[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Notices]
[Pages 81948-81950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study on 
Consumer Responses to Nutrition Facts Labels With Various Footnote 
Formats and Declaration of Amount of Added Sugars

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 January 
30, 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 [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Experimental Study on Consumer Responses to Nutrition Facts 
Labels With Various Footnote Formats and Declaration of Amount of Added 
Sugars.'' 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, 
[email protected].

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 Nutrition Facts Labels With 
Various Footnote Formats and Declaration of Amount of Added Sugars--
(OMB Control Number 0910-New)

I. Background

    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 to 
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, a succinct statement about daily caloric intake, and general 
guidelines for high and low nutrient levels.
    This study will also explore how declaring the added sugars content 
of foods might affect consumers' attention to and understanding of the 
sugars and calorie contents and other information on the Nutrition 
Facts label. FDA is contemplating requiring the amount of added sugars 
to be declared under sugars with a double indention format because 
added sugars are a component of sugars. This new requirement would be 
the first time that the mandatory declaration of a nutrient is shown in 
this format on the Nutrition Facts label. Because added sugars have 
been linked to obesity, a significant public health problem in the 
country (Ref. 9), it is important that this new requirement is 
supported by evidence so that consumers can correctly use the 
information. The Agency is not aware of any existing consumer research 
that has examined this topic and is therefore interested in using this 
study to enhance understanding of how consumers would comprehend and 
use this new information.
    In the Federal Register of May 23, 2011 (76 FR 29758), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. In that notice, the Agency announced its 
intention to examine

[[Page 81949]]

consumer reactions to the declaration of vitamins and minerals on the 
Nutrition Facts label. The intention was prompted by the 2003 Institute 
of Medicine report that recommended declaration of weight amounts of 
all nutrients, including vitamins and minerals, on the label (Ref. 10). 
As the report noted, public health advice on nutrient intake is often 
given in absolute amounts, but in the case of a nutrient such as 
calcium, consumers may not be able to determine the amount of calcium 
in a food when it is listed only as Percent Daily Values on the 
Nutrition Facts label. Block and Peracchio (Ref. 11) demonstrated this 
difficulty and the potential merits of providing consumers with easy-
to-use information in helping them increase their calcium intakes. The 
Agency considers the recommendation of the Institute of Medicine as 
well as the findings by Block and Peracchio adequate support for 
requiring the weight amounts of vitamins and minerals be declared on 
the Nutrition Facts label. On the other hand, consumer evidence on the 
effects of declaring added sugars is lacking. Therefore, the Agency has 
determined that the utility of the study would be enhanced by replacing 
the examination of declaring amounts of vitamins and minerals with the 
examination of declaring amount of added sugars. This change would have 
minimal effects on the planned length and respondent burden of the 
study and would not change the study's primary focus, which remains on 
examining footnote options.
    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 
series of label images from a set of food labels that will be created 
for the study and systematically varied in the presence or absence of: 
(1) A definition for Percent Daily Value, (2) a general guideline for 
``high'' and ``low'' nutrient levels, and (3) a declaration for added 
sugars. A sample definition 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.'' 
A sample guideline for high and low nutrient levels may include, for 
example, ``Five percent or less is low, and 20 percent or more is 
high.'' Finally, the study will also examine effects of including 
reference to FDA within the Nutrition Facts footnote and a succinct 
statement about daily caloric intake. All label images will be mockups 
resembling food labels that may be found in the marketplace. Images 
will show product identity (e.g., yogurt or frozen meal) 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 healthfulness, (2) 
ability to use the Nutrition Facts label in tasks such as identifying a 
product's nutrient contents and evaluating the Percent Daily Values for 
specific nutrients, 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, 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 May 23, 2011, FDA published a 60-day 
notice requesting public comment on the proposed collection of 
information. The Agency received two comments. One of the comments was 
outside of the scope of the proposed collection of information 
described in the 60-day notice and is not addressed here.,
    (Comment 1) The comment suggested that, in place of the proposed 
research, an educational effort be undertaken to inform consumers about 
the meaning of Percent Daily Value as it is currently presented on the 
Nutrition Facts label. The comment also questioned whether a study 
sample obtained from the proposed online consumer panel would 
sufficiently reflect the demographic diversity of the U.S. adult 
population.
    (Response) FDA agrees that consumer education is important to help 
consumers understand Percent Daily Value and has been conducting and 
sponsoring this type of education through its Web site (Refs. 12 to 16) 
and programs such as the ``Spot the Block'' campaign (Ref. 16 and 17). 
FDA does not agree, however, that consumer education about how to use 
the food label can substitute for consumer research, which is the 
primary approach for generating empirical and scientifically valid 
evidence about consumer understanding in response to any considered 
modifications to the Nutrition Facts label. Consumer research allows 
the Agency to evaluate objectively which considered modifications to 
the Nutrition Facts label are most likely to help consumers; 
additionally, such research may help enhance the design and utility of 
consumer education efforts. Although the study will use an online 
consumer panel, the Agency expects that, based on prior experience with 
these types of panels, this approach will achieve a sample of 
participants that is reflective of the Census distributions in key 
demographic characteristics (gender, age, education, and race/
ethnicity). As in our previous online research, we will develop a 
Census-balanced sample (Ref. 18) by setting a quota prior to the study 
so that the overall sample of panelists who participate in the study 
will be balanced against the U.S. Census in gender, age, education, and 
race/ethnicity, i.e., inbound-balanced. The planned balancing 
categories are: (1) Gender: female and male; (2) age: 18-34, 35-54, and 
55+; (3) education: high-school graduate or less and 1 year or more 
college education; and (4) race/ethnicity: non-Hispanic white and 
other.
    To help design and refine the questionnaire, FDA plans to conduct 
cognitive interviews by screening 72 panelists 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 1,000 
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 survey, we 
estimate that 40,000 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 survey activities is 3,820 hours (1,320 hours +

[[Page 81950]]

2,500 hours). Thus, the total estimated burden is 3,906 hours. This 
estimate is 1,352 hours lower than the 5,258 hours published in the 60-
day notice and reflects 20 fewer hours for the pretest invitation, 12 
fewer hours for the pretest, and 1,320 fewer hours for the survey 
invitation. Recent evidence available to the Agency suggests the study 
will not need to send as many pretest or survey invitations as 
originally estimated to achieve its target sample sizes in the pretest 
and survey. The number of pretests was changed from 200 to 150 to 
correct an error that was made in the 60-day notice.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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Cognitive Interview Screener................              72               1              72  0.083 (5 min.)............................               6
Cognitive Interview.........................               9               1               9  1.........................................               9
Pretest Invitation..........................           1,000               1           1,000  0.033 (2 min.)............................              33
Pretest.....................................             150               1             150  0.25 (15 min.)............................              38
Survey Invitation...........................          40,000               1          40,000  0.033 (2 min.)............................           1,320
Survey......................................          10,000               1          10,000  0.25 (15 min.)............................           2,500
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          3,906
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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 sites after this document is 
published in the Federal Register.)

1. Levy, A.S., S.B. Fein, and R.E. Schucker, ``Nutrition Labeling 
Formats: Performance and Preference,'' Food Technology, vol. 45, pp. 
116-121, 1991.
2. Levy, A.S., S.B. Fein, and R.E. Schucker, ``More Effective 
Nutrition Label Formats Are Not Necessarily Preferred,'' Journal of 
the American Dietetic Association, vol. 92, pp. 1230-1234, 1992.
3. Levy, A.S., S.B. Fein, and R.E. Schucker, ``Performance 
Characteristics of Seven Nutrition Label Formats,'' Journal of 
Public Policy and Marketing, vol. 15, pp. 1-15, 1996.
4. Lando, A.M. and J. Labiner-Wolfe, ``Helping Consumers 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, vol. 39, 
pp. 157-163, 2007.
5. Food and Drug Administration, ``Calories Count: Report of the 
Working Group on Obesity,'' (http://www.fda.gov/Food/LabelingNutrition/ReportsResearch/ucm081696.htm), 2004.
6. Food and Drug Administration, ``2008 Health and Diet Survey--
Topline Frequencies (Weighted),'' (http://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/ucm193895.htm), 2010.
7. Li, F., P.W. Miniard, and M.J. Barone, ``The Facilitating 
Influence of Consumer Knowledge on the Effectiveness of Daily Value 
Reference Information,'' Journal of the Academy of Marketing 
Science, vol. 28, pp. 425-436, 2000.
8. Levy, L., R.E. Patterson, A.R. Kristal, et al., ``How Well Do 
Consumers Understand Percentage Daily Value on Food Labels?'' 
American Journal of Health Promotion, vol. 14, pp. 157-160, 2000.
9. U.S. Department of Agriculture and U.S. Department of Health and 
Human Services, ``Dietary Guidelines for Americans, 2010,'' 7th 
Edition, Washington, DC: U.S. Government Printing Office, December 
2010.
10. Institute of Medicine, ``Dietary Reference Intakes: Guiding 
Principles for Nutrition Labeling and Fortification,'' (http://www.nap.edu/catalog.php?record_id=10872), 2003.
11. Block, L.G. and L.A. Peracchio, ``The Calcium Quandary: How 
Consumers Use Nutrition Labels,'' Journal of Public Policy and 
Marketing, vol. 25, pp. 188-196, 2006.
12. Food and Drug Administration, ``A Key to Choosing Healthful 
Foods: Using the Nutrition Facts on the Food Label,'' (http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079449.htm), 2011.
13. Food and Drug Administration, ``The Food Label and You--Video,'' 
(http://www.fda.gov/Food/ResourcesForYou/Consumers/NFLPM/ucm275409.htm), 2011.
14. Food and Drug Administration, ``How to Understand and Use the 
Nutrition Facts Label,'' (http://www.fda.gov/Food/ResourcesForYou/Consumers/NFLPM/ucm274593.htm), 2011.
15. U.S. Food and Drug Administration, ``Using the Nutrition Facts 
Label. A How-to Guide for Older Adults,'' (http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm267499.htm), 2010.
16. Food and Drug Administration, ``Spot the Block Using the 
Nutrition Facts Label to Make Healthy Food Choices--A Program for 
Tweens,'' (http://www.fda.gov/Food/ResourcesForYou/Consumers/NFLPM/ucm281746.htm), 2011.
17. Food and Drug Administration, ``Spot the Block: Cartoon Network 
and the FDA Encourage Kids to SPOT THE BLOCK,'' (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048815.htm), 2011.
18. American Association for Public Opinion Research (AAPOR). 
``AAPOR Report on Online Panels,'' (http://www.aapor.org/AM/Template.cfm?Section=AAPOR_Committee_and_Task_Force_Reports&Template=/CM/ContentDisplay.cfm&ContentID=2223), March 2010.

    Dated: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33303 Filed 12-28-11; 8:45 am]
BILLING CODE 4160-01-P