Hims & Hers Health Inc. (NYSE:HIMS) stock is trading lower on Tuesday. The U.S. Food and Drug Administration (FDA) issued a warning letter to Hims & Hers Health, dated Sept. 9, addressed to the company’s CEO, Andrew Dudum.
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The FDA flagged misleading claims made by Hims & Hers Health regarding its compounded semaglutide products. Semaglutide is an active ingredient in Novo Nordisk A/S’ (NYSE:NVO) flagship Wegovy and Ozempic.
In a warning letter, the FDA said the company's website promotes its semaglutide offerings with claims that imply equivalence to FDA-approved drugs, which the agency says is false and deceptive under federal law.
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According to the FDA, the website's statements, including "Same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients," suggest that the compounded products are as safe and effective as approved alternatives.
Compounded drugs are not subject to FDA approval, and these claims violate sections 502(a) and 502(bb) of the Federal Food, Drug and Cosmetic Act (FDCA), rendering them misbranded.
The agency further noted that introducing or distributing misbranded products across state lines is prohibited under section 301(a) of the FDCA.
The warning letter clarified that this action is not an exhaustive list of violations, but it puts Hims & Hers on notice that these practices could lead to further regulatory action if not corrected.
The FDA's letter also reminded the company that compounded products must not be marketed as substitutes for approved treatments. The agency stressed continued promotion of such misleading claims could result in enforcement actions, including product seizure and legal injunctions, without further warning.
Hims & Hers has been instructed to respond within 15 working days of receiving the letter. The company must outline the corrective steps it has taken, share supporting documents, and explain how it plans to prevent similar violations in the future.
The letter also invites the company to present any information or arguments that could clarify its position or demonstrate compliance with the FDCA.
HIMS Price Action: Hims & Hers Health stock is down 7.21% at $50.12 at publication on Tuesday.
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