1

Introduction

Over the past decade, tremendous growth has occurred in the use of nutrition rating systems and symbols designed to summarize the key nutritional aspects and characteristics of food products. These symbols and the systems that underlie them have become known as front-of-package (FOP) nutrition rating systems, even though the symbols or ratings themselves can be found anywhere on the front of a food package or on a retail shelf tag. The systems are part of a constellation of efforts targeted at encouraging healthier consumer food choices. However, the proliferation of various FOP systems with different nutrition criteria by manufacturers, retailers, health organizations, and others with the intention of helping consumers make healthier choices, or of enhancing marketing/sales, along with other packaging attributes, may have contributed to consumer confusion. In addition, despite this proliferation of FOP systems, there is little evidence to indicate that they have contributed positively to consumer food choices or purchase behaviors.

The Nutrition Labeling and Education Act of 1990 (NLEA) requires that manufacturers of most packaged food products regulated by the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services disclose certain nutrition information on a standardized nutrition label, the Nutrition Facts panel (NFP), usually on the back or side of the package. The NLEA does not apply to meat and poultry products regulated by the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), but parallel regulations, to the extent possible, exist for these products (see Chapter 3).

Although inconsistent in format, content, and criteria, current FOP systems and symbols have the potential to provide useful guidance to consumers as well as to maximize their effectiveness in reaching consumers. Consequently, FDA and USDA have undertaken consumer research to identify an FOP nutrition label that is “driven by sound nutrition criteria, consumer research, and design expertise.”1 Their stated goal for an FOP system 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.”

In fiscal year (FY) 2009 Congress directed the Centers for Disease Control and Prevention (CDC) to undertake a study with the Institute of Medicine (IOM) to examine and provide recommendations regarding FOP nutrition

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175 FR 22602.



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1 Introduction Over the past decade, tremendous growth has occurred in the use of nutrition rating systems and symbols designed to summarize the key nutritional aspects and characteristics of food products. These symbols and the systems that underlie them have become known as front-of-package (FOP) nutrition rating systems, even though the symbols or ratings themselves can be found anywhere on the front of a food package or on a retail shelf tag. The systems are part of a constellation of efforts targeted at encouraging healthier consumer food choices. However, the proliferation of various FOP systems with different nutrition criteria by manufacturers, retailers, health organizations, and others with the intention of helping consumers make healthier choices, or of enhancing marketing/sales, along with other packaging attributes, may have contributed to consumer confusion. In addition, despite this proliferation of FOP systems, there is little evidence to indicate that they have contributed positively to consumer food choices or purchase behaviors. The Nutrition Labeling and Education Act of 1990 (NLEA) requires that manufacturers of most packaged food products regulated by the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services disclose certain nutrition information on a standardized nutrition label, the Nutrition Facts panel (NFP), usually on the back or side of the package. The NLEA does not apply to meat and poultry products regulated by the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), but parallel regulations, to the extent possible, exist for these products (see Chapter 3). Although inconsistent in format, content, and criteria, current FOP systems and symbols have the potential to provide useful guidance to consumers as well as to maximize their effectiveness in reaching consumers. Con - sequently, FDA and USDA have undertaken consumer research to identify an FOP nutrition label that is “driven by sound nutrition criteria, consumer research, and design expertise.” 1 Their stated goal for an FOP system 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.” In fiscal year (FY) 2009 Congress directed the Centers for Disease Control and Prevention (CDC) to undertake a study with the Institute of Medicine (IOM) to examine and provide recommendations regarding FOP nutrition 1 75 FR 22602. 9

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10 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS BOX 1-1 Statements of Task for Phase I and II The committee was charged with the following tasks: Phase I • dentify front-of-package systems being used by manufacturers, supermarkets, health organiza- I tions, and governments in the United States and abroad; • onsider the purpose and overall merits of front-label nutrition icons; C • dentify the criteria underlying the systems and evaluate their scientific basis; I • onsider advantages and disadvantages of various approaches for adults and children; and C • sing knowledge gained from its compilation and assessment of front-of-package systems, plan U the second phase (to be executed as a separate activity) that would consider the potential benefits of a single, standardized front-of-package food guidance system regulated by the Food and Drug Administration and would develop conclusions about which system(s) are most effective in promot- ing health and how to maximize the use and effectiveness of the system(s). Phase II • onsider the potential benefits of a single, standardized front-label food guidance system regulated C by the Food and Drug Administration, • ssess which icons are most effective with consumer audiences, and A • evelop conclusions about the systems/icons that best promote health and how to maximize their D use. rating systems and symbols.2 In FY 2010, Congress directed CDC to continue the study,3 for which FDA and later the USDA Center for Nutrition Policy and Promotion provided support. An ad hoc committee was convened to review systems being used in the United States and abroad and to determine advantages and disadvantages of various approaches as well as the potential benefits of a single, standard - ized, front-label food guidance system regulated by FDA. The study was conducted in two phases. Phase I focused primarily on the nutrition criteria underlying FOP systems. Phase II, the subject of this report, built on the results of Phase I while focusing on the aspects of consumer understanding and behavior related to the development of a standardized FOP system. Box 1-1 shows the statement of task for both Phases I and II. The Phase I and II committees reviewed information on packages as well as on shelf tags, and the use of the term FOP symbol systems throughout this report encompasses both methods of conveying information. In addi - tion, for the purposes of this report, the broad statement “making healthier choices” refers to consumers’ meeting guidelines of qualifying criteria for saturated and trans fats, sodium, and added sugars. The committee’s adopted definitions for common terms used throughout the report are provided in Appendix A. This chapter will review the main findings and conclusions from the Phase I report and describe the study goals and process for this report. 2Omnibus Appropriations Act, 2009. Division F—Labor, Health and Human Services and Education, and Related Agencies Appropriations Act, 2009 on Public Law No. 111-8, House Appropriations Committee Print, p. 1398. 3 Consolidated Appropriations Act, 2010. Division D—Departments of Labor, Health and Human Services, and Education, and Related Agencies. Appropriations Act, 2010 on Public Law 111-17. House Conference Report 111-366, p. 1021.

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11 INTRODUCTION SUMMARY OF PHASE I REPORT Approach to the Study For its approach to meeting the Phase I goals, the Phase I committee developed four guiding principles to assist in identifying systems and their elements most important to improving the health of the American people and the nutritional criteria that could be realistically implemented. The four guiding principles were as follows: • A well-balanced, high-quality diet consistent with the recommendations of the 2010 Dietary Guidelines for Americans is essential for the health of Americans, and FOP labeling is one tool among many geared toward helping Americans make healthy choices. Other such tools include MyPyramid,4 the NFP, and health and nutrient content claims. • FOP systems will focus on nutrients or food components that are most strongly associated with the diet- related health risks affecting the greatest number of Americans. • The information highlighted in FOP systems will be consistent with the NFP. • FOP systems will apply to as many foods as possible. The committee identified 20 systems, representative of those already in the marketplace (described in the Phase I report). These systems were grouped into three broad categories based on general characteristics: • Nutrient-specific systems display the amount per serving of selected nutrients from the NFP or use symbols based on claim criteria; • Summary indicator systems use a single symbol, icon, or score to provide summary information about the nutrient content of the product in the package; and • Food group information systems use symbols awarded to a product based on the presence of a certain food group or ingredient. Although the systems used different criteria to rate foods, their primary purpose was to provide consumers with easy-to-use information that would help them to quickly determine if a food was a healthier choice and to compare foods in a category. Findings and Conclusions from Phase I The Phase I report presented the following two findings regarding the nutrient and diet-related health concerns that FOP systems should target (Box 1-2), which strongly shaped this report: 1. Obesity, cardiovascular disease, type 2 diabetes, and certain types of cancers are the health risks affecting the greatest number of Americans that are most strongly associated with diet, and 2. Americans consume too many calories, saturated and trans fats, and added sugars; too much sodium; and too little vitamin D,5 calcium, potassium, and fiber. These findings are consistent with the two overarching concepts of the 2010 Dietary Guidelines for Americans (USDA, 2010), that is, maintaining calorie balance to achieve a healthy weight while focusing on consuming nutrient-dense foods and beverages, and informed the committee’s identification of the FOP system options, con - sideration of the potential benefits of a single, standardized FOP system, and conclusions about the systems and icons that best promote human health. 4 MyPlate replaces MyPyramid as the primary federal government food group symbol and directs consumers to the ChooseMyPlate.gov website to learn how to apply the Dietary Guidelines. 5 A subsequent IOM report, Dietary Reference Intakes for Calcium and Vitamin D (IOM, 2011), on vitamin D concluded that vitamin D intake in Americans is not deficient.

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12 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS BOX 1-2 Obesity and Diet-Related Health Concerns in America According to the National Center for Health Statistics, about two-thirds of U.S. adults and about one- third of children aged 2 through 19 years are overweight or obese (Ogden et al., 2010). Although obesity is far from a new problem in our nation, its increased prevalence over recent decades and its subsequent negative impacts on rates of chronic disease and premature death and health care costs make its reduction a national health priority for the 21st century. The prevalance of obesity, defined in adults as a body mass in- dex (BMI) greater than or equal to 30, doubled between the 1976-1980 and the 1999-2000 National Health and Nutrition Examination Surveys (NCHS, 2010). Only recently has the rate of obesity in adults leveled off, albeit at record high levels. The rates of overweight (BMI of 25.0-29.9) have remained fairly constant over the past 30 years, but the increased rates of those classified as obese, and the shift of those classified as healthy to overweight, has resulted in Americans weighing much more than they did in the 1960s (NCHS, 2010). Childhood obesity, defined as a BMI at or above the sex- and age-specific 95th percentile cut points from the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts, has also recently leveled off after several decades of increase, but again at record high levels. These alarming trends have given rise to a major, national public health campaign to reduce obesity rates over the next decade. Obesity and overweight increase the risk for premature death and a host of comorbidities. Comorbidi- ties include coronary heart disease (CHD) and stroke, type 2 diabetes, metabolic syndrome, certain types of cancer, sleep apnea, osteoarthritis, gallbladder disease, fatty liver disease, and pregnancy complica- tions (NIH, 2004). In 2006 three of the most prevalent comorbidities, heart disease, stroke, and diabetes, together accounted for approximately 34 percent of age-related deaths (NCHS, 2010). Additionally, in a prospectively studied cohort of U.S. adults, Calle et al. (2003) estimated that 14 percent and 20 percent of cancer deaths among men and women, respectively, were due to overweight and obesity. It has been estimated that $169 billion in annual medical savings could potentially be saved if overweight and obesity problems were eliminated in the United States, and even modest caloric reductions (100 calories per day) across the population could save as much as $58 billion in medical costs (Dall et al., 2009). The committee reached the following conclusions regarding the nutrition science underlying its review of FOP systems: 1. FOP rating systems and symbols would be best geared toward the general population. 2. Consistent with FDA’s goals and purposes for FOP systems announced in April 2010, the most useful primary purpose of FOP rating systems would be to help consumers identify and select foods by providing information about the nutrients most strongly linked to public health concerns for Americans. 3. Regardless of system type, it would be useful to prominently declare calorie and serving size information with FOP symbols. 4. The most critical nutritional components to include in FOP nutrition rating systems are calories, saturated fat and trans fats, and sodium. 5. There is insufficient evidence at this time to suggest that inclusion of the following nutrients in all types of FOP systems would be useful: total fat, cholesterol, total carbohydrate, total or added sugars, protein, fiber, vitamins, and minerals other than sodium. 6. Several options exist for setting criteria for two types of rating systems (nutrient-specific information and a summary indicator based on nutrient thresholds), but further testing of consumer use and understanding is required to assess their overall viability.

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13 INTRODUCTION The committee’s decision to not include positive nutrients in FOP systems was based on several reasons includ- ing (1) the lack of an identified critical public health need, (2) concerns about over-fortification, (3) limited space for FOP symbols on food packages, and (4) the use of nutrient content claims (e.g., good source of calcium) to call attention to specific products. Lastly, vitamins, minerals, and fiber, for which there is a public health need to increase intake, tend to be food-category specific (e.g., calcium in dairy products and fiber in legumes and whole grains), which complicates the development of nutritional criteria. STATEMENT OF TASK AND GUIDING PRICIPLES FOR PHASE II The second phase of Examination of Front-of-Package Nutrition Rating Systems and Symbols draws on the work completed in the first phase and considers the potential benefits of a single, standardized FOP symbol system regulated by the FDA. For this second phase of the study, the CDC, with additional support from the FDA and the Center for Nutrition Policy and Promotion (CNPP) of the USDA, requested the IOM Phase II committee to: • Consider the potential benefits of a single, standardized front-label food guidance system regulated by the FDA, • Assess which icons are most effective with consumer audiences, and • Develop conclusions about the systems and icons that best promote health and how to maximize their use. APPROACH TO THE PHASE II TASK Using the Phase I guiding principles, findings, and conclusions as a baseline, the committee turned its focus to assessment of consumer use and understanding of FOP symbols. The Phase I findings about diet-related health concerns, including obesity and related chronic diseases, and food consumption patterns served to underpin the committee’s understanding of the effectiveness of FOP systems and symbols relative to consumer behavior. The Phase I committee concluded that added sugars should not be a component of an FOP nutrition rating system because of insufficient evidence about the contribution of added sugars beyond calories to the most pressing diet-related health concerns among Americans, the inability to distinguish analytically between added and naturally occurring sugars in foods without obtaining proprietary product information and including that information on the NFP, and the relatively small number of food categories with high amounts of added sugars. This committee reconsidered the Phase I conclusions in light of events occurring after the release of the Phase I report, specifically the release of the 2010 Dietary Guidelines for Americans and the development of an approach to evaluating added sugars content. The 2010 Dietary Guidelines for Americans, which is the federal government’s nutrition policy document, strongly recommends reducing intakes of calories from added sugars and consumption of foods containing added sugars. The committee also determined that failure to address added sugars would result in major contributors of added sugars to diets, such as sugar-sweetened beverages, erroneously appearing to be “healthful” because they are low in saturated and trans fats and sodium (see Chapter 7 for details). The committee conducted a comprehensive review of peer-reviewed published evidence, as well as of non- peer reviewed evidence submitted by industry and government and non-government stakeholders. The committee also reviewed commissioned data collection and analyses of the prevalence of FOP systems and package clutter (discussed in Chapter 6), information obtained from presentations made in a public workshop, and new evidence on consumer use of FOP labeling information at the point-of-purchase compared to the point of consumption. Consultants provided the committee with non-published evidence and assisted with creating examples of simple symbols that would convey clear meaning to consumers. The committee’s process for reviewing evidence is further described in Appendix D. In its reviews and analyses, the committee gave consideration to the multi-disciplinary approach needed to fairly and objectively assess the totality of the evidence. The range of disciplines considered included: • Marketing and social marketing, • Public health,

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14 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS • Health literacy, • Health communication, • Nutrition science/nutrition education, • Information processing, • Visual/package design, • Behavioral economics, and • Nutrition labeling policy. Finally, the committee considered the components necessary to the effective development, design, and testing of model FOP systems, recognizing that, at the current rate of technology proliferation, in the future there may be additional ways to convey information to help consumers make healthier choices. ORGANIZATION OF THE REPORT The report is organized into nine chapters. This chapter provides background for the study, summarizes the Phase I conclusions, and describes the committee’s task and approach. Chapters 2 and 3 describe FOP food pack - age labeling and the regulatory environment for FOP labeling, respectively. Chapter 4 examines consumer use of FOP systems, and Chapter 5 examines the evidence related to consumer understanding of FOP systems. Chapter 6 discusses the current food package environment, how consumers process food package information, and how this knowledge can be applied to designing an effective FOP nutrition labeling system. The characteristics of model FOP systems and an approach to developing criteria to evaluate saturated and trans fats, sodium, and added sugars in food and beverage products consistent with a successful FOP system are discussed in Chapter 7. Chapter 8 discusses the promotion of FOP labeling in the context of social marketing. Lastly, the committee’s overall conclu - sions and recommendations are found in Chapter 9. REFERENCES Calle, E. E., C. Rodriguez, K. Walker-Thurmond, and M. J. Thun. 2003. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. New England Journal of Medicine 348:1625-1638. Dall, T. M., V. L. Fulgoni, Y. Zhang, K. J. Reimers, P. T. Packard, and J. D. Astwood. 2009. Potential health benefits and medi- medi- cal cost savings from calorie, sodium and saturated fat reductions in the American diet. American Journal of Health Promotion 23:412-422. IOM (Institute of Medicine). 2011. Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: The National Academies Press. NCHS (National Center for Health Statistics). 2010. Health, United States, 2009, with Special Feature on Medical Technology. PHS Publication No. 2010-1232. Hyattsville, MD: National Center for Health Statistics, Centers for Disease Control and Prevention. NIH (National Institutes of Health). 2004. Do You Know the Health Risks of Being Overweight? NIH Publication No. 07-4098. Available online: http://win.niddk.nih.gov/publications/PDFs/hlthrisks1104.pdf. Ogden, C. L., M. D. Carroll, L. R. Curtin, M. M. Lamb, and K. M. Flegal. 2010. Prevalence of high body mass index in US children and adolescents, 2007-2008. Journal of the American Medical Association 303:242-249. USDA (U.S. Department of Agriculture). 2010. Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office.