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

Contains Nonbinding Recommendations

Labeling of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration:
Guidance for Industry
Additional copies are available from:
Office of Nutrition and Food Labeling
Division of Food Labeling and Standards HFS-820
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
(Tel) 240-402-2371
http://www.fda.gov/FoodGuidances
You may submit electronic or written comments regarding this guidance at any time. Submit
electronic comments to http://www.regulations.gov. Submit written comments on the
guidance to the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with
docket number FDA-2009-D-0268 and with the title of the guidance document.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
April 2023
OMB Control No. 0910-0728
Current expiration date available at https://www.reginfo.gov
*See additional PRA statements in Section IV of this guidance

This is a revision to this guidance, which was originally issued in December 2014.
Revisions are noted by date at the end of the guidance.

Contains Nonbinding Recommendations

Table of Contents
I. Introduction........................................................................................................3
II. Background ........................................................................................................3
III. Discussion ...........................................................................................................4
IV. Paperwork Reduction Act of 1995 ...................................................................6
V. References ...........................................................................................................7
Document History ....................................................................................................7

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Contains Nonbinding Recommendations

Labeling of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration:
Guidance for Industry1
This guidance represents the current thinking of the Food and Drug Administration (FDA or we)
on this topic. It does not establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the requirements of the applicable
statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible
for this guidance at the phone number listed on the title page.

I.

Introduction

This guidance is intended to assist manufacturers on how to label bottled or otherwise packaged
beers that are subject to the Food and Drug Administration’s (FDA’s) labeling laws and
regulations. This guidance has been issued following a 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 (FD&C Act), 21 U.S.C. 341-350; the Fair Packaging and Labeling Act (FPLA), 15 U.S.C.
1451-1461; and FDA’s implementing regulations.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe our 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 FD&C Act 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 food-related provisions of the FD&C Act and implementing regulations. For example,
manufacturers of alcoholic beverages are responsible for adhering to the registration of food
This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and
Applied Nutrition at the U.S. Food and Drug Administration.

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facilities requirements in 21 CFR part 1 and to the good manufacturing practices in 21 CFR part
117. There are also certain requirements for nutrition labeling on menus, menu boards, and
other written materials for alcohol beverages served in restaurants or similar retail food
establishments in 21 CFR part 101. 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, certain 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. 2 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, or 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 FD&C Act and the
implementing regulations that are administered by FDA. In addition, as provided for under the
FPLA, 3 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 described in the TTB’s Ruling as not being a “malt beverage” are subject to
the labeling requirements under the FD&C Act 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 FD&C Act, the FPLA, and FDA’s regulations. These
requirements are explained below. Importantly, manufacturers have the responsibility to comply
with all applicable requirements under the FD&C Act and FPLA, as well as FDA’s
implementing regulations, regardless of whether 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 bottled or otherwise packaged 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. 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
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, of 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.
3
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 FD&C Act but excludes “any beverage subject to or complying with packaging or labeling
requirements” imposed under the FAA Act.
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Contains Nonbinding Recommendations

2.

3.
4.

5.

“Sorghum Beer”;
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 statement in metric units
in addition to inch/pound units;
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);
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) name of
any chemical preservatives 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); and
Nutrition labeling (21 CFR 101.9) unless exempt. (Note: Some products are exempt
under the provisions in 21 CFR 101.9(j)). 4

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
labeling requirements of the FD&C Act, the food source name of any “major food allergen”
present must be declared (21 U.S.C. 343(w)(1)). The FD&C Act defines “major food allergen”
as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, as well
as any food ingredient that contains protein derived from one of them, with the exception of
highly refined oils (21 U.S.C. 321(qq)). For additional information on the labeling of food
allergens, see FDA’s “Questions and Answers Regarding Food Allergens, Including the Food
Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5):
Guidance for Industry (available at https://www.fda.gov/regulatory-information/search-fdaguidance-documents/guidance-industry-questions-and-answers-regarding-food-allergenlabeling-edition-5).

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 a small business exemption from nutrition labeling, see
“Small Business Nutrition Labeling Exemption” (available at https://www.fda.gov/food/labeling-nutrition-guidancedocuments-regulatory-information/small-business-nutrition-labeling-exemption).
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Contains Nonbinding Recommendations
There are FDA requirements for labeling to ensure the safe use of food additives. 5 For more
information on the labeling of specific ingredients, including food additives, color additives, and
ingredients that are generally recognized as safe (GRAS), see 21 CFR parts 1-99 and parts 170199.
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, see FDA’s “Food Labeling Guide” (available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industryfood-labeling-guide).
There are no preclearance labeling requirements or certificate of label approvals for FDA
regulated food products. 6 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 non-malt beverage beers 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, toll free at
(866) 927-2533. For requirements of the U.S. Customs and Border Protection, please contact the
Tariff Classification and Marketing Branch, Regulations and Rulings, U.S. Customs and Border
Protection, U.S. Department of Homeland Security, at 1-800-232-5378.

IV. Paperwork Reduction Act of 1995
This guidance contains information collections that are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 35013520).
The time required to complete this information collection is estimated to average 30 minutes per
disclosure for 21 CFR 101.3, 1 hour per disclosure for 21 CFR 101.4, 15 minutes per disclosure
for 21 CFR 101.5, 4 hours per disclosure for 21 CFR 101.9, 30 minutes per disclosure for 21
CFR 101.22, 30 minutes per disclosure for 21 CFR 101.105, 1 hour per disclosure for section
403(w)(1) of the FD&C Act, including the time to review instructions, search existing data
resources, gather the data needed, and complete and review the information collection. Send
comments regarding this burden estimate or suggestions for reducing this burden to:
Office of Nutrition and Food Labeling
Division of Food Labeling and Standards HFS-820
For example, if a product contains aspartame, its label must bear on the principal display panel or the information
panel the following statement: PHENYKLETONURICS: CONTAINS PHENYLANINE, as specified in 21 CFR
172.804.
6
By contrast, TTB has alcohol beverage labeling and taxing authorities that include, for example, premarket label
review and approval.
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Contains Nonbinding Recommendations
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
This guidance also refers to previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR 101.3, 101.4, 101.5, 101.9, 101.22, and
101.105 have been approved under OMB Control No. 0910-0381.
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number.
The OMB control number for this information collection is 0910-0728 (To find the
current expiration date, search for this OMB Control No. available at
https://www.reginfo.gov).

V.

References

We have placed the following references on display in the Dockets Management Staff, Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at
that location between 9 a.m. and 4 p.m., Monday through Friday.
1. TTB Ruling 2008-3, July 7, 2008. https://www.ttb.gov/images/pdfs/rulings/2008-3.pdf
(last accessed March 3, 2023).
2. Memorandum of Understanding 225-88-2000 between FDA and Bureau of Alcohol,
Tobacco and Firearms. https://www.fda.gov/about-fda/domestic-mous/mou-225-88-2000
(last accessed March 3, 2023).

Document History
•
•

December 2014 – First edition of guidance was issued.
April 2023 – The guidance was updated to refer to 21 CFR part 117, to include the
allergen sesame, to remove outdated enforcement discretion text, and to make other nonsubstantive formatting or editorial revisions.

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