[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Rules and Regulations]
[Pages 72230-72231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27868]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2018-D-1459]


Food Labeling: Serving Sizes of Foods That Can Reasonably Be 
Consumed at One Eating Occasion, Reference Amounts Customarily 
Consumed, Serving Size-Related Issues, Dual-Column Labeling, and 
Miscellaneous Topics; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a final guidance for industry entitled ``Food Labeling: 
Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating 
Occasion, Reference Amounts Customarily Consumed, Serving Size-Related 
Issues, Dual-Column Labeling, and Miscellaneous Topics.'' The final 
guidance provides questions and answers on topics related primarily to 
implementing two final rules, one entitled ``Food Labeling: Serving 
Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; 
Dual-Column Labeling; Updating, Modifying, and Establishing Certain 
Reference Amounts Customarily Consumed; Serving Size for Breath Mints; 
and Technical Amendments,'' and the other entitled ``Food Labeling: 
Revision of the Nutrition and Supplement Facts Labels.'' The final 
guidance also discusses formatting issues for dual-column labeling, 
products that have limited space for nutrition labeling, and additional 
issues dealing with compliance.

DATES: December 31, 2019.

ADDRESSES: You may submit either electronic or written comments on FDA 
guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-1459 for ``Food Labeling: Serving Sizes of Foods That Can 
Reasonably Be Consumed at One Eating Occasion, Reference Amounts 
Customarily Consumed, Serving Size-Related Issues, Dual-Column 
Labeling, and Miscellaneous Topics; Draft Guidance for Industry.'' 
Received comments will be placed in the docket and, except for those 
submitted as

[[Page 72231]]

``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Nutrition and Food Labeling, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
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: Jillonne Kevala, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1450.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a final guidance for industry 
entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be 
Consumed At One Eating Occasion, Reference Amounts Customarily 
Consumed, Serving Size-Related Issues, Dual-Column Labeling, and 
Miscellaneous Topics.'' We are issuing this guidance consistent with 
our good guidance practices regulation (21 CFR 10.115). The guidance 
represents the current thinking of FDA 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.
    In the Federal Register of November 5, 2018 (83 FR 55323), we 
announced the availability of a draft guidance entitled, ``Food 
Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One 
Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-
Related Issues, Dual-Column Labeling, and Miscellaneous Topics.'' The 
draft guidance was intended to provide questions and answers on topics 
related primarily to two final rules: (1) ``Food Labeling: Serving 
Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; 
Dual-Column Labeling; Updating, Modifying, and Establishing Certain 
Reference Amounts Customarily Consumed; Serving Size for Breath Mints; 
and Technical Amendments'' (81 FR 34000 (May 27, 2016)); and (2) ``Food 
Labeling: Revision of the Nutrition and Supplement Facts Labels'' (81 
FR 33742 (May 27, 2016)).
    We gave interested parties until January 4, 2019, to submit 
comments for us to consider before beginning work on the final version 
of the guidance. We received over 40 comments on the draft guidance and 
have modified the final guidance where appropriate. Changes to the 
guidance include:
     Providing additional background information in response to 
a question regarding reference amounts customarily consumed (RACCs) for 
non-juice beverages for infants and young children;
     Modifying for clarity a question and response concerning 
whether the Nutrition Facts label for products sold in small packages 
(e.g., certain sugar-free chewing gums) must list all nutrients that 
are contained in insignificant amounts; and
     Modifying the response to a question regarding the 
placement of the Nutrition Facts and Supplement Facts labels to clarify 
that the Nutrition Facts or Supplement Facts label should not be placed 
on the bottom of packages (such as the bottom of boxes, cans, and 
bottles), unless they are visible during normal retail display and 
consumer handling.
    The guidance announced in this notice finalizes the draft guidance 
dated November 2018.

II. Paperwork Reduction Act of 1995

    This final guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The 
collections of information in 21 CFR part 101 have been approved under 
OMB control number 0910-0381.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: December 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27868 Filed 12-30-19; 8:45 am]
BILLING CODE 4164-01-P


