EvoLife Wellness
FDA issued a warning letter to EvoLife Wellness (Boca Raton, FL) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied FDA approval. The claims 'FDA-Approved' and 'Clinically Proven: Semaglutide is FDA-approved for chronic weight management…' were deemed false or misleading under FDCA sections 502(a) and 502(bb) because compounded drug products are not FDA-approved. FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (2)
FDA-Approved
Clinically Proven: Semaglutide is FDA-approved for chronic weight management….
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