FDA WARNING_LETTER - Cosmo Medical Spa dba Cosmo Med Spa - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to Cosmo Medical Spa, also known as Cosmo Med Spa, based in Markham, Ontario, Canada. This letter followed an August 2025 review of the company’s website, which revealed significant violations regarding the marketing of compounded drug products, specifically semaglutide. The primary issue identified is the misbranding of these products under the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA found that the company’s website used the brand name "Ozempic" to promote its compounded semaglutide injections. Because compounded drugs are not FDA-approved, the agency determined that using a protected brand name is false and misleading, as it incorrectly implies that the compounded product is identical to the approved brand-name drug. The introduction of these misbranded products into commerce is a violation of federal law. The FDA has directed Cosmo Med Spa to take immediate action to correct these violations, including removing the misleading language from its advertising. The company is required to provide a written response within 15 working days outlining the specific steps taken to address the issues and prevent their recurrence. The FDA warned that failure to comply could result in legal actions such as product seizures, injunctions, or the refusal of their products at the U.S. border.