Proposed Rule2023-27450
Menu Labeling: Supplemental Guidance for Industry (Edition 2); Draft Guidance for Industry; Availability
Primary source
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Published
December 14, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Menu Labeling: Supplemental Guidance for Industry (Edition 2)." The draft guidance, when finalized, will update the existing guidance to add new questions and answers to address voluntary declaration of added sugars and voluntary declaration of nutrition information for menus on third-party platforms.
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[Federal Register Volume 88, Number 239 (Thursday, December 14, 2023)]
[Proposed Rules]
[Pages 86613-86614]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27450]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 /
Proposed Rules
[[Page 86613]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2011-F-0172]
Menu Labeling: Supplemental Guidance for Industry (Edition 2);
Draft Guidance for Industry; Availability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availability of a draft guidance for industry entitled ``Menu Labeling:
Supplemental Guidance for Industry (Edition 2).'' The draft guidance,
when finalized, will update the existing guidance to add new questions
and answers to address voluntary declaration of added sugars and
voluntary declaration of nutrition information for menus on third-party
platforms.
DATES: Submit either electronic or written comments on the draft
guidance by February 12, 2024 to ensure that we consider your comment
on the draft guidance before we begin work on the final version of the
guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2011-F-0172 for ``Menu Labeling: Supplemental Guidance for
Industry.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
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 draft 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 draft guidance.
FOR FURTHER INFORMATION CONTACT: Sonia Hudson, Office of Nutrition and
Food Labeling (HFS-820), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-2731; or Holli Kubicki, Office of Regulations and Policy (HFS-
024), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 1, 2014 (79 FR 71156), we
published a final rule on nutrition labeling of standard menu items in
restaurants and similar retail food establishments to implement the
menu labeling provisions
[[Page 86614]]
of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343(q)(5)(H)) (``Food Labeling; Nutrition Labeling of Standard
Menu Items in Restaurants and Similar Retail Food Establishments'').
The menu labeling requirements are codified at Sec. 101.11 (21 CFR
101.11). Before these requirements, consumers could find nutrition
information on most packaged foods; however, this labeling was not
generally and consistently available in restaurants and similar retail
food establishments that serve ready-to-eat, prepared food. Providing
calorie and other nutrition information for ready-to-eat prepared foods
in restaurants and similar retail food establishments enables consumers
to make informed and healthful dietary choices.
In the Federal Register of May 5, 2018 (83 FR 20731), we announced
the availability of a final guidance entitled ``Menu Labeling:
Supplemental Guidance for Industry'' that addresses stakeholder
questions regarding the implementation of nutrition labeling
requirements for foods sold in covered establishments and includes
examples of alternatives to aid in compliance. A ``covered
establishment'' is a restaurant or similar retail food establishment
that is a part of a chain with 20 or more locations doing business
under the same name (regardless of the type of ownership, e.g.,
individual franchises) and offering for sale substantially the same
menu items, as well as a restaurant or similar retail food
establishment that voluntarily registers with FDA to be covered by the
Federal menu labeling requirements (Sec. 101.11(a); see 21 U.S.C.
343(q)(5)(H)(i)).
We are announcing the availability of a draft guidance for industry
entitled ``Menu Labeling: Supplemental Guidance for Industry (Edition
2).'' The draft guidance is a revision to the guidance issued in May
2018. We are including two new questions and answers regarding
voluntarily declaring added sugars as part of additional written
nutrition information and voluntarily providing nutrition information
consistent with the menu labeling requirements through third-party
platforms. The guidance, if finalized, will support further alignment
of menu labeling with our Nutrition Facts label regulation at 21 CFR
101.9, because we recommend that covered establishments voluntarily
include the declaration of ``added sugars'' as part of the additional
written nutrition information under Sec. 101.11(b)(2)(ii)(A).
Additionally, with the popularity of using third-party platforms, such
as third-party online ordering websites and delivery applications to
order food for pickup and delivery from chain restaurants and similar
retail food establishments, we recommend the voluntary disclosure of
calorie information for standard menu items to help consumers make
informed and healthful decisions when ordering their meals online using
a third-party platform.
On November 6-8, 2023, FDA hosted a virtual public meeting and
listening session to explore what Federal Agencies, communities, and
private industry are doing to encourage the reduced consumption of
added sugars. Issuing this draft guidance is one important step that
FDA can take to make progress towards this goal.
FDA is issuing the draft guidance to receive comments on the new
questions and answers, and, as appropriate, will move the questions and
answers to the final guidance document, after reviewing comments and
incorporating any changes to the questions and answers. For ease of
reference, a question retains the same number when it moves from the
draft guidance to the final guidance.
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.
II. Paperwork Reduction Act of 1995
This draft guidance contains proposed information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3521). ``Collection of information'' is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, we will publish a 60-day notice of the
proposed collection of information in a future issue of the Federal
Register.
This draft guidance also refers to previously approved FDA
collections of information. The collections of information in Sec.
101.11 have been approved under OMB control number 0910-0782.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
Dated: December 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27450 Filed 12-13-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on December 14, 2023.
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