[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
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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