[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 [www.gpo.gov]
[FR Doc No: 2023-27450]


 ========================================================================
 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.
 
 ========================================================================
 

  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Draft Guidance for Industry; Availability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.

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

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availability of a draft guidance for industry entitled ``Menu Labeling: 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 The draft guidance, 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DATES: Submit either electronic or written comments on the draft 
guidance by February 12, 2024 to ensure that we consider your comment 
on the draft guidance before we begin work on the final version of the 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:
     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-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 https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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.govinfo.gov/content/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, 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 https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. 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