Voluntary Alcohol Beverage Recalls
To: Producers, Importers, Wholesalers, and Retailers of Alcohol Beverage Products, and Others Concerned
(1) What is the purpose of this circular?
The purpose of this circular is to provide the alcohol beverage industry with guidance and an explanation of the Alcohol and Tobacco Tax and Trade Bureau (TTB) policy on the voluntary recall of certain mislabeled or adulterated alcohol beverages (wines, malt beverages, and distilled spirits) from the marketplace. A recall is a voluntary action taken by an industry member who removes from the marketplace an alcohol beverage that TTB considers to be in violation of TTB regulations or which, after consultation with the Food and Drug Administration (FDA), TTB considers to be mislabeled because it is in violation of FDA administered laws or regulations regarding permitted substances and/or tolerances of ingredients in alcohol beverages. The recalling industry member will then destroy the product; re-label it, if appropriate, with corrected, approved labels before placing it back into interstate commerce; or take other appropriate corrective action.
This circular updates and supersedes Industry Circular 2010-6, dated September 10, 2010.
(2) What products are subject to this circular?
The guidance in this circular applies to wine, malt beverages, or distilled spirits as defined in the Federal Alcohol Administration Act (FAA Act) that are mislabeled or adulterated. Low alcohol wines (containing less than 7 percent alcohol by volume) and non-malt or non-hops beers are not included in the definitions of wine, malt beverages or distilled spirits under the FAA Act and therefore recall of such products is not addressed in this circular. These products are subject to FDA's recall policies under title 21, Code of Federal Regulations (CFR) part 7.
Under the FAA Act, if you introduce alcohol beverages into interstate or foreign commerce or remove them from customs custody, you have an obligation to ensure that your products are labeled truthfully and in a manner that is not misleading, as required by title 27, United States Code (U.S.C.) section 205(e) and 27 CFR parts 4, 5 and 7, and that they are otherwise labeled in accordance with these provisions. Also, you have an obligation to ensure that these beverages are not adulterated, as defined in Section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 342, and FDA's implementing regulations.
(3) What is TTB's policy concerning alcohol beverage recalls?
TTB does not have statutory authority to require an industry member to recall an adulterated or mislabeled alcohol beverage. However, in determining the appropriate sanction, TTB may consider in any case whether an industry member might choose to voluntarily detain or recall an adulterated or mislabeled product. Under the Internal Revenue Code of 1986 (IRC) TTB officers may detain any container that will be removed in violation of law (26 U.S.C. 5311). In addition, it is TTB's position that alcohol beverages found by FDA to be adulterated under the FD&C Act are considered mislabeled within the meaning of the FAA Act. Under the FAA Act mislabeled alcohol 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 by a producer, importer, wholesaler, or others 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). TTB also may seek an injunction or criminal prosecution by the Attorney General in the name of the United States, and any person convicted of a misdemeanor under section 203 or 205 of Title 27 can be fined up to $1,000 per offense. TTB may enter into 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. In addition, FDA may take enforcement action (including seizure) where an alcohol beverage is in violation of FDA's statutory and regulatory authorities.
(4) How does TTB interact with other Federal agencies in handling alcohol beverage recalls?
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 FD&C Act and establishes procedures for coordination between the two agencies. Under the terms of this MOU, TTB has primary responsibility for seeking and monitoring voluntary recalls of alcohol beverages that are adulterated under the FD&C Act and mislabeled under the FAA Act by reason of being adulterated.
The MOU with FDA also provides that when TTB learns or is advised that an alcohol beverage is or may be adulterated, TTB consults with FDA before proposing any voluntary recall action. Under the MOU, FDA will provide TTB with a written health hazard evaluation of each product involved in a recall situation or potential recall situation.
Upon receipt of FDA's health hazard evaluation indicating a definitive hazard, TTB will advise the responsible industry member as to an appropriate course of action, which might include a voluntary recall. Even if FDA concludes there is no adverse risk to health, TTB may still find that the product contains unauthorized substances and is, therefore, mislabeled in violation of section 105(e) of the FAA Act (27 U.S.C. 205 (e)).
Regarding adulteration involving pesticides, Section 408 of the FD&C Act, 21 U.S.C. 346a, authorizes the Environmental Protection Agency (EPA) to establish a tolerance or grant an exemption from the requirement of a tolerance for a pesticide chemical residue on or in foods (which include alcohol beverages). TTB analyzes alcohol beverage products to ensure that they do not contain pesticides in excess of the tolerances established by EPA. TTB also conducts appropriate analyses of alcohol beverage products to determine whether those products are adulterated with any other substances.
TTB-regulated industry members should also be aware of the reporting obligations outlined in the requirements of the FD&C Act regarding the "Reportable Food Registry," 21 U.S.C. 350f. FDA's Reportable Food Registry reporting requirements do apply to alcohol beverage industry members that are required to register with FDA under 21 U.S.C. 350d (generally, in this context, domestic or foreign facilities that manufacture, process, pack or hold alcohol beverages for consumption in the United States). Those requirements concern a "reportable food," which means "an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals." Additional information on these requirements can be found on FDA's website at www.fda.gov.
(13) Questions?
If you have any questions concerning this industry circular, please contact the Market Compliance Office at 202-453-2251 or by email at market.compliance@ttb.gov.
Date Signed: September 29, 2017
Signed by John Manfreda
John J. Manfreda
Administrator
Alcohol and Tobacco Tax and Trade Bureau
Page last reviewed: February 9, 2018
Page last updated: February 9, 2018
Maintained by: Regulations and Rulings Division