
[Federal Register Volume 78, Number 104 (Thursday, May 30, 2013)]
[Notices]
[Pages 32394-32400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. 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, domini.bean@fda.hhs.gov.

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

[[Page 32395]]

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

[[Page 32396]]

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

[[Page 32397]]

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

[[Page 32398]]

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

[[Page 32399]]

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

[[Page 32400]]

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


