Overview

• The FDA publicly posted roughly 100 letters dated Sept. 9 that use cease‑and‑desist language and, for the first time, directly police telehealth platforms’ drug promotion.
• A letter to Hims & Hers says its compounded semaglutide claims imply equivalence to FDA‑approved Ozempic and Wegovy, with regulators reiterating that compounded drugs are not FDA‑approved.
• Hims said it looks forward to engaging with the agency and noted its materials state compounded treatments are not evaluated or approved by the FDA.
• Eli Lilly and Novo Nordisk also received warnings over content including a 2024 Oprah Winfrey special and online videos that the FDA says gave a misleading impression of safety for GLP‑1 drugs.
• Recipients have 15 working days to propose corrective actions, with the FDA warning that continued violations could trigger product seizures or injunctions as HHS and FDA pursue broader DTC ad rule changes.