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GUIDANCE DOCUMENT

Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration April 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0268
Issued by:
Guidance Issuing Office
Human Foods Program

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 has been issued following 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.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.  Instead, guidances describe our 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.

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All written comments should be identified with this document's docket number: FDA-2009-D-0268.

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