\Telehealth company Hims & Hers quietly scrapped plans to sell a low-cost, compounded version of the weight-loss drug Wegovy after the U.S. Food and Drug Administration warned it would take decisive action against unapproved “copycat” drugs and refer the case for legal enforcement. The abrupt reversal came two days after the product’s launch and amid mounting pressure from both federal regulators and the drug’s manufacturer.
Hims & Hers initially announced it would offer a compounded semaglutide pill — the active ingredient in Wegovy — at an introductory price of $49 per month, far below the $149+ price tag of the FDA-approved version. The company positioned the product as a more affordable weight-loss option for consumers.
Regulators objected. The FDA said it would take “decisive steps” to curb companies mass-marketing unapproved treatments and protect consumers from drugs whose quality, safety, and efficacy cannot be verified. The Department of Health and Human Services also referred the case to the Department of Justice for potential violations of the Federal Food, Drug, and Cosmetic Act.
Hims & Hers responded by announcing it would stop offering the compounded semaglutide pill after “constructive conversations” with “stakeholders across the industry.” The company did not disclose whether it will pursue similar products in the future.
The FDA’s intervention reflects broader concerns over compounding pharmacies selling mass-produced drug alternatives without going through the agency’s rigorous approval process. Compounded drugs can be legal in limited situations — such as individualized prescriptions when drugs are in short supply — but regulators have warned that marketing these products as equivalents to FDA-approved therapies may mislead patients about their safety and effectiveness.
Novo Nordisk, maker of Wegovy, had threatened legal action against Hims & Hers, accusing the company of “illegal mass compounding” and emphasizing that its own approved version uses proprietary technology to ensure proper absorption of semaglutide. That dispute intensified scrutiny around Hims & Hers’ pill.
Financial markets reacted sharply to the back-and-forth. Hims & Hers’ stock lost value following the FDA’s statement and the product’s withdrawal, while shares of major pharmaceutical competitors rose as regulatory clarity supported the approved drug market.
The episode underscores growing federal enforcement against unapproved weight-loss drug copies and highlights ongoing tensions between regulators, telehealth startups, and established drugmakers over access, pricing, and patient safety.
