FDA Targets Hims & Hers Over $49 Weight-Loss Pill, Raising Legal and Safety Concerns

The U.S. Food and Drug Administration (FDA) announced on Friday that it will take enforcement action against telehealth provider Hims & Hers over its $49 weight-loss pill, escalating scrutiny of compounded GLP-1 drugs sold as lower-cost alternatives to branded treatments. The move includes plans to restrict access to key GLP-1 ingredients and a referral of the company to the Department of Justice (DOJ) for potential violations of federal law, signaling a tougher stance on non-FDA-approved weight-loss medications.

The announcement sent shares of Hims & Hers down more than 14% in after-hours trading, highlighting investor concerns about the company’s weight-loss business. The FDA said it is particularly concerned about the quality, safety, and legality of compounded drugs that have not been approved or clinically tested, but are marketed to consumers as substitutes for authorized GLP-1 therapies such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.

Hims recently revealed plans to offer compounded versions of Novo Nordisk’s new Wegovy pill at an introductory price of $49 per month, significantly undercutting the branded product. Novo Nordisk responded by stating it would pursue legal action, while welcoming the FDA’s decision to crack down on what it described as unapproved “knockoff” drugs made with potentially unsafe or inauthentic ingredients. Eli Lilly also praised the FDA’s actions, arguing that unlawful mass production of compounded drugs puts patients at risk.

Compounded medications are legal in limited situations under U.S. law, such as when patients require customized doses or during drug shortages. However, Hims’ weight-loss pill is not FDA-approved and has not undergone clinical trials to demonstrate safety or effectiveness. Legal experts say potential enforcement options could include warning letters, injunctions, or product seizures, though the FDA would need DOJ support to pursue court action.

Hims defended its practices, stating it operates in compliance with applicable laws and is committed to patient safety. Meanwhile, FDA Commissioner Marty Makary emphasized that the agency will use all available tools to combat misleading advertising and unsubstantiated claims, reinforcing that compounded drugs cannot be marketed as generics or clinically proven alternatives to FDA-approved weight-loss medications.