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FDA Warns Hims Over Ads About Compounded Weight-Loss Drugs

The FDA's warnings target false marketing claims by Hims & Hers, while AstraZeneca halts a $270 million UK research investment due to a challenging business environment, Reuters reports.

  • On Tuesday, the FDA issued more than 100 warning letters to various companies, including the telehealth provider Hims & Hers, addressing misleading marketing claims.
  • The letters followed President Donald Trump's recent memo targeting direct-to-consumer drug ads and addressed telehealth companies promoting unapproved compounded weight-loss drugs.
  • The FDA warned Hims & Hers that its website falsely implied its compounded products matched FDA-approved drugs like Wegovy and Ozempic, despite compounding only being permitted during drug shortages.
  • Shares of Hims & Hers dropped over 6.47% on Tuesday amid the regulatory action and the FDA's use of 'cease and desist' language emphasized in the letters.
  • This FDA crackdown signals increased regulatory scrutiny on telemedicine firms' marketing and may affect the growth of inexpensive compounded weight-loss drug sales.
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29 Articles

The Billings GazetteThe Billings Gazette
+4 Reposted by 4 other sources
Center

FDA targets Hims & Hers, unofficial medications

WASHINGTON — For the first time, federal health officials took aim at telehealth companies promoting unofficial versions of prescription drugs, part of the Trump administration’s crackdown on pharmaceutical advertising.

·Billings, United States
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STAT broke the news in Boston, United States on Monday, September 15, 2025.
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