[Federal Register Volume 77, Number 70 (Wednesday, April 11, 2012)]
[Notices]
[Pages 21779-21782]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8699]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0221]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study on 
Consumer Responses to 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 (the PRA).

DATES: Fax written comments on the collection of information by May 11, 
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 Labeling Statements 
on Food Packages.'' 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 Labeling Statements on Food 
Packages--(OMB Control Number 0910-NEW)

I. Background

    The Nutrition Labeling and Education Act requires almost all 
packaged foods to bear nutrition labeling in the form of the Nutrition 
Facts label. The law also allows manufacturers to provide other 
nutrition information on labels in the form of various types of 
statements, including claims, as long as such statements comply with 
the regulatory limits that govern the use of each type of statement. 
There are three types of claims that the food industry can voluntarily 
use on food labels: (1) Health claims, (2) nutrient content claims 
(e.g., ``Low fat''), and (3) structure/function claims (e.g., ``Calcium 
builds strong bones.''). Although the different types of claims are 
regulated differently, they all must be truthful and not misleading 
(Ref. 1).
    With the increased public interest in identifying healthier foods, 
U.S. food processors have been adding nutritional information in the 
form of nutrition symbols to food labels in addition to claims. 
Examples of nutrition symbols that have been used or suggested include 
nutrient-specific disclosures (e.g., ``Guideline Daily Amounts'') (Ref. 
2), calorie declarations (Ref. 3), summary product rating (e.g., 
``Smart Spot'') (Ref. 4), a hybrid summary indicator with nutrient-
specific disclosure (e.g., ``Sensible Solution: Good Source of Calcium, 
Good Sources of 8 Vitamins and Minerals'') (Ref. 5), the Facts-Up-Front 
icon, with and without positive nutrients (Ref. 6), and the symbol 
recommended by the Institute of Medicine (Ref. 7). Claims related to 
non-nutritional product characteristics are also used in food labeling. 
The claims may feature, among other things, statements about how foods 
are grown or made (e.g., ``Organic'' and ``All Natural'') or absence of 
a substance (e.g., ``Gluten-free'').
    Many consumers use claims and the Nutrition Facts label in food 
choice decisions (Refs. 8 through 10). While some products carry only a 
single labeling statement (e.g., either one claim or one symbol) on 
their packages, many products carry two or more labeling statements. In 
addition, on the same package the attributes of one statement may 
differ from those of other statements in terms of featured nutrient, 
type of claim, framing of statement, nature of statement, and 
presentation of statement. For example, a package may display one or 
more statements such as symbols relating to nutrition content, 
statements in words relating to the presence of certain nutrients, 
statements in words relating to the absence of other nutrients, 
statements in words describing the health benefits of consuming foods 
containing or not containing certain nutrients, and statements in words 
describing how the product was produced. Moreover, all of those symbols 
and statements are distributed in various places on the package in 
different font sizes and colors.
    There exists a large body of literature on the impacts of different 
types of labeling statements on consumer perceptions and choices of 
products (Refs. 11 and 12). The majority of the research, including the 
consumer research that the Agency has previously conducted (Refs. 13 
and 14), has focused on single labeling statements by eliciting study 
participants' reactions to variants of a given statement. An advantage 
of this research approach is that it helps isolate the effects of 
individual statements and avoid potential confounding effects caused by 
the presence of other statements. A disadvantage of this research 
approach, however, is that it does not necessarily reflect the labels 
consumers see in the marketplace. In particular, the existing

[[Page 21780]]

literature provides little information about how the coexistence of two 
or more different labeling statements affects product perceptions and 
choices. This information, however, is critical for understanding the 
roles played by labeling statements in dietary decisions.
    Research suggests consumer product perceptions and purchase 
decisions can be influenced by labeling statements and different 
labeling statements may have different influences (Refs. 11 through 
14). Therefore, FDA, as part of its effort to promote public health, 
proposes to use this study to explore consumer responses to food labels 
that bear multiple labeling statements. Specifically, the study plans 
to examine: (1) Consumer responses to food labels that exhibit various 
combinations of the number and type of statements, (2) whether and how 
consumer responses to one label characteristic may be affected by the 
other characteristic (i.e., the interactions between different 
characteristics of labeling statements), and (3) whether and how 
labeling statements affect consumers' use of the Nutrition Facts label.
    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 4,000 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 of its participants to view two 
label images from a set of food labels that will be created for the 
study. These images will be systematically varied in the following 
aspects: (1) Number of statements (ranging from none to three); (2) 
featured nutrient and food product (fat--snack bar, sodium--chips, or 
fiber--breakfast cereal); (3) type of statement (text such as 
``Supports Cardiovascular Functioning'' or graphic, specifically the 
Facts-Up-Front icons and one of the icon concepts proposed by the 
Institute of Medicine) (Refs. 13 and 14); and (4) nature of featured 
product attribute (such as ``Supports the Immune System'' or ``All 
Natural''). With regard to claims, the study will focus on examples of 
nutrient content claims and structure/function claims that can be found 
on many food packages (Ref. 15). All label images will be mockups 
resembling food labels that may be found in the marketplace. Images 
will show product identity (e.g., tortilla chips) but not any real or 
fictitious brand name. The study will provide interested participants 
access to the Nutrition Facts label but not together with a product 
image.
    The survey will ask its participants to view label images and 
answer questions about their perceptions and reactions related to the 
viewed product and label. Product perceptions (e.g., healthfulness, 
potential health benefits, levels of nutrients, and taste) 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' 
background, such as familiarity with and consumption, purchase, and 
perception of the categories of food included in the study; awareness 
and knowledge of nutrients; dietary interests; motivation regarding 
label use and 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 enrich the 
Agency's understanding of how multiple claims and other 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 April 13, 2011 (76 FR 20675), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. The Agency received four responses to the 
notice. One of the responses was outside of the scope of the proposed 
collection of information described in the 60-day notice and is not 
addressed here. The remaining three responses contained multiple 
comments. These comments, and the Agency's responses, are discussed in 
the following paragraphs.
    (Comment 1) Two comments suggested that FDA provide mock stimuli 
for public comment prior to initiating the study.
    (Response) We appreciate the suggestion for the Agency to provide 
the experimental stimuli for public comment prior to initiating the 
study. Per the PRA, a copy of the proposed experimental stimuli is 
provided in the Appendix of the supporting document.
    (Comment 2) One comment suggested that the study include questions 
to probe how non-misleading nutrient content, health, and structure/
function claims may improve consumers' understanding of a product's 
nutritional attributes.
    (Response) We agree and have included measures to assess how 
participants' understanding of a product's nutritional attributes may 
be affected by non-misleading claims.
    (Comment 3) Two comments expressed concerns about four questions 
proposed in the draft questionnaire. Two of the questions of concern 
asked if participants had ever heard or read that certain foods 
(unnamed) may help lower the risk of seven different types of health 
problems, such as cancer, diabetes, and others. The third and fourth 
questions of concern asked whether specific nutrients (e.g., calcium, 
potassium, etc.) or a particular food product, respectively, might help 
reduce the risk of the same health problems asked about in the other 
two questions. Both comments suggested that such questions would 
demonstrate that ``consumers misinterpret structure function claims as 
health claims'' and argued that such a demonstration would be 
inconsistent with the stated purpose of the information collection.
    (Response) FDA does not agree that the proposed questions on 
participants' prior knowledge of foods' health benefits and inferences 
from reading a label would bias the study toward health claims rather 
than structure/function claims. Since label inferences can be affected 
by what consumers already know or believe about a food, the prior 
knowledge questions are included to help understand study participants' 
reactions to labeling statements. The question about perceived health 
benefits of a product is one of the most important measures of label 
inferences. The Agency's previous research has shown that consumer 
inferences of the health benefits of a product do not necessarily vary 
between types of labeling statements (i.e., health claims, structure/
function claims, and nutrient content claims). Hence, this question is 
not expected to produce erroneous data with respect to inferences about 
structure/function claims.
    (Comment 4) One comment suggested that FDA consider including an 
experimental condition in which participants would view a label bearing 
up to three different labeling statements because consumers are 
routinely exposed to this amount of information on food packages. In 
the originally proposed design, FDA included label manipulations 
involving only up to two different labeling statements.
    (Response) We agree with the comment and have revised the study to 
include experimental conditions containing up to three labeling 
statements on a label.
    (Comment 5) One comment suggested including an assessment of how 
the

[[Page 21781]]

various labeling statements affect whether participants intend to 
purchase the product or not.
    (Response) As we proposed in the draft questionnaire, we will 
include a question about purchase intention.
    (Comment 6) One commenter noted that prior research has shown that 
the appearance of packaging and statements on the front of the package 
can increase the likelihood of consumers using the Nutrition Facts 
label.
    (Response) FDA agrees that information about consumers' use of the 
Nutrition Facts label is important and plans to record and analyze how 
likely the study's participants are to consult the Nutrition Facts 
label when viewing claims and other statements on the front label of a 
product.
    (Comment 7) One comment questioned the relevance of asking 
participants to rate the safety or trustworthiness of a product based 
on the label information they view.
    (Response) Although the label content of a product may not be 
intended to influence consumer assumptions regarding the safety of a 
product, prior research has demonstrated that such influence may occur 
(Ref. 16). Therefore, it would be useful to understand whether similar 
reactions happen in a multiclaim context. Nevertheless, the products 
that the proposed study plans to include (breakfast cereal, chips, and 
snack bars) are generally not associated with safety issues that may 
lead to foodborne illness or other safety hazards. Therefore, the study 
will omit the proposed question on perceived product safety. On the 
other hand, the Agency has determined that it is still important and 
relevant to elicit study participants' perceptions of the 
trustworthiness of various labeling statements (not foods, as stated in 
the comment), especially when these statements feature different 
nutrients or product benefits. Thus, the study will keep the proposed 
question on perceived trustworthiness of the label.
    (Comment 8) One comment suggested that the study ask about 
participants' interest in nutrients for which there is concern of 
inadequate intake among Americans. The comment recommended replacing 
Vitamin D and omega-3 fatty acids for Vitamins A and C, as proposed in 
the previous draft questionnaire.
    (Response) We agree with the comment and have incorporated the 
suggestion in the revised questionnaire.
    (Comment 9) One comment suggested that a plausible distractor or 
wrong choice be included in the question about the nutrients 
participants try to limit or increase in their diet to test the 
validity of the responses.
    (Response) We disagree with the comment. Our previous surveys 
indicate respondents can provide valid responses to these questions 
(for example, Ref. 17). Furthermore, we are concerned that the validity 
of the responses would suffer if a distractor or wrong choice is 
included because participants may be confused by the presence of such 
options in the question.
    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 
1 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 32,000 invitations, each 
taking 2 minutes (0.033 hour) to complete, will need to be sent to the 
consumer panel to have 4,000 of its members complete a 15-minute (0.25 
hour) questionnaire. The total for the survey activities is 2,056 hours 
(1,056 hours + 1,000 hours). Thus, the total estimated burden is 2,174 
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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                                                                                No. of
                         Activity                               No. of       responses per   Total annual        Average  burden per        Total hours
                                                              respondents     respondent       responses              response
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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........................................           1,600               1           1,600             0.033 (2 minutes)              53
Pretest...................................................             200               1             200             0.25 (15 minutes)              50
Survey invitation.........................................          32,000               1          32,000             0.033 (2 minutes)           1,056
Survey....................................................           4,000               1           4,000             0.25 (15 minutes)           1,000
                                                           ---------------------------------------------------------------------------------------------
    Total.................................................  ..............  ..............  ..............  ............................           2,174
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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 (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 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 site 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. Kellogg's, ``How to Read a Nutrition Label,'' 2010. Available 
at http://www.kelloggs.com/en_US/the-benefits-of-cereal/how-to-read-a-nutrition-label.html.
    3. PepsiCo, ``Nutrition Labeling,'' 2010. Available at http://www.pepsico.com/Purpose/Human-Sustainability/Nutrition-Labeling.html.
    4. Schmit, J., ``PepsiCo Labels Some of Its Snacks `Smart,' '' 
USA Today, September 2, 2004. Available at http://www.usatoday.com/money/industries/food/2004-09-02-smart-spot_x.htm.
    5. Kraft Foods, ``Sensible Solution,'' 2010. Available at http://www.kraftrecipes.com/kf/HealthyLiving/SensibleSolution/SensibleSolution_Landing.aspx.
    6. FactsUpFront.org, ``Facts Up Front,'' 2011. Available at 
http://factsupfront.com/.
    7. Institute of Medicine, ``Front-of-Package Nutrition Rating 
Systems and Symbols: Promoting Healthier Choices,'' 2011. Available 
at http://www.iom.edu/Reports/

[[Page 21782]]

2011/Front-of-Package-Nutrition-Rating-Systems-and-Symbols-
Promoting-Healthier-Choices.aspx.
    8. Centers for Disease Control and Prevention, ``2005-2006 
National Health and Examination Survey Questionnaire, Diet Behavior 
and Nutrition section,'' Unpublished results of questions DBQ.750 
and DBQ.780. Questionnaire available at http://www.cdc.gov/nchs/data/nhanes/nhanes_05_06/sp_dbq_d.pdf.
    9. U.S. Food and Drug Administration, ``2008 Health and Diet 
Survey,'' March 20, 2010. Available at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/ucm193895.htm.
    10. Food Marketing Institute, ``2009 U.S. Grocery Shopper Trends 
Survey,'' Washington, DC 2009.
    11. 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. 
Available at http://www.amsreview.org/articles/drichoutis09-2006.pdf.
    12. L[auml]hteenm[auml]ki, L., P. Lampila, K. Grunert, et. al, 
``Impact of Health-Related Claims on the Perception of Other Product 
Attributes,'' Food Policy, 23: 230-239, 2010.
    13. Labiner-Wolfe, J., C.-T. J. Lin, and L. Verrill, ``Effect of 
Low Carbohydrate Claims on Consumer Perceptions About Food Products' 
Healthfulness and Helpfulness for Weight Management,'' Journal of 
Nutrition Education and Behavior, 42(5): 315-320, 2010.
    14. Roe, B., A.S. Levy, and B.M. Derby, ``The Impact of Health 
Claims on Consumer Search and Product Evaluation Outcomes: Evidence 
From FDA Experimental Data,'' Journal of Public Policy and 
Marketing, 18(1): 89-105, 1999.
    15. LeGault, L., M.B. Brandt, N. McCabe, et. al, ``2000-2001 
Food Label and Package Survey: An Update on Prevalence of Nutrition 
Labeling and Claims on Processed, Packaged Foods,'' Journal of the 
American Dietetic Association, 104(6): 952-958, 2004.
    16. Kapsak, W.R., D. Schmidt, N.M. Childs, et. al, ``Consumer 
Perceptions of Graded, Graphic and Text Label Presentations for 
Qualified Health Claims,'' Critical Reviews in Food Science and 
Nutrition, 48: 248-256, 2008.
    17. U.S. Food and Drug Administration, ``Health and Diet Survey: 
Dietary Guidelines Supplement--Report of Findings (2004 and 2005), 
2008. Available at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/ucm080331.htm.

    Dated: April 5, 2012.
David Dorsey,
Acting Association Commissioner for Policy and Planning.
[FR Doc. 2012-8699 Filed 4-10-12; 8:45 am]
BILLING CODE 4160-01-P