On May 23, 2012, the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter to the manufacturers of the widely popular RockStar energy products, Rockstar , Inc. (“the Company”). Found here, the Letter contains various allegations that the Company’s products are adulterated under the Federal Food, Drug and Cosmetic Act (“FFDCA”) and FDA regulations. In particular, the Company’s RockStar Roasted Coffee & Energy products, including Premium Blended Mocha Cream & Coffee, Premium Blended Latte Cream & Coffee, and Light Vanilla flavors, are allegedly adulterated under the FFDCA because of the ingredients used and the way they are marketed.
Pursuant to Section 402(a)(2)(C) of the FFDCA, a food will be deemed adulterated where it contains an unsafe food additive. Under the FFDCA and FDA regulations, a food additive will be considered unsafe and may not be used unless permitted by prior sanction or is generally recognized as safe (“GRAS”). Here, because the food additive at issue, Ginkgo biloba leaf extract (Ginkgo), is not authorized for use in food under a food additive regulation or a GRAS petition, the FDA has found that the use of this ingredient causes the RockStar coffee and energy products to be deemed adulterated.
In addition to the issues posed by the use of Ginkgo, the FDA cited the RockStar Company for marketing its products as conventional foods, as opposed to dietary supplements, as the products’ labeling suggest. In particular, the FDA noted that the FFDCA “excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet.” According to the FDA, despite using the phrase “energy supplement” and displaying Supplement Facts panels (as opposed to Nutrition Facts panels used in foods), the products are considered conventional foods inasmuch as coffee is considered a beverage, and beverages, in turn, are regulated as foods. Thus, according to the FDA, a product marketed as coffee is considered a conventional food.
Warning letters are typically the FDA’s first course of action against companies for alleged non-compliance with the Federal Food, Drug & Cosmetic Act (“FFDCA”) and/or FDA regulations. Under the terms of a warning letter, the FDA gives recipients fifteen (15) business days to respond in writing, detailing the specific steps taken to correct all violations of the FFDCA and accompanying regulations. Because appropriate corrective measures often preclude further enforcement, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance. For more information about establishing or maintaining compliance with the regulations or laws FDA enforces, please contact us at email@example.com.