FDA WARNING_LETTER - Vitality Distributing, Inc. - March 11, 2012

The FDA reviewed Vitality Distributing, Inc.'s website (www.myavitae.com) in March 2012 and found that their "avitae caffeinated water" product is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The website claims, such as caffeine reducing chances of cancer, Alzheimer's disease, Parkinson's disease, and heart disease, establish the product's intent for cure, mitigation, treatment, or prevention of disease.

Additionally, promotional material collected at the 2012 Natural Products Expo West trade show included similar claims, such as caffeine reducing heart disease risk, cutting brain cancer risk, and being protective against cognitive decline.

Because the product is not generally recognized as safe and effective for these conditions, it is considered a "new drug" under section 201(p) of the Act, requiring prior FDA approval. Furthermore, the product is misbranded under section 502(f)(1) of the Act because it is offered for conditions not amenable to self-diagnosis and treatment, meaning adequate directions for layperson use cannot be provided. The introduction of a misbranded drug into interstate commerce violates section 301(a) of the Act.

The FDA also noted similar claims on the company's Facebook and Twitter accounts, linking to an article promoting