[Federal Register Volume 77, Number 38 (Monday, February 27, 2012)]
[Notices]
[Pages 11547-11550]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4423]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 March 
28, 2012.

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 Whole Grain 
Labeling Statements on Food Packages.'' Please also include the FDA 
docket number found in brackets in the heading of this document.

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

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 Whole Grain Labeling 
Statements on Food Packages--(OMB Control Number 0910-New)

I. Background

    The Nutrition Labeling and Education Act, which amended the Federal 
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, 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-grain 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 
labeling statement in terms of its credibility, helpfulness, and other 
attributes; (3) consumer interpretations of different terms and 
statements, such as ``Made with Whole Grain'', ``Multi-Grain'', and 
``100% Whole Wheat''; (4) consumer extrapolation of whole grain 
statements beyond the scope of the statements themselves (i.e., halo 
effects);

[[Page 11548]]

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 one label 
image from a set of food labels that will be created for the study and 
systematically varied in the (1) whole grain labeling statement; (2) 
featured product (e.g., bread, salty snacks, and breakfast bars); (3) 
access to the Nutrition Facts label; and (4) nutritional profile 
(differing by the amount of fiber and the ranking order of whole grain 
products on the ingredient list). 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 half of the participants access to the Nutrition Facts but not 
together with a product image (i.e., these participants can look at the 
Nutrition Facts if they choose to). The study will show the other half 
of the respondents a label in which the Nutrition Facts is located next 
to the product image.
    The survey will ask its participants to view label images and 
answer questions about their perceptions and reactions related to the 
product and claim. 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 response in the experiment. To help understand the data, 
the survey will also collect information about participants' 
backgrounds, such as consumption and purchase patterns, awareness and 
knowledge of nutrients and substances, 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 
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.
    In the Federal Register of May 26, 2011 (76 FR 30725), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received eight letters in response to 
the notice, each containing multiple comments. Several comments were 
generally supportive of FDA's study. Additional comments were outside 
the scope of the four collection of information topics on which the 
notice solicits comments and will not be discussed in this document. 
The comments on the four collection of information topics, and the 
Agency's responses, are discussed in the following paragraphs.
    (Comment 1) One comment questioned the necessity of the study given 
FDA's many pressing responsibilities. The comment suggested that the 
``Dietary Guidelines for Americans 2005'' and the prevalence of Whole 
Grain Stamps on products have increased consumer ability to understand 
the benefits of whole grains and to find and purchase them in stores.
    (Response) FDA disagrees with this comment. Research suggests that 
although consumers may be aware of the benefits of whole grain foods, 
they still have difficulties in understanding the meaning of whole 
grains or recognizing whole grain foods (Refs. 6 through 8). Given the 
multitude of whole grain statements appearing in the marketplace and 
the importance of whole grains in maintaining a healthy diet, there is 
a genuine need for systematic investigation of how consumers interpret 
various whole-grain statements.
    (Comment 2) Several comments suggested improvements to the proposed 
survey instrument. One comment questioned whether the terms 
``healthiness'' and ``nutritional qualities'' should be equated to one 
another as in a proposed response item ``healthiness or nutritional 
qualities.'' A few comments noted that the scales of the ranking 
questions need to be revised from a four or six point scale to a five 
point scale with a ``neutral position'' (e.g., neither agree nor 
disagree). Several comments questioned whether a ``don't know'' choice 
should be included or omitted in several places. One comment suggested 
that the section on general knowledge of whole grains should be asked 
before questions on specific labels. One comment stated that the 
questions on evaluating the trustworthiness and helpfulness of the 
whole grain statement may be biased or leading because all the negative 
terms are placed on the left-hand side of the scale. Another comment 
stated that the perceptions of the claim statement may be confounded by 
product cues such as color and graphics.
    (Response) FDA has carefully reviewed the survey instrument and has 
incorporated all necessary clarifications and improvements in response 
to the comments. In terms of the perceived connection between 
``healthiness'' and ``nutritional qualities,'' FDA found in previous 
cognitive testing that some respondents understood nutritional 
qualities as an element of healthiness and equated the two concepts, as 
in ``healthiness or nutritional qualities.'' The testing also found 
that this expression performed best in respondent comprehension and in 
conveying the intent of the item, which is the nutritional aspect of 
health. Therefore, we have decided to retain the expression 
``healthiness or nutritional qualities.'' Regarding inclusion of a 
``neutral'' (neither agree nor disagree) response in the rating scales, 
research (e.g., Ref. 12) has suggested that such a response can be 
interpreted as a ``don't know'' response by some respondents. 
Therefore, we have kept the six point rating scale and added a ``don't 
know'' option. Questions whose response options purposefully omit a 
``don't know'' option will be further evaluated in the cognitive 
interviews to confirm that participants are able to select one of the 
provided choices. Regarding the order of the general knowledge and 
label response sections, we disagree with the suggestion and believe 
the suggested change would create more biases than the current order. 
We also disagree that claim perceptions may be biased because negative 
terms are placed on the left-hand side of the scale. Existing research 
has not produced consensus about whether placing negative or positive 
terms at the beginning of a scale is more likely to cause biases. More 
importantly, because this is an experimental study that employs random 
assignment, bias is irrelevant as we are mainly interested in 
quantitative differences in dependent measures between tested stimuli 
(e.g., claims). We agree that product cues may make it difficult to 
isolate the impact of whole grain claims. For this reason, the study 
has created mock-up labels that do not include real or fictitious brand 
names and only resemble, but are not identical to, real packages. 
Moreover, the study will compare responses to labels that differ only 
in the presence or absence of a claim, and in the claim language, but 
not in any other respect.
    (Comment 3) One comment suggested that FDA should clearly define in 
the

[[Page 11549]]

study concepts such as ``whole grains'', ``foods made from whole 
grains'', and ``whole grain food'' when asking about whole grain 
consumption.
    (Response) We disagree with this suggestion. How consumers 
interpret these labeling statements is the core question that FDA is 
interested in answering and clear definitions would defeat this 
purpose. In the modified version of our questionnaire, we have provided 
specific examples of whole grain products (such as cereal or bread, 
pasta that are made with whole grains) when we ask participants about 
their whole grain consumption patterns.
    (Comment 4) One comment proposed revising a question in the survey 
that is intended to assess potential consumer confusion about the 
meaning of organic versus whole grain. The question we proposed asked 
participants to judge the likelihood that a product is organic based on 
the information shown on the experimental label stimuli.
    (Response) The question FDA originally proposed (how likely a 
product shown in the survey is organic) has been removed from the 
revised questionnaire. Instead, we have added a new question that asks 
whether respondents think the statement ``All whole grain foods are 
organic'' is true or false.
    (Comment 5) One comment stated that consumers do not understand 
``ounce-equivalents'' when trying to answer the whole grain consumption 
questions. The comment suggested using grams or servings as a 
measurement of whole grain, or other basic descriptions of amounts as 
included in the ``Dietary Guidelines for Americans'' or MyPlate (e.g., 
half of the grains you consume, half of a plate).
    (Response) We agree that consumers are probably more familiar with 
measurements expressed in servings or grams than with measurements 
expressed in ounce-equivalents and have replaced ounce-equivalents with 
servings or grams in the study. Also, we have removed the question 
about whether consumers are aware of the recommended amount of whole 
grains they should consume according to the Dietary Guidelines for 
Americans because respondents may not know details in the ``Dietary 
Guidelines for Americans'' or MyPlate.
    (Comment 6) One comment suggested that FDA should incorporate the 
three standards listed in the ``Dietary Guidelines for Americans 2010'' 
(``look for 100% whole grain foods''; ``look for products using the FDA 
whole grain health claim''; ``look for products with at least 8 grams 
of whole grain'') into the study to see whether consumers can use them 
to seek out whole grains.
    (Response) We agree that this information is useful and have 
included these standards in the study. We will examine how well 
respondents understand them and whether they can evaluate the amount of 
whole grain in a certain food based on the claim on the front of the 
food package and the Nutrition Facts and the ingredient list on the 
back.
    (Comment 7) One comment suggested that FDA add a variety of grains 
and more non-wheat-based foods (e.g., brown rice, oatmeal, and popcorn) 
to see if consumers understand these are whole grain foods. The same 
comment also suggested FDA include more foods lower in overall grain 
content than the three planned (bread, cereal, breakfast bars), as 
these are likely to be high in grain content.
    (Response) We agree with the comment and have included bread, salty 
snacks (instead of cereal), and breakfast bars in the study.
    (Comment 8) One comment suggested that FDA add more questions on 
participants' consumption, purchases of the food categories studied, 
and health and nutrition attitude questions. The comment also suggested 
that FDA explore consumers' understanding of whole grains relative to 
consumers' understanding of other aspects of a healthy diet, such as 
consumption of leafy green vegetables or legumes. The comment stated 
that the information can help reveal whether consumer knowledge about 
dietary practices other than whole grain consumption might require 
greater Agency resources and attention.
    (Response) We have added questions on participants' consumption and 
purchase of the food categories that will be studied (bread, breakfast 
bars, and salty snacks). Due to resource limitations, we will not be 
able to ask additional questions about participants' understanding of 
other aspects of a healthy diet or expand the study to include a larger 
group of foods.
    (Comment 9) One comment suggested that, in addition to testing two 
nutritional profiles for a given product (one high in fiber amount and 
one low in fiber amount), the study should include at least one product 
that provides a good source of fiber.
    (Response) We agree that the suggested addition will increase our 
understanding of consumer reactions to products with various fiber 
contents. We have included three types of foods: Bread, breakfast bars, 
and salty snacks (instead of cereal), each with two nutritional 
profiles (one high in fiber amount and one low in fiber amount) in the 
study. Bread usually provides a good source of fiber.
    (Comment 10) One comment suggested that, because the focus of the 
proposed research is on interpretation of whole grain label statements, 
the data analysis should treat the label statements as fixed effects 
and the product categories and nutrition profiles as random effects.
    (Response) We will consider the need and appropriateness of the 
suggested analytic approach during data analysis.
    (Comment 11) Several comments urged FDA to provide graphics and 
revised instruments in the 30-day notice for public comment.
    (Response) We agree and have included these materials in the 
information collection request.
    (Comment 12) One comment encouraged FDA to revise its draft 
guidance to provide clear guidance to industry as to the types of 
claims that may be made about whole grains and also to limit whole 
grain claims to foods that provide at least a good source of fiber (10% 
Daily Value) for foods with a mid to large size Reference Amount 
Customarily Consumed (RACC), such as those associated with ready-to-eat 
cereals.
    (Response) The comment is outside of the scope of the proposed 
collection of information described in the 60-day notice and therefore 
is not addressed here. Nonetheless, the comment has been forwarded to 
the docket for the whole grain draft guidance.
    FDA estimates the burden of this collection of information as 
follows (Table 1). FDA plans to conduct cognitive interviews by 
screening 72 panelists in order to obtain 9 individuals for cognitive 
interviews. Each screening is expected to take 5 minutes (0.083 hour), 
and each cognitive interview is expected to take 1 hour. The total for 
cognitive interview activities is 15 hours (6 hours + 9 hours). 
Subsequently, we plan to screen 1,152 individuals for pretest, each 
taking 2 minutes (0.033 hours), in order to have 576 of them complete a 
15-minute (0.25 hours) pretest. The 576 target responses are 376 more 
than the 200 target responses described in the 60-day notice. The 
change is because we increased the number of our experimental 
conditions from 156 to 288, and we wanted to ensure two responses per 
experimental condition (288 * 2). Thus, the total for the pretest 
activities is 182 hours (38 hours + 144 hours). For the survey, we 
estimate that 5,400 invitations, each taking 2 minutes (0.033 hours), 
will need to be sent to adult members of an online consumer

[[Page 11550]]

panel to have 2,700 of them complete a 15-minute (0.25 hours) 
questionnaire. The total for the survey activities is 855 hours (180 
hours + 675 hours). Therefore, the total estimated burden is 1,052 
hours. This estimate is 454 hours lower than the 1,506 hours described 
in the 60-day notice and reflects 15 fewer hours for pretest 
invitation, 533 fewer hours for survey invitation, and 94 more hours 
for the pretest, respectively. Recent experience by our contractor 
suggests that the Agency will not need to send as many invitations as 
originally estimated to achieve its target sample sizes in pretest and 
survey. FDA's burden estimate is based on prior experience with 
research that is similar to this proposed study.

                                                     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 minutes)...............                 6
Cognitive interview...........................                 9                 1                 9  1 hour..........................                 9
Pretest invitation............................             1,152                 1             1,152  0.033 (2 minutes)...............                38
Pretest.......................................               576                 1               576  0.25 (15 minutes)...............               144
Survey invitation.............................             5,400                 1             5,400  0.033 (2 minutes)...............               180
Survey........................................             2,700                 1             2,700  0.25 (15 minutes)...............               675
                                                                                                                                       -----------------
    Total.....................................  ................  ................  ................  ................................             1,052
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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 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, et al., 
``Dietary Intake of Whole Grains,'' Journal of the American College 
of Nutrition, vol. 19, pp. 331S-338S, 2000.
    3. Kantor, L.S., J.N. Variyam, J.E. Allshouse, et al., ``Choose 
a Variety of Grains Daily, Especially Whole Grains: A Challenge for 
Consumers,'' Journal of Nutrition, vol. 131, pp. 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 17, 2010, available at http://supermarketnews.com/news/whole_grains_0917/#.
    6. Arvola, A., L. L[auml]hteenm[auml]ki, M. Dean, et al., 
``Consumers' Beliefs About Whole and Refined Grain Products in the 
UK, Italy and Finland,'' Journal of Cereal Science, vol. 46, pp. 
197-206, 2007.
    7. Kantor, L.S., J.N. Variyam, J.E. Allshouse, et al., ``Choose 
a Variety of Grains Daily, Especially Whole Grains: A Challenge for 
Consumers,'' Journal of Nutrition, vol. 131, pp. 473S-486S, 2001.
    8. Marquart, L., K.L. Wiemer, J.M. Jones, et al., ``Whole Grain 
Health Claims in the USA and Other Efforts to Increase Whole-Grain 
Consumption,'' Proceedings of the Nutrition Society, vol. 62, pp. 
151-160, 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, vol. 10.9, 2006.
    10. Grunert, K.G. and J.M. Willis, ``A Review of European 
Research on Consumer Response to Nutrition Information on Food 
Labels,'' Journal of Public Health, vol. 15, pp. 384-399, 2007.
    11. Kellogg Company. ``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.
    12. Clark, L.A. and D. Watson, ``Constructing Validity: Basic 
Issues in Objective Scale Development,'' Psychological Assessment, 
vol. 7(3), pp. 309-319, 1995.

    Dated: February 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4423 Filed 2-24-12; 8:45 am]
BILLING CODE 4160-01-P