On September 9, 2025, the FDA issued 50+ warning letters to GLP-1 compounders, telehealth providers, and manufacturers. This was the agency's most significant enforcement action since the semaglutide and tirzepatide shortages ended.
Most letters targeted companies making claims that compounded products are "the same as" or "generic versions of" FDA-approved drugs like Ozempic and Wegovy. Several also cited illegal sale of unapproved retatrutide.
What Happened
In what the FDA described as an effort to address "misleading advertisements," the agency sent warning letters to more than 50 companies on September 9, 2025. According to an analysis by Holland & Knight, the FDA also sent "thousands of letters warning pharmaceutical companies to remove misleading ads and approximately 100 cease-and-desist letters."
The Timeline
- December 19, 2024: FDA declares tirzepatide (Mounjaro/Zepbound) shortage over
- February 21, 2025: FDA declares semaglutide (Ozempic/Wegovy) shortage over
- 60-90 days later: Compounding pharmacies required to wind down operations
- September 9, 2025: FDA issues 50+ warning letters
What Triggered Enforcement
The FDA flagged two primary categories of violations:
1. False or Misleading Claims (Misbranding)
Under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act, companies received warnings for statements like:
"Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy"
"Doctors frequently recommend Compounded Tirzepatide or Compounded Semaglutide, both of which are GLP-1 agonists with the same active ingredient as the brand name medications."
"Clinically proven weight loss treatments"— Examples from FDA Warning Letters, September 2025
The FDA emphasized that compounded drugs are not FDA-approved and have not been evaluated for safety, effectiveness, or quality — making any claims suggesting equivalence to approved products misleading.
2. Unapproved New Drugs (Retatrutide)
Several companies received additional violations for selling retatrutide, a next-generation GLP-1/GIP/glucagon triple agonist still in clinical trials. Retatrutide has not been approved by the FDA for any use and cannot legally be compounded.
Sample Warning Letters
| Company | Violation Type | Full Text |
|---|---|---|
| GLP-1 Solution | Unapproved Misbranding | FDA.gov → |
| ASN-Labs | Unapproved Misbranding | FDA.gov → |
| MedClub by Dr. Jenn | Unapproved Misbranding | FDA.gov → |
| Amazing Meds | Unapproved Misbranding | FDA.gov → |
| JulyMD | Misbranding | FDA.gov → |
| Slendid | Misbranding | FDA.gov → |
Full database: FDA Warning Letters Database — search "semaglutide" or "tirzepatide" for complete list.
What This Means for Consumers
Compounded GLP-1s Are Still Legal — With Conditions
According to analysis from Spencer Fane, 503A pharmacies can still compound semaglutide and tirzepatide if they:
- Have valid patient-specific prescriptions
- Assert the "clinical need" exception for personalized versions
- Comply with state pharmacy board requirements
- Avoid making misleading marketing claims
What to Watch For
The FDA's action signals that providers who survive will be those with compliant marketing. When evaluating a compounding pharmacy or telehealth provider, avoid those claiming their products are:
- "The same as" Ozempic, Wegovy, Mounjaro, or Zepbound
- "Generic" versions of brand-name drugs
- "FDA-approved" (compounded drugs are never FDA-approved)
- "Clinically proven" (unless referring to the brand-name trials, not the compounded version)
Brand Manufacturers Got Letters Too
Notably, the FDA also sent warning letters to Novo Nordisk and Eli Lilly for separate advertising violations — demonstrating that the FDA's enforcement applies across the industry, not just to compounders.
The Sources
Primary Sources (FDA.gov)
- FDA Warning Letters Database — Searchable Archive
- FDA: Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
Legal Analysis
- Holland & Knight: FDA Taking Action Against Telehealth's Compounded Drug Advertising
- Spencer Fane: Beyond the Headlines — FDA Warning Letters to GLP-1 Compounders
- Wilson Sonsini: FDA Sends Warning Letters to More Than 50 GLP-1 Compounders
Medical Analysis
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Disclaimer: This article is for informational purposes only. It does not constitute legal advice. Compounded medications are NOT FDA-approved. Always verify provider credentials with your state pharmacy board.