Hims & Hers announced on February 5 that it is pulling its weight‑loss medication after the U.S. Food and Drug Administration opened a formal investigation into the drug’s safety data and marketing claims. The FDA sent a warning letter on January 15, citing missing clinical trial results and alleged off‑label promotion. Simultaneously, Novo Nordisk filed a patent infringement lawsuit claiming the product copies elements of its Wegovy formulation.

The telehealth firm had launched the drug in late 2023, targeting the booming obesity market that generated $77.8 billion in 2027. However, the combined regulatory and legal pressure prompted Hims & Hers to cease sales and refund existing prescriptions, affecting roughly 2,000 patients who had received the treatment.

Industry analysts say the episode illustrates the heightened scrutiny on fast‑track weight‑loss therapies and the risks for newcomers lacking extensive trial data. The company will refocus on its core telehealth services while the FDA continues its review of similar products.

Fact: The FDA issued 12 warning letters in 2023 to companies marketing unapproved weight‑loss drugs.