[Federal Register Volume 76, Number 102 (Thursday, May 26, 2011)]
[Notices]
[Pages 30725-30727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13060]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0320]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study on Consumer Responses to Whole 
Grain Labeling Statements on Food Packages

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 Whole Grain Labeling Statements on Food 
Packages.''

DATES: Submit either electronic or written comments on the collection 
of information by July 25, 2011.

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

[[Page 30726]]

docket number found in brackets in the heading of this document. For 
access to the docket to read background documents or comments received, 
go to http://www.regulations.gov and insert the docket number, found in 
brackets in the heading of this document, into the ``Search'' box and 
follow the prompts.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3793.

I. Background

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 Whole Grain Labeling 
Statements on Food Packages, 21 U.S.C. 393(d)(2)(C)--(OMB Control 
Number 0910--New)

    The Nutrition Labeling and Education Act (NLEA), which amended the 
Food, Drug and Cosmetic Act, requires most foods to bear nutrition 
labeling (i.e., the Nutrition Facts), and requires food labels that 
bear nutrient content claims and certain health messages to comply with 
specific requirements. There are three different types of claims 
(health claims, nutrient content claims, and structure/function claims) 
that the food industry can voluntarily use on food labels. Although 
they are regulated differently, they all must be truthful and not 
misleading (Ref. 1).
    In the past 30 years, whole-grain consumption has been greatly 
promoted by government agencies and scientific communities as an 
important part of a healthy diet (Refs. 2 and 3). For example, the 
newly-released ``Dietary Guidelines for Americans 2010'' recommends 
Americans eat fewer refined grains, and consume more nutrient-dense 
whole grains instead (Ref. 4). At the same time, whole grain labeling 
statements, such as ``Made With Whole Grain,'' on food products have 
also become more prevalent in recent years (Ref. 5). Given the variety 
of whole-grain statements on food products and the importance of whole 
grains in maintaining a healthy diet, it is important for policy makers 
to gain a better understanding of how consumers interpret these 
statements.
    Several studies indicate that consumers may have difficulties in 
understanding the meaning of whole grains or recognizing whole-grain 
foods (Refs. 6 to 8). Research also suggests consumer product 
perceptions and purchase decisions can be influenced by labeling 
statements and different labeling statements may have different 
influences (Refs. 9 and 10). The majority of existing studies focus on 
whole grain intake or the relationships between whole grain and disease 
prevention. There is a lack of systematic investigation of consumers' 
understanding of different whole-grain labeling statements. We are 
aware of at least one existing study related to the statements (Ref. 
11). However, the study did not compare consumer reactions to various 
whole-grain statements. Therefore, the FDA, as part of its effort to 
promote public health, plans to use the proposed study to explore and 
compare consumer responses to food labels that use whole grains 
labeling statements.
    Specifically, the study plans to examine: (1) Consumer judgments 
about a food product including its nutritional attributes, overall 
healthiness, and health benefits; (2) consumer judgments about a label 
in terms of its credibility in conveying the product's nutritional 
attributes and its helpfulness in making product purchasing decisions; 
(3) consumer perceptions about differences between different 
statements, such as ``Made with Whole Grain,'' ``Contains Whole 
Grain,'' and ``Whole Grain;'' (4) consumer extrapolation of whole grain 
statements beyond the scope of the statements themselves (i.e., halo 
effects); and (5) how whole grain statements influence consumer use of 
the Nutrition Facts.
    The proposed collection of information is a controlled randomized 
experimental study. The study will use a 15-minute Web-based survey to 
collect information from 2,700 English-speaking adult members of an 
online consumer panel maintained by a contractor. The study will aim to 
produce a sample that reflects the U.S. Census on gender, education, 
age, and ethnicity/race.
    The study will randomly assign each participant to view two label 
images from a set of food labels that will be created for the study and 
systematically varied in the: (1) Whole grain labeling statements; (2) 
nutritional profiles (differing by the amount of fiber); (3) ingredient 
lists (differing by the ranking order of whole grain wheat on the 
list); and (4) featured product (e.g., bread, cereal, and breakfast 
bars). With regard to claims, the study will focus on examples of whole 
grain statements that can be found on food packages. All label images 
will be mock-ups resembling food labels that may be found in the 
marketplace. Images will show product identity (e.g., bread), but not 
any real or fictitious brand name. The study will provide interested 
participants access to the Nutrition Facts, but not together with a 
product image.
    The survey will ask its participants to view two label images one 
at a time and answer questions about their perceptions and reactions 
related to each of the products and labels. Product perceptions (e.g., 
healthiness, potential health benefits, levels of whole grains and 
fiber amount) and label perceptions (e.g., helpfulness and credibility) 
will constitute the measures of responses in the experiment. To help 
understand the data, the survey will also collect information about 
participants' backgrounds, such as consumption, purchase history, 
perception, and familiarity with a category of food; awareness and 
knowledge of nutrients and substances; health literacy; and health 
status and demographic characteristics.
    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 whole grains claims and other related

[[Page 30727]]

labeling statements on food packages 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 conduct pretests of the 
questionnaire before it is administered in the study. We expect that 
1,600 invitations, each taking 2 minutes (0.033 hour), will need to be 
sent to panelists to have 200 of them complete a 15-minute (0.25 hour) 
pretest. The total for the pretest activities is 103 hours (53 hours + 
50 hours). For the survey, we estimate that 21,600 invitations, each 
taking 2 minutes (0.033 hour) to complete, will need to be sent to the 
consumer panel to have 2,700 of its members complete a 15-minute (0.25 
hour) questionnaire. The total for the survey activities is 1,388 hours 
(713 hours + 675 hours). Thus, the total estimated burden is 1,506 
hours. FDA's burden estimate is based on prior experience with research 
that is similar to this proposed study.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden  per
        Portion of study            respondents   responses  per     responses     response (in     Total hours
                                                     respondent                     hours) \2\
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Cognitive interview screener....              72               1              72            5/60               6
Cognitive interview.............               9               1               9               1               9
Pretest invitation..............           1,600               1           1,600            2/60              53
Pretest.........................             200               1             200           15/60              50
Survey invitation...............          21,600               1          21,600            2/60             713
Survey..........................           2,700               1           2,700           15/60             675
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    Total.......................  ..............  ..............  ..............  ..............           1,506
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

II. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20857, under Docket No. FDA-2011-N-0320 and may 
be seen by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday. We have verified all 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. U.S. Food and Drug Administration, ``Claims That Can Be Made for 
Conventional Foods and Dietary Supplements,'' September 2003, 
available at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm.
2. Cleveland, L. E., A.J. Moshfegh, A.M. Albertson, and J.D. 
Goldman, ``Dietary intake of whole grains,'' Journal of the American 
College of Nutrition, 19, 331S-338S, 2000.
3. Kantor, L. S., J.N. Variyam, J.E. Allshouse, J.J. Putnam, and 
B.H. Lin, ``Choose a variety of grains daily, especially whole 
grains: A challenge for consumers,'' Journal of Nutrition, 131, 
473S-486S, 2001.
4. U.S. Department of Agriculture and U.S. Department of Health and 
Human Services. ``Executive Summary of Dietary Guidelines for 
Americans, 2010,'' January 2011, available at http://www.cnpp.usda.gov/Publications/DietaryGuidelines/2010/PolicyDoc/ExecSumm.pdf.
5. Supermarket News, ``Report: Whole Grains Gain Momentum,'' 
September 2010, available at http://supermarketnews.com/news/whole_grains_0917/#.
6. Arvola, A., L.L[auml]hteenm[auml]ki, M. Dean, M. Vassallo, M. 
Winkelmann, E. Claupein, A. Saba, and R. Shepherd, ``Consumers' 
beliefs about whole and refined grain products in the UK, Italy and 
Finland,'' Journal of Cereal Science, 46, 197-206, 2007.
7. Kantor, L. S., J.N. Variyam, J.E. Allshouse, J.J. Putnam, and 
B.H.Lin, ``Choose a variety of grains daily, especially whole 
grains: A challenge for consumers,'' Journal of Nutrition, 131, 
473S-486S, 2001.
8. Marquart, L., K.L. Wiemer, J.M. Jones, and B.Jacob, ``Whole grain 
health claims in the U.S.A. and other efforts to increase whole-
grain consumption,'' Proceedings of the Nutrition Society, 62, 151-
159, 2003.
9. Drichoutis, A.C., P. Lazaridis, and R.M. Nayga, ``Consumers' Use 
of Nutritional Labels: A Review of Research Studies and Issues,'' 
Academy of Marketing Science Review, 2006(9), 2006.
10. Willis, Josephine M., and K.G. Grunert, ``A Review of Research 
on Consumer Response to Nutrition Information on Food Packaging,'' 
2007.
11. Kellogg Co. ``A Survey of Consumers' Whole Grain & Fiber 
Consumption Behaviors, and the Perception of Whole Grain Foods as a 
Source of Dietary Fiber,'' 2010. FDA Docket No. 2006-D-0298, July 
2010, available at http://www.regulations.gov/#!documentDetail;D=FDA-2006-D-0298-0016.

    Dated: May 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13060 Filed 5-25-11; 8:45 am]
BILLING CODE 4160-01-P