Celmade – FDA Warning Letter, Sep 1, 2026

On September 14, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Celmade, a South Korean company, following reviews of its websites on August 4 and September 1, 2026. The agency found that the company was marketing and selling unapproved and misbranded injectable botulinum toxin products, such as "Wonder tox 100," to consumers in the United States. Under the Federal Food, Drug, and Cosmetic Act, these products are classified as new drugs that require FDA approval to ensure safety and effectiveness before they can be legally sold. The FDA highlighted significant health risks, noting that injectable drugs bypass the body"s natural defenses and can lead to life-threatening conditions like sepsis or the dangerous spread of toxins. Additionally, the products were deemed misbranded because they lacked adequate directions for safe use and are restricted to prescription use under the supervision of a licensed medical professional. To resolve these violations, the FDA has directed Celmade to immediately stop offering these unapproved drugs to U.S. customers and to perform a thorough investigation into the causes of these breaches. The company must provide a written response to the FDA within 15 business days, detailing the specific corrective and preventive measures implemented to ensure ongoing compliance with federal law.