Industry members should contact FDA with all inquiries as to the GRAS* status of ingredients added to alcohol beverages. TTB will continue to coordinate with FDA on this matter.
* generally recognized as safe
Industry members should contact FDA with all inquiries as to the GRAS* status of ingredients added to alcohol beverages. TTB will continue to coordinate with FDA on this matter.
* generally recognized as safe
No. Among other things, the FAA Act's prohibitions against consignment sales apply only to the conditions agreed to at the time of a sale. Furthermore, these prohibitions do not apply to transactions involving solely the bona fide return of merchandise for ordinary and usual commercial reasons arising after the merchandise has been sold. See 27 U.S.C. 205(d). The regulations at 27 CFR Part 11, Subpart D set forth several examples of "ordinary and usual commercial reasons" that may arise after the product has been sold, including a situation in which products may no longer be lawfully sold. See 27 CFR 11.34. The actions of a retailer or wholesaler in returning to an industry member alcohol beverages containing added caffeine, after the sale of the product, for cash or credit against outstanding indebtedness, due to concerns about the legal status of such products under Federal, State, or local law, would not violate the consignment sales provisions of 27 U.S.C. 205(d). Of course, the regulations do not mandate that the industry member accept such a return. See 27 CFR 11.31(b).
TTB is reviewing all approved formulas and labels for such products and will consult with FDA prior to taking action with regard to approved labels or formulas. We encourage all industry members who have received approvals from TTB and who have reason to believe that their products may not be in compliance with the FFDCA, to voluntarily surrender their approved labels and formulas to TTB.
TTB urges all industry members to carefully consider their responsibilities to comply with the requirements of the FFDCA and to consult with FDA regarding the GRAS* status of their intended use of caffeine prior to submitting any such applications to TTB. TTB will consult with FDA before taking action with regard to any such new applications.
Yes. TTB will continue to coordinate with FDA on this matter that affects issues within the jurisdiction of both agencies. TTB has already shared information with FDA regarding approved labels for alcohol beverages containing added caffeine, and we will continue to do so, as needed. In addition, upon receipt of a formal request from FDA, we will provide information to FDA about formulas for beers containing added caffeine that are approved under 27 CFR Part 25. This disclosure will be made pursuant to our authority under 26 U.S.C. 6103(o)(1) to share return information with employees of a Federal agency whose official duties require such disclosure. Such a disclosure is contingent upon an agreement by FDA to safeguard the confidentiality of this information.
While TTB regulates the labeling of alcohol beverages pursuant to the FAA Act, it is FDA's responsibility to evaluate the safety of ingredients added to alcohol beverages, pursuant to FDA's authority under the FFDCA. TTB operates under a 1987 Memorandum of Understanding (MOU) with FDA that clarifies and delineates the enforcement responsibilities of each agency with respect to alcohol beverages that may be adulterated under the FFDCA and establishes procedures for coordination between the two agencies. The MOU acknowledges that TTB is the agency with a system of specific statutory and regulatory controls over alcohol beverages and that FDA has authority regarding determinations regarding the safety of food additives used in the production of alcohol beverages and over making determinations about when an alcohol beverage is considered adulterated.
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.
It is TTB's position that adulterated malt beverages, distilled spirits, and wines are mislabeled within the meaning of the FAA Act. This means, as explained further below, that the sale or shipment of an adulterated alcohol beverage in interstate or foreign commerce by an industry member subject to the provisions of 27 U.S.C. 205(e) constitutes a violation of the FAA Act, even if the bottler or importer of the product in question has obtained a certificate of label approval (COLA) or an approved formula.
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.
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 any violations of the FAA Act and will at the same time address the concerns expressed by FDA.
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 certificates of label approval from TTB for these products. The TTB letters, along with other TTB guidance on the issue of alcohol beverage products containing added caffeine, may be found on the TTB web site at http://www.ttb.gov/main_pages/caffeine-added.
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 Federal Food, Drug, and Cosmetic Act (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 them of the specific steps they 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.