FDA WARNING_LETTER - Filler Lux dba Filler Lux USA - November 01, 2025

On November 3, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to Korea Filler Experts following a review of the company"s website. The agency found that the firm is illegally distributing unapproved and misbranded injectable drug products, specifically botulinum toxin type A marketed as "Nabota 100UI", to consumers in the United States. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, these products are classified as unapproved new drugs because they lack the necessary FDA authorization to ensure safety and effectiveness. The FDA also deemed the products misbranded because their labeling fails to include adequate directions for safe use by a layperson. Because injectable botulinum toxins are high-risk prescription medications that require professional medical supervision, they cannot be safely administered without a licensed practitioner"s oversight. The agency emphasized that unapproved injectables pose significant health risks, including potential contamination and life-threatening conditions such as sepsis or the dangerous spread of toxin effects. Korea Filler Experts is required to immediately cease the sale of these unauthorized products to U.S. consumers and must submit a written response to the FDA within 15 working days. This response must detail the specific steps taken to correct the violations and prevent their recurrence. Failure to comply may lead to legal action, including product seizures or injunctions.