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FDA Issues Draft Guidance on Labeling of Certain Beer Products

Sep 15, 2009

The U.S. Food and Drug Administration (FDA) issued a draft guidance on the labeling of non-malted beers that contain substitutes for malted barley, such as sorghum, rice or wheat, or are made without hops. In an August 17 Federal Register notice (77 Fed. Reg. 41438), FDA stated that the draft guidance is being issued in light of a recent ruling by the Alcohol and Tobacco Tax and Trade Bureau (TTB) clarifying that certain beers do not meet the definition of a ‘‘malt beverage'' under the Federal Alcohol Administration Act (FAA Act).

The draft guidance, "Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration," explains that non-malt beer—along with wine beverages containing less than 7% alcohol by volume, such as wine coolers, cooking wine, and ciders (in which the alcohol has been removed)—are subject to the food labeling provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), the Fair Packaging and Labeling Act (FPLA), and FDA's implementing regulations. The draft guidance also reviews the information required on labels under these laws and regulations.

TTB ruling number 2008-3, issued July 7, 2008, clarified that while certain brewed products that are classified as "beer" under the Internal Revenue Code of 1986, they do not meet the definition of a "malt beverage" under the FAA Act, which defines the term "malt beverage" as "a beverage made by the alcoholic fermentation of an infusion or decoction, or combination of both, in potable brewing water, of malted barley with hops, or their parts, or their products, and with or without other malted cereals, and with or without the addition of unmalted or prepared cereals, other carbohydrates or products prepared there from, and with or without the addition of carbon dioxide, and with or without other wholesome products suitable for human food consumption."

In the ruling, TTB explained that "beers (other than saké and similar products) that do not conform to the definition of a ‘malt beverage' in the FAA Act are outside the scope of the FAA Act and, therefore, are not subject to the labeling, advertising, and other provisions of the TTB regulations promulgated under the FAA Act." However, they are still subject to some TTB labeling requirements, such as the Government Health Warning Statement under the Alcoholic Beverage Labeling Act (ABLA) and certain marking requirements under the IRC. (For more information, see the Packaginglaw.com article, The Regulation of Packaging by the Alcohol and Tobacco Tax and Trade Bureau: An Added Level of Complexity.)

Manufacturers of non-malt beers are expected to comply with FDA's labeling requirements by Jan. 1, 2012, according to the draft guidance. Comments on the draft guidance are due by October 16, 2009.