FDA WARNING_LETTER - Dermax Co., Ltd - November 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Dermax Co., Ltd. on November 3, 2025, following a review of their website, www.dermaxshop.com. The FDA found the company is introducing unapproved new drugs and misbranded drugs, specifically injectable botulinum toxin products such as "Botulax 100U," into U.S. interstate commerce. These actions violate several sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The main issues include offering products that are unapproved new drugs, meaning they lack FDA authorization for safety and effectiveness, and are therefore prohibited from sale. Additionally, the products are considered misbranded because, as prescription-only drugs, they do not bear adequate directions for safe use by a layperson, which is a requirement for their intended use. The FDA emphasized the significant health risks to consumers who purchase these unregulated products, noting potential contamination, counterfeiting, and serious adverse health effects from injectables.

Dermax Co., Ltd. is required to immediately stop selling all unapproved and misbranded drugs to U.S. consumers. The company must submit a written response to the FDA within 15 working days, detailing the specific steps taken to rectify the violations and prevent their recurrence, along with supporting documentation. Non-compliance could result in further legal actions, including product seizure and injunction.