Cosmenic – FDA Warning Letter, Nov 1, 2025

The FDA issued a Warning Letter to Cosmenic on November 3, 2025, after reviewing its website, www.cosmenic.net. The agency identified that Cosmenic is introducing unapproved new drugs and misbranded drugs, specifically injectable botulinum toxin products such as "NABOTA® (JEUVEAU®) 100u," into U.S. interstate commerce. These actions violate multiple sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA found the products to be unapproved new drugs because they lack the necessary FDA approval to ensure their safety and effectiveness for their labeled uses. Additionally, the products are deemed misbranded as their labeling fails to provide adequate directions for use by a layperson. As prescription-only injectable drugs, they present significant health risks if not administered under professional supervision, potentially leading to serious conditions like septicemia.

Cosmenic is mandated to immediately stop offering all unapproved and misbranded drugs for sale to U.S. consumers. The company must respond in writing within 15 working days, outlining the specific corrective actions taken to address these violations and prevent future occurrences. Cosmenic is also advised to review all its websites, product labels, and promotional materials for full compliance with the FD&C Act.