Online telehealth company Hims & Hers has reversed its recent launch of a low-cost, compounded semaglutide pill after the U.S. Food and Drug Administration signaled it would move against such products. The company said it will stop offering access to the compounded treatment following discussions with stakeholders across the industry.
The pill had been marketed as a $49-per-month alternative to Novo Nordisk’s branded Wegovy, and was pitched as a cheaper copy of the prescription weight-loss therapy. The FDA on Friday said it plans to restrict GLP-1 ingredients used in compounded drugs, citing concerns about product quality, patient safety and potential violations of federal law.
In parallel, the Department of Health and Human Services said it would refer matters to the Department of Justice, although officials did not clarify whether that referral would enable a swift removal of the Hims product from the market. Earlier this week, Hims had begun offering copies of the Wegovy pill at an introductory price that was roughly $100 lower than the brand-name therapy.
The immediate market reaction included a selloff in shares of Novo Nordisk and rival Eli Lilly, whose own oral GLP-1 is expected to reach the market in April. Some of those losses were later retraced after comments from regulators, while shares of Hims declined.
"No one should be mass-compounding or selling knockoff GLP-1 products regardless of how they’re administered," a spokesperson for Eli Lilly said in a statement after Hims & Hers announced it would discontinue the pill offering.
The practice of compounding - where pharmacies mix ingredients to create specialized medicines or to replicate a product at different dosages - has grown as patients seek lower-cost alternatives. Under the Federal Food, Drug, and Cosmetic Act, compounding remains legal in certain circumstances, but regulators have expressed concern about broader production and distribution that mimic approved products.
Both Novo Nordisk and Eli Lilly pushed back after the low-cost offering appeared on the market. Novo warned it would pursue legal action over the copies, and Lilly, which has faced compounded rivals to its injectable Zepbound, argued that patients deserve better than unproven copies with no clinical evidence backing them.
Hims’ compounded semaglutide product is not approved by the FDA and has not undergone clinical trials to demonstrate efficacy. Novo did not immediately reply to a request for comment, and Hims & Hers did not provide a response when asked whether it planned to continue selling compounded semaglutide injections on its website.
Complicating the commercial backdrop, Hims, Novo and Lilly are all spending heavily on advertising around a major sporting event this weekend, investing in promotion even as disputes over product copies and regulatory oversight intensify.
Industry dynamics have also been shifting: Novo has been losing market share in the weight-loss sector to Eli Lilly and to telehealth companies such as Hims. The two firms previously struck a partnership in 2025 that allowed Hims to sell injectable Wegovy, but that relationship unraveled amid accusations from Novo that Hims had promoted copycat products. Hims’ chief executive, Andrew Dudum, has accused Novo of seeking to control how clinicians affiliated with Hims make prescribing decisions.
FDA Commissioner Dr. Marty Makary reiterated the agency’s stance, saying it will "use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns." The Department of Health and Human Services, which oversees the FDA, was not immediately available for comment.
Regulatory letters, legal threats from major drugmakers and questions about the safety and efficacy of compounded alternatives have together created an uncertain environment for telehealth providers, compounding pharmacies and biotech firms competing in the fast-growing market for GLP-1 weight-loss therapies.