Hims & Hers Faces FDA Heat As Commissioner Martin Makary Calls Out Super Bowl Ad For Hiding Drug Risks

Mohd Haider

September 13, 2025

Food and Drug Administration Commissioner Martin Makary stated on Friday that Hims & Hers Health Inc. (NYSE:HIMS) broke federal law with its Super Bowl commercial promoting weight-loss drugs.

Check out the current price of HIMS stock here.

FDA Cites Federal Law Breach

The advertisement failed to adequately disclose the drugs' potential side effects, violating rules that require prescription medication ads to present a balanced view of benefits and risks, Reuters reported. Makary expressed this view in JAMA, a peer-reviewed medical journal of the American Medical Association.

Company Disputes Violation Claims

A Hims & Hers spokesperson defended the February advertisement, stating it “did not advertise any one treatment or solution” but aimed to raise awareness about the obesity crisis and access barriers to weight loss care.

See Also: Elon Musk’s $1 Trillion Pay Package Is ‘A Little Bit Weird’ To Compare Monetarily, Says Tesla Board Chair: It’s About ‘Voting Influence’

The Super Bowl ad showcased compounded versions of Novo Nordisk A/S‘s (NYSE:NVO) Wegovy during nationwide supply shortages.

Trump Orders Enforcement Crackdown

This violation comes after a memorandum from President Trump on Tuesday, which called for stricter enforcement of rules around direct-to-consumer pharmaceutical advertising. In response, the FDA revealed it plans to send out about 100 cease-and-desist orders and thousands of warning letters to pharmaceutical companies that have been running misleading ads.

Enforcement Historically Declined

Makary highlighted weak FDA enforcement, noting the agency issued hundreds of warning letters annually in the late 1990s compared to just one in 2023 and none in 2024.

According to the report, he referred to the Hims & Hers ad as “the most overt breach” of FDA advertising regulations.

Hims & Hers Health stock closed at $55.50, up by $3.74 on Friday- Benzinga Pro data.

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Photo Courtesy: Lori Butcher / Shutterstock.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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