
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1347-1348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-32005]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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Quantitative Amounts of Vitamins and Minerals; Draft Guidance for 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability with request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Questions and 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.'' The draft guidance, when finalized, will 
provide questions and answers on topics related to compliance, labeling 
of added sugars, declaration of quantitative amounts of vitamins and 
minerals, and format for Nutrition and Supplement Facts labels.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
March 6, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``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.'' 
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 Division of Dockets Management 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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 Division of Dockets Management. 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''

[[Page 1348]]

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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Nutrition and Food Labeling/Nutrition Programs Staff, 
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 draft guidance.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration (HFS-830), 
5001 Campus Dr., College Park, MD 20740, 240-402-5429.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of 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.'' We are issuing the 
draft guidance consistent with our good guidance practices regulation 
(21 CFR 10.115). The draft guidance, when finalized, will represent 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 
alternate approach if it satisfies the requirements of the applicable 
statutes and regulations.
    In the Federal Register of May 27, 2016, we issued a final rule 
entitled ``Food Labeling: Revision of the Nutrition and Supplement 
Facts Labels'' (81 FR 33742). The final rule amends our 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 final rule 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). The final 
rule also revised the Nutrition Facts label to replace ``sugars'' with 
``total sugars'' and to include the declaration of added sugars. The 
draft guidance is intended for conventional food and dietary supplement 
manufacturers and will, when finalized, provide questions and answers 
on topics related to compliance, labeling of added sugars, declaration 
of quantitative amounts of vitamins and minerals, and format.

II. Additional Issues for Consideration

    We invite interested persons to comment on topics related to 
compliance, labeling of added sugars, declaration of quantitative 
amounts of vitamins and minerals, and format. However, we are 
particularly interested in responses to the following questions:
    1. What, if any, concerns are there for manufacturers to use Brix 
values from 21 CFR 101.30 when calculating the added sugars content of 
products containing fruit juice concentrates?
    2. For purposes of calculating the amount of added sugars, what, if 
any, concerns are there if we consider that all of the water in a 
formulation with fruit or vegetable juice concentrate is used to 
reconstitute the fruit or vegetable juice? To illustrate the issue, 
assume that fruit juice concentrate is added to a food and that the 
manufacturer also adds water to the food. We recognize that the water 
may reconstitute the fruit juice, but also recognize that some portion 
of the water may have other purposes or affect ingredients other than 
the fruit juice concentrate. Nevertheless, to calculate the amount of 
added sugars, we would consider that all of the water goes towards 
reconstituting the fruit juice.
    3. What, if any, concerns are there if we consider that all of the 
water that has been removed from a product during processing 
contributes towards the concentration of juice added as an ingredient 
during the formulation of the product?
    When responding to these questions, please explain your reasoning.

III. Paperwork Reduction Act of 1995

    This 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. 3501-3520). The 
collections of information in 21 CFR part 101 have been approved under 
OMB control number 0910-0813.

IV. Electronic Access

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

V. Reference

    The following reference is on display in the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

    1. U.S. Department of Health and Human Services. 2015 Dietary 
Guidelines for Americans. Accessed online at http://www.health.gov/dietaryguidelines/dga2005/document/default.htm.

    Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-32005 Filed 1-4-17; 8:45 am]
 BILLING CODE 4164-01-P


