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U.S. Department of Health and Human Services

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for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration; Draft Guidance

Contains Nonbinding Recommendations

August 2009

Draft Guidance

Additional copies are available from:
Office of Nutrition, Labeling and Dietary Supplements
Food Labeling and Standards Staff
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-2371 (Updated phone: 240-402-2371)

http://www.fda.gov/FoodGuidances

You may submit written or electronic comments regarding this guidance at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
August 2009


Contains Nonbinding Recommendations

Draft — Not for Implementation

Table of Contents

  1. Introduction
  2. Background
  3. Discussion
  4. References

Contains Nonbinding Recommendations

Draft — Not for Implementation

Guidance for Industry1
Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

 

I. Introduction

The purpose of this document is to provide guidance to industry on how to label beers that are subject to the Food and Drug Administration's (FDA's) labeling laws and regulations. This guidance is being issued in light of the recent 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 (FFDCA), 21 U.S.C. 341-415; the Fair Packaging and Labeling Act (FPLA), 15 U.S.C. 1451-1461; and FDA's implementing regulations. In addition, FDA reminds manufacturers of wine beverages that wine beverages containing less than 7 percent alcohol by volume are also subject to the labeling laws and regulations administered by FDA.2

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

 

II. Background

The definition of "food" under the FFDCA includes "articles used for food or drink" and thus includes alcoholic beverages. See 21 U.S.C. 321(f). As such, alcoholic beverages are subject to the FFDCA adulteration and misbranding provisions, and implementing regulations, related to food. For example, manufacturers of alcoholic beverages are responsible for adhering to the registration of food facilities requirements in 21 CFR part 1 and to the good manufacturing practices in 21 CFR part 110. However, as reflected in the 1987 Memorandum of Understanding (MOU) between FDA and TTB's predecessor agency (ATF) (Ref. 2), TTB is responsible for the promulgation and enforcement of regulations with respect to the labeling of distilled spirits, wines, and malt beverages pursuant to the FAA Act.

In TTB Ruling 2008-3, dated July 7, 2008, TTB clarified that certain beers, which are not made from both malted barley and hops but are instead made from substitutes for malted barley (such as sorghum, rice or wheat) or are made without hops, do not meet the definition of a malt beverage under the FAA Act.3 Accordingly, TTB stated in its Ruling that such products (other than sake, which is classified as a wine under the FAA Act), are not subject to the labeling, advertising, and other provisions of the TTB regulations promulgated under the FAA Act.

In cases where an alcoholic beverage is not covered by the labeling provisions of the FAA Act, the product is subject to ingredient and other labeling requirements under the FFDCA and the implementing regulations that are administered by FDA. In addition, as provided for under the FPLA,4 alcoholic beverages that are not covered by the labeling provisions of the FAA Act are subject to the provisions of the FPLA, which is administered by FDA.

Therefore, the beers covered by TTB's recent Ruling are subject to the labeling requirements under the FFDCA and FPLA, and FDA's implementing regulations. In general, FDA requires that food products under its jurisdiction be truthfully and informatively labeled in accordance with the FFDCA, the FPLA, and FDA's regulations. These requirements are explained below. Importantly, it is your responsibility to comply with all applicable requirements under the FFDCA and FPLA, as well as FDA's implementing regulations, regardless of whether or not we refer to them in this guidance.

Furthermore, 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), continue to apply to these products.

 

III. Discussion

Labels of beers that are subject to FDA's labeling requirements must conform to the requirements in 21 CFR part 101. For example, these labels must bear:

  1. (1) on the principal display panel: a statement of identity (21 CFR 101.3). The statement of identity can be similar to the statement of composition that is required for certain malt beverages under the FAA Act regulations, such as “Beer made from sorghum” or "Sorghum Beer";
  2. (2) an accurate statement of the net quantity of contents in inch/pound units (e.g., 12 fl oz). The statement of the net quantity of contents must appear in the lower 30 percent of the principal display panel. The type size used for the net quantity of contents statement is dependent on the size of the principal display panel (21 CFR 101.105). We also recommend that manufacturers declare net quantity of contents in metric units in addition to inch/pound units;
  3. (3) the name and place of business of the manufacturer, packer or distributor (e.g., Imported by ABC Brewers, Chicago, IL 52705) (21 CFR 101.5);
  4. (4) in the statement of ingredients: the common or usual name of each ingredient if the product is made from two or more ingredients, in descending order of predominance by weight (e.g., Ingredients: sorghum, water, rice, yeast, molasses, FD&C Yellow No. 5) (21 CFR 101.4). This includes, but is not limited to, the following ingredients: (a) the name of any chemical preservative present and a description of the function of the preservative (e.g., Ingredients: sorghum, water, rice, yeast, molasses, ascorbic acid to promote color retention), as specified in 21 CFR 101.22(j); (b) a declaration of any added coloring, as specified in 21 CFR 101.22(k), and (c) a declaration of added flavor, such as any spices, natural flavors, or artificial flavors, as specified in 21 CFR 101.22(h);
  5. (5) nutrition labeling (21 CFR 101.9) unless exempt. (Note: Some products are exempt under the provisions in 101.9(j));5

All of the FDA mandatory label information must appear either on the principal display panel (21 CFR 101.1) or the information panel (21 CFR 101.2) unless otherwise specified by FDA regulation. Furthermore, all information appearing on the information panel must appear in one place without other intervening material (21 CFR 101.2(e)).

There are other FDA labeling provisions in addition to the requirements listed above. Under the FFDCA, as amended by the Food Allergen Labeling and Consumer Protection Act of 2004, the food source name of any "major food allergen" present must be declared (section 403(w)(1) of the FFDCA, 21 U.S.C. 343(w)(1)). Section 201(qq) of the FFDCA, 21 U.S.C. 321(qq), defines "major food allergen" as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of them, with the exception of highly refined oils. For additional information on the labeling of food allergens, we refer you to FDA's "Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004."

There are FDA requirements for labeling to ensure the safe use of food additives.6 For more information on the labeling of specific ingredients, including food additives, color additives, and ingredients that are generally recognized as safe, we refer you to 21 CFR parts 1-199.

In addition, there are FDA labeling requirements for voluntary claims, such as, nutrient content claims and health claims, and other labeling statements. For more information regarding FDA's general labeling requirements, we refer you to FDA's "Food Labeling Guide."

There are no preclearance labeling requirements or certificate of label approvals for FDA regulated food products.7 Instead, manufacturers are responsible for ensuring that their labels conform to all applicable FDA labeling laws and regulations. Products that do not meet these labeling requirements may be subject to regulatory action (e.g., warning letter, seizure, etc.).

There are also labeling requirements for these products that are enforced by other government agencies. These include requirements under the ABLA and IRC, which are both enforced by TTB, and U.S. Customs and Border Protection requirements applicable to imported products. For questions about TTB’s labeling requirements and the requirements of the IRC and ABLA, please contact the Advertising, Labeling and Formulation Division, TTB, at (202) 453-2250 or toll free at (866) 927-2533. For requirements of the U.S. Customs and Border Protection, please contact the Tariff Classification and Marking Branch, Regulations and Rulings, U.S. Customs and Border Protection, U.S. Department of Homeland Security, at (202) 325-0010.

FDA recognizes that manufacturers of the beers covered by the recent TTB Ruling may need time to change their labels to comply with FDA’s applicable laws and regulations. Consequently, FDA intends to exercise enforcement discretion in allowing manufacturers until January 1, 2012, which is FDA’s next uniform compliance date for other food labeling changes, to revise the labels on their non-malt beverage beers. In the interim, however, we recommend that manufacturers review their product labels and change labels on their next printing. Further, we would not object to a manufacturer using stickers as a short-term measure. If a manufacturer chooses this option, the sticker should adhere to the package under customary storage conditions throughout the shelf life of the product and the corrected label must comply with all applicable laws and regulations. FDA expects that after January 1, 2012, all labels for these products will comply with all applicable laws and regulations.

 

IV. References

  1. TTB Ruling 2008-3, July 7, 2008. (FDA has verified the Web site address, but it is not responsible for any subsequent changes to the web site address after this document publishes in the Federal Register).
  2. Memorandum of Understanding 225-88-2000 between FDA and Bureau of Alcohol, Tobacco and Firearms.

Notes

1. This guidance has been prepared by the Office of Nutrition, Labeling and Dietary Supplements in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

2. Wine beverages containing less than 7 percent alcohol by volume, such as wine coolers, diluted wine beverages, dealcoholized or partially dealcoholized wine and ciders, are not covered by the labeling provisions of the FAA Act. (The definition of the term “wine” in the FAA Act (27 U.S.C. 211(a)(6)) covers only products containing not less than 7% of alcohol by volume). Instead, these wines are subject to the labeling requirements under the FFDCA and FPLA, and FDA’s implementing regulations. See FDA Compliance Policy Guide (CPG) 7101.04 (Dealcoholized Wine and Malt Beverages- Labeling) and CPG 7101.05 (Labeling - Diluted Wines and Cider with Less Than 7% Alcohol).

3. The term "malt beverage" is defined in the FAA Act (27 U.S.C. 211(a)(7)) 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 therefrom, and with or without the addition of carbon dioxide, and with or without other wholesome products suitable for human food consumption.

4. The term "consumer commodity" is defined under the FPLA, 15 U.S.C. 1459(a)(4), in part as any "food" as defined under the FFDCA, but excludes "any beverage subject to or complying with packaging or labeling requirements” imposed under the FAA Act.

5. We also point out that food products may qualify for an exemption from nutrition labeling based on the fact that the firm claiming the exemption is a small business. For FDA’s requirements for qualifying for a small business exemption from nutrition labeling, we refer you to "Small Business Nutrition Labeling Exemption."

6. For example, if a product contains aspartame, its label must bear on the principal display panel or the information panel the following statement: PHENYLKETONURICS: CONTAINS PHENYLANINE, as specified in 21 CFR 172.804.

7. By contrast, TTB has alcohol beverage labeling and taxing authorities that include, for example, premarket label review and approval.