[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Rules and Regulations]
[Pages 55266-55267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-D-4414]


Nutrition and Supplement Facts Labels: Questions and Answers 
Related to the Compliance Date, Added Sugars, and Declaration of 
Quantitative Amounts of Vitamins and Minerals; 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 guidance for industry entitled ``Nutrition and 
Supplement Facts Labels: Questions and Answers Related to the 
Compliance Date, Added Sugars, and Declaration of Quantitative Amounts 
of Vitamins and Minerals; Guidance for Industry.'' This guidance is 
intended for conventional food and dietary supplement manufacturers. 
The guidance finalizes the draft guidance we issued in January 2017, 
which provides questions and answers (Q&A) on topics related to 
compliance with the Nutrition Facts and Supplement Facts label and 
Serving Size final rules, the labeling of added sugars, declaration of 
quantitative amounts of vitamins and minerals, and format issues on the 
Nutrition Facts and Supplement Facts labels.

DATES: The announcement of the guidance is published in the Federal 
Register on November 5, 2018.

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-2016-D-4414 for ``Nutrition and Supplement Facts Labels: Questions 
and Answers Related to the Compliance Date, Added Sugars, and 
Declaration of Quantitative Amounts of Vitamins and Minerals.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``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 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: Blakeley Fitzpatrick, 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 guidance for industry 
entitled ``Nutrition and Supplement Facts Labels: Questions and Answers 
Related to the Compliance Date, Added Sugars, and Declaration of 
Quantitative Amounts of Vitamins and Minerals.'' This guidance is 
intended to help industry determine when manufacturers must comply with 
the two final rules on Nutrition and Supplement Facts labels and 
serving size, and how their products will need to comply with these 
rules. We are issuing this guidance consistent with our good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current

[[Page 55267]]

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. This guidance is not subject to Executive 
Order 12866.
    In the Federal Register of May 27, 2016, FDA issued two final rules 
entitled ``Food Labeling: Revision of the Nutrition and Supplement 
Facts Labels'' (81 FR 33742; the ``Nutrition Facts label final rule'') 
and the ``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; the ``Serving Size final rule''). The Nutrition Facts label 
final rule amends the regulations for the nutrition labeling of 
conventional foods and dietary supplements to provide updated nutrition 
information and to improve how the nutrition information is presented 
to consumers. The Nutrition Facts label final rule also revised the 
Nutrition Facts label to replace ``sugars'' with ``total sugars'' and 
to include the declaration of added sugars. The Serving Size final rule 
amended the definition of a single-serving container, required dual-
column labeling on certain packages, and amended several reference 
amounts customarily consumed that are used by manufacturers to 
determine their label serving size. The two final rules provided two 
compliance dates distinguishing between manufacturers with $10 million 
or more in annual food sales (July 26, 2018) and manufacturers with 
less than $10 million in annual food sales (July 26, 2019). As 
discussed below, FDA extended the compliance dates for these final 
rules.
    In the Federal Register of January 5, 2017 (82 FR 1347), we made 
available a draft guidance for industry entitled ``Questions and 
Answers on the Nutrition and Supplement Facts Labels Related to the 
Compliance Date, Added Sugars, and Declaration of Quantitative Amounts 
of Vitamins and Minerals; Draft Guidance for Industry; Availability'' 
and gave interested parties an opportunity to submit comments by March 
6, 2017, for us to consider before beginning work on the final version 
of the guidance. We received several comments on the draft guidance 
primarily related to compliance dates and labeling requirements for 
added sugars, and have modified the final guidance where appropriate in 
response to the comments. Changes to the guidance include new Q&A(s) 
regarding added sugars, which include examples for calculating added 
sugars in certain products. The guidance notes that, although the 
Nutrition Facts label and Serving Size final rules became effective on 
July 26, 2016, their compliance dates (originally scheduled to be July 
26, 2018, for manufacturers with $10 million or more in annual food 
sales and July 26, 2019, for manufacturers with less than $10 million 
in annual food sales) have not been realized yet. In the Federal 
Register of October 2, 2017 (82 FR 45753), however, we proposed to 
extend the compliance date for manufacturers with $10 million or more 
in annual food sales from July 26, 2018, to January 1, 2020, and the 
compliance date for manufacturers with less than $10 million in annual 
food sales from July 26, 2019, to January 1, 2021. We finalized the 
changes to the compliance date in the Federal Register of May 4, 2018 
(83 FR 19619). In addition, we made editorial changes to the draft 
guidance language to improve clarity. The guidance announced in this 
notice finalizes the draft guidance dated January 2017.

II. 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: October 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24125 Filed 11-2-18; 8:45 am]
 BILLING CODE 4164-01-P