Hims & Hers receives warning letter from FDA over weight loss claims

The FDA sent a warning letter to Hims & Hers CEO Andrew Dudum over the company’s weight loss claims. The letter says in part: “This letter is to advise you that the United States Food and Drug Administration reviewed your website content in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. Your claims concerning compounded semaglutide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act, resulting in products being introduced or delivered for introduction into interstate commerce. The following claims concerning your compounded semaglutide products appear on your website: ‘Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy’ and ‘Clinically proven ingredients.’ Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded… You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations.You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.” Hims & Hers was instructed to provide a written response to the Office of Compounding Quality and Compliance within 15 working days of receipt of the letter.