FDA WARNING_LETTER - Derma Solution - November 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Derma Solution on November 3, 2025, following a review of their website. The company is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for introducing unapproved new drugs and misbranded drugs into interstate commerce.

Specifically, Derma Solution is selling injectable botulinum toxin drug products, such as "Botulax 300 Units," without the required FDA approval. These products are marketed with claims for treating conditions like hyperhidrosis, blepharospasm, migraines, and excessive sweating. The FDA emphasizes that unapproved drugs lack assurances of safety and effectiveness, and injectables carry inherent risks such as contamination, varying active ingredient amounts, and potential for serious infections or adverse effects like septicemia.

Furthermore, these products are considered misbranded because they are prescription-only drugs intended for use under the supervision of a licensed practitioner, yet they are offered for sale without adequate directions for use by a layperson. FDA-approved botulinum toxin products bear strong "boxed warnings" due to risks like distant toxin spread, swallowing, and breathing difficulties.

Derma Solution is required to immediately cease offering all unapproved and misbranded drugs for sale to U.S. consumers. The company must provide a written response to the FDA within 15 working days, detailing specific corrective actions taken to address the violations and prevent their recurrence. This includes reviewing all website content, product labels, and promotional materials to ensure full compliance with the FD&C Act.