FDA WARNING_LETTER - Medica Weight Loss - March 01, 2026

On June 8, 2026, the FDA issued a warning letter to Medica Weight Loss following a March 2026 review of the company’s website. The agency identified several significant violations concerning the promotion of compounded drug products, specifically semaglutide and tirzepatide. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, the FDA determined these products are misbranded due to false and misleading claims. Primary issues included labels that suggested Medica Weight Loss was the manufacturer when they were not, as well as claims that the compounded drugs were FDA-approved. The FDA emphasized that compounded medications do not undergo the agency"s pre-market review for safety and effectiveness. Furthermore, the company incorrectly claimed to use an "FDA-approved pharmacy," a designation that does not exist under federal law. Medica Weight Loss is required to investigate the root causes of these violations and implement corrective actions. They must submit a written response to the FDA within 15 business days outlining the steps taken to address the misleading claims and identify the actual entities producing the drugs. Failure to correct these issues may result in legal actions such as product seizures or injunctions.