The FDA's Peptide Crackdown: A Complete Timeline
From Category 2 designations to criminal convictions — how federal enforcement reshaped the peptide market in 18 months.
Why This Matters
If you use peptides — or are considering them — the regulatory ground has shifted dramatically since September 2023. The FDA has moved from a largely hands-off posture toward aggressive enforcement, including criminal prosecutions, millions in forfeitures, and 50+ warning letters in a single month. Understanding this timeline isn’t academic — it affects what you can legally obtain, from whom, and at what risk.
The FDA has escalated from categorization to criminal prosecution in under two years. The “research chemical” loophole is not a legal defense — the FDA’s Intended Use Doctrine examines actual marketing, not label disclaimers. At least one compounding pharmacy owner has been convicted and sentenced.
The Timeline
September 2023: The Category 2 Bombshell
The FDA’s Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B placed 17 popular peptides into Category 2 — meaning they are prohibited for compounding by outsourcing facilities and pharmacies. The affected substances included:
BPC-157, TB-500 (Thymosin Beta-4 fragment), Thymosin Alpha-1, CJC-1295 (with and without DAC), Ipamorelin, AOD-9604, Melanotan II, LL-37, MOTS-c, KPV, Selank, Semax, DSIP, Epitalon, PEG-MGF, and others.
Category 1 substances (allowed for compounding) included: Sermorelin, GHK-Cu (topical only), VIP (Vasoactive Intestinal Peptide), and NAD+.
This single action eliminated the legal pathway for compounding pharmacies to produce the most popular peptides. The market responded immediately — grey-market vendors saw increased demand, while compounding pharmacies scrambled to pivot to Category 1 substances.
October 2020 (Background): The Tailor Made Conviction
While predating the Category 2 designations, the Tailor Made Compounding case set the criminal precedent. TMC pleaded guilty to one felony count of distributing unapproved new drugs including BPC-157, CJC-1295, Ipamorelin, and LGD-4033. The company forfeited $1,788,906.82. Owner Jeremy Delk received 3 years probation, 4 months home incarceration, a $20,000 fine, and was barred from prescription drug distribution.
Critically, Delk had attempted to hide records from FDA inspectors during a 2018 inspection — conduct that escalated the federal response. TMC subsequently issued a sterility recall in 2022, and connections to a horse racing doping ring emerged.
2014–2019 (Background): All American Peptide
The All American Peptide case established that the “for research purposes only” label is not a legal shield. The company’s owners forfeited over $3 million in proceeds. The FDA explicitly stated that labeling products “for research purposes only” is “a ruse to avoid scrutiny” and that the Intended Use Doctrine examines actual marketing — website language, customer communications, product positioning — not just the label disclaimer.
December 2024: PCAC Votes Against More Peptides
The Pharmacy Compounding Advisory Committee (PCAC) voted against allowing compounding of Ipamorelin, MK-677, CJC-1295, and AOD-9604 — effectively confirming these substances cannot be legally compounded. This closed the door on industry hopes that some Category 2 substances might be reclassified.
January 2025: Category System Restructured
The FDA eliminated the Category 2 and 3 designations, replacing them with a simplified framework. However, the substances that were prohibited under Category 2 remain prohibited — the restructuring was administrative, not a relaxation of restrictions.
February 2025: Semaglutide Shortage Resolved
The FDA declared the semaglutide shortage officially resolved, triggering significant consequences for compounding pharmacies that had been producing compounded semaglutide under the shortage exception. With the shortage over, the legal basis for compounding semaglutide evaporated — setting the stage for aggressive enforcement.
September 2025: The Warning Letter Blitz
In a single month, the FDA issued 50+ warning letters to compounders and sellers of GLP-1 receptor agonists (primarily compounded semaglutide and tirzepatide). This represented the most aggressive enforcement wave in the compounding space in recent memory.
The letters targeted pharmacies, telehealth platforms, and medspa operations that continued producing or prescribing compounded semaglutide after the shortage resolution. The Department of Justice was confirmed to be involved, suggesting criminal referrals were being considered.
November 2025: State-Level Enforcement Accelerates
Alabama obtained a Temporary Restraining Order against GLP-1 distributors — the first state-level injunctive relief targeting peptide/GLP-1 sales.
Ohio led aggressive state enforcement with summary license suspensions for practitioners found possessing BPC-157 and AOD-9604 for clinical use.
Connecticut Attorney General issued formal notice to medspas offering peptide therapies, warning of enforcement consequences.
40+ state Attorneys General sent a joint letter to the FDA requesting stronger enforcement against unapproved peptide sellers.
Ongoing: Import Alert 66-80
The FDA established Import Alert 66-80, creating a framework for automatic detention of peptide imports without physical examination. This particularly affects Chinese peptide suppliers — imports of Chinese peptides to the US doubled to $328 million in the first three quarters of 2025.
International Enforcement Context
The US enforcement trend mirrors global patterns:
Australia (TGA): The most aggressive international enforcement. Peptide Clinics received a $10 million penalty. Evolution Supplements was fined $12 million. Peptides are controlled under Schedule 4 with Appendix D restrictions. Australia demonstrates what escalated enforcement looks like.
United Kingdom (MHRA): Raided an illicit GLP-1 production facility in 2025, seizing approximately 2,000 counterfeit semaglutide pens. Active investigation into online peptide marketplaces.
European Union (EMA): Peptides require full clinical trial authorization and cannot be sold as dietary supplements. The EU framework is the strictest among major markets.
The “Research Chemical” Defense Is Dead
If you’re buying peptides labeled “for research purposes only,” understand that this label provides no legal protection. The FDA’s Intended Use Doctrine, confirmed through multiple enforcement actions and court cases, examines:
- How the product is actually marketed (website copy, social media)
- What customers communicate about intended use
- Whether the seller knows or reasonably should know the product will be used for human consumption
- The overall context of the transaction
A “not for human consumption” label on a product sold through channels that clearly target human users, with dosing guidance, mixing instructions, and user testimonials, does not create a legal shield. The All American Peptide forfeiture proved this conclusively.
What This Means for Consumers
If you currently use compounded peptides: The legal landscape has shifted against your supplier. Compounding pharmacies that produced BPC-157, TB-500, CJC-1295, or other Category 2 substances can no longer legally do so. Any pharmacy still offering these is operating outside regulatory bounds.
If you use research chemical vendors: You are purchasing products with no regulatory oversight, no guaranteed quality, and no legal protection. The “research” label doesn’t protect you or the vendor.
If you use oral peptide supplements: The FDA has not yet pursued enforcement against oral BPC-157 or PDA supplement sellers at scale, but legal experts consistently note these products lack legal dietary supplement status under DSHEA.
If you use prescribed semaglutide alternatives: The September 2025 warning letters signal that the compounded GLP-1 market is the FDA’s top enforcement priority. Expect continued escalation.
What We’re Watching
PeptideExaminer monitors regulatory developments continuously. Key areas we’re tracking:
- Whether DOJ involvement in the GLP-1 space leads to criminal charges similar to Tailor Made Compounding
- Whether FDA enforcement expands from compounding pharmacies to oral supplement sellers
- The MAHA (Make America Healthy Again) political initiative’s potential impact on FDA enforcement priorities
- State-level enforcement patterns following the Ohio/Alabama/Connecticut precedents
- Australian TGA enforcement as a leading indicator of where US policy may head
This timeline is compiled from FDA.gov enforcement databases, Federal Register notices, DOJ press releases, state pharmacy board records, PCAC meeting minutes, and independent journalism from STAT News, Reuters Health, and Bloomberg Law. All dates and figures are verified against primary federal sources.
This timeline is updated as new enforcement actions occur. Last reviewed: February 20, 2026.