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FDA Issues Guidance on Labeling of Certain Beer Products Made without Malted Barley and Hops

CFSAN Constituent Update - Fruit Basket
CFSAN Constituent Update - CFSAN FDA

August 18, 2009

The U.S. Food and Drug Administration this week issued draft guidance to manufacturers on the labeling of non-malted beers that contain substitutes for malted barley such as sorghum, rice or wheat, or are made without hops. Such beer products fall under FDA rather than the Alcohol and Tobacco Tax and Trade Bureau (TTB) regulatory authority. The guidance advises industry on how to label beers that are subject to the FDA's labeling laws.

This action follows a July 2008 ruling by the TTB that beers made from substitutes for malted barley or that do not contain hops do not meet the definition of a malted beverage contained in the Federal Alcohol Administration Act (FAA Act). Under that Act, the TTB regulates the labeling and other aspects of malted beverages. The 2008 TTB ruling means that beers that are not made from malted barley or that do not contain hops are subject to labeling requirements under the Federal Food, Drug and Cosmetic Act and the Fair Packaging and Labeling Act, and fall under FDA regulatory authority.

FDA's new draft guidance -- "Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration" -- specifies the mandatory information required on the labels of these non-malt beers. These mandatory labeling components include, among other information, a listing of ingredients in the product, a nutrition facts panel, and the name of any major food allergen present in the product.

Malt beverage is a term for both alcoholic and non-alcoholic fermented beverages in which the primary ingredient is barley. The most predominant malt beverage is beer. FDA also regulates the labeling of wine beverages containing less than 7 percent alcohol by volume, such as wine coolers, cooking wine, and ciders (in which the alcohol has been removed).

Manufacturers of non-malt beers are expected to comply with the FDA's labeling requirements by Jan. 1, 2012. The Federal Register notice (74 FR 41438) can be viewed on the GPO Access web site and the guidance can be viewed on the FDA website.