FDA WARNING_LETTER - COSMO KOREAN - November 01, 2025

The FDA issued a Warning Letter to COSMO KOREA on November 3, 2025, following a review of its website, www.cosmo-korea.com. The agency identified that the company is introducing unapproved and misbranded injectable botulinum toxin drug products, specifically "Nabota 200ui," into U.S. interstate commerce. These actions violate several sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including provisions for unapproved new drugs and misbranded drugs that lack adequate directions for use. The FDA emphasized the significant health risks to consumers from such products, which lack assurances of safety and effectiveness, may be contaminated, and can cause serious harm, particularly as injectables bypass natural body defenses. As "Nabota 200ui" is not recognized as safe and effective and lacks FDA approval, it is considered an unapproved new drug. Furthermore, as a prescription drug, it is misbranded because its labeling fails to provide adequate directions for safe use by a layperson, requiring professional supervision. COSMO KOREA is required to immediately cease selling all unapproved and misbranded drugs to U.S. consumers. The company must also review its websites, product labels, and promotional materials to ensure full compliance. A written response detailing specific corrective actions and preventative measures must be submitted to the FDA within 15 working days to avoid potential legal consequences like seizure or injunction.