
[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Proposed Rules]
[Pages 30763-30766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12362]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. FDA-2012-N-1210 and FDA-2004-N-0258]


Proposed Rules on Food Labeling: Revision of the Nutrition and 
Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably 
Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, 
Modifying, and Establishing Certain Reference Amounts Customarily 
Consumed; Serving Size for Breath Mints; and Technical Amendments; 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing a 
public meeting to discuss two proposed rules aimed at updating 
nutrition information and serving size requirements on the nutrition 
facts labels to provide consumers with information that could be used 
to maintain healthy dietary practices. The purpose of the public 
meeting is to inform the public of the provisions of the proposed rules 
and the rulemaking process (including how to submit comments, data, and 
other information to both dockets) as well as solicit oral stakeholder 
and public comments on the proposed rules and to respond to questions 
about the proposed rules.

DATES: See ``How to Participate in the Public Meeting'' in the 
SUPPLEMENTARY INFORMATION section of this document for dates and times 
of the public meeting, closing dates for advance registration, 
requesting special accommodations due to disability, and information on 
deadlines for submitting either electronic or written comments to FDA's 
Division of Dockets Management.

ADDRESSES: See ``How to Participate in the Public Meeting'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: 
    For questions about registering for this meeting, registering to 
make oral comments, to register by phone, or to submit a notice of 
participation by mail, fax, or email: Cindy de Sales, The Event 
Planning Group, LLC, 7910 Woodmont Ave., Suite 310, Bethesda, MD 20814, 
240-316-3207, FAX: 240-316-3201, email: cindy@tepgevents.com.
    For general questions about this meeting or for special 
accommodations due to disability, contact: Juanita Yates, Center for 
Food Safety and Applied Nutrition (HFS-005), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1731, email: Juanita.yates@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Nutrition Facts Label Proposed Rule

    After the passage of the Nutrition Labeling and Education Act of 
1990 (NLEA) (Pub. L. 101-535), which added section 403(q) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q), 
we issued various regulations related to nutrition information on food 
labels, including regulations requiring the declaration of certain 
nutrients, regulations specifying the format for nutrition labeling, 
regulations setting reference values for use in declaring nutrient 
content for certain nutrients, and regulations exempting certain 
products from nutrition labeling (see 21 CFR 101.9). In addition, after 
the passage of the Dietary Supplement Health and Education Act of 1994 
(Pub. L. 103-417), we amended our food labeling regulations to 
establish requirements for the nutrition labeling of dietary 
supplements (Sec.  101.9(j)(6) and 21 CFR 101.36). Section 403(q) of 
the FD&C Act specifies certain nutrients to be declared in nutrition 
labeling, and authorizes the Secretary of Health and Human Services to 
require other nutrients to be declared if the Secretary determines that 
a nutrient will provide information regarding the nutritional value of 
such food that will assist consumers in maintaining healthy dietary 
practices. The Secretary also has discretion under section 403(q) of 
the FD&C Act to remove, by regulation and under certain

[[Page 30764]]

circumstances, nutrient information that is otherwise explicitly 
required in food labeling under this section.
    In the Federal Register of March 3, 2014 (79 FR 11879), we 
published a proposed rule entitled ``Food Labeling: Revision of the 
Nutrition and Supplement Facts Labels'' (the Nutrition Facts label 
proposed rule). In the Nutrition Facts label proposed rule, we proposed 
to revise our regulations to update, among other things, the nutrients 
that are required and/or permitted to be declared and the daily values, 
as applicable, for required and permitted nutrients; amend requirements 
for foods represented or purported to be specifically for children 
under the age of 4 years and pregnant and lactating women and establish 
nutrient reference values specifically for these population subgroups; 
and update the format of the Nutrition Facts label. We based the 
proposed rule on the latest science and public health information, 
dietary recommendations of the most recent consensus reports, and 
public comments received in response to advance notices of proposed 
rulemaking.

B. Serving Size Proposed Rule

    After the passage of the NLEA, we issued various regulations 
related to serving size requirements (see Sec.  101.9 and 21 CFR 
101.12). Since we established those regulations, developments have 
compelled us to re-evaluate our regulations on serving sizes and 
determine whether and what, if any, revisions are needed to ensure that 
the Nutrition Facts label meets its intended goal of helping consumers 
maintain healthy dietary practices. Specifically, such developments 
include the availability of newer consumption data, research showing 
that amounts of food consumed by the American public have changed, and 
recent consumer research on the use and understanding of the Nutrition 
Facts label.
    Therefore, in the Federal Register of March 3, 2014 (79 FR 11989), 
we published a proposed rule entitled ``Food Labeling: Serving Sizes of 
Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-
Column Labeling; Updating, Modifying, and Establishing Certain 
Reference Amounts Customarily Consumed; Serving Size for Breath Mints; 
and Technical Amendments'' (the serving size proposed rule). In the 
serving size proposed rule, we proposed to amend the definition of a 
single-serving container; require dual-column labeling for certain 
packages; update and modify certain reference amounts customarily 
consumed (RACCs); add several food products and food product categories 
to the RACCs for the general food supply; amend the label serving size 
for breath mints; and make technical amendments to various aspects of 
the serving size regulations.

II. Purpose and Format of the Public Meeting

    FDA is holding the public meeting on the Nutrition Facts label and 
serving size proposed rules to inform the public of the provisions of 
the proposed rules and the rulemaking process (including how to submit 
comments, data, and other information to both dockets) as well as 
solicit oral stakeholder and public comments on the proposed rules and 
to respond to questions about the proposed rules. In general, the 
meeting format will include introductory presentations by FDA with time 
to hear stakeholder perspectives, questions and public comments.

III. How To Participate in the Public Meeting

    The meeting will be held on June 26, 2014, from 8:30 a.m. to 5 p.m. 
Eastern Standard Time (EST) at the Jefferson Auditorium, U.S. 
Department of Agriculture (USDA), Wing 5 Entrance, 14th and 
Independence Ave. SW., Washington, DC 20024. FDA encourages all persons 
who wish to attend the meeting to register in advance of the meeting. 
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.
    If you preregister and would like to make an oral presentation at 
the meeting, please submit a request when you preregister. Due to the 
anticipated high level of interest in presenting public comment and 
limited time available, FDA will allocate time (typically 3 to 4 
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. 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.
    FDA encourages persons and groups who have similar interests to 
consolidate their information for presentation by a single 
representative. After reviewing the oral presentation requests, FDA 
will notify each participant before the meeting if their presentation 
request is granted, and, if so, the approximate time their presentation 
is scheduled to begin and remind them of the presentation format (e.g., 
3-minute oral presentation without visual media).
    While oral presentations from specific individuals and 
organizations will be limited to a certain length of time due to time 
constraints during the public meeting, stakeholders may submit 
electronic or written comments discussing any issues of concern to the 
dockets for the proposed rules. All relevant data and documentation 
should be submitted with the comments to the relevant docket, i.e., 
Nutrition Facts label proposed rule, Docket No. FDA-2012-N-1210 http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1210-0002, or serving 
size proposed rule, Docket No. FDA-2004-N-0258 http://www.regulations.gov/#!documentDetail;D=FDA-2004-N-0258-0006.
    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 Dockets for the Proposed
                                                      Rules
----------------------------------------------------------------------------------------------------------------
                                         Date         Electronic address        Address        Other information
----------------------------------------------------------------------------------------------------------------
Attend public meeting...........  June 26, 2014,      Please preregister  Jefferson           Registration check-
                                   from 8:30 a.m. to   at http://          Auditorium, U.S.    in begins at 8
                                   5 p.m. EST.         www.fda.gov/Food/   Department of       a.m.
                                                       NewsEvents/         Agriculture
                                                       WorkshopsMeetings   (USDA), Wing 5
                                                       Conferences/        Entrance, 14th
                                                       default.htm.        and Independence
                                                                           Ave. SW.,
                                                                           Washington, DC
                                                                           20024. Photo ID
                                                                           Required.

[[Page 30765]]

 
View Web cast...................  June 26, 2014,      Please preregister  ..................  The Web cast will
                                   from 8:30 a.m. to   at http://                              have closed
                                   5 p.m. EST.         www.fda.gov/Food/                       captioning.
                                                       NewsEvents/
                                                       WorkshopsMeetings
                                                       Conferences/
                                                       default.htm.
Preregister.....................  Register by June    Individuals who     We encourage the    There is no
                                   20, 2014.           wish to             use of electronic   registration fee
                                                       participate in      registration, if    for the public
                                                       person or via Web   possible.\1\        meeting.
                                                       Cast are asked to
                                                       preregister at
                                                       http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Request special accommodations    Request by June     Juanita Yates,      See For Further     ..................
 due to disability.                12, 2014.           email:              Information
                                                       Juanita.yates@fda   Contact.
                                                       .hhs.gov.
Request to make oral              Register by June    http://www.fda.gov/ ..................  We will grant
 presentation.                     12, 2014.           Food/NewsEvents/                        requests made on
                                                       WorkshopsMeetings                       the day of the
                                                       Conferences/                            meeting to make
                                                       default.htm.\2\                         an oral
                                                                                               presentation as
                                                                                               time permits.
                                                                                               Information on
                                                                                               requests to make
                                                                                               an oral
                                                                                               presentation may
                                                                                               be posted without
                                                                                               change to http://www.regulations.gov ov, including any
                                                                                               personal
                                                                                               information.
Submit electronic or written      Submit comments by  Federal             Mail/Hand delivery/ Identify your
 comments.                         August 1, 2014.     eRulemaking         Courier (for        comments with the
                                                       Portal: http://     paper               appropriate
                                                       www.regulations.g   submissions):       docket number
                                                       ov. Follow the      Division of         (Docket No. FDA-
                                                       instructions for    Dockets             012-N-1210 http://
                                                       submitting          Management (HFA-    www.regulations.g
                                                       comments.           305), Food and      ov/
                                                                           Drug                #!documentDetail;
                                                                           Administration,     D=FDA-2012-N-1210-
                                                                           5360 Fishers        0002 for
                                                                           Lane, rm. 1061,     Nutrition Facts
                                                                           Rockville, MD       label proposed
                                                                           20852.              rule or Docket
                                                                                               No. FDA-2004-N-
                                                                                               0258 http://www.regulations.gov/#!documentDetail;
                                                                                               D=FDA-2004-N-0258-
                                                                                               0006 for serving
                                                                                               size proposed
                                                                                               rule). We
                                                                                               encourage you to
                                                                                               submit electronic
                                                                                               comments by using
                                                                                               the Federal
                                                                                               eRulemaking
                                                                                               Portal.
----------------------------------------------------------------------------------------------------------------
\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: Cindy de Sales, The Event Planning Group,
  LLC, 7910 Woodmont Avenue, suite 310, Bethesda, MD 20814, 240-316-3207, FAX: 240-316-3201, email:
  cindy@tepgevents.com.
\2\ You may also request to make an oral presentation at the public meeting via email. Please include your name,
  title, firm name, address, and phone and fax numbers, and send to Cindy de Sales (see FOR FURTHER INFORMATION
  CONTACT).

IV. Comments, Transcripts, and Recorded Video

    Information and data, including any personal information, submitted 
to FDA during the public meeting and the comment period for the 
proposed rules will become part of the administrative record for the 
relevant rulemaking. This information and data will be accessible to 
the public at http://www.regulations.gov and between 9 a.m. and 4 p.m., 
Monday through Friday, at the Division of Dockets Management (see 
Addresses in table 1).
    Regardless of attendance at the public meeting, interested persons 
may submit to FDA's Division of Dockets Management (see Addresses in 
table 1) either electronic or written comments. You only need to send 
one set of comments. Identify the comments with the appropriate docket 
number (Docket No. FDA-2012-N-1210 for the Nutrition Facts label 
proposed rule or Docket No. FDA-2004-N-0258 for the serving size 
proposed rule). If you have comments pertaining to both proposed rules, 
submit them separately for each rule to ensure consideration.
    The transcript of the proceedings from the public meeting will 
become part of the administrative record for each of the rulemakings. 
As soon as the transcript is ready, we will make it available at http://www.regulations.gov and at http://www.fda.gov/Food/. It may also be 
viewed between 9 a.m. and 4 p.m., Monday through Friday, at the 
Division of Dockets Management (see Addresses in table 1). The 
transcript will also be available in either hardcopy or on CD-ROM after 
submission of a Freedom of Information request. Send written requests 
to the Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
    Additionally, FDA will be video recording the public meeting. Once 
the

[[Page 30766]]

recorded video is available, you can access it at http://www.fda.gov/Food/.

    Dated: May 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12362 Filed 5-28-14; 8:45 am]
BILLING CODE 4160-01-P


