Cosmo Medical Spa dba Cosmo Med Spa
FDA issued a warning letter to Cosmo Medical Spa dba Cosmo Med Spa, a Canadian-based telehealth/med spa operator, for selling compounded semaglutide products to U.S. consumers via its website while labeling them as 'Ozempic (semaglutide)' — falsely implying equivalence to an FDA-approved drug. The claims were found to constitute misbranding under FDCA sections 502(a) and 502(bb), and the interstate sale of these products violates section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure, injunction, or product detention at the U.S. border.
Flagged claims (2)
Ozempic (semaglutide) injection (10 weeks supply)
Ozempic (semaglutide) injection (4 weeks supply)
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.
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