Hims & Hers Health, Inc. dba Hims
FDA issued a warning letter to Hims & Hers Health, Inc. dba Hims (CEO Andrew Dudum) on September 9, 2025, after reviewing the hims.com website and finding that marketing claims for compounded semaglutide products were false or misleading under FDCA sections 502(a) and 502(bb). Specifically, the claims 'Same active ingredient as Ozempic and Wegovy' and 'Clinically proven ingredients' were found to falsely imply equivalence to FDA-approved products, which compounded drugs are not. FDA determined the products are misbranded and introduced into interstate commerce in violation of section 301(a), and warned that failure to correct violations may result in seizure or injunction.
Flagged claims (2)
Same active ingredient as Ozempic and Wegovy
Clinically proven ingredients
Required actions (3)
You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most glp-1 / weight loss sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker