FDA WARNING_LETTER - Revolt Distribution Inc. - July 29, 2011

On December 8, 2011, the FDA issued a Warning Letter to Revolt Distribution, Inc. following an inspection from July 14-29, 2011, of their Kennesaw, GA distribution center. The letter addresses violations concerning their "Wownie Relaxation Cookie" (also called "Wownie Relaxation Brownie") and "Slowtivate Relaxation Drink" products.

The FDA determined that both products are conventional foods, not dietary supplements, despite the "Slowtivate Relaxation Drink" being marketed as such with a "Supplement Facts" panel. This determination is based on product labeling (e.g., "drink," "cookie," "brownie"), packaging (single-serving can, cookie shape), and ingredients (sugar, flour, cocoa).

The primary violation is that both products are adulterated under section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(2)(C)] because they contain melatonin (5-methoxy-N-acetyltryptamine), an unapproved food additive under section 409 of the Act [21 U.S.C. 348]. Melatonin is a neurohormone and is not authorized for use in conventional foods by any food additive regulation, nor is it generally recognized as safe (GRAS) for such use. The