82_FR_1350 82 FR 1347 - 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Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Draft Guidance for Industry; Availability

82 FR 1347 - 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Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 3 (January 5, 2017)

Page Range1347-1348
FR Document2016-32005

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of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 The draft guidance, when finalized, will provide questions and answers on topics related to compliance, labeling of added sugars, declaration of quantitative amounts of vitamins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.

Federal Register, Volume 82 Issue 3 (Thursday, January 5, 2017) 
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1347-1348]
From the Federal Register Online  [www.thefederalregister.org]
[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Quantitative Amounts of Vitamins and Minerals; Draft Guidance for 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.

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

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availability of a draft guidance for industry entitled ``Questions and 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 The draft guidance, when finalized, will 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

Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices 1347 brief statement of the general nature of DEPARTMENT OF HEALTH AND comments, that information will be the evidence or arguments they wish to HUMAN SERVICES posted on https://www.regulations.gov. present, the names and addresses of • If you want to submit a comment proposed participants, and an Food and Drug Administration with confidential information that you indication of the approximate time do not wish to be made available to the [Docket No. FDA–2016–D–4414] public, submit the comment as a requested to make their presentation on or before February 17, 2017. Time written/paper submission and in the Questions and Answers on the allotted for each presentation may be manner detailed (see ‘‘Written/Paper Nutrition and Supplement Facts Labels Submissions’’ and ‘‘Instructions’’). limited. If the number of registrants Related to the Compliance Date, Added requesting to speak is greater than can Sugars, and Declaration of Written/Paper Submissions be reasonably accommodated during the Quantitative Amounts of Vitamins and Submit written/paper submissions as scheduled open public hearing session, Minerals; Draft Guidance for Industry; follows: FDA may conduct a lottery to determine Availability • Mail/Hand delivery/Courier (for the speakers for the scheduled open AGENCY: Food and Drug Administration, written/paper submissions): Division of public hearing session. The contact HHS. Dockets Management (HFA–305), Food person will notify interested persons and Drug Administration, 5630 Fishers ACTION: Notification of availability with Lane, Rm. 1061, Rockville, MD 20852. regarding their request to speak by request for comments. • For written/paper comments February 21, 2017. submitted to the Division of Dockets Persons attending FDA’s advisory SUMMARY: The Food and Drug Management, FDA will post your committee meetings are advised that the Administration (FDA or we) is comment, as well as any attachments, Agency is not responsible for providing announcing the availability of a draft except for information submitted, access to electrical outlets. guidance for industry entitled marked and identified, as confidential, ‘‘Questions and Answers on the FDA is establishing a docket for if submitted as detailed in Nutrition and Supplement Facts Labels public comment on this document. The ‘‘Instructions.’’ Related to the Compliance Date, Added Instructions: All submissions received docket number is FDA–2016–N–0567. Sugars, and Declaration of Quantitative The docket will close on February 17, must include the Docket No. FDA– Amounts of Vitamins and Minerals.’’ 2016–D–4414 for ‘‘Questions and 2017. Comments received on or before The draft guidance, when finalized, will February 17, 2017 will be provided to Answers on the Nutrition and provide questions and answers on Supplement Facts Labels Related to the the committee. Comments received after topics related to compliance, labeling of Compliance Date, Added Sugars, and the date will be taken into consideration added sugars, declaration of quantitative Declaration of Quantitative Amounts of by the Agency. For press inquiries, amounts of vitamins and minerals, and Vitamins and Minerals.’’ Received please contact the Office of Media format for Nutrition and Supplement comments will be placed in the docket Affairs at fdaoma@fda.hhs.gov or 301– Facts labels. and, except for those submitted as 796–4540. DATES: Although you can comment on ‘‘Confidential Submissions,’’ publicly FDA welcomes the attendance of the any guidance at any time (see 21 CFR viewable at https://www.regulations.gov public at its advisory committee 10.115(g)(5)), to ensure that we consider or at the Division of Dockets meetings and will make every effort to your comment on the draft guidance Management between 9 a.m. and 4 p.m., accommodate persons with disabilities. before we begin work on the final Monday through Friday. If you require accommodations due to a version of the guidance, submit either • Confidential Submissions—To disability, please contact Marieann Brill electronic or written comments on the submit a comment with confidential at least 7 days in advance of the draft guidance by March 6, 2017. information that you do not wish to be meeting. ADDRESSES: You may submit comments made publicly available, submit your as follows: comments only as a written/paper FDA is committed to the orderly submission. You should submit two conduct of its advisory committee Electronic Submissions copies total. One copy will include the meetings. Please visit our Web site at Submit electronic comments in the information you claim to be confidential http://www.fda.gov/ following way: with a heading or cover note that states AdvisoryCommittees/ • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS AboutAdvisoryCommittees/ https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The ucm111462.htm for procedures on instructions for submitting comments. Agency will review this copy, including public conduct during advisory Comments submitted electronically, the claimed confidential information, in committee meetings. including attachments, to https:// its consideration of comments. The Notice of this meeting is given under www.regulations.gov will be posted to second copy, which will have the the Federal Advisory Committee Act (5 the docket unchanged. Because your claimed confidential information U.S.C. app. 2). comment will be made public, you are redacted/blacked out, will be available solely responsible for ensuring that your for public viewing and posted on Dated: December 30, 2016. comment does not include any https://www.regulations.gov. Submit Leslie Kux, confidential information that you or a both copies to the Division of Dockets third party may not wish to be posted, Management. If you do not wish your mstockstill on DSK3G9T082PROD with NOTICES Associate Commissioner for Policy. [FR Doc. 2016–32019 Filed 1–4–17; 8:45 am] such as medical information, your or name and contact information to be BILLING CODE 4164–01–P anyone else’s Social Security number, or made publicly available, you can confidential business information, such provide this information on the cover as a manufacturing process. Please note sheet and not in the body of your that if you include your name, contact comments and you must identify this information, or other information that information as ‘‘confidential.’’ Any identifies you in the body of your information marked as ‘‘confidential’’ VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1

1348 Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices will not be disclosed except in how the nutrition information is 3520). The collections of information in accordance with 21 CFR 10.20 and other presented to consumers. The final rule 21 CFR part 101 have been approved applicable disclosure law. For more provided two compliance dates under OMB control number 0910–0813. information about FDA’s posting of distinguishing between manufacturers IV. Electronic Access comments to public dockets, see 80 FR with $10 million or more in annual food 56469, September 18, 2015, or access sales (July 26, 2018) and manufacturers Persons with access to the Internet the information at: http://www.fda.gov/ with less than $10 million in annual may obtain the draft guidance at either regulatoryinformation/dockets/ food sales (July 26, 2019). The final rule http://www.fda.gov/FoodGuidances or default.htm. also revised the Nutrition Facts label to https://www.regulations.gov. Use the Docket: For access to the docket to replace ‘‘sugars’’ with ‘‘total sugars’’ and FDA Web site listed in the previous read background documents or the to include the declaration of added sentence to find the most current electronic and written/paper comments sugars. The draft guidance is intended version of the guidance. received, go to https:// for conventional food and dietary V. Reference www.regulations.gov and insert the supplement manufacturers and will, docket number, found in brackets in the when finalized, provide questions and The following reference is on display heading of this document, into the answers on topics related to in the Division of Dockets Management ‘‘Search’’ box and follow the prompts compliance, labeling of added sugars, (see ADDRESSES) and is available for and/or go to the Division of Dockets declaration of quantitative amounts of viewing by interested persons between Management, 5630 Fishers Lane, Rm. vitamins and minerals, and format. 9 a.m. and 4 p.m., Monday through 1061, Rockville, MD 20852. Friday; it are also available II. Additional Issues for Consideration electronically at https:// Submit written requests for single copies of the draft guidance to the Office We invite interested persons to www.regulations.gov. FDA has verified of Nutrition and Food Labeling/ comment on topics related to the Web site address, as of the date this Nutrition Programs Staff, Center for compliance, labeling of added sugars, document publishes in the Federal Food Safety and Applied Nutrition, declaration of quantitative amounts of Register, but Web sites are subject to Food and Drug Administration, 5001 vitamins and minerals, and format. change over time. Campus Dr., College Park, MD 20740. However, we are particularly interested 1. U.S. Department of Health and Human Send two self-addressed adhesive labels in responses to the following questions: Services. 2015 Dietary Guidelines for to assist that office in processing your 1. What, if any, concerns are there for Americans. Accessed online at http:// manufacturers to use Brix values from www.health.gov/dietaryguidelines/dga2005/ request. See the SUPPLEMENTARY 21 CFR 101.30 when calculating the document/default.htm. INFORMATION section for electronic access to the draft guidance. added sugars content of products Dated: December 30, 2016. containing fruit juice concentrates? Leslie Kux, FOR FURTHER INFORMATION CONTACT: 2. For purposes of calculating the Associate Commissioner for Policy. Blakeley Fitzpatrick, Center for Food amount of added sugars, what, if any, Safety and Applied Nutrition, Food and concerns are there if we consider that all [FR Doc. 2016–32005 Filed 1–4–17; 8:45 am] Drug Administration (HFS–830), 5001 of the water in a formulation with fruit BILLING CODE 4164–01–P Campus Dr., College Park, MD 20740, or vegetable juice concentrate is used to 240–402–5429. reconstitute the fruit or vegetable juice? SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND To illustrate the issue, assume that fruit HUMAN SERVICES I. Background juice concentrate is added to a food and that the manufacturer also adds water to Food and Drug Administration We are announcing the availability of the food. We recognize that the water a draft guidance for industry entitled may reconstitute the fruit juice, but also [Docket No. FDA–2016–N–0586] ‘‘Questions and Answers on the recognize that some portion of the water Nutrition and Supplement Facts Labels Food and Drug Administration Tribal may have other purposes or affect Consultation Policy; Availability Related to the Compliance Date, Added ingredients other than the fruit juice Sugars, and Declaration of Quantitative concentrate. Nevertheless, to calculate AGENCY: Food and Drug Administration, Amounts of Vitamins and Minerals.’’ the amount of added sugars, we would HHS. We are issuing the draft guidance consider that all of the water goes ACTION: Notice of availability. consistent with our good guidance towards reconstituting the fruit juice. practices regulation (21 CFR 10.115). 3. What, if any, concerns are there if SUMMARY: The Food and Drug The draft guidance, when finalized, will we consider that all of the water that has Administration (FDA or we) is represent the current thinking of FDA been removed from a product during announcing the availability of the FDA on this topic. It does not establish any processing contributes towards the Tribal Consultation Policy. The purpose rights for any person and is not binding concentration of juice added as an of the FDA Tribal Consultation Policy is on FDA or the public. You can use an ingredient during the formulation of the to further the government-to- alternate approach if it satisfies the product? government relationship between FDA requirements of the applicable statutes When responding to these questions, and American Indian and Alaskan and regulations. please explain your reasoning. Native Tribes (Indian Tribes) and In the Federal Register of May 27, facilitate tribal consultation with FDA. 2016, we issued a final rule entitled III. Paperwork Reduction Act of 1995 The FDA Tribal Consultation Policy mstockstill on DSK3G9T082PROD with NOTICES ‘‘Food Labeling: Revision of the This guidance refers to previously provides background on FDA’s mission Nutrition and Supplement Facts Labels’’ approved collections of information and organizational structure and (81 FR 33742). The final rule amends found in FDA regulations. These elaborates on the principles and our regulations for the nutrition labeling collections of information are subject to guidelines in the U.S. Department of of conventional foods and dietary review by the Office of Management and Health and Human Services (HHS) supplements to provide updated Budget (OMB) under the Paperwork Tribal Consultation Policy. This policy nutrition information and to improve Reduction Act of 1995 (44 U.S.C. 3501– finalizes the draft FDA Tribal VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1


Document Created: 2018-02-01 14:51:28
Document Modified: 2018-02-01 14:51:28
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotification of availability with request for comments.
DatesAlthough 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.
ContactBlakeley Fitzpatrick, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-830), 5001 Campus Dr., College Park, MD 20740, 240-402-5429.
FR Citation82 FR 1347 
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