Front-of-Pack and Shelf Tag Nutrition Symbols; Establishment of Docket; Request for Comments and Information, 22602-22606 [2010-9939]
Download as PDF
22602
Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices
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.
Title: Draft Guidance for Industry and
FDA Staff: User Fees for 513(g) Requests
for Information
Description: Section 513(g) of the act
(21 U.S.C. 360c(g)) provides a means for
obtaining the FDA’s views about
classification information and the
regulatory requirements that may be
applicable to a particular device. Title II
of the Food and Drug Administration
Amendments Act of 2007 (FDAAA),
also termed the Medical Device User
Fee Amendments of 2007, Public Law
110–85, extends FDA’s authority to
collect medical device user fees by
establishing a fee for ‘‘a request for
classification information.’’ Form No.
3601, Medical Device User Fee Cover
Sheet, is being revised to include the
addition of user fees for 513(g) Request
for Information.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Sec.
738(a)(2)(A)(ix) of
FDAAA
Sec.513(g) of the
FD&C Act
Form FDA
No.
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total hours
CDRH
3601
110
1
110
2
220
CBER
3601
4
1
4
2
8
Total Hours
mstockstill on DSKH9S0YB1PROD with NOTICES
1 There
228
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based these estimates on the
number of 513(g) Requests for
Information received by CDRH and
CBER during calendar year (CY) 2008.
Elsewhere in this Federal Register we
are publishing a document announcing
the availability of a draft guidance
document entitled ‘‘Guidance for
Industry and FDA Staff; FDA and
Industry Procedures for Section 513(g)
Requests for Information under the
Federal Food, Drug, and Cosmetic Act.’’
This guidance describes the procedures
we recommend when seeking the
Agency’s views about classification
information and regulatory
requirements that may be applicable to
a particular device. The burden estimate
is based on the amount of time needed
to satisfy the completion of these
procedures.
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 807 subpart E
have been approved under OMB control
number 0910–0120; the collections of
information in 21 CFR part 814 have
been approved under OMB control
number 0910–0231.
VerDate Mar<15>2010
16:19 Apr 28, 2010
Jkt 220001
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: April 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–9938 Filed 4–28–10; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0210]
Front-of-Pack and Shelf Tag Nutrition
Symbols; Establishment of Docket;
Request for Comments and
Information
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice; establishment of docket;
request for comments and information.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
establishment of a docket to obtain data
and other information that will inform
the agency’s deliberations about ways to
enhance the usefulness to consumers of
point-of-purchase nutrition information,
such as information on the principal
display panel of food products (‘‘frontof-pack’’ labeling) or on shelf tags in
retail stores. In particular, FDA is
interested in the following: Data and
information on the extent to which
consumers notice, use, and understand
nutrition symbols on front-of-pack
labeling of food packages or on shelf
tags in retail stores; research assessing
and comparing the effectiveness of
particular possible approaches to front-
E:\FR\FM\29APN1.SGM
29APN1
Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
of-pack labeling; graphic design,
marketing, and advertising data and
information that can inform and guide
the development of better point-ofpurchase nutrition information; and the
extent to which point-of-purchase
nutrition information may affect
decisions by food manufacturers to
reformulate products. The goal of this
front-of-pack nutrition labeling effort is
to maximize the number of consumers
who readily notice, understand, and use
point-of-purchase information to make
more nutritious choices for themselves
and their families. FDA is establishing
this docket in order to provide an
opportunity for interested parties to
provide data and information and share
views that will inform future agency
actions with respect to these matters.
DATES: Submit electronic or written
comments by July 28, 2010.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Chung-Tung Jordan Lin, Center for Food
Safety and Applied Nutrition (HFS–
020), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–1831.
SUPPLEMENTARY INFORMATION:
I. Background
The Nutrition Labeling and Education
Act of 1990 (NLEA) (Public Law 101–
535) amended the Federal Food, Drug,
and Cosmetic Act (the act) to require
nutrition labeling on packaged foods
and to provide for the use of nutrient
content claims and health claims in
food labeling. The purpose of these
amendments was to enable consumers
to make more informed and healthier
food choices in the context of their daily
diet. In 1993, FDA established
regulations that implemented NLEA.
Among those regulations, FDA set forth
general principles for nutrient content
claims (21 CFR 101.13), which are
claims that characterize the level of a
nutrient in a food (e.g., ‘‘low fat,’’ ‘‘good
source of fiber’’) and for health claims,
which are claims that characterize the
relationship of a food substance to a
disease or health-related condition (e.g.,
‘‘calcium may reduce the risk of
osteoporosis’’). The cornerstone of the
NLEA is the requirement that packaged
foods bear product-specific information
on serving size, calories, and nutrient
content (21 CFR 101.2(b) and (d)). For
conventional foods, this information is
provided in a Nutrition Facts box on the
VerDate Mar<15>2010
16:19 Apr 28, 2010
Jkt 220001
package label. FDA’s final regulations
establishing nutrition labeling were
published in 1993 (58 FR 2079, January
6, 1993).
An important goal of NLEA was to
make available to consumers nutrition
information that can assist them in
selecting foods that contribute to
healthier diets. Research conducted by
FDA and others shows that many
consumers use the Nutrition Facts box
in their food choices (Ref. 1). Yet, as
Margaret A. Hamburg, the
Commissioner of Food and Drugs, noted
recently, ‘‘Today, ready access to
reliable information about the calorie
and nutrient content of foods is even
more important, given the prevalence of
obesity and diet-related diseases in the
United States’’ (Ref. 2). Data published
by the U.S. Centers for Disease Control
and Prevention (CDC) indicate that 68
percent of the U.S. adult population is
overweight or obese (Ref. 3), and among
children 2 to 19 years old, nearly 32
percent were at or above the 85th
percentile for body-mass index on
CDC’s 2000 age- and sex-specific growth
charts, which are based primarily on
data from the 1960s and 1970s (Ref. 4).
Body mass index (BMI) is a weight-toheight ratio. High BMI among children
and adults is a significant public health
concern in the United States. Children
with high BMI often become obese
adults, and obese adults are at risk for
many chronic conditions such as
diabetes, cardiovascular disease, and
certain cancers. Healthy eating must be
incorporated into the habits and diets of
children to promote healthy lifelong
practices to prevent obesity and chronic
disease. First Lady Michelle Obama
recently announced a coordinated
national campaign to reduce the
prevalence of overweight and obesity in
the United States particularly among
children (Ref. 5).
The prevalence of diet-related
diseases in the U.S. population and the
need to accommodate Americans’
increasingly busy lifestyles and demand
for quick and nutritious food choices
illustrate the importance of tailoring
nutrition information to help
consumers. FDA and others in the
public health community, as well as
consumer and industry groups, are
actively exploring ways to improve the
usefulness of food labeling to
consumers.
A number of U.S. food processors and
retailers are now incorporating nutrition
symbols and other nutrition-related
representations on food packages,
particularly symbols intended to denote
nutritional quality of a food (e.g., the
Smart Choices checkmark (Ref. 6)),
selected nutrient level disclosures (e.g.,
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
22603
Kellogg’s Nutrition at a Glance (Ref. 7)),
and nutrient content claims. Because
this information is usually placed on the
principal display panels (PDPs) of food
packages, it is commonly referred to as
front-of-pack (FOP) labeling, and we use
that term as a synonym for principal
display panel in this document.1
Nutrition symbol schemes have also
been used in other countries, including
the United Kingdom (Ref. 8) and
Sweden (Ref. 9). In addition, some
retailers have been adding nutrition
symbols on the shelf tags of foods sold
in the store to provide information
about the overall nutritional quality of
the food (e.g., Guiding Stars (Ref. 10)) or
the levels of selected nutrients it
contains.
FDA and the U.S. Department of
Agriculture are working with public and
private stakeholders to develop a
voluntary FOP nutrition label that is
driven by sound nutrition criteria,
consumer research, and design
expertise. Research should be designed
to support the choice of an FOP label
that will achieve the goal and satisfy the
criteria for success outlined in the
following paragraphs.
The goal of an FOP nutrition label is
to increase the proportion of consumers
who readily notice, understand, and use
the available information to make more
nutritious choices for themselves and
their families, and thereby prevent or
reduce obesity and other diet-related
chronic disease. FDA believes that
information in front-of-pack labeling
can be useful to supplement the
information in the Nutrition Facts box.
In addition, because of its prominent
location, front-of-pack labeling may
provide a more convenient and effective
information tool for consumers seeking
quick and accurate information about
the nutritional quality of the food they
are purchasing and accessing, and using
this information may serve to educate
consumers and to help them make
healthier food choices. It is also possible
that information disclosed in front-ofpack labeling may foster industry
reformulation of products because some
consumers may notice the information
and make their product selection
accordingly. Through these mechanisms
of improved consumer understanding
and use of nutrition information and
product reformulation, it is possible that
a well-designed and science-based frontof-pack nutrition labeling program
could bring about significant positive
1 Under 21 CFR 101.1, the PDP of a food in
package form is defined as the part of the label ‘‘that
is most likely to be displayed * * * or examined
under customary conditions of display for retail
sale.’’ It is usually, but not always, on the front of
the food package.
E:\FR\FM\29APN1.SGM
29APN1
mstockstill on DSKH9S0YB1PROD with NOTICES
22604
Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices
changes in Americans’ diet and play a
role in lowering the incidence and
prevalence of diet-related disease in the
United States.
To be successful in achieving this
goal, a front-of-pack label should be:
• Based on standardized nutrition
criteria that are grounded in the Dietary
Guidelines for Americans (Ref. 11),
which provides science-based advice to
promote health and reduce the risk of
chronic disease;
• Widely adopted by food retailers
and manufacturers;
• In a standardized format consumers
can readily notice, understand, and use;
• Designed to enable consumers with
a wide range of literacy, educational
levels, age, and other characteristics to
compare the relative healthiness of
products within and across food
categories in the context of routine food
shopping.
FDA has already begun developing a
scientific foundation for decisionmaking
on nutrition symbols and front-of-pack
labeling. The agency held a public
hearing in September 2007 (Ref. 12) and
completed a focus group study in April
2008 to obtain comments and
information about consumer issues
related to the use of nutrition symbols
on front-of-pack labeling and shelf tags.
The public hearing notice requested
comments on a number of consumer
research questions, including consumer
attitudes about nutrition symbols, how
consumers interpret such symbols, how
the presence of multiple and different
symbols on products in the same food
category and across categories affects
consumer perceptions, how nutrition
symbols interact with the Nutrition
Facts box, and whether such symbols
affect consumers’ ability to make good
dietary choices. On April 21, 2009, FDA
released a document entitled
‘‘Comments on Symbols Public Hearing
and Current Plans for Addressing
Issues’’ (Ref. 13). This document
describes the questions FDA requested
comments on in the public hearing
notice, the comments that FDA received
at the public hearing and that were
submitted to the public docket for the
hearing, FDA’s remarks on the
comments received, and FDA’s current
plans for evaluating issues regarding the
use of nutrition symbols in food
labeling.
Although the public hearing
generated some useful information on
consumer issues related to nutrition
symbols, very limited data and research
were submitted to the agency. To fill
remaining gaps in our knowledge base,
in addition to opening this docket, FDA
has designed and begun to implement a
plan to conduct consumer research on
VerDate Mar<15>2010
16:19 Apr 28, 2010
Jkt 220001
nutrition symbols (Refs. 14 and 15).
Currently, FDA is conducting two
experimental studies to help enhance
the agency’s knowledge about consumer
understanding and use of a selected
sample of nutrition symbol schemes
currently in use in the domestic market,
and to examine whether those schemes
or certain others are better ways to
impart useful nutrition information to
U.S. consumers.
In addition, FDA believes the food
industry has acquired extensive market
experience with consumer reaction to
nutrition symbols since 2005, when the
voluntary use of nutrition symbols in
food labeling began to proliferate in the
U.S. market. FDA also is aware that
many foreign governments, industry
groups, food manufacturers, consumer
advocacy groups, and academic
researchers have conducted or are
conducting consumer research on
nutrition symbols. Although some of
this research is publicly available (see
Refs. 16 through 24), most of it remains
unpublished and unavailable to the
agency. Because there are limitations to
the currently available published
literature, we are particularly interested
in obtaining access to unpublished
research. For example, we are interested
in research on a much wider range of
nutrition symbol schemes than has been
examined in the literature. In addition,
studies seldom compare consumer
responses to different symbol schemes.
Finally, most of the publicly available
research was done in European or other
countries whose labeling requirements
and regulatory framework are quite
different from those in the United
States. As a result, it is unclear whether
and to what extent such findings
derived from these studies are
applicable to the U.S. market.
In addition to developing the
scientific foundation for agency
decisionmaking with respect to
nutrition symbols and other front-ofpack labeling information, FDA is
considering a number of other efforts to
help guide food manufacturers in their
use of front-of-pack labeling, such as
issuance of a draft guidance on
voluntary calorie declarations and a
draft guidance and/or a proposed rule
on dietary guidance statements.
• The assessment and comparison of
the effectiveness of particular possible
approaches to front-of-pack labeling;
• Graphic design, package design,
information architecture, advertising,
marketing, and human factors that affect
noticeability, understandability and use;
and
• The extent to which point-ofpurchase nutrition information may
affect decisions by food manufacturers
to reformulate products.
These data and other information will
be used to inform the agency’s
deliberations about approaches to
enhancing the usefulness to consumers
of point-of-purchase nutrition
information, such as information on the
front-of-pack or on shelf tags in retail
stores, and to fostering decisions by
food manufacturers to reformulate
products.
FDA solicits comment, data, and
information from all interested parties,
domestic and foreign, including
consumers, industry, graphic designers,
package designers, marketing experts,
the nutrition community, and others
with specific expertise in nutrition and
in conveying scientific information to
ordinary citizens. FDA is particularly
interested in the following topics:
Design Considerations
1. Design features from labels used in
the United States or in other countries
that are viewed as superior in ensuring
consumer attention, understanding and
use, i.e., features that attract attention,
make it easier for consumers to
understand how foods with a nutrition
symbol fit into a healthy diet, enhance
the credibility of the symbol, and
encourage use of the symbol in purchase
decisions. Examples of such features
could include:
• Color;
• Location;
• Contrast.
2. The risk of ‘‘too much clutter’’ on
the label. For example:
• The point at which a format is
sufficiently ‘‘overpacked’’ to put off
consumers;
• How many nutrients can be
included in a nutrient-specific
approach without creating
information overload or putting off
consumers;
II. Request for Comments and
• An easy-to-understand range (e.g.,
Information
on a scale of 0 to 3 or 1 to 5) for
FDA is interested in a range of data
use in ranking the overall
and information relevant to the use of
nutritional value of a food; and
front-of-pack nutrition symbol schemes
• Whether a certain amount of blank
on food packages or shelf tags, to
space is needed around FOP
include research concerning:
nutrition symbols to maximize the
chances that consumers will notice
• Consumer perception and consumer
and comprehend them.
behavior;
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
E:\FR\FM\29APN1.SGM
29APN1
Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices
3. Whether certain shapes (such as
stars or checks) have inherent meaning.
4. The size of an FOP symbol relative
to the rest of the package.
5. Factors that influence ease of
comprehension (e.g., whether a symbol
scheme is easy enough for consumers to
understand at a glance (3 seconds or
less) in a crowded grocery store),
particularly in terms of:
• The amount of information;
• The words (e.g., sodium versus salt;
the term ‘‘daily value’’); or
6. Whether a uniform FOP symbol
across product categories helps
consumer recognition, understanding,
trust and use of the symbol.
mstockstill on DSKH9S0YB1PROD with NOTICES
B. Consumer Use and Understanding
7. Consumer attitudes toward
nutrition symbols in general;
8. Consumer attitudes toward
different types of symbols, e.g.:
• FOP vs. shelf tag;
• Nutrient-specific symbol (such as
General Mills’ nutrition highlights)
(Ref. 25) vs. a summary symbol
(such as Smart Choices (Ref. 6));
and
• Symbols with and without an
explicit endorsement from a third
party such as the American Heart
Association (e.g., the Heart-Check
Mark (Ref. 26));
9. Consumer attitudes toward
products or brands that carry a nutrition
symbol compared to:
• Other products or brands in the
same product category (e.g.,
breakfast cereals) that do not carry
a nutrition symbol; and
• Products or brands in other
categories that do not carry such a
symbol.
10. Consumer interpretations of
symbol-carrying products or brands in
terms of:
• Their overall healthfulness and
quality;
• Specific health benefits;
• Featured nutrition attributes;
• Non-featured nutrition attributes;
and
• Any other non-nutrition attributes.
11. Consumer perception of and
reaction to the presence of multiple and
different nutrition symbols on the FOP
or shelf tags of different brands in a
given product category (e.g., breakfast
cereals);
12. Consumer interpretation of the coexistence on the food label of symbols
and other nutrition messages (e.g., a
nutrient content claim);
13. Consumer interpretation of the coexistence on the food label of nutrition
symbols and quantitative nutrition
information (e.g., the Nutrition Facts
box);
VerDate Mar<15>2010
16:19 Apr 28, 2010
Jkt 220001
14. Consumer interpretation of the coexistence of FOP nutrition symbols and
nutrition symbols on shelf tags;
15. The extent to which consumers
notice nutrition symbols;
16. When consumers use nutrition
symbols and the purposes for which
consumers use nutrition symbols, under
time, pressure, and otherwise;
17. Whether and to what extent
nutrition symbols on food labels and
shelf tags direct consumers toward
purchasing brands or foods that bear
them and, if so, whether the shift in
purchase is accompanied with a
displacement of purchase of other
brands or foods;
18. Whether symbols affect the
nutritional quality of the overall diet of
consumers who use the symbols and, if
so, to what extent;
19. The differences, if any, in
consumer response to nutrition symbols
when all products in a given category
carry symbols, compared to when only
some products in the category carry
symbols;
20. The differences, if any, in
consumer response to nutrition symbols
among various demographic subgroups,
such as subgroups differentiated by:
• Level of education;
• Interest in or concern about
nutrition or health;
• Age;
• Race;
• Role as shopper (e.g., primary
shoppers for the household vs.
other consumers); and
• Income.
21. The differences, if any, in
consumer response to nutrition symbols
in the labeling of various product
categories, such as:
• Snacks;
• Meals;
• Dairy products; and
• Vegetables and fruits.
22. Evidence, if any, that use of
symbols helps:
• Reduce time needed for product
selection;
• Improve nutritional quality of
choices; or
• Both.
23. Consumer perceptions when there
are multiple health messages or
nutrition symbols (e.g., some related to
nutrition and others related to
organoleptic or process attributes) on a
given package.
In addition to comments submitted in
response to this document, FDA will
consider those previously submitted to
the agency for the following Federal
Register documents and dockets.
• ‘‘Food Labeling; Use of Symbols to
Communicate Nutrition Information,
Consideration of Consumer Studies and
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
22605
Nutritional Criteria; Public Hearing;
Request for Comments’’ (72 FR 39815,
July 20, 2007) (Docket No. 2007–N–
0198, formerly Docket No. 2007N–
0277);
• ‘‘Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental Study
of Nutrition Symbols on Food Packages’’
(74 FR 26244, June 1, 2009) (Docket No.
FDA–2009–N–0220); and
• ‘‘Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Studies of Nutrition Symbols on Food
Packages’’ (74 FR 62786, December 1,
2009) (Docket No. FDA–2009–N–0220).
Data and information submitted to
these previous dockets do not need to be
resubmitted.
III. Submission of Comments and
Information
FDA has established a public docket
to provide an opportunity for interested
parties to submit consumer research and
design information to inform the
development of a governmentsponsored nutrition symbol program to
help consumers make informed dietary
choices and to provide the food industry
incentives to make more nutritious food
products available.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. References
FDA has placed the following
references 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 FDA is not
responsible for any subsequent changes
to Web sites after this document
publishes in the Federal Register.)
1. FDA, ‘‘2008 Health and Diet Survey:
Topline Frequencies (Weighted),’’ Available
at https://www.fda.gov/Food/Science
Research/ResearchAreas/ConsumerResearch/
ucm193895.htm.
2. FDA, ‘‘FDA Calls on Food Companies to
Correct Labeling Violations; FDA
Commissioner Issues an Open Letter to the
Industry,’’ FDA Press Release, Available at
https://www.fda.gov/NewsEvents/Newsroom/
E:\FR\FM\29APN1.SGM
29APN1
mstockstill on DSKH9S0YB1PROD with NOTICES
22606
Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices
PressAnnouncements/ucm202814.htm,
March 3, 2010.
3. Flegal, K.M., M.D. Carroll, C.L. Ogden,
et al.,‘‘Prevalence and Trends in Obesity
Among U.S. Adults,’’ 1999 to 2008, Journal
of the American Medical Association,
2010;303(3):235–241, Published online,
(doi:10.1001/jama.2009.2014), January 13,
2010.
4. Ogden, C.L., M.D. Carroll, L.R. Curtin, et
al., ‘‘Prevalence of High Body Mass Index in
U.S. Children and Adolescents,’’ 2007 to
2008, Journal of the American Medical
Association, 2010;303(3):242–249, Published
online (doi:10.1001/jama.2009.2012), January
13, 2010.
5. Let’s Move, Available at https://
letsmove.gov/.
6. Smart Choices Program, Available at
https://www.smartchoicesprogram.com/.
7. Kellogg Co., ‘‘Nutrition at a Glance,’’
Available at https://www.kelloggs
nutrition.com/learn-about-labels/nutritionat-a-glance.html.
8. Food Standards Agency, ‘‘Traffic Light
Labeling,’’ Available at https://www.eatwell.
gov.uk/foodlabels/trafficlights/.
9. Livsmedelsverket, National Food
Administration, ‘‘The Keyhole Symbol,’’
Available at https://www.slv.se/en-gb/Group1/
Food-and-Nutrition/Keyhole-symbol/.
10. Hannaford, ‘‘What is Guiding Stars?,’’
Available at https://www.hannaford.com/
Contents/Healthy_Living/Guiding_Stars/
index.shtml?lid=mb.
11. U.S. Department of Health and Human
Services and U.S. Department of Agriculture,
‘‘Dietary Guidelines for Americans, 2005,’’
6th ed., Washington, DC, U.S. Government
Printing Office, January 2005, Available at
https://www.health.gov/dietaryguidelines/
dga2005/document/.
12. FDA, ‘‘Food Labeling: Use of Symbols
to Communicate Nutrition Information,
Consideration of Consumer Studies and
Nutritional Criteria; Public Hearing; Request
for Comments,’’ (72 FR 39815, July 20, 2007),
Available at https://edocket.access.gpo.gov/
2007/pdf/E7-14046.pdf.
13. FDA, ‘‘Comments on Symbols Public
Hearing and Current Plans for Addressing
Issues,’’ Available at https://
www.regulations.gov/search/Regs/home.
html#documentDetail?R=09000064809623e8,
April 21, 2009.
14. FDA, ‘‘Agency Information Collection
Activities; Proposed Collection; Comment
Request; Experimental Study of Nutrition
Symbols on Food Packages,’’ (74 FR 26244,
June 1, 2009), Available at https://
edocket.access.gpo.gov/2009/E9-12669.htm.
15. FDA, ‘‘Agency Information Collection
Activities; Proposed Collection; Comment
Request; Experimental Studies of Nutrition
Symbols on Food Packages,’’ (74 FR 62786,
December 1, 2009), Available at https://
edocket.access.gpo.gov/2009/E9-28699.htm.
16. Sutherland, L.A., L.A. Kaley, and L.
Fischer, ‘‘Guiding Stars: The Effect of a
Nutrition Navigation Program on Consumer
Purchases at the Supermarket,’’ American
Journal of Clinical Nutrition, Available at
https://www.ajcn.org/cgi/content/abstract/
ajcn.2010.28450Cv1, February 10, 2010.
17. Malam, S., S. Clegg, S. Kirwin, et al.,
‘‘Comprehension and Use of UK Nutrition
VerDate Mar<15>2010
16:19 Apr 28, 2010
Jkt 220001
Signpost Labelling Schemes,’’ British Market
Research Bureau, Available at https://
www.food.gov.uk/multimedia/pdfs/
pmpreport.pdf, 2009.
18. Kelly, B., C. Hughes, K. Chapman, et
al., ‘‘Consumer Testing of the Acceptability
and Effectiveness of Front-of-Pack Food
Labelling Systems for the Australian Grocery
Market,’’ Health Promotion International,
24(2): 120–9, 2009.
19. Borgmeier I., and J. Westenhoefer,
‘‘Impact of Different Food Label Formats on
Healthiness Evaluation and Food Choice of
Consumers: A Randomized-Controlled
Study,’’ BMC Public Health, 9: 184, 2009.
20. Feunekes, G.I., I.A. Gortemaker, A.A.
Willems, et al., ‘‘Front-of-Pack nutrition
Labelling: Testing Effectiveness of Different
Nutrition Labelling Formats Front-of-Pack in
Four European Countries,’’ Appetite, 50(1):
57–70, 2008.
21. Which?, ‘‘Healthy Signs?,’’ Campaign
Report, London, United Kingdom, Available
at https://www.which.co.uk/documents/pdf/
healthy-signs--which---campaign-report-176909.pdf, 2006.
22. Food Standards Agency, Quantitative
Evaluation of Alternative Food Signposting
Concepts: Report of Findings, London,
United Kingdom, Available at https://
www.food.gov.uk/multimedia/pdfs/signpost
quanresearch.pdf, 2005.
23. Young, L., and B. Swinburn, ‘‘Impact of
the Pick the Tick Food Information
Programme on the Salt Content of Food in
New Zealand,’’ Health Promotion
International 17(1): 13–9, 2002.
24. Scott, V. and A.F. Worsley, ‘‘Ticks,
Claims, Tables and Food Groups: A
Comparison for Nutrition Labelling,’’ Health
Promotion International, 9(1): 27–37, 1994.
25. General Mills, ‘‘Nutrition Highlights,’’
Available at https://www.generalmills.com/
corporate/health_wellness/nutrition_
highlights.aspx.
26. American Heart Association, ‘‘HeartCheck Mark,’’ Available at https://
www.americanheart.org/presenter.
jhtml?identifier=2115.
Dated: April 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–9939 Filed 4–26–10; 11:15 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory General Medical
Sciences Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
General Medical Sciences Council.
Date: May 20–21, 2010.
Closed: May 20, 2010, 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Conference Rooms E1 &
E2, 45 Center Drive, Bethesda, MD 20892.
Open: May 21, 2010, 8:30 a.m. to
Adjournment.
Agenda: For the discussion of program
policies and issues, opening remarks, report
of the Director, NIGMS, and other business
of the Council.
Place: National Institutes of Health,
Natcher Building, Conference Rooms E1 &
E2, 45 Center Drive, Bethesda, MD 20892.
Contact Person: Ann A. Hagan, PhD,
Associate Director for Extramural Activities,
NIGMS, NIH, DHHS, 45 Center Drive, Room
2AN24H, MSC6200, Bethesda, MD 20892–
6200, (301) 594–4499,
hagana@nigms.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.nigms.nih.gov/about/
advisory_council.html, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
E:\FR\FM\29APN1.SGM
29APN1
Agencies
[Federal Register Volume 75, Number 82 (Thursday, April 29, 2010)]
[Notices]
[Pages 22602-22606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9939]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0210]
Front-of-Pack and Shelf Tag Nutrition Symbols; Establishment of
Docket; Request for Comments and Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of docket; request for comments and
information.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a docket to obtain data and other information that
will inform the agency's deliberations about ways to enhance the
usefulness to consumers of point-of-purchase nutrition information,
such as information on the principal display panel of food products
(``front-of-pack'' labeling) or on shelf tags in retail stores. In
particular, FDA is interested in the following: Data and information on
the extent to which consumers notice, use, and understand nutrition
symbols on front-of-pack labeling of food packages or on shelf tags in
retail stores; research assessing and comparing the effectiveness of
particular possible approaches to front-
[[Page 22603]]
of-pack labeling; graphic design, marketing, and advertising data and
information that can inform and guide the development of better point-
of-purchase nutrition information; and the extent to which point-of-
purchase nutrition information may affect decisions by food
manufacturers to reformulate products. The goal of this front-of-pack
nutrition labeling effort is to maximize the number of consumers who
readily notice, understand, and use point-of-purchase information to
make more nutritious choices for themselves and their families. FDA is
establishing this docket in order to provide an opportunity for
interested parties to provide data and information and share views that
will inform future agency actions with respect to these matters.
DATES: Submit electronic or written comments by July 28, 2010.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Chung-Tung Jordan Lin, Center for Food
Safety and Applied Nutrition (HFS-020), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1831.
SUPPLEMENTARY INFORMATION:
I. Background
The Nutrition Labeling and Education Act of 1990 (NLEA) (Public Law
101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) to
require nutrition labeling on packaged foods and to provide for the use
of nutrient content claims and health claims in food labeling. The
purpose of these amendments was to enable consumers to make more
informed and healthier food choices in the context of their daily diet.
In 1993, FDA established regulations that implemented NLEA. Among those
regulations, FDA set forth general principles for nutrient content
claims (21 CFR 101.13), which are claims that characterize the level of
a nutrient in a food (e.g., ``low fat,'' ``good source of fiber'') and
for health claims, which are claims that characterize the relationship
of a food substance to a disease or health-related condition (e.g.,
``calcium may reduce the risk of osteoporosis''). The cornerstone of
the NLEA is the requirement that packaged foods bear product-specific
information on serving size, calories, and nutrient content (21 CFR
101.2(b) and (d)). For conventional foods, this information is provided
in a Nutrition Facts box on the package label. FDA's final regulations
establishing nutrition labeling were published in 1993 (58 FR 2079,
January 6, 1993).
An important goal of NLEA was to make available to consumers
nutrition information that can assist them in selecting foods that
contribute to healthier diets. Research conducted by FDA and others
shows that many consumers use the Nutrition Facts box in their food
choices (Ref. 1). Yet, as Margaret A. Hamburg, the Commissioner of Food
and Drugs, noted recently, ``Today, ready access to reliable
information about the calorie and nutrient content of foods is even
more important, given the prevalence of obesity and diet-related
diseases in the United States'' (Ref. 2). Data published by the U.S.
Centers for Disease Control and Prevention (CDC) indicate that 68
percent of the U.S. adult population is overweight or obese (Ref. 3),
and among children 2 to 19 years old, nearly 32 percent were at or
above the 85th percentile for body-mass index on CDC's 2000 age- and
sex-specific growth charts, which are based primarily on data from the
1960s and 1970s (Ref. 4). Body mass index (BMI) is a weight-to-height
ratio. High BMI among children and adults is a significant public
health concern in the United States. Children with high BMI often
become obese adults, and obese adults are at risk for many chronic
conditions such as diabetes, cardiovascular disease, and certain
cancers. Healthy eating must be incorporated into the habits and diets
of children to promote healthy lifelong practices to prevent obesity
and chronic disease. First Lady Michelle Obama recently announced a
coordinated national campaign to reduce the prevalence of overweight
and obesity in the United States particularly among children (Ref. 5).
The prevalence of diet-related diseases in the U.S. population and
the need to accommodate Americans' increasingly busy lifestyles and
demand for quick and nutritious food choices illustrate the importance
of tailoring nutrition information to help consumers. FDA and others in
the public health community, as well as consumer and industry groups,
are actively exploring ways to improve the usefulness of food labeling
to consumers.
A number of U.S. food processors and retailers are now
incorporating nutrition symbols and other nutrition-related
representations on food packages, particularly symbols intended to
denote nutritional quality of a food (e.g., the Smart Choices checkmark
(Ref. 6)), selected nutrient level disclosures (e.g., Kellogg's
Nutrition at a Glance (Ref. 7)), and nutrient content claims. Because
this information is usually placed on the principal display panels
(PDPs) of food packages, it is commonly referred to as front-of-pack
(FOP) labeling, and we use that term as a synonym for principal display
panel in this document.\1\ Nutrition symbol schemes have also been used
in other countries, including the United Kingdom (Ref. 8) and Sweden
(Ref. 9). In addition, some retailers have been adding nutrition
symbols on the shelf tags of foods sold in the store to provide
information about the overall nutritional quality of the food (e.g.,
Guiding Stars (Ref. 10)) or the levels of selected nutrients it
contains.
---------------------------------------------------------------------------
\1\ Under 21 CFR 101.1, the PDP of a food in package form is
defined as the part of the label ``that is most likely to be
displayed * * * or examined under customary conditions of display
for retail sale.'' It is usually, but not always, on the front of
the food package.
---------------------------------------------------------------------------
FDA and the U.S. Department of Agriculture are working with public
and private stakeholders to develop a voluntary FOP nutrition label
that is driven by sound nutrition criteria, consumer research, and
design expertise. Research should be designed to support the choice of
an FOP label that will achieve the goal and satisfy the criteria for
success outlined in the following paragraphs.
The goal of an FOP nutrition label is to increase the proportion of
consumers who readily notice, understand, and use the available
information to make more nutritious choices for themselves and their
families, and thereby prevent or reduce obesity and other diet-related
chronic disease. FDA believes that information in front-of-pack
labeling can be useful to supplement the information in the Nutrition
Facts box. In addition, because of its prominent location, front-of-
pack labeling may provide a more convenient and effective information
tool for consumers seeking quick and accurate information about the
nutritional quality of the food they are purchasing and accessing, and
using this information may serve to educate consumers and to help them
make healthier food choices. It is also possible that information
disclosed in front-of-pack labeling may foster industry reformulation
of products because some consumers may notice the information and make
their product selection accordingly. Through these mechanisms of
improved consumer understanding and use of nutrition information and
product reformulation, it is possible that a well-designed and science-
based front-of-pack nutrition labeling program could bring about
significant positive
[[Page 22604]]
changes in Americans' diet and play a role in lowering the incidence
and prevalence of diet-related disease in the United States.
To be successful in achieving this goal, a front-of-pack label
should be:
Based on standardized nutrition criteria that are grounded
in the Dietary Guidelines for Americans (Ref. 11), which provides
science-based advice to promote health and reduce the risk of chronic
disease;
Widely adopted by food retailers and manufacturers;
In a standardized format consumers can readily notice,
understand, and use;
Designed to enable consumers with a wide range of
literacy, educational levels, age, and other characteristics to compare
the relative healthiness of products within and across food categories
in the context of routine food shopping.
FDA has already begun developing a scientific foundation for
decisionmaking on nutrition symbols and front-of-pack labeling. The
agency held a public hearing in September 2007 (Ref. 12) and completed
a focus group study in April 2008 to obtain comments and information
about consumer issues related to the use of nutrition symbols on front-
of-pack labeling and shelf tags. The public hearing notice requested
comments on a number of consumer research questions, including consumer
attitudes about nutrition symbols, how consumers interpret such
symbols, how the presence of multiple and different symbols on products
in the same food category and across categories affects consumer
perceptions, how nutrition symbols interact with the Nutrition Facts
box, and whether such symbols affect consumers' ability to make good
dietary choices. On April 21, 2009, FDA released a document entitled
``Comments on Symbols Public Hearing and Current Plans for Addressing
Issues'' (Ref. 13). This document describes the questions FDA requested
comments on in the public hearing notice, the comments that FDA
received at the public hearing and that were submitted to the public
docket for the hearing, FDA's remarks on the comments received, and
FDA's current plans for evaluating issues regarding the use of
nutrition symbols in food labeling.
Although the public hearing generated some useful information on
consumer issues related to nutrition symbols, very limited data and
research were submitted to the agency. To fill remaining gaps in our
knowledge base, in addition to opening this docket, FDA has designed
and begun to implement a plan to conduct consumer research on nutrition
symbols (Refs. 14 and 15). Currently, FDA is conducting two
experimental studies to help enhance the agency's knowledge about
consumer understanding and use of a selected sample of nutrition symbol
schemes currently in use in the domestic market, and to examine whether
those schemes or certain others are better ways to impart useful
nutrition information to U.S. consumers.
In addition, FDA believes the food industry has acquired extensive
market experience with consumer reaction to nutrition symbols since
2005, when the voluntary use of nutrition symbols in food labeling
began to proliferate in the U.S. market. FDA also is aware that many
foreign governments, industry groups, food manufacturers, consumer
advocacy groups, and academic researchers have conducted or are
conducting consumer research on nutrition symbols. Although some of
this research is publicly available (see Refs. 16 through 24), most of
it remains unpublished and unavailable to the agency. Because there are
limitations to the currently available published literature, we are
particularly interested in obtaining access to unpublished research.
For example, we are interested in research on a much wider range of
nutrition symbol schemes than has been examined in the literature. In
addition, studies seldom compare consumer responses to different symbol
schemes. Finally, most of the publicly available research was done in
European or other countries whose labeling requirements and regulatory
framework are quite different from those in the United States. As a
result, it is unclear whether and to what extent such findings derived
from these studies are applicable to the U.S. market.
In addition to developing the scientific foundation for agency
decisionmaking with respect to nutrition symbols and other front-of-
pack labeling information, FDA is considering a number of other efforts
to help guide food manufacturers in their use of front-of-pack
labeling, such as issuance of a draft guidance on voluntary calorie
declarations and a draft guidance and/or a proposed rule on dietary
guidance statements.
II. Request for Comments and Information
FDA is interested in a range of data and information relevant to
the use of front-of-pack nutrition symbol schemes on food packages or
shelf tags, to include research concerning:
Consumer perception and consumer behavior;
The assessment and comparison of the effectiveness of
particular possible approaches to front-of-pack labeling;
Graphic design, package design, information architecture,
advertising, marketing, and human factors that affect noticeability,
understandability and use; and
The extent to which point-of-purchase nutrition
information may affect decisions by food manufacturers to reformulate
products.
These data and other information will be used to inform the
agency's deliberations about approaches to enhancing the usefulness to
consumers of point-of-purchase nutrition information, such as
information on the front-of-pack or on shelf tags in retail stores, and
to fostering decisions by food manufacturers to reformulate products.
FDA solicits comment, data, and information from all interested
parties, domestic and foreign, including consumers, industry, graphic
designers, package designers, marketing experts, the nutrition
community, and others with specific expertise in nutrition and in
conveying scientific information to ordinary citizens. FDA is
particularly interested in the following topics:
Design Considerations
1. Design features from labels used in the United States or in
other countries that are viewed as superior in ensuring consumer
attention, understanding and use, i.e., features that attract
attention, make it easier for consumers to understand how foods with a
nutrition symbol fit into a healthy diet, enhance the credibility of
the symbol, and encourage use of the symbol in purchase decisions.
Examples of such features could include:
Color;
Location;
Contrast.
2. The risk of ``too much clutter'' on the label. For example:
The point at which a format is sufficiently ``overpacked''
to put off consumers;
How many nutrients can be included in a nutrient-specific
approach without creating information overload or putting off
consumers;
An easy-to-understand range (e.g., on a scale of 0 to 3 or
1 to 5) for use in ranking the overall nutritional value of a food; and
Whether a certain amount of blank space is needed around
FOP nutrition symbols to maximize the chances that consumers will
notice and comprehend them.
[[Page 22605]]
3. Whether certain shapes (such as stars or checks) have inherent
meaning.
4. The size of an FOP symbol relative to the rest of the package.
5. Factors that influence ease of comprehension (e.g., whether a
symbol scheme is easy enough for consumers to understand at a glance (3
seconds or less) in a crowded grocery store), particularly in terms of:
The amount of information;
The words (e.g., sodium versus salt; the term ``daily
value''); or
6. Whether a uniform FOP symbol across product categories helps
consumer recognition, understanding, trust and use of the symbol.
B. Consumer Use and Understanding
7. Consumer attitudes toward nutrition symbols in general;
8. Consumer attitudes toward different types of symbols, e.g.:
FOP vs. shelf tag;
Nutrient-specific symbol (such as General Mills' nutrition
highlights) (Ref. 25) vs. a summary symbol (such as Smart Choices (Ref.
6)); and
Symbols with and without an explicit endorsement from a
third party such as the American Heart Association (e.g., the Heart-
Check Mark (Ref. 26));
9. Consumer attitudes toward products or brands that carry a
nutrition symbol compared to:
Other products or brands in the same product category
(e.g., breakfast cereals) that do not carry a nutrition symbol; and
Products or brands in other categories that do not carry
such a symbol.
10. Consumer interpretations of symbol-carrying products or brands
in terms of:
Their overall healthfulness and quality;
Specific health benefits;
Featured nutrition attributes;
Non-featured nutrition attributes; and
Any other non-nutrition attributes.
11. Consumer perception of and reaction to the presence of multiple
and different nutrition symbols on the FOP or shelf tags of different
brands in a given product category (e.g., breakfast cereals);
12. Consumer interpretation of the co-existence on the food label
of symbols and other nutrition messages (e.g., a nutrient content
claim);
13. Consumer interpretation of the co-existence on the food label
of nutrition symbols and quantitative nutrition information (e.g., the
Nutrition Facts box);
14. Consumer interpretation of the co-existence of FOP nutrition
symbols and nutrition symbols on shelf tags;
15. The extent to which consumers notice nutrition symbols;
16. When consumers use nutrition symbols and the purposes for which
consumers use nutrition symbols, under time, pressure, and otherwise;
17. Whether and to what extent nutrition symbols on food labels and
shelf tags direct consumers toward purchasing brands or foods that bear
them and, if so, whether the shift in purchase is accompanied with a
displacement of purchase of other brands or foods;
18. Whether symbols affect the nutritional quality of the overall
diet of consumers who use the symbols and, if so, to what extent;
19. The differences, if any, in consumer response to nutrition
symbols when all products in a given category carry symbols, compared
to when only some products in the category carry symbols;
20. The differences, if any, in consumer response to nutrition
symbols among various demographic subgroups, such as subgroups
differentiated by:
Level of education;
Interest in or concern about nutrition or health;
Age;
Race;
Role as shopper (e.g., primary shoppers for the household
vs. other consumers); and
Income.
21. The differences, if any, in consumer response to nutrition
symbols in the labeling of various product categories, such as:
Snacks;
Meals;
Dairy products; and
Vegetables and fruits.
22. Evidence, if any, that use of symbols helps:
Reduce time needed for product selection;
Improve nutritional quality of choices; or
Both.
23. Consumer perceptions when there are multiple health messages or
nutrition symbols (e.g., some related to nutrition and others related
to organoleptic or process attributes) on a given package.
In addition to comments submitted in response to this document, FDA
will consider those previously submitted to the agency for the
following Federal Register documents and dockets.
``Food Labeling; Use of Symbols to Communicate Nutrition
Information, Consideration of Consumer Studies and Nutritional
Criteria; Public Hearing; Request for Comments'' (72 FR 39815, July 20,
2007) (Docket No. 2007-N-0198, formerly Docket No. 2007N-0277);
``Agency Information Collection Activities; Proposed
Collection; Comment Request; Experimental Study of Nutrition Symbols on
Food Packages'' (74 FR 26244, June 1, 2009) (Docket No. FDA-2009-N-
0220); and
``Agency Information Collection Activities; Proposed
Collection; Comment Request; Experimental Studies of Nutrition Symbols
on Food Packages'' (74 FR 62786, December 1, 2009) (Docket No. FDA-
2009-N-0220).
Data and information submitted to these previous dockets do not
need to be resubmitted.
III. Submission of Comments and Information
FDA has established a public docket to provide an opportunity for
interested parties to submit consumer research and design information
to inform the development of a government-sponsored nutrition symbol
program to help consumers make informed dietary choices and to provide
the food industry incentives to make more nutritious food products
available.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. References
FDA has placed the following references 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 FDA is not responsible for any
subsequent changes to Web sites after this document publishes in the
Federal Register.)
1. FDA, ``2008 Health and Diet Survey: Topline Frequencies
(Weighted),'' Available at https://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/ucm193895.htm.
2. FDA, ``FDA Calls on Food Companies to Correct Labeling
Violations; FDA Commissioner Issues an Open Letter to the
Industry,'' FDA Press Release, Available at https://www.fda.gov/
NewsEvents/Newsroom/
[[Page 22606]]
PressAnnouncements/ucm202814.htm, March 3, 2010.
3. Flegal, K.M., M.D. Carroll, C.L. Ogden, et al.,``Prevalence
and Trends in Obesity Among U.S. Adults,'' 1999 to 2008, Journal of
the American Medical Association, 2010;303(3):235-241, Published
online, (doi:10.1001/jama.2009.2014), January 13, 2010.
4. Ogden, C.L., M.D. Carroll, L.R. Curtin, et al., ``Prevalence
of High Body Mass Index in U.S. Children and Adolescents,'' 2007 to
2008, Journal of the American Medical Association, 2010;303(3):242-
249, Published online (doi:10.1001/jama.2009.2012), January 13,
2010.
5. Let's Move, Available at https://letsmove.gov/.
6. Smart Choices Program, Available at https://www.smartchoicesprogram.com/.
7. Kellogg Co., ``Nutrition at a Glance,'' Available at https://www.kelloggsnutrition.com/learn-about-labels/nutrition-at-a-glance.html.
8. Food Standards Agency, ``Traffic Light Labeling,'' Available
at https://www.eatwell.gov.uk/foodlabels/trafficlights/.
9. Livsmedelsverket, National Food Administration, ``The Keyhole
Symbol,'' Available at https://www.slv.se/en-gb/Group1/Food-and-Nutrition/Keyhole-symbol/.
10. Hannaford, ``What is Guiding Stars?,'' Available at https://www.hannaford.com/Contents/Healthy_Living/Guiding_Stars/index.shtml?lid=mb.
11. U.S. Department of Health and Human Services and U.S.
Department of Agriculture, ``Dietary Guidelines for Americans,
2005,'' 6th ed., Washington, DC, U.S. Government Printing Office,
January 2005, Available at https://www.health.gov/dietaryguidelines/dga2005/document/.
12. FDA, ``Food Labeling: Use of Symbols to Communicate
Nutrition Information, Consideration of Consumer Studies and
Nutritional Criteria; Public Hearing; Request for Comments,'' (72 FR
39815, July 20, 2007), Available at https://edocket.access.gpo.gov/2007/pdf/E7-14046.pdf.
13. FDA, ``Comments on Symbols Public Hearing and Current Plans
for Addressing Issues,'' Available at https://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809623e8, April 21,
2009.
14. FDA, ``Agency Information Collection Activities; Proposed
Collection; Comment Request; Experimental Study of Nutrition Symbols
on Food Packages,'' (74 FR 26244, June 1, 2009), Available at https://edocket.access.gpo.gov/2009/E9-12669.htm.
15. FDA, ``Agency Information Collection Activities; Proposed
Collection; Comment Request; Experimental Studies of Nutrition
Symbols on Food Packages,'' (74 FR 62786, December 1, 2009),
Available at https://edocket.access.gpo.gov/2009/E9-28699.htm.
16. Sutherland, L.A., L.A. Kaley, and L. Fischer, ``Guiding
Stars: The Effect of a Nutrition Navigation Program on Consumer
Purchases at the Supermarket,'' American Journal of Clinical
Nutrition, Available at https://www.ajcn.org/cgi/content/abstract/ajcn.2010.28450Cv1, February 10, 2010.
17. Malam, S., S. Clegg, S. Kirwin, et al., ``Comprehension and
Use of UK Nutrition Signpost Labelling Schemes,'' British Market
Research Bureau, Available at https://www.food.gov.uk/multimedia/pdfs/pmpreport.pdf, 2009.
18. Kelly, B., C. Hughes, K. Chapman, et al., ``Consumer Testing
of the Acceptability and Effectiveness of Front-of-Pack Food
Labelling Systems for the Australian Grocery Market,'' Health
Promotion International, 24(2): 120-9, 2009.
19. Borgmeier I., and J. Westenhoefer, ``Impact of Different
Food Label Formats on Healthiness Evaluation and Food Choice of
Consumers: A Randomized-Controlled Study,'' BMC Public Health, 9:
184, 2009.
20. Feunekes, G.I., I.A. Gortemaker, A.A. Willems, et al.,
``Front-of-Pack nutrition Labelling: Testing Effectiveness of
Different Nutrition Labelling Formats Front-of-Pack in Four European
Countries,'' Appetite, 50(1): 57-70, 2008.
21. Which?, ``Healthy Signs?,'' Campaign Report, London, United
Kingdom, Available at https://www.which.co.uk/documents/pdf/healthy-
signs_which_-campaign-report_176909.pdf, 2006.
22. Food Standards Agency, Quantitative Evaluation of
Alternative Food Signposting Concepts: Report of Findings, London,
United Kingdom, Available at https://www.food.gov.uk/multimedia/pdfs/signpostquanresearch.pdf, 2005.
23. Young, L., and B. Swinburn, ``Impact of the Pick the Tick
Food Information Programme on the Salt Content of Food in New
Zealand,'' Health Promotion International 17(1): 13-9, 2002.
24. Scott, V. and A.F. Worsley, ``Ticks, Claims, Tables and Food
Groups: A Comparison for Nutrition Labelling,'' Health Promotion
International, 9(1): 27-37, 1994.
25. General Mills, ``Nutrition Highlights,'' Available at https://www.generalmills.com/corporate/health_wellness/nutrition_highlights.aspx.
26. American Heart Association, ``Heart-Check Mark,'' Available
at https://www.americanheart.org/presenter.jhtml?identifier=2115.
Dated: April 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9939 Filed 4-26-10; 11:15 am]
BILLING CODE 4160-01-S