Document ID: FDA-2009-N-0532-0039
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study of Nutrition Facts LabelFormats
Posted Date: 2010-11-17T05:00Z

[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Notices]
[Pages 70266-70268]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28966]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0532]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study of 
Nutrition Facts Label Formats

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 
December 17, 2010.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--New and 
title ``Experimental Study of Nutrition Facts Label Formats.'' Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., 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.

I. Experimental Study of Nutrition Facts Label Format--(OMB Control No. 
0910--New)

    Nutrition information is required on most packaged foods and this 
information must be provided in a specific format as defined in 21 CFR 
101.9. When FDA was determining which Nutrition Facts label format to 
require, the Agency undertook consumer research to evaluate 
alternatives (Refs. 1, 2, and 3). More recently, FDA conducted 
qualitative consumer research on the format of the Nutrition Facts 
label on behalf of the Agency's Obesity Working Group (OWG) (Ref. 4), 
which was formed in 2003 and tasked with outlining a plan to help 
confront the problem of obesity in the United States (Ref. 5). In 
addition to conducting consumer research, in response to the OWG plan 
FDA issued two advance notices of proposed rulemaking (ANPRM) 
requesting comments on format changes to the Nutrition Facts label. One 
ANPRM requested comments on whether and, if so, how to give greater 
emphasis to calories on the Nutrition Facts label (Ref. 6) and the 
other requested comments on whether and, if so, how to amend the 
Agency's serving size regulations (Ref. 7). In 2007, FDA issued an 
ANPRM requesting comments on whether the Agency should require that 
certain nutrients be added or removed from the Nutrition Facts label 
(Ref. 8).
    FDA conducts consumer research under its broad statutory authority, 
set forth in section 903(b)(2)(A) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(A), to protect the 
public health by ensuring that ``foods are safe, wholesome, sanitary, 
and properly labeled;'', and in section 903(d)(2)(C) (21 U.S.C. 
393(d)(2)(C)), to conduct research relating to foods, drugs, cosmetics 
and devices in carrying out the FD&C Act.
    FDA is proposing to conduct an experimental study to quantitatively 
assess consumer reactions to potential options for modifying the 
Nutrition Facts label format. The purpose of the study is to help 
enhance FDA's understanding of consumer comprehension and acceptance of 
modifications to the Nutrition Facts label format. The study is part of 
the Agency's continuing effort to enable consumers to make informed 
dietary choices and construct healthful diets.
    The proposed study will use a Web-based experiment to collect 
information from a sample of adult members in an online consumer panel 
established by a contractor. The study plans to randomly assign each of 
10,000 participants to view Nutrition Facts labels from a set of 
Nutrition Facts labels that vary by the format, the type of food 
product, and the quality of nutritional attributes of the product. The 
study will focus on the following types of consumer reactions: (1) 
Judgments about a food product in terms of its nutritional attributes 
and overall healthfulness and (2) ability to use the Nutrition Facts 
label to, for example, calculate calories and estimate serving sizes 
needed to meet objectives. To help understand consumer reactions, the 
study will also collect information on participants' background, 
including but not limited to use of the Nutrition Facts label and 
health status.
    The study results will be used to help the Agency to understand 
whether modifications to the Nutrition Facts label format could help 
consumers make informed food choices. The results of the experimental 
study will not be used to develop population estimates.
    In the Federal Register of November 18, 2009 (74 FR 59553), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. The Agency received 36 responses, some of 
them containing multiple comments. The comments, and the Agency's 
responses, are discussed in the following paragraphs. Some of the 
comments received were not responsive to the comment request on the 
four topics of the collection of information. These non-responsive 
comments are not addressed.
    (Comment 1) Several comments cited the importance of studying ways 
to improve the Nutrition Facts label on

[[Page 70267]]

packaged foods and commended FDA for doing it.
    (Response 1) FDA agrees that the study will help FDA learn how 
consumers react and respond to Nutrition Facts label modification 
options presented.
    (Comment 2) One comment suggested adding questions about product 
purchase intent, amount the consumer would likely eat, and impression 
of the product's taste and safety.
    (Response 2) FDA agrees that these questions are worthwhile and has 
included questions on product purchase intent. However, given the study 
designs focus solely on the nutrition label for use to choose healthier 
and lower calorie products and mode of data collection (Internet), 
questions on amount of product likely to be eaten and on taste are not 
meaningful to include.
    (Comment 3) One comment suggested that the study include various 
formats with different methods of presenting nutrition information be 
tested so that the format can be found which helps consumers understand 
the total nutrition package without causing confusion regarding the 
other properties of the product.
    (Response 3) FDA agrees that various formats should be tested that 
help consumers make more informed decisions about the healthfulness of 
the product. We will include questions about the product to test how 
consumers use the Nutrition Facts label for making those evaluations.
    (Comment 4) One comment suggested the inclusion of real-time, one-
on-one chats between live moderators and respondents during the 
fielding of the study to enhance the quality of the quantitative data 
collected.
    (Response 4) FDA disagrees with this suggestion. FDA has already 
conducted a series of eight focus groups to learn how and why consumers 
react to the formats being tested. Also, prior to conducting the on-
line experiment, FDA will conduct at least nine one-on-one interviews 
where we observe respondents taking the questionnaire, and get their 
feedback about what they were thinking as they answered each question. 
We believe that, taken together, the focus groups and the one-on-one 
interviews will give us a good feel as to why respondents answer the 
questions as they do.
    (Comment 5) A number of comments asked the Agency to publish the 
revised instrument and mock stimuli for public comment prior to 
initiating the study. They had questions and recommendations about the 
design of the experiment, for example, whether there will be a control 
group and how many designs will be shown to the consumers and how many 
label formats will be tested and whether the subjects will be asked to 
rank the different formats in terms of preference.
    (Response 5) We appreciate the suggestion for the Agency to publish 
the instrument and stimuli for public comment prior to initiating the 
study. Per the PRA, a copy of the revised instrument is attached to the 
supporting statement for public comment. We will also include examples 
of stimuli as an appendix of the supporting document. FDA will have a 
control group for this experiment. Ten different label formats will be 
tested. Each subject will only perform two tasks--an evaluation of a 
single label and a label comparison task.
    (Comment 6) Several comments were about who should be included in 
the study. One comment said that FDA should give careful consideration 
to the gender and age distribution of the study subjects and that older 
subjects may have difficulty in using the Web. One comment said it was 
important to include people with special health concerns, those that do 
the majority of grocery shopping or food preparation for their 
households, and groups that may be underrepresented online.
    (Response 6) FDA agrees that demographic factors such as age and 
gender, health concerns, grocery shopping, and food preparation 
experiences are important factors. FDA will collect the previously 
mentioned information and include them in the analyses. FDA will aim to 
have a sample resemble the American adult population. FDA will do pre-
tests to make sure everyone can read and understand the survey.
    (Comment 7) One comment suggested that FDA should consider as part 
of the proposed study how consumers interpret the Nutrition Facts label 
in the context of all the other information on the package, and raised 
the question of whether the information on the Nutrition Facts label 
would be lost, diluted, or confounded by all of the other information 
that appears on the package. The comment suggested that, as part of the 
study design, FDA could present the Nutrition Facts label by itself and 
also how it would appear alongside the other package information, to 
see if consumers view or interpret the Nutrition Facts label 
differently in light of the total package.
    (Response 7) While FDA agrees that the Nutrition Facts label is 
perceived in the context of the entire package, the goal of this study 
is to test various modifications to the Nutrition Facts label that 
would be suitable for all food products regardless of the context of 
the package. The study design proposes to test different options of 
modified Nutrition Facts label without other aspects of the food 
package.
    (Comment 8) One comment stated that, in selecting the final sample 
for the experimental study, FDA should consider whether a certain 
percentage of the subjects should be recruited based on their concerns 
about allergy information. The comment stated that although most of the 
information on the Nutrition Facts label has relevance to all 
consumers, label information about allergens may be of interest only to 
a relatively small number of subjects who have food allergies. The 
comment suggested that the responses from this group could be analyzed 
separately, in addition as part of the total sample.
    (Response 8) It is estimated that the prevalence of food allergies 
ranges from approximately 1 to 10 percent of the population (Ref. 9). 
The study will use a convenience sample (not a representative sample) 
consisting of members of an online panel, 18 years of age or older. 
Therefore, the number of respondents who have food allergies or are 
caretakers of children who have food allergies would be too small for 
the purpose of statistically sound analysis.
    (Comment 9) One comment asked that FDA consider ways to minimize 
the burden of the collection of information on respondents, including 
the use of automated collection techniques, when appropriate, and other 
forms of information technology.
    (Response 9) FDA has taken steps to minimize the burden of data 
collection on respondents. Participants of the study will be members of 
the existing online panel and data will be collected through the 
Internet. Respondents will be sent e-mail invitations to participate in 
the study.
    (Comment 10) One comment asked whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility.
    (Response 10) FDA believes that collecting this information is 
necessary for FDA's regulatory oversight of the Nutrition Facts label. 
Because one of the purposes for initially developing and implementing 
the Nutrition Facts label was to help consumers make informed food 
choices, it is important for FDA to be able to evaluate whether 
consumers understand how to properly interpret the label, especially 
for health purposes.
    (Comment 11) One comment requested that FDA consider using some or 
all of the label format changes suggested by the Center for Science in 
the Public Interest (CSPI) (Ref. 10).

[[Page 70268]]

    (Response 11) CSPI suggested extensive changes to the Nutrition 
Facts label that affect many parts of the label. In this research, the 
Agency is focused on how consumers use labels for products that are 
customarily consumed at one eating occasion but may contain more than 
one serving per container as well as on how consumers react to 
different ways that calorie information is declared on the label. FDA 
believes these changes have the potential to be among the most useful 
changes to help consumers make informed choices. Therefore, FDA 
identified and chose the proposed formats, such as dual column formats 
and prominence of calorie formats, for this study. The variety of 
different experimental conditions for just these changes requires a 
very large number of respondents. It is not feasible to test the 
additional extensive changes such as those suggested by CSPI in this 
study because the number of respondents needed would become 
unmanageable.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Number of       Annual frequency      Total annual
                  Portion of study                       respondents        per response          responses       Hours per response      Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interview screener.......................                  96                   1                  96                0.083                   8
Cognitive interview................................                  12                   1                  12                1                      12
Pretest invitation.................................               1,000                   1               1,000                0.033                  33
Pretest............................................                 150                   1                 150                0.25                   38
Experiment invitation..............................              50,000                   1              50,000                0.033               1,650
Experiment.........................................              10,000                   1              10,000                0.25                2,500
                                                    ----------------------------------------------------------------------------------------------------
    Total..........................................  ..................  ..................  ..................  ...................               4,241
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the 60-day notice that published in the Federal Register of 
November 18, 2009, we estimated a total burden of 1,595 hours for the 
study. In this document, table 1 has been modified to reflect our re-
evaluation of the original study design. The new total estimated burden 
is 4,241 hours.
    To help design and refine the questionnaire to be used for the 
experimental study, we plan to conduct cognitive interviews by 
screening 96 adult consumers in order to obtain 12 participants in the 
interviews. Each screening is expected to take 5 minutes (0.083 hours) 
and each cognitive interview is expected to take 1 hour. The total for 
cognitive interview activities is 20 hours (8 hours + 12 hours). 
Subsequently, we plan to conduct pretests of the questionnaire before 
it is administered in the study. We expect that 1,000 invitations, each 
taking 2 minutes (0.033 hours), will need to be sent to adult members 
of an online consumer panel to have 150 of them complete a 15-minute 
(0.25 hours) pretest. The total for the pretest activities is 71 hours 
(33 hours + 38 hours). For the experiment, we estimate that 50,000 
invitations, each taking 2 minutes (0.033 hours), will need to be sent 
to adult members of an online consumer panel to have 10,000 of them 
complete a 15-minute (0.25 hours) questionnaire. The total for the 
experiment activities is 4,150 hours (1,650 hours + 2,500 hours). Thus, 
the total estimated burden is 4,241 hours. FDA's burden estimate is 
based on prior experience with research that is similar to this 
proposed study.

II. References

1. Levy A., S. Fein, and R. Schucker, ``Nutrition Labeling Formats: 
Performance and Preference,'' Food Technology 45: 116-121, 1991.
2. Levy A., S. Fein, and R. Schucker, ``More Effective Nutrition Label 
Formats Are Not Necessarily Preferred,'' Journal of the American 
Dietetic Association 92: 1230-1234, 1992.
3. Levy A., S. Fein, and R. Schucker, ``Performance Characteristics of 
Seven Nutrition Label Formats,'' Journal of Public Policy and Marketing 
15: 1-15, 1996.
4. Lando A. and J. Labiner-Wolfe, ``Helping Consumers to Make More 
Healthful Food Choices: Consumer Views on Modifying Food Labels and 
Providing Point-of-Purchase Nutrition Information at Quick-Service 
Restaurants,'' Journal of Nutrition Education and Behavior 39: 157-163, 
2007.
5. U.S. Food and Drug Administration, Calories Count: Report of the 
Working Group on Obesity, 2004, (http://www.fda.gov/Food/LabelingNutrition/ReportsResearch/ucm081696.htm).
6. 70 FR 17008, April 4 2005.
7. 70 FR 17010, April 4 2005.
8. 72 FR 62149, November 2 2007.
9. Schnieder Chafer, J.J., S.J. Newbery, M.A. Riedl, et al., 
``Diagnosing and Managing Common Food Allergies: A Systematic Review,'' 
Journal of the American Medical Association 303(18): 1848-1856.
10. Silverglade, B and I.R. Heller, ``Food Labeling Chaos: The Case for 
Reform,'' Center for Science in the Public Interest, March 2010, 
available at: http://www.cspinet.org/new/pdf/food_labeling_chaos_report.pdf.

    Dated: November 10, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28966 Filed 11-16-10; 8:45 am]
BILLING CODE 4160-01-P