[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Notices]
[Pages 32120-32122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-13141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a study entitled ``Experimental Study on 
Consumer Responses to Nutrition Facts Labels With Various Footnote 
Formats and Declaration of Amount of Added Sugars.''

DATES: Submit either electronic or written comments on the collection 
of information by July 30, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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 protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

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

[[Page 32121]]

(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 various definitions for percent Daily Value, a succinct 
statement about daily caloric intake, and general guidelines for high 
and low nutrient levels.
    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 understanding of how consumers would comprehend and use this 
new information.
    In the Federal Register of May 23, 2011 (76 FR 29758), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. In that notice, the Agency announced its 
intention to examine consumer reactions to the declaration of vitamins 
and minerals by weight on the Nutrition Facts label. This intention was 
prompted by the 2003 Institute of Medicine report that recommended 
declaration of weight amounts of all nutrients, including vitamins and 
minerals, on the food label (Ref. 9). As the report noted, public 
health advice on nutrient intake is often given in absolute amounts, 
but in the case of a nutrient such as calcium, consumers may not be 
able to determine the amount of calcium in a food when it is listed 
only as Percent Daily Values on the Nutrition Facts label. Block and 
Peracchio (Ref. 10) demonstrated this difficulty and the potential 
merits of providing consumers with easy-to-use information in helping 
them increase their calcium intakes. The findings by Block and 
Peracchio provide data on the issue we were planning to study. On the 
other hand, consumer evidence on the effects of declaring added sugars 
is lacking. Therefore, the Agency has determined that the utility of 
the study would be enhanced by replacing the examination of declaring 
amounts of vitamins and minerals by weight with an examination of 
declaring the amount of added sugars. This change would have minimal 
effects on the planned length and respondent burden of the study and 
would not change the study's primary focus, which remains on examining 
footnote options.
    In the Federal Register of December 29, 2011 (76 FR 81949), FDA 
published a notice informing interested parties that the proposed 
collection of information had been submitted to OMB for review and 
clearance under the PRA and inviting the public to submit comments on 
the proposed study to OMB. The notice also announced FDA's plans to 
change the study by examining consumer reactions to the declaration of 
added sugars instead of the declaration of vitamins and minerals by 
weight. OMB received requests for an extension of time to comment on 
this change to the study. In response to these requests, FDA is 
providing an opportunity for comment on the current design of the 
study, including the added sugars component, by publishing a new 60-day 
notice describing the study as currently envisioned and inviting the 
public to submit comments to the Agency's docket. After considering any 
comments received, the Agency will resubmit the proposed collection of 
information to OMB. In the meantime, the Agency is withdrawing the 
proposed collection of information from OMB review, as announced 
elsewhere in this issue of the Federal Register.
    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 a 
series of label images from a set of food labels that will be created 
for the study and systematically varied in the presence or absence of: 
(1) A definition for percent Daily Value, (2) a general guideline for 
``high'' and ``low'' nutrient levels, and (3) a declaration for added 
sugars. A sample definition for percent Daily Value may include, for 
example, ``The percent Daily Value is the amount of a nutrient listed 
in this document that one serving of this product contributes to the 
daily diet.'' A sample guideline for high and low nutrient levels may 
include, for example, ``5 percent or less is low, and 20 percent or 
more is high.'' Finally, the study will also examine effects of 
including reference to FDA within the Nutrition Facts footnote and a 
succinct statement about daily caloric intake. All label images will be 
mock-ups resembling food 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 identifying 
a product's nutrient contents and evaluating the percent Daily Values 
for specific nutrients; 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. 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. Results of the 
study will not be used to develop population estimates.
    To help design and refine the questionnaire, FDA plans to conduct 
cognitive interviews by screening 72 panelists in order to obtain 9 
participants in the interviews. Each screening is expected to take 5 
minutes (0.083 hour) and each cognitive interview is expected to take 
one hour. The total for cognitive interview activities is 15 hours (6 
hours + 9 hours). Subsequently, we plan to

[[Page 32122]]

conduct pretests of the questionnaire before it is administered in the 
study. We expect that 1,000 invitations, each taking 2 minutes (0.033 
hours), will need to be sent to adult members of an online consumer 
panel to have 150 of them complete a 15-minute (0.25 hours) pretest. 
The total for the pretest activities is 71 hours (33 hours + 38 hours). 
For the survey, we estimate that 40,000 invitations, each taking 2 
minutes (0.033 hours), will need to be sent to adult members of an 
online consumer panel to have 10,000 of them complete a 15-minute (0.25 
hours) questionnaire. The total for the survey activities is 3,820 
hours (1,320 hours + 2,500 hours). Thus, the total estimated burden is 
3,906 hours.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
                  Activity                       Number of     responses per   Total annual          Average  burden per  response          Total hours
                                                respondents     respondent       responses
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Cognitive interview screener................              72               1              72  0.083 (5 min.)............................               6
Cognitive interview.........................               9               1               9  1.........................................               9
Pretest invitation..........................           1,000               1           1,000  0.033 (2 min.)............................              33
Pretest.....................................             150               1             150  0.25 (15 min.)............................              38
Survey invitation...........................          40,000               1          40,000  0.033 (2 min.)............................           1,320
Survey......................................          10,000               1          10,000  0.25 (15 min.)............................           2,500
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           3,906
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\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. 
(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, vol. 45, pp. 
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, vol. 15, pp. 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/Food/LabelingNutrition/ReportsResearch/ucm081696.htm.
6. U.S. Food and Drug Administration, ``2008 Health and Diet 
Survey--Preliminary Topline Frequencies (Weighted),'' 2010, 
available at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/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. Institute of Medicine. Dietary Reference Intakes: Guiding 
Principles for Nutrition Labeling and Fortification, 2003, available 
at http://www.nap.edu/catalog.php?record_id=10872.
10. Block, L.G. and L.A. Peracchio, ``The Calcium Quandary: How 
Consumers Use Nutrition Labels,'' Journal of Public Policy and 
Marketing, vol. 25, pp. 188-196, 2006.

    Dated: May 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13141 Filed 5-30-12; 8:45 am]
BILLING CODE 4160-01-P