
[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Proposed Rules]
[Pages 54446-54447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22757]


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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; Administrative Docket Update; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; notification.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of certain documents to update the administrative docket 
of the proposed rule to amend FDA's labeling regulations for 
conventional foods and dietary supplements to provide updated nutrition 
information on the Nutrition Facts and Supplement Facts labels to 
assist consumers in maintaining healthy dietary practices.

DATES: We are extending the comment period that was scheduled to close 
on September 25, 2015, until October 13, 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: Serena Lo, Center for Food Safety and 
Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 240-402-2488, email: 
ConsumerStudiesBranch@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 3, 2014 (79 FR 11879), we 
published a proposed rule that would amend our

[[Page 54447]]

labeling regulations for conventional foods and dietary supplements to 
provide updated nutrition information. More recently, in the Federal 
Register of July 27, 2015 (80 FR 44302), we reopened the comment period 
through September 25, 2015, for the proposed rule 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. We also issued a 
supplemental proposed rule (80 FR 44303) with a comment period through 
October 13, 2015. The supplemental proposal included two additional 
consumer studies pertaining to the declaration of added sugars and 
alternative footnote statements. We proposed text for the footnotes to 
be used on the Nutrition Facts label, after completing our consumer 
research in which we tested various footnote text options for the 
label, and to establish a Daily Reference Value of 10 percent of total 
energy intake from added sugars. The supplemental proposal also would 
require the declaration of the percent Daily Value for added sugars on 
the label and provide an additional rationale for the declaration of 
added sugars on the label. We explained that we were taking these 
actions based, in part, on the science underlying a new report released 
by the 2015 Dietary Guidelines Advisory Committee.
    We have received some comments suggesting we are not eliciting 
comment on the consumer studies in the supplemental proposal published 
in July 2015. We clarify in this notice that: (1) The consumer studies 
on the added sugars declaration and the alternative footnote statements 
in the supplemental proposal relate to topics on which we sought 
comment and (2) the consumer studies on the format published in a 
separate notice in July 2015 were included for comment, and were placed 
in the docket at that time. We are now responding to additional 
requests for the raw data for each of these consumer studies that are 
relevant to the summary memoranda for the studies, also now available 
for comment.

II. Updated Information

    We are updating the docket for the rulemaking with two additional 
documents: A request from the Grocery Manufacturers Association for the 
raw data associated with the four consumer studies described in this 
document, and our response to that request indicating that we will 
provide the raw data underlying the four consumer studies to anyone who 
submits a request to ConsumerStudiesBranch@fda.hhs.gov.
    These documents may be seen by interested persons at the Division 
of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday 
through Friday, and are available electronically at http://www.regulations.gov.
    In addition, we are extending to October 13, 2015, the comment 
period on the two consumer studies pertaining to proposed changes to 
the Nutrition Facts label formats, which had been scheduled to close on 
September 25, 2015, to align the comment periods for all consumer 
studies.
    We will continue to take comment on the supplemental proposed rule, 
including taking comment on the consumer studies on added sugars and 
the footnote, until October 13, 2015.

    Dated: September 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22757 Filed 9-9-15; 8:45 am]
BILLING CODE 4164-01-P


