FDA WARNING_LETTER - Estaderma - November 01, 2025

On November 3, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Estaderma, a company based in South Korea. This action followed a review of their website, www.estaderma.com, which was found to be introducing unapproved and misbranded injectable botulinum toxin drug products, such as "Liztox 100u" and "Liztox," into interstate commerce.The primary violations stem from the products being unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they lack FDA clearance for safety and effectiveness. Additionally, they are deemed misbranded as prescription drugs intended for conditions not amenable to self-treatment, thereby failing to provide adequate directions for use. The FDA highlighted significant health risks associated with unapproved injectable drugs, including contamination and potential life-threatening complications.Estaderma is required to promptly cease offering all unapproved and misbranded drugs for sale to U.S. consumers. The company must submit a written response to the FDA within 15 working days, detailing the specific corrective actions taken to address these violations and prevent their recurrence, along with supporting documentation. Non-compliance could lead to further regulatory enforcement.