Regulatory Scrutiny Intensifies for Telehealth Provider Hims & Hers

The U.S. Food and Drug Administration (FDA) has launched a significant regulatory action, placing telehealth company Hims & Hers under intense scrutiny. A formal warning letter issued by the agency on September 9th directly challenges the marketing practices for the company’s widely used weight loss supplements. This development raises critical questions about whether this is a temporary obstacle or the precursor to more substantial operational challenges.

At the heart of the regulatory action are allegations of “false and misleading” claims in the promotion of compounded semaglutid products. The FDA specifically cited improper comparisons with the approved prescription drugs Ozempic and Wegovy, alongside efficacy assertions that lack substantiation. According to the agency, these promotional tactics violate multiple sections of the... Read more...