GUIDE TO NUTRITION LABELING AND EDUCATION ACT [NLEA] REQUIREMENTS FDAThe Nutrition Labeling and Education Act of 1990 [NLEA] provides FDA with specific authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims [i.e., 'high fiber', 'low fat', etc.] and health claims be consistent with agency regulations. Regulations implementing the NLEA labeling provisions issued on January 6, 1993, with technical amendments published on August 18, 1993.The regulations became effective for health claims, ingredient declarations, and percent juice labeling on May 8, 1993 [percent juice labeling was subsequently exempted until May 8, 1994]. The regulations for nutrition labeling and other provisions became effective on May 8, 1994. However, by an Act of Congress, these provisions do not apply to certain products until after August 8, 1994.//www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074948.htm
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Submit electronic comments to //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.
Start Further Info
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.
End Further Info End Preamble
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 [ and ]. 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.
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 Start Printed 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.Start Printed 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 //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 //www.fda.gov/NewsEvents/Newsroom/Start Printed 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 //letsmove.gov/.
6. Smart Choices Program, Available at //www.smartchoicesprogram.com/.
7. Kellogg Co., “Nutrition at a Glance,” Available at //www.kelloggsnutrition.com/learn-about-labels/nutrition-at-a-glance.html.
8. Food Standards Agency, “Traffic Light Labeling,” Available at //www.eatwell.gov.uk/foodlabels/trafficlights/.
9. Livsmedelsverket, National Food Administration, “The Keyhole Symbol,” Available at //www.slv.se/en-gb/Group1/Food-and-Nutrition/Keyhole-symbol/.
10. Hannaford, “What is Guiding Stars?,” Available at //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 //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 //edocket.access.gpo.gov/2007/pdf/E7-14046.pdf.
13. FDA, “Comments on Symbols Public Hearing and Current Plans for Addressing Issues,” Available at , 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 //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 //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 //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 //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 //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 //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 //www.generalmills.com/corporate/health_wellness/nutrition_highlights.aspx.
26. American Heart Association, “Heart-Check Mark,” Available at //www.americanheart.org/presenter.jhtml?identifier=2115.