Regulatory Tracker
FDA warning letters, enforcement actions, court rulings, and vendor status changes across the peptide and GLP-1 market — logged as they are published, each with a primary source. See also GLP-1 medications, the provider comparison, and what these actions mean for compounded semaglutide.
- Warning letters
- Enforcement actions
- Vendor status changes
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Two men charged over counterfeit Ozempic smuggled from China
Read more: Two men charged over counterfeit Ozempic smuggled from ChinaOn September 29, 2026, the U.S. Attorney’s Office for the Middle District of Florida and the Justice Department’s Criminal Division announced conspiracy and smuggling charges against Swapnadip Roy and Vicky Ramancha, both Indian nationals, with the FDA’s Office of Criminal Investigations assisting. The indictment alleges that between July 2023 and April 2024 they obtained counterfeit…
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FDA warns Online Generic Medicine over unapproved injectable semaglutide
Read more: FDA warns Online Generic Medicine over unapproved injectable semaglutideOn 23 September 2026 the FDA’s Center for Drug Evaluation and Research issued a warning letter to the operator of www.onlinegenericmedicine.com, an internet pharmacy, after reviewing the site on 26 August and 2 September. The agency said the site offered U.S. consumers an injectable semaglutide product sold as “Semanat Injection (Semaglutide)”, which has no FDA…
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FDA warns Empower Pharmacy over compounded semaglutide and tirzepatide
Read more: FDA warns Empower Pharmacy over compounded semaglutide and tirzepatideOn September 18, 2026, the FDA issued a warning letter to Empower Clinic Services, LLC, doing business as Empower Pharmacy, of Houston, Texas, following an inspection of its facility in November 2025. The agency said the pharmacy compounded tirzepatide/niacinamide and semaglutide/cyanocobalamin products that appear to be essentially copies of FDA-approved drugs — the legal line…
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FAA proposes to drop Special Issuance for pilots with non-insulin diabetes
Read more: FAA proposes to drop Special Issuance for pilots with non-insulin diabetesThe Federal Aviation Administration published a notice of proposed rulemaking on 4 September 2026 that would let pilots whose type 2 diabetes is controlled without insulin be certified by an aviation medical examiner at their examination, rather than through the FAA Authorization for Special Issuance process. The proposal would strike the phrase “or any other…
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FDA warns BioDrive over its “GLP-1 biomimetic” peptide supplement
Read more: FDA warns BioDrive over its “GLP-1 biomimetic” peptide supplementOn 24 August 2026 the US Food and Drug Administration issued a warning letter to BioDrive, Inc. over Evolv GLP-1 Biomimetic, a dietary supplement whose labeling declares “Saccharomyces cerevisiae S288C EV-1 Peptide” as a dietary ingredient. FDA classed that ingredient as a new dietary ingredient and found the product adulterated under section 402(f)(1)(B) of the…
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FDA warns five research-peptide sellers over GLP-1 products
Read more: FDA warns five research-peptide sellers over GLP-1 productsThe FDA’s Center for Drug Evaluation and Research issued warning letters dated 24 August 2026 to five online peptide sellers — TXP Innovations LLC dba Tex Peptides, Royal Peptides LLC, NuScience Peptides LLC, Peptide Partners LLC and Peak Performance Peptides — posted 1 September 2026. Each followed a July 2026 review of the firm’s website…
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Lilly files six lawsuits over black-market retatrutide sales
Read more: Lilly files six lawsuits over black-market retatrutide salesEli Lilly filed six lawsuits on 12 August 2026 against US entities selling black-market retatrutide, an investigational molecule in Phase 3 trials that no regulator has approved for human use. The defendants are Aesthetic Envy Cosmetic Centers, Astra Peptides, Legendary Peptides, Striker Pharmacy, Texas Peptides and Lone Star Peptide: compounding pharmacies, medical spas and online…
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Comment period on the 503B bulks list proposal extended to 30 July
Read more: Comment period on the 503B bulks list proposal extended to 30 JulyThe FDA extended the comment period on its 1 May proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list. Comments were originally due 30 June 2026; the deadline moved to 30 July 2026. Sources: Federal Register 2026-12937
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FDA warning letter to Wholesale Peptide over Prostamax and gonadorelin
Read more: FDA warning letter to Wholesale Peptide over Prostamax and gonadorelinOn 17 June 2026 the FDA’s Center for Drug Evaluation and Research issued a warning letter to Wholesale Peptide of Brooksville, Florida, after reviewing the firm’s website in May 2026. The letter names two products, “Prostamax” and “Gonadorelin”, as unapproved new drugs under section 505(a) of the FD&C Act, quoting site copy stating that Prostamax…
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Third wave of warning letters over compounded GLP-1 claims
Read more: Third wave of warning letters over compounded GLP-1 claimsThe FDA issued a further round of warning letters on 8 June 2026, including to Altru Telehealth, Medica Weight Loss and FITISH, continuing the enforcement line it opened in September 2025 and widened in March 2026. Sources: Altru Telehealth · Medica Weight Loss · FITISH