FDA WARNING_LETTER - Meamo - November 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Meamo on November 3, 2025, after reviewing its website, www.meamoshop.com. The FDA found that Meamo is illegally introducing unapproved and misbranded injectable botulinum toxin drug products, including "X4 Wondertox 100U Set" and "Wondertox," into U.S. interstate commerce. These products are considered unapproved new drugs under the Federal Food, Drug, and Cosmetic Act because they lack the required FDA approval for safety and effectiveness, posing inherent health risks to consumers. Additionally, the products are deemed misbranded as they are prescription-only drugs marketed without adequate directions for use by a layperson and without the necessary supervision of a licensed practitioner. The FDA highlighted the dangers of unapproved injectable drugs, which can be contaminated or contain varying active ingredients, potentially leading to serious conditions. Meamo is required to immediately 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 specific corrective actions taken to address the violations and prevent their recurrence. Failure to comply may result in further legal actions.