Re-visiting Issue of Supplements vs. Beverages

In a FDA Warning Letter for RockStar, Inc., referencing their January 3, 2012 inspection of the facility, FDA warned Rockstar, Inc. that several of their Rockstar Roasted Coffee & Energy products contained “unsafe food additives.” Once again focusing attention on the question of Supplements vs. Beverages, FDA concluded that Rockstars’ Rockstar Roasted Coffee & Energy Premium Blended Mocha Cream & Coffee, Rockstar Roasted Coffee & Energy Premium Blended Latte Cream & Coffee and Rockstar Roasted Coffee & Energy Light Vanilla, are not dietary supplements, although they are labeled as such, but are instead beverages, which are conventional foods. Because conventional foods are subject to the regulations that govern food additives, the only permitted food additives are those that are “Generally Recognized as Safe” or GRAS, unless they are the subject of a prior sanction. FDA concluded that Ginkgo biloba leaf extract (“Ginkgo”) is not GRAS for use as a food additive and therefore the inclusion of Ginkgo causes the products to be adulterated. The most troubling aspect of this letter are the facts and circumstances FDA relied upon in concluding that these products are conventional foods and not dietary supplements, despite the products’ labeling and the use of Supplement Facts Panel. This Warning Letter should serve as notice to companies that are seeking to market or currently marketing “energy drinks.” Product claims and even packaging can create enough ambiguity to draw the ire of FDA. Consult with qualified legal counsel and be sure to have your packaging, labels and marketing materials reviewed before going to market.