FDA WARNING_LETTER - AceCosm - November 01, 2025

The FDA issued a Warning Letter to AceCosm on November 3, 2025, following a review of their website, www.acecosm.com. The agency found that AceCosm is unlawfully introducing unapproved new drugs and misbranded drugs, specifically injectable botulinum toxin products such as "NABOTA 200U," into U.S. interstate commerce. These actions violate multiple sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including those related to the sale of unapproved new drugs (Sections 301(d) and 505(a)) and misbranded drugs (Sections 301(a) and 502(f)(1)). The FDA emphasized that these products lack the necessary assurances of safety and effectiveness required for U.S. market approval, posing significant health risks to consumers. Furthermore, as prescription-only injectable drugs, they are considered misbranded because they lack adequate directions for safe use by a layperson. AceCosm is required to immediately cease offering these unapproved and misbranded drugs for sale to U.S. consumers. The company must also review all its products, labels, and promotional materials to ensure full compliance with the FD&C Act. A detailed written response outlining specific corrective actions taken and preventive measures, along with supporting documentation, must be submitted to the FDA within 15 working days.