
[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Proposed Rules]
[Pages 44302-44303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17929]



[[Page 44302]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2012-N-1210]
RIN 0910-AF22


Food Labeling: Revision of the Nutrition and Supplement Facts 
Labels; Reopening of the Comment Period as to Specific Documents

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period as to specific 
documents.

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SUMMARY: The Food and Drug Administration (FDA or we) is reopening, as 
to specific documents, the comment period regarding our proposed rule 
to revise the Nutrition Facts and Supplement Facts labels. We are 
reopening the comment period for 60 days for the sole purpose of 
inviting public comments on two consumer studies being added to the 
administrative record. The consumer studies pertained to proposed 
changes to the Nutrition Facts label formats.

DATES: The comment period for the proposed rule published March 3, 2014 
(79 FR 11879), is reopened for the limited purpose described in this 
document. Submit either electronic or written comments by September 25, 
2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
(FDA-2012-N-1210) for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), 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: Philip L. Chao, Center for Food Safety 
and Applied Nutrition (HFS-24), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2112.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 3, 2014 (79 FR 11879), we 
published a proposed rule to amend our labeling regulations for 
conventional foods and dietary supplements to provide updated nutrition 
information on the label to assist consumers in maintaining healthy 
dietary practices. The proposed rule would update the list of nutrients 
that are required or permitted to be declared; provide updated Daily 
Reference Values and Reference Daily Intake values that are based on 
current dietary recommendations from consensus reports; 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 revise the format and appearance of the Nutrition Facts 
label. In the preamble to the proposed rule (79 FR 11879 at 11905, 
11947 to 11948, 11952), we indicated that we intended to conduct 
consumer studies related to proposed changes to the format of the 
Nutrition Facts label and that we might use the results of the studies 
to help inform our future actions on certain label-related issues. We 
also indicated that we would publish the results of the studies when 
they became available (79 FR 11879 at 11952), and we invited comment on 
the use of an alternative format design and other format-related issues 
(79 FR 11879 at 11961).
    We recently completed two consumer studies and, as a result, are 
adding two documents pertaining to those studies to the administrative 
record and providing an opportunity for public comment. We believe that 
a public comment period of 60 days is adequate in this case because we 
are specifically limiting the reopened comment period to comments on 
the two consumer studies. Comments are invited, and will be considered, 
only to the extent that they are focused on the two consumer studies 
being added to the record. These two consumer studies (Refs. 1 and 2) 
being added to the record are as follows:

1. FDA, Eye-Tracking Experimental Study on Consumer Responses to 
Modifications to the Nutrition Facts Label Outlined in the Food and 
Drug Administration's Proposed Rulemaking, June 2015. This was a 
study in which 160 participants participated in a computer-based 
research of the potential effects of several possible changes to the 
label on consumer viewing and use of the label.
2. FDA, Experimental Study of Proposed Changes to the Nutrition 
Facts Label Formats, June 2015. This was a Web-based experiment, 
involving more than 5,000 participants, designed to explore whether 
modifications to the format of the Nutrition Facts label would 
affect consumers' interpretation of information on the Nutrition 
Facts label.

After reviewing the comments on the proposed rule, we have tentatively 
concluded that we do not intend to further consider the alternative 
format for the Nutrition Facts label. A review of the results of the 
consumer research made available in this document has not provided 
information to change our planned approach. Therefore, interested 
persons who intend to submit comments may wish to focus on the study 
results relevant to the current and proposed formats.

II. Comments

    Interested persons may submit either electronic comments regarding 
the guidance to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov.

1. FDA, Eye-Tracking Experimental Study on Consumer Responses to 
Modifications to the Nutrition Facts Label Outlined in the Food and 
Drug Administration's Proposed Rulemaking, June 2015.
2. FDA, Experimental Study of Proposed Changes to the Nutrition 
Facts Label Formats, June 2015.


[[Page 44303]]


    Dated: July 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17929 Filed 7-24-15; 8:45 am]
 BILLING CODE 4164-01-P


