RockStar, Inc. DBA Livingston Chocolate Company – FDA Warning Letter, Jan 3, 2012

On January 3, 2012, an FDA inspection of Rockstar, Inc.'s manufacturing facility in Livingston, Tennessee, revealed that Rockstar Roasted Coffee & Energy products (Premium Blended Mocha Cream & Coffee, Premium Blended Latte Cream & Coffee, and Light Vanilla) are adulterated. These products contain Ginkgo biloba leaf extract (Ginkgo), which is an unapproved food additive under Section 409 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC § 348].

The FDA determined these products are conventional foods, not dietary supplements, despite "energy supplement" labeling and "Supplement Facts" panels, due to their coffee-based identity, "refreshing beverage" claims, and typical canned beverage packaging. Any substance added to conventional food must be approved as a food additive, be subject to a prior sanction, or be Generally Recognized As Safe (GRAS). Ginkgo is not approved as a food additive, nor is it subject to a prior sanction. The FDA is unaware of any basis for Ginkgo to be considered GRAS for use in conventional foods, citing a lack of scientific evidence and concerns from scientific literature, including National Toxicology Program studies showing carcinogenic activity in animals.

Therefore, the use of Ginkgo in Rockstar's coffee products renders them adulterated under Section 402(a)(2)(C) of the Act [21 USC § 342(a)(2