80 FR 44302 - Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Reopening of the Comment Period as to Specific Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 143 (July 27, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 143 (July 27, 2015)
| Page Range | 44302-44303 | |
| FR Document | 2015-17929 |
[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)] [Proposed Rules] [Pages 44302-44303] From the Federal Register Online [www.thefederalregister.org] [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: 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
![44302 Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Proposed Rules
DEPARTMENT OF HEALTH AND Docket: For access to the docket to the two consumer studies being added
HUMAN SERVICES read background documents or to the record. These two consumer
comments received, go to http:// studies (Refs. 1 and 2) being added to
Food and Drug Administration www.regulations.gov and insert the the record are as follows:
docket number(s), found in brackets in 1. FDA, Eye-Tracking Experimental Study on
21 CFR Part 101 the heading of this document, into the Consumer Responses to Modifications to
[Docket No. FDA–2012–N–1210] ‘‘Search’’ box and follow the prompts the Nutrition Facts Label Outlined in the
and/or go to the Division of Dockets Food and Drug Administration’s
RIN 0910–AF22 Management, 5630 Fishers Lane, Rm. Proposed Rulemaking, June 2015. This
1061, Rockville, MD 20852. was a study in which 160 participants
Food Labeling: Revision of the participated in a computer-based
Nutrition and Supplement Facts FOR FURTHER INFORMATION CONTACT:
research of the potential effects of several
Labels; Reopening of the Comment Philip L. Chao, Center for Food Safety possible changes to the label on
Period as to Specific Documents and Applied Nutrition (HFS–24), Food consumer viewing and use of the label.
and Drug Administration, 5100 Paint 2. FDA, Experimental Study of Proposed
AGENCY: Food and Drug Administration, Branch Pkwy., College Park, MD 20740, Changes to the Nutrition Facts Label
HHS. 240–402–2112. Formats, June 2015. This was a Web-
Proposed rule; reopening of
ACTION: SUPPLEMENTARY INFORMATION: based experiment, involving more than
comment period as to specific 5,000 participants, designed to explore
documents. I. Background whether modifications to the format of
the Nutrition Facts label would affect
In the Federal Register of March 3, consumers’ interpretation of information
SUMMARY: The Food and Drug
2014 (79 FR 11879), we published a on the Nutrition Facts label.
Administration (FDA or we) is
proposed rule to amend our labeling
reopening, as to specific documents, the After reviewing the comments on the
regulations for conventional foods and
comment period regarding our proposed proposed rule, we have tentatively
dietary supplements to provide updated
rule to revise the Nutrition Facts and concluded that we do not intend to
nutrition information on the label to
Supplement Facts labels. We are further consider the alternative format
reopening the comment period for 60 assist consumers in maintaining healthy
for the Nutrition Facts label. A review
days for the sole purpose of inviting dietary practices. The proposed rule
of the results of the consumer research
public comments on two consumer would update the list of nutrients that
made available in this document has not
studies being added to the are required or permitted to be declared;
provided information to change our
administrative record. The consumer provide updated Daily Reference Values
planned approach. Therefore, interested
studies pertained to proposed changes and Reference Daily Intake values that
persons who intend to submit
to the Nutrition Facts label formats. are based on current dietary
comments may wish to focus on the
recommendations from consensus
DATES: The comment period for the study results relevant to the current and
reports; amend requirements for foods
proposed rule published March 3, 2014 proposed formats.
represented or purported to be
(79 FR 11879), is reopened for the
specifically for children under the age of II. Comments
limited purpose described in this
4 years and pregnant and lactating
document. Submit either electronic or Interested persons may submit either
women and establish nutrient reference
written comments by September 25, electronic comments regarding the
2015. values specifically for these population
guidance to http://www.regulations.gov
subgroups; and revise the format and
ADDRESSES: You may submit comments or written comments to the Division of
appearance of the Nutrition Facts label.
by any of the following methods: Dockets Management (see ADDRESSES). It
In the preamble to the proposed rule (79
is only necessary to send one set of
Electronic Submissions FR 11879 at 11905, 11947 to 11948,
comments. Identify comments with the
11952), we indicated that we intended
Submit electronic comments in the docket number found in brackets in the
to conduct consumer studies related to
following way: heading of this document. Received
proposed changes to the format of the
• Federal eRulemaking Portal: http:// comments may be seen in the Division
Nutrition Facts label and that we might
www.regulations.gov. Follow the of Dockets Management between 9 a.m.
instructions for submitting comments. use the results of the studies to help
and 4 p.m., Monday through Friday, and
inform our future actions on certain
will be posted to the docket at http://
Written Submissions label-related issues. We also indicated
www.regulations.gov.
Submit written submissions in the that we would publish the results of the
following ways: studies when they became available (79 III. References
• Mail/Hand delivery/Courier (for FR 11879 at 11952), and we invited The following references have been
paper submissions): Division of Dockets comment on the use of an alternative placed on display in the Division of
Management (HFA–305), Food and Drug format design and other format-related Dockets Management (see ADDRESSES)
Administration, 5630 Fishers Lane, Rm. issues (79 FR 11879 at 11961). and may be seen by interested persons
1061, Rockville, MD 20852. We recently completed two consumer between 9 a.m. and 4 p.m., Monday
Instructions: All submissions received studies and, as a result, are adding two through Friday, and are available
must include the Docket No. (FDA– documents pertaining to those studies to electronically at http://
2012–N–1210) for this rulemaking. All the administrative record and providing
mstockstill on DSK4VPTVN1PROD with PROPOSALS
www.regulations.gov.
comments received may be posted an opportunity for public comment. We
without change to http:// believe that a public comment period of 1. FDA, Eye-Tracking Experimental Study on
www.regulations.gov, including any 60 days is adequate in this case because Consumer Responses to Modifications to
the Nutrition Facts Label Outlined in the
personal information provided. For we are specifically limiting the Food and Drug Administration’s
additional information on submitting reopened comment period to comments Proposed Rulemaking, June 2015.
comments, see the ‘‘Comments’’ heading on the two consumer studies. Comments 2. FDA, Experimental Study of Proposed
of the SUPPLEMENTARY INFORMATION are invited, and will be considered, only Changes to the Nutrition Facts Label
section of this document. to the extent that they are focused on Formats, June 2015.
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![Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Proposed Rules 44303
Dated: July 17, 2015. Reduction Act of 1995 (the PRA) must foods and dietary supplements to
Leslie Kux, be submitted to the Office of provide updated nutrition information
Associate Commissioner for Policy. Information and Regulatory Affairs, on the NFL/SFL proposed rule.
[FR Doc. 2015–17929 Filed 7–24–15; 8:45 am] Office of Management and Budget In the NFL/SFL proposed rule, we
BILLING CODE 4164–01–P
(OMB) (see the ‘‘Paperwork Reduction proposed to remove the requirement for
Act of 1995’’ section of this document). the footnote listing the reference values
for certain nutrients for 2,000 and 2,500
Electronic Submissions calorie diets and reserved space to
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Submit electronic comments in the provide a proposed footnote. We stated
following way: in the preamble of the NFL/SFL
Food and Drug Administration • Federal eRulemaking Portal: http:// proposed rule that we would continue
www.regulations.gov. Follow the to perform research during this
21 CFR Part 101 instructions for submitting comments. rulemaking process to evaluate how
variations in label format may affect
[Docket No. FDA–2012–N–1210] Written Submissions
consumer understanding and use of the
Submit written submissions in the Nutrition Facts label. We also stated that
Food Labeling: Revision of the following ways: we would publish the results of our
Nutrition and Supplement Facts • Mail/Hand delivery/Courier (for research for public review and
Labels; Supplemental Proposed Rule paper submissions): Division of Dockets comment. We are making results of our
To Solicit Comment on Limited Management (HFA–305), Food and Drug research available in this document. We
Additional Provisions Administration, 5360 Fishers Lane, Rm. are also proposing text for the footnotes
AGENCY: Food and Drug Administration, 1061, Rockville, MD 20852. to be used on the Nutrition Facts label.
HHS. Instructions: All submissions received We are taking this action after
must include the Docket No. FDA– completing our consumer research in
ACTION: Proposed rule; supplemental
2012–N–1210 for this rulemaking. All which we tested various footnote text
notice of proposed rulemaking.
comments received may be posted options for the label. We are also
SUMMARY: The Food and Drug without change to http:// providing an exemption from the
Administration (FDA or we) is revising www.regulations.gov, including any footnote requirement for certain foods.
certain provisions of the proposed rule, personal information provided. For In addition, the NFL/SFL proposed
issued in March 2014, that would additional information on submitting rule would require the declaration of
amend FDA’s labeling regulations for comments, see the ‘‘How to Submit added sugars as an indented line item
conventional foods and dietary Comments’’ heading of the underneath the declaration of ‘‘Sugars’’
supplements to provide updated SUPPLEMENTARY INFORMATION section of on the Nutrition Facts label. We
nutrition information on the Nutrition this document. discussed in the NFL/SFL proposed rule
Facts and Supplement Facts labels to Docket: For access to the docket to that we were considering whether to use
assist consumers in maintaining healthy read background documents or the term ‘‘Total Sugars’’ instead of
dietary practices (‘‘the NFL/SFL comments received, go to http:// ‘‘Sugars’’ on the label if we finalize a
proposed rule’’). We are proposing text www.regulations.gov and insert the declaration of added sugars.
for the footnotes to be used on the docket number, found in brackets in the We stated in the NFL/SFL proposed
Nutrition Facts label. We are taking this heading of this document, into the rule that we were planning to conduct
action after completing our consumer ‘‘Search’’ box and follow the prompts a consumer study that would include,
research in which we tested various and/or go to the Division of Dockets among other things, questions regarding
footnote text options for the label. We Management, 5600 Fishers Lane, Rm. the declaration of added sugars on the
are also proposing to establish a Daily 1061, Rockville, MD 20852. Nutrition Facts label in order to help
Reference Value (DRV) of 10 percent of FOR FURTHER INFORMATION CONTACT:
enhance our understanding of how
With regard to the supplemental notice consumers would comprehend and use
total energy intake from added sugars,
of proposed rulemaking: Blakeley this new information. We also stated
proposing to require the declaration of
Fitzpatrick, Center for Food Safety and that we would publish the results of the
the percent Daily Value (DV) for added
study when they become available.
sugars on the label, and are providing Applied Nutrition (HFS–830), Food and
As we prepared to make the consumer
additional rationale for the declaration Drug Administration, 5100 Paint Branch
study results for the footnote and added
of added sugars on the label. We are Pkwy., College Park, MD 20740, 240– sugars declaration available, new
taking these actions based, in part, on 402–5429, email: information emerged from the
the science underlying a new report NutritionProgramStaff@fda.hhs.gov. ‘‘Scientific Report of the 2015 Dietary
released by the 2015 Dietary Guidelines With regard to the information Guidelines Advisory Committee’’ (the
Advisory Committee. collection: FDA PRA Staff, Office of 2015 DGAC report) regarding added
DATES: Submit either electronic or Operations, Food and Drug sugars. The new information on added
written comments on the supplemental Administration, 8455 Colesville Rd., sugars led us to reconsider our thinking
notice of proposed rulemaking by COLE–14526, Silver Spring, MD 20993– for not establishing a DRV or requiring
October 13, 2015. Submit comments on 0002, email: PRAStaff@fda.hhs.gov. the declaration of a percent DV for
information collection issues under the SUPPLEMENTARY INFORMATION: added sugars on the Nutrition Facts and
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Paperwork Reduction Act of 1995 by Executive Summary Supplement Facts labels. Specifically,
August 26, 2015, (see the ‘‘Paperwork the 2015 DGAC report provided
Reduction Act of 1995’’ section of this Purpose of the Regulatory Action evidence suggesting a strong association
document). FDA is revising certain provisions of between a dietary pattern of intake
ADDRESSES: You may submit comments the proposed rule that published in the characterized, in part, by a reduced
by any of the following methods, except Federal Register on March 3, 2014 (79 intake of added sugars and a reduced
that comments on information FR 11879), that would amend FDA’s risk of cardiovascular disease. The
collection issues under the Paperwork labeling regulations for conventional evidence also suggested an applicable
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Document Created: 2018-02-23 09:27:10
Document Modified: 2018-02-23 09:27:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule; reopening of comment period as to specific documents. | |
| 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. | |
| 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. | |
| FR Citation | 80 FR 44302 | |
| RIN Number | 0910-AF22 |
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