FDA WARNING_LETTER - Bodyhealth.com, LLC - October 31, 2014

The FDA and FTC issued a Warning Letter to BodyHealth.com in October 2014, following a review of their website and product, "BodyHealth Optimum Health Survival Kit," which includes "Complete + Detox," "MAP amino acids," "Body Detox," "Silver Biotics," "Lugol's Solution Iodine," "Vitamin C," "Vitamin D3," and "Vitamin A."

The FDA determined that the website promotes the product for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], due to therapeutic claims for the cure, mitigation, treatment, or prevention of disease, specifically Ebola. Examples of drug claims include banners and product descriptions linking the kit and its components to preventing or treating Ebola, found on their website, Facebook, and Twitter pages, and through metatag keywords like "ebola."

The product is deemed a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for the claimed uses. Introducing a new drug into interstate commerce without FDA approval violates section 505(a) and 301(d) of the Act [21 U.S