Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration
- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Nutrition and Food Labeling
OMB Control No. 0910--0728
Expiration Date: 01/31/2016
*See additional PRA statements in Section IV of this guidance
This guidance is intended to assist manufacturers on how to label bottled or otherwise packaged beers that are subject to the Food and Drug Administration’s (FDA’s) labeling laws and regulations. This guidance is being issued in light of a ruling by the Alcohol and Tobacco Tax and Trade Bureau (TTB) (formerly the Bureau of Alcohol, Tobacco and Firearms (ATF)) clarifying that certain beers do not meet the definition of a “malt beverage” under the Federal Alcohol Administration Act (FAA Act) (See TTB Ruling 2008-3, dated July 7, 2008) (Ref. 1). As discussed in more detail below, these beers are not subject to the labeling provisions of the FAA Act, but are subject to the food labeling provisions of the Federal Food, Drug, and Cosmetic Act (FD& C Act), 21 U.S.C. 341-350; the Fair Packaging and Labeling Act (FPLA), 15 U.S.C. 1451-1461; and FDA’s implementing regulations.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2009-D-0268.