FDA WARNING_LETTER - Curex - August 01, 2025

In September 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Curex, based in Miami, Florida, following a review of the company"s website in August 2025. The FDA identified significant violations regarding the marketing of compounded drug products, specifically semaglutide and tirzepatide. According to the letter, Curex made false or misleading claims that these compounded drugs are the same as FDA-approved medications like Ozempic, Wegovy, and Mounjaro. The agency noted that since compounded drugs do not undergo the same rigorous approval process as brand-name medications, claiming they have "the same active ingredients" or "clinically proven success" is deceptive. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FDCA), these products are considered misbranded. The FDA stated that introducing such misbranded drugs into interstate commerce is a violation of federal law. To resolve these issues, Curex is required to take immediate action to remove any misleading language from its marketing materials and ensure all operations comply with FDA regulations. The company must investigate the root cause of these violations and implement measures to prevent their recurrence. Curex is required to provide a written response to the FDA within fifteen working days, detailing the specific steps taken to address the violations and including supporting documentation. Failure to comply with these requirements may result in legal action, including product seizures or injunctions.