Shares of Hims & Hers Health Inc. (NYSE:HIMS) fell 8% Tuesday following a warning letter from the U.S. Food and Drug Administration concerning the company’s marketing claims related to its compounded semaglutide products.
The FDA criticized the telehealth firm for making “false or misleading” statements on its website regarding compounded semaglutide offerings. Specific claims flagged included “Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy” and “Clinically proven ingredients.”
In the warning letter dated September 9, the FDA stressed that compounded drug products are not FDA-approved, noting that Hims & Hers’ statements implied equivalence with FDA-approved medications, which is inaccurate. According to the agency, these representations violate sections of the Federal Food, Drug, and Cosmetic Act.
The FDA has provided the company with 15 working days to submit a response outlining corrective actions. Failure to adequately resolve the issues could trigger legal measures, including seizure and injunction.
Semaglutide is the key ingredient in popular weight management and diabetes drugs Ozempic and Wegovy, produced by Novo Nordisk (NYSE:NVO). With demand for these medications rising, some telehealth companies have offered compounded versions as alternatives.
This warning underscores the regulatory scrutiny facing telehealth providers marketing compounded GLP-1 products amid the booming weight management sector.
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