[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20675-20677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 Labeling Statements on Food Packages.''

DATES: Submit either electronic or written comments on the collection 
of information by June 13, 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 docket 
number found in brackets in the heading of this document.

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.

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 Labeling Statements on Food 
Packages; 21 U.S.C. 393(d)(2)(C)--(OMB 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

[[Page 20676]]

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.''). 
There are three types of health claims: (1) Those that meet the 
Significant Scientific Standard (e.g., ``Adequate calcium and Vitamin D 
throughout life, as part of a well-balanced diet, may reduce the risk 
of osteoporosis.''), (2) those that are based on authoritative 
statements from a recognized scientific body of the U.S. government or 
the National Academy of Sciences (e.g., ``Diets containing foods that 
are a good source of potassium and that are low in sodium may reduce 
the risk of high blood pressure and stroke.''), and (3) qualified 
health claims that are granted under enforcement discretion (e.g., 
``Supportive but not conclusive research shows that consumption of EPA 
and DHA omega-3 fatty acids may reduce the risk of coronary heart 
disease. One serving of [Name of the food] provides [ ] grams of EPA 
and DHA omega-3 fatty acids. [See nutrition information for total fat, 
saturated fat, and cholesterol content.]''). 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 or are planned to be used 
on food labels include nutrient-specific disclosure (e.g., ``Guideline 
Daily Amounts'') (Ref. 2), calorie declaration (Ref. 3), summary 
product rating (e.g., ``Smart Spot'') (Ref. 4), and 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). 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. 6 through 8). 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 relating the health benefits of consuming foods 
containing or not containing certain other 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. 9 and 10). The majority of the research, including the 
consumer research that the Agency has previously conducted (Refs. 11 
and 12), 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 
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. 9 through 12). 
Therefore, the 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 characteristics of labeling statements (i.e., 
nutrients, types of claim, framing of statement, nature of statement, 
and presentation of statement), (2) whether and how consumer responses 
to one of the characteristics may be affected by other characteristics 
(i.e., the interactions between different characteristics of labeling 
statements), and (3) whether and how labeling statements affect the 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 and systematically varied in the (1) number of statements (none, 
one, or two); (2) featured nutrient and substance (e.g., fat, sodium, 
sugars, fiber, whole grain, calories, antioxidant vitamins, or 
allergen); (3) type of statement (text or graphic, specifically the 
Guideline Daily Amounts nutrition symbol); (4) framing of statement 
(``good source of,'' ``low,'' or ``free''); (5) nature of statement 
(nutrition or method of production such as ``natural''); (6) type size 
of statement (large or small); and (7) featured product (e.g., snacks, 
breakfast cereals, breads, soups, or frozen meals). With regard to 
claims, the study will focus on examples of nutrient content claims and 
structure/function claims, which can be found on many food packages 
(Ref. 13). All label images will be mock-ups resembling food labels 
that may be found in the marketplace. Images will show product identity 
(e.g., potato 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., healthiness, 
potential health benefits, levels of nutrients and substances, taste, 
and safety) 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 consumption, purchase, perception, 
and familiarity with a category of food; awareness and knowledge of 
nutrients and substances; 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

[[Page 20677]]

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.
    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 106 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 3,000 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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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
        Portion of study            respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
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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...............          32,000               1          32,000            2/60           1,056
Survey..........................           4,000               1           4,000           15/60           1,000
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    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 (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 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. Nutrition at a Glance. 2010. Available at http://www.kelloggnutrition.com/learn-about-labels/nutrition-at-a-glance.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 Products `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. 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 is available at http://www.cdc.gov/nchs/data/nhanes/nhanes_05_06/sp_dbq_d.pdf.
7. 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.
8. Food Marketing Institute. 2009 U.S. Grocery Shopper Trends 
Survey. Washington, DC 2009.
9. Drichoutis, A.C., Lazaridis, P. and Nayga, R.M., ``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.
10. L[auml]hteenm[auml]ki, L., Lampila, P.. Grunert, K., Boztug, Y., 
Ueland, [Oslash]., [Aring]str[ouml]m, A. and Martinsd[oacute]ttir, 
E., ``Impact of Health-Related Claims on the Perception of Other 
Product Attributes,'' Food Policy, 23: 230-9. 2010.
11. Labiner-Wolfe, J., Lin, C.-T. J. and Verrill L., ``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.
12. Roe, B., Levy, A.S., and Derby, B.M., ``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.
13. LeGault, L., Brandt, M.B., McCabe, N., Adler, C., Brown, A.-M., 
and Brecher, S., ``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): 952-8, 2004.

    Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8908 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P