[Federal Register Volume 79, Number 246 (Tuesday, December 23, 2014)]
[Notices]
[Pages 77013-77014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29988]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Labeling of Certain Beers Subject 
to the Labeling Jurisdiction of the Food and Drug Administration.'' The 
document provides guidance to industry on how to label bottled or 
otherwise packaged beers that are subject to FDA's labeling laws and 
regulations. This guidance is being issued in light of the ruling by 
the Alcohol and Tobacco Tax and Trade Bureau (TTB) (formerly the Bureau 
of Alcohol, Tobacco, and Firearms) (TTB Ruling 2008-3, dated July 7, 
2008) clarifying that certain beers do not meet the definition of a 
``malt beverage'' under the Federal Alcohol Administration Act (FAA 
Act). Because these beers are not subject to the labeling provisions of 
the FAA Act, they are subject to the labeling provisions of the Federal 
Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit electronic comments on the guidance to http://www.regulations.gov. 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 written 
requests for single copies of the guidance to the Office of Nutrition, 
Labeling and Dietary Supplements, Center for Food Safety and Applied 
Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels 
to assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 17, 2009 (74 FR 41438), we 
announced the availability of a draft guidance entitled ``Guidance for 
Industry; Labeling of Certain Beers Subject to the Labeling 
Jurisdiction of the Food and Drug Administration; Availability; Agency 
Information Collection Activities; Proposed Collection; Comment 
Request'' and gave interested parties an opportunity to submit comments 
on the draft guidance at any time and comments on the proposed 
collection of information by October 16, 2009. We received one comment 
which we reviewed and evaluated. On our own initiative, we added a 
reference to the nutrition labeling requirements for certain beers and 
other alcohol beverages served in restaurants or similar retail food 
establishments, under FDA's final rule for menu labeling which appeared 
in the Federal Register on December 1, 2014 (79 FR 71156). We also 
clarified that the guidance pertains to bottled or otherwise packaged 
beers subject to our jurisdiction. We are issuing the guidance with no 
substantive changes.
    The final guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
our current thinking on the labeling of certain

[[Page 77014]]

bottled or otherwise packaged beers subject to our jurisdiction. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternate approach may be used if 
such approach satisfies the requirements of the applicable statutes and 
regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0728.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. 
Always access an FDA guidance document using FDA's Web site listed 
previously to find the most current version of the guidance.

V. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified all the Web site addresses in this reference section, but 
we are not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)

    1. TTB Ruling 2008-3, July 7, 2008, available at: http://www.ttb.gov/rulings/2008-3.pdf.
    2. Memorandum of Understanding 225-88-2000 between FDA and 
Bureau of Alcohol, Tobacco and Firearms, available at: http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm116370.htm.


    Dated: December 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29988 Filed 12-22-14; 8:45 am]
BILLING CODE 4164-01-P