Cosmo Medical Spa dba Cosmo Med Spa

Warning LetterOpen

CanadaIssued 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: Cosmo Medical Spa dba Cosmo Med Spa
Location: Canada
FEI Number: N/A
Country: Canada
Issue Date: September 09, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Cosmo Medical Spa was cited for unlawfully selling unapproved and misbranded compounded semaglutide drugs over the internet to U.S. consumers. The company's website falsely marketed compounded semaglutide products using FDA-approved drug names like "Ozempic," implying the compounded versions were equivalent to the approved medications, in violation of Federal Food, Drug, and Cosmetic Act sections 502(a) and 502(bb). This misrepresentation rendered the products misbranded and their introduction into interstate commerce a prohibited act under section 301(a) of the FDCA.

Cosmo Medical Spa dba Cosmo Med Spa FDA Warning Letter, September 9, 2025