FDA WARNING_LETTER - Korean Aesthetic dba Korean Fillers - November 01, 2025

The FDA issued a Warning Letter to Korean Aesthetic dba Korean Fillers on November 3, 2025, after reviewing their website, www.koreanfillers.com. The company is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for introducing unapproved and misbranded injectable botulinum toxin drug products into interstate commerce. Specifically, products like "MEDITOXIN BOTULINUM TOXIN," "Cosmetics Medi 2," and "Meditoxin Botulinum Toxin 200U" are deemed unapproved new drugs because they lack necessary FDA approval for safety and effectiveness, posing inherent risks to consumers. These risks include potential contamination, inconsistent active ingredient levels, or serious life-threatening infections due to their injectable nature. Additionally, the products are misbranded as they are prescription drugs sold without adequate directions for layperson use and without the required supervision of a licensed practitioner. The FDA mandates that Korean Aesthetic immediately cease offering all unapproved and misbranded drugs for sale to U.S. consumers. The company must also review all websites, product labels, and promotional materials to ensure full compliance. A written response detailing specific corrective actions and prevention strategies is required within 15 working days.