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

FinalHuman Foods Program04/04/2023

Description

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.

Scope & Applicability

Product Classes

2
Sorghum Beer

Example of a beer subject to FDA labeling jurisdiction

Malt Beverage

Defined under the Federal Alcohol Administration Act

Stakeholders

2
manufacturers

manufacturers are responsible for ensuring that their labels conform to all applicable FDA labeling laws

Manufacturer

Entity responsible for submitting NDINs

Identified Hazards

Hazards

1
Major Food Allergen

Includes milk, egg, fish, wheat, and sesame

Related CFR Sections (3)

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See Also (8)

Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration | Guideline Explorer | BioRegHub