Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Consumer Responses to Nutrition Facts Labels With Various Footnote Formats and Declaration of Amount of Added Sugars, 32120-32122 [2012-13141]
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Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Notices
1218. For all other issues call 410–786–
1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email
your request, including your address,
phone number, OMB number, and CMS
document identifier, to Paperwork@cms.
hhs.gov, or call the Reports Clearance
Office on (410) 786–1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on July 2, 2012. OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–6974, Email:
OIRA_submission@omb.eop.gov.
DATES:
Dated: May 25, 2012.
Martique Jones,
Director, Regulations Development Group,
Division-B, Office of Strategic Operations and
Regulatory Affairs.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2012–13206 Filed 5–30–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0495]
Agency Information Collection
Activities; Proposed Collection;
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.
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 Declaration of Amount of Added
Sugars.’’
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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17:53 May 30, 2012
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Submit either electronic or
written comments on the collection of
information by July 30, 2012.
Submit electronic
comments on the collection of
information to https://
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850, domini.
bean@fda.hhs.gov.
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
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.
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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 § 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
E:\FR\FM\31MYN1.SGM
31MYN1
srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Notices
(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
§ 101.9(d)(9); and (3) changes to the
presentation of and amount of
information provided in the Nutrition
Facts label. Therefore, the 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
received numerous comments regarding
the declaration of added sugars in
response to the 2007 ANPRM even
though the Agency did not ask any
questions regarding the declaration of
added sugars. 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
consumer reactions to the declaration of
vitamins and minerals by weight on the
Nutrition Facts label. This 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 food label (Ref. 9). 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
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17:53 May 30, 2012
Jkt 226001
amount of calcium in a food when it is
listed only as Percent Daily Values on
the Nutrition Facts label. Block and
Peracchio (Ref. 10) demonstrated this
difficulty and the potential merits of
providing consumers with easy-to-use
information in helping them increase
their calcium intakes. The findings by
Block and Peracchio provide data on the
issue we were planning to study. 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 by weight with
an examination of declaring the 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.
In the Federal Register of December
29, 2011 (76 FR 81949), FDA published
a notice informing interested parties
that the proposed collection of
information had been submitted to OMB
for review and clearance under the PRA
and inviting the public to submit
comments on the proposed study to
OMB. The notice also announced FDA’s
plans to change the study by examining
consumer reactions to the declaration of
added sugars instead of the declaration
of vitamins and minerals by weight.
OMB received requests for an extension
of time to comment on this change to
the study. In response to these requests,
FDA is providing an opportunity for
comment on the current design of the
study, including the added sugars
component, by publishing a new 60-day
notice describing the study as currently
envisioned and inviting the public to
submit comments to the Agency’s
docket. After considering any comments
received, the Agency will resubmit the
proposed collection of information to
OMB. In the meantime, the Agency is
withdrawing the proposed collection of
information from OMB review, as
announced elsewhere in this issue of
the Federal Register.
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 Englishspeaking 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
PO 00000
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32121
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 in this document that one
serving of this product contributes to
the daily diet.’’ A sample guideline for
high and low nutrient levels may
include, for example, ‘‘5 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.
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 one hour.
The total for cognitive interview
activities is 15 hours (6 hours + 9
hours). Subsequently, we plan to
E:\FR\FM\31MYN1.SGM
31MYN1
32122
Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Notices
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 +
2,500 hours). Thus, the total estimated
burden is 3,906 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Cognitive interview screener ....................................
Cognitive interview ...................................................
Pretest invitation ......................................................
Pretest ......................................................................
Survey invitation .......................................................
Survey ......................................................................
72
9
1,000
150
40,000
10,000
1
1
1
1
1
1
72
9
1,000
150
40,000
10,000
0.083 (5 min.) ............
1 ................................
0.033 (2 min.) ............
0.25 (15 min.) ............
0.033 (2 min.) ............
0.25 (15 min.) ............
6
9
33
38
1,320
2,500
Total ..................................................................
........................
........................
........................
....................................
3,906
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
srobinson on DSK4SPTVN1PROD with NOTICES
II. References
The following references have been
placed 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. (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. 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 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, vol. 39, pp.
157–163, 2007.
5. U.S. Food and Drug Administration,
Calories Count: Report of the Working
Group on Obesity, 2004, available at
https://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 https://www.fda.gov/Food/
ScienceResearch/ResearchAreas/
ConsumerResearch/ucm193895.htm.
7. Li, F., P.W. Miniard, and M.J. Barone, ‘‘The
Facilitating Influence of Consumer
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Jkt 226001
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, and
S.S. Li, ‘‘How Well Do Consumers
Understand Percentage Daily Value on
Food Labels?’’ American Journal of
Health Promotion, vol. 14, pp. 157–160,
2000.
9. Institute of Medicine. Dietary Reference
Intakes: Guiding Principles for Nutrition
Labeling and Fortification, 2003,
available at https://www.nap.edu/
catalog.php?record_id=10872.
10. 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.
Dated: May 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–13141 Filed 5–30–12; 8:45 am]
BILLING CODE 4160–01–P
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; Withdrawal
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Withdrawal of notice.
Frm 00042
Fmt 4703
Sfmt 4703
This document withdraws a
Food and Drug Administration (FDA)
notice that published in the Federal
Register of December 29, 2011 (76 FR
81948).
SUMMARY:
This notice is withdrawn on May
31, 2012.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850, domini.
bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA
published a notice in the Federal
Register of December 29, 2011,
informing interested parties that the
proposed collection of information
entitled ‘‘Experimental Study on
Consumer Responses to Nutrition Facts
Labels With Various Footnote Formats
and Declaration of Amount of Added
Sugars’’ had been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
and inviting the public to submit
comments on the proposed study to
OMB. The notice also announced FDA’s
plans to change the study by examining
consumer reactions to the declaration of
added sugars instead of the declaration
of vitamins and minerals by weight.
OMB received requests for an extension
of time to comment on this change to
the study. In response to these requests,
FDA is providing an opportunity for
comment on the current design of the
study, including the added sugars
component, by publishing a new 60-day
notice, elsewhere in this issue of the
Federal Register, describing the study
as currently envisioned and inviting the
public to submit comments to the
DATES:
E:\FR\FM\31MYN1.SGM
31MYN1
]]>Agencies
[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Notices]
[Pages 32120-32122]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13141]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0495]
Agency Information Collection Activities; Proposed Collection;
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.
-----------------------------------------------------------------------
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 Declaration of Amount of Added Sugars.''
DATES: Submit either electronic or written comments on the collection
of information by July 30, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, domini.bean@fda.hhs.gov.
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 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.
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
[[Page 32121]]
(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, the 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 received numerous comments regarding the declaration
of added sugars in response to the 2007 ANPRM even though the Agency
did not ask any questions regarding the declaration of added sugars.
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 consumer reactions to the declaration of vitamins
and minerals by weight on the Nutrition Facts label. This 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 food label (Ref. 9). 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. 10) demonstrated this difficulty and the potential
merits of providing consumers with easy-to-use information in helping
them increase their calcium intakes. The findings by Block and
Peracchio provide data on the issue we were planning to study. 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 by weight with an examination of
declaring the 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.
In the Federal Register of December 29, 2011 (76 FR 81949), FDA
published a notice informing interested parties that the proposed
collection of information had been submitted to OMB for review and
clearance under the PRA and inviting the public to submit comments on
the proposed study to OMB. The notice also announced FDA's plans to
change the study by examining consumer reactions to the declaration of
added sugars instead of the declaration of vitamins and minerals by
weight. OMB received requests for an extension of time to comment on
this change to the study. In response to these requests, FDA is
providing an opportunity for comment on the current design of the
study, including the added sugars component, by publishing a new 60-day
notice describing the study as currently envisioned and inviting the
public to submit comments to the Agency's docket. After considering any
comments received, the Agency will resubmit the proposed collection of
information to OMB. In the meantime, the Agency is withdrawing the
proposed collection of information from OMB review, as announced
elsewhere in this issue of the Federal Register.
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
in this document that one serving of this product contributes to the
daily diet.'' A sample guideline for high and low nutrient levels may
include, for example, ``5 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
mock-ups 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.
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
one hour. The total for cognitive interview activities is 15 hours (6
hours + 9 hours). Subsequently, we plan to
[[Page 32122]]
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 + 2,500 hours). Thus, the total estimated burden is
3,906 hours.
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 per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 (see ADDRESSES) 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
publishes 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 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,
vol. 39, pp. 157-163, 2007.
5. U.S. Food and Drug Administration, Calories Count: Report of the
Working Group on Obesity, 2004, available at https://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 https://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/ucm193895.htm.
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, and S.S. Li, ``How Well
Do Consumers Understand Percentage Daily Value on Food Labels?''
American Journal of Health Promotion, vol. 14, pp. 157-160, 2000.
9. Institute of Medicine. Dietary Reference Intakes: Guiding
Principles for Nutrition Labeling and Fortification, 2003, available
at https://www.nap.edu/catalog.php?record_id=10872.
10. 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.
Dated: May 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13141 Filed 5-30-12; 8:45 am]
BILLING CODE 4160-01-P
