83 FR 55266 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 214 (November 5, 2018)

Page Range		55266-55267
FR Document		2018-24125

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 The guidance finalizes the draft guidance we issued in January 2017, which provides questions and answers (Q&A) on topics related to compliance with the Nutrition Facts and Supplement Facts label and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.

Federal Register, Volume 83 Issue 214 (Monday, November 5, 2018)

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

=======================================================================
-----------------------------------------------------------------------

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.

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

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.thefederalregister.org/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

Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Rules and Regulations 55267

thinking of FDA on this topic. It does guidance include new Q&A(s) regarding Director and Midwest Regional Director,
not establish any rights for any person added sugars, which include examples and to update the mail stop for BIA’s
and is not binding on FDA or the public. for calculating added sugars in certain Central Office in Washington, DC for
You can use an alternative approach if products. The guidance notes that, filing ICWA adoption notices. This rule
it satisfies the requirements of the although the Nutrition Facts label and is a technical amendment that corrects
applicable statutes and regulations. This Serving Size final rules became effective the addresses for filing ICWA
guidance is not subject to Executive on July 26, 2016, their compliance dates documents with the Alaska Regional
Order 12866. (originally scheduled to be July 26, Director, Midwest Regional Director,
In the Federal Register of May 27, 2018, for manufacturers with $10 and Central Office in Washington, DC.
2016, FDA issued two final rules million or more in annual food sales
entitled ‘‘Food Labeling: Revision of the and July 26, 2019, for manufacturers DATES: Effective November 5, 2018.
Nutrition and Supplement Facts Labels’’ with less than $10 million in annual FOR FURTHER INFORMATION CONTACT:
(81 FR 33742; the ‘‘Nutrition Facts label food sales) have not been realized yet. Elizabeth Appel, Director, Office of
final rule’’) and the ‘‘Food Labeling: In the Federal Register of October 2, Regulatory Affairs & Collaborative
Serving Sizes of Foods That Can 2017 (82 FR 45753), however, we Action, (202) 273–4680;
Reasonably Be Consumed At One Eating proposed to extend the compliance date elizabeth.appel@bia.gov.
Occasion; Dual-Column Labeling; for manufacturers with $10 million or
Updating, Modifying, and Establishing more in annual food sales from July 26, SUPPLEMENTARY INFORMATION: ICWA
Certain Reference Amounts Customarily 2018, to January 1, 2020, and the requires, in any involuntary proceeding,
Consumed; Serving Size for Breath compliance date for manufacturers with the party seeking foster-care placement
Mints; and Technical Amendments (81 less than $10 million in annual food of, or termination of parental rights to,
FR 34000; the ‘‘Serving Size final rule’’). sales from July 26, 2019, to January 1, an Indian child must notify the parents,
The Nutrition Facts label final rule 2021. We finalized the changes to the Indian custodians, and child’s Tribe and
amends the regulations for the nutrition compliance date in the Federal Register send a copy to the appropriate BIA
labeling of conventional foods and of May 4, 2018 (83 FR 19619). In Regional Director. This notice updates
dietary supplements to provide updated addition, we made editorial changes to the addresses for two of the Regional
nutrition information and to improve the draft guidance language to improve Director offices. ICWA also requires that
how the nutrition information is clarity. The guidance announced in this any State court entering a final adoption
presented to consumers. The Nutrition notice finalizes the draft guidance dated decree or order in any Indian child
Facts label final rule also revised the January 2017. adoptive placement furnish a copy of
Nutrition Facts label to replace ‘‘sugars’’ the decree or order to BIA Chief of
with ‘‘total sugars’’ and to include the II. Electronic Access Human Services at BIA’s Central Office.
declaration of added sugars. The Persons with access to the internet This rule also updates the mail stop for
Serving Size final rule amended the may obtain the guidance at either Central Office in Washington, DC,
definition of a single-serving container, https://www.fda.gov/FoodGuidances or because the mail stop has moved.
required dual-column labeling on https://www.regulations.gov. Use the
certain packages, and amended several FDA website listed in the previous Procedural Requirements
reference amounts customarily sentence to find the most current A. Regulatory Planning and Review
consumed that are used by version of the guidance. (E.O. 12866 and 13563)
manufacturers to determine their label
serving size. The two final rules Dated: October 30, 2018.
Executive Order (E.O.) 12866 provides
provided two compliance dates Leslie Kux,
that the Office of Information and
distinguishing between manufacturers Associate Commissioner for Policy.
Regulatory Affairs (OIRA) at the Office
with $10 million or more in annual food [FR Doc. 2018–24125 Filed 11–2–18; 8:45 am] of Management and Budget (OMB) will
sales (July 26, 2018) and manufacturers BILLING CODE 4164–01–P review all significant rules. OIRA has
with less than $10 million in annual determined that this rule is not
food sales (July 26, 2019). As discussed significant.
below, FDA extended the compliance DEPARTMENT OF THE INTERIOR
dates for these final rules. E.O. 13563 reaffirms the principles of
In the Federal Register of January 5, Bureau of Indian Affairs E.O. 12866 while calling for
2017 (82 FR 1347), we made available improvements in the nation’s regulatory
[190A2100DD/AAKC001030/ system to promote predictability, to
a draft guidance for industry entitled A0A501010.999900 253G]
‘‘Questions and Answers on the reduce uncertainty, and to use the best,
Nutrition and Supplement Facts Labels 25 CFR Part 23 most innovative, and least burdensome
Related to the Compliance Date, Added tools for achieving regulatory ends. The
Sugars, and Declaration of Quantitative RIN 1076–AF42 E.O. directs agencies to consider
Amounts of Vitamins and Minerals; regulatory approaches that reduce
Change of Address; Indian Child burdens and maintain flexibility and
Draft Guidance for Industry;
Welfare Act freedom of choice for the public where
Availability’’ and gave interested parties
an opportunity to submit comments by AGENCY: Bureau of Indian Affairs, these approaches are relevant, feasible,
March 6, 2017, for us to consider before Interior. and consistent with regulatory
beginning work on the final version of ACTION: Final rule; technical objectives. E.O. 13563 emphasizes
the guidance. We received several amendment. further that regulations must be based
comments on the draft guidance on the best available science and that
primarily related to compliance dates SUMMARY: The Bureau of Indian Affairs the rulemaking process must allow for
and labeling requirements for added (BIA) is amending its regulations to public participation and an open
sugars, and have modified the final reflect a change of addresses for filing exchange of ideas. The Department has
guidance where appropriate in response copies of Indian Child Welfare Act developed this rule in a manner
to the comments. Changes to the (ICWA) notices to the Alaska Regional consistent with these requirements.

VerDate Sep<11>2014 16:30 Nov 02, 2018 Jkt 247001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\05NOR1.SGM 05NOR1

Document Created: 2018-11-03 00:29:00
Document Modified: 2018-11-03 00:29:00

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Notification of availability.
Dates		The announcement of the guidance is published in the Federal Register on November 5, 2018.
Contact		Blakeley Fitzpatrick, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450.
FR Citation		83 FR 55266

83 FR 55266 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 214 (November 5, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration