FDA WARNING_LETTER - Cosmo Medical Spa dba Cosmo Med Spa - August 31, 2025

The FDA issued a Warning Letter to Cosmo Med Spa, located at 1068-8321 Kennedy Rd, Markham, ON, Canada, on September 9, 2025, following a review of their website in August 2025. The FDA identified that Cosmo Med Spa"s website offers compounded drug products, including semaglutide, with claims that are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggest that the compounded products are equivalent to FDA-approved drugs, which they are not, resulting in the products being misbranded.

The regulatory framework cited includes sections 502(a), 502(bb), and 301(a) of the FDCA, which address false or misleading labeling and the introduction of misbranded drugs into interstate commerce. The FDA emphasized that the receipt and delivery of such misbranded drugs violate section 301(c) of the FDCA.

Cosmo Med Spa is required to take immediate corrective actions, including ceasing the use of misleading language on their website. They must provide a written response within 15 working days to the Office of Compounding Quality and Compliance, detailing the steps taken to rectify the violations and prevent recurrence. Failure to comply may lead to legal actions such as seizure or injunction. The FDA also warned that misbranded products might be detained or refused entry into the U.S., and foreign regulatory bodies may be notified. Correspondence should be directed to the FDA with a clear subject line indicating a response to the Warning Letter.