
[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Proposed Rules]
[Pages 44303-44312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2012-N-1210]


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.

ACTION: Proposed rule; supplemental notice of proposed rulemaking.

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SUMMARY: 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 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).

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, 
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 http://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 http://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 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

[[Page 44304]]

reference amount for added sugars, i.e., limiting added sugars intake 
to no more than 10 percent of total daily caloric intake. As a result 
of our review of the science underlying the 2015 DGAC report, we are 
proposing to establish a DRV for added sugars and to require the 
percent DV declaration of added sugars on the Nutrition Facts and 
Supplement Facts labels. We are not proposing to establish a DRV for 
total sugars or to require the mandatory declaration of a percent DV 
for total sugars because there is no quantitative intake level or other 
reference amount for which there is sufficient scientific evidence upon 
which we can base a DRV for total sugars. We are proposing to establish 
a DRV for added sugars because science underlying the 2015 DGAC report 
provided a scientific basis for a reference amount for added sugars 
upon which we can propose a DRV (a recommended maximum of 10 percent of 
total energy intake). We also received many comments suggesting that, 
if added sugars are declared on the label, a percent DV declaration 
would assist consumers in putting the amount of added sugars in a 
serving of a product into the context of their total daily diet.
    A summary of the results of FDA's consumer research on footnote 
text options and on the added sugars declaration is available in 
section I.C., and a detailed description of the results is available in 
the docket.

Summary of the Major Provisions of the Regulatory Action in Question

    We are proposing to establish a DRV for added sugars of 50 grams 
(g) for children 4 years of age and older and adults, and of 25 g for 
children 1 through 3 years of age. We are also proposing to require the 
declaration of the percent DV for added sugars on Nutrition and 
Supplement Facts labels, and have proposed revisions to the NFL/SFL 
proposed rule codified to reflect these changes. These proposed 
revisions are outlined in section III. We are also proposing footnote 
text for the space reserved in Sec.  101.9(d)(9) (21 CFR 101.9(d)(9)) 
of the NFL/SFL proposed rule. The footnote text would explain that the 
% Daily Value tells you how much a nutrient in a serving of food 
contributes to a daily diet and that 2,000 calories a day is used for 
general nutrition advice. The language in this footnote is similar to 
the wording of one of the options tested in our study (as described in 
section I.C.), except that the sentences have been reversed. We believe 
this footnote explains the %DV in the most concise manner by providing 
a brief description of ``% Daily Value,'' which is lacking in the 
current footnote. While the consumer research study did not suggest 
strong support for a particular footnote, the language in this footnote 
was perceived by study participants to be more useful than the current 
footnote. We consider that switching the order of the sentences is 
important because it allows the first sentence to clearly follow the 
asterisk in the ``%DV'' column heading that leads to the footnote. When 
consumers look down to the footnote to see what additional information 
is linked to the asterisk that they see after the ``%DV'' column 
heading, they may expect to find the sentence that explains percent 
daily value first, rather than a sentence about calories. This 
supplemental notice of proposed rulemaking would also allow the 
footnote proposed in Sec.  101.9(d) to be omitted from products that 
qualify for a simplified format (Sec.  101.9(f)), and on small or 
intermediate packages (Sec.  101.9(j)(13)(ii)(A)(1); Sec.  
101.9(j)(13)(ii)(A)(2)), provided that the following abbreviated 
statement is used: ``%DV = % Daily Value.''
    The proposed statement is shorter than the current statement to 
allow for more space on the label. In addition, we realize that the 
standard format in the NFL/SFL proposed rule for the Nutrition Facts 
label had a placeholder for the footnote and did not explain the 
``%DV.'' It is important for consumers to know what ``%DV'' on the 
label means. Consequently, we are proposing a statement that spells out 
``%DV'' for products that qualify for a simplified format and on small 
or intermediate packages.
    This supplemental notice of proposed rulemaking also proposes an 
exemption to the proposed footnote requirement in section Sec.  
101.9(d)(9) for the foods that can use the terms ``calorie free,'' 
``free of calories,'' ``no calories,'' ``zero calories,'' ``without 
calories,'' ``trivial source of calories,'' ``negligible source of 
calories,'' or ``dietary insignificant source of calories'' on the 
label or in the labeling of foods as defined in 21 CFR 101.60(b). Such 
products would have little to no impact on the average daily 2,000 
calorie intake, which the footnote addresses. Exempting the footnote 
for these packages is a practical solution that would assure adequate 
space is still available for the required nutrient declarations.
    We are inviting comment only with respect to the following issues 
discussed in greater detail later in this document: (1) New information 
from the 2015 DGAC report and the science upon which that report is 
based regarding added sugars; (2) the proposal to establish a DRV for 
added sugars and to require the declaration of the percent DV for added 
sugars on the Nutrition and Supplement Facts labels; (3) using the term 
``Total Sugars'' instead of ``Sugars'' on the label (4) the proposed 
text for the footnotes to be used on the Nutrition Facts label; (5) 
exemptions from the proposed footnote requirement; (6) whether we 
should make changes to the footnote used on the Supplement Facts label; 
and (7) whether there should be a footnote on labels of food 
represented for infants 7 through 12 months of age or children 1 
through 3 years of age, and, if so, what that footnote should say. We 
will not consider comments outside the scope of these issues.

Costs and Benefits

    In the NFL/SFL proposed rule we stated that we have developed one 
comprehensive Preliminary Regulatory Impact Analysis (PRIA) that 
presents the benefits and costs of this proposed rule as well as the 
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 original PRIA). As stated earlier, we are proposing 
revisions to the NFL/SFL proposed rule. We are proposing footnote text 
and an exemption to that text for certain foods, and we are proposing 
that manufacturers declare the percent DV for added sugars on the 
Nutrition Facts and Supplement Facts labels. We estimate that just the 
changes specified in this supplemental notice of proposed rulemaking, 
if finalized, will generate annualized costs of $10 million (at 7 
percent discount rate) and $8 million (at 3 percent discount rate), 
annualized benefits of $200 million (at 7 percent) and $300 million (at 
3 percent), and annualized net benefits of $190 million (at 7 percent) 
and $292 million (at 3 percent) on top of those estimated in the 
previous proposed rules. In total, we estimate that these rules, 
including the changes outlined in this proposal, if finalized, will 
generate annualized costs of $200 million (at both 3 and 7 percent), 
annualized benefits of $2.1 billion (at 7 percent) and $2.3 billion (at 
3 percent), and annualized net benefits of $1.9 billion (at 7 percent) 
and $2.1 billion (at 3 percent). This represents an annual increase in 
net benefits from the original PRIA's estimates of approximately $200 
million per year.
    We summarize the annualized costs and benefits (over a 20-year 
period discounted at both 3 percent and 7

[[Page 44305]]

percent) of the previous and revised proposed rules in the following 
table.

          Summary of Annualized Costs and Benefits Over 20 Years of Previous and Revised Proposed Rules
                                          [In billions of 2011 dollars]
----------------------------------------------------------------------------------------------------------------
                                                                     Benefits          Costs       Net benefits
----------------------------------------------------------------------------------------------------------------
Previous Proposed Rules:
    Annualized @3%..............................................            $2.0            $0.2            $1.8
    Annualized @7%..............................................             1.9             0.2             1.7
Revised Proposed Rules:
    Annualized @3%..............................................             2.3             0.2             2.1
    Annualized @7%..............................................             2.1             0.2             1.9
----------------------------------------------------------------------------------------------------------------
Notes: Compliance period is 24 months. Analysis assumes that the proposed rules will be enacted together. Costs
  include relabeling and reformulation costs, which are one-time costs, as well as recordkeeping costs, which
  recur. Recordkeeping costs, because of their recurring nature, differ by discount rate; however, such costs
  comprise a very small percentage of total costs.

I. Background

A. NFL/SFL Proposed Rule

    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 ``NFL/SFL proposed 
rule''). The NFL/SFL proposed rule would 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. In the NFL/SFL proposed rule, we proposed 
to: (1) Update the list of nutrients that are required or permitted to 
be declared; (2) provide updated DRVs and Reference Daily Intake values 
that are based on current dietary recommendations from U.S. consensus 
reports; (3) 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 (4) revise the format and 
appearance of the Nutrition Facts label.
    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 (proposed Sec.  101.9(d)(9)). 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 (79 FR 11879 at 11882). See section I.C. for 
a summary of the consumer study results.
    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 (proposed Sec.  
101.9(c)(6)(iii)). Such a declaration would only be required for the 
Supplement Facts label if added sugars are present in quantitative 
amounts that exceed the amount that can be declared as zero in Sec.  
101.9(c) (see proposed Sec.  101.36(b)(2)(i)). Given our proposal to 
require the declaration of added sugars, we also considered 
establishing a DRV for added sugars. However, based on our review of 
scientific evidence and recommendations of U.S. consensus reports, we 
tentatively concluded in the NFL/SFL proposed rule that there was no 
sound scientific basis for the establishment of a quantitative intake 
recommendation upon which a DRV could be derived for total sugars (79 
FR 11879 at 11902) and added sugars (79 FR 11879 at 11906). Therefore, 
we did not propose a DRV for added sugars. Accordingly, we proposed to 
require the declaration of added sugars on the Nutrition Facts label 
only in absolute amounts (in grams), similar to the declaration of 
total 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 to help enhance our understanding of how consumers would 
comprehend and use this new information. We stated that we would 
publish the results of the study when they became available. We also 
stated that we were interested in receiving, as part of any comment, 
other available research data and other factual information relevant to 
these issues, including the proposed double indented placement of added 
sugars below total sugars (79 FR 11879 at 11952). See section I.C. for 
a summary of the consumer study results.

B. Public Outreach

    We requested comments on the NFL/SFL proposed rule by June 2, 2014, 
and comments on information collection issues under the PRA by April 2, 
2014 (79 FR 11879). In the Federal Register of May 27, 2014 (79 FR 
30055), we extended the comment period until August 1, 2014. In the 
Federal Register of May 29, 2014 (79 FR 30763), we announced our intent 
to hold a public meeting to discuss the NFL/SFL proposed rule and a 
proposed rule on serving sizes. The purpose of the public meeting was 
to inform the public of the provisions of the proposed rules, to invite 
oral stakeholder and public comments on the proposed rules, and to 
respond to questions about the proposed rules.
    Nearly 300,000 comments were submitted to the docket on the NFL/SFL 
proposed rule. We continue to review these comments as part of our 
development of the NFL/SFL final rule. However, for the reasons 
discussed in section II., we are issuing revisions to certain 
provisions in the NFL/SFL proposed rule and requesting comment on the 
revisions.

C. Experimental Study on Consumer Responses to Nutrition Facts Labels 
With Various Footnote Formats and Declaration of Amount of Added Sugars

    We conducted research to examine how a declaration of added sugars 
and alternative footnote statements may influence consumer use of the 
Nutrition Facts label in the absence of any consumer education. The 
study was a controlled, randomized, Web-based experiment completed in 
2014. Although the research involved a single data collection effort, 
this data collection was composed of two separate experiments; one 
designed to address the effects of added sugars declarations and the 
other designed to address the effects of modified

[[Page 44306]]

footnotes. At the time the research was designed, we were not aware of 
any previous studies of consumer responses to added sugars information. 
This research was undertaken to help inform consumer education if added 
sugars were declared on the Nutrition Facts label. The research design 
did not include a percent DV for added sugars on the food label or the 
ingredient listing that will appear on packages, so we do not have data 
on how those pieces of information would affect consumer responses to 
an added sugars declaration. The study achieved its intended objectives 
of providing an initial understanding of potential consumer reactions 
to added sugars declarations and modified footnote information on 
Nutrition Facts labels. This information will help inform our future 
educational efforts related to food labeling. As with other new 
information, we would expect consumer understanding of an added sugars 
declaration, if finalized, to improve as the public's exposure to added 
sugars information increases and educational activities to explain the 
concept and how to use the new information on the Nutrition Facts label 
are undertaken.
1. Added Sugars Experiment
    In the added sugars experiment, participants viewed Nutrition Facts 
label images displayed in one of three possible Nutrition Facts formats 
(see Ref. 1 for label formats):
     The ``Added Sugars'' Format, where an added sugars 
declaration was indented below a ``Sugars'' declaration;
     The ``Total Sugars + Added Sugars'' Format, where an added 
sugars declaration was indented below a ``Total Sugars'' declaration; 
and
     The Control Format, where participants viewed the current 
Nutrition Facts label throughout the study.
    While viewing these label images, participants were asked a series 
of questions on their ability to accurately recognize and compare 
nutrients on the Nutrition Facts label, and their judgments about the 
foods' overall healthfulness and relative nutrient levels. Participants 
responded to these questions in the context of a one-product judgment 
task and a two-product comparison task. Participants were not given the 
proposed definition of added sugars or provided with the ingredients 
lists for the products tested, which could have affected their 
understanding.
    The study found that when both total and added sugars declarations 
appeared on the label, the majority correctly reported the added sugars 
amount and accurately identified which products had less added sugars. 
The ``Total Sugars + Added Sugars'' format appeared to help 
participants better comprehend the total amount of sugars in a food 
than the ``Added Sugars'' format. The effect of the added sugars 
declarations on product judgments varied depending on the food category 
and the level of added sugars in the product. When declared, higher 
amounts of added sugars tended to produce more negative judgments about 
the product's healthfulness. Although the majority of the respondents 
correctly identified the total amount of sugars in a serving of food 
with each label presented that included an added sugars declaration, 
the added sugars experiment results show that a number of participants 
were confused about the distinction between sugars and added sugars, 
regardless of whether added sugars declarations appeared on the 
Nutrition Facts label. When participants were viewing Nutrition Facts 
labels without added sugars declarations, they could not accurately 
determine the amount of added sugars in the products, with the majority 
reporting that the total sugars amount was the amount of added sugars. 
Moreover, many participants who viewed Nutrition Facts labels without 
added sugars declarations assumed that the more nutritious products in 
the study had less added sugars.
    A full description of the Added Sugars Experiment is in the Docket 
(Ref. 1).
2. Footnote Experiment
    The footnote experiment compared consumer reactions to seven 
footnote formats, which included five modified footnotes, in addition 
to the current footnote and no footnote at all, for explaining percent 
DVs and how to use them. Results indicated that none of the modified 
footnotes significantly affected product perceptions or judgments of 
nutrient levels; all five footnote options produced similar perceptions 
and judgments relative to the current footnote and a no-footnote 
control. Nevertheless, all five modified footnotes were rated as easier 
to understand than the current footnote. Footnote 1 was perceived to be 
more believable than the current footnote. Footnote 1 stated the 
following: ``2,000 calories a day is used for general nutrition advice. 
*The % Daily Value tells you how much a nutrient in a serving of food 
contributes to a daily diet.'' We are proposing footnote text from 
Footnote 1 in this supplemental notice of proposed rulemaking. See 
section III.B. A full description of the Footnote Experiment is in the 
Docket (Ref. 2).

II. Decision To Issue Supplemental Notice of Proposed Rulemaking 
Regarding Limited Additional Provisions

    As we prepared to make the consumer study results discussed in 
section I.C. available, new information emerged from the 2015 DGAC 
report (Ref. 3) regarding added sugars. The DGAC reviews the scientific 
evidence on specific topics and provides their assessment of the 
scientific evidence and recommendations. 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. The 2015 DGAC report also 
included new important information and analysis related to requiring 
the declaration of added sugars on the Nutrition Facts label, which we 
had proposed in the NFL/SFL proposed rule, specifically evidence 
related to dietary patterns and risk of disease.
    We have considered the evidence that the DGAC relied upon and have 
tentatively concluded that the new evidence provided in the 2015 DGAC 
report related to dietary patterns of intake that are associated with a 
reduced risk of chronic disease (specifically cardiovascular disease 
(CVD)) as well as the evidence provided in the report related to excess 
intake of added sugars in the U.S. supports our proposal to require the 
mandatory declaration of added sugars on the Nutrition and Supplement 
Facts labels. The DGAC report also provides evidence to support a 
reference amount for added sugars upon which we can establish a DRV for 
use in calculating a percent DV on the label. The percent DV is 
included to assist consumers in understanding the relative significance 
of the amount of added sugars in a serving of a product in the context 
of a total daily diet.
    The 2015 DGAC report does not contain federal government 
recommendations. The independent advisory committee's views will be 
taken into consideration by the Federal government as the dietary 
guidelines are updated. In this supplemental notice of proposed 
rulemaking, we have considered the scientific evidence underpinning the 
recommendations provided in the advisory committee's report. As a 
result of our review of the 2015 DGAC report and the evidence that the 
DGAC relied upon, we are proposing to establish a DRV and to require 
the

[[Page 44307]]

percent DV declaration for added sugars on the Nutrition Facts and 
Supplement Facts labels.
    We are also proposing text for the footnotes to be used on the 
Nutrition Facts label. We are not proposing any revisions to the 
footnote text used on the Supplement Facts label. As discussed in the 
NFL/SFL proposed rule, the current footnote statement required for the 
Supplement Facts label differs from that which is currently required on 
the Nutrition Facts label. We stated that based on the results of the 
consumer study, we will consider whether it is necessary to make 
corresponding changes to the footnote used on the Supplement Facts 
label when certain macronutrients are declared. We invited comment on 
whether we should consider changes to the footnote statement on the 
Supplement Facts label to be consistent with any changes to the 
footnote statement in the Nutrition Facts label (79 11879 at 11948). We 
also noted that ``[a] comment to the 2007 ANPRM requested that we 
permit the use of a footnote statement about not limiting fat intake on 
foods represented or purported to be specifically for infants and 
children less than 2 years to enable consumers to make informed 
choices, should the Agency decide to propose the mandatory declaration 
of saturated fat for infants and children less than 2 years. The 
comment noted that saturated fat should not be limited in the diets of 
children less than 2 years of age. The comment provided no consumer 
data about such a footnote statement. At this time, we are not 
proposing to require a footnote stating that total fat and other types 
of fat should not be limited in infants and children less than 2 years 
in response to this comment. However, we request comments and 
information on how consumers would understand and use the amount of 
saturated fat and cholesterol declared on the Nutrition Facts label, as 
well as on the need for an explanatory footnote to accompany the 
declaration of saturated fat and cholesterol, on food represented or 
purported to specifically for infants 7 through 12 months or children 1 
through 3 years'' (79 FR 11879 at 11934-11935). We did not receive many 
comments on these issues in response to the proposed rule. We are 
inviting comment on whether we should consider requiring, instead of 
the current footnote for the Supplement Facts label that links the 
percent DV with a 2,000 calorie level, part of the Nutrition Facts 
label footnote text we are proposing for the Nutrition Facts label that 
states ``2,000 calories a day is used for general nutrition advice.'' 
We are also inviting further comment on whether we should consider a 
footnote for foods, other than infant formula, represented or purported 
to be specifically for infants 7 through 12 months or children 1 
through 3 years of age in the NFL/SFL proposed rule, and if so, what 
the footnote should say.
    This supplemental notice of proposed rulemaking provides the public 
with the opportunity to provide comment on our tentative conclusions 
with respect to the footnote, the DRV, the percent DV declaration for 
added sugars, and the new information from the 2015 DGAC report for the 
added sugars declaration. As noted, we are not seeking and will not 
consider comments with respect to other issues.

III. Description of the Supplemental Notice of Proposed Rulemaking

A. Proposing To Establish a DRV and Require the Declaration of the 
Percent DV for ``Added Sugars''

    As originally proposed, the NFL/SFL proposed rule would require the 
declaration of the gram amount of added sugars on the Nutrition Facts 
and Supplement Facts labels, but would not establish a DRV or require 
the disclosure of the percent DV for added sugars. The proposed 
requirement for the declaration of the gram amount of ``added sugars'' 
was based, in large part, on data and information in the Dietary 
Guidelines for Americans, 2010 (2010 DGA)(Ref. 4) related to the intake 
of excess calories in the U.S. diet from solid fats and added sugars, 
and the impact that these excess calories may have on the nutrient 
density of the diet. As discussed in the NFL/SFL proposed rule, no more 
than 5 to 15 percent of calories from solid fats and added sugars 
combined can be reasonably accommodated in the U.S. Department of 
Agriculture (USDA) Food Patterns for most people to avoid excess 
calorie consumption, yet added sugars alone contributed an average of 
16 percent of the total calories in American diets (79 FR 11879 at 
11903 through 11904).
    In the 2014 NFL/SFL proposed rule we stated that although there is 
sufficient science to support a relationship between the intake of 
sugar-sweetened beverages and an increase in adiposity (body fat) in 
children, ``inadequate evidence exists to support the direct 
contribution of added sugars to obesity or heart disease.'' (79 FR 
11879 at 11904). Thus, we included the evidence that added sugars 
contribute excess calories to the American diet as part of our 
rationale for proposing the mandatory declaration of added sugars.
    We did not propose to establish a DRV or to require the declaration 
of a percent DV for added sugars in the NFL/SFL proposed rule because, 
at the time we issued the NFL/SFL proposed rule, there was ``no 
scientifically supported quantitative intake recommendation for added 
sugars on which a DRV for added sugars can be derived'' (79 FR 11879 at 
11906). Following publication of the NFL/SFL proposed rule, the 2015 
DGAC, a group of outside experts, submitted its recommendations to the 
Secretaries of the Department of Health and Human Services (HHS) and 
USDA, to inform the Dietary Guidelines for Americans, 2015. The 
Secretaries released the advisory committee's recommendations report 
online on February 19, 2015, making it available for public review and 
comment (see http://www.health.gov/dietaryguidelines/2015-scientific-report/).
    The 2015 DGAC reaffirmed recommendations in the 2010 DGA, which 
included recommending reducing the intake of added sugars. The 2015 
DGAC examined the relationship between dietary patterns and health 
outcomes more extensively than did earlier DGAC reports, through the 
use of a food modeling approach using the USDA Food Patterns (Ref. 5). 
The 2015 DGAC reviewed the current science, status and trends in the 
dietary pattern of intake in the U.S. population compared to a 
``Healthy U.S.-style Pattern,'' a ``Healthy Mediterranean-style 
Pattern,'' and a ``Healthy Vegetarian Pattern'' associated with health 
benefits. The report found the current U.S. population intake of solid 
fats and added sugars is high across all age groups and genders with 
nearly 90 percent of the general population ``exceeding the recommended 
daily limits'' (Ref. 6). Added sugars intake alone remains high at 13.4 
percent of total calories per day among the total population ages 1 
year and older (Ref. 7). Importantly, the 2015 DGAC found strong and 
consistent evidence demonstrating that, relative to less healthy 
patterns, dietary patterns associated with decreased risk of 
cardiovascular disease (CVD) are characterized by higher consumption of 
vegetables, fruits, whole grains, low-fat dairy, and seafood, and lower 
consumption of red and processed meat, and lower intakes of refined 
grain, and sugar-sweetened foods and beverages (Ref. 8). The 2015 DGAC 
suggested the NFL/SFL should include an added sugars declaration and 
the declaration of a percent DV for added sugars (Ref. 9). The Federal 
government has not issued

[[Page 44308]]

a final 2015 Dietary Guidelines for Americans report.
    Based on our review of the evidence presented in the 2015 DGAC 
report (see link to individual studies reviewed by the 2015 DGAC--
(http://www.nel.gov/--then click on ``Dietary Patterns and Health 
Outcomes Systematic Review Report.''), we find that the evidence 
further supports FDA's proposal to require an added sugars declaration 
in the Nutrition and Supplement Facts labels. Specifically, there is 
evidence of a strong association between a dietary pattern of intake 
characterized, in part, by a reduced intake of sugar-sweetened foods 
and beverages and a reduced risk of CVD. There is also evidence to 
support a reference amount for added sugars, i.e., limiting added 
sugars intake to no more than 10 percent of total daily caloric intake.
    The 2015 DGAC report also recommended that Americans keep added 
sugars intake below 10 percent of total energy intake (Ref. 10). The 
2015 DGAC based this ``less than 10 percent'' recommendation on 
modeling of dietary patterns, current added sugars consumption data, 
and a published meta-analysis on sugars intake and body weight. (Ref. 
11). Based on the scientific evidence, we tentatively conclude that 
limiting consumption of added sugars to 10 percent of daily calories is 
a reasonable goal for consumers to achieve and is consistent with the 
goals of the Dietary Guidelines for Americans to provide advice for 
choosing and maintaining a healthful dietary pattern.
    In the NFL/SFL proposed rule, we recognized that we did not have a 
scientifically supported quantitative intake recommendation for added 
sugars, based on a biomarker of risk of disease or other public health 
endpoint, on which a DRV for added sugars could be derived. However, we 
did consider a reference point for added sugars consumption based on 
the calories from solid fats and added sugars limits at each calorie 
level in the USDA Food Patterns in the 2010 DGAC report (79 FR 11879 at 
11906). Based on that analysis, and without a declaration in the 
Nutrition Facts label of ``calories from solid fats and added sugars,'' 
consumers would have to multiply grams of saturated, trans fats, and 
added sugars by the number of calories per gram to determine the amount 
of calories from solid fats and added sugars in a product. The 2015 
DGAC report, in its analysis of added sugars as part of a dietary 
pattern of intake among the U.S. population, found a strong association 
with that pattern of intake to an increase in CVD risk, in comparison 
to healthier dietary patterns with lower added sugars intakes. This 
analysis included publications of clinical trials and prospective 
cohort studies (http://www.nel.gov/--then click on ``Dietary Patterns 
and Health Outcomes Systematic Review Report.'') Therefore, we 
tentatively conclude that the 2015 DGAC report and the scientific 
information on which it relies provide a basis for FDA to establish a 
DRV reference point for the added sugars declaration at 10 percent of 
calories that is based on a public health endpoint and is necessary to 
assist consumers to maintain healthy dietary practices.
    We are proposing a DRV of 50 g for added sugars from which the 
percent DV can be calculated. We determine a DRV of 50 g by first 
multiplying the 2,000 reference calorie intake by 10 percent (2,000 x 
.10 = 200 calories). The 2,000 reference calorie intake is used for 
other nutrients to calculate the DRV when the recommendations for the 
nutrient intake may fluctuate based on calorie intake. The 2,000 
calorie value represents a reference intake for adults and children 4 
years of age and older, including pregnant and lactating women. 
Dividing 200 calories by 4 calories/g (200 calories / 4 calories/g = 50 
g) provides us with the gram amount (50 g) of added sugars as a 
reference amount for use as the DRV. A 1,000 calorie reference amount 
would be used to calculate the DRV for children 1 through 3 years of 
age at 25 g of added sugars (1,000 calories x .10 = 100 calories and 
100 calories / 4 calories/g = 25 g).
    The comments we received on the NFL/SFL proposed rule were 
generally supportive of a DRV of no more than 10 percent of total 
energy intake from added sugars. Many of the comments in support of a 
DRV of no more than 10 percent of total energy intake cited the 2014 
World Health Organization (WHO) draft guideline. This WHO guideline, 
however, is not a U.S consensus report and was not specific to added 
sugars. There were also some comments that did not support a DRV for 
added sugars, citing a lack of scientific evidence to set a 
quantitative intake recommendation. We now have the 2015 DGAC report 
that supports a proposal to establish a DRV of 10 percent of total 
energy intake from added sugars and to require the declaration of 
percent DV for added sugars on the label. Specifying and requiring a 
percent DV declaration is also supported by comments we received 
stating that such a declaration will help consumers determine the 
amount of added sugars on the label in the context of their total daily 
diet.
    If we finalize a declaration of added sugars, we tentatively 
conclude that a DRV or point of reference for consumers to understand 
the declaration of added sugars and what that number means in the 
context of the total daily diet is needed. We are proposing in section 
III.A. that a percent DV be declared for added sugars on the label.
    Further, as discussed in the NFL/SFL proposed rule (79 FR 11879 at 
11902), we are considering whether to use the term ``Total Sugars'' 
instead of ``Sugars'' on the label if we finalize a declaration of 
added sugars. The use of ``Total Sugars'' was supported by many 
comments. In addition, our added sugars experiment did show that use of 
the term ``Total Sugars'' helped improve study participants' 
understanding that added sugars are part of the total amount of sugars 
in the product. Therefore, we intend to consider finalizing the use of 
the term ``Total Sugars'' instead of ``Sugars'' on the label, if we 
finalize a declaration of added sugars. We are not proposing to 
establish a DRV for total sugars or to require the mandatory 
declaration of a percent DV for total sugars because there is no 
quantitative intake level or other reference amount for which there is 
sufficient scientific evidence upon which we can base a DRV for total 
sugars.
    Given the discussion in section III.A., this supplemental notice of 
proposed rulemaking would:
     Amend Sec.  101.9(c)(9) to add ``Added sugars'' to the 
list of food components with established DRVs with a unit of 
measurement of ``Grams (g),'' and to establish a DRV for adults and 
children 4 years of age and older, including pregnant and lactating 
women, of 50 g and a DRV for children 1 through 3 years of age of 25 g.
     Amend Sec.  101.36(b)(2)(iii)(D) to require that the 
percent DV for added sugars be declared when added sugars are present 
in a dietary supplement at an amount greater than 1 gram per serving, 
such that the proposed requirement would say that if the percent of 
Daily Value is declared for total fat, saturated fat, total 
carbohydrate, dietary fiber, protein, or added sugars, a symbol shall 
follow the value listed for those nutrients that refers to the same 
symbol that is placed at the bottom of the nutrition label, below the 
bar required under Sec.  101.9(e)(6) and inside the box, that is 
followed by the statement ``Percent Daily Values are based on a 2,000 
calorie diet.''

Proposing to require the declaration of the percent DV for added sugars 
on the label are not the only revisions to the codified that would be 
needed if we

[[Page 44309]]

finalized the added sugars provisions. We proposed additional 
amendments related to added sugars and they are described in the NFL/
SFL proposed rule (79 FR 11879 at 11905-11907).

B. Proposing the Footnote Text That Would Be Required on Certain 
Packages and Proposed Exemptions From the Footnote Requirement

    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 (proposed Sec.  101.9(d)(9)). We consider that a succinct 
statement about daily calorie intake (2,000 calories) is a necessary 
part of the footnote because 2,000 calories is consistent with widely 
used food plans, the percent DV of certain nutrients (e.g., total fat, 
total carbohydrate, and dietary fiber) is based on 2,000 calories, and 
2,000 calories approximates the estimated energy need for adults who 
are sedentary to moderately active. However, we recognize that a 
succinct statement about daily calorie intake should not suggest that 
the percent DV of all nutrients is linked to a 2,000 calorie diet.
    We received comments on the footnote and many comments requested 
that the footnote continue to explain that percent DVs are based on a 
2,000 calorie diet but individual calorie needs may be higher or lower. 
Many comments also emphasized that any revisions to the footnote should 
be research-based and that the results of our consumer research studies 
should be made available for review and comment.
    Many comments emphasized that because the NFL/SFL proposed rule 
does not specify the exact footnote text and the amount of space the 
new footnote would require, more information is needed in order to 
comment on the footnote. Some comments emphasized that the footnote 
should be brief and not take up too much space, and expressed concerns 
about how the footnote would fit on small packages.
    This supplemental notice of proposed rulemaking would add language 
to the space reserved in proposed Sec.  101.9(d)(9) to explain that the 
% Daily Value tells you how much a nutrient in a serving of food 
contributes to a daily diet and that 2,000 calories a day is used for 
general nutrition advice. The language in this footnote is similar to 
one of the options tested during the consumer research study described 
in section I.C., except that we have reversed the order of the 
sentences from the footnote tested. While the consumer research study 
did not suggest strong support for a particular footnote, the language 
in this footnote was perceived by study participants to be more useful 
than the current footnote. We consider that switching the order of the 
sentences is important because it allows the first sentence to clearly 
follow the asterisk in the ``%DV'' column heading that leads to the 
footnote. When consumers look down to the footnote, to see what 
additional information is linked to the asterisk that they see after 
the ``% DV'' column heading, they may expect to find the sentence that 
explains percent daily value first, rather than a sentence about 
calories. We believe that this footnote explains the ``% DV'' in the 
most concise manner.
    Previously, in the 1993 final rule entitled ``Food Labeling: 
Mandatory Status of Nutrition Labeling and Nutrient Content Revision, 
Format for Nutrition'' (58 FR 2079 (January 6, 1993)) (1993 final 
rule), we noted that prior research had shown that although most 
consumers do not notice footnotes, those who are given the information 
(and by inference, those who do read the footnote) are able to 
interpret it appropriately (58 FR 2079 at 2131). Consistent with our 
rationale in 1993, we continue to expect that the provision of a simple 
footnote will help those consumers who do read it in understanding the 
information on the nutrition label. The second sentence of the proposed 
footnote is the same as the succinct statement that will be required on 
menus and menu boards under our final rule entitled ``Food Labeling; 
Nutrition Labeling of Standard Menu Items in Restaurants and Similar 
Retail Food Establishments'' (79 FR 71156 (December 1, 2014)). It is 
important to explain calories in the context of the total daily diet 
and also provide consistency in the wording of this nutritional advice 
between packaged and restaurant foods.
    Some packaged foods do not require the full footnote. The footnote 
information specified in Sec.  101.9(d)(9)(i) (which includes the 
footnote table) can be omitted from products that qualify for a 
simplified format and small or intermediate packages, provided that the 
following abbreviated footnote statement is used: ``Percent Daily 
Values are based on a 2,000 calorie diet'' (Sec. Sec.  101.9(f)(5) and 
101.9(j)(13)). In this supplemental notice of proposed rulemaking, we 
propose to allow the footnote proposed in Sec.  101.9(d) to be omitted 
from products that qualify for a simplified format (Sec.  101.9(f)), 
and from small or intermediate packages (Sec.  101.9(j)(13)(ii)(A)(1); 
Sec.  101.9(j)(13)(ii)(A)(2)), provided that the following abbreviated 
statement is used: ``%DV =% Daily Value.'' The proposed statement for 
these packages shortens it from what is currently required and allows 
for more space on the label. In addition, we realize that the standard 
format in the NFL/SFL proposed rule for the Nutrition Facts label had a 
placeholder for the footnote and did not explain the ``%DV.'' It is 
important for consumers to know what ``%DV'' on the label means. 
Consequently, we are proposing a statement for these packages that 
spells out ``%DV.'' We recognize that for these packages, additional 
information in the footnote is not needed. In this supplemental 
proposed rulemaking, we apply the same rationale we used in the 1993 
final rule with regards to exempting small and intermediate packages 
from some of the footnote language we required for large packages. The 
1993 final rule allowed manufacturers flexibility in using the complete 
footnote on all product labels. We recognized that the benefits of 
requiring this footnote were not relative to the specific product that 
carries the information, and that the information would be available to 
consumers if it appeared on a significant percentage of food labels (58 
FR 2079 at 2129).
    This supplemental notice of proposed rulemaking proposes an 
exemption to the proposed footnote requirement in Sec.  101.9(d)(9) for 
the foods that can use the terms ``calorie free,'' ``free of 
calories,'' ``no calories,'' ``zero calories,'' ``without calories,'' 
``trivial source of calories,'' ``negligible source of calories,'' or 
``dietary insignificant source of calories'' on the label or in the 
labeling of foods as defined in Sec.  101.60(b). Such products would 
have little to no impact on the average daily 2,000 calorie intake, 
which the footnote addresses. Exempting the footnote for these packages 
is a practical solution that would assure adequate space is still 
available for the required nutrient declarations.
    We believe that consumer education programs regarding using and 
understanding the Nutrition Facts and Supplement Facts labels 
(including the footnote) are important, and plan to work with our 
federal partners to develop such programs after publication of the 
final rule.
    Given the discussion in section III.B., this supplemental notice of 
proposed rulemaking would:
    a. Amend Sec.  101.9(d)(9) to replace the reserved space. 
Specifically, after the language in Sec.  101.9(d)(8) explaining that 
when listed horizontally in two

[[Page 44310]]

columns, vitamin D and calcium should be listed on the first line and 
iron and potassium should be listed on the second line--the proposed 
requirement would replace ``[Reserved]'' with text stating that a 
footnote, preceded by an asterisk, shall be placed beneath the list of 
vitamins and minerals and be separated from the list by a hairline, 
except that the footnote may be omitted from foods that can use the 
terms ``calorie free,'' ``free of calories,'' ``without calories,'' 
``trivial source of calories,'' ``negligible source of calories,'' or 
``dietary insignificant source of calories'' on the label or in the 
labeling of foods as defined in Sec.  101.60(b). The footnote text 
would explain that the %Daily Value tells you how much a nutrient in a 
serving of food contributes to a daily diet and that 2,000 calories a 
day is used for general nutrition advice.
    b. Amend Sec.  101.9(j)(13)(ii)(C) to revise the footnote text. 
Specifically, after ``Sugar alcohol--Sugar alc,'' the proposed 
requirement would provide for omitting the footnote statement and 
placing another asterisk at the bottom of the label followed by the 
statement `%DV = %Daily Value'.''

C. Other Related Provisions-Future Revisions to the Sample Labels

    The revisions to the NFL/SFL proposed rule described in this 
section would require revisions to the labels illustrated in Sec. Sec.  
101.9(d)(11)(iii), 101.9(d)(12), 101.9(d)(13)(ii), 101.9(e)(5), 
101.9(e)(6)(i), 101.9(e)(6)(ii), 101.9(f)(4), 101.9(j)(13)(ii)(A)(1), 
and 101.9(j)(13)(ii)(A)(2) of the NFL/SFL proposed rule. As stated in 
section VII. we provided a sample label in proposed Sec.  
101.9(j)(5)(i) for foods, other than infant formula, represented or 
purported to be specifically for infants 7 through 12 months or 
children 1 through 3 years of age in the NFL/SFL proposed rule, 
however, we invite further input on whether such a footnote is needed 
and, if so, what it should say. If the NFL/SFL is finalized as proposed 
in this supplemental notice, we will make the changes needed to the 
labels in the codified in the NFL/SFL final rule.

IV. Preliminary Regulatory Economic Analysis of Impacts

    As explained in the NFL/SFL proposed rule, we performed the 
necessary analyses to examine the impacts of the proposed rule under 
Executive Order 12866, Executive Order 13563, the Regulatory 
Flexibility Act (5 U.S.C. 601-612), the Unfunded Mandates Reform Act of 
1995 (Pub. L. 104-4), and the PRA (44 U.S.C. 3501-3520). We provided a 
PRIA of the proposed rule (see Ref. 187 of the NFL/SFL proposed rule) 
for public input (79 FR 11879 at 11959).
    We performed additional analysis to examine the impacts of the 
revised proposed provisions described in the Federal Register document 
under Executive Order 12866, Executive Order 13563, the Regulatory 
Flexibility Act, the Unfunded Mandates Reform Act of 1995, and the PRA. 
We present our additional analyses, including the total estimated costs 
and benefits of this supplement to the NFL/SFL proposed rule, in our 
supplemental PRIA for this proposed rule (Ref. 12), which will be made 
available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/. We invite comment on our additional analyses.

V. Paperwork Reduction Act of 1995

    This supplemental notice of proposed rulemaking contains 
information collection provisions that are subject to review by OMB 
under the PRA. As explained in the NFL/SFL proposed rule, we performed 
the necessary analyses to examine the impacts of the proposed rule 
under Executive Order 12866, Executive Order 13563, the Regulatory 
Flexibility Act, the Unfunded Mandates Reform Act of 1995, and the PRA. 
We provided a PRIA of the NFL/SFL proposed rule (see Ref. 187 of the 
NFL/SFL proposed rule) for public input (79 FR 11879 at 11959). A 
description of the information collection provisions of the NFL/SFL 
proposed rule was given in the PRIA of the NFL/SFL proposed rule with 
an estimate of the annual third-party disclosure burden. A description 
of the information collection provisions of the supplemental notice of 
proposed rulemaking is given in the Description section with an 
estimate of the annual third-party disclosure burden. Included in the 
estimate is the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing each collection of information.
    We invite comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
our functions, including whether the information will have practical 
utility; (2) the accuracy of our estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) ways to minimize 
the burden of the collection of information on respondents, including 
through the use of automated collection techniques, when appropriate, 
and other forms of information technology.
    Title: Revision of the Nutrition and Supplement Facts Labels and 
Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating 
Occasion.
    Description: This supplemental notice of proposed rulemaking 
proposes two changes to the third-party disclosure requirements 
discussed in the analysis of the NFL/SFL proposed rule: A percent DV 
labeling requirement as well as footnote requirements.
    Description of Respondents: The likely respondents to this 
information collection are manufacturers of retail food products 
marketed in the United States whose products contain (1) a mixture of 
naturally occurring and added sugars or (2) a mixture of non-digestible 
carbohydrates that do and do not meet the proposed definition of 
dietary fiber. The likely respondents to this information collection 
also include manufacturers of retail food products marketed in the 
United States whose products contain (1) mixtures of different forms of 
vitamin E or (2) both folate and folic acid.
    We estimate the burden of the information collection provisions of 
the supplemental notice of proposed rulemaking as follows. After 
careful review of the burden estimate analysis provided in the PRIA for 
the NFL/SFL proposed rule, we tentatively conclude that our previous 
estimate of the burden hours has not changed meaningfully as a result 
of this supplemental notice of proposed rulemaking. Thus, we have 
calculated no additional burden related to the proposed percent DV 
labeling requirement for added sugars described in this supplemental 
notice of proposed rulemaking.
    With regard to the proposed footnote labeling requirements in this 
supplemental notice of proposed rulemaking, we note that the text of 
the footnote statements would be supplied by FDA in the final 
regulation. We tentatively conclude that the proposed footnote 
provisions in this supplemental notice of proposed rulemaking are 
``public disclosure[s] of information originally supplied by the 
Federal government to the recipient for the purpose of disclosure to 
the public'' (5 CFR 1320.3(c)(2)) and are therefore not subject to 
review by OMB under the PRA. Thus, we have calculated no additional 
burden related to the proposed footnote labeling requirements in this 
supplemental notice of proposed rulemaking.
    To ensure that comments on information collection are received, OMB 
recommends that written

[[Page 44311]]

comments be faxed to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to 
oira_submission@omb.eop.gov. All comments should be identified with the 
title, ``Revision of the Nutrition and Supplement Facts Labels and 
Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating 
Occasion.''
    In compliance with the PRA, we have submitted the information 
collection provisions of this proposed rule to OMB for review. These 
requirements will not be effective until we obtain OMB approval. We 
will publish a notice concerning OMB approval of these requirements in 
the Federal Register.

VI. Analysis of Environmental Impact

    We have carefully considered the potential environmental effects of 
this action. This action revises certain provisions of the NFL/SFL 
proposed rule. For the NFL/SFL proposed rule, we concluded that the 
action would not have a significant impact on the human environment, 
and that an environmental impact statement was not required. Our 
finding of no significant impact and the evidence supporting that 
finding may be seen in the Division of Dockets Management (see 
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
    We have not received any new information or comments that would 
affect our previous determination. Furthermore, we have reviewed the 
revisions to the NFL/SFL proposed rule as described herein, and have 
determined the revisions do not impact our previous determination. 
Therefore, our finding of no significant impact remains unchanged.

VII. Request for Comments

    We are seeking comment only with respect to the following issues: 
(1) The new information from the 2015 DGAC report regarding added 
sugars; (2) the proposal to establish a DRV for added sugars and to 
require the declaration of the percent DV for added sugars on the 
Nutrition and Supplement Facts labels; (3) using the term ``Total 
Sugars'' instead of ``Sugars'' on the label; (4) the proposed text for 
the footnotes to be used on the Nutrition Facts label; (5) the 
exemptions from the proposed footnote requirement; (6) whether we 
should make changes to the footnote used on the Supplement Facts label; 
and (7) whether we should propose a footnote for foods other than 
infant formula, represented or purported to be specifically for infants 
7 through 12 months or children 1 through 3 years of age. We 
acknowledge that in the NFL/SFL proposed rule, we provided in proposed 
Sec.  101.9(j)(5)(i) a sample label for these foods that included a 
placeholder for a footnote. However, we would appreciate further input 
on whether such a footnote is needed and, if so, what it should say. We 
will not consider comments outside the scope of these issues.
    Comments previously submitted to the Division of Dockets Management 
do not need to be resubmitted, because all comments submitted to the 
docket number, found in brackets in the heading of this document, will 
be considered in development of the final rule.

VIII. How To Submit Comments

    Interested persons may submit either electronic or written comments 
regarding this document 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.

IX. 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. 
These references are also available electronically at http://www.regulations.gov. We have verified the Web site addresses in this 
section, but we are not responsible for subsequent changes to the Web 
sites after this document published in the Federal Register.

1. FDA Memorandum to the File--``Experimental Study on Consumer 
Responses to the Nutrition Facts Labels with Declaration of Amount 
of Added Sugars'' (OMB Control Number 0910-0764), 2015.
2. FDA Memorandum to the File--``Experimental Study on Consumer 
Responses to Nutrition Facts Labels with Various Footnote Formats'' 
(OMB Control Number 0910-0764), 2015.
3. USDA and HHS, Scientific Report of Dietary Guidelines for 
Americans, 2015, available at http://www.health.gov/dietaryguidelines/2015-scientific-report/.
4. USDA and HHS, Dietary Guidelines for Americans, 2010. 7th Ed., 
Washington, DC: U.S. Government Printing Office (2010). Retrieved 
from http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm.
5. USDA and HHS, Scientific Report of the 2015 Dietary Guidelines 
Advisory Committee, 2015, Part D. ``Chapter 1: Food and Nutrient 
Intakes, and Health: Current Status and Trends,'' pg. 3, available 
at http://www.health.gov/dietaryguidelines/2015-scientific-report/.
6. USDA and HHS, Scientific Report of the 2015 Dietary Guidelines 
Advisory Committee, 2015, Part D. ``Chapter 1: Food and Nutrient 
Intakes, and Health: Current Status and Trends,'' pg. 35, available 
at http://www.health.gov/dietaryguidelines/2015-scientific-report/.
7. USDA and HHS, Scientific Report of the 2015 Dietary Guidelines 
Advisory Committee, 2015, Part D. ``Chapter 5: Food Sustainability 
and Safety,'' pg. 18, available at http://www.health.gov/dietaryguidelines/2015-scientific-report/.
8. USDA and HHS, Scientific Report of the 2015 Dietary Guidelines 
Advisory Committee, 2015, Part D. ``Chapter 2: Dietary Patterns, 
Foods and Nutrients, and Health Outcomes,'' pg. 8, available at 
http://www.health.gov/dietaryguidelines/2015-scientific-report/.
9. USDA and HHS, Scientific Report of the 2015 Dietary Guidelines 
Advisory Committee, 2015, Part D. ``Chapter 6: Cross-Cutting Topics 
of Public Health Importance,'' pg. 27, available at http://www.health.gov/dietaryguidelines/2015-scientific-report/.
10. USDA and HHS, Scientific Report of the 2015 Dietary Guidelines 
Advisory Committee, 2015, Part D. ``Chapter 6: Cross-Cutting Topics 
of Public Health Importance,'' pgs. 20-21, available at http://www.health.gov/dietaryguidelines/2015-scientific-report/.
11. Te Morenga, L., S. Mallard, J. Mann, ``Dietary Sugars and Body 
Weight: Systematic Review and Meta-Analysis of Randomised Controlled 
Trials and Cohort Studies,'' BMJ 2013;346:e7492.
12. FDA, Supplemental Preliminary Regulatory Impact Analysis for 
Proposed Rules On ``Food Labeling: Revision of the Nutrition and 
Supplement Facts Labels'' (Docket No. FDA-2012-N-1210) and ``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'' (Docket No. FDA-
2004-N-0258), 2015.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 101, as proposed to be amended on March 3, 
2014 (79 FR 11879), be further amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR part 101 continues to read as 
follows:


[[Page 44312]]


    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. In Sec.  101.9, revise paragraphs (c)(9), (d)(9), and (j)(13)(ii)(C) 
to read as follows:


Sec.  101.9  Nutrition labeling of food.

* * * * *
    (c) * * *
    (9) The following DRVs, nomenclature, and units of measure are 
established for the following food components:

----------------------------------------------------------------------------------------------------------------
                                                                                DRV
                                                 ---------------------------------------------------------------
        Food component               Unit of        Adults and       Infants 7      Children 1     Pregnant and
                                   measurement     children >= 4    through 12       through 3       lactating
                                                       years          months           years           women
----------------------------------------------------------------------------------------------------------------
Fat...........................  Grams (g).......          \1\ 65              30          \2\ 39          \1\ 65
Saturated fatty acids.........  Grams (g).......          \1\ 20             N/A          \2\ 10          \1\ 20
Cholesterol...................  Milligrams (mg).             300             N/A             300             300
Total carbohydrate............  Grams (g).......         \1\ 300              95         \2\ 150         \1\ 300
Sodium........................  Milligrams (mg).           2,300             N/A           1,500           2,300
Dietary fiber.................  Grams (g).......          \1\ 28             N/A          \2\ 14          \1\ 28
Protein.......................  Grams (g).......          \1\ 50             N/A          \2\ 13             N/A
Added Sugars..................  Grams (g).......          \1\ 50             N/A          \2\ 25          \1\ 50
----------------------------------------------------------------------------------------------------------------
\1\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and
  for pregnant and lactating women.
\2\ Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.

    (d) * * *
    (9) A footnote, preceded by an asterisk, shall be placed beneath 
the list of vitamins and minerals and shall be separated from the list 
by a hairline, except that the footnote may be omitted from foods that 
can use the terms ``calorie free,'' ``free of calories,'' ``without 
calories,'' ``trivial source of calories,'' ``negligible source of 
calories,'' or ``dietary insignificant source of calories'' on the 
label or in the labeling of foods as defined in Sec.  101.60(b). The 
footnote shall state: *The % Daily Value tells you how much a nutrient 
in a serving of food contributes to a daily diet. 2,000 calories a day 
is used for general nutrition advice.
* * * * *
    (j) * * *
    (13) * * *
    (ii) * * *
    (C) Omitting the footnote statement required in paragraph (d)(9) of 
this section and placing another asterisk at the bottom of the label 
followed by the statement ``%DV=%Daily Value.''
* * * * *
0
3. In Sec.  101.36, revise paragraph (b)(2)(iii)(D) to read as follows:


Sec.  101.36  Nutrition labeling of dietary supplements.

* * * * *
    (b) * * *
    (2) * * *
    (iii) * * *
    (D) If the percent of Daily Value is declared for total fat, 
saturated fat, total carbohydrate, dietary fiber, protein, or added 
sugars, a symbol shall follow the value listed for those nutrients that 
refers to the same symbol that is placed at the bottom of the nutrition 
label, below the bar required under paragraph (e)(6) of this section 
and inside the box, that is followed by the statement ``Percent Daily 
Values are based on a 2,000 calorie diet.'' If the product is 
represented or purported to be for use by children 1 through 3 years of 
age, and if the percent of Daily Value is declared for total fat, total 
carbohydrate, dietary fiber, protein, or added sugars, a symbol shall 
follow the value listed for those nutrients that refers to the same 
symbol that is placed at the bottom of the nutrition label, below the 
bar required under paragraph (e)(6) of this section and inside the box, 
that is followed by the statement ``Percent Daily Values are based on a 
1,000 calorie diet.''
* * * * *

    Dated: July 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17928 Filed 7-24-15; 8:45 am]
 BILLING CODE 4164-01-P


