Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Reopening of the Comment Period as to Specific Documents, 44302-44303 [2015-17929]
Download as PDF
<![CDATA[
44302
Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Proposed Rules
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.
Proposed rule; reopening of
comment period as to specific
documents.
ACTION:
I. Background
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:
SUMMARY:
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
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 https://
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.
VerDate Sep<11>2014
16:26 Jul 24, 2015
Jkt 235001
Docket: For access to the docket to
read background documents or
comments received, go to https://
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:
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
PO 00000
Frm 00002
Fmt 4702
Sfmt 4702
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 Webbased 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 https://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 https://
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 https://
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.
E:\FR\FM\27JYP1.SGM
27JYP1
Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Proposed Rules
Dated: July 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Reduction Act of 1995 (the PRA) must
be submitted to the Office of
Information and Regulatory Affairs,
Office of Management and Budget
(OMB) (see the ‘‘Paperwork Reduction
Act of 1995’’ section of this document).
[FR Doc. 2015–17929 Filed 7–24–15; 8:45 am]
BILLING CODE 4164–01–P
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 101
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
[Docket No. FDA–2012–N–1210]
Written Submissions
Food and Drug Administration
Food Labeling: Revision of the
Nutrition and Supplement Facts
Labels; Supplemental Proposed Rule
To Solicit Comment on Limited
Additional Provisions
AGENCY:
Food and Drug Administration,
HHS.
Proposed rule; supplemental
notice of proposed rulemaking.
ACTION:
The Food and Drug
Administration (FDA or we) is revising
certain provisions of the proposed rule,
issued in March 2014, that would
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 (‘‘the NFL/SFL
proposed rule’’). We are proposing text
for the footnotes to be used on the
Nutrition Facts label. We are taking this
action after completing our consumer
research in which we tested various
footnote text options for the label. We
are also proposing to establish a Daily
Reference Value (DRV) of 10 percent of
total energy intake from added sugars,
proposing to require the declaration of
the percent Daily Value (DV) for added
sugars on the label, and are providing
additional rationale for the declaration
of added sugars on the label. We are
taking these actions based, in part, on
the science underlying a new report
released by the 2015 Dietary Guidelines
Advisory Committee.
DATES: Submit either electronic or
written comments on the supplemental
notice of proposed rulemaking by
October 13, 2015. Submit comments on
information collection issues under the
Paperwork Reduction Act of 1995 by
August 26, 2015, (see the ‘‘Paperwork
Reduction Act of 1995’’ section of this
document).
ADDRESSES: You may submit comments
by any of the following methods, except
that comments on information
collection issues under the Paperwork
mstockstill on DSK4VPTVN1PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
16:26 Jul 24, 2015
Jkt 235001
Submit written submissions in the
following ways:
• Mail/Hand delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5360 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 https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘How to Submit
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 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, 5600 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
With regard to the supplemental notice
of proposed rulemaking: Blakeley
Fitzpatrick, Center for Food Safety and
Applied Nutrition (HFS–830), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–5429, email:
NutritionProgramStaff@fda.hhs.gov.
With regard to the information
collection: FDA PRA Staff, Office of
Operations, Food and Drug
Administration, 8455 Colesville Rd.,
COLE–14526, Silver Spring, MD 20993–
0002, email: PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Executive Summary
Purpose of the Regulatory Action
FDA is revising certain provisions of
the proposed rule that published in the
Federal Register on March 3, 2014 (79
FR 11879), that would amend FDA’s
labeling regulations for conventional
PO 00000
Frm 00003
Fmt 4702
Sfmt 4702
44303
foods and dietary supplements to
provide updated nutrition information
on the NFL/SFL proposed rule.
In the NFL/SFL proposed rule, we
proposed to remove the requirement for
the footnote listing the reference values
for certain nutrients for 2,000 and 2,500
calorie diets and reserved space to
provide a proposed footnote. We stated
in the preamble of the NFL/SFL
proposed rule that we would continue
to perform research during this
rulemaking process to evaluate how
variations in label format may affect
consumer understanding and use of the
Nutrition Facts label. We also stated that
we would publish the results of our
research for public review and
comment. We are making results of our
research available in this document. We
are also proposing text for the footnotes
to be used on the Nutrition Facts label.
We are taking this action after
completing our consumer research in
which we tested various footnote text
options for the label. We are also
providing an exemption from the
footnote requirement for certain foods.
In addition, the NFL/SFL proposed
rule would require the declaration of
added sugars as an indented line item
underneath the declaration of ‘‘Sugars’’
on the Nutrition Facts label. We
discussed in the NFL/SFL proposed rule
that we were considering whether to use
the term ‘‘Total Sugars’’ instead of
‘‘Sugars’’ on the label if we finalize a
declaration of added sugars.
We stated in the NFL/SFL proposed
rule that we were planning to conduct
a consumer study that would include,
among other things, questions regarding
the declaration of added sugars on the
Nutrition Facts label in order to help
enhance our understanding of how
consumers would comprehend and use
this new information. We also stated
that we would publish the results of the
study when they become available.
As we prepared to make the consumer
study results for the footnote and added
sugars declaration available, new
information emerged from the
‘‘Scientific Report of the 2015 Dietary
Guidelines Advisory Committee’’ (the
2015 DGAC report) regarding added
sugars. The new information on added
sugars led us to reconsider our thinking
for not establishing a DRV or requiring
the declaration of a percent DV for
added sugars on the Nutrition Facts and
Supplement Facts labels. Specifically,
the 2015 DGAC report provided
evidence suggesting a strong association
between a dietary pattern of intake
characterized, in part, by a reduced
intake of added sugars and a reduced
risk of cardiovascular disease. The
evidence also suggested an applicable
E:\FR\FM\27JYP1.SGM
27JYP1
]]>Agencies
[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]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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 https://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 https://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 https://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 https://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
