The FDA's War on Peptides: A Complete 2024-2026 Enforcement Timeline
From Category 2 designations to ITC exclusion orders — how federal enforcement reshaped the peptide market.
The Landscape Shift
The period from late 2024 through early 2026 represents the most aggressive regulatory enforcement campaign the peptide market has ever seen. What was once a loosely regulated grey market operating in the gaps between FDA oversight and consumer demand has become the target of coordinated federal action involving the FDA, ITC, DOJ, and major pharmaceutical companies.
This article is your comprehensive timeline of what happened, who was affected, and what it means going forward.
Timeline of Major Enforcement Actions
2024
March 2024
- Eli Lilly files complaint with the US International Trade Commission (ITC Investigation No. 337-TA-1386) against multiple vendors selling imported tirzepatide products
- Named respondents include Strate Labs, Arctic Peptides, Triggered Brand, Swiss Chems, Paradigm Peptides, GenX Peptides, Audrey Beauty, Mew Mews, SHS, AustroPeptide, Biolabshop, Total Compounding
May 2024
- Strate Labs, Arctic Peptides, Audrey Beauty, Biolabshop, Mew Mews, SHS, Triggered Brand, and AustroPeptide found in default by ITC for failure to respond to complaint
September 2024
- FDA issues wave of warning letters to online peptide vendors
- Targeted vendors selling semaglutide, tirzepatide, and other GLP-1 products
- Focus on evidence that “research only” labeling contradicts actual marketing to consumers
November 2024
- BPC-157 added to FDA “do not compound” list: FDA determines BPC-157 lacks sufficient safety and efficacy data for compounding use
- This effectively bans compounding pharmacies from producing BPC-157 formulations
- Affects both 503A (traditional) and 503B (outsourcing facility) compounders
December 2024
- ITC Order No. 26: Administrative Law Judge grants summary determination of violation against multiple respondents in the tirzepatide case
- Cease and desist orders recommended against Strate Labs, Arctic Peptides, and Triggered Brand
- FDA Warning Letters — December 10, 2024: Letters issued to Prime Peptides (Prime Vitality, Inc.), Xcel Peptides, SwissChems, and Summit Research for selling semaglutide, tirzepatide, and/or retatrutide as unapproved drugs
- Lilly confirmed Strate Labs was importing tirzepatide manufactured by Semathin Ltd (Ontario, Canada) and reselling from Spring, Texas
2025
January 2025
- ITC issues final determination in Investigation No. 337-TA-1386
- General Exclusion Order (GEO) issued: Prohibits ALL importation of products containing or purporting to contain tirzepatide that infringe Lilly’s trademark — applies to ALL importers, not just named respondents
- Limited Exclusion Orders against SHS, AustroPeptide, and Arctic Peptides for false advertising
- Cease and Desist Orders against Arctic Peptides, Triggered Brand, and Strate Labs
February 2025
- FDA declares semaglutide is no longer in shortage
- This removes the legal basis for compounding pharmacies to produce semaglutide
- Compounding pharmacies given limited wind-down period
- Grey-market semaglutide now has no legal pathway whatsoever
April 2025
- Federal Register publishes final ITC orders (FR Vol. 90, No. 71)
- Enforcement mechanisms activated for GEO and CDOs
- US Customs and Border Protection begins implementation
Throughout 2025
- Multiple smaller vendors shut down or pivot away from GLP-1 products
- Compounding pharmacy lawsuits challenging FDA shortage determination
- Continued price pressure on branded semaglutide and tirzepatide
2026 (Current Year)
January-February 2026
- GEO enforcement continues at ports of entry
- Vendor landscape consolidation: some vendors exit market entirely
- Surviving vendors increasingly focus on non-GLP-1 peptides
- Premium pricing for remaining GLP-1 sources reflects enforcement risk
Key Regulatory Mechanisms Explained
FDA Warning Letters
The FDA’s primary enforcement tool for online vendors. Warning letters:
- Identify specific violations (unapproved drugs, misbranding, false claims)
- Give the company 15 working days to respond with corrective action plan
- Failure to respond can trigger seizure, injunction, or criminal prosecution
- Published publicly on FDA website — permanent public record
ITC General Exclusion Order
The nuclear option for import enforcement:
- Applies to ALL importers, not just named parties
- US Customs actively screens incoming shipments
- Violation carries civil penalties up to $100,000/day
- Does not require customs to identify specific violators in advance
ITC Cease and Desist Orders
Targeted at specific domestic companies:
- Prohibits the respondent from engaging in the specified activity
- Violation penalties: up to $100,000/day or twice the domestic value of violating goods
- Enforced by US Customs and the ITC
FDA Compounding Restrictions
- 503A pharmacies: Traditional compounding pharmacies. Can compound drugs on the FDA shortage list or those nominated to the FDA’s Bulks List
- 503B outsourcing facilities: Can compound drugs in bulk without individual prescriptions. Subject to more FDA oversight
- When FDA removes a drug from shortage list, compounding authority ends
- BPC-157’s addition to the “do not compound” list is a separate mechanism: FDA determined it doesn’t meet safety standards for compounding regardless of shortage status
Who’s Been Affected
Vendors with Federal Enforcement Actions
| Vendor | Action | Date | Status |
|---|---|---|---|
| Strate Labs | ITC Cease & Desist Order | Jan 2025 | Active CDO |
| Arctic Peptides | ITC CDO + LEO | Jan 2025 | Active |
| Triggered Brand | ITC CDO | Jan 2025 | Active |
| Prime Peptides | FDA Warning Letter | Dec 2024 | Pending response |
| SwissChems | FDA Warning Letter | Dec 2024 | Pending response |
| Xcel Peptides | FDA Warning Letter | Dec 2024 | Pending response |
| Summit Research | FDA Warning Letter | Dec 2024 | Pending response |
| SHS | ITC LEO | Jan 2025 | Active |
| AustroPeptide | ITC LEO | Jan 2025 | Active |
| Tailor Made Compounding | Federal indictment (2023) | Ongoing | Criminal prosecution |
Vendors Investigated but Not Penalized
- Paradigm Peptides (insufficient evidence of proper service in ITC case)
- GenX Peptides (found in default separately)
- Total Compounding (allegations withdrawn by Lilly)
- Biolabshop (allegations withdrawn by Lilly)
What This Means for Consumers
GLP-1 Peptides (Semaglutide, Tirzepatide, Retatrutide)
- Grey-market GLP-1 peptides now carry the highest legal and quality risk in the market
- No legal compounding pathway for semaglutide since February 2025
- Tirzepatide never had a legal compounding pathway
- Vendors still selling these products are operating in direct defiance of federal enforcement
- Recommendation: Work with a licensed physician for FDA-approved branded products
Non-GLP-1 Peptides (BPC-157, TB-500, Ipamorelin, etc.)
- BPC-157 cannot be legally compounded (November 2024 ban)
- Grey-market research chemical sales of non-GLP-1 peptides continue in a legal grey area
- FDA enforcement focus has been primarily on GLP-1 products
- Quality verification remains essential — use our vendor report cards
What to Watch Next
- Potential expansion of FDA’s “do not compound” list to additional peptides
- Novo Nordisk litigation (parallel to Lilly’s ITC strategy)
- State-level enforcement actions
- Compounding pharmacy legal challenges to FDA shortage determinations
- Congressional attention to grey-market peptide sales
PeptideExaminer tracks all federal enforcement actions against peptide vendors. Bookmark this page for updates.