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FDA Chief Slams Hims & Hers for Misleading Ad

9/14/2025

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Summary

Story summary

FDA Commissioner Marty Makary criticized Hims & Hers for misleading Super Bowl advertising of its obesity drug, omitting side effects.
He urged stricter regulations on pharmaceutical ads, particularly on social media, where promotional content often resembles user-generated media.
Makary pointed out a drop in FDA enforcement actions, from hundreds of warning letters in the late 1990s to just one in 2023.
The FDA plans to issue about 100 cease-and-desist notices to enforce direct-to-consumer advertising rules.
Hims & Hers defended its ad, stating it aimed to raise awareness about obesity, not promote a specific treatment.

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Story summary

FDA Commissioner Marty Makary criticized Hims & Hers for misleading Super Bowl advertising of its obesity drug, omitting side effects.
He urged stricter regulations on pharmaceutical ads, particularly on social media, where promotional content often resembles user-generated media.
Makary pointed out a drop in FDA enforcement actions, from hundreds of warning letters in the late 1990s to just one in 2023.
The FDA plans to issue about 100 cease-and-desist notices to enforce direct-to-consumer advertising rules.
Hims & Hers defended its ad, stating it aimed to raise awareness about obesity, not promote a specific treatment.