Regulatory Pressure Mounts for Telehealth Provider Hims & Hers

Shares of telehealth company Hims & Hers Health came under significant selling pressure after the U.S. Food and Drug Administration (FDA) issued a formal warning letter targeting the company’s advertising practices. The September 9, 2025 communication accused the company of making “false or misleading” claims regarding its weight loss medications, directly challenging a core segment of its business operations.

The regulatory action focuses on how Hims & Hers has presented its semaglutide-based formulations. According to the FDA, the company’s website created a misleading impression by stating these products contain the “same active ingredient as Ozempic and Wegovy” and feature “clinically proven ingredients.” These assertions are particularly problematic because the compounded medications lack formal FDA approval for these uses.

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