FDA WARNING_LETTER - Hims & Hers Health, Inc. dba Hims - August 01, 2025

The FDA issued a Warning Letter to Hims & Hers Health, Inc. (dba Hims) on September 9, 2025, following a review of the company’s website conducted in August 2025. The agency’s investigation focused on the marketing of compounded semaglutide products. The main issue identified is the use of false or misleading claims that characterize these compounded drugs as being equivalent to FDA-approved medications. Specifically, the FDA cited marketing language such as "Same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients" as deceptive because compounded drugs are not FDA-approved and their safety and efficacy have not been established in the same manner as approved brand-name products. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FDCA), these claims constitute misbranding, making the sale of these products a violation of federal law. The FDA requires Hims & Hers Health to take immediate action to correct these violations, including ceasing the use of the misleading language. The company is required to submit a written response within 15 working days detailing the specific corrective measures taken and the steps implemented to prevent future occurrences. Failure to comply may result in further legal actions, such as product seizures or court-ordered injunctions.