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DEPARTMENT OF THE TREASURY |
Industry CircularNumber: 2010-8Date: November 23, 2010 |
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Alcohol Beverages Containing Added CaffeineTo: Producers, Importers, Wholesalers, and Retailers of Alcohol Beverages, and Others Concerned: 1. What is the Purpose of this Circular? The Food and Drug Administration (FDA) has advised four companies that their alcohol beverages containing added caffeine are adulterated under the Federal Food, Drug, and Cosmetic Act (FFDCA). The purpose of this circular is to advise you that FDA's determination that a product is adulterated under the FFDCA would have consequences under the laws enforced by the Alcohol and Tobacco Tax and Trade Bureau (TTB). TTB enforces the labeling provisions of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e). Pursuant to these provisions, it is TTB's responsibility to issue regulations governing the labeling of distilled spirits, wines, and malt beverages. While TTB regulates the labeling of alcohol beverages, it is FDA's responsibility to evaluate the safety of ingredients added to alcohol beverages, pursuant to its authority under the FFDCA. It is TTB's position that adulterated distilled spirits, wines, and malt beverages are mislabeled within the meaning of the FAA Act. Subject to the jurisdictional requirements of the FAA Act, mislabeled distilled spirits, wines, and malt beverages, including adulterated products, may not be sold or shipped, delivered for sale or shipment, or otherwise introduced or received in interstate or foreign commerce, or removed from customs custody for consumption, by a producer, importer, or wholesaler, or other industry member subject to 27 U.S.C. 205(e), even if the bottler or importer of the product in question has obtained a certificate of label approval (COLA) or an approved formula. 2. What Actions Has FDA Taken with Regard to Malt Beverages Containing Added Caffeine? By letter dated November 17, 2010, FDA advised four industry members that it had reviewed the regulatory status of seven malt beverage products, each of which contains caffeine that has been directly added to an alcohol beverage and packaged in combined caffeine and alcohol form. The FDA letter warned the industry members that as it was used in their products, caffeine is an unsafe food additive, and therefore the products are adulterated under section 402(a)(2)(C) of the FFDCA, 21 U.S.C. 342(a)(2)(C). Among other things, the FDA letter stated that "FDA is not aware of any publicly available data to establish affirmatively safe conditions of use for caffeine added directly to alcoholic beverages and packaged in a combined form." FDA provided these industry members with fifteen (15) days to advise FDA of the specific steps the companies have taken to correct the violation identified above and to assure that similar violations do not occur. The FDA letter provided that their responses should include any documentation necessary to show that correction has been achieved. Finally, the FDA letter provided that if the industry members cannot complete all corrections within the 15 days, they should explain the reason for the delay and the date by which each such item will be corrected and documented. The warning letters, as well as other information on the issue of alcohol beverage products containing added caffeine, may be found on the FDA Web site at http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190366.htm. On November 18, 2010, TTB issued letters to those four industry members regarding the seven malt beverage products that FDA identified in its warning letters as being adulterated. The TTB letters put these companies on notice that FDA’s determination that a product is adulterated under the FFDCA would have consequences under the FAA Act, because of TTB's position that adulterated alcohol beverages are mislabeled within the meaning of the FAA Act. Consistent with the terms of the FDA warning letters, TTB asked that the companies advise TTB within the same 15-day period of the steps that they have taken to correct any violations of the FAA Act and the date by which each violation will be corrected. TTB sent copies of these letters to the brewers who have obtained COLAs from TTB for these products. 4. Will TTB Take Enforcement Action with Regard to the Alcohol Beverages that FDA Has Identified as Adulterated? Consistent with the actions taken by FDA, TTB is not planning to take enforcement action pending expiration of the 15-day period provided to the companies to respond to our letters. At that point, we will evaluate their responses and we will consult with FDA prior to taking enforcement action. It is our expectation that the companies will take voluntary action that will prevent violations of the FAA Act and, at the same time, will address the concerns expressed by FDA. 5. What are the Consequences under the FAA Act of a Determination that An Alcohol Beverage Product is Adulterated? As previously indicated, it is TTB's position that adulterated distilled spirits, wines, and malt beverages are mislabeled within the meaning of the FAA Act. Subject to the jurisdictional requirements of the FAA Act, mislabeled distilled spirits, wines, and malt beverages, including adulterated products, may not be sold or shipped, delivered for sale or shipment, or otherwise introduced or received in interstate or foreign commerce, or removed from customs custody for consumption, by a producer, importer, or wholesaler, or other industry member subject to 27 U.S.C. 205(e). TTB may pursue action to suspend or to revoke the FAA Act basic permit of industry members who willfully violate the conditions of their permit with respect to mislabeled, adulterated products. See 27 U.S.C. 204(e). Violations of the labeling provisions of the FAA Act are punishable as misdemeanors and the Government may seek injunctive relief to prevent and restrain such violations. TTB also may seek an offer in compromise covering the liability arising with respect to such violations in the sum of not more than $500 for each offense. See 27 U.S.C. 207. Under the Internal Revenue Code of 1986, TTB officers may, in appropriate circumstances, temporarily detain any alcohol beverage container that is being removed in violation of law, or seek a voluntary detention agreement with the industry member. See 26 U.S.C. 5311. 6. What if I Have Obtained a COLA or Formula Approval for My Alcohol Beverage Product? TTB reminds you that each producer and importer of alcohol beverages is responsible for ensuring that the ingredients in its products comply with the laws and regulations that FDA administers. TTB's approval of a COLA or formula does not imply or otherwise constitute a determination that the product complies with the FFDCA, including a determination as to whether the product is adulterated because it contains an unapproved food additive. Subject to the jurisdictional requirements of the FAA Act, mislabeled distilled spirits, wines, and malt beverages, including adulterated products, may not be sold or shipped, delivered for sale or shipment, or otherwise introduced or received in interstate or foreign commerce, or removed from customs custody for consumption, by a producer, importer, or wholesaler, or other industry member subject to 27 U.S.C. 205(e), even if the bottler or importer of the product in question has obtained a COLA or an approved formula. 7. Where Can I Find Current Information Regarding TTB's Position on Alcohol Beverages Containing Added Caffeine? TTB has published Frequently Asked Questions, along with other information on this topic, on the TTB Web site at http://www.ttb.gov/main_pages/caffeine-added.shtm. As new information is available, we will update this site. 8. Questions? If you have any questions concerning this circular, please contact the Advertising, Labeling and Formulation Division at 1-866-927-2533 (option 5) or at ALFD@ttb.gov.
John J. Manfreda |
