[Federal Register Volume 83, Number 89 (Tuesday, May 8, 2018)]
[Rules and Regulations]
[Pages 20731-20733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09725]


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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.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Menu Labeling: 
Supplemental Guidance for Industry.'' The guidance addresses 
stakeholder concerns regarding the implementation of nutrition labeling 
required for foods sold in covered establishments, includes expanded 
and new examples of alternatives to aid in compliance, identifies 
places where we intend to be more flexible in our approach, and advises 
of our intent to exercise enforcement discretion regarding nutrient 
declaration for ``calories from fat'' as part of the additional written 
nutrition information. The guidance also includes many graphical 
depictions to convey our thinking on various topics and to provide 
examples of options for implementation, and 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, when determining nutrition labeling for 
such 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: The announcement of the guidance is published in the Federal 
Register on May 8, 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

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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 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 guidance.

FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, 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 guidance for industry 
entitled ``Menu Labeling: Supplemental Guidance for Industry.'' We are 
issuing this guidance consistent with our good guidance practices 
regulation (21 CFR 10.115). The guidance represents 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 
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 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 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.
    In the Federal Register of November 9, 2017 (82 FR 52036), we made 
available a draft guidance for industry entitled ``Menu Labeling: 
Supplemental Guidance for Industry'' and gave interested parties an 
opportunity to submit comments by January 8, 2018, for us to consider 
before beginning work on the final version of the guidance. The draft 
guidance addressed concerns raised by stakeholders regarding the 
implementation of nutrition labeling required for foods sold in covered 
establishments. It included expanded and new examples of alternatives 
to aid in compliance and identified places where we intend to be more 
flexible in our approach. The draft guidance also included many 
graphical depictions to convey our thinking on various topics and to 
provide examples of options for implementation. It addressed 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.
    We received numerous comments on the draft guidance and have 
modified the final guidance where appropriate. Changes to the guidance 
include adding new questions and answers 3.4, 3.5, and 8.3 and Figures 
12, 13, 16, 17, and 18. In addition, we made editorial changes to 
improve clarity in questions and answers 4.1, 5.4, 6.2, 7.1, 8.1, 10.1, 
and 10.2 and clarified the headings for the graphics in Figures 3 and 
14.
    In addition, the final guidance announces our intent to exercise 
enforcement discretion regarding the ``calories from fat'' nutrient 
declaration requirement as part of the additional written nutrition 
information required in Sec.  101.11(b)(2)(ii)(A). As discussed in the 
final guidance, we are taking this position because the current science 
supports a view that the type of fat is more relevant with respect to 
the risk of chronic disease than the overall caloric fat intake, and to 
align with the final rule, ``Food Labeling: Revision of the Nutrition 
and Supplement Facts Labels'' (81 FR 33742, May 27, 2016). (Our current 
thinking on this issue is discussed in the preamble to the final rule 
titled, ``Food Labeling: Revision of the Nutrition and Supplement Facts 
Labels'' (81 FR 33742 at 33780 through

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33781) now codified primarily at 21 CFR 101.9 and 101.36). With respect 
to our enforcement discretion policy pertaining to ``calories from 
fat'' declarations, this part of the guidance is immediately effective 
because we have determined that prior public participation is not 
feasible or appropriate (21 CFR 10.115(g)(2)). The guidance announced 
in this notice finalizes the draft guidance dated November 2017.

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 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: May 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09725 Filed 5-7-18; 8:45 am]
 BILLING CODE 4164-01-P


