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

The FDA issued a Warning Letter to Mr. Dudum of ForHers, located at 2269 Chestnut St., San Francisco, CA, following a review of the company"s website in August 2025. The review identified misleading claims about compounded drug products, specifically semaglutide, which were marketed with statements such as "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients." These claims suggest equivalence to FDA-approved products, which is misleading as compounded drugs are not FDA-approved. This constitutes misbranding under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), violating section 301(a) by introducing misbranded products into interstate commerce.

The FDA requires ForHers to take immediate corrective actions, including ceasing the use of misleading language. The company must submit a written response within 15 working days to the Office of Compounding Quality and Compliance, detailing steps taken to rectify the violations and prevent future occurrences. Failure to comply may result in legal actions, such as product seizure or injunction. The letter serves as a formal notification of the issues, allowing ForHers an opportunity to address the FDA"s concerns. Correspondence should be directed to compoundinginspections@fda.hhs.gov.