
[Federal Register Volume 78, Number 163 (Thursday, August 22, 2013)]
[Notices]
[Pages 52201-52202]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20469]



[[Page 52201]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0871]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Studies 
on Consumer Responses to Nutrient Content Claims on Fortified Foods

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 
September 23, 2013.

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 Studies on Consumer Responses to Nutrient Content 
Claims on Fortified Foods.'' Also include the FDA docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400T, Rockville, 
MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.

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 Studies on Consumer Responses to Nutrient Content Claims 
on Fortified Foods--OMB Control Number 0910-New)

I. Background

    The Nutrition Labeling and Education Act gave FDA the authority to 
issue regulations that require almost all packaged foods to bear 
nutrition labeling. 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, and 
(3) structure/function claims. All claims must be truthful and not 
misleading (Ref. 1).
    FDA's policy on fortification (21 CFR 104.20) establishes a set of 
principles that serve as a model for the rational addition of nutrients 
to foods. FDA has an interest in the American public achieving and 
maintaining diets with optimal levels of nutritional quality, wherein 
healthy diets are composed of foods from a variety of nutrient sources. 
FDA does not encourage the addition of nutrients to certain food 
products (including sugars or snack foods such as [cookies] candies, 
and carbonated beverages). FDA is interested in studying whether 
fortification of these foods could cause consumers to believe that 
substituting fortified snack foods for more nutritious foods would 
ensure a nutritionally sound diet.
    Research suggests consumer product perceptions and purchase 
decisions can be influenced by labeling statements and different 
labeling statements may have different influences (Refs. 2 through 5). 
FDA, as part of its effort to promote public health, proposes to 
conduct a controlled, randomized experiment to explore consumer 
responses to expressed and implied nutrient content claims on the 
labels of snack foods such as cookies, carbonated beverages, and candy. 
The study will use a 15-minute Web-based questionnaire to collect 
information from 7,500 English-speaking adult members of an online 
consumer panel maintained by a contractor. Researchers will endeavor to 
collect samples that reflect the U.S. Census on gender, education, age, 
and ethnicity/race for both modes of administration.
    Potential conditions for the study include the following: (1) A 
mock snack product with a claim similar to ``[a]s much [nutrient] as a 
serving of [food product];'' (2) a mock candy with the claim ``[g]ood 
source of [nutrient];'' and (3) a mock carbonated beverage with the 
claim, ``product name] plus [nutrient].'' Each participant in each 
study will be randomly assigned to view a label image. Each participant 
in each study will also be randomly allowed or disallowed to access the 
Nutrition Facts label of the product. All label images will be mock 
products resembling actual food labels found in the marketplace.
    Participants will view label images and answer questions about 
their perceptions and reactions to the label. Product perceptions 
(e.g., healthiness, potential health benefits, levels of nutrients), 
label perceptions (e.g., helpfulness and credibility), and purchase/
choice questions will constitute the measures of response in the 
experiment. To help understand the data, the study will also collect 
information about participants' background, such as purchase and 
consumption of similar products; nutrition knowledge; dietary 
interests; motivation regarding label use; health status and 
demographic characteristics.
    The study is a 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 inform the 
Agency's understanding of how claims on the packages of fortified food 
may affect how consumers perceive a product or a label, which may in 
turn affect their dietary choices. The results of the study will not be 
used to develop population estimates.
    In accordance with 5 CFR 1320.8(d), in the Federal Register of 
August 15, 2012 (77 FR 48988), FDA published a 60-day notice requesting 
public comment on the proposed information collection. FDA received six 
letters in response to the notice, each containing one or more 
comments. The comments, and the agency's responses, are discussed in 
the following paragraphs. One of the comments received was not 
responsive to the comment request on the four specified aspects of the 
collection of information. This non-responsive comment will not be 
addressed in this document. We respond to the remaining comments in 
this document. For ease of reading, we preface each comment with a 
numbered ``Comment'' and each response by a corresponding numbered 
``Response.'' We have numbered each comment to help distinguish between 
different topics. The number assigned to each comment is for 
organizational purposes only and does not signify the comment's value, 
or importance, or the order in which it was received.
    (Comment 1) Four comments expressed support of the utility of the 
study for FDA's mission, stating that use of the study results will 
help FDA: (1) Fulfill its role as a steward of the public health; (2) 
continue to help consumers use the food label to make informed 
consumption decisions; and (3) help FDA to continue the policy against 
fortifying sugars or snack foods such as cookies, candies, and 
carbonated beverages.

[[Page 52202]]

    (Response 1) FDA agrees with the comments.
    (Comment 2) Reacting to FDA's declaration in the 60-day notice (77 
FR 48988), that it intends to use ``a mock snack product'' to study 
nutrient content claims on fortified foods, one comment requested that 
FDA limit testing of such claims to sugars, cookies, candy, and 
carbonated beverages.
    (Response 2) FDA agrees with the comment. FDA will limit testing of 
nutrient content claims on fortified snack foods to mock cookies, 
candy, and carbonated beverages.
    (Comment 3) One comment requested that FDA use images of actual 
commercially available labels for fortified snack products in the study 
instead of the proposed mock snack food labels, claiming that use of 
actual labels will increase the external validity of the studies.
    (Response 3) FDA disagrees with the comment. Actual labels will 
increase the external validity of the findings but actual labels also 
are highly likely to introduce brand effects, a bias that may be 
difficult to separate from effects of the claims themselves, which is 
the focus of the studies.
    Recent study design decisions have indicated that the Agency needs 
a larger sample size for Study 1 than originally expected; therefore, 
the Agency will not conduct Study 2 (a shopping simulation study) which 
was described in the 60-day notice.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener..              75               1              75  0.083...........               6
                                                                                (5 minutes).....
Cognitive interview...........               9               1               9  1 hour..........               9
                                                                                (60 minutes)....
Pretest invitation............           1,600               1           1,600  0.033...........              53
                                                                                (2 minutes).....
Pretest.......................             400               1             400  0.25............             100
                                                                                (15 minutes)....
Survey invitation.............          32,000               1          32,000  0.033...........           1,056
                                                                                (2 minutes).....
Survey........................           7,500               1           7,500  0.25............           1,875
                                                                                (15 minutes)....
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           3,099
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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, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the 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/IngredientsPackagingLabeling/LabelingNutrition/ucm111447.htm.
    2. 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.
    3. L[auml]hteenm[auml]ki, L., P. Lampila, and K. Grunert, et 
al., ``Impact of Health-Related Claims on the Perception of Other 
Product Attributes,'' Food Policy, 23: 230-239, 2010.
    4. 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.
    5. 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.

    Dated: August 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20469 Filed 8-21-13; 8:45 am]
BILLING CODE 4160-01-P


