "civil", "court_or_agency": "U.S. District Court, Middle District of Florida", "docket_number": "8:24-cv-02292", "jurisdiction": "United States", "record_scope": "seller_marketing_and_compounding", "brands": [ "IV Harmony Clinic" ], "parties": [ "Novo Nordisk A/S", "Novo Nordisk Inc.", "IV Harmony Clinic LLC" ], "filed_date": "2024-09-30", "status_date": "2025-04-16", "analysis": { "id": "novo-ivharmony-2024", "summary": { "text": "Novo’s Florida case against IV Harmony centers on allegedly deceptive claims that compounded semaglutide was FDA-approved and on use of Ozempic or Wegovy references in promotion. The April 2025 opinion allowed those theories past dismissal, distinguishing allegations about misleading advertising from attempts merely to enforce the federal approval requirement. The distinction helps explain why some seemingly similar Novo suits were dismissed while this pleading survived. The order also rejected the defendant’s First Amendment argument at that stage. It did not resolve whether the challenged advertisements were ultimately false or award damages.", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ] }, "products": [ { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "The opinion describes the complaint’s allegations about compounded semaglutide and FDA-approval/brand representations.", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "The source identifies advertisements as supporting evidence but does not explain the first discovery of them or describe an agency investigation.", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ] }, "challenged_conduct": [ { "text": "Novo alleged deceptive FDA-approval and branded-drug representations. The court decided legal sufficiency and defenses on assumed pleading facts.", "attribution": "allegation", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ] } ], "outcome": { "class": "procedural_order", "text": "The motion to dismiss was denied April 16, 2025. This is a pleading-stage ruling, not a liability judgment or a product-quality determination.", "as_of": "2025-04-16", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ] }, "timeline": [ { "date": "2024-09-30", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ] }, { "date": "2025-04-16", "event": "Court denied dismissal of claims alleging misleading FDA-approval and brand references in semaglutide advertising; rejected preemption and First Amendment arguments at pleading stage.", "kind": "order", "date_basis": "event", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ] } ], "timing_pairs": [ { "label": "Complaint filing to denial of dismissal", "start": "2024-09-30", "end": "2025-04-16", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ], "days": 198 } ], "next_watch": { "text": "Look for the answer, factual discovery and a later merits or settlement order to assess what was actually proved.", "basis": "inference", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ] }, "unknowns": [ "Later disposition, damages and seller-specific test results are not established." ], "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "review_basis": "archived_full_text", "locator": "April 16, 2025 opinion, preemption and First Amendment analysis" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2025-04-16", "sources": [ { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "title": "IV Harmony April 16, 2025 order", "source_type": "court_document", "document_type": "order", "supports": "Case identity, allegations and procedural event described in this record." } ], "business_profile": { "id": "novo-ivharmony-2024", "display_name": "IV Harmony Clinic", "identities": [ { "name": "IV Harmony Clinic LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ] }, { "name": "IV Harmony Clinic", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "locator": "April 16, 2025 opinion, preemption and First Amendment analysis" } ] } }, { "id": "novo-liferxmd-2024", "case_name": "Novo Nordisk A/S et al. v. LifeRxMD Inc.", "category": "civil", "court_or_agency": "U.S. District Court, District of New Jersey", "docket_number": "3:24-cv-09018", "jurisdiction": "United States", "record_scope": "seller_marketing_and_compounding", "brands": [ "LifeRxMD" ], "parties": [ "Novo Nordisk A/S", "Novo Nordisk Inc.", "LifeRxMD Inc." ], "filed_date": "2024-09-06", "status_date": "2026-01-28", "analysis": { "id": "novo-liferxmd-2024", "summary": { "text": "Novo’s LifeRxMD case focuses on whether promotion of compounded semaglutide implied FDA approval or equivalence to Ozempic and Wegovy. The January 2026 opinion describes specific approval and brand references, then rejects LifeRxMD’s attempts to dismiss on standing, preemption and pleading-sufficiency grounds. Novo plausibly alleged commercial injury at that stage, which allowed its federal and New Jersey unfair-competition claims to continue. The opinion’s background also recites broader adverse-event statistics; those are not LifeRxMD-specific injury findings and should not be republished as such.", "sources": [ "https://dockets.justia.com/docket/new-jersey/njdce/3%3A2024cv09018/554270", "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf", "https://app.midpage.ai/document/novo-nordisk-a-s-v--8ab89894-2d47-4957-8797-75fe900bbab0" ] }, "products": [ { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "The opinion identifies LifeRxMD’s purported compounded semaglutide offering and quotations from challenged marketing.", "sources": [ "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf", "https://app.midpage.ai/document/novo-nordisk-a-s-v--8ab89894-2d47-4957-8797-75fe900bbab0" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "Marketing materials are the documented evidence source. The opinion does not explain the initial discovery route or establish a seller-specific sample purchase or test.", "sources": [ "https://dockets.justia.com/docket/new-jersey/njdce/3%3A2024cv09018/554270", "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf", "https://app.midpage.ai/document/novo-nordisk-a-s-v--8ab89894-2d47-4957-8797-75fe900bbab0" ] }, "challenged_conduct": [ { "text": "Novo alleges compounded products were misleadingly presented as FDA-approved or equivalent to branded medicines, causing consumer confusion and commercial injury.", "attribution": "allegation", "sources": [ "https://dockets.justia.com/docket/new-jersey/njdce/3%3A2024cv09018/554270", "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf", "https://app.midpage.ai/document/novo-nordisk-a-s-v--8ab89894-2d47-4957-8797-75fe900bbab0" ] } ], "outcome": { "class": "procedural_order", "text": "LifeRxMD’s motion to dismiss was denied in its entirety January 28, 2026. The court accepted sufficiently pleaded allegations for that motion, without entering a liability judgment.", "as_of": "2026-01-28", "sources": [ "https://dockets.justia.com/docket/new-jersey/njdce/3%3A2024cv09018/554270", "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf", "https://app.midpage.ai/document/novo-nordisk-a-s-v--8ab89894-2d47-4957-8797-75fe900bbab0" ] }, "timeline": [ { "date": "2024-09-06", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://dockets.justia.com/docket/new-jersey/njdce/3%3A2024cv09018/554270", "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf", "https://app.midpage.ai/document/novo-nordisk-a-s-v--8ab89894-2d47-4957-8797-75fe900bbab0" ] }, { "date": "2026-01-28", "event": "Court denied LifeRxMD’s motion to dismiss Novo’s false-advertising and unfair-competition claims.", "kind": "order", "date_basis": "event", "sources": [ "https://app.midpage.ai/document/novo-nordisk-a-s-v--8ab89894-2d47-4957-8797-75fe900bbab0" ] } ], "timing_pairs": [ { "label": "Complaint filing to denial of dismissal", "start": "2024-09-06", "end": "2026-01-28", "sources": [ "https://dockets.justia.com/docket/new-jersey/njdce/3%3A2024cv09018/554270", "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf" ], "days": 509 } ], "next_watch": { "text": "Look for evidence-stage rulings, a settlement or judgment establishing which representations were actually false.", "basis": "inference", "sources": [ "https://dockets.justia.com/docket/new-jersey/njdce/3%3A2024cv09018/554270", "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf", "https://app.midpage.ai/document/novo-nordisk-a-s-v--8ab89894-2d47-4957-8797-75fe900bbab0" ] }, "unknowns": [ "Later outcome and any seller-specific injury or composition evidence remain unverified." ], "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf", "review_basis": "court_pdf", "locator": "Document 37, archived image PDF; OCR and full-text mirror reviewed" }, { "url": "https://app.midpage.ai/document/novo-nordisk-a-s-v--8ab89894-2d47-4957-8797-75fe900bbab0", "review_basis": "official_web_full_text", "locator": "Primary judicial opinion reproduced on Midpage, background and conclusion" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2026-01-28", "sources": [ { "url": "https://dockets.justia.com/docket/new-jersey/njdce/3%3A2024cv09018/554270", "title": "LifeRxMD docket", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Case identity, allegations and procedural event described in this record." }, { "url": "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf", "title": "LifeRxMD January 28, 2026 opinion PDF", "source_type": "court_document", "document_type": "order", "supports": "Case identity, allegations and procedural event described in this record." }, { "url": "https://app.midpage.ai/document/novo-nordisk-a-s-v--8ab89894-2d47-4957-8797-75fe900bbab0", "title": "LifeRxMD opinion text mirror", "source_type": "court_document", "document_type": "order", "supports": "Case identity, allegations and procedural event described in this record." } ], "business_profile": { "id": "novo-liferxmd-2024", "display_name": "LifeRxMD", "identities": [ { "name": "LifeRxMD Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf" ] }, { "name": "LifeRxMD", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/new-jersey/njdce/3%3A2024cv09018/554270/37/0.pdf", "locator": "Document 37, archived image PDF; OCR and full-text mirror reviewed" }, { "url": "https://app.midpage.ai/document/novo-nordisk-a-s-v--8ab89894-2d47-4957-8797-75fe900bbab0", "locator": "Primary judicial opinion reproduced on Midpage, background and conclusion" } ] } }, { "id": "novo-brooksville-2023", "case_name": "Novo Nordisk Inc. v. Brooksville Pharmaceuticals Inc.", "category": "civil", "court_or_agency": "U.S. District Court, M.D. Florida", "docket_number": "8:23-cv-01503", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Brooksville Pharmaceuticals" ], "parties": [ "Novo Nordisk Inc.", "Brooksville Pharmaceuticals Inc." ], "filed_date": "2023-07-06", "status_date": "2025-07-28", "analysis": { "id": "novo-brooksville-2023", "summary": { "text": "Novo’s Brooksville Pharmaceuticals suit reached a substantive summary-judgment record, unlike the many complaint-only cases in this collection. The May 2025 opinion rejected its remaining Florida unfair-practices claim on three grounds: mootness, implied federal preemption, and failure to demonstrate consumer injury. The opinion references Novo’s acquisition and testing of three compounded-semaglutide samples, but concluded the record did not support the required claim. That evidentiary failure is significant and should not be reduced to a generic procedural dismissal. It still is not a blanket finding that every Brooksville product was safe or FDA-approved.", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf", "https://law.justia.com/cases/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/210/", "https://dockets.justia.com/docket/florida/flmdce/8%3A2023cv01503/415925" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "The summary-judgment record addresses Brooksville’s compounded semaglutide and Novo’s acquisition of three samples.", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "Sample acquisition and testing are documented as litigation evidence. The initial trigger and exact first-investigation date are not established.", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf", "https://law.justia.com/cases/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/210/", "https://dockets.justia.com/docket/florida/flmdce/8%3A2023cv01503/415925" ] }, "challenged_conduct": [ { "text": "Novo alleged unlawful and unfair compounded-semaglutide sales; the court found the remaining claim failed, including for lack of evidence of consumer injury.", "attribution": "mixed", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf", "https://law.justia.com/cases/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/210/", "https://dockets.justia.com/docket/florida/flmdce/8%3A2023cv01503/415925" ] } ], "outcome": { "class": "dismissal", "text": "Summary judgment entered for Brooksville May 12, 2025. A July 28 order denied a Rule 58(e) request concerning appeal timing; appellate outcome is unverified.", "as_of": "2025-07-28", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf", "https://law.justia.com/cases/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/210/", "https://dockets.justia.com/docket/florida/flmdce/8%3A2023cv01503/415925" ] }, "timeline": [ { "date": "2023-07-06", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf", "https://law.justia.com/cases/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/210/", "https://dockets.justia.com/docket/florida/flmdce/8%3A2023cv01503/415925" ] }, { "date": "2025-05-12", "event": "Court granted summary judgment for Brooksville. Subsequent appellate outcome not verified.", "kind": "order", "date_basis": "event", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf" ] }, { "date": "2025-07-28", "event": "Following summary judgment for Brooksville, court denied Novo’s Rule 58(e) motion concerning extension of the appeal deadline. Appellate outcome unverified.", "kind": "order", "date_basis": "event", "sources": [ "https://law.justia.com/cases/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/210/" ] } ], "timing_pairs": [ { "label": "Complaint filing to summary judgment", "start": "2023-07-06", "end": "2025-05-12", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf", "https://dockets.justia.com/docket/florida/flmdce/8%3A2023cv01503/415925" ], "days": 676 } ], "next_watch": { "text": "Check the notice of appeal and appellate disposition before presenting the district result as final.", "basis": "inference", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf", "https://law.justia.com/cases/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/210/", "https://dockets.justia.com/docket/florida/flmdce/8%3A2023cv01503/415925" ] }, "unknowns": [ "Complete appellate history and independent assessment of the sampled products remain outside this review." ], "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf", "review_basis": "archived_full_text", "locator": "Summary-judgment opinion, conclusion and consumer-injury analysis, pp. 40–43" }, { "url": "https://law.justia.com/cases/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/210/", "review_basis": "registry_support_only", "locator": "Post-judgment Rule 58(e) order" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2025-07-28", "sources": [ { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf", "title": "Novo Nordisk Inc. v. Brooksville Pharmaceuticals Inc. — summary judgment", "source_type": "court_document", "document_type": "order", "supports": "Court granted summary judgment for Brooksville. Subsequent appellate outcome not verified." }, { "url": "https://law.justia.com/cases/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/210/", "title": "Brooksville post-judgment opinion", "source_type": "court_document", "document_type": "order", "supports": "Denial of Rule 58(e) motion concerning appeal timing." }, { "url": "https://dockets.justia.com/docket/florida/flmdce/8%3A2023cv01503/415925", "title": "Brooksville docket", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Caption, filing date and docket." } ], "business_profile": { "id": "novo-brooksville-2023", "display_name": "Brooksville Pharmaceuticals", "identities": [ { "name": "Brooksville Pharmaceuticals Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf" ] }, { "name": "Brooksville Pharmaceuticals", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/187/0.pdf", "locator": "Summary-judgment opinion, conclusion and consumer-injury analysis, pp. 40–43" }, { "url": "https://law.justia.com/cases/federal/district-courts/florida/flmdce/8%3A2023cv01503/415925/210/", "locator": "Post-judgment Rule 58(e) order" } ] } }, { "id": "novo-dunklau-2024", "case_name": "Novo Nordisk Inc. v. Dunklau Pharmacy Holdings LLC et al.", "category": "civil", "court_or_agency": "U.S. District Court, M.D. Tennessee", "docket_number": "3:24-cv-00667", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Midtown Express Pharmacy", "247Health" ], "parties": [ "Novo Nordisk Inc.", "Dunklau Pharmacy Holdings LLC", "Dr Hank LLC" ], "filed_date": "2024-05-30", "status_date": "2025-04-25", "analysis": { "id": "novo-dunklau-2024", "summary": { "text": "Novo sued two connected semaglutide businesses: Dunklau Pharmacy Holdings, doing business as Midtown Express Pharmacy, and Dr Hank, doing business as 247 Health. Their outcomes must be separated. The August 2024 consent judgment applies to Dr Hank and expressly leaves the Dunklau claims unresolved. Novo subsequently announced a permanent semaglutide restriction against Midtown Express in April 2025, connecting it to the company’s allegation that tested material contained no semaglutide. That is a party account of a later result, not a substitute for the uncollected judgment or an independently reviewed laboratory report.", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/", "https://dockets.justia.com/docket/tennessee/tnmdce/3%3A2024cv00667/99691", "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "The consent judgment states Dr Hank offered purported semaglutide. It does not independently verify the contents of Midtown products.", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/", "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "How Novo first identified the businesses is not documented. Novo reports product testing, but the acquisition method and date of initial discovery are unknown.", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/", "https://dockets.justia.com/docket/tennessee/tnmdce/3%3A2024cv00667/99691", "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ] }, "challenged_conduct": [ { "text": "Novo challenged semaglutide-related branding and advertising; its later statement alleges a product sold as semaglutide contained none of that ingredient.", "attribution": "allegation", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/", "https://dockets.justia.com/docket/tennessee/tnmdce/3%3A2024cv00667/99691", "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ] } ], "outcome": { "class": "mixed", "text": "Dr Hank consent judgment entered August 13, 2024: semaglutide marketing/sales injunction, a process for discussing legally compliant sales, dismissal without prejudice, retained enforcement jurisdiction and no monetary award in the judgment. Dunklau claims were expressly unaffected. Novo later reported a Midtown restriction April 25, 2025; that later order is missing.", "as_of": "2025-04-25", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/", "https://dockets.justia.com/docket/tennessee/tnmdce/3%3A2024cv00667/99691", "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ] }, "timeline": [ { "date": "2024-05-30", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/", "https://dockets.justia.com/docket/tennessee/tnmdce/3%3A2024cv00667/99691", "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ] }, { "date": "2024-08-13", "event": "Consent judgment and injunction entered against Dr Hank LLC only; expressly did not resolve claims against Dunklau.", "kind": "order", "date_basis": "event", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/" ] }, { "date": "2025-04-25", "event": "August 2024 Dr Hank consent judgment verified. Novo later announced a permanent semaglutide restriction against Midtown Express; later order and its entry date were not independently obtained.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ] } ], "timing_pairs": [ { "label": "Complaint filing to Dr Hank consent judgment", "start": "2024-05-30", "end": "2024-08-13", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/", "https://dockets.justia.com/docket/tennessee/tnmdce/3%3A2024cv00667/99691" ], "days": 75 } ], "next_watch": { "text": "Retrieve the later Dunklau/Midtown judgment and testing record to separate the two defendants’ obligations.", "basis": "inference", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/", "https://dockets.justia.com/docket/tennessee/tnmdce/3%3A2024cv00667/99691", "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ] }, "unknowns": [ "No original later Midtown judgment or laboratory report reviewed. Announcement date is not judgment date." ], "source_review": [ { "url": "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/", "review_basis": "court_pdf", "locator": "Document 29, downloaded to civil-source-review/dunklau.pdf; paragraphs 4–6 and signed date" }, { "url": "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "review_basis": "registry_support_only", "locator": "Novo April 25, 2025 announcement; current page yields no substantive text" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2025-04-25", "sources": [ { "url": "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/", "title": "Novo Nordisk Inc. v. Dunklau Pharmacy Holdings LLC et al. — consent judgment", "source_type": "court_document", "document_type": "order", "supports": "Consent judgment and injunction entered against Dr Hank LLC only; expressly did not resolve claims against Dunklau." }, { "url": "https://dockets.justia.com/docket/tennessee/tnmdce/3%3A2024cv00667/99691", "title": "Dunklau docket mirror", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Caption, docket and filing date." }, { "url": "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "title": "Novo reports later judgment against Midtown Express", "source_type": "party_statement", "document_type": "press_release", "supports": "Plaintiff reports permanent semaglutide restriction against Midtown Express; actual later order not obtained." } ], "business_profile": { "id": "novo-dunklau-2024", "display_name": "Midtown Express Pharmacy / 247Health", "identities": [ { "name": "Dunklau Pharmacy Holdings LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/" ] }, { "name": "Dr Hank LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/" ] }, { "name": "Midtown Express Pharmacy", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/" ] }, { "name": "247Health", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://law.justia.com/cases/federal/district-courts/tennessee/tnmdce/3%3A2024cv00667/99691/29/", "locator": "Document 29, downloaded to civil-source-review/dunklau.pdf; paragraphs 4–6 and signed date" }, { "url": "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "locator": "Novo April 25, 2025 announcement; current page yields no substantive text" } ] } }, { "id": "novo-trulife-2023", "case_name": "Novo Nordisk Inc. v. Live Well Drugstore LLC dba TruLife Pharmacy", "category": "civil", "court_or_agency": "U.S. District Court, M.D. Florida", "docket_number": "3:23-cv-00808", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "TruLife Pharmacy" ], "parties": [ "Novo Nordisk Inc.", "Live Well Drugstore LLC" ], "filed_date": null, "status_date": "2025-01-30", "analysis": { "id": "novo-trulife-2023", "summary": { "text": "Novo’s private Florida unfair-competition suit concerned semaglutide marketed by Live Well Drugstore, doing business as TruLife Pharmacy. A July 2024 order let Novo add allegations of impurities and below-label strength; it expressly reserved whether those allegations could survive dismissal. An April 2025 opinion in a different Novo case identifies a January 30, 2025 dismissal in this matter on preemption grounds. That later judicial citation establishes an important procedural development, but does not replace the missing original dismissal order. This pharmacy is unrelated in the collected evidence to the LiveWell Peptides defendant sued in October 2026.", "sources": [ "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] }, "products": [ { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "The amendment order describes products purporting to contain semaglutide and Novo’s proposed potency/purity allegations.", "sources": [ "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "The initial lead and sample-acquisition route are not established. The amendment request is evidence of later case development, not a documented detection date.", "sources": [ "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] }, "challenged_conduct": [ { "text": "Novo alleged unlawful marketing and unfair competition, later adding impurity and under-strength claims. Permission to plead those claims did not establish their truth.", "attribution": "allegation", "sources": [ "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] } ], "outcome": { "class": "dismissal", "text": "A later court cites dismissal on January 30, 2025. A related appeal is identified, but the original dismissal’s exact scope and appellate merits outcome remain unverified.", "as_of": "2025-01-30", "sources": [ "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] }, "timeline": [ { "date": "2024-07-09", "event": "Court permitted amended complaint with potency/purity allegations and denied original dismissal motion as moot. No accuracy findings or final disposition.", "kind": "order", "date_basis": "event", "sources": [ "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=" ] }, { "date": "2025-01-30", "event": "An April 16, 2025 order in Novo v IV Harmony cites a January 30, 2025 dismissal/preemption ruling in the Live Well Drugstore case. Original order and exact scope remain unverified in this collection.", "kind": "dismissal", "date_basis": "event", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain the original dismissal and appeal 25-10697’s disposition before describing the result as final.", "basis": "inference", "sources": [ "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] }, "unknowns": [ "Original filing date, dismissal text, testing details, and appellate outcome remain gaps." ], "source_review": [ { "url": "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=", "review_basis": "archived_full_text", "locator": "July 9, 2024 order, pp. 1–3" }, { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "review_basis": "archived_full_text", "locator": "IV Harmony opinion discussion of related Florida rulings" }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681", "review_basis": "registry_support_only", "locator": "Related appeal references in collected docket metadata" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2025-01-30", "sources": [ { "url": "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=", "title": "Novo Nordisk Inc. v. Live Well Drugstore LLC dba TruLife Pharmacy — amendment order", "source_type": "court_document", "document_type": "order", "supports": "Court permitted amended complaint with potency/purity allegations and denied original dismissal motion as moot. No accuracy findings or final disposition." }, { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "title": "IV Harmony opinion citing Live Well Drugstore January 30 order", "source_type": "court_document", "document_type": "order", "supports": "Case identity and the described procedural event." }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681", "title": "WELLHealth appeal docket identifying related appeal 25-10697", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Case identity and the described procedural event." } ], "business_profile": { "id": "novo-trulife-2023", "display_name": "TruLife Pharmacy", "identities": [ { "name": "Live Well Drugstore LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=" ] }, { "name": "TruLife Pharmacy", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations.", "Live Well Drugstore LLC / TruLife Pharmacy is a different named business from William Ian Brown d/b/a LiveWell Peptides." ] }, "source_review": [ { "url": "https://ecf.flmd.uscourts.gov/cgi-bin/show_public_doc?2023-00808-69-3-cv=", "locator": "July 9, 2024 order, pp. 1–3" }, { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "locator": "IV Harmony opinion discussion of related Florida rulings" }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681", "locator": "Related appeal references in collected docket metadata" } ] } }, { "id": "novo-medioak-2024", "case_name": "Novo Nordisk Inc. v. MediOAK Pharmacy LLC", "category": "civil", "court_or_agency": "U.S. District Court, S.D. Texas", "docket_number": "4:24-cv-02032", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "MediOAK Pharmacy" ], "parties": [ "Novo Nordisk Inc.", "MediOAK Pharmacy LLC" ], "filed_date": "2024-05-30", "status_date": "2025-04-25", "analysis": { "id": "novo-medioak-2024", "summary": { "text": "Novo’s Texas complaint against MediOAK is unusually specific about an alleged potency discrepancy. It says testing performed on Novo’s behalf calculated 1.91 mg per 0.75 mL in a product labeled 2.4 mg per 0.75 mL, at least 20% below its labeled strength. These are the plaintiff’s testing allegations, not independent laboratory verification by this collection. Novo sought an injunction against alleged misbranding and unfair competition, rather than compensation for past sales. Its April 2025 announcement later reported a final judgment and permanent injunction, but the operative order remains uncollected.", "sources": [ "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf" ] }, "products": [ { "name": "semaglutide", "role": "tested_contents", "basis": "Complaint paragraphs 24–27 report Novo-sponsored testing of a purported semaglutide product; the laboratory report and methodology have not been independently reviewed.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "Novo-sponsored testing is expressly documented as an evidence-gathering method. The initial lead, sample acquisition and test date are not established.", "sources": [ "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf" ] }, "challenged_conduct": [ { "text": "Novo alleged a materially under-strength semaglutide product was misbranded under Texas law and that selling it constituted unfair competition.", "attribution": "allegation", "sources": [ "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf" ] } ], "outcome": { "class": "mixed", "text": "Novo announced a final judgment and permanent injunction April 25, 2025. That is the announcement date; exact entry date, consent status and operative restrictions await the original order.", "as_of": "2025-04-25", "sources": [ "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf" ] }, "timeline": [ { "date": "2024-05-30", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf" ] }, { "date": "2025-04-25", "event": "Novo announced final judgment/permanent injunction against MediOAK. Actual order date/full scope not independently obtained; date is the announcement.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain the judgment and underlying test report to verify scope, method and any admissions.", "basis": "inference", "sources": [ "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf" ] }, "unknowns": [ "The older registry caveat describing the PDF as only a cover sheet is stale: the current archive includes the full complaint." ], "source_review": [ { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf", "review_basis": "archived_full_text", "locator": "Complaint paragraphs 24–31, followed by civil cover sheet" }, { "url": "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "review_basis": "registry_support_only", "locator": "Novo announcement, current page does not expose substantive text" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [], "tested_compounds": [ "semaglutide" ], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2025-04-25", "sources": [ { "url": "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "title": "Novo Nordisk Inc. v. MediOAK Pharmacy LLC — party reported judgment", "source_type": "party_statement", "document_type": "press_release", "supports": "Novo announced final judgment/permanent injunction against MediOAK. Actual order date/full scope not independently obtained; date is the announcement." }, { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf", "title": "MediOAK civil cover sheet", "source_type": "court_document", "document_type": "civil_cover_sheet", "supports": "Filing metadata only; despite filename, this PDF contains a cover sheet rather than full complaint." } ], "business_profile": { "id": "novo-medioak-2024", "display_name": "MediOAK Pharmacy", "identities": [ { "name": "MediOAK Pharmacy LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ] }, { "name": "MediOAK Pharmacy", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf", "locator": "Complaint paragraphs 24–31, followed by civil cover sheet" }, { "url": "https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915977", "locator": "Novo announcement, current page does not expose substantive text" } ] } }, { "id": "novo-wellhealth-2023", "case_name": "Novo Nordisk Inc. v. WELLHealth Inc.", "category": "civil", "court_or_agency": "U.S. District Court, Middle District of Florida", "docket_number": "3:23-cv-00782", "jurisdiction": "United States", "record_scope": "seller_marketing_and_compounding", "brands": [ "WELLHealth" ], "parties": [ "Novo Nordisk Inc.", "WELLHealth Inc." ], "filed_date": "2023-07-06", "status_date": "2025-04-23", "analysis": { "id": "novo-wellhealth-2023", "summary": { "text": "Novo’s private suit against WELLHealth challenged semaglutide compounding under Florida unfair-practices law. The collected sources identify a January 2025 dismissal and an ensuing Eleventh Circuit appeal. The April 2025 IV Harmony opinion explains that WELLHealth’s challenged conduct was framed as unfair because its semaglutide lacked FDA approval, a theory the earlier court treated as impermissible private enforcement of federal drug law. This procedural theory matters when comparing outcomes: dismissal of that theory does not establish that every label, batch or marketing statement was accurate.", "sources": [ "https://dockets.justia.com/docket/florida/flmdce/3%3A2023cv00782/415932", "https://www.leagle.com/decision/764254192fsupp3d119367", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] }, "products": [ { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "The related judicial opinion describes WELLHealth’s compounded semaglutide as the subject of Novo’s challenged sales theory.", "sources": [ "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "The first lead and any initial sample testing are not established in the reviewed records. The FDA is regulatory background, not the plaintiff in this suit.", "sources": [ "https://dockets.justia.com/docket/florida/flmdce/3%3A2023cv00782/415932", "https://www.leagle.com/decision/764254192fsupp3d119367", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] }, "challenged_conduct": [ { "text": "Novo alleged unfair competition from sale of unapproved semaglutide. The later judicial discussion distinguishes this theory from independently deceptive FDA-approval advertising.", "attribution": "allegation", "sources": [ "https://dockets.justia.com/docket/florida/flmdce/3%3A2023cv00782/415932", "https://www.leagle.com/decision/764254192fsupp3d119367", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] } ], "outcome": { "class": "dismissal", "text": "The district court dismissed the case January 30, 2025. Appeal 25-10681 has recorded briefing activity and clerical consolidation with related appeals; a merits disposition has not been verified.", "as_of": "2025-04-23", "sources": [ "https://dockets.justia.com/docket/florida/flmdce/3%3A2023cv00782/415932", "https://www.leagle.com/decision/764254192fsupp3d119367", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] }, "timeline": [ { "date": "2023-07-06", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://dockets.justia.com/docket/florida/flmdce/3%3A2023cv00782/415932", "https://www.leagle.com/decision/764254192fsupp3d119367", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] }, { "date": "2025-01-30", "event": "Court granted WELLHealth’s motion to dismiss; the later IV Harmony opinion describes the ruling as FDCA preemption of unfair-practice claims concerning unapproved semaglutide.", "kind": "dismissal", "date_basis": "event", "sources": [ "https://www.leagle.com/decision/764254192fsupp3d119367" ] }, { "date": "2025-04-23", "event": "Eleventh Circuit appeal 25-10681 docket reflects briefing activity and clerical consolidation with 25-10697 and 25-10783; appellate merits outcome not verified.", "kind": "appeal", "date_basis": "event", "sources": [ "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] } ], "timing_pairs": [ { "label": "Complaint filing to district-court dismissal", "start": "2023-07-06", "end": "2025-01-30", "sources": [ "https://dockets.justia.com/docket/florida/flmdce/3%3A2023cv00782/415932", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf" ], "days": 574 } ], "next_watch": { "text": "Read the consolidated appellate disposition and original dismissal before treating the district ruling as the last word.", "basis": "inference", "sources": [ "https://dockets.justia.com/docket/florida/flmdce/3%3A2023cv00782/415932", "https://www.leagle.com/decision/764254192fsupp3d119367", "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681" ] }, "unknowns": [ "Original opinion access is partial; full appellate outcome is missing." ], "source_review": [ { "url": "https://www.leagle.com/decision/764254192fsupp3d119367", "review_basis": "registry_support_only", "locator": "Partial/paywalled opinion page only" }, { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "review_basis": "archived_full_text", "locator": "IV Harmony opinion, preemption discussion" }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681", "review_basis": "registry_support_only", "locator": "Collected appeal docket events" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2025-04-23", "sources": [ { "url": "https://dockets.justia.com/docket/florida/flmdce/3%3A2023cv00782/415932", "title": "WELLHealth district docket", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Case identity and the described procedural event." }, { "url": "https://www.leagle.com/decision/764254192fsupp3d119367", "title": "January 30, 2025 WELLHealth opinion mirror", "source_type": "court_document", "document_type": "order", "supports": "Case identity and the described procedural event." }, { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "title": "IV Harmony opinion describing WELLHealth preemption holding", "source_type": "court_document", "document_type": "order", "supports": "Case identity and the described procedural event." }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681", "title": "WELLHealth appeal docket", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Case identity and the described procedural event." } ], "business_profile": { "id": "novo-wellhealth-2023", "display_name": "WELLHealth", "identities": [ { "name": "WELLHealth Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.leagle.com/decision/764254192fsupp3d119367" ] }, { "name": "WELLHealth", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.leagle.com/decision/764254192fsupp3d119367" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.leagle.com/decision/764254192fsupp3d119367" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations." ] }, "source_review": [ { "url": "https://www.leagle.com/decision/764254192fsupp3d119367", "locator": "Partial/paywalled opinion page only" }, { "url": "https://cases.justia.com/federal/district-courts/florida/flmdce/8%3A2024cv02292/432872/18/0.pdf", "locator": "IV Harmony opinion, preemption discussion" }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca11/25-10681", "locator": "Collected appeal docket events" } ] } }, { "id": "novo-wells-2023", "case_name": "Novo Nordisk Inc. v. Wells Pharmacy Network LLC", "category": "civil", "court_or_agency": "U.S. District Court, M.D. Florida", "docket_number": "5:23-cv-00689", "jurisdiction": "United States", "record_scope": "matter_record", "brands": [ "Wells Pharmacy Network" ], "parties": [ "Novo Nordisk Inc.", "Wells Pharmacy Network LLC" ], "filed_date": "2023-11-29", "status_date": "2025-03-24", "analysis": { "id": "novo-wells-2023", "summary": { "text": "Novo sued Wells Pharmacy Network over compounded semaglutide, including a semaglutide/BPC-157 formulation and challenged advertising. The district court granted Wells summary judgment in February 2025 because the requested injunction addressed products and representations Wells had already stopped offering. The collected record therefore illustrates mootness and the limits of forward-looking relief, rather than a court certification of peptide purity or approval of every former marketing practice. An Eleventh Circuit appeal followed, so the district outcome should always be reported with that procedural qualification.", "sources": [ "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246", "https://www.statnews.com/wp-content/uploads/2023/11/DE-1-Complaint-Wells-Pharmacy-Network-LLC.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10783", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "The summary-judgment opinion describes Wells compounding and dispensing semaglutide+BPC-157 beginning in 2022, citing its president’s declaration. This documents the business account, not an independent assay.", "sources": [ "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf" ], "normalized_names": [ "semaglutide" ] }, { "name": "BPC-157", "role": "reported_marketing_or_supply", "basis": "The summary-judgment opinion describes Wells compounding and dispensing semaglutide+BPC-157 beginning in 2022, citing its president’s declaration. This documents the business account, not an independent assay.", "sources": [ "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf" ], "normalized_names": [ "BPC-157" ] } ], "discovery": { "known": false, "text": "The initial lead is not documented. The available procedural history does not establish a discovery-to-lawsuit interval or independently verified product testing.", "sources": [ "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246", "https://www.statnews.com/wp-content/uploads/2023/11/DE-1-Complaint-Wells-Pharmacy-Network-LLC.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10783", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf" ] }, "challenged_conduct": [ { "text": "Novo challenged unapproved-product sales and advertising. Cessation of the challenged conduct became central to whether an injunction could still redress a live dispute.", "attribution": "allegation", "sources": [ "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246", "https://www.statnews.com/wp-content/uploads/2023/11/DE-1-Complaint-Wells-Pharmacy-Network-LLC.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10783", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf" ] } ], "outcome": { "class": "dismissal", "text": "Summary judgment for Wells entered February 12, 2025 on mootness grounds. Appeal 25-10783 is recorded; its disposition is not verified in this collection.", "as_of": "2025-03-24", "sources": [ "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246", "https://www.statnews.com/wp-content/uploads/2023/11/DE-1-Complaint-Wells-Pharmacy-Network-LLC.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10783", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf" ] }, "timeline": [ { "date": "2023-11-29", "event": "Private civil complaint filed.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246", "https://www.statnews.com/wp-content/uploads/2023/11/DE-1-Complaint-Wells-Pharmacy-Network-LLC.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10783", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf" ] }, { "date": "2025-02-12", "event": "Court entered summary judgment for Wells, finding injunctive claims moot after cessation of challenged products/advertisements. A later appeal exists; outcome unverified.", "kind": "order", "date_basis": "event", "sources": [ "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246" ] }, { "date": "2025-03-24", "event": "District court granted summary judgment for Wells. Appeal 25-10783 recorded in Eleventh Circuit; appellate disposition not verified.", "kind": "appeal", "date_basis": "event", "sources": [ "https://dockets.justia.com/docket/circuit-courts/ca11/25-10783" ] } ], "timing_pairs": [ { "label": "Complaint filing to summary judgment", "start": "2023-11-29", "end": "2025-02-12", "sources": [ "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246", "https://www.statnews.com/wp-content/uploads/2023/11/DE-1-Complaint-Wells-Pharmacy-Network-LLC.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf" ], "days": 441 } ], "next_watch": { "text": "Obtain the appeal’s merits disposition and any remand order before describing the legal issue as conclusively resolved.", "basis": "inference", "sources": [ "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246", "https://www.statnews.com/wp-content/uploads/2023/11/DE-1-Complaint-Wells-Pharmacy-Network-LLC.pdf", "https://dockets.justia.com/docket/circuit-courts/ca11/25-10783", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf" ] }, "unknowns": [ "Complete appellate history missing; no general safety or legality conclusion follows from mootness." ], "source_review": [ { "url": "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246", "review_basis": "registry_support_only", "locator": "Previously collected summary-judgment discussion" }, { "url": "https://www.statnews.com/wp-content/uploads/2023/11/DE-1-Complaint-Wells-Pharmacy-Network-LLC.pdf", "review_basis": "registry_support_only", "locator": "Archived complaint is image-based; text extraction is insufficient" }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca11/25-10783", "review_basis": "registry_support_only", "locator": "Appeal docket metadata" }, { "url": "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "review_basis": "court_pdf", "locator": "Document 48, February 12, 2025, pp. 5–6 and summary-judgment conclusion; civil-source-review/wells.pdf" } ] }, "compounds": [ "BPC-157", "semaglutide" ], "marketing_or_supply_compounds": [ "BPC-157", "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "BPC-157", "semaglutide" ], "latest_documented_date": "2025-03-24", "sources": [ { "url": "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246", "title": "Novo Nordisk Inc. v. Wells Pharmacy Network LLC — summary judgment", "source_type": "court_document", "document_type": "order", "supports": "Court entered summary judgment for Wells, finding injunctive claims moot after cessation of challenged products/advertisements. A later appeal exists; outcome unverified." }, { "url": "https://www.statnews.com/wp-content/uploads/2023/11/DE-1-Complaint-Wells-Pharmacy-Network-LLC.pdf", "title": "Novo Nordisk Inc. v. Wells Pharmacy Network LLC — complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Original filing and allegation context; allegations are not findings." }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca11/25-10783", "title": "Eleventh Circuit Wells appeal docket", "source_type": "court_document", "document_type": "docket_mirror", "supports": "Appeal 25-10783 and March 24, 2025 docket activity; later outcome not verified." } ], "business_profile": { "id": "novo-wells-2023", "display_name": "Wells Pharmacy Network", "identities": [ { "name": "Wells Pharmacy Network LLC", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246" ] }, { "name": "Wells Pharmacy Network", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246" ] }, { "name": "Kristopher Fishman", "kind": "operator", "basis": "February 2025 opinion identifies him as President of Wells Pharmacy Network in the cited declaration.", "sources": [ "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf" ] } ], "activity": { "summary": "The February 2025 opinion describes compounding semaglutide plus BPC-157 beginning in 2022. It records cessation of BPC-157 compounding after inventory was sold and says the last dispensed product had been requested November 28, 2023.", "kind": "documented_period", "start": "2022", "end": null, "sources": [ "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf" ], "limits": [ "This period concerns a particular preparation, not the full pharmacy business.", "November 28 is the last request date reported, not necessarily dispensing or business-closure date." ] }, "source_review": [ { "url": "https://app.midpage.ai/document/novo-nordisk-inc-v-wells-1000430066246", "locator": "Previously collected summary-judgment discussion" }, { "url": "https://www.statnews.com/wp-content/uploads/2023/11/DE-1-Complaint-Wells-Pharmacy-Network-LLC.pdf", "locator": "Archived complaint is image-based; text extraction is insufficient" }, { "url": "https://dockets.justia.com/docket/circuit-courts/ca11/25-10783", "locator": "Appeal docket metadata" }, { "url": "https://www.statnews.com/wp-content/uploads/2025/02/novo-vs-wells-ruling.pdf", "locator": "Opinion PDF p. 5, product-line start and president; pp. 7-8, inventory, request date and cessation." } ] } }, { "id": "uk-ob-health-fitness-2025", "case_name": "OB Health & Fitness Ltd SARMs seizure", "category": "foreign_enforcement", "court_or_agency": "Telford & Wrekin Council; West Mercia Police; UK Anti-Doping", "docket_number": null, "jurisdiction": "United Kingdom — England and Wales", "record_scope": "matter_record", "brands": [ "OB Health & Fitness" ], "parties": [ "OB Health & Fitness Ltd" ], "filed_date": null, "status_date": "2025-11-20", "analysis": { "id": "uk-ob-health-fitness-2025", "summary": { "text": "Telford & Wrekin Council reported seizing SARMs marketed as fitness supplements at OB Health & Fitness in Ellerdine. The action involved local police and anti-doping cooperation. The official account identifies a product class but no individual SARM ingredient, so it cannot support molecule-specific claims about retatrutide or another peptide.", "sources": [ "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements" ] }, "products": [ { "name": "unspecified SARMs", "role": "reported_marketing_or_supply", "basis": "The council describes seized SARMs sold as fitness supplements without naming individual active ingredients.", "sources": [ "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements" ], "normalized_names": [ "unspecified SARMs" ] } ], "discovery": { "known": false, "text": "The source describes a coordinated enforcement operation, not the initial complaint or intelligence that identified this business.", "sources": [ "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements" ] }, "challenged_conduct": [ { "text": "The council characterized the fitness-supplement offers as illegal SARMs sales. Its general discussion of health risks is not a finding of a particular customer’s injury.", "attribution": "allegation", "sources": [ "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements" ] } ], "outcome": { "class": "seizure_or_investigation", "text": "The announcement reports seizure and investigation, without a conviction, sentence or quantified final financial penalty.", "as_of": "2025-11-20", "sources": [ "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements" ] }, "timeline": [ { "date": "2025-11-20", "event": "The council announced the seizure operation.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements" ] } ], "timing_pairs": [], "next_watch": { "text": "Watch for a council prosecution update or court record identifying charges, ingredients and disposition.", "basis": "inference", "sources": [ "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements" ] }, "unknowns": [ "Individual compounds, seizure quantities, exact operation date, initial trigger and final court disposition are not established." ], "source_review": [ { "url": "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" } ] }, "compounds": [ "unspecified SARMs" ], "marketing_or_supply_compounds": [ "unspecified SARMs" ], "tested_compounds": [], "direct_compounds": [ "unspecified SARMs" ], "latest_documented_date": "2025-11-20", "sources": [ { "url": "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements", "title": "Telford & Wrekin Council seizes illegal SARMs sold as fitness supplements", "source_type": "official_agency", "document_type": "enforcement_press_release", "supports": "Named seller, locality, seizure and participating agencies." } ], "business_profile": { "id": "uk-ob-health-fitness-2025", "display_name": "OB Health & Fitness Ltd", "identities": [ { "name": "OB Health & Fitness Ltd", "kind": "legal_entity", "basis": "The council identifies the company at Ellerdine as the premises connected to the seizure.", "sources": [ "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements" ] } ], "activity": { "summary": "The council’s November 20, 2025 announcement describes SARMs seized from the Ellerdine company and goods sold online. No trading start/end dates or precise seizure date are established in the reviewed account.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements" ], "limits": [ "The reviewed source does not establish the business launch, continuous operating period, or current trading status." ] }, "source_review": [ { "url": "https://newsroom.telford.gov.uk/news/telford-wrekin-council-seizes-illegal-sarms-sold-as-fitness-supplements", "locator": "Opening paragraph naming OB Health & Fitness Ltd and describing seizure/online sales" } ] } }, { "id": "oh-medspa-warning-letters-2025", "case_name": "Ohio AG warning letters to 14 named medical spas concerning compounded GLP-1 marketing", "category": "state_enforcement", "court_or_agency": "Ohio Attorney General", "docket_number": null, "jurisdiction": "United States — Ohio", "record_scope": "regulatory_action_group", "brands": [ "Beneficial Health", "Docere Medical and Aesthetic Center", "Glow Medispa", "Jiva Med Spa", "Limelight Laser and Medical Spa", "Live Well Chiropractic & Medical", "New Pathways Clinic", "Ohio Weight Loss & Wellness Clinic", "Personalized Vitality Clinic", "Restore Hyper Wellness OH", "Summit MedAesthetics", "TrueForm Health and Wellness", "Youngstown Medical Weight Loss", "Zinni Family Practice" ], "parties": [ "Beneficial Health", "Docere Medical and Aesthetic Center", "Glow Medispa", "Jiva Med Spa", "Limelight Laser and Medical Spa", "Live Well Chiropractic & Medical", "New Pathways Clinic", "Ohio Weight Loss & Wellness Clinic", "Personalized Vitality Clinic", "Restore Hyper Wellness OH", "Summit MedAesthetics", "TrueForm Health and Wellness", "Youngstown Medical Weight Loss", "Zinni Family Practice" ], "filed_date": null, "status_date": "2025-04-16", "analysis": { "id": "oh-medspa-warning-letters-2025", "summary": { "text": "Ohio’s attorney general announced warning letters to 14 named medical spas over compounded GLP-1 marketing. This catalogue row is one grouped announcement, not 14 filed lawsuits. The agency objected to representations that compounded products were FDA-approved or equivalent in safety and effectiveness to branded medicines; it did not report batch testing.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "The grouped announcement identifies compounded GLP-1 marketing involving these drugs; it does not establish that every recipient offered both.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "The grouped announcement identifies compounded GLP-1 marketing involving these drugs; it does not establish that every recipient offered both.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The reviewed marketing supplies the evidence basis, but the announcement does not disclose whether a complaint, referral or routine review began the inquiry.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, "challenged_conduct": [ { "text": "The attorney general alleged misleading consumer-facing claims about FDA approval and equivalence of compounded products.", "attribution": "allegation", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] } ], "outcome": { "class": "administrative_action", "text": "Fourteen warning letters were announced. The source does not establish a lawsuit, fine, injunction or later resolution for every recipient.", "as_of": "2025-04-16", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, "timeline": [ { "date": "2025-04-16", "event": "Ohio announced the grouped warning-letter action.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] } ], "timing_pairs": [], "next_watch": { "text": "Monitor recipient-specific corrections and any separately filed consumer-protection cases.", "basis": "inference", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, "unknowns": [ "Individual recipient responses, exact product attribution to every spa and later dispositions are not established." ], "source_review": [ { "url": "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A", "review_basis": "archived_full_text", "locator": "Agency announcement, factual account and action section" } ] }, "compounds": [ "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide", "tirzepatide" ], "latest_documented_date": "2025-04-16", "sources": [ { "url": "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A", "title": "AG Yost Warns Med Spas: Stop Misleading Consumers About Weight-Loss Drugs", "source_type": "official_agency", "document_type": "named_warning_letter_campaign_announcement", "supports": "14 recipients, subject of warning and announcement date." } ], "business_profile": { "id": "oh-medspa-warning-letters-2025", "display_name": "Fourteen Ohio medical spas (grouped warning action)", "identities": [ { "name": "Beneficial Health", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "Docere Medical and Aesthetic Center", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "Glow Medispa", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "Jiva Med Spa", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "Limelight Laser and Medical Spa", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "Live Well Chiropractic & Medical", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "New Pathways Clinic", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "Ohio Weight Loss & Wellness Clinic", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "Personalized Vitality Clinic", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "Restore Hyper Wellness OH", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "Summit MedAesthetics", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "TrueForm Health and Wellness", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "Youngstown Medical Weight Loss", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] }, { "name": "Zinni Family Practice", "kind": "trading_name", "basis": "Named business in the agency account; corporate ownership was not independently established.", "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ] } ], "activity": { "summary": "The April 16, 2025 announcement identifies 14 separate medical spas whose compounded GLP-1 advertising drew warning letters. It gives no common operating period or store-specific first/last sale dates.", "kind": "mixed_entities", "start": null, "end": null, "sources": [ "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A" ], "limits": [ "This is one grouped agency record, not one shop or one legal entity.", "Named recipients are not established to share ownership.", "Warning dates are not business-opening dates." ] }, "source_review": [ { "url": "https://ohioattorneygeneral.gov/Media/News-Releases/April-2025/AG-Yost-Warns-Med-Spas-Stop-Misleading-Consumers-A", "locator": "Opening advertising description and list headed Yost issued letters to the following med spas" } ] } }, { "id": "au-biov8-2026", "case_name": "Secretary of Health, Disability and Ageing v. A.C.N. 641 483 703 Pty Ltd and others", "category": "foreign_enforcement", "court_or_agency": "Federal Court of Australia / TGA", "docket_number": "NSD1717/2026", "jurisdiction": "Australia — federal", "record_scope": "matter_record", "brands": [ "BioV8" ], "parties": [ "A.C.N. 641 483 703 Pty Ltd (in liquidation)", "Nicholas Austin", "Edward McGill" ], "filed_date": "2026-09-15", "status_date": "2026-09-28", "analysis": { "id": "au-biov8-2026", "summary": { "text": "Australia commenced a civil-penalty proceeding over BioV8 advertising, naming the former operating company and directors Edward McGill and Nicholas Austin. The concise statement alleges unlawful promotion of unregistered and prescription-only products, including peptides, during June 2024–July 2025. Retatrutide is not identified in the reviewed pleading; this cannot be counted as a retatrutide advertising case.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] }, "products": [ { "name": "BPC-157", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "BPC-157" ] }, { "name": "CJC-1295", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "CJC-1295" ] }, { "name": "GHRP-6", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "GHRP-6" ] }, { "name": "ipamorelin", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "ipamorelin" ] }, { "name": "GHRP-2", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "GHRP-2" ] }, { "name": "thymosin beta-4", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "thymosin beta-4" ] }, { "name": "ibutamoren", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "ibutamoren" ] }, { "name": "human chorionic gonadotropin", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "human chorionic gonadotropin" ] }, { "name": "AOD-9604", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "AOD-9604" ] }, { "name": "ostarine", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "ostarine" ] }, { "name": "Dihexa", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "Dihexa" ] }, { "name": "selank", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "selank" ] }, { "name": "glutathione", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "glutathione" ] }, { "name": "unspecified SARMs", "role": "alleged_marketing_or_supply", "basis": "Named in the pleaded advertisements, guides or annexures. Alleged advertising does not itself prove a completed sale or product contents.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ], "normalized_names": [ "unspecified SARMs" ] } ], "discovery": { "known": false, "text": "The pleading describes website, member-area and social-media advertising used as evidence. It does not disclose the initial complaint or monitoring event that triggered the investigation.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] }, "challenged_conduct": [ { "text": "The regulator alleges prohibited public advertising and restricted serious-disease representations, including cancer and mental-health claims, plus misleading safety/effectiveness promotion. Access through member pages did not, in the pleaded case, remove the advertising issues.", "attribution": "allegation", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] } ], "outcome": { "class": "pending_or_unknown", "text": "The Federal Court matter NSD1717/2026 seeks declarations, pecuniary penalties and costs. TGA said leave was needed to proceed against the company because it was in liquidation. No judgment or penalty is established.", "as_of": "2026-09-28", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] }, "timeline": [ { "date": "2024-06-06", "event": "The alleged advertising period began.", "kind": "conduct_start", "date_basis": "reported_period", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ] }, { "date": "2025-07-14", "event": "The alleged advertising period ended.", "kind": "other", "date_basis": "reported_period", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ] }, { "date": "2026-09-15", "event": "The proceeding was filed in the Federal Court.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf" ] }, { "date": "2026-09-28", "event": "TGA announced the proceeding and liquidation-related leave issue.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] } ], "timing_pairs": [], "next_watch": { "text": "Monitor leave to proceed against the company, defences, liability findings and any eventual penalty orders.", "basis": "inference", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] }, "unknowns": [ "Initial trigger, defendants’ substantive responses, leave determination and final court outcome are not established. The originating application itself was inaccessible; the concise statement and official announcement were reviewed." ], "source_review": [ { "url": "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "review_basis": "court_pdf", "locator": "Filed concise statement, paragraphs 1–53 and product/advertising annexures" }, { "url": "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides", "review_basis": "official_web_full_text", "locator": "TGA proceeding announcement and company-liquidation qualification" } ] }, "compounds": [ "AOD-9604", "BPC-157", "CJC-1295", "Dihexa", "GHRP-2", "GHRP-6", "glutathione", "human chorionic gonadotropin", "ibutamoren", "ipamorelin", "ostarine", "selank", "thymosin beta-4", "unspecified SARMs" ], "marketing_or_supply_compounds": [ "AOD-9604", "BPC-157", "CJC-1295", "Dihexa", "GHRP-2", "GHRP-6", "glutathione", "human chorionic gonadotropin", "ibutamoren", "ipamorelin", "ostarine", "selank", "thymosin beta-4", "unspecified SARMs" ], "tested_compounds": [], "direct_compounds": [ "AOD-9604", "BPC-157", "CJC-1295", "Dihexa", "GHRP-2", "GHRP-6", "glutathione", "human chorionic gonadotropin", "ibutamoren", "ipamorelin", "ostarine", "selank", "thymosin beta-4", "unspecified SARMs" ], "latest_documented_date": "2026-09-28", "sources": [ { "url": "https://www.tga.gov.au/sites/default/files/2026-09/biov8-originating-application.pdf", "title": "BioV8 originating application", "source_type": "court_document", "document_type": "originating_application", "supports": "Filing date, case number, defendants, relief sought." }, { "url": "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "title": "BioV8 concise statement", "source_type": "court_document", "document_type": "pleading", "supports": "Detailed allegations and advertising exhibits." }, { "url": "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides", "title": "TGA announces BioV8 proceedings", "source_type": "official_agency", "document_type": "press_release", "supports": "Proceeding context and summary of allegations." } ], "business_profile": { "id": "au-biov8-2026", "display_name": "BioV8 / former BioV8 Pty Limited", "identities": [ { "name": "BioV8", "kind": "trading_name", "basis": "Brand of the online retail business described in the filed statement.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] }, { "name": "A.C.N. 641 483 703 Pty Limited (in liquidation)", "kind": "legal_entity", "basis": "First respondent; the statement identifies it as formerly BioV8 Pty Limited.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] }, { "name": "BioV8 Pty Limited", "kind": "legal_entity", "basis": "Former name of the first respondent; not a separate additional defendant.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] }, { "name": "biov8.com.au", "kind": "historical_domain", "basis": "Paragraph 7 identifies the website operated by the respondent during the pleaded period.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] }, { "name": "Nicholas Austin", "kind": "operator", "basis": "Paragraph 5 alleges director and CEO roles, with CEO tenure June 2020–March 3, 2025.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] }, { "name": "Edward McGill", "kind": "operator", "basis": "Paragraph 6 alleges director and executive roles, including CEO from March 3, 2025; it separately records a suspension from December 12, 2024 to March 3, 2025.", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ] } ], "activity": { "summary": "The filed statement alleges a retail business from 2020 and operation of biov8.com.au from at least August 2020 to at least September 23, 2025. The narrower challenged advertising period is June 6, 2024–July 14, 2025. These are pleaded periods, not findings after trial or a verified current ownership history.", "kind": "documented_period", "start": "2020-08", "end": "2025-09-23", "sources": [ "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides" ], "limits": [ "Both website endpoints are expressly at least; September 23 is not a closure date.", "The source is a party’s filed allegations, not an adjudicated operating history.", "Liquidation of the former company does not identify who may operate the brand or domain now." ] }, "source_review": [ { "url": "https://www.tga.gov.au/sites/default/files/2026-09/biov8-concise-statement.pdf", "locator": "Filed concise statement, paragraphs 1 and 4–9 (identity, executive roles and operating dates); TGA September 28 announcement on former-company/liquidation status" }, { "url": "https://www.tga.gov.au/news/media-releases/former-company-and-directors-behind-biov8-face-court-alleged-unlawful-advertising-peptides", "locator": "Filed concise statement, paragraphs 1 and 4–9 (identity, executive roles and operating dates); TGA September 28 announcement on former-company/liquidation status" } ] } }, { "id": "strive-antitrust-2026", "case_name": "Strive Specialties Inc. v. Eli Lilly & Company et al.", "category": "civil", "court_or_agency": "U.S. District Court, Western District of Texas", "docket_number": "5:26-cv-00155", "jurisdiction": "United States", "record_scope": "seller_antitrust_counteroffensive", "brands": [ "Strive Pharmacy" ], "parties": [ "Strive Specialties Inc.", "Eli Lilly and Company", "Novo Nordisk A/S", "Novo Nordisk Inc." ], "filed_date": "2026-01-14", "status_date": "2026-08-03", "analysis": { "id": "strive-antitrust-2026", "summary": { "text": "Strive is the plaintiff in this case, accusing Lilly and Novo of restricting competition in compounded GLP-1 medicines. Its allegations concern exclusive telehealth relationships, disparagement and interference with technology platforms and payment channels. These are seller-side antitrust claims, not findings that the manufacturers colluded or government charges against Strive. The August 2026 opinion dismissed the claims with prejudice, finding deficiencies in the pleaded competitive market and antitrust injury. The case broadens the history beyond lawsuits against sellers, but its adverse result must accompany any account of Strive’s accusations.", "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf", "https://app.midpage.ai/document/strive-specialties-inc-v-eli--07dc71f1-6d6f-4cd0-9a03-4c181641a312" ] }, "products": [ { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "Strive’s complaint describes its compounded GLP-1 business competing with semaglutide products; the statement is the plaintiff’s own business account.", "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "The complaint includes compounded tirzepatide in the market affected by the alleged exclusionary practices.", "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf" ], "normalized_names": [ "tirzepatide" ] } ], "discovery": { "known": false, "text": "The complaint describes Strive’s claimed business injuries and commercial relationships. It does not establish a single initial detection event or government investigation.", "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf", "https://app.midpage.ai/document/strive-specialties-inc-v-eli--07dc71f1-6d6f-4cd0-9a03-4c181641a312" ] }, "challenged_conduct": [ { "text": "Strive alleged exclusionary agreements, disparagement and commercial interference by the drug manufacturers; the court did not adjudicate those allegations as proven misconduct.", "attribution": "allegation", "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf", "https://app.midpage.ai/document/strive-specialties-inc-v-eli--07dc71f1-6d6f-4cd0-9a03-4c181641a312" ] } ], "outcome": { "class": "dismissal", "text": "The signed opinion dated August 3, 2026 dismissed all claims with prejudice. The mirror’s August 5 header differs from the signature date; the timing anchor uses the signed date.", "as_of": "2026-08-03", "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf", "https://app.midpage.ai/document/strive-specialties-inc-v-eli--07dc71f1-6d6f-4cd0-9a03-4c181641a312" ] }, "timeline": [ { "date": "2026-01-14", "event": "Strive alleged anticompetitive restrictions on telehealth and pharmacy relationships, disparagement and interference with its compounded GLP-1 business.", "kind": "complaint", "date_basis": "filing", "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf" ] }, { "date": "2026-08-03", "event": "Court granted defendants’ motions and dismissed Strive’s claims with prejudice.", "kind": "dismissal", "date_basis": "event", "sources": [ "https://app.midpage.ai/document/strive-specialties-inc-v-eli--07dc71f1-6d6f-4cd0-9a03-4c181641a312" ] } ], "timing_pairs": [ { "label": "Complaint filing to signed dismissal opinion", "start": "2026-01-14", "end": "2026-08-03", "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf", "https://app.midpage.ai/document/strive-specialties-inc-v-eli--07dc71f1-6d6f-4cd0-9a03-4c181641a312" ], "days": 201 } ], "next_watch": { "text": "Check any appeal and later complaints for changes to market definition or evidence of antitrust injury.", "basis": "inference", "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf", "https://app.midpage.ai/document/strive-specialties-inc-v-eli--07dc71f1-6d6f-4cd0-9a03-4c181641a312" ] }, "unknowns": [ "Appellate history unverified; the case does not resolve every separate advertising dispute involving Strive." ], "source_review": [ { "url": "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf", "review_basis": "archived_full_text", "locator": "Complaint, introduction and challenged commercial arrangements" }, { "url": "https://app.midpage.ai/document/strive-specialties-inc-v-eli--07dc71f1-6d6f-4cd0-9a03-4c181641a312", "review_basis": "official_web_full_text", "locator": "Primary judicial opinion reproduced on Midpage; conclusion signed August 3, 2026" } ] }, "compounds": [ "semaglutide", "tirzepatide" ], "marketing_or_supply_compounds": [ "semaglutide", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide", "tirzepatide" ], "latest_documented_date": "2026-08-03", "sources": [ { "url": "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf", "title": "Filed Strive antitrust complaint", "source_type": "court_document", "document_type": "complaint", "supports": "Case identity, allegations and procedural event described in this record." }, { "url": "https://app.midpage.ai/document/strive-specialties-inc-v-eli--07dc71f1-6d6f-4cd0-9a03-4c181641a312", "title": "Strive August 3, 2026 dismissal opinion", "source_type": "court_document", "document_type": "order", "supports": "Case identity, allegations and procedural event described in this record." } ], "business_profile": { "id": "strive-antitrust-2026", "display_name": "Strive Pharmacy", "identities": [ { "name": "Strive Specialties Inc.", "kind": "legal_entity", "basis": "Entity identified in the collected court caption or source-attributed case record; inclusion does not establish current ownership or operating status.", "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf" ] }, { "name": "Strive Pharmacy", "kind": "trading_name", "basis": "Business/trading name identified in the reviewed case record; this is a historical attribution, not a current corporate-registry certification.", "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf" ] }, { "name": "strivepharmacy.com", "kind": "historical_domain", "basis": "Related Delaware complaint identifies Strive's business website; reused only for identity, not proof of operation on this proceeding's dates.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2019/09/Lilly-Strive-Pharmacy-LLC.pdf" ] } ], "activity": { "summary": "The reviewed sources identify this business in the dispute but do not establish a reliable opening-to-closure period. Filing and ruling dates are not treated as business operating dates.", "kind": "unknown", "start": null, "end": null, "sources": [ "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf" ], "limits": [ "Business opening date and closure date were not verified.", "Litigation activity does not prove contemporaneous business operations.", "Related Strive proceedings should not be presented as additional distinct shops or inferred operating periods." ] }, "source_review": [ { "url": "https://www.statnews.com/wp-content/uploads/2026/01/strive-vs-lilly-and-novo.pdf", "locator": "Complaint, introduction and challenged commercial arrangements" }, { "url": "https://app.midpage.ai/document/strive-specialties-inc-v-eli--07dc71f1-6d6f-4cd0-9a03-4c181641a312", "locator": "Primary judicial opinion reproduced on Midpage; conclusion signed August 3, 2026" } ] } }, { "id": "au-nsw-influencer-seizure-2026", "case_name": "TGA seizure at two NSW residences linked to unnamed influencer", "category": "foreign_enforcement", "court_or_agency": "Therapeutic Goods Administration / NSW Police", "docket_number": null, "jurisdiction": "Australia — New South Wales / federal", "record_scope": "matter_record", "brands": [], "parties": [], "filed_date": "2026-08-04", "status_date": "2026-08-17", "analysis": { "id": "au-nsw-influencer-seizure-2026", "summary": { "text": "TGA reported seizing more than A$120,000 in peptide and steroid products at two New South Wales residences linked to an unnamed influencer. The agency named retatrutide, CJC1295 and a Wolverine Stack identified as BPC157 plus TB500. The person had previously been warned, but the release did not identify them or announce a conviction.", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ] }, "products": [ { "name": "retatrutide", "role": "alleged_marketing_or_supply", "basis": "TGA identifies products associated with alleged importation, relabeling, advertising and supply; no complete assay results are reported.", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ], "normalized_names": [ "retatrutide" ] }, { "name": "CJC-1295", "role": "alleged_marketing_or_supply", "basis": "TGA identifies products associated with alleged importation, relabeling, advertising and supply; no complete assay results are reported.", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ], "normalized_names": [ "CJC-1295" ] }, { "name": "BPC-157", "role": "alleged_marketing_or_supply", "basis": "TGA identifies products associated with alleged importation, relabeling, advertising and supply; no complete assay results are reported.", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ], "normalized_names": [ "BPC-157" ] }, { "name": "TB-500", "role": "alleged_marketing_or_supply", "basis": "TGA identifies products associated with alleged importation, relabeling, advertising and supply; no complete assay results are reported.", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ], "normalized_names": [ "TB-500" ] }, { "name": "unspecified steroids", "role": "alleged_marketing_or_supply", "basis": "TGA identifies products associated with alleged importation, relabeling, advertising and supply; no complete assay results are reported.", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ], "normalized_names": [ "unspecified steroids" ] } ], "discovery": { "known": false, "text": "The release mentions an earlier warning and later warrants, but gives neither the warning date nor the first event that brought the activity to TGA’s attention.", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ] }, "challenged_conduct": [ { "text": "TGA alleged unlawful importation and supply alongside online/social advertising, including relabeling. The source does not establish guilt or identify a convicted person.", "attribution": "allegation", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ] } ], "outcome": { "class": "seizure_or_investigation", "text": "TGA executed warrants and seized products. The reviewed release does not establish charges, a final penalty or a court determination.", "as_of": "2026-08-17", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ] }, "timeline": [ { "date": "2026-08-04", "event": "TGA executed warrants at two residences.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ] }, { "date": "2026-08-17", "event": "TGA announced the seizures and allegations.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ] } ], "timing_pairs": [], "next_watch": { "text": "Monitor official charge or civil-penalty announcements; do not identify the unnamed person through speculation.", "basis": "inference", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ] }, "unknowns": [ "Person’s identity, first trigger, actual batch contents and final enforcement outcome remain undisclosed." ], "source_review": [ { "url": "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids", "review_basis": "official_web_full_text", "locator": "TGA account of warrants, alleged conduct and identified products" } ] }, "compounds": [ "BPC-157", "CJC-1295", "retatrutide", "TB-500", "unspecified steroids" ], "marketing_or_supply_compounds": [ "BPC-157", "CJC-1295", "retatrutide", "TB-500", "unspecified steroids" ], "tested_compounds": [], "direct_compounds": [ "BPC-157", "CJC-1295", "retatrutide", "TB-500", "unspecified steroids" ], "latest_documented_date": "2026-08-17", "sources": [ { "url": "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids", "title": "TGA flexes its muscle against illegal peptides and steroids", "source_type": "official_agency", "document_type": "press_release", "supports": "Search date, products, seizure, unnamed subject description." } ], "business_profile": { "id": "au-nsw-influencer-seizure-2026", "display_name": "Unnamed NSW influencer-linked premises", "identities": [], "activity": { "summary": "The TGA describes products seized at two residences on August 4, 2026, linked to an unnamed social-media influencer previously warned. The public account supplies no shop name, operator name or first/last trading dates.", "kind": "dated_observation", "start": "2026-08-04", "end": "2026-08-04", "sources": [ "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids" ], "limits": [ "The date records seized inventory, not proven completion of sales.", "A previous warning does not establish when the business began.", "Alleged links and conduct are not a conviction." ] }, "source_review": [ { "url": "https://www.tga.gov.au/news/media-releases/tga-flexes-its-muscle-against-illegal-peptides-and-steroids", "locator": "TGA August 17 release: August 4 warrants, unnamed influencer and previous warning" } ] } }, { "id": "uk-private-pharmacy-clinic-2026", "case_name": "The Private Pharmacy Clinic conditions and falsified Mounjaro investigation", "category": "foreign_enforcement", "court_or_agency": "General Pharmaceutical Council; Medicines and Healthcare products Regulatory Agency", "docket_number": "GPhC premises registration 9012397", "jurisdiction": "United Kingdom — England and Wales", "record_scope": "matter_record", "brands": [ "The Private Pharmacy Clinic", "Mounjaro" ], "parties": [ "The Private Pharmacy Clinic" ], "filed_date": "2026-02-19", "status_date": "2026-02-24", "analysis": { "id": "uk-private-pharmacy-clinic-2026", "summary": { "text": "The Private Pharmacy Clinic faced pharmacy restrictions and a separate investigation into five falsified Mounjaro 15 mg pens. Faulty dose knobs helped reveal the falsification; Lilly informed MHRA. Testing of recovered pens found tirzepatide, but sterility remained uncertain. This does not establish that the pharmacy manufactured the falsified products or knew their origin.", "sources": [ "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf", "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens" ] }, "products": [ { "name": "tirzepatide", "role": "tested_contents", "basis": "MHRA reports that recovered falsified Mounjaro pens contained tirzepatide; the assay does not establish sterility or every pen’s composition.", "sources": [ "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens" ], "normalized_names": [ "tirzepatide" ] }, { "name": "prescription medicines and medical devices", "role": "background", "basis": "The pharmacy conditions restrict obtaining, selling or supplying these classes; this describes administrative restriction scope, not a tested ingredient or settlement admission.", "sources": [ "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf" ], "normalized_names": [ "prescription medicines", "medical devices" ] } ], "discovery": { "known": true, "text": "For the falsified pens, the source documents dose-knob faults in four of five pens and notification from Lilly to MHRA. The separate pharmacy-inspection programme’s original trigger is not established.", "sources": [ "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf", "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens" ] }, "challenged_conduct": [ { "text": "GPhC identified repeated inspection failures and deficient oversight/response to quality concerns. MHRA investigated falsified branded pens; responsibility for their manufacture and knowing distribution was not established in the update.", "attribution": "mixed", "sources": [ "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf", "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens" ] } ], "outcome": { "class": "mixed", "text": "Conditions effective February 19 restricted prescription-medicine/device activity. MHRA’s February 24 update reported an ongoing investigation and no then-reported patient harm requiring treatment; that limited observation is not a safety clearance.", "as_of": "2026-02-24", "sources": [ "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf", "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens" ] }, "timeline": [ { "date": "2026-02-19", "event": "GPhC conditions took effect.", "kind": "order", "date_basis": "event", "sources": [ "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf" ] }, { "date": "2026-02-24", "event": "MHRA published its falsified-pen update.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens" ] } ], "timing_pairs": [], "next_watch": { "text": "Monitor revised pharmacy conditions and MHRA findings about supply-chain responsibility and tested product quality.", "basis": "inference", "sources": [ "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf", "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens" ] }, "unknowns": [ "Falsification source, exact detection dates, pharmacy knowledge, sterility and final investigative disposition remain unresolved." ], "source_review": [ { "url": "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf", "review_basis": "archived_full_text", "locator": "GPhC one-page conditions, effective February 19, 2026" }, { "url": "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens", "review_basis": "archived_full_text", "locator": "MHRA falsified Mounjaro update: identification, testing and patient reports" } ] }, "compounds": [ "medical devices", "prescription medicines", "tirzepatide" ], "marketing_or_supply_compounds": [], "tested_compounds": [ "tirzepatide" ], "direct_compounds": [ "tirzepatide" ], "latest_documented_date": "2026-02-24", "sources": [ { "url": "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf", "title": "The Private Pharmacy Clinic — Enforcement Action Summary — Conditions", "source_type": "official_agency", "document_type": "enforcement_conditions_pdf", "supports": "Effective date, pharmacy identity and registration number, restriction and ongoing status." }, { "url": "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens", "title": "Falsified Mounjaro KwikPen 15mg pre-filled pens", "source_type": "official_agency", "document_type": "drug_safety_update", "supports": "Named pharmacy, batch-specific falsification, recovered-product testing and ongoing investigation." }, { "url": "https://assets.publishing.service.gov.uk/media/699da78e532c9ad91ebbcbe3/Falsified_Mounjaro_-_DSU_.pdf", "title": "Falsified Mounjaro KwikPen 15mg pre-filled pens — downloadable notice", "source_type": "official_agency", "document_type": "drug_safety_update_pdf", "supports": "Direct downloadable copy of MHRA safety notice." } ], "business_profile": { "id": "uk-private-pharmacy-clinic-2026", "display_name": "The Private Pharmacy Clinic (Birmingham)", "identities": [ { "name": "The Private Pharmacy Clinic", "kind": "trading_name", "basis": "The GPhC condition notice expressly labels this as the pharmacy trading name, premises registration 9012397.", "sources": [ "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf", "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens" ] } ], "activity": { "summary": "The February 19, 2026 GPhC notice states patients continued using the pharmacy and immediately prohibited obtaining, selling or supplying prescription-only medicines and medical devices. MHRA’s February 24 report identifies prior supply of falsified pens. Neither source supplies the first opening or first/last affected sale date.", "kind": "dated_observation", "start": "2026-02-19", "end": "2026-02-19", "sources": [ "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf", "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens" ], "limits": [ "The date is a contemporaneous observation and restriction date, not a verified closure of the entire business.", "Mounjaro is the affected product branding, not the pharmacy’s alternative name.", "No individual owner or falsified-product manufacturer is established here." ] }, "source_review": [ { "url": "https://inspections.pharmacyregulation.org/pharmacy/enforcement/9012397-2026-02-19-4292.pdf", "locator": "GPhC one-page notice: trading name, effective date, ongoing patient use and condition; MHRA February 24 background and supplied-through statement" }, { "url": "https://www.gov.uk/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens", "locator": "GPhC one-page notice: trading name, effective date, ongoing patient use and condition; MHRA February 24 background and supplied-through statement" } ] } }, { "id": "us-v-brandon-piper-milestonepurity", "case_name": "United States v. Brandon Piper and related defendants", "category": "criminal", "court_or_agency": "U.S. District Court, Western District of Michigan", "docket_number": "1:26-cr-00018-RJJ", "jurisdiction": "United States federal", "record_scope": "related_proceedings_group", "brands": [ "MilestonePurity" ], "parties": [ "Brandon Piper", "Mayze Nichols" ], "filed_date": "2026-02-19", "status_date": "2026-07-23", "analysis": { "id": "us-v-brandon-piper-milestonepurity", "summary": { "text": "Brandon Piper’s case specifically names semaglutide and tirzepatide sold through an unnamed Canadian company and later Milestone Purity. The information alleges that he worked with the Canadian business from at least October 2023, then established Milestone Purity around August 2024, with the conspiracy continuing into May 2025. It describes sales without prescriptions, inadequate directions, false research-only statements despite intended human use, and false American-origin representations for China-sourced products. The charging document includes sample transactions, but neither it nor the sentencing release identifies those transactions as the original investigative trigger. That distinction prevents a documented shipment from being mislabeled as the event that started the case. The information was filed February 19, 2026. DOJ announced a 21-month prison sentence on July 23, 2026; its wording does not independently identify the sentencing hearing date. The release also discusses co-defendant Mayze Nichols and a future sentencing setting, whose actual disposition remains unverified here. Neither reviewed source names retatrutide. This is evidence of a misbranding-conspiracy prosecution involving named GLP-1 products, not a product-specific retatrutide conviction or proof that all research-only peptide listings share those facts.", "sources": [ "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR", "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "Named sold product in DOJ sentencing account; charging information also gives a sample shipment.", "sources": [ "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR", "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ], "normalized_names": [ "semaglutide" ] }, { "name": "tirzepatide", "role": "reported_marketing_or_supply", "basis": "Named sold product in DOJ sentencing account and charging information.", "sources": [ "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR", "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ], "normalized_names": [ "tirzepatide" ] }, { "name": "other peptides, unspecified", "role": "reported_marketing_or_supply", "basis": "Sentencing account refers more broadly to peptides without naming all compounds.", "sources": [ "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR" ], "normalized_names": [ "unspecified peptides" ] } ], "discovery": { "known": false, "text": "FDA-OCI investigated, but the reviewed sources do not identify the initiating lead. Sample shipments in information paragraphs 20–21 and social-media/customer communications are evidence of alleged conduct; the document does not establish them as the first detection event.", "sources": [ "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf", "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR" ] }, "challenged_conduct": [ { "text": "Conspiracy involving imported, unapproved products sold without prescriptions and adequate directions, and falsely presented as research-only despite intended human use.", "attribution": "mixed", "sources": [ "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR", "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ] }, { "text": "False domestic-origin statements and human-use promotional communications are described in the charging information and sentencing account.", "attribution": "mixed", "sources": [ "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf", "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR" ] } ], "outcome": { "class": "mixed", "text": "DOJ announced Piper’s21-month prison sentence on July 23, 2026. The release set Nichols sentencing for September 15, 2026; actual Nichols outcome is not verified by this review.", "as_of": "2026-07-23", "sources": [ "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR" ] }, "timeline": [ { "date": "2023-10", "event": "Alleged Canadian-company affiliation/conspiracy existed by this month.", "kind": "conduct_start", "date_basis": "reported_period", "sources": [ "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ] }, { "date": "2024-08", "event": "Milestone Purity reportedly established.", "kind": "other", "date_basis": "reported_period", "sources": [ "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ] }, { "date": "2025-05", "event": "Alleged conspiracy continued into this month.", "kind": "other", "date_basis": "reported_period", "sources": [ "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ] }, { "date": "2026-02-19", "event": "Felony information filed; signature date was February 18.", "kind": "other", "date_basis": "filing", "sources": [ "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ] }, { "date": "2026-07-23", "event": "DOJ announced21-month sentence; exact hearing day not independently stated.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain Piper’s judgment for the actual sentencing date and full terms, and Nichols’s docket or judgment following the September 15 setting. Review any later papers identifying additional compounds.", "basis": "inference", "sources": [ "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR", "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ] }, "unknowns": [ "No verified retatrutide product or count.", "Canadian business is unnamed in the reviewed information; no brand identification inferred.", "Initial investigation trigger unknown.", "Piper exact sentencing hearing date and Nichols actual outcome unverified.", "No event-to-event elapsed interval calculated from the announcement date." ], "source_review": [ { "url": "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR", "review_basis": "archived_full_text", "locator": "DOJ release, July 23, 2026" }, { "url": "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf", "review_basis": "court_pdf", "locator": "ECF 1 filedFebruary19,2026; paragraphs 6–9,13–23; image PDF OCR reviewed" } ] }, "compounds": [ "semaglutide", "tirzepatide", "unspecified peptides" ], "marketing_or_supply_compounds": [ "semaglutide", "tirzepatide", "unspecified peptides" ], "tested_compounds": [], "direct_compounds": [ "semaglutide", "tirzepatide", "unspecified peptides" ], "latest_documented_date": "2026-07-23", "sources": [ { "url": "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR", "title": "Gobles Man Sentenced for Selling Chinese Drugs Without FDA Approval", "source_type": "official_agency", "document_type": "press_release", "supports": "DOJ reports 21 months imprisonment for Piper for a misbranded-drug conspiracy involving research-only sales of semaglutide and tirzepatide." }, { "url": "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf", "title": "United States v. Brandon Piper, Charging Document, ECF 1", "source_type": "court_document", "document_type": "charging_document", "supports": "Court charging document hosted by public-radio archive; ECF footer verifies 1:26-cr-00018-RJJ, Document 1, filed February 19, 2026. The reproduced allegations concern MilestonePurity and an unnamed Canadian supplier." } ], "business_profile": { "id": "us-v-brandon-piper-milestonepurity", "display_name": "Milestone Purity / Brandon Piper", "identities": [ { "name": "Milestone Purity", "kind": "trading_name", "basis": "Information ¶7 names the company established by Piper and others around August 2024; incorporation/legal suffix not supplied.", "sources": [ "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ] }, { "name": "MilestonePurity", "kind": "trading_name", "basis": "Joined spelling used in the DOJ sentencing account and website reference; same named operation.", "sources": [ "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR" ] }, { "name": "milestonepurity.com", "kind": "historical_domain", "basis": "Information ¶¶7 and 22 identify the website and allege Piper bought the domain around August 2024.", "sources": [ "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ] }, { "name": "Brandon Piper", "kind": "operator", "basis": "Information identifies his Canadian-company affiliation and establishment of Milestone Purity; DOJ identifies his own later site.", "sources": [ "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf", "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR" ] } ], "activity": { "summary": "The information alleges Piper worked for an unnamed Canadian company from at least October 2023 until around August 2024, then established Milestone Purity with others around August 2024. Its overall conspiracy period runs from at least around October 2023 through around May 2025. The Canadian period must not be assigned to Milestone Purity.", "kind": "mixed_entities", "start": "2023-10", "end": "2025-05", "sources": [ "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf" ], "limits": [ "Charging-document dates retain their approximate/alleged character; the sentencing release confirms the sequence but does not independently restate each month.", "August 2024 is the alleged Milestone Purity establishment/domain-purchase month, not an independently verified incorporation date.", "May 2025 ends the charged conspiracy period; it does not establish website shutdown.", "The Canadian business and its owners are unnamed in the reviewed sources; no identity inferred.", "Mayze Nichols is named as a co-defendant by DOJ, but her operator/ownership role is not established, so she is not assigned as an operator." ] }, "source_review": [ { "url": "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf", "locator": "ECF 1, pp. 2–3, ¶¶6–7", "excerpt": "From at least October 2023 until in or about August 2024" }, { "url": "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf", "locator": "ECF 1, p. 3, ¶7", "excerpt": "Beginning in approximately August 2024" }, { "url": "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf", "locator": "ECF 1, p. 5, ¶15", "excerpt": "continuing until in or about May 2025" }, { "url": "https://npr.brightspotcdn.com/11/c7/f8a5daa94664b19db0e064909a31/usa-v-piper-consipracy.pdf", "locator": "ECF 1, p. 8, ¶22", "excerpt": "purchased the domain name milestonepurity.com." }, { "url": "https://www.justice.gov/usao-wdmi/pr/2026_0723_Piper_Sentencing_PR", "locator": "July 23, 2026 sentencing announcement, first two body paragraphs" } ] } }, { "id": "us-v-jeffrey-mcindoo-sarms-pharm", "case_name": "United States v. Jeffrey McIndoo and JeffMac Investments LLC", "category": "criminal", "court_or_agency": "U.S. District Court, District of Arizona", "docket_number": null, "jurisdiction": "United States federal", "record_scope": "single_proceeding", "brands": [ "SARMS Pharm LLC" ], "parties": [ "Jeffrey McIndoo", "JeffMac Investments LLC" ], "filed_date": null, "status_date": "2026-06-03", "analysis": { "id": "us-v-jeffrey-mcindoo-sarms-pharm", "summary": { "text": "The McIndoo/SARMS Pharm matter involves a seller and its company, with different plea outcomes that should be retained together but distinguished. DOJ announced on June 3, 2026 that Jeffrey McIndoo pleaded guilty to introducing an unapproved drug into interstate commerce; JeffMac Investments LLC, doing business as SARMS Pharm LLC, pleaded guilty to conspiring to smuggle SARMs from China. The release describes sales during 2017–2022 and an agreement for the company to forfeit $1.8 million and close. An agreed forfeiture and closure should not be reported as verified completed compliance without a judgment or follow-up record. The source identifies the product class as SARMs but does not name individual compounds, establish retatrutide sales or provide product-level laboratory results. It also does not explain what first brought the business to investigators’ attention. Naming FDA-OCI is not an answer to that discovery question. The announcement establishes that the pleas had occurred by June 3; it does not give an independently specified hearing date from which to calculate a prosecution timeline. No sentence was verified. The next documents to seek are the plea agreements and judgments for both defendants, including the basis for the corporate import charge and implementation of forfeiture and closure.", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] }, "products": [ { "name": "SARMs, individual compounds unspecified", "role": "reported_marketing_or_supply", "basis": "DOJ guilty-plea account identifies SARMs sold by the business without naming individual compounds.", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ], "normalized_names": [ "unspecified SARMs" ] } ], "discovery": { "known": false, "text": "The announcement identifies FDA-OCI involvement but not the original lead, investigation start or specific purchase/testing method.", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] }, "challenged_conduct": [ { "text": "McIndoo admitted introducing an unapproved drug into interstate commerce.", "attribution": "admission", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] }, { "text": "JeffMac Investments LLC, doing business as SARMS Pharm LLC, pleaded guilty to conspiring to smuggle SARMs from China; distinguish this corporate plea from McIndoo’s individual offense.", "attribution": "admission", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] } ], "outcome": { "class": "guilty_plea", "text": "DOJ announced individual and company guilty pleas by June 3, 2026. Company agreed to forfeit $1.8 million and cease operations; actual sentencing and completed compliance were not established.", "as_of": "2026-06-03", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] }, "timeline": [ { "date": "2017", "event": "Reported sales period began.", "kind": "conduct_start", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] }, { "date": "2022", "event": "Reported sales period ended.", "kind": "other", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] }, { "date": "2026-06-03", "event": "DOJ announced guilty pleas and company forfeiture/closure agreement; actual plea-hearing day not separately given.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain both defendants’ plea agreements and judgments, including actual hearing dates, individual sentence and the company’s forfeiture and cessation obligations.", "basis": "inference", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] }, "unknowns": [ "No named individual SARM or verified retatrutide involvement.", "Original investigative trigger unknown.", "Actual plea-hearing dates, sentences and completed forfeiture/closure not verified.", "Year-only conduct dates and an announcement do not support an enforcement-speed calculation." ], "source_review": [ { "url": "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances", "review_basis": "archived_full_text", "locator": "DOJ guilty-plea announcement, June 3, 2026" } ] }, "compounds": [ "unspecified SARMs" ], "marketing_or_supply_compounds": [ "unspecified SARMs" ], "tested_compounds": [], "direct_compounds": [ "unspecified SARMs" ], "latest_documented_date": "2026-06-03", "sources": [ { "url": "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances", "title": "Arizona Man Pleads Guilty to Selling Illicit Chemical Substances", "source_type": "official_agency", "document_type": "press_release", "supports": "McIndoo pleaded guilty to introducing an unapproved drug; his company pleaded guilty to conspiracy to smuggle SARMs from China, agreed to $1.8 million forfeiture and to stop the business." } ], "business_profile": { "id": "us-v-jeffrey-mcindoo-sarms-pharm", "display_name": "SARMS Pharm / JeffMac Investments / Jeffrey McIndoo", "identities": [ { "name": "JeffMac Investments LLC", "kind": "legal_entity", "basis": "DOJ explicitly names the corporate defendant and its d/b/a.", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] }, { "name": "SARMS Pharm LLC", "kind": "trading_name", "basis": "DOJ expressly gives JeffMac Investments LLC doing business as SARMS Pharm LLC; not assumed to be a separately proved corporate defendant.", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] }, { "name": "SARMS Pharm", "kind": "trading_name", "basis": "Short form defined in DOJ release.", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] }, { "name": "Jeffrey McIndoo", "kind": "operator", "basis": "DOJ identifies him as the owner/operator of SARMS Pharm.", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ] } ], "activity": { "summary": "DOJ reports SARMS Pharm sales and gross profits between 2017 and 2022. Its June 3, 2026 plea announcement says the company agreed to forfeit $1.8 million and shutter its business.", "kind": "documented_period", "start": "2017", "end": "2022", "sources": [ "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances" ], "limits": [ "Year-only sales/profit period, not exact opening or closing dates.", "The future-facing closure obligation does not prove completed closure.", "No historical domain is supplied in this reviewed primary source.", "Individual sentence and actual forfeiture collection remain unverified." ] }, "source_review": [ { "url": "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances", "locator": "June 3, 2026 plea announcement, third body paragraph", "excerpt": "between 2017 and 2022, SARMS Pharm earned gross profits" }, { "url": "https://www.justice.gov/opa/pr/arizona-man-pleads-guilty-selling-illicit-chemical-substances", "locator": "Fourth body paragraph: future closure obligation", "excerpt": "JeffMac Investments LLC will shutter its business" } ] } }, { "id": "us-v-jeremy-brown-warrior-labz", "case_name": "United States v. Jeremy Spencer Brown", "category": "criminal", "court_or_agency": "U.S. District Court, District of Vermont", "docket_number": null, "jurisdiction": "United States federal", "record_scope": "single_proceeding", "brands": [ "Warrior Labz SARMs" ], "parties": [ "Jeremy Spencer Brown" ], "filed_date": null, "status_date": "2026-02-12", "analysis": { "id": "us-v-jeremy-brown-warrior-labz", "summary": { "text": "Warrior Labz sold a broad catalog that included SARMs and products represented as semaglutide, sildenafil and tadalafil. That mix should not be reduced to a peptide-only case. FDA’s later debarment decision describes undercover purchases beginning in March 2023, before Brown received a warning on June 12, 2023. It does not identify the original lead that prompted those purchases. The decision also supplies unusually specific testing evidence: products labeled ostarine and ligandrol, bought in August 2023, both contained ostarine and undeclared clomiphene; neither contained ligandrol. This is a finding about the tested products, not proof about every item in the catalog. DOJ described false research-only representations, intended human consumption, misleading manufacturing and quality claims, and continued selling after the warning. On February 3, 2025 it announced a sentence including one year of supervised release and $100,000 forfeiture. FDA subsequently imposed a five-year drug-import debarment effective February 12, 2026. The criminal sentence and administrative restriction are distinct outcomes. Neither reviewed source establishes a retatrutide offering, and the DOJ release does not specify a custodial component that should be invented or equated with probation.", "sources": [ "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet", "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "Named among drugs marketed and sold in the FDA debarment account; not a verified retatrutide product.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "normalized_names": [ "semaglutide" ] }, { "name": "sildenafil", "role": "reported_marketing_or_supply", "basis": "Named offered drug in FDA account.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "normalized_names": [ "sildenafil" ] }, { "name": "tadalafil", "role": "reported_marketing_or_supply", "basis": "Named offered drug in FDA account.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "normalized_names": [ "tadalafil" ] }, { "name": "ostarine", "role": "reported_marketing_or_supply", "basis": "Named offered/labeled product.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "normalized_names": [ "ostarine" ] }, { "name": "ligandrol", "role": "reported_marketing_or_supply", "basis": "Named labeled product; testing did not confirm ligandrol in the sampled products.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "normalized_names": [ "LGD-4033" ] }, { "name": "YK-11", "role": "reported_marketing_or_supply", "basis": "Named marketed compound; identity of all units not analytically established.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "normalized_names": [ "YK-11" ] }, { "name": "cardarine", "role": "reported_marketing_or_supply", "basis": "Named marketed compound; retained by name without adopting the source grouping of all compounds as SARMs.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "normalized_names": [ "cardarine" ] }, { "name": "ostarine and clomiphene", "role": "tested_contents", "basis": "FDA reports that August 2023 ostarine- and ligandrol-labeled products both contained ostarine and undeclared clomiphene, and neither contained ligandrol.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "normalized_names": [ "ostarine", "clomiphene" ] } ], "discovery": { "known": false, "text": "Original trigger is not established. FDA describes undercover purchases from March through December 2023 and subsequent laboratory analysis. These methods predated the June 12 warning and must not be presented as consequences that began only after it.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] }, "challenged_conduct": [ { "text": "Selling unapproved drugs with intent to defraud, alongside false research-only and manufacturing/quality representations, was the conduct described in DOJ’s conviction and sentencing account.", "attribution": "mixed", "sources": [ "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet" ] }, { "text": "FDA described continued conduct after receipt of a warning and misidentified/undeclared contents in sampled products.", "attribution": "agency_assessment", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] } ], "outcome": { "class": "mixed", "text": "DOJ reported one year of supervised release and $100,000 forfeiture on February 3, 2025; the release does not specify a custodial component. FDA imposed five-year debarment from importing or offering drugs for import, effective February 12, 2026.", "as_of": "2026-02-12", "sources": [ "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet", "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] }, "timeline": [ { "date": "2019-03", "event": "Reported start of Warrior Labz conduct.", "kind": "conduct_start", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet" ] }, { "date": "2023-03", "event": "Undercover purchases began during this month.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] }, { "date": "2023-06-12", "event": "Brown received FDA warning.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] }, { "date": "2023-08", "event": "Sample purchases later found to contain ostarine and clomiphene.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] }, { "date": "2025-02-03", "event": "Judgment/conviction and sentence described by FDA and DOJ.", "kind": "sentence", "date_basis": "event", "sources": [ "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet", "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] }, { "date": "2025-04-16", "event": "FDA sent proposed-debarment notice by certified mail.", "kind": "other", "date_basis": "event", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] }, { "date": "2026-02-12", "event": "Five-year drug-import debarment took effect.", "kind": "order", "date_basis": "event", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] } ], "timing_pairs": [ { "label": "Warning receipt to sentence", "start": "2023-06-12", "end": "2025-02-03", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf", "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet" ], "days": 602 }, { "label": "Sentence to effective import debarment", "start": "2025-02-03", "end": "2026-02-12", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "days": 374 } ], "next_watch": { "text": "Obtain the criminal judgment to complete sentence details and monitor any FDA debarment modification; do not equate a release summarizing supervised release with a complete custody record.", "basis": "inference", "sources": [ "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet", "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] }, "unknowns": [ "Original investigative trigger unknown.", "No verified retatrutide involvement.", "Complete criminal judgment and any custody component not established here." ], "source_review": [ { "url": "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet", "review_basis": "archived_full_text", "locator": "DOJ sentencing release, February 3, 2025" }, { "url": "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf", "review_basis": "court_pdf", "locator": "Federal Register, February 12, 2026, pages 6644–6645" } ] }, "compounds": [ "cardarine", "clomiphene", "LGD-4033", "ostarine", "semaglutide", "sildenafil", "tadalafil", "YK-11" ], "marketing_or_supply_compounds": [ "cardarine", "LGD-4033", "ostarine", "semaglutide", "sildenafil", "tadalafil", "YK-11" ], "tested_compounds": [ "clomiphene", "ostarine" ], "direct_compounds": [ "cardarine", "clomiphene", "LGD-4033", "ostarine", "semaglutide", "sildenafil", "tadalafil", "YK-11" ], "latest_documented_date": "2026-02-12", "sources": [ { "url": "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet", "title": "California Man Sentenced for Selling Unapproved Drugs with Intent to Defraud over the Internet", "source_type": "official_agency", "document_type": "press_release", "supports": "DOJ reports one year supervised release and $100,000 forfeiture for unapproved-drug sales with intent to defraud or mislead. The website sold SARMs and unapproved versions of prescription products under research-only claims." }, { "url": "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf", "title": "Jeremy Spencer Brown: Final Debarment Order", "source_type": "official_agency", "document_type": "final_debarment_order", "supports": "FDA administrative docket FDA-2025-N-0435; five-year drug-import debarment effective 2026-02-12; original Federal Register PDF." } ], "business_profile": { "id": "us-v-jeremy-brown-warrior-labz", "display_name": "Warrior Labz SARMs / Jeremy Spencer Brown", "identities": [ { "name": "Warrior Labz SARMs", "kind": "trading_name", "basis": "DOJ and FDA identify Brown’s company under this name; legal suffix not supplied.", "sources": [ "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet", "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] }, { "name": "warriorlabzvip.com", "kind": "historical_domain", "basis": "FDA says Brown created this website in January 2023; nickname VIP SARMs Site.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ] }, { "name": "Jeremy Spencer Brown", "kind": "operator", "basis": "FDA order identifies the owner/operator; DOJ uses Jeremy Brown.", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf", "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet" ] } ], "activity": { "summary": "DOJ and FDA describe Brown operating Warrior Labz SARMs from March 2019 through December 2023. FDA separately dates creation of warriorlabzvip.com to January 2023.", "kind": "documented_period", "start": "2019-03", "end": "2023-12", "sources": [ "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet", "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf" ], "limits": [ "Operating/conduct period is not a verified corporate formation/dissolution interval.", "FDA prints the original site as warriorlabzarms without a domain suffix; no repaired domain is inferred.", "VIP-site creation in January 2023 does not move the overall business start from March 2019." ] }, "source_review": [ { "url": "https://www.justice.gov/usao-vt/pr/california-man-sentenced-selling-unapproved-drugs-intent-defraud-over-internet", "locator": "February 3, 2025 sentencing release, second paragraph", "excerpt": "between March 2019 and December 2023, Brown operated a company, Warrior Labz SARMs" }, { "url": "https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02786.pdf", "locator": "Federal Register p. 6644, Background", "excerpt": "In January 2023, Mr. Brown created the website warriorlabzvip.com" } ] } }, { "id": "us-v-justin-watkins", "case_name": "United States v. Justin Bradley Watkins", "category": "criminal", "court_or_agency": "U.S. District Court, District of Utah", "docket_number": "1:26-cr-00015-DBB", "jurisdiction": "United States federal", "record_scope": "single_proceeding", "brands": [], "parties": [ "Justin Bradley Watkins" ], "filed_date": "2026-04-01", "status_date": "2026-04-01", "analysis": { "id": "us-v-justin-watkins", "summary": { "text": "Justin Bradley Watkins is the clearest retatrutide connection among these criminal records, but it is an allegation in a pending-or-unverified prosecution, not a retatrutide conviction. DOJ says his orders through a middleman included retatrutide alongside tirzepatide, semaglutide, cagrilintide, BPC-157, TB500, ipamorelin, CJC1295, GHK, GHK-Cu and NAD+. The release alleges that between February 2024 and April 2025 he obtained drugs from China, applied labels lacking the manufacturer, packer or distributor’s identity and location, and recommended or supplied misbranded products to more than 200 patients. That collective description does not establish which compound each patient received, the identity established by testing, or that every listed substance supports a separate count. NAD+ should not be categorized as a peptide simply because the release groups the inventory together. A grand jury returned the indictment on April 1, 2026. DOJ identifies a joint FDA-OCI and Utah licensing-agency investigation but not its initial trigger. The reviewed primary announcement gives no plea, verdict or sentence. The next meaningful documents are the full indictment, product-specific transaction evidence and later docket entries. Watkins is presumed innocent; neither inventory allegations nor scheduled appearances establish guilt.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ] }, "products": [ { "name": "retatrutide", "role": "alleged_marketing_or_supply", "basis": "DOJ identifies this substance among alleged orders; the release collectively alleges patient supply but does not prove this particular compound was delivered to each patient or analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "normalized_names": [ "retatrutide" ] }, { "name": "tirzepatide", "role": "alleged_marketing_or_supply", "basis": "DOJ identifies this substance among alleged orders; the release collectively alleges patient supply but does not prove this particular compound was delivered to each patient or analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "normalized_names": [ "tirzepatide" ] }, { "name": "semaglutide", "role": "alleged_marketing_or_supply", "basis": "DOJ identifies this substance among alleged orders; the release collectively alleges patient supply but does not prove this particular compound was delivered to each patient or analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "normalized_names": [ "semaglutide" ] }, { "name": "cagrilintide (rendered Cagrilinitide in DOJ release)", "role": "alleged_marketing_or_supply", "basis": "DOJ identifies this substance among alleged orders; the release collectively alleges patient supply but does not prove this particular compound was delivered to each patient or analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "normalized_names": [ "cagrilintide" ] }, { "name": "BPC-157", "role": "alleged_marketing_or_supply", "basis": "DOJ identifies this substance among alleged orders; the release collectively alleges patient supply but does not prove this particular compound was delivered to each patient or analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "normalized_names": [ "BPC-157" ] }, { "name": "TB500", "role": "alleged_marketing_or_supply", "basis": "DOJ identifies this substance among alleged orders; the release collectively alleges patient supply but does not prove this particular compound was delivered to each patient or analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "normalized_names": [ "TB-500" ] }, { "name": "ipamorelin", "role": "alleged_marketing_or_supply", "basis": "DOJ identifies this substance among alleged orders; the release collectively alleges patient supply but does not prove this particular compound was delivered to each patient or analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "normalized_names": [ "ipamorelin" ] }, { "name": "CJC1295", "role": "alleged_marketing_or_supply", "basis": "DOJ identifies this substance among alleged orders; the release collectively alleges patient supply but does not prove this particular compound was delivered to each patient or analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "normalized_names": [ "CJC-1295" ] }, { "name": "GHK", "role": "alleged_marketing_or_supply", "basis": "DOJ identifies this substance among alleged orders; the release collectively alleges patient supply but does not prove this particular compound was delivered to each patient or analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "normalized_names": [ "GHK" ] }, { "name": "GHK-Cu", "role": "alleged_marketing_or_supply", "basis": "DOJ identifies this substance among alleged orders; the release collectively alleges patient supply but does not prove this particular compound was delivered to each patient or analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "normalized_names": [ "GHK-Cu" ] }, { "name": "NAD+", "role": "alleged_marketing_or_supply", "basis": "DOJ identifies this substance among alleged orders; the release collectively alleges patient supply but does not prove this particular compound was delivered to each patient or analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "normalized_names": [ "NAD+" ] } ], "discovery": { "known": false, "text": "The release names FDA-OCI and Utah DOPL but does not identify the original complaint, referral, interception or other initiating event. The alleged sourcing and relabeling are conduct allegations, not proof of how authorities discovered the case.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ] }, "challenged_conduct": [ { "text": "Allegedly receiving and delivering misbranded drugs for pay with intent to defraud or mislead, including labels omitting required manufacturer, packer or distributor information.", "attribution": "allegation", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ] }, { "text": "Allegedly obtaining unapproved products through a middleman and recommending or supplying them to more than 200 patients; product-by-patient attribution is not supplied.", "attribution": "allegation", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ] } ], "outcome": { "class": "pending_or_unknown", "text": "Indicted April 1, 2026; no plea, verdict or sentence verified in reviewed primary material. Initial appearance was scheduled for April 22, 2026, but occurrence and result are not established here.", "as_of": "2026-04-01", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ] }, "timeline": [ { "date": "2024-02", "event": "Alleged sourcing period began.", "kind": "conduct_start", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ] }, { "date": "2025-04", "event": "Alleged sourcing period ended.", "kind": "other", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ] }, { "date": "2026-04-01", "event": "Grand jury returned indictment.", "kind": "indictment", "date_basis": "event", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain the full indictment and subsequent docket to determine count-specific products, any plea or trial result, and whether analytical or patient evidence establishes retatrutide delivery.", "basis": "inference", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ] }, "unknowns": [ "Retatrutide is specifically named in alleged orders; a retatrutide-specific conviction is not established.", "The reviewed release does not resolve actual contents or compound-specific patient supply.", "Original investigation trigger unknown.", "Linked indictment returned 404 during direct retrieval; indexed excerpts are not treated here as a full-document review.", "No exact earlier comparable milestone supports an elapsed interval." ], "source_review": [ { "url": "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china", "review_basis": "archived_full_text", "locator": "DOJ indictment announcement, April 1, 2026; archived text and live official page reviewed" }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/04/Justin-Bradley-Watkins-Indictment-1.pdf", "review_basis": "registry_support_only", "locator": "Full PDF unavailable on direct retrieval; no substantive conclusion relies solely on this link." } ] }, "compounds": [ "BPC-157", "cagrilintide", "CJC-1295", "GHK", "GHK-Cu", "ipamorelin", "NAD+", "retatrutide", "semaglutide", "TB-500", "tirzepatide" ], "marketing_or_supply_compounds": [ "BPC-157", "cagrilintide", "CJC-1295", "GHK", "GHK-Cu", "ipamorelin", "NAD+", "retatrutide", "semaglutide", "TB-500", "tirzepatide" ], "tested_compounds": [], "direct_compounds": [ "BPC-157", "cagrilintide", "CJC-1295", "GHK", "GHK-Cu", "ipamorelin", "NAD+", "retatrutide", "semaglutide", "TB-500", "tirzepatide" ], "latest_documented_date": "2026-04-01", "sources": [ { "url": "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china", "title": "Utah Licensed Osteopathic Physician Indicted for Allegedly Receiving Misbranded Drugs from China and Selling them to Patients", "source_type": "official_agency", "document_type": "press_release", "supports": "DOJ announced an indictment alleging a physician obtained misbranded Chinese drugs, relabeled them and sold them to more than 200 patients. Charges allege receipt and delivery of misbranded drugs with intent to defraud or mislead and aiding and abetting." }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/04/Justin-Bradley-Watkins-Indictment-1.pdf", "title": "United States v. Justin Bradley Watkins, Indictment, ECF 1", "source_type": "court_document", "document_type": "indictment", "supports": "Court indictment reproduced by Partnership for Safe Medicines; ECF header verifies District of Utah case 1:26-cr-00015-DBB and filing April 1, 2026. Charges are allegations, not findings of guilt." } ], "business_profile": { "id": "us-v-justin-watkins", "display_name": "Justin Bradley Watkins / unnamed clinic", "identities": [ { "name": "Justin Bradley Watkins", "kind": "operator", "basis": "DOJ identifies the physician accused of ordering, labeling and supplying drugs; no clinic or trading name is identified.", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ] } ], "activity": { "summary": "The indictment announcement alleges Watkins obtained drugs through a middleman between February 2024 and April 2025 and supplied misbranded products to patients during the fraud period.", "kind": "documented_period", "start": "2024-02", "end": "2025-04", "sources": [ "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china" ], "limits": [ "Alleged conduct only; no conviction is established.", "This is not a verified clinic opening/closure period.", "Clinic name, legal entity and historical domain are unknown in the reviewed primary announcement.", "Retatrutide is among alleged orders; no patient-specific retatrutide supply or retatrutide conviction established." ] }, "source_review": [ { "url": "https://www.justice.gov/usao-ut/pr/utah-licensed-osteopathic-physician-indicted-allegedly-receiving-misbranded-drugs-china", "locator": "April 1, 2026 indictment announcement, second paragraph", "excerpt": "Watkins obtained the drugs through a middleman between February 2024 to April 2025." } ] } }, { "id": "us-v-kawa-stechkober-paradigm", "case_name": "United States v. Matthew Kawa and Jennifer Stechkober", "category": "criminal", "court_or_agency": "U.S. District Court, Northern District of Indiana", "docket_number": "3:25-cr-00091-CCB-SJF", "jurisdiction": "United States federal", "record_scope": "single_proceeding", "brands": [ "Paradigm Peptides", "Paradigm R.E. LLC" ], "parties": [ "Matthew Kawa", "Jennifer L. Stechkober" ], "filed_date": null, "status_date": "2026-07-30", "analysis": { "id": "us-v-kawa-stechkober-paradigm", "summary": { "text": "Paradigm Peptides provides unusually concrete evidence separating catalog claims from tested contents. Jennifer Stechkober’s plea identifies thymosin alpha-1 and BPC-157 shipments whose listed lab results matched those names, and YK-11, ostarine and ibutamoren products whose results were testosterone. The government’s sentencing memorandum describes six sampled SARM-labeled products testing as testosterone; those findings must not be generalized to every Paradigm peptide. Stechkober also expressly admitted forged certificates of analysis, false United States manufacturing and FDA-registration representations, and research-only statements despite known human use. The record describes FDA warnings, border stops, investigative product testing and a March 2024 search, but does not establish which event initiated the criminal inquiry. An information was filed October 27, 2025. Both defendants pleaded guilty December 10, and both were sentenced July 30, 2026: Matthew Kawa received 70 months and Stechkober16 months. Kawa’s judgment includes an additional unlawful-importation count involving hCG; his prison terms run concurrently. They share a $78,317.52 restitution obligation. No reviewed filing names retatrutide. The case supports a focused account of admitted deception and particular analytical results, with follow-up needed for exhibits, restitution and any later court developments. Kawa’s judgment separately orders $5 million in forfeiture and expressly imposes no fine; collection was not verified.", "sources": [ "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa", "https://www.safemedicines.org/wp-content/uploads/2026/09/Kawa-Paradigm-Peptides-Judgment.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-US-sentencing-memo.pdf" ] }, "products": [ { "name": "thymosin alpha-1", "role": "reported_marketing_or_supply", "basis": "Named marketed and shipped peptide in information and plea.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ], "normalized_names": [ "thymosin alpha-1" ] }, { "name": "BPC-157", "role": "reported_marketing_or_supply", "basis": "Named marketed and shipped peptide in information and plea.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ], "normalized_names": [ "BPC-157" ] }, { "name": "thymosin alpha-1", "role": "tested_contents", "basis": "Stechkober plea table lists a matching lab result for a February 2023 shipment; underlying analytical report is not reproduced.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ], "normalized_names": [ "thymosin alpha-1" ] }, { "name": "BPC-157", "role": "tested_contents", "basis": "Stechkober plea table lists a matching lab result for a February 2023 shipment; underlying analytical report is not reproduced.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ], "normalized_names": [ "BPC-157" ] }, { "name": "YK-11", "role": "reported_marketing_or_supply", "basis": "Named label/offering; listed tested sample instead contained testosterone.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ], "normalized_names": [ "YK-11" ] }, { "name": "ostarine / MK-2866", "role": "reported_marketing_or_supply", "basis": "Named label/offering; listed tested sample instead contained testosterone.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ], "normalized_names": [ "ostarine" ] }, { "name": "ibutamoren / MK-677", "role": "reported_marketing_or_supply", "basis": "Named product label; retained by name without adopting the filing’s SARM classification.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ], "normalized_names": [ "ibutamoren" ] }, { "name": "testosterone", "role": "tested_contents", "basis": "Plea table records testosterone in YK-11-, ostarine- and ibutamoren-labeled shipments. Government memorandum says six sampled SARM-labeled products tested as testosterone.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-US-sentencing-memo.pdf" ], "normalized_names": [ "testosterone" ] }, { "name": "human chorionic gonadotropin / hCG", "role": "reported_marketing_or_supply", "basis": "DOJ describes sales; information count 2 alleges Kawa unlawfully imported hCG, and judgment records his conviction on that count.", "sources": [ "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa", "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Kawa-Paradigm-Peptides-Judgment.pdf" ], "normalized_names": [ "human chorionic gonadotropin" ] } ], "discovery": { "known": false, "text": "FDA warning letters, at least 15 reported hCG border stops, later product testing and a March 2024 search are documented. They do not establish the first criminal-investigation trigger. A customer’s independent test is also mentioned in the government memo, without showing that it originated the case.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-US-sentencing-memo.pdf" ] }, "challenged_conduct": [ { "text": "Stechkober admitted knowingly false research-only statements, false purity/manufacturing/FDA-registration claims and forged certificates of analysis.", "attribution": "admission", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ] }, { "text": "Stechkober admitted introduction of unapproved products and that some SARM-labeled products actually consisted of testosterone; the plea table specifies sampled products.", "attribution": "admission", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ] }, { "text": "Kawa’s judgment establishes convictions for introducing unapproved drugs and importing merchandise contrary to law; information count 2 identifies hCG.", "attribution": "judicial_finding", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Kawa-Paradigm-Peptides-Judgment.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf" ] } ], "outcome": { "class": "conviction_or_sentence", "text": "Both pleaded guilty December 10, 2025 and were sentenced July 30, 2026. Kawa: 70 months total imprisonment through concurrent terms, 1 year supervised release, a $5,000,000 forfeiture order and a $200 assessment; the judgment expressly imposes no fine. Stechkober: 16 months and 1 year supervised release, with a $100 assessment reported by DOJ. Restitution of $78,317.52 is jointly and severally owed by both, not a separate award to add twice. These are ordered obligations; payment or recovery was not verified.", "as_of": "2026-08-03", "sources": [ "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa", "https://www.safemedicines.org/wp-content/uploads/2026/09/Kawa-Paradigm-Peptides-Judgment.pdf" ] }, "timeline": [ { "date": "2019-04", "event": "Reported business/conduct period began.", "kind": "conduct_start", "date_basis": "reported_period", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ] }, { "date": "2020-12", "event": "FDA warning about thymosin alpha-1 described by prosecutors.", "kind": "warning_letter", "date_basis": "reported_period", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-US-sentencing-memo.pdf" ] }, { "date": "2022-03-30", "event": "FDA warning and Stechkober response described in information/plea.", "kind": "warning_letter", "date_basis": "event", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ] }, { "date": "2024-03", "event": "Investigators executed warrant and business shut down, per government memorandum.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-US-sentencing-memo.pdf" ] }, { "date": "2025-10-27", "event": "Information and written Stechkober plea agreement filed; this is not the later plea-hearing date.", "kind": "other", "date_basis": "filing", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ] }, { "date": "2025-12-10", "event": "Both defendants entered guilty pleas.", "kind": "plea", "date_basis": "event", "sources": [ "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa" ] }, { "date": "2026-07-30", "event": "Both defendants sentenced.", "kind": "sentence", "date_basis": "event", "sources": [ "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa", "https://www.safemedicines.org/wp-content/uploads/2026/09/Kawa-Paradigm-Peptides-Judgment.pdf" ] } ], "timing_pairs": [ { "label": "Information filing to guilty pleas", "start": "2025-10-27", "end": "2025-12-10", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa" ], "days": 44 }, { "label": "Guilty pleas to sentences", "start": "2025-12-10", "end": "2026-07-30", "sources": [ "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa" ], "days": 232 }, { "label": "March 2022 FDA warning to information filing, not detection-to-charge", "start": "2022-03-30", "end": "2025-10-27", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ], "days": 1307 } ], "next_watch": { "text": "Seek the underlying analytical exhibits and any later restitution or post-conviction orders. Retain the difference between plea admissions, prosecutor sentencing arguments and final judgments.", "basis": "inference", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-US-sentencing-memo.pdf", "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa" ] }, "unknowns": [ "First investigative trigger unknown.", "No verified retatrutide involvement.", "Analytical reports behind the plea table and six-product testing assertion were not independently examined.", "Government sentencing advocacy is not automatically a judicial finding on every asserted injury or guideline fact.", "Whether ordered forfeiture or restitution was paid or recovered is not established by the judgment or DOJ status page." ], "source_review": [ { "url": "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa", "review_basis": "archived_full_text", "locator": "DOJ case page, updated August 3, 2026" }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Kawa-Paradigm-Peptides-Judgment.pdf", "review_basis": "court_pdf", "locator": "ECF 72 filed July 30, 2026; pp. 1–2 (counts, concurrent prison terms), p. 5 (no fine and shared restitution), p. 11 ($5,000,000 forfeiture)." }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "review_basis": "court_pdf", "locator": "ECF 1 filed October 27, 2025, paragraphs 7,13–20 and count 2; image PDF OCR reviewed" }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf", "review_basis": "court_pdf", "locator": "ECF 3 filed October 27, 2025, factual admissions pp 4–7; image PDF OCR reviewed" }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-US-sentencing-memo.pdf", "review_basis": "court_pdf", "locator": "Government sentencing memorandum, ECF 65 filed July 16, 2026, pp 2–7" } ] }, "compounds": [ "BPC-157", "human chorionic gonadotropin", "ibutamoren", "ostarine", "testosterone", "thymosin alpha-1", "YK-11" ], "marketing_or_supply_compounds": [ "BPC-157", "human chorionic gonadotropin", "ibutamoren", "ostarine", "thymosin alpha-1", "YK-11" ], "tested_compounds": [ "BPC-157", "testosterone", "thymosin alpha-1" ], "direct_compounds": [ "BPC-157", "human chorionic gonadotropin", "ibutamoren", "ostarine", "testosterone", "thymosin alpha-1", "YK-11" ], "latest_documented_date": "2026-07-30", "sources": [ { "url": "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa", "title": "United States v. Matthew Kawa", "source_type": "official_agency", "document_type": "official_case_status_page", "supports": "DOJ case page records guilty pleas December 10, 2025 and sentences July 30, 2026: Kawa 70 months, Stechkober 16 months; joint and several restitution $78,317.52. Investigators reported testosterone in products labeled as SARMs." }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Kawa-Paradigm-Peptides-Judgment.pdf", "title": "United States v. Matthew J. Kawa, Judgment in a Criminal Case, ECF 72", "source_type": "court_document", "document_type": "judgment", "supports": "Court judgment reproduced by Partnership for Safe Medicines; ECF 72 filed July 30, 2026 verifies 3:25-cr-00091-CCB-SJF. Records December 10, 2025 guilty plea to introducing unapproved new drugs and importing merchandise contrary to law, concurrent 36- and 70-month prison terms, one year supervised release, $200 assessment, no fine, and $78,317.52 restitution jointly with Jennifer Stechkober." }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "title": "United States v. Kawa and Stechkober, Information", "source_type": "court_document", "document_type": "information", "supports": "Image-based court charging Information reproduced in Partnership for Safe Medicines case archive. Document located; its complete text and precise filing date were not extracted in this pass." }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf", "title": "United States v. Jennifer Stechkober, Plea Agreement", "source_type": "court_document", "document_type": "plea_agreement", "supports": "Image-based court plea document reproduced in Partnership for Safe Medicines case archive. Document located; its complete text and precise filing date were not extracted in this pass." }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-US-sentencing-memo.pdf", "title": "United States v. Jennifer Stechkober, Government Sentencing Memorandum, ECF 65", "source_type": "court_document", "document_type": "government_sentencing_memorandum", "supports": "Court filing ECF 65 dated July 16, 2026, reproduced by Partnership for Safe Medicines. Government states six SARM products tested as testosterone, alleges altered/forged certificates, and requests 36 months imprisonment. The request is distinct from the subsequently reported 16-month sentence." } ], "business_profile": { "id": "us-v-kawa-stechkober-paradigm", "display_name": "Paradigm Peptides / Matthew Kawa and Jennifer Stechkober", "identities": [ { "name": "Paradigm Peptides", "kind": "trading_name", "basis": "Information ¶5 and plea factual basis identify the name used by the business.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ] }, { "name": "Paradigm RE LLC", "kind": "legal_entity", "basis": "Business name expressly stated in Information ¶5 and plea p. 4; formation record not obtained.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ] }, { "name": "Paradigm R.E. LLC", "kind": "legal_entity", "basis": "Punctuated spelling on the DOJ case page; treated as a spelling variant of the same business described there.", "sources": [ "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa" ] }, { "name": "Paradigm", "kind": "trading_name", "basis": "Information ¶5 explicitly identifies this short form.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf" ] }, { "name": "paradigmpeptides.com", "kind": "historical_domain", "basis": "Information ¶6 and plea p. 4 name the website.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ] }, { "name": "Matthew J. Kawa", "kind": "operator", "basis": "Information ¶5 identifies the operator; Stechkober admits her brother was in charge.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ] }, { "name": "Jennifer L. Stechkober", "kind": "operator", "basis": "Operational employee, not labeled owner: plea admits packaging, labeling, shipping and customer communications from around February 2020 through March 2024.", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ] } ], "activity": { "summary": "The information alleges Kawa operated Paradigm from at least April 2019 through March 2024. Stechkober admits Paradigm sales from approximately April 2019 through March 2024 and her own employment from around February 2020 through March 2024. Her plea also says marketing continued after the March 30, 2022 FDA warning until March 20, 2024.", "kind": "documented_period", "start": "2019-04", "end": "2024-03", "sources": [ "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf" ], "limits": [ "These are sourced operating/conduct periods, not corporate formation or dissolution dates.", "Stechkober’s employment began later than the overall sales period.", "The March 20, 2024 endpoint describes continued marketing in the plea; it does not independently establish legal dissolution or permanent website closure." ] }, "source_review": [ { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Paradigm-Peptides-Information.pdf", "locator": "ECF 1, p. 3, ¶5", "excerpt": "From at least April 2019 through March 2024" }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf", "locator": "ECF 3, p. 4, factual basis", "excerpt": "from around February 2020 through March 2024" }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf", "locator": "ECF 3, p. 5, continued marketing after FDA warning", "excerpt": "Following the issuance of the FDA warning letter until March 20, 2024" }, { "url": "https://www.safemedicines.org/wp-content/uploads/2026/09/Stechkober-Paradigm-Peptide-Plea.pdf", "locator": "ECF 3, p. 6, admitted sales period", "excerpt": "From approximately April 2019 through March 2024" }, { "url": "https://www.justice.gov/usao-ndin/united-states-v-matthew-kawa", "locator": "Case Information and Final Court Hearings; updated August 3, 2026" } ] } }, { "id": "us-v-matthew-lewis-semaglutide", "case_name": "United States v. Matthew Lewis", "category": "criminal", "court_or_agency": "U.S. District Court, Eastern District of Kentucky", "docket_number": null, "jurisdiction": "United States federal", "record_scope": "single_proceeding", "brands": [ "Lewis Family Care" ], "parties": [ "Matthew Lewis" ], "filed_date": null, "status_date": "2025-04-15", "analysis": { "id": "us-v-matthew-lewis-semaglutide", "summary": { "text": "Matthew Lewis’s case concerns semaglutide supplied through a medical practice, rather than a research storefront selling an unspecified peptide catalog. DOJ says he pleaded guilty on April 14, 2025 to distributing misbranded semaglutide. From May 2023 through February 2024, he obtained the material from California and Georgia businesses that were not registered drug manufacturers or outsourcing facilities and were not licensed pharmacies. The vials bore research-only labels and lacked the directions, warnings and other labeling described in the release. Lewis admitted distributing the products to clinic patients without disclosing that these versions were unapproved, and disguising the purpose of purchases in payment records. The distinction is the status and handling of the actual supplied products; the case is not evidence that all semaglutide is unapproved. The release identifies FDA’s criminal-investigation office but gives no complaint, border interception or other initial discovery trigger. It scheduled sentencing for August 18, 2025. A scheduled hearing is not a verified sentencing outcome, and no actual judgment was established in the reviewed sources. Retatrutide is not identified. The next consequential document is the judgment or docket entry confirming disposition, sentence and any restitution or forfeiture.", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] }, "products": [ { "name": "semaglutide", "role": "reported_marketing_or_supply", "basis": "DOJ guilty-plea account states Lewis obtained and distributed research-labeled semaglutide to clinic patients; specific products were unapproved, not all semaglutide medicines.", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ], "normalized_names": [ "semaglutide" ] } ], "discovery": { "known": false, "text": "DOJ names FDA-OCI as investigating agency but does not disclose the initial trigger or a specific investigative purchase, inspection or test.", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] }, "challenged_conduct": [ { "text": "Obtaining research-labeled semaglutide from businesses without the listed drug-manufacturing, outsourcing or pharmacy status and distributing it to patients without disclosing the products’ unapproved status.", "attribution": "admission", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] }, { "text": "Misbranded labeling and payment descriptions intended to disguise the purchases.", "attribution": "admission", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] } ], "outcome": { "class": "guilty_plea", "text": "DOJ reported a guilty plea entered April 14, 2025. Sentencing was scheduled for August 18, 2025; the reviewed source does not verify that it occurred or establish its result.", "as_of": "2025-04-15", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] }, "timeline": [ { "date": "2023-05", "event": "Reported conduct began.", "kind": "conduct_start", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] }, { "date": "2024-02", "event": "Reported conduct period ended.", "kind": "other", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] }, { "date": "2025-04-14", "event": "Lewis pleaded guilty.", "kind": "plea", "date_basis": "event", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] }, { "date": "2025-04-15", "event": "DOJ announced plea and future sentencing setting.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] } ], "timing_pairs": [], "next_watch": { "text": "Find the actual sentencing judgment or docket history following the August 18, 2025 setting; do not describe that setting as a completed hearing.", "basis": "inference", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] }, "unknowns": [ "Actual sentence and later disposition unverified.", "Original investigative trigger and laboratory results unreported.", "No retatrutide involvement established.", "Only one exact substantive completed milestone is available, so no meaningful elapsed interval is calculated." ], "source_review": [ { "url": "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide", "review_basis": "archived_full_text", "locator": "DOJ plea release, April 15, 2025" } ] }, "compounds": [ "semaglutide" ], "marketing_or_supply_compounds": [ "semaglutide" ], "tested_compounds": [], "direct_compounds": [ "semaglutide" ], "latest_documented_date": "2025-04-15", "sources": [ { "url": "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide", "title": "Ashland Doctor Pleads Guilty to Distribution of Misbranded Semaglutide", "source_type": "official_agency", "document_type": "plea_announcement", "supports": "April 14, 2025 guilty plea announced April 15; clinic, compound, admitted conduct, and scheduled August 18 sentencing. Release reports clinic revenue $249,044.40 from this activity May 2023–February 2024." } ], "business_profile": { "id": "us-v-matthew-lewis-semaglutide", "display_name": "Lewis Family Care / Matthew Lewis", "identities": [ { "name": "Lewis Family Care", "kind": "trading_name", "basis": "DOJ names the practice and its weight-loss clinic; legal suffix not established.", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] }, { "name": "Matthew Lewis", "kind": "operator", "basis": "DOJ identifies him as physician and owner of Lewis Family Care.", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ] } ], "activity": { "summary": "DOJ says Lewis admitted obtaining unapproved semaglutide beginning in May 2023 and describes revenue from administration at the clinic between May 2023 and February 2024.", "kind": "documented_period", "start": "2023-05", "end": "2024-02", "sources": [ "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide" ], "limits": [ "This is the documented semaglutide activity, not the lifespan of the medical practice.", "No practice opening or closure date is established.", "Revenue period is used only for timing; it is not a fine or forfeiture." ] }, "source_review": [ { "url": "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide", "locator": "April 15, 2025 plea announcement, product-sourcing paragraph", "excerpt": "beginning in May 2023" }, { "url": "https://www.justice.gov/usao-edky/pr/ashland-doctor-pleads-guilty-distribution-misbranded-semaglutide", "locator": "Paragraph describing clinic administration/revenue", "excerpt": "Between May 2023 and February 2024" } ] } }, { "id": "us-v-ryan-fields-lisa-mahan-pinned-aminos", "case_name": "United States v. Ryan Fields and Lisa Mahan", "category": "criminal", "court_or_agency": "U.S. District Court, District of Connecticut", "docket_number": "3:23-cr-00144-VAB", "jurisdiction": "United States federal", "record_scope": "single_proceeding", "brands": [ "Pinned Aminos LLC", "Pinned Aminos", "Project Aminos" ], "parties": [ "Ryan Fields", "Lisa Mahan" ], "filed_date": "2023-08-08", "status_date": "2026-09-21", "analysis": { "id": "us-v-ryan-fields-lisa-mahan-pinned-aminos", "summary": { "text": "Pinned Aminos and Project Aminos were mixed-drug storefronts, not a retatrutide-specific prosecution. The FDA affidavit describes products labeled ivermectin intercepted at the border and an undercover purchase of products sold as thymosin alpha-1, albuterol and prostaglandin E1. It documents a CBP officer notifying the investigator about the interception on August 31, 2022; that is an early documented investigative lead, not proof that no inquiry existed earlier. Later evidence included website review, a purchase without a prescription, correspondence and statements about human use. An indictment followed on August 8, 2023. DOJ reported that trial evidence established false research-only representations, intended human use, unlawful imports and sales without prescriptions. On September 18, 2026, a jury convicted Ryan Fields of two conspiracies involving drug distribution and smuggling, and money laundering. Lisa Mahan had pleaded guilty on April 6 and received three years of probation on August 13. Fields had not been sentenced when DOJ announced the verdict. The record supports scrutiny of the transaction and intended use; it does not establish that every research-only label is unlawful or that every labeled substance was analytically confirmed.", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and", "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf", "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ] }, "products": [ { "name": "thymosin alpha-1", "role": "alleged_marketing_or_supply", "basis": "FDA affidavit describes an undercover purchase; no laboratory identity result is supplied in the reviewed passage.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ], "normalized_names": [ "thymosin alpha-1" ] }, { "name": "albuterol", "role": "alleged_marketing_or_supply", "basis": "Named in the same undercover purchase.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ], "normalized_names": [ "albuterol" ] }, { "name": "prostaglandin E1", "role": "alleged_marketing_or_supply", "basis": "Named in the same undercover purchase.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ], "normalized_names": [ "prostaglandin E1" ] }, { "name": "ivermectin", "role": "alleged_marketing_or_supply", "basis": "Intercepted shipment was labeled ivermectin; the label is not an independent identity test.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ], "normalized_names": [ "ivermectin" ] } ], "discovery": { "known": true, "text": "The affidavit records CBP notifying the FDA investigator on August 31, 2022 about a shipment addressed to Pinned Aminos. Website examination, undercover buying and correspondence followed. This is the earliest dated trigger described here, not a demonstrated start date for every agency inquiry.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ] }, "challenged_conduct": [ { "text": "Using false research-only descriptions while intending human consumption, supplying drugs without prescriptions, and unlawful importation formed part of the prosecution proved against Fields; Mahan separately pleaded guilty to conspiracy.", "attribution": "mixed", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ] }, { "text": "The affidavit alleged mislabeled imports and documented purchases and human-use representations. Those investigative allegations should not be treated as independent analytical confirmation of every product.", "attribution": "allegation", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ] } ], "outcome": { "class": "mixed", "text": "Fields: jury conviction on two conspiracy counts, with sentencing unscheduled in the September 21 release. Mahan: guilty plea and three years of probation. Jury also ordered forfeiture of a residence and vehicle associated with Fields.", "as_of": "2026-09-21", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ] }, "timeline": [ { "date": "2021-09", "event": "Reported start of storefront conduct.", "kind": "conduct_start", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ] }, { "date": "2022-08-31", "event": "CBP notified FDA investigator of intercepted shipment.", "kind": "investigation", "date_basis": "event", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ] }, { "date": "2022-12-05", "event": "Undercover order described in affidavit.", "kind": "investigation", "date_basis": "event", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf" ] }, { "date": "2023-08-08", "event": "Indictment filed.", "kind": "indictment", "date_basis": "filing", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf" ] }, { "date": "2023-08-23", "event": "Defendants arrested.", "kind": "other", "date_basis": "event", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ] }, { "date": "2026-04-06", "event": "Mahan pleaded guilty.", "kind": "plea", "date_basis": "event", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ] }, { "date": "2026-08-13", "event": "Mahan sentenced to three years of probation.", "kind": "sentence", "date_basis": "event", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ] }, { "date": "2026-09-18", "event": "Fields convicted by jury.", "kind": "verdict", "date_basis": "event", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ] } ], "timing_pairs": [ { "label": "Documented CBP notification to indictment filing", "start": "2022-08-31", "end": "2023-08-08", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf", "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf" ], "days": 342 }, { "label": "Indictment filing to Fields verdict", "start": "2023-08-08", "end": "2026-09-18", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf", "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ], "days": 1137 }, { "label": "Mahan plea to sentence", "start": "2026-04-06", "end": "2026-08-13", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ], "days": 129 } ], "next_watch": { "text": "Monitor the Fields sentencing judgment and any post-verdict motions; the public verdict release said sentencing was not yet scheduled.", "basis": "inference", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ] }, "unknowns": [ "No retatrutide offering or retatrutide-specific count was verified.", "Initial inquiry before the documented CBP notification is unknown.", "Fields final sentence and any subsequent appeal are not established by reviewed sources." ], "source_review": [ { "url": "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and", "review_basis": "archived_full_text", "locator": "DOJ verdict announcement, September 21, 2026" }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf", "review_basis": "court_pdf", "locator": "ECF 1 header and charging allegations" }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf", "review_basis": "court_pdf", "locator": "Affidavit paragraphs 69 and 77–81, approximately PDF pages 20–24" } ] }, "compounds": [ "albuterol", "ivermectin", "prostaglandin E1", "thymosin alpha-1" ], "marketing_or_supply_compounds": [ "albuterol", "ivermectin", "prostaglandin E1", "thymosin alpha-1" ], "tested_compounds": [], "direct_compounds": [ "albuterol", "ivermectin", "prostaglandin E1", "thymosin alpha-1" ], "latest_documented_date": "2026-09-18", "sources": [ { "url": "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and", "title": "Former Connecticut Resident Guilty of Operating Websites to Illegally Sell Misbranded and Unapproved Drugs", "source_type": "official_agency", "document_type": "verdict_announcement", "supports": "September 18, 2026 Fields guilty verdict, Mahan April plea and August probation sentence, research-use disclaimers contradicted by human-use advice; sentencing for Fields not scheduled as of release September 21." }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf", "title": "United States v. Fields and Mahan, Indictment, ECF 1", "source_type": "court_document", "document_type": "indictment", "supports": "Docket 3:23-cr-00144-VAB and August 8, 2023 filing verified in ECF headers; identifies Pinned Aminos/Project Aminos and undercover thymosin alpha 1 purchase." }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.ctd.153159/gov.uscourts.ctd.153159.1.1.pdf", "title": "In re Search Warrant Application, 3:23-mj-00123-MEG, FDA-OCI Affidavit", "source_type": "court_document", "document_type": "search_warrant_affidavit", "supports": "FDA-OCI allegations and investigative history concerning Pinned Aminos research-compound sales; filed February 16, 2023." } ], "business_profile": { "id": "us-v-ryan-fields-lisa-mahan-pinned-aminos", "display_name": "Pinned Aminos / Project Aminos / Ryan Fields and Lisa Mahan", "identities": [ { "name": "Pinned Aminos", "kind": "trading_name", "basis": "Indictment and DOJ name the storefront and associated social-media group.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf", "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ] }, { "name": "Pinned Aminos LLC", "kind": "legal_entity", "basis": "Information in indictment ¶3: Fields principal/sole member; Connecticut LLC formed on or about July 26, 2022. Formation is distinct from earlier trading activity.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf" ] }, { "name": "Project Aminos", "kind": "trading_name", "basis": "Indictment website heading and DOJ identify the second storefront operated by Fields and Mahan.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf", "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and" ] }, { "name": "pinnedaminos.com", "kind": "historical_domain", "basis": "Indictment ¶17(a): created around September 5, 2021, operational by November 24, 2021, stopped around February 14, 2023.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf" ] }, { "name": "projectaminos.com", "kind": "historical_domain", "basis": "Indictment ¶17(b): created around March 31, 2023, operational by April 7, 2023, stopped around June 29, 2023.", "sources": [ "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf" ] }, { "name": "Ryan Fields", "kind": "operator", "basis": "DOJ trial account identifies joint operation with Mahan; indictment identifies sole LLC membership.", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and", "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf" ] }, { "name": "Lisa Mahan", "kind": "operator", "basis": "DOJ trial account identifies joint operation; indictment describes customer communication and order processing, without identifying LLC ownership.", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and", "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf" ] } ], "activity": { "summary": "DOJ’s trial account describes the overall sales operation from September 2021 to June 2023. The indictment provides separate site milestones: pinnedaminos.com operational by November 24, 2021 and stopped around February 14, 2023; projectaminos.com operational by April 7, 2023 and stopped around June 29, 2023.", "kind": "documented_period", "start": "2021-09", "end": "2023-06", "sources": [ "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and", "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf" ], "limits": [ "The two websites were not both operating throughout the overall period.", "Detailed website milestones are allegations in ¶17 of the indictment; DOJ’s later trial account supplies the overall month-level operation period.", "A domain creation date is not a verified launch date.", "The LLC’s July 2022 formation is later than the documented activity and must not replace the business-history start.", "Website stoppage is not a corporate dissolution record." ] }, "source_review": [ { "url": "https://www.justice.gov/usao-ct/pr/former-connecticut-resident-guilty-operating-websites-illegally-sell-misbranded-and", "locator": "September 21, 2026 verdict announcement, second body paragraph", "excerpt": "from September 2021 to June 2023" }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf", "locator": "ECF 1, p. 1, ¶3", "excerpt": "formed on or about July 26, 2022." }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf", "locator": "ECF 1, pp. 4–5, ¶17(a)", "excerpt": "the website was operational by November 24, 2021." }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf", "locator": "ECF 1, p. 5, ¶17(a)", "excerpt": "The pinnedaminos.com website stopped operating on or about February 14, 2023." }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf", "locator": "ECF 1, p. 5, ¶17(b)", "excerpt": "the website was operational by April 7, 2023." }, { "url": "https://storage.courtlistener.com/recap/gov.uscourts.ctd.155532/gov.uscourts.ctd.155532.1.0.pdf", "locator": "ECF 1, p. 5, ¶17(b)", "excerpt": "The projectaminos.com website stopped operating on or about June 29, 2023." } ] } }, { "id": "us-v-skyler-garman", "case_name": "United States v. Skyler Garman", "category": "criminal", "court_or_agency": "U.S. District Court, Middle District of Pennsylvania", "docket_number": null, "jurisdiction": "United States federal", "record_scope": "single_proceeding", "brands": [ "Body Science Supplements", "Savior Research Sarms", "Savior Research Serms" ], "parties": [ "Skyler Garman" ], "filed_date": null, "status_date": "2026-09-30", "analysis": { "id": "us-v-skyler-garman", "summary": { "text": "Skyler Garman’s case concerns SARMs and SERMs sold through Body Science Supplements and Savior Research brands. The official account does not identify particular compounds actually sold. Names appearing in the release’s general discussion of drug classes should therefore not be converted into a verified catalog. DOJ says Garman admitted distributing misbranded drugs from 2019 to 2021, knowingly using false not-for-human-consumption labeling while providing human-use advice, and participating in financial transactions involving the proceeds. The same source describes two conspiracy offenses, one concerning drug distribution and one money laundering. On September 30, 2026 DOJ announced a sentence of one year of probation and $180,000 forfeiture. Its wording does not independently establish that the hearing occurred on the announcement day. The release identifies FDA-OCI but does not explain the initiating complaint, investigative purchase, seizure or test. It is therefore possible to describe the admitted conduct and reported punishment without inventing a detection history or an enforcement-speed interval. No retatrutide involvement is established. Meaningful follow-up would recover the judgment, exact hearing dates and any publicly identified related proceedings, while preserving that this broader research-chemical matter is not proof of a peptide-specific conviction.", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] }, "products": [ { "name": "SARMs, individual compounds unspecified", "role": "reported_marketing_or_supply", "basis": "DOJ identifies the class as sold through Body Science Supplements and associated brands, without listing specific sold compounds.", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ], "normalized_names": [ "unspecified SARMs" ] }, { "name": "SERMs, individual compounds unspecified", "role": "reported_marketing_or_supply", "basis": "DOJ identifies the class as sold. Examples in background paragraphs are not verified product attribution.", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ], "normalized_names": [ "unspecified SERMs" ] } ], "discovery": { "known": false, "text": "DOJ names FDA-OCI but does not provide an original trigger, investigation start, purchase method or analytical evidence.", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] }, "challenged_conduct": [ { "text": "Garman admitted interstate distribution of misbranded drugs, knowing research-only labels were false in the context of intended human use and customer advice.", "attribution": "admission", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] }, { "text": "The official sentencing account describes a separate money-laundering conspiracy involving proceeds from the business.", "attribution": "mixed", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] } ], "outcome": { "class": "conviction_or_sentence", "text": "DOJ announced one year of probation and $180,000 forfeiture for drug-distribution and money-laundering conspiracy offenses. Actual hearing day was not independently supplied.", "as_of": "2026-09-30", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] }, "timeline": [ { "date": "2019", "event": "Reported conduct period began.", "kind": "conduct_start", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] }, { "date": "2021", "event": "Reported conduct period ended.", "kind": "other", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] }, { "date": "2026-09-30", "event": "DOJ announced sentence of one year of probation and $180,000 forfeiture.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] } ], "timing_pairs": [], "next_watch": { "text": "Obtain the judgment and docket for actual plea/sentencing dates, precise counts and forfeiture terms; identify related defendants only when court records support a match.", "basis": "inference", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] }, "unknowns": [ "Specific compounds sold are not established by the release.", "No verified retatrutide or peptide-specific role.", "Original investigative trigger and exact hearing dates unknown.", "Approximate business opening and year-only conduct dates do not support a precise elapsed-time calculation." ], "source_review": [ { "url": "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money", "review_basis": "archived_full_text", "locator": "DOJ sentencing announcement, September 30, 2026" } ] }, "compounds": [ "unspecified SARMs", "unspecified SERMs" ], "marketing_or_supply_compounds": [ "unspecified SARMs", "unspecified SERMs" ], "tested_compounds": [], "direct_compounds": [ "unspecified SARMs", "unspecified SERMs" ], "latest_documented_date": "2026-09-30", "sources": [ { "url": "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money", "title": "Dauphin County Man Ordered To Forfeit $180,000 For Distributing Misbranded Drugs And Money Laundering", "source_type": "official_agency", "document_type": "press_release", "supports": "DOJ reports one year probation and $180,000 forfeiture for misbranded-drug and money-laundering conspiracies; the record describes dosing advice alongside not-for-human-consumption labels." } ], "business_profile": { "id": "us-v-skyler-garman", "display_name": "Body Science Supplements / Savior Research / Skyler Garman", "identities": [ { "name": "Body Science Supplements", "kind": "trading_name", "basis": "DOJ names the store Garman opened around March 30, 2019; legal entity suffix not supplied.", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] }, { "name": "Savior Research Sarms", "kind": "trading_name", "basis": "DOJ expressly identifies this as an associated product brand, not a separate proved company.", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] }, { "name": "Savior Research Serms", "kind": "trading_name", "basis": "DOJ expressly identifies this as an associated product brand, not a separate proved company.", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] }, { "name": "Skyler Garman", "kind": "operator", "basis": "DOJ identifies the store founder/operator and associates, but does not name the associates.", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ] } ], "activity": { "summary": "DOJ reports Garman opened Body Science Supplements around March 30, 2019 and admitted distributing misbranded drugs during 2019–2021 through the store and associated brands.", "kind": "documented_period", "start": "2019", "end": "2021", "sources": [ "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money" ], "limits": [ "The year-level range describes admitted distribution, while the separate opening observation is approximate March 30, 2019.", "2021 is not a verified store closure date.", "The associated product brands do not each have an independently established operating interval." ] }, "source_review": [ { "url": "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money", "locator": "September 30, 2026 sentencing announcement, second paragraph", "excerpt": "from 2019 to 2021" }, { "url": "https://www.justice.gov/usao-mdpa/pr/dauphin-county-man-ordered-forfeit-180000-distributing-misbranded-drugs-and-money", "locator": "Paragraph beginning Garman opened Body Science Supplements", "excerpt": "around March 30, 2019." } ] } }, { "id": "us-v-tyler-hall-rats-army", "case_name": "United States v. Tyler Jordan Hall", "category": "criminal", "court_or_agency": "U.S. District Court, District of Montana", "docket_number": null, "jurisdiction": "United States federal", "record_scope": "single_proceeding", "brands": [ "Rat’s Army" ], "parties": [ "Tyler Jordan Hall" ], "filed_date": null, "status_date": "2026-01-23", "analysis": { "id": "us-v-tyler-hall-rats-army", "summary": { "text": "Rat’s Army is relevant to research-chemical marketing but should not be labeled a peptide or retatrutide conviction. DOJ and FDA identify raloxifene, tamoxifen and pramipexole among the drugs sold. Hall’s operation imported ingredients, made and packaged products, and marketed them to bodybuilding and fitness customers. DOJ says Hall admitted introducing unapproved drugs into interstate commerce and describes false research-only representations despite intended human consumption, misleading certificates of analysis and false claims about legitimacy. FDA’s later administrative decision records manufacturing and import-related conduct as well. None of the reviewed sources establishes which tip, shipment or consumer complaint first prompted investigators to act. Hall pleaded guilty in January 2025; the exact plea day is not supplied by DOJ. On May 15, 2025 he received five years of probation. FDA then imposed a separate five-year drug-import debarment effective January 23, 2026. These are two different sanctions, not a five-year prison sentence. The case illustrates how marketing, actual intended use and representations about evidence can matter alongside the product’s identity. It supplies no tested-content result for individual vials, no verified retatrutide link and no basis to assume every research-chemical seller shares the same facts.", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] }, "products": [ { "name": "raloxifene", "role": "reported_marketing_or_supply", "basis": "Named among unapproved drug products sold in official conviction accounts.", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ], "normalized_names": [ "raloxifene" ] }, { "name": "tamoxifen", "role": "reported_marketing_or_supply", "basis": "Named among unapproved drug products sold; no product-level identity test supplied.", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ], "normalized_names": [ "tamoxifen" ] }, { "name": "pramipexole", "role": "reported_marketing_or_supply", "basis": "Named among unapproved drug products sold; not a peptide.", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ], "normalized_names": [ "pramipexole" ] } ], "discovery": { "known": false, "text": "Reviewed DOJ and FDA accounts identify the investigating agency and underlying conduct but not the original tip or trigger. No undercover purchase or laboratory result is established in these sources.", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] }, "challenged_conduct": [ { "text": "Introducing unapproved drugs in interstate commerce was the offense admitted; DOJ also describes false research-only labeling, intended human use and misleading certificates of analysis.", "attribution": "mixed", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs" ] }, { "text": "FDA’s debarment findings describe manufacturing, importation and misleading regulatory representations connected to the conviction.", "attribution": "agency_assessment", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] } ], "outcome": { "class": "mixed", "text": "Five years of probation imposed May 15, 2025. FDA separately imposed five years of debarment from importing or offering drugs for import, effective January 23, 2026.", "as_of": "2026-01-23", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] }, "timeline": [ { "date": "2020-06", "event": "Reported conduct began around June 17.", "kind": "conduct_start", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] }, { "date": "2022-03", "event": "Reported conduct ended around March 30.", "kind": "other", "date_basis": "reported_period", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] }, { "date": "2025-01", "event": "Hall pleaded guilty; exact day not supplied.", "kind": "plea", "date_basis": "reported_period", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs" ] }, { "date": "2025-05-15", "event": "Hall sentenced to five years of probation.", "kind": "sentence", "date_basis": "event", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] }, { "date": "2025-07-28", "event": "FDA sent proposed-debarment notice by certified mail.", "kind": "other", "date_basis": "event", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] }, { "date": "2026-01-23", "event": "Five-year drug-import debarment became effective.", "kind": "order", "date_basis": "event", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] } ], "timing_pairs": [ { "label": "Sentence to effective import debarment", "start": "2025-05-15", "end": "2026-01-23", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ], "days": 253 } ], "next_watch": { "text": "Monitor debarment-related orders and obtain the judgment if detailed probation conditions are needed; these sources do not establish subsequent compliance or violations.", "basis": "inference", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] }, "unknowns": [ "Initial discovery unknown.", "Individual-product analytical contents not established.", "No verified retatrutide or other peptide-specific role." ], "source_review": [ { "url": "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "review_basis": "archived_full_text", "locator": "DOJ sentencing release, May 15, 2025" }, { "url": "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf", "review_basis": "court_pdf", "locator": "Federal Register, January 23, 2026, final debarment order" } ] }, "compounds": [ "pramipexole", "raloxifene", "tamoxifen" ], "marketing_or_supply_compounds": [ "pramipexole", "raloxifene", "tamoxifen" ], "tested_compounds": [], "direct_compounds": [ "pramipexole", "raloxifene", "tamoxifen" ], "latest_documented_date": "2026-01-23", "sources": [ { "url": "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "title": "Tennessee man sentenced to 5 years of probation for selling unapproved drugs", "source_type": "official_agency", "document_type": "press_release", "supports": "DOJ reports five years probation after a January 2025 guilty plea. The release describes misleading certificates of analysis and research-chemical labeling used for drugs intended for human use." }, { "url": "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf", "title": "Tyler Jordan Hall: Final Debarment Order", "source_type": "official_agency", "document_type": "final_debarment_order", "supports": "FDA administrative docket FDA-2025-N-1331; five-year drug-import debarment effective 2026-01-23; original Federal Register PDF." } ], "business_profile": { "id": "us-v-tyler-hall-rats-army", "display_name": "Rat’s Army / Tyler Jordan Hall", "identities": [ { "name": "Rat’s Army, LLC", "kind": "legal_entity", "basis": "Name expressly given by DOJ and FDA.", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] }, { "name": "Rat’s Army", "kind": "trading_name", "basis": "Short form expressly used in both official accounts.", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] }, { "name": "Tyler Jordan Hall", "kind": "operator", "basis": "Official sources identify Hall as the business operator.", "sources": [ "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf" ] } ], "activity": { "summary": "FDA’s account of the information and plea describes Hall operating Rat’s Army from on or about June 17, 2020 through on or about March 30, 2022.", "kind": "documented_period", "start": "2020-06-17", "end": "2022-03-30", "sources": [ "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf", "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs" ], "limits": [ "Both endpoints are expressly approximate, despite day precision.", "This is the operation/conduct period underlying the conviction; corporate formation or dissolution is not established.", "No exact historical website domain is supplied by these reviewed records." ] }, "source_review": [ { "url": "https://www.govinfo.gov/content/pkg/FR-2026-01-23/pdf/2026-01296.pdf", "locator": "Federal Register p. 2941, Background", "excerpt": "from on or about June 17, 2020, through on or about March 30, 2022" }, { "url": "https://www.justice.gov/usao-mt/pr/tennessee-man-sentenced-5-years-probation-selling-unapproved-drugs", "locator": "May 15, 2025 sentencing announcement, paragraph beginning The government alleged" } ] } }, { "id": "au-victoria-pied-prosecutions-2026", "case_name": "Victorian PIED and injectable-peptide importation investigation — three charged", "category": "foreign_enforcement", "court_or_agency": "Australian Border Force; Therapeutic Goods Administration; Melbourne Magistrates Court", "docket_number": null, "jurisdiction": "Australia — Victoria", "record_scope": "related_proceedings_group", "brands": [], "parties": [], "filed_date": null, "status_date": "2026-08-13", "analysis": { "id": "au-victoria-pied-prosecutions-2026", "summary": { "text": "Australian authorities described a Victorian importation investigation involving steroids and injectable peptides. An August 2025 border interception of 640 vials triggered the investigation; later warrants and seizures led to charges against three people. Further charges in August 2026 belonged to the same investigation and must not be added as two new, independent defendants.", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ] }, "products": [ { "name": "unspecified injectable peptides", "role": "alleged_marketing_or_supply", "basis": "The releases describe alleged imports and seized product classes; individual peptide molecules are not named.", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ], "normalized_names": [ "unspecified injectable peptides" ] }, { "name": "unspecified anabolic steroids", "role": "alleged_marketing_or_supply", "basis": "The releases describe alleged imports and seized product classes; individual peptide molecules are not named.", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ], "normalized_names": [ "unspecified anabolic steroids" ] } ], "discovery": { "known": true, "text": "The agencies explicitly trace the investigation to an August 2025 air-cargo interception of 640 vials. This is a documented initiating event, unlike a later warrant simply described as evidence gathering.", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ] }, "challenged_conduct": [ { "text": "Authorities alleged prohibited Tier 1 imports; the later release also described alleged further offences while on bail. The reported charges are not convictions.", "attribution": "allegation", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ] } ], "outcome": { "class": "pending_or_unknown", "text": "Three people were initially charged; two people faced further charges in the later update. They were released on bail, with an October 26, 2026 court date reported in the August update. No verdict is established.", "as_of": "2026-08-13", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ] }, "timeline": [ { "date": "2025-08", "event": "Border interception of 640 vials initiated the investigation.", "kind": "investigation", "date_basis": "reported_period", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga" ] }, { "date": "2026-03-26", "event": "Authorities executed initial warrants and charged a man.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga" ] }, { "date": "2026-03-31", "event": "Further action led to charges against a man and a woman.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga" ] }, { "date": "2026-04-17", "event": "Agencies announced the initial investigation and charges.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga" ] }, { "date": "2026-08-06", "event": "Further warrants, charges and a court appearance occurred.", "kind": "investigation", "date_basis": "event", "sources": [ "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ] }, { "date": "2026-08-13", "event": "Authorities announced the additional charges.", "kind": "announcement", "date_basis": "announcement", "sources": [ "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ] } ], "timing_pairs": [], "next_watch": { "text": "Check the reported October 26, 2026 court appearance and subsequent court records for pleas, orders or verdicts.", "basis": "scheduled_event", "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ] }, "unknowns": [ "Individual peptide identities and final court outcomes are unknown. Age descriptions across releases should not be used alone to silently resolve defendant identities." ], "source_review": [ { "url": "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "review_basis": "official_web_full_text", "locator": "Agency account of interceptions, warrants, charges, bail and next court date" }, { "url": "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs", "review_basis": "official_web_full_text", "locator": "Agency account of interceptions, warrants, charges, bail and next court date" } ] }, "compounds": [ "unspecified anabolic steroids", "unspecified injectable peptides" ], "marketing_or_supply_compounds": [ "unspecified anabolic steroids", "unspecified injectable peptides" ], "tested_compounds": [], "direct_compounds": [ "unspecified anabolic steroids", "unspecified injectable peptides" ], "latest_documented_date": "2026-08-13", "sources": [ { "url": "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "title": "Three Victorians arrested following seizure of over $2 million worth of steroids and peptides by the ABF and TGA", "source_type": "official_agency", "document_type": "joint_enforcement_and_prosecution_announcement", "supports": "March raids, three charged persons and specific court appearances." }, { "url": "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs", "title": "Two Victorians charged with further offences related to alleged importation of illicit performance and image enhancing drugs", "source_type": "official_agency", "document_type": "joint_prosecution_update", "supports": "August additional charges and October 26 scheduled court date." } ], "business_profile": { "id": "au-victoria-pied-prosecutions-2026", "display_name": "Unnamed Victorian importation defendants (three people)", "identities": [], "activity": { "summary": "The agency records an August 2025 border interception and searches/charges in March and August 2026. It does not name a shop or the defendants, or specify a common operating period for their alleged importation/supply activities.", "kind": "mixed_entities", "start": null, "end": null, "sources": [ "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs" ], "limits": [ "Investigation dates are not trading start/end dates.", "Later charges belong to the same investigation and do not create new shop identities.", "Charges are allegations; no conviction is established." ] }, "source_review": [ { "url": "https://www.tga.gov.au/news/media-releases/three-victorians-arrested-following-seizure-over-2-million-worth-steroids-and-peptides-abf-and-tga", "locator": "April 17 and August 13 TGA releases: interception, warrants, unnamed defendants and further charges" }, { "url": "https://www.tga.gov.au/news/media-releases/two-victorians-charged-further-offences-related-alleged-importation-illicit-performance-and-image-enhancing-drugs", "locator": "April 17 and August 13 TGA releases: interception, warrants, unnamed defendants and further charges" } ] } } ], "identity_reviewed_at": "2026-10-11", "identity_method": "Sourced shop/trading names, legal entities, historical domains and named operators. Documented activity or conduct periods and dated observations are not necessarily continuous operating lifespans. Formation, ownership, inspection, filing and closure dates remain distinct. Missing dates are explicit; court filings may allege rather than establish a period. Historical domains are identifiers, not current contacts or endorsements." }