Regulatory Pressure Mounts for Telehealth Firm Hims & Hers Following FDA Warning

The telehealth sector faces renewed scrutiny as Hims & Hers Health finds itself in the crosshairs of US regulators. A formal warning letter from the Food and Drug Administration (FDA), issued on September 9, has cast a shadow over the company’s advertising practices for its weight-loss medications, sending its shares lower and prompting market analysts to reassess their outlook.

At the heart of the regulatory action are assertions made by Hims & Hers regarding its compounded semaglutide products. The FDA’s letter charges the company with making “false and misleading” claims by suggesting these offerings contain “the same active ingredient as Ozempic and Wegovy” and utilize “clinically proven ingredients.”

The agency delivered an unambiguous message: compounded medications lack... Read more...