Overview

• The FDA publicly posted more than 100 warning letters dated Sept. 9 to drugmakers and online prescribers over allegedly misleading promotions of weight‑loss medicines.
• Hims & Hers was cited for website language implying its compounded semaglutide is equivalent to FDA‑approved products like Wegovy and Ozempic, which regulators note it is not.
• Compounded drugs are not reviewed or approved by the FDA, and the agency warned that misbranding violations could prompt product seizure or court injunctions.
• The Hims letter requires a response within 15 working days detailing corrective actions and plans to prevent future violations.
• FDA letters also faulted Novo Nordisk and Eli Lilly over materials including a televised special and promotional videos that regulators say mislead on GLP‑1 drug risks, while Hims shares fell about 5%–7% after the postings.