The U.S. Food and Drug Administration sent a new batch of warning letters—30 in the latest round—targeting telehealth companies that marketed compounded versions of GLP‑1 obesity drugs and made claims comparable to approved products. FDA Commissioner Marty Makary signaled aggressive enforcement, saying compounders should not attempt to circumvent the agency’s approval process. The letters, stemming from website reviews, accuse firms of implying their compounded products are equivalent to branded semaglutide or tirzepatide therapies without FDA approval. Firms have 15 days to respond or face potential legal action. The enforcement activity follows high‑profile disputes, including Hims & Hers and Strive Pharmacy, and underlines regulatory risk for telehealth and compounding businesses selling copycat GLP‑1 formulations.
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