Unapproved Drug Products Seized by US Marshals from Missouri Distributor as Part of FDA Action

Federal marshals seized more than 1,600 containers of products held by Notions-n-Things Distribution of Bogard, MO, that allegedly violate FDA approval and labeling requirements. Three products were seized from the distributor: “Chickweed Healing Salve, allegedly marketed as a skin cancer treatment containing comfrey; To-Mor-Gone, which allegedly claims to cure cancer and other diseases; and R.E.P., which allegedly claims to cure stress headaches and sinus infections, but contains no ingredient information on its label,” as detailed in an FDA news release.

FDA explains that the company’s “products claim to treat or cure diseases but have not received FDA approval, and are not exempt from such approval requirements.” In addition, the FDA complaint indicates that the seized products contain ingredients that could cause toxic or allergic reactions in consumers sensitive to these ingredients. Specifically, Chickweed Healing Salve contains comfrey, which may cause toxic reactions, and “To-More-Gone [sic] contains bloodroot, a caustic, corrosive substance that produces a thick scar that can mask tumor recurrence.” In addition, the seized products are “misbranded” under the Federal Food, Drug, and Cosmetic Act. Dara A. Corrigan, FDA associate commissioner for regulatory affairs, stated that “When a firm disregards these protections, it not only violates the law but also creates a risk for consumers, who may rely on a bogus product and forego effective and proven treatment. FDA must and will take aggressive enforcement action.”