FDA WARNING_LETTER - Hims & Hers Health, Inc. dba Hims - August 31, 2025

The FDA issued a Warning Letter to Hims, Inc., located at 2269 Chestnut St., San Francisco, CA, on September 9, 2025, following a review of their website in August 2025. The review identified that Hims offers compounded drug products, including semaglutide, with claims that are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). Specifically, the website claims that their compounded semaglutide products have the "same active ingredient as Ozempic and Wegovy" and contain "clinically proven ingredients," implying equivalence to FDA-approved products, which they are not.

These claims result in the products being misbranded, violating section 301(a) of the FDCA, which prohibits the introduction of misbranded drugs into interstate commerce. The FDA requires Hims to take immediate corrective actions, such as ceasing the use of misleading language. Hims must respond within 15 working days with a written plan detailing steps taken to address the violations and prevent recurrence. Failure to comply may lead to legal actions, including product seizure and injunctions.

The letter serves as a formal notification of the FDA"s concerns and offers Hims an opportunity to rectify the issues. Hims is responsible for ensuring compliance with all federal laws and FDA regulations. Correspondence regarding this matter should be directed to the FDA"s Office of Compounding Quality and Compliance.