[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
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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 (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