[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Proposed Rules]
[Pages 52036-52037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24246]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0172]


Menu Labeling: Supplemental 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availability of a draft guidance for industry entitled ``Menu Labeling: 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.'' The draft guidance, when 
finalized, will address concerns raised by stakeholders regarding the 
implementation of nutrition labeling required for foods sold in covered 
establishments. It includes expanded and new interpretations of policy, 
and identifies places where FDA intends to be more flexible in its 
approach. This draft guidance also includes many graphical depictions 
in order to convey our thinking on various topics and to provide 
examples of options for implementation. It addresses calorie disclosure 
signage for self-service foods, including buffets and grab-and-go 
foods; reasonable basis, and the criteria for considering the natural 
variation of foods; various methods for providing calorie disclosure 
information, including those for pizza; compliance and enforcement; and 
criteria for distinguishing between menus and other information 
presented to the consumer.

DATES: Submit either electronic or written comments on the draft 
guidance by January 8, 2018 to ensure that the Agency considers your 
comment on the draft guidance before it begins work on the final 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.
     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.gpo.gov/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 draft guidance to 
the Office of Nutrition and Food Labeling, HFS-800, 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: Ashley Rulffes, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Menu Labeling Supplemental Guidance for Industry.'' 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

[[Page 52037]]

applicable statutes and regulations. This guidance is not subject to 
Executive Order 12866.
    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 of section 403(q)(5)(H) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(H)). The menu labeling 
requirements are codified at Title 21 of the Code of Federal 
Regulations, Sec.  101.11 (21 CFR 101.11).
    In the Federal Register of May 4, 2017 (82 FR 20825), we published 
an interim final rule (IFR) extending the compliance date to May 7, 
2018. Our goals are to ensure that consumers are provided with 
consistent nutrition information they can use to make informed choices 
for themselves and their families, and to guide industry in clearly 
understanding the flexible ways in which the requirements can be 
implemented.
    This draft guidance addresses concerns raised by stakeholders 
regarding the implementation of nutrition labeling required for foods 
sold in covered establishments. The draft guidance reflects extensive 
further analysis by FDA in light of the comments we received to the 
IFR. In addition, given extensive further analysis by the Agency, we 
are withdrawing Questions and Answers 5.17 and 5.18 in our previous 
guidance entitled ``A Labeling Guide for Restaurants and Retail 
Establishments Selling Away-From-Home Foods--Part II (Menu Labeling 
Requirements in Accordance With FDA's Food Labeling Regulations)'' 
announced in the Federal Register of May 5, 2016 (81 FR 27067). We 
address the issue of distinguishing between menus and other information 
presented to the consumer in this draft guidance, and once finalized, 
this will represent our current thinking on this topic. The draft 
guidance also includes many graphical depictions to further illustrate 
our thinking on various topics. As previously stated, although you can 
comment on any guidance at any time (see 21 CFR 10.115(g)(5)), we do 
not intend to extend the comment period for the guidance, as we intend 
to finalize this guidance and provide clarity to the industry on these 
remaining questions ahead of the new compliance date of May 7, 2018.

II. 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 Sec.  101.11(b)(2), (c)(3), and (d) have 
been approved under OMB control number 0910-0783.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://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.

    Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24246 Filed 11-7-17; 11:15 am]
 BILLING CODE 4164-01-P