[Federal Register Volume 78, Number 104 (Thursday, May 30, 2013)]
[Notices]
[Pages 32394-32400]
[FR Doc No: 2013-12824]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0495]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study on
Consumer Responses to Nutrition Facts Labels With Various Footnote
Formats and Declaration of Amount of Added Sugars

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 1,
2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-New and
title ``Experimental Study on Consumer Responses to Nutrition Facts
Labels with Various Footnote Formats and Declaration of Amount of Added
Sugars.'' Also include the FDA docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Experimental Study on Consumer Responses to Nutrition Facts Labels with
Various Footnote Formats and Declaration of Amount of Added Sugars--
(OMB Control Number 0910-New)

I. Background

    Under the Nutrition Labeling and Education Act of 1990 (Pub. L.
101-535), the Nutrition Facts label is required on most packaged foods
and this information must be provided in a specific format in
accordance with the provisions of Sec.  101.9 (21 CFR 101.9). When FDA
was determining which Nutrition Facts label format to require, the
Agency undertook consumer research to evaluate alternatives (Refs. 1 to
3). More recently, FDA conducted qualitative consumer research on the
format of the Nutrition Facts label on behalf of the Agency's Obesity
Working Group (Ref. 4), which was formed in 2003 and tasked with
outlining a plan to help confront the problem of obesity in the United
States (Ref. 5). In addition to conducting consumer research, in the
Federal Register of November 2, 2007 (72 FR 62149), FDA issued an
Advance Notice of Proposed Rulemaking (ANPRM) entitled, ``Food
Labeling: Revision of Reference Values and Mandatory Nutrients'' (the
2007 ANPRM), which requested comments on a variety of topics related to
a future proposed rule to update the presentation of nutrients and
content of nutrient values on food labels. In the 2007 ANPRM, the
Agency included a request for comments on how consumers use the percent
Daily Value in the Nutrition Facts label when evaluating the
nutritional content of food items and making purchases.
    Research has suggested that consumers use the Nutrition Facts label
in various ways, including, but not limited to, using the Nutrition
Facts label to determine if products are high or low in a specific
nutrient and to compare products (Ref. 6). One component of the
Nutrition Facts label that serves as an aid in these uses is the
percent Daily Value. Early consumer research indicated that the percent
Daily Value format improved consumers' abilities to make correct
dietary judgments about a food in the context of a total daily diet
(Ref. 3), which led FDA to require both quantitative and percentage
declarations of nutrient Daily Values in the Nutrition Facts label in
the 1993 Nutrition Labeling final rule (58 FR 2079, January 6, 1993).
    Research in subsequent years, however, suggested that consumers'
understanding and use of percent Daily Value may be somewhat
inconsistent (Refs. 7 and 8). Additionally, FDA has received several
public comments suggesting that further research on percent Daily
Values may be warranted, along with research on other modifications to
the Nutrition Facts label. Suggested research on potential
modifications includes research on: (1) The removal of the statements,
``Percent Daily Values are based on a 2,000 calorie diet. Your Daily
Values may be higher or lower depending on your calorie needs''; (2)
the removal of the table in the footnote that lists the Daily Values
for total fat, saturated fat, cholesterol, sodium, total carbohydrate,
and dietary fiber based on 2,000 and 2,500 calorie diets as described
in Sec.  101.9(d)(9); and (3) changes to the presentation of and amount
of information provided in the Nutrition Facts label. Therefore, the
FDA, as part of its effort to promote public health, proposes to use
this study to explore consumer responses to various food label formats
for the footnote area of the Nutrition Facts label, including those
that exhibit information such as a description of percent Daily Value,
a succinct statement about daily caloric intake, a general guideline
for interpreting percent Daily Values, or a footnote about nutrients
whose daily intake should be limited.
    This study will also explore how declaring the added sugars content
of foods might affect consumers' attention to and understanding of the
sugars and calorie contents and other information on the Nutrition
Facts label. FDA received numerous comments regarding the declaration
of added sugars in response to the 2007 ANPRM even though the Agency
did not ask any

questions regarding the declaration of added sugars. The Agency is not
aware of any existing consumer research that has examined this topic
and is therefore interested in using this study to enhance its
understanding of how consumers might currently perceive and use this
new information if it is presented on the Nutrition Facts label.
    The proposed collection of information is a controlled, randomized,
experimental study. The study will use a Web-based survey, which will
take about 15 minutes to complete, to collect information from 10,000
English-speaking adult members of an online consumer panel maintained
by a contractor. The study will aim to recruit a sample that reflects
the U.S. Census on gender, education, age, and ethnicity/race.
    The study will randomly assign each of its participants to view
Nutrition Facts label images from a set of food labels that will be
created for the study. The label formats will vary in the presence or
absence of: (1) A footnote describing percent Daily Value (``The %
Daily Value tells you how much a nutrient in a serving of food
contributes to a daily diet''); (2) a footnote indicating those
nutrients whose daily intake should be limited (i.e., saturated fat,
trans fat, cholesterol, sodium, and sugars); (3) a footnote including a
general guideline for interpreting percent Daily Values, such as, ``5%
or less is a little, 20% or more is a lot''; (4) a footnote including a
succinct statement about daily caloric intake (e.g., ``2,000 calories a
day is used for general nutrition advice, but people have different
calorie needs''); and (5) a declaration for added sugars. All label
images will be mockups resembling Nutrition Facts labels that may be
found in the marketplace. Images will show product identity (e.g.,
yogurt or frozen meal), but not any real or fictitious brand name.
    The survey will ask its participants to view label images and
answer questions about their understanding, perceptions, and reactions
related to the viewed label. The study will focus on the following
types of consumer reactions: (1) Judgments about a food product in
terms of its nutritional attributes and overall healthfulness; (2)
ability to use the Nutrition Facts label in tasks, such as comparing
two products, identifying a product's nutrient contents, and evaluating
the levels of vitamin, mineral, and other nutrient content of a
product; and (3) label perceptions (e.g., helpfulness and credibility).
To help understand consumer reactions, the study will also collect
information on participants' background, including but not limited to,
use of the Nutrition Facts label and health status.
    The study is part of the Agency's continuing effort to enable
consumers to make informed dietary choices and construct healthful
diets through labeling, consumer education, or both. Results of the
study will be used primarily to enhance the Agency's understanding of
how various potential modifications to the Nutrition Facts label may
affect how consumers perceive a product or a label, which may in turn
affect their dietary choices, and how to better educate people in using
the Nutrition Facts label. Results of the study will not be used to
develop population estimates.
    In the Federal Register of May 31, 2012 (77 FR 32120), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. The Agency received 19 written responses
containing multiple comments. Many comments outlined detailed technical
feedback regarding the design of a draft questionnaire that was
associated with a Federal Register notice published on December 29,
2011 (76 FR 81948). That notice was officially withdrawn in a
subsequent Federal Register notice published on May 31, 2012 (77 FR
32122), and all documentation associated with the withdrawn notice is
considered obsolete. The Agency also received comments related to the
declaration of added sugars on the Nutrition Facts label. To the extent
that comments about added sugars declarations raised regulatory,
policy, and nutrition science issues, the Agency notes that such
comments are not directly related to the proposed consumer research and
are therefore not addressed in this notice.
    The responses included in this notice address comments that pertain
directly to the currently proposed collection of information.
Specifically, this notice addresses those comments that relate to the
topics on which the FDA invited comments in the Federal Register of May
31, 2012: (1) Whether the proposed collection of information is
necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's 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.
    (Comment 1) While a number of comments supported the proposed
collection of information, a number of comments also questioned whether
the proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility. Among the issues raised with regard to whether
the information is necessary for the proper performance of FDA's
functions was whether the Agency has sufficient justification to
require, or the ability to enforce, added sugars declarations on
Nutrition Facts labels. These comments discussed an uncertain
relationship between added sugars and chronic health conditions, the
current inability of most analytical methods to detect added sugars
content in foods, and views on added sugars declarations that the
Agency has historically expressed.
    (Response 1) The Dietary Guidelines for Americans 2010 (2010 DGA)
recommend the reduction in consumption of added sugars which currently
comprise 16% of the daily energy intake. The DGA noted that ``many
foods that contain added sugars often supply calories, but few or no
essential nutrients and no dietary fiber.'' The current Nutrition Facts
label does not permit the declaration of added sugars on the label.
Section 403(q)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343) provides that the Secretary of Health and Human Services
may, by regulation, require other nutrients to be declared in nutrition
labeling if the Secretary determines that a nutrient will provide
information regarding the nutritional value of a food that will assist
consumers in maintaining healthy dietary practices. The Agency proposes
to examine added sugars declarations, along with other label
modifications, in this information collection. The information gathered
will have utility for the Agency as general information about
consumers' current perceptions and use of information appearing on the
Nutrition Facts label and will inform future education efforts. The
study may also inform the Agency about what changes it should consider
related to the Nutrition Facts label. The Agency's proposal to conduct
consumer research on added sugars declarations does not constitute a
proposal for changes in which nutrients must or may be declared on the
Nutrition Facts label. Comments concerning regulatory, policy, and
nutrition science related to added sugars declarations are outside the
scope of this proposed collection of information. If and when the
Agency

proposes changes to the current format and content of the Nutrition
Facts label, the public will be invited to comment on the relevant
regulatory, policy, and nutrition science questions. Further, the
concerns raised by the comments would not necessarily preclude the
Agency from proposing changes to the Nutrition Facts label that may be
informed by this study.
    (Comment 2) A number of comments offered suggestions about
additional consumer research or raised policy or nutrition science
matters for consideration. Specifically, one comment recommended that
FDA evaluate the effects of labels that show only added sugars and
juice sugars, instead of showing total sugars. The same comment also
suggested that FDA test consumers' understanding of how much sugar a
food contains when amounts are provided in teaspoons as opposed to
grams. Two comments urged FDA to set a daily value for sugars, added
sugars, or both. One comment urged FDA to evaluate the effect on
consumers of distinguishing between whole versus refined fiber on the
Nutrition Facts label, as recommended by the Institute of Medicine. One
comment suggested identifying a disqualifying level of total or added
sugars that would make a product ineligible to have a health claim on
its packaging because certain foods that are high in sugars may bear
health claims and mislead consumers to think a product is healthier
than it is. One comment noted that certain juice products may have more
added sugars than, but the same or lower level of total sugars as,
other juice or dried fruit products. The comment claimed that
highlighting added sugars would minimize the health benefits of those
products that contain more added sugar but lower total sugar than other
juice or fruit products.
    (Response 2) These comments are outside of the scope of the
proposed collection of information described in the 60-day notice and
therefore are not addressed here.
    (Comment 3) Multiple comments cited the importance of evaluating
consumer responses to potential changes to the Nutrition Facts label
and how consumer understanding of the nutritional attributes of
packaged foods may be affected by these changes, and therefore
supported the proposed study.
    (Response 3) The Agency agrees with these comments.
    (Comment 4) Multiple comments noted the importance of educating
consumers about how to make positive food choices, rather than relying
solely on Nutrition Facts labeling as a method of assisting consumers
in maintaining healthy dietary practices.
    (Response 4) FDA agrees that consumer education is important to
help consumers understand how to make healthy dietary choices, and has
been conducting and sponsoring a variety of education efforts through
its Web site (e.g., Refs. 9 to 14) and other programs such as the
``Spot the Block'' campaign (Refs. 13 and 14). The results of the
proposed study will provide the Agency additional information to help
guide future consumer education about how to use food labels to make
healthy dietary choices.
    (Comment 5) One comment noted that while Internet-administered
questionnaires minimize burden on respondents and possible
administration errors, expedite the timeliness of data collection and
processing, and are less intrusive and less costly than other modes of
questionnaire administration, there are also drawbacks to this mode of
survey administration. Two comments noted limitations pertaining to
online consumer panels, specifying that because panel-based samples are
not representative of the general U.S. population, the results of the
study cannot be applied to all U.S. consumers. One comment questioned
why the Agency has not elected to restrict the research to respondents
who shop for food or who read Nutrition Facts labels. The comment
suggested that the study should screen for consumers who have a high
probability of seeing Nutrition Facts labels or who actually consume or
purchase the types of food products to be included in the proposed
study.
    (Response 5) The Agency acknowledges the limitations of Internet-
administered research and the constraints associated with using samples
drawn from online consumer panels. We note that the study is a
controlled experimental study that would employ random assignment and
is intended to examine causal relationships between certain label
format modifications and respondents' reactions to the modifications.
The study is not a survey that aims to generate population estimates of
how many consumers would react to different modifications in particular
ways. Because the study is not intended to generate population
estimates, the Agency disagrees that the limitations of the sample
would preclude meaningful conclusions about potential effects of the
label format modifications, or that the study should be limited to
participants characterized by particular label use or product use
habits. In describing the data collected and results of the analysis,
FDA will clearly acknowledge that the experimental data do not provide
nationally representative population estimates of consumer
understanding, behaviors, or perceptions, but nevertheless provide
valid and quantitative estimates of differences across experimental
conditions.
    (Comment 6) Three comments expressed concern about asking
respondents to judge the overall healthfulness of the products they
view in the study. These comments noted that consumers' definitions of
healthfulness may or may not be consistent with FDA's regulatory
definition of healthy. Because different consumers are likely to define
``healthier'' using different criteria, one comment suggested providing
a definition of ``healthier'' to ensure that all respondents are using
the same definition. The comment asserted that because respondents may
use idiosyncratic bases for responding to such questions, it is unclear
how the results can be compared across respondents. The same comment
noted similar concerns about asking participants to report their
perceptions of how much sugar a product contains, how well they
understand the content of a given label, or how likely they would be to
include a given product as part of their diet.
    (Response 6) The Agency disagrees with these comments. These
comments fail to account for the randomized, controlled, experimental
design of the proposed research and mischaracterize the primary
function of the selected measures in the context of the proposed study.
The proposed study is not a cross-sectional survey, but rather an
experiment. Relative to cross-sectional surveys, properly designed
experiments are better able to determine causal effects attributable to
the independent variables, such as the nutrient levels shown on the
Nutrition Facts label, which have been systematically varied by the
experimenter. As an experiment, the focus is on the differences
observed between treatment groups (e.g., those who see labels with
format modifications) and control groups (e.g., those who see labels in
the current Nutrition Facts format). Because participants will be
randomly assigned to experimental conditions that systematically vary
in certain respects, idiosyncratic variations, such as individuals'
understanding of healthfulness and different ways of judging the
relative nutrient content of various foods, are likely to be
distributed evenly across conditions. As a result, differences in
outcomes that

may be observed between conditions would most likely be due to
experimental factors as opposed to individual idiosyncrasies.
    Thus, the Agency has proposed an experimental method for
understanding the causal effects of added sugars declarations on
consumer responses to Nutrition Facts labels. The measurement
approaches selected for the proposed study are well-established and
have been employed in numerous peer-reviewed scientific publications
(see, for example, Refs. 1 to 3; 15 to 24). In studies such as these,
participants demonstrate their practical understanding of the
nutritional information about selected foods through their completion
of selected dietary tasks, such as comparing the healthfulness of
different food items or judging how healthful they think a product is.
Importantly, research has demonstrated that if consumers perceive that
a product is healthful, they may be more likely to purchase or consume
more of that food, and may be more likely to view that food as
possessing other positive attributes that it may not objectively have
(Refs. 25 and 26). Thus, consumer judgments of product healthfulness as
well as calorie and nutrient levels will serve as vital indicators of
how various Nutrition Facts information and formats may assist
consumers in identifying healthful food products and in comparing the
calorie and nutrient contents of different food products. In turn, data
derived from this research will assist the Agency in determining
directions for future research and educational activities.
    For the purposes of this study, it is not necessary to provide
consumers with a specific definition of ``healthier.'' The study aims
to examine what consumers may infer from the Nutrition Facts labels
based on their own interpretations, not to examine definitions of
``healthy'' or ``healthier'' according to regulatory or scientific
perspectives. Evaluating potential effects of added sugars declarations
on consumers with a diverse range of nutrition knowledge using a
randomized, controlled, experimental study will provide useful
information about consumers' current perceptions and use of information
appearing on the Nutrition Facts label and will inform future education
efforts.
    While random assignment is the most robust method for significantly
reducing the plausibility of individual difference explanations for
observed differences between treatment and control conditions, we also
plan to collect measures of individual characteristics that will allow
for some statistical control of potential confounders. The measurement
of these additional covariates (e.g., how often people eat and purchase
the categories of foods included in the study, people's typical label
use frequency, demographic characteristics, etc.) will further enhance
the study's explanatory power.
    (Comment 7) One comment questioned the utility of collecting
participants' ratings of a given label's usefulness and helpfulness for
making various dietary judgments.
    (Response 7) The measures to which this comment refers (e.g.,
asking respondents to rate on a scale from 1 = ``not at all'' to 5 =
``very'' how hard it is to understand the information shown on the
label) are indicators of consumers' attitudinal responses toward the
label formats. FDA draws a distinction between these types of
attitudinal measures and behavioral performance measures (i.e., how
well consumers use a label format for completing a specific task, such
as judging healthfulness and identifying nutritional characteristics of
a product). The Agency has typically considered behavioral performance
measures to be more consequential than ratings of label usefulness,
understandability, and helpfulness. Nevertheless, the Agency also
collects these ratings because it is possible that inferior ratings of
usefulness, understandability, and helpfulness could be indicative of a
potential problem with a particular label modification or label format.
It is therefore important to collect these kinds of ratings.
    (Comment 8) Some comments asserted that including added sugars
declarations would detract from consumers' focus on other nutrition
information, specifically total calories. Related comments noted that
consumers would be confused or misled by added sugars declarations. A
few comments proposed that consumer research should focus on exactly
how consumers understand the term ``added sugars,'' the particular
meanings that consumers attach to various kinds of sugars, and the
health effects that consumers associate with added sugars. Two comments
asked if FDA plans to explore whether including ``added sugar'' and
``naturally occurring sugar'' on the Nutrition Facts label under total
sugars would increase consumer understanding of products' nutritional
attributes and healthfulness. One comment requested that the Agency
establish definitions that differentiate between added sugars and
naturally occurring sugars before conducting consumer research. These
comments expressed concern that consumer understanding about sugars
does not match definitions that might be endorsed by various regulatory
or scientific entities. Another comment suggested that the Agency study
how information about added sugars in ingredient listings might affect
attention to and understanding of information in the Nutrition Facts.
    (Response 8) The Agency agrees that the questions raised in these
comments would be suitable for future research. The purpose of the
currently proposed study is to provide the Agency with an initial
understanding of potential consumer reactions to added sugars
declarations on Nutrition Facts labels, information that would, in
turn, help guide education efforts. In response to comments that raised
concerns about the potential for added sugars declarations to affect
consumer attention to and perceptions of other nutritional attributes
presented in Nutrition Facts labels, FDA notes that the proposed
experimental design is intended to address this possibility through the
collection of respondent judgments of the nutritional attributes and
overall healthfulness of foods that contain varying levels of calories,
fat, and other nutrients. Additionally, as previously noted, FDA
recognizes the importance of evaluating the potential effects of any
proposed Nutrition Facts label modifications on consumer understanding.
The proposed study will therefore include systematically varied
experimental conditions and controls, and will employ appropriate
measures to assess how various format modifications may affect consumer
understanding of the Nutrition Facts label information. Due to resource
limitations, the study cannot accommodate additional experimental
conditions to evaluate consumer responses to ingredient listings. The
study will, however, collect information about what names of various
types of added sugars respondents recognize that might appear in
ingredient listings.
    (Comment 9) One comment objected to asking consumers about health
effects (e.g., heart disease and diabetes) that consumers would
associate with consuming a particular food product. The comment argued
that consumer research questions should align with FDA's regulations
regarding health claims, regulations which preclude suggestions that
food substances may prevent, treat, or cure any particular disease or
condition.
    (Response 9) FDA disagrees with these comments. Several health
conditions have been linked to dietary quality, and dietary quality is

influenced by consumer perceptions and food choices. Regardless of
FDA's regulations, consumers often make their own inferences about the
relationships between food substances and the risk of various health
conditions from labeling information. Rigorous and informative consumer
research that aims to assess consumer understanding of labeling
information typically accounts for the broader inferences consumers may
make about food products, although the particular health conditions of
interest in a particular consumer research study may vary (as evident
in Refs. 1 to 3 and 15 to 24). In order to assess the extent to which
consumers may infer broader health outcomes from nutrition information
on the label, the study will ask respondents to judge whether people
concerned about conditions such as osteoporosis or cancer should
include a particular food item in their diet.
    (Comment 10) One comment suggested that, instead of asking
respondents if they use Nutrition Facts labels ``To see if something
said in advertising or on the package is actually true,'' the item be
reworded to say ``To confirm a statement in advertising or on the
package,'' arguing that the former implies that inconsistency may exist
between advertising and labeling statements and that consumers can
independently verify label declarations.
    (Response 10) The comment did not provide any data to support this
rationale, and the Agency is not aware of any evidence to suggest that
consumers interpret the survey item in question in the manner described
in the comment. Nevertheless, this comment is no longer applicable to
the proposed study because the item in question has been removed in
order to prioritize collection of other information that is considered
more relevant to the objectives of the current study.
    (Comment 11) One comment stated that if the Agency is intending to
include added sugars information on the Nutrition Facts label by
indenting the phrase ``Added Sugars'' below where the declaration for
``Sugars'' appears, it is possible that consumers may not understand
that added sugars are a subset of the amount of sugars. The comment
suggested that the Agency study consumer responses to a Nutrition Facts
format that adds the word ``total'' to the sugars declaration, so that
this alternative format can also be evaluated in the proposed consumer
research, noting that it might be beneficial to test more than one
added sugars declaration format.
    (Response 11) The Agency agrees with this comment and will plan to
include an alternative label format that adds the word ``total'' to the
sugars declaration in the proposed research. Thus, the study will
include two formats for declaring ``Added Sugars'' on the Nutrition
Facts label: One format in which the declaration is indented below a
``Sugars'' declaration, and one format in which the declaration is
indented below a ``Total Sugars'' declaration.
    (Comment 12) One comment suggested that the Agency use the
cognitive interviews to ask consumers their understanding of the phrase
``added sugars'' as it appears on some of the experimental Nutrition
Facts formats. The comment also recommended that the number of
cognitive interviews be sufficient to assess the level of comprehension
of this terminology.
    (Response 12) The Agency plans to conduct in-person cognitive
interviews with participants of various ages, educational levels, and
household incomes. The Agency agrees that it may be useful to ask
cognitive interview participants about their understanding of the
phrase ``added sugars'' and will include questions about this topic in
all of the cognitive interviews that are conducted for the proposed
study. Given that the primary purpose of the cognitive interviews is to
assist with refinement of the questionnaire, the Agency does not agree
that the number of cognitive interviews should be modified for
assessing comprehension of added sugars terminology.
    (Comment 13) One comment suggested that the proposed sample size
for the study might be larger than necessary, unless the Agency expects
to conduct subgroup analyses within experimental conditions.
    (Response 13) As the comment noted, the Agency confirms that
allowing for subgroup analyses constitutes one of the reasons for the
proposed sample size. Another reason for the proposed sample size is to
allow for assessment of interactions between the various experimental
factors (e.g., label format x food category x nutrition profile).
Indeed, the ability to detect interactions is of equal, if not more,
importance to fulfilling the Agency's information objectives than the
ability to detect only the main effects of experimental factors such as
label format, food category, or nutrition profile.
    (Comment 14) One comment suggested two alternative definitions for
percent Daily Value: (1) ``The Percent Daily Value tells you how much
of a day's worth of a nutrient one serving of this food provides''; and
(2) ``The Percent Daily Value tells you how much of a day's worth of a
nutrient you would get from one serving of this food.''
    (Response 14) Due to resource limitations, the Agency is not able
to test the alternative definitions of percent Daily Value suggested in
this comment.
    (Comment 15) One comment objected to asking respondents to evaluate
whether a product is an ``excellent source'' of or ``low'' in a
particular nutrient relative to footnote messages that indicate that 5%
or less of the Daily Value for a nutrient is ``low'' or ``a little''
and 20% or more of the Daily Value is ``high'' or ``a lot.'' The
comment raised concerns that consumers may not interpret or apply such
footnote messages as FDA intends.
    (Response 15) FDA agrees that some consumers may not interpret or
apply a particular footnote message as FDA intends. That is one reason
for asking respondents to characterize the vitamin and nutrient content
of selected products. Collecting information about differences between
consumer interpretations of information versus FDA definitions will
help guide FDA's ongoing informational efforts to provide consumer
guidance on how to use percent Daily Values.
    (Comment 16) Two comments suggested that FDA test effects of
including ``high'' and ``low'' text next to the appropriate nutrients
on the NF label in accordance with the 5% and 20% guideline levels. One
of these comments also suggested certain nutrients and their amounts be
printed in red ink or against a red background, in conjunction with the
word ``high'' being printed in red and positioned between the amount of
the nutrient and the percent Daily Value.
    (Response 16) The Agency has studied the use of adjectives such as
``high'' and ``low'' on Nutrition Facts labels in prior research (Refs.
1 and 3). That research found that Nutrition Facts formats that
included adjectives did not significantly improve respondents' accuracy
in dietary judgment tasks relative to Nutrition Facts formats that did
not include such adjectives. Specifying a particular color scheme for
selected content in the Nutrition Facts label or adding amount
descriptors next to certain nutrients are beyond the scope of this
study.
    (Comment 17) One comment suggested testing alternative statements
for recommended caloric intake, including statements of calorie ranges;
statements indicating that calorie requirements change with age,
height, and activity level; and statements suggesting consumers check
their own caloric needs on a Government run Web site (e.g.,
www.choosemyplate.gov). A proposed sample statement offered was: ``The
recommended daily intake for an

average adult is 2,000 calories. See www.xxx.gov for individual calorie
needs based on gender, age and activity level.''
    (Response 17) Due to resource limitations, the Agency is not able
to test the alternative statements for recommended caloric intake
suggested in this comment. In addition to calorie requirements changing
with age, height, and activity level, as the comment stated, calorie
requirements also vary according to a number of other factors,
including body composition (percentages of lean body mass and body
fat), basal and resting metabolic rate, ambient temperature, genetic
factors, whether a woman is pregnant or lactating, and others. An
accurate label statement explaining how calorie needs vary would be too
lengthy and complex for inclusion on Nutrition Facts labels. Using the
phrase ``recommended daily intake'' for calorie requirements, as the
comment suggests, could also be problematic, since 2,000 calories is
not a recommended intake level, but is rather used as the basis for
setting Daily Reference Values (DRVs) for nutrients having DRVs that
are based on caloric intake. Finally, there are many Web sites that
provide information on estimating individual calorie needs. The
question of whether it would be suitable for the Nutrition Facts label
to single out any one particular Web site is beyond the scope of the
study.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                 Activity                      Number of        responses per       Total annual       Average burden per response        Total hours
                                              respondents         respondent         responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interview screener.............                 72                  1                 72  0.083............................                  6
                                                                                (5 min.).........................
Cognitive interview......................                  9                  1                  9  1................................                  9
Pretest invitation.......................              1,000                  1              1,000  0.033............................                 33
                                                                                (2 min.).........................
Pretest..................................                150                  1                150  0.25.............................                 38
                                                                                (15 min.)........................
Survey invitation........................             40,000                  1             40,000  0.033............................              1,320
                                                                                (2 min.).........................
Survey...................................             10,000                  1             10,000  0.25.............................              2,500
                                                                                (15 min.)........................
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  .................  .................  .................  .................................              3,906
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. 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. (FDA
has verified the Web site addresses, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. Levy, A. S., S. B. Fein, and R. E. Schucker, ``Nutrition Labeling
Formats: Performance and Preference,'' Food Technology, 45: 116-121,
1991.
2. Levy, A. S., S. B. Fein, and R. E. Schucker, ``More Effective
Nutrition Label Formats are not Necessarily Preferred,'' Journal of
the American Dietetic Association, vol. 92, pp. 1230-1234, 1992.
3. Levy, A. S., S. B. Fein, and R. E. Schucker, ``Performance
Characteristics of Seven Nutrition Label Formats,'' Journal of
Public Policy and Marketing, 15: 1-15, 1996.
4. Lando, A. M. and J. Labiner-Wolfe, ``Helping Consumers to Make
More Healthful Food Choices: Consumer Views on Modifying Food Labels
and Providing Point-of-Purchase Nutrition Information at Quick-
Service Restaurants,'' Journal of Nutrition Education and Behavior,
vol. 39, pp. 157-163, 2007.
5. U.S. Food and Drug Administration, Calories Count: Report of the
Working Group on Obesity, 2004, available at http://www.fda.gov/ohrms/dockets/ac/04/briefing/4039b1_01_calories%20count.pdf.
6. U.S. Food and Drug Administration, ``2008 Health and Diet
Survey--Preliminary Topline Frequencies (Weighted),'' 2010,
available at http://www.fda.gov/Food/FoodScienceResearch/ConsumerBehaviorResearch/ucm193895.htm.
7. Li, F., P. W. Miniard, and M. J. Barone, ``The Facilitating
Influence of Consumer Knowledge on the Effectiveness of Daily Value
Reference Information,'' Journal of the Academy of Marketing
Science, vol. 28, pp. 425-436, 2000.
8. Levy, L., R. E. Patterson, A. R. Kristal, and S. S. Li, ``How
Well Do Consumers Understand Percentage Daily Value on Food
Labels?'' American Journal of Health Promotion, vol. 14, pp. 157-
160, 2000.
9. U.S. Food and Drug Administration, ``A Key to Choosing Healthful
Foods: Using the Nutrition Facts on the Food Label,'' available at
http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079449.htm.
10. U.S. Food and Drug Administration, ``The Food Label and You--
Video,'' available at http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm275409.htm.
11. U.S. Food and Drug Administration, ``How to Understand and Use
the Nutrition Facts Label,'' available at http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm274593.htm.
12. U.S. Food and Drug Administration, ``Using the Nutrition Facts
Label. A How-to Guide for Older Adults,'' available at http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm267499.htm.
13. U.S. Food and Drug Administration, ``Spot The Block Campaign For
Tweens,'' available at http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm281757.htm.
14. U.S. Food and Drug Administration. ``Spot the Block: Get Your
Food Facts First,'' available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048815.htm.
15. Andrews, J. C., S. Burton, and R. G. Netemeyer, ``Are Some
Comparative Nutrition Claims Misleading? The Role of Nutrition
Knowledge, Ad Claim Type and Disclosure Conditions,'' Journal of
Advertising, vol. 29, pp. 29-42, 2000.
16. Barone, M. J., R. L. Rose, K. C. Manning, and P. W. Miniard,
``Another Look at the Impact of Reference Information on Consumer
Impressions of Nutrition Information,'' Journal of Public Policy &
Marketing, vol. 15, pp. 55-62, 1996.
17. Burton, S., J. A. Garretson, and A. M. Velliquette,
``Implications of Accurate Usage of Nutrition Facts Panel
Information for Food Product Evaluations and Purchase Intentions,''
Journal of the Academy of Marketing Science, vol. 27, pp. 470-480,
1999.
18. Crites, S. L. and S. N. Aikman, ``Impact of Nutrition Knowledge
on Food

Evaluations,'' European Journal of Clinical Nutrition, vol. 59, pp.
1191-1200, 2005.
19. Ford, G. T., M. Hastak, A. Mitra, and D. J. Ringold, ``Can
Consumers Interpret Nutrition Information in the Presence of a
Health Claim? A Laboratory Investigation,'' Journal of Public Policy
& Marketing, vol. 15, pp. 16-27, 1996.
20. Howlett, E., S. Burton, and J. Kozup, ``How Modification of the
Nutrition Facts Panel Influences Consumers at Risk for Heart
Disease: The Case of Trans Fat,'' Journal of Public Policy &
Marketing, vol. 27, pp. 83-97, 2008.
21. Lando, A. M. and S. C. Lo, ``Single-Larger-Portion-Size and
Dual-Column Nutrition Labeling may Help Consumers Make More
Healthful Food Choices,'' Journal of the Academy of Nutrition and
Dietetics, vol. 113, pp. 241-250, 2013.
22. Roberto, C. A., M. A. Bragg, M. J. Seamans, R. L. Mechulan, et
al, ``Evaluation of Consumer Understanding of Different Front-of-
Package Nutrition Labels, 2010-2011,'' Preventing Chronic Disease,
vol. 9, 120015. DOI: http://dx.doi.org/10.5888/pcd9.120015.
23. Roberto, C. A., M. A. Bragg, M. B. Schwartz, M. J. Seamans, et
al, ``Facts Up Front Versus Traffic Light Food Labels. A Randomized
Controlled Trial,'' American Journal of Preventive Medicine, vol.
43, pp. 134-141, 2012b.
24. Roe, B., A. S. Levy, and B. M. Derby, ``The Impact of Health
Claims on Consumer Search and Product Evaluation Outcomes: Results
from FDA Experimental Data,'' Journal of Public Policy & Marketing,
vol. 18, pp. 89-105, 1999.
25. Chandon, P. ``How Package Design and Package-Based Marketing
Claims Lead to Overeating.'' Applied Economic Perspectives and
Policy, vol. 35, pp. 123-147, 2013.
26. Chandon P. and B. Wansink, ``Does Food Marketing Need to Make Us
Fat? A Review and Solutions,'' Nutrition Reviews, vol. 70, pp. 571-
593, 2012.

    Dated: May 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12824 Filed 5-29-13; 8:45 am]
BILLING CODE 4160-01-P