Regulatory, Scrutiny

Regulatory Scrutiny Intensifies for Hims & Hers Following Super Bowl Ad

13.09.2025 - 15:00:07

FDA Launches Unusually Sharp Rebuke

The telehealth provider Hims & Hers finds itself navigating turbulent regulatory waters. Its recent expansion into the multi-billion dollar testosterone therapy market has been immediately overshadowed by a significant confrontation with the U.S. Food and Drug Administration (FDA). The clash was triggered by a multi-million dollar Super Bowl advertisement for weight-loss medications that the agency has flagged for an “egregious” violation of marketing rules, raising questions about potential constraints on the company’s aggressive growth strategy.

In an unusually forceful public statement, FDA Commissioner Marty Makary took a definitive stance. He characterized the advertisement for the company’s GLP-1 copycat drugs as the “most obvious” rule violation he was aware of, citing a presentation that communicated only the benefits of... Read more...

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