By Susan J. Matthees –
FDA has published a new draft guidance titled Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration. Last month we reported that the Alcohol and Tobacco Tax and Trade Bureau ("TTB") issued a ruling clarifying that certain beer drinks that are not made from both malted barley and hops (e.g., beer made with sorghum, rice, or wheat), are not malt beverages as defined by the Federal Alcohol Administration Act ("FAA Act"). As such, these products are subject to the labeling requirements of the FDC Act.
FDA’s draft guidance is intended to help industry comply with the labeling requirements for these products. The guidance document explains that beer must conform to the requirements set forth in 21 C.F.R. Part 101. These requirements include a statement of identity, which FDA explains “can be similar to the statement of composition that is required for malt beverages . . . such as ‘Beer made from sorghum’ or ‘Sorghum Beer;’” the net quantity of contents; the name and place of business of the manufacturer; packer, or distributor; a statement of ingredients; and nutrition labeling, unless exempt under 21 C.F.R. § 101.9(j). In addition, beers subject to the FDC Act must include allergen labeling pursuant to FDC Act §§ 201(qq) and 403(w)(1). Beer must also comply with FDA requirements for food additives, color additives, and ingredients.
FDA understands that manufactures will need time to change their labels. FDA has stated that it will exercise enforcement discretion until January 1, 2012 to give time to manufacturers to revise their labels. However, the Agency recommends that manufacturers change their labels at the next printing or use stickers to place on the labels in the short term.