[Federal Register Volume 82, Number 31 (Thursday, February 16, 2017)]
[Proposed Rules]
[Pages 10868-10870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03117]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 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. 82, No. 31 / Thursday, February 16, 2017 / 
Proposed Rules  

[[Page 10868]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-D-2335]


Use of the Term ``Healthy'' in the Labeling of Human Food 
Products; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
following public meeting entitled ``Use of the Term `Healthy' in the 
Labeling of Human Food Products.'' The purpose of the public meeting is 
to give interested persons an opportunity to discuss the use of the 
term ``healthy'' in the labeling of human food.

DATES: The public meeting will be held on March 9, 2017, from 8:30 a.m. 
until 5:30 p.m. See section III ``How to Participate in the Public 
Meeting'' in the SUPPLEMENTARY INFORMATION section of this document for 
dates and times of the public meetings, closing dates for advance 
registration, requesting special accommodations due to disability, and 
other information regarding meeting participation.

ADDRESSES: The public meeting will be held at the Hilton Washington DC/
Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852.
    You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2335 for ``Use of the Term `Healthy' in the Labeling of 
Human Food Products; Request for Information and Comments.'' 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 Division of Dockets Management 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 Division of Dockets Management. 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: 
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 
    For questions about registering for the meeting or to register by 
phone: Jim Nakayama, The Nakamoto Group, Inc., 11820 Parklawn Dr., 
Suite 240, Rockville, MD 20852, 301-468-6535, ext. 212, FAX: 301-468-
6536, email: [email protected].
    For general questions about the meeting or for special 
accommodations due to a disability: Juanita Yates, Center for Food 
Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1731, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of September 28, 2016, we published a 
document inviting public comment on the possibility of redefining the 
``healthy'' nutrient content claim for food labeling (81 FR 66562). 
This action was

[[Page 10869]]

consistent with our recently released 2016-2025 Foods and Veterinary 
Medicine (FVM) Program's strategic plan with specific goals for 
nutrition and other planned and recent activity including the issuance 
of final rules updating certain of our nutrition labeling regulations. 
The document also contained several specific questions on which we 
sought input (81 FR 66562 at 66564 to 66565). In the Federal Register 
of December 30, 2016, we published a document extending the comment 
period for the docket to receive information and comments on the use of 
the term ``healthy'' in the labeling of human food (81 FR 96404); the 
comment period, which was originally scheduled to end on January 26, 
2017, was extended to April 26, 2017.
    We also recently announced the availability of a guidance for 
industry entitled ``Use of the Term `Healthy' in the Labeling of Human 
Food Products: Guidance to Industry'' (81 FR 66527). The guidance 
advises manufacturers who wish to use the implied nutrient content 
claim ``healthy'' to label their food products as provided by our 
regulations. More specifically, the guidance advises food manufacturers 
of FDA's intent to exercise enforcement discretion with respect to the 
implied nutrient content claim ``healthy'' on foods that have a fat 
profile of predominantly mono and polyunsaturated fats, but do not meet 
the regulatory definition of ``low fat,'' or that contain at least 10 
percent of the Daily Value (DV) per reference amount customarily 
consumed (RACC) of potassium or vitamin D.
    In addition, we received a citizen petition asking that we update, 
among other things, our nutrient content claim regulations to be 
consistent with current federal dietary guidance (see Docket No. FDA-
2015-P-4564 (citizen petition from KIND LLC)). In particular, the 
petitioners requested that FDA amend the regulation defining the 
nutrient content claim ``healthy'' with respect to total fat intake and 
amend the regulation to emphasize whole foods and dietary patterns 
rather than specific nutrients.

II. Purpose and Format of the Public Meeting

    We are holding the public meeting to give interested parties an 
opportunity to discuss the use of the term ``healthy'' in the labeling 
of human food. At the meeting, following introductory presentations, 
parties will have an opportunity to participate in their choice of 
breakout sessions on topics referenced in the notice and related 
documents and engage in an open comment and question and answer 
session. We invite interested parties to provide information, share 
experiences, and raise issues specifically related to the nutrient 
content claim ``healthy,'' including (but not limited to): ``healthy'' 
as a nutrient-based claim, food component-based claim, or both; 
``healthy'' single definition or definition by category; consumer 
understanding of and responses to the term ``healthy''; and when, if 
ever, the use of the term ``healthy'' may be false or misleading. 
Interested parties may also submit electronic or written comments to 
the docket by April 26, 2017. The agenda and other documents will be 
accessible on our FDA public meetings Web site at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm before the 
public meeting.
    In general, the meeting format will include introductory 
presentations, perspectives panels, and multiple opportunities for 
individuals to express their opinions at the meeting through oral 
presentations, participation in breakout sessions, and submission of 
electronic or written comments (see ADDRESSES for information on 
submitting comments). There will be an opportunity for parties who are 
unable to participate in person to join the meeting via Webcast. (See 
section III for more information on the Webcast option.)

III. How To Participate in the Public Meeting

    Due to limited space and time, we encourage all persons who wish to 
attend the meeting to register in advance. There is no fee to register 
for the public meeting, and registration will be on a first-come, 
first-served basis. Early registration is recommended because seating 
is limited. Onsite registration will be accepted, if space permits, 
after all preregistered attendees are seated.
    Those requesting an opportunity to make an oral presentation during 
the time allotted for public comment at the meeting should submit a 
request in advance (see table 1 for details) and provide the specific 
topic or issue to be addressed. Due to the anticipated high level of 
interest in presenting public comment and the limited time available, 
we are allocating 3 minutes to each speaker to make an oral 
presentation. Speakers will be limited to making oral remarks; there 
will not be an opportunity to display materials such as slide shows, 
videos, or other media during the meeting. If time permits, individuals 
or organizations that did not register in advance may be granted the 
opportunity to make an oral presentation. We would like to maximize the 
number of individuals who make a presentation at the meeting and will 
do our best to accommodate all persons who wish to make a presentation 
or express their opinions at the meeting.
    We encourage persons and groups who have similar interests to 
consolidate their information for presentation by a single 
representative. After reviewing the presentation requests, we will 
notify each participant before the meeting of the approximate time 
their presentation is scheduled to begin, and remind them of the 
presentation format (i.e., 3-minute oral presentation without visual 
media).
    Table 1 of this document provides information on participation in 
the public meeting.

          Table 1--Information on Participation in the Meeting and on Submitting Comments to the Docket
----------------------------------------------------------------------------------------------------------------
            Activity                    Date         Electronic addresses        Address       Other information
----------------------------------------------------------------------------------------------------------------
Attend public meeting..........  March 9, 2017,      Preregister at http:/ ..................  Registration
                                  from 8:30 a.m. to   /www.fda.gov/Food/                        check-in begins
                                  5:30 p.m.           NewsEvents/                               at 8 a.m.
                                                      WorkshopsMeetingsCo
                                                      nferences/
                                                      default.htm.
View Webcast...................  March 9, 2017,      Webcast participants  ..................  The Webcast will
                                  from 8:30 a.m. to   are asked to                              have closed
                                  5:30 p.m.           preregister at                            captioning.
                                                      http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.

[[Page 10870]]

 
Advance registration...........  Register by March   To participate in     We encourage the    There is no
                                  2, 2017.            person preregister    use of electronic   registration fee
                                                      at http://            registration, if    for the public
                                                      www.fda.gov/Food/     possible \1\.       meeting.
                                                      NewsEvents/
                                                      WorkshopsMeetingsCo
                                                      nferences/
                                                      default.htm.
Request to make an oral          By February 21,     To request to make
 presentation.                    2017.               an oral
                                                      presentation sign-
                                                      up at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Submit either electronic or      Submit comments by  http://               Division of         See ADDRESSES for
 written comments.                April 26, 2017.     www.regulations.gov.  Dockets             information on
                                                                            Management (HFA-    submitting
                                                                            305), Food and      comments.
                                                                            Drug
                                                                            Administration,
                                                                            5630 Fishers
                                                                            Lane, Rm. 1061,
                                                                            Rockville, MD
                                                                            20852.
Request special accommodations   Request by          Juanita Yates,        See FOR FURTHER
 due to a disability.             February 21, 2017.  email:                INFORMATION
                                                      [email protected]   CONTACT.
                                                      hs.gov.
----------------------------------------------------------------------------------------------------------------
\1\ You may also register via email, mail, or fax. Please include your name, title, firm name, address, and
  phone and fax numbers in your registration information and send to: Jim Nakayama (see FOR FURTHER INFORMATION
  CONTACT).

IV. Transcripts and Recorded Video

    Please be advised that as soon as a transcript of the public 
meeting is available, it will be accessible at https://www.regulations.gov. The transcript will also be accessible at the 
Division of Dockets Management (see ADDRESSES) and FDA public meetings 
Web site at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    Additionally, we will be video recording the public meeting. Once 
the recorded video is available, it will be accessible on our FDA 
public meetings Web site at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.

    Dated: February 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03117 Filed 2-15-17; 8:45 am]
BILLING CODE 4164-01-P