[Federal Register Volume 75, Number 82 (Thursday, April 29, 2010)]
[Notices]
[Pages 22602-22606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9939]


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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.

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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 http://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.
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    \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.
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    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 http://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 http://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 http://letsmove.gov/.
    6. Smart Choices Program, Available at http://www.smartchoicesprogram.com/.
    7. Kellogg Co., ``Nutrition at a Glance,'' Available at http://www.kelloggsnutrition.com/learn-about-labels/nutrition-at-a-glance.html.
    8. Food Standards Agency, ``Traffic Light Labeling,'' Available 
at http://www.eatwell.gov.uk/foodlabels/trafficlights/.
    9. Livsmedelsverket, National Food Administration, ``The Keyhole 
Symbol,'' Available at http://www.slv.se/en-gb/Group1/Food-and-Nutrition/Keyhole-symbol/.
    10. Hannaford, ``What is Guiding Stars?,'' Available at http://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 http://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 http://edocket.access.gpo.gov/2007/pdf/E7-14046.pdf.
    13. FDA, ``Comments on Symbols Public Hearing and Current Plans 
for Addressing Issues,'' Available at http://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 http://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 http://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 http://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 http://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 http://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 http://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 http://www.generalmills.com/corporate/health_wellness/nutrition_highlights.aspx.
    26. American Heart Association, ``Heart-Check Mark,'' Available 
at http://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