[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29758-29760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0345]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study on Consumer Responses to Nutrition 
Facts Labels With Various Footnote Formats and Disclosure of Amounts of 
Vitamins and Minerals

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 Nutrition Facts Labels With Various Footnote 
Formats and Disclosure of Amounts of Vitamins and Minerals.''

DATES: Submit either electronic or written comments on the collection 
of information by July 22, 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, Jr., 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

[[Page 29759]]

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.

I. Experimental Study on Consumer Responses to Nutrition Facts Labels 
With Various Footnote Formats and Disclosure of Amounts of Vitamins and 
Minerals--(OMB Control Number 0910-New)

    Under the Nutrition Labeling and Education Act of 1990 (Pub. L. 
101-535), the Nutrition Facts label is required on most packaged foods, 
and this information must be provided in a specific format in 
accordance with the provisions of Sec.  101.9 (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 
through 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 (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 
the Federal Register of November 2, 2007 (72 FR 62149) FDA issued an 
advance notice of proposed rulemaking (ANPRM) entitled, ``Food 
Labeling: Revision of Reference Values and Mandatory Nutrients'' (the 
2007 ANPRM), which requested comments on a variety of topics related to 
a future proposed rule to update the presentation of nutrients and 
content of nutrient values on food labels. In the 2007 ANPRM, the 
Agency included a request for comments on how consumers use the percent 
Daily Value in the Nutrition Facts label when evaluating the 
nutritional content of food items and making purchases.
    Research has suggested that consumers use the Nutrition Facts label 
in various ways, including, but not limited to, using the Nutrition 
Facts label to determine if products are high or low in a specific 
nutrient and to compare products (Ref. 6). One component of the 
Nutrition Facts label that serves as an aid in these uses is the 
percent Daily Value. Early consumer research indicated that the percent 
Daily Value format improved consumers' abilities to make correct 
dietary judgments about a food in the context of a total daily diet 
(Ref. 3), which led FDA to require both quantitative and percentage 
declarations of nutrient daily values in the Nutrition Facts label in 
the 1993 Nutrition Labeling final rule (58 FR 2079, January 6, 1993).
    Research in subsequent years, however, suggested that consumers' 
understanding and use of percent Daily Value may be somewhat 
inconsistent (Refs. 7 and 8). Additionally, FDA has received several 
public comments suggesting that further research on percent Daily 
Values may be warranted, along with research on other modifications to 
the Nutrition Facts label. Suggested research on potential 
modifications includes research on: (1) The removal of the statements, 
``Percent Daily Values are based on a 2,000 calorie diet. Your daily 
values may be higher or lower depending on your calorie needs''; (2) 
the removal of the table in the footnote that lists the Daily Values 
for total fat, saturated fat, cholesterol, sodium, total carbohydrate, 
and dietary fiber based on 2,000 and 2,500 calorie diets as described 
in Sec.  101.9(d)(9); and (3) changes to the presentation of and amount 
of information provided in the Nutrition Facts label. Therefore, FDA, 
as part of its effort to promote public health, proposes to use this 
study to explore consumer responses to various food label formats for 
the footnote area of the Nutrition Facts label, including those that 
exhibit information such as various definitions for percent Daily Value 
and general guidelines for high and low nutrient levels. In addition, 
the Agency will use this study to explore consumer responses to 
inclusion of weight amount information in the declaration of vitamins 
and minerals described in Sec.  101.9(c)(8)(ii) (i.e., vitamin A, 
vitamin C, calcium, and iron), which may have potential health value to 
consumers (Ref. 9).
    The proposed collection of information is a controlled, randomized, 
experimental study. The study will use a Web-based survey, which will 
take about 15 minutes to complete, to collect information from 10,000 
English-speaking adult members of an online consumer panel maintained 
by a contractor. The study will aim to recruit 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 a 
total of three label images from a set of food labels that will be 
created for the study and systematically varied in the presence or 
absence of the following items: (1) A definition for percent Daily 
Value, (2) a general guideline for ``high'' and ``low'' nutrient 
levels, and (3) weight amounts for vitamins and minerals. Various 
definitions for percent Daily Value may include, for example, ``The 
percent Daily Value is the amount of a nutrient listed above that one 
serving of this product contributes to the daily diet''; ``The percent 
Daily Value is the amount of a nutrient listed above that one serving 
of this product contributes to what you eat in a day''; and ``The 
percent Daily Value is the amount of a nutrient listed above that one 
serving of this product contributes to a 2,000 calorie diet.'' A sample 
guideline for high and low nutrient levels may include, for example, 
``A percent Daily Value that is 5 percent or less is low, and 20 
percent or more is high.'' To correspond with FDA's other experimental 
study of Nutrition Facts label formats described in the November 17, 
2010, Federal Register (75 FR 70266), this study will evaluate 
performance of the footnote statements in combination with single and 
dual column labeling. Finally, the study will also examine effects of 
including reference to FDA within the Nutrition Facts footnote. 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 survey will ask its participants to view label images and 
answer questions about their understanding, perceptions, and reactions 
related to the viewed label. 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 healthiness; (2) 
ability to use the Nutrition Facts label to, for example, compare 
products and calculate the number of servings of a product needed to 
meet nutritional objectives; and (3) label perceptions (e.g., 
helpfulness and credibility). 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 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 enhance the 
Agency's understanding of how various potential modifications to the 
Nutrition Facts label may affect how consumers perceive a product or a 
label,

[[Page 29760]]

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 103 hours (53 hours + 
50 hours). For the survey, we estimate that 80,000 invitations, each 
taking 2 minutes (0.033 hour) to complete, will need to be sent to the 
consumer panel to have 10,000 of its members complete a 15-minute (0.25 
hour) questionnaire. The total for the survey activities is 5,140 hours 
(2,640 hours + 2,500 hours). Thus, the total estimated burden is 5,258 
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
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                      hours) \2\
----------------------------------------------------------------------------------------------------------------
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...............          80,000               1          80,000            2/60           2,640
Survey..........................          10,000               1          10,000           15/60           2,500
    Total.......................  ..............  ..............  ..............  ..............           5,258
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

II. References

    The following references are 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.

1. Levy, A.S., Fein, S.B., and Schucker, R.E. ``Nutrition Labeling 
Formats: Performance and Preference,'' Food Technology, 45: 116-121, 
1991.
2. Levy, A.S., Fein, S.B., and Schucker, R.E. ``More Effective 
Nutrition Label Formats Are Not Necessarily Preferred,'' Journal of 
the American Dietetic Association, 92: 1230-1234, 1992.
3. Levy, A.S., Fein, S.B., and Schucker, R.E. ``Performance 
Characteristics of Seven Nutrition Label Formats,'' Journal of 
Public Policy and Marketing, 15: 1-15, 1996.
4. Lando, A.M. and Labiner-Wolfe, J. ``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, available at http://www.fda.gov/Food/LabelingNutrition/ReportsResearch/ucm081696.htm.
6. U.S. Food and Drug Administration. ``2008 Health and Diet 
Survey--Preliminary Topline Frequencies (Weighted),'' 2010, 
available at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/ucm193895.htm.
7. Li, F., Miniard, P.W., and Barone, M.J. ``The Facilitating 
Influence of Consumer Knowledge on the Effectiveness of Daily Value 
Reference Information,'' Journal of the Academy of Marketing 
Science, 28: 425-436, 2000.
8. Levy, L., Patterson, R.E., Kristal, A.R., and Li, S.S. ``How Well 
Do Consumers Understand Percentage Daily Value on Food Labels?'' 
American Journal of Health Promotion, 14: 157-160, 2000.
9. Institute of Medicine. Dietary Reference Intakes: Guiding 
Principles for Nutrition Labeling and Fortification. Washington, DC: 
National Academies Press, 2003.

    Dated: May 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12556 Filed 5-20-11; 8:45 am]
BILLING CODE 4160-01-P