[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