[Federal Register Volume 86, Number 221 (Friday, November 19, 2021)]
[Notices]
[Pages 64941-64943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0268]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Labeling of Certain 
Beers Subject to the Labeling Jurisdiction of the Food and Drug 
Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by December 20, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0728. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

OMB Control Number 0910-0728--Extension

    The definition of ``food'' under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act (21 U.S.C. 321(f))) includes ``articles used for 
food or drink'' and thus includes alcoholic beverages. As such, 
alcoholic beverages are subject to the FD&C Act's 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 practice regulations in 21 CFR 
part 110. 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 a 1987 Memorandum of Understanding 
between FDA and the Alcohol and Tobacco Tax and Trade Bureau (TTB), TTB 
is responsible for the dissemination and enforcement of regulations 
with respect to the labeling of distilled spirits, certain wines, and 
malt beverages issued in the Federal Alcohol Administration Act (the 
FAA Act). In TTB Ruling 2008-3, dated July 7, 2008, TTB clarified that 
certain beers, which are not made from both malted

[[Page 64942]]

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. Accordingly, 
TTB stated in its ruling that such products (other than sak[eacute], 
which is classified as a wine under the FAA Act), are not subject to 
the labeling, advertising, or other provisions of TTB regulations 
issued 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 we administer. In addition, as provided for under the 
Fair Packaging and Labeling Act (FPLA), alcoholic beverages that are 
not covered by the labeling provisions of the FAA Act are subject to 
the provisions of the FPLA, which we administer.
    Therefore, the beers described in TTB's ruling as not being a 
``malt beverage'' are subject to the labeling requirements under the 
FD&C Act and FPLA, and our implementing regulations. In general, we 
require that food products under our jurisdiction be truthfully and 
informatively labeled in accordance with the FD&C Act, the FPLA, and 
FDA's regulations. Furthermore, some TTB labeling requirements, such as 
the Government Health Warning Statement under the Alcoholic Beverage 
Labeling Act and certain marking requirements under the Internal 
Revenue Code, continue to apply to these products.
    Persons with access to the internet may obtain the guidance 
entitled ``Labeling of Certain Beers Subject to the Labeling 
Jurisdiction of the Food and Drug Administration,'' located at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-labeling-certain-beers-subject-labeling-jurisdiction-food-and-drug-administration. This guidance is intended to assist 
manufacturers on how to label bottled or otherwise packaged beers that 
are subject to our labeling laws and regulations.
    Our food labeling regulations under parts 101, 102, 104, and 105 
(21 CFR parts 101, 102, 104, and 105) were issued under the authority 
of sections 4, 5, and 6 of the FPLA (15 U.S.C. 1453, 1454, and 1455) 
and under sections 201, 301, 402, 403, 409, 411, 701, and 721 of the 
FD&C Act (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most 
of these regulations derive from section 403 of the FD&C Act, which 
provides that a food product shall be deemed to be misbranded if, among 
other things, its label or labeling fails to bear certain required 
information concerning the food product, is false or misleading in any 
particular, or bears certain types of unauthorized claims. The 
disclosure requirements and other collections of information in the 
regulations in parts 101, 102, 104, and 105 are necessary to ensure 
that food products produced or sold in the United States are in 
compliance with the labeling provisions of the FD&C Act and the FPLA.
    The primary user of the information to be disclosed on the label or 
labeling of food products is the consumer that purchases the food 
product. Consumers will use the information to assist them in making 
choices concerning their purchase of a food product, including choices 
related to substances that the consumer must avoid to prevent adverse 
reactions. This information also enables the consumer to determine the 
role of the food product in a healthful diet. Additionally, FDA intends 
to use the information to determine whether a manufacturer or other 
supplier of food products is meeting its statutory and regulatory 
obligations. Failure of a manufacturer or other supplier of food 
products to label its products in compliance with section 403 of the 
FD&C Act and parts 101, 102, 104, and 105 of FDA's food labeling 
regulations may result in a product being misbranded under the FD&C 
Act, subjecting the firm and product to regulatory action.
    Description of Respondents: The respondents to this collection of 
information are manufacturers of beers that are subject to our labeling 
laws and regulations.
    In the Federal Register of May 21, 2021 (86 FR 27631), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received two comments pertaining to the 
necessity and practical utility of the information being collected and 
the accuracy of our burden estimate.
    (Comment 1) One comment questioned the necessity and practical 
utility of treating beer as a ``food'' making it subject to food 
labeling regulations. A related comment questioned the need to label 
beer at all.
    (Response) As stated in the guidance as well in the above-
referenced 60-day notice, the definition of ``food'' under the FD&C Act 
(see 21 U.S.C. 321(f)), includes ``articles used for food or drink'' 
and thus includes alcoholic beverages. 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, 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.
    The primary user of the information to be disclosed on the label or 
labeling of food products is the consumer that purchases the food 
product. Consumers will use the information to assist them in making 
choices concerning their purchase of a food product, including choices 
related to substances that the consumer must avoid to prevent adverse 
reactions. This information also enables the consumer to determine the 
role of the food product in a healthful diet.
    (Comment 2) One comment argued that the burden estimate 
underestimated the number of respondents affected by this collection.
    (Response) This collection of information applies to alcoholic 
beverages not covered by the labeling provisions of the FAA Act. Our 
estimate of the number of respondents is based on the number of 
regulatory submissions to TTB for beers that do not meet the definition 
of a ``malt beverage'' under the FAA Act. Based on its records of 
submissions received from manufacturers of such products, TTB estimates 
the annual number of respondents to be 12.
    We estimate the burden of this collection of information as 
follows:

[[Page 64943]]



                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                  Number of
          21 CFR section; activity               Number of     disclosures per   Total annual         Average burden per disclosure         Total hours
                                                respondents      respondent       disclosures
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101.3 and 101.22; statement of identity                   12                 2              24  0.5 (30 minutes)........................              12
 labeling requirements.
101.4; ingredient labeling requirements.....              12                 2              24  1.......................................              24
101.5; requirement to specify the name and                12                 2              24  0.25 (15 minutes).......................               6
 place of business of the manufacturer,
 packer, or distributor.
101.9; labeling requirements for disclosure               12                 2              24  4.......................................              96
 of nutrition information.
101.7; declaration of net quantity of                     12                 2              24  0.5 (30 minutes)........................              12
 contents.
Section 403(w)(1) of the FD&C Act;                        12                 2              24  1.......................................              24
 declaration of food allergens.
Guidance document entitled ``Labeling of                  12                 1              12  1.......................................              12
 Certain Beers Subject to the Labeling
 Jurisdiction of the Food and Drug
 Administration''.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ................  ..............  ........................................             186
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate. Our estimate of the number of respondents is based on the 
number of regulatory submissions to TTB for beers that do not meet the 
definition of a ``malt beverage'' under the FAA Act. Based on its 
records of submissions received from manufacturers of such products, 
TTB estimates the annual number of respondents to be 12 and the annual 
number of disclosures to be 24.
    Our estimates of the average burden per disclosure for each 
collection provision are based on our experience with food labeling 
under the Agency's jurisdiction. The estimated average burden per 
disclosure for Sec. Sec.  101.3, 101.4, 101.5, 101.9, 101.22, and 101.7 
(21 CFR 101.3, 101.4, 101.5, 101.9, 101.22, and 101.7) are equal to, 
and based upon, the estimated average burden per disclosure approved by 
OMB control number 0910-0381. We further estimate that the labeling 
burden of section 403(w)(1) of the FD&C Act, which specifies 
requirements for the declaration of food allergens, will be 1 hour 
based upon the similarity of the requirements to that of Sec.  101.4. 
Finally, we estimate that a respondent will spend 1 hour reading the 
guidance.
    The guidance also refers to previously approved collections of 
information found in our regulations. The collections of information in 
Sec. Sec.  101.3, 101.4, 101.5, 101.9, 101.22, and 101.7 have been 
approved under OMB control number 0910-0381. Allergen labeling of these 
beers under section 403(w)(1) of the FD&C Act, which was added by the 
Food Allergen Labeling and Consumer Protection Act of 2004, has been 
approved under OMB control number 0910-0792.

    Dated: November 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25300 Filed 11-18-21; 8:45 am]
BILLING CODE 4164-01-P


