Surprisingly, required information on labels of beer sold in the U.S. depends on what ingredients are used to make the beer, not the alcohol level. Beers that meet the definition of “malt beverages” are subject to one set of federal labeling regulations, while beers made from substitutes for malted barley (that is, sorghum, rice or wheat) and beers made without hops are subject to a different set of regulations.
The discrepancy is due to concurrent jurisdiction by the U.S. Food and Drug Administration (FDA) and the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) over alcohol beverages. The Food Drug and Cosmetic Act (FD&CA) defines “food” as “articles used for food or drink.” Therefore, alcohol beverages are subject to certain FD&C Act provisions, such those governing adulteration and misbranding. At the same time, the Federal Alcohol Administration Act (FAAA), administered by TTB, establishes regulations for beer, wine and distilled spirits, over and above those imposed by FDA.
Some clarity was achieved in 1987 when a Memorandum of Understanding (MOU) between FDA and TTB’s predecessor—the Bureau of Alcohol, Tobacco, Firearms and Explosives—outlined that TTB was responsible for the promulgation and enforcement of regulations with respect to the labeling of distilled spirits, certain wines and malt beverages. But then TTB issued a ruling in 2008 stating that beers that are not made from both malted barley and hops, but instead are made from substitutes for malted barley, do not meet the definition of a “malt beverage” under the FAA Act. As a result, these beverages are not subject to the labeling, advertising or other provisions of the TTB regulations promulgated under the FAA Act. Rather, they are subject to the provisions of the Fair Packaging and Labeling Act (FPLA) and under FDA’s jurisdiction.
FDA issues guidance on beer labeling
The year after TTP issued its “malt beverage” ruling, in August 2009, FDA issued a draft guidance on the labeling requirements for beers under its jurisdiction. In that guidance, FDA stated that manufacturers had until Jan. 1, 2012, to revise labels on their non-malt beers. On Dec. 22, 2014, the Agency finalized that guidance, noting that it now expects all labels for these products to comply with all applicable laws and regulations.
Under FDA labeling requirements, non-malt beers are required to display the following:
• Statement of identity on the principal display panel (that is, “Beer made from sorghum” or “Sorghum Beer”);
• Net quantity of contents;
• Name and location of the manufacturer, packer or distributor;
• Statement of ingredients; and
• Nutrition labeling unless exempt.
FDA labeling requirements also specify that any major food allergen must be declared. However, labels do not require pre-clearance from the agency. In addition to non-malt beers, wine beverages containing less than 7% alcohol by volume—such as wine cookers, diluted wine beverages, dealcoholized or partially dealcoholized wine, and ciders—also are subject to FDA labeling requirements rather than TTP requirements.
In addition to FDA labeling requirements, some TTB labeling requirements—such as the Government Health Warning Statement under the Alcoholic Beverage Labeling Act (ABLA) and certain marking requirements under the Internal Revenue Code (IRC)—also apply to these products.
In contrast to FDA labeling regulations, the FAA Act’s labeling provisions require pre-approval of labels. With respect to alcohol content, TTB regulations allow an optional statement of alcohol content expressed in percent by volume to appear on the label. However, federal regulations require the alcohol content to appear on the labels of flavored malt beverages that derive alcohol from added flavors. Additionally, some states have laws with requirements with regard to alcohol content statements.
Nutritional labeling is not required under the FAA Act, although, TTB issued a ruling in May 2013 permitting Serving Facts statements on labels and in advertisements of malt beverages, along with wines and distilled spirits, on a voluntary basis. A Serving Facts statement can include: the serving size; the number of servings per container; the number of calories; and the number of grams of carbohydrates, protein and fat per serving size. TTB also stated that alcohol content may be included on a Serving Facts statement.
In comments on FDA’s 2009 draft guidance on labeling requirements for beers under its jurisdiction, the Center for Science in the Public Interest (CSPI), the Consumer Federation of America (CFA) and the National Consumers League (NCL) requested that FDA require alcohol content labeling for non-malt beverage beers. However, FDA’s 2014 “Guidance for Industry: Labeling of Certain Beers Subject to the Labeling jurisdiction of the Food and Drug Administration” did not address alcohol content.
Author George Misko is a partner at Keller and Heckman. Founded in 1962, the respected law firm has a broad practice in the areas of regulatory law, litigation and business transactions, serving both domestic and international clients. Reach him at [email protected].