On March 3, 2026, FDA announced it had issued 30 warning letters to telehealth companies marketing compounded GLP‑1 products whose promotion of compounded GLP‑1s, in FDA’s view, implies equivalence to FDA-approved products and/or branding that obscures the actual compounder. These letters build on earlier GLP‑1enforcement actions and public safety communications, signaling that the agency now views this area as an ongoing enforcement priority. Indeed, FDA already issued warning letters to companies compounding semaglutide and tirzepatide products in September of 2025 for misleading claims, and in his most recent statement, FDA Commissioner Marty Makary stated that the agency is “paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action.”
The latest batch of warning letters focuses on how these products are marketed and presented to consumers. Specifically, FDA objects to 1) online claims that present compounded GLP-1’s as effectively the same as the approved drug and 2) private label presentation that could mislead consumers about which entity is actually compounding the product. FDA did not address the fundamental question of whether these compounded GLP-1’s are “essentially a copy” of the commercially available drugs (which would render them ineligible for compounding under Section 503B of the Federal Food, Drug and Cosmetic Act).
Commissioner Makary made it clear in announcing this second wave of letters that “compounders should not try to circumvent the FDA’s approval process by mass-marketing compounded drugs.” At the same time, FDA is building a record of safety concerns around unapproved GLP‑1 products as it sharpens its messaging that these drugs sit outside the traditional approval and generic frameworks. Over the past two years, FDA has raised escalating concerns about dosing errors, questionable API sourcing, and serious adverse events tied to compounded semaglutide and tirzepatide. The agency has also taken issue with certain GLP‑1 ingredients, including salt forms of semaglutide and investigational agents like retatrutide and cagrilintide, making clear they cannot lawfully be used in compounding.
Takeaways: For pharmacies, outsourcing facilities, and virtual weight‑management providers, several practical priorities emerge:
- Review websites, social media, and advertising materials for statements implying “sameness,” “generic” status, or FDA approval
- Ensure labels and online materials accurately identify which party is actually compounding the product and avoid private‑label presentations that confuse the source of the drug
- Confirm that all GLP‑1 ingredients and dosage forms are legally compoundable (excluding prohibited GLP‑1‑related substances and salt forms) and that dosing practices are medically supportable and clearly communicated to patients
- Monitor evolving policy closely, recognizing that even if certain peptides are reclassified to permit compounding, GLP‑1 copy‑compounding used as a commercial workaround to the approval process is likely to remain an enforcement priority
- Telehealth companies should also ensure they perform due diligence with these compounding pharmacies, verifying that they are not mass producing these products. If they are producing injectables, they should have appropriate clean rooms and aseptic bottling procedures to prevent microcontamination.
- While not specifically addressed in this warning letter, Telehealth companies should also engage in proper due diligence when purchasing research use only peptides.
The Bigger Picture: In parallel, HHS Secretary Robert F. Kennedy Jr. recently mentioned that FDA is considering reclassifying approximately 14 previously restricted peptides in a way that would once again permit lawful compounding pursuant to a prescription, and he has framed this potential change as a way to move peptide use into more formal, regulated clinical channels and away from unregulated online sources.
Taken together, these developments suggest that FDA is distinguishing between expanding access to certain standalone peptides through established compounding pathways and tightening oversight of compounded “copycat” versions of approved GLP-1 drugs marketed as substitutes.
This remains a rapidly evolving area of FDA regulation and enforcement, and companies operating in the GLP-1 and peptide space should expect continued scrutiny. Contact Venable’s Food and Drug Law team with any questions.