What have FDA warning letters said about compounded GLP-1s?

The Hims & Hers letter

FDA's warning letter to Hims & Hers Health, Inc. dba Hims is dated Sept. 9, 2025 and was posted Sept. 16, 2025. It concerns compounded semaglutide products. FDA objected to the claims “same active ingredient as Ozempic and Wegovy” and “clinically proven ingredients,” saying they falsely or misleadingly imply a compounded product equals an approved drug. It cites sections 502(a) and 502(bb) of the FD&C Act on misbranding, along with sections 301(a) and 301(c), and gave the firm 15 working days to respond.

FDA's letter says compounded drug products are not FDA-approved, and says the products are unapproved new drugs under section 201(p).

Later letters

Further letters followed in 2026. A Feb. 20, 2026 letter to a telehealth company cited “proven” claims, brand-name references, and the telehealth firm's name on the label implying it made the drug. A June 8, 2026 letter said a company falsely called products and compounding pharmacies “FDA approved.” FDA also announced warning letters to 30 telehealth companies on Mar. 3, 2026. We have linked those documents and have not verified each count or wording.

The supply background

FDA's page on compounding policy says tirzepatide was re-evaluated on Dec. 19, 2024 and semaglutide was declared resolved on Feb. 21, 2025. It gives dates until which 503A pharmacies (to Feb. 18, 2025 for tirzepatide and Apr. 22, 2025 for semaglutide) and 503B facilities (to Mar. 19 and May 22, 2025) could keep compounding copies. After those dates FDA says it may take action for other violations.

How these differ from the research-use-only letters

• Recipients are telehealth firms, not sellers labeled for research.
• The main theory is misleading marketing and implied equivalence to approved drugs, with misbranding sections cited.
• The research-use-only letters turn on intended use and cite sections 301(d) and 505(a).
• All of these are FDA's allegations in letters. They are not court findings.