Hims & Hers Health, Inc. dba Hers

Warning LetterOpen

United StatesIssued Sep 9, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateSep 9, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Hims & Hers Health, Inc. dba Hers
Location: United States
FEI Number: N/A
Country: United States
Issue Date: September 09, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Hims & Hers Health, Inc. was cited for unlawfully selling unapproved and misbranded compounded semaglutide drugs through its website, violating sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act. The company made false or misleading claims stating its compounded semaglutide products contained "the same active ingredient as Ozempic and Wegovy" and were "clinically proven," implying equivalence to FDA-approved products when compounded drugs are not FDA-approved. These misbranding violations resulted in the prohibited introduction and delivery of drugs into interstate commerce under section 301(a) of the FDCA.

Hims & Hers Health, Inc. dba Hers FDA Warning Letter, September 9, 2025