Natuzem – FDA Warning Letter, Oct 1, 2026

On October 26, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to the Mexican-based company Natuzem after a review of its website in September 2026 revealed several regulatory violations. The FDA determined that Natuzem is marketing unapproved new drugs, including "Testitón Extra Strong vials," "Reumofan Plus," and "Artrifan King." These products are being promoted with therapeutic claims to treat serious conditions such as arthritis, osteoporosis, and bone cancer, as well as to improve circulatory functions. Under the Federal Food, Drug, and Cosmetic Act, any product intended for use in the diagnosis, cure, or prevention of disease is classified as a drug and must undergo an FDA approval process to verify its safety and effectiveness before being sold. Furthermore, the agency raised alarms regarding "RMSOL Gracian," "Kuka Flex Forte," and "Reuma King." Previous laboratory tests of similar products found hidden, undeclared drug ingredients that could pose significant health risks to consumers. The FDA reminded Natuzem of its legal obligation to ensure all marketed products are safe and compliant with federal standards. Natuzem is required to respond in writing within fifteen business days, outlining the specific steps taken to correct these violations and the measures implemented to prevent their return. Continued non-compliance may result in legal action, such as the seizure of products or an injunction to stop sales.