7

A Model Front-of-Package Symbol System Including Criteria for Evaluating Nutrients

INTRODUCTION

This chapter describes the characteristics of a model front-of-package (FOP) symbol system and presents an approach for evaluating food and beverage products for the amount of saturated and trans fats, sodium, and added sugars. This chapter also presents evaluation criteria for products using the term “points” to indicate that a critical component nutrient met its defined criteria, discusses how nutritional criteria might be based on current Food and Drug Administration (FDA) regulations for labeling nutrient content and health claims, and highlights the strengths, limitations, and regulatory issues pertaining to such a system. The assessment is based on a convenience sample of food and beverage products whose relevant nutrition information is provided in Appendix E.

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 Nutrition Facts panel (NFP); and the relatively small number of food categories with high amounts of added sugars. This committee reconsidered this Phase I conclusion 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. These products contribute to energy intake; generally contain no or low amounts of saturated and trans fats and sodium; and provide little or no essential nutrients unless fortified, which is not consistent with FDA fortification policy.1 A relatively small number of food and beverage categories contribute more than half the added sugars in the American diet.

The development of criteria, discussed in this chapter, to evaluate foods with added sugars makes it possible to give no FOP points to such foods while allowing some foods that contain small amounts of added sugars to earn FOP points. The committee’s approach addressed previous logistical issues around determining added sugars content that would allow some foods that are major contributors of added sugars to the diet, i.e., beverages and sweets, to erroneously appear to be healthy because they are low in saturated and trans fats and sodium.

The strong recommendation from the 2010 Dietary Guidelines for Americans, along with the development of

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1 21 CFR 104.20.



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7 A Model Front-of-Package Symbol System Including Criteria for Evaluating Nutrients INTRODUCTION This chapter describes the characteristics of a model front-of-package (FOP) symbol system and presents an approach for evaluating food and beverage products for the amount of saturated and trans fats, sodium, and added sugars. This chapter also presents evaluation criteria for products using the term “points” to indicate that a critical component nutrient met its defined criteria, discusses how nutritional criteria might be based on current Food and Drug Administration (FDA) regulations for labeling nutrient content and health claims, and highlights the strengths, limitations, and regulatory issues pertaining to such a system. The assessment is based on a convenience sample of food and beverage products whose relevant nutrition information is provided in Appendix E. 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 Nutrition Facts panel (NFP); and the relatively small number of food categories with high amounts of added sugars. This committee reconsidered this Phase I conclusion 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. These products contribute to energy intake; generally contain no or low amounts of saturated and trans fats and sodium; and provide little or no essential nutrients unless fortified, which is not consistent with FDA fortification policy.1 A relatively small number of food and beverage categories contribute more than half the added sugars in the American diet. The development of criteria, discussed in this chapter, to evaluate foods with added sugars makes it possible to give no FOP points to such foods while allowing some foods that contain small amounts of added sugars to earn FOP points. The committee’s approach addressed previous logistical issues around determining added sugars content that would allow some foods that are major contributors of added sugars to the diet, i.e., beverages and sweets, to erroneously appear to be healthy because they are low in saturated and trans fats and sodium. The strong recommendation from the 2010 Dietary Guidelines for Americans, along with the development of 1 21 CFR 104.20. 71

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72 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS this approach to evaluating added sugars, led the committee to conclude that added sugars are an important com - ponent that should be included in an FOP nutrition rating system. This conclusion is consistent with the principle that an FOP symbol system should not inadvertently promote products that are inconsistent with current federal dietary guidance. FRONT-OF-PACKAGE MODEL SYSTEM The committee reviewed published evidence and data submitted by stakeholders and consultants and developed conclusions about FOP systems that will be effective in attracting consumer attention and encouraging them to make healthier food choices. Specifically, the committee’s examination of the totality of the available evidence led to the following conclusions: • o be effective, FOP nutrition labels must compete in a very busy and ever-changing package environment T that includes an array of messages designed to capture consumer attention and promote products. • utrition information provided in an FOP symbol system should be based on the most recent Dietary N Guidelines for Americans and current consensus reports. • here is a need for a standardized FOP nutrition rating system that moves beyond providing information to T one that encourages product comparison and healthier food choices by consumers at the point of purchase. • OP systems that are simple and easy to understand more effectively encourage consumers to choose F healthier products. • onsumers are making point-of-purchase decisions about food products in very little time and in the face C of a diverse and growing number of stimuli on food packages. • ampaigns that guide consumers to look in a specific location for the specific symbol would maximize the C use and benefit of an FOP system. Furthermore, the committee identified three outcomes that an FOP system should produce in order to be suc - cessful among a broad range of consumers. The system must: • ncourage consumers to make healthier choices at the point of purchase, e • ncourage food and beverage companies to provide healthier offerings by reformulating products or e developing new ones, and promoting those healthier offerings, and • ncourage retailers to highlight those healthier offerings. e POTENTIAL FOR SUCCESS Given the goal of increasing healthier choices, the committee looked closely at a number of FOP and shelf tag systems that have demonstrated some success in the marketplace. The committee focused less on what consumers said and more on what they did, as measured by in-market retail sales. The committee also focused on consum - ers’ processing and use of nutrition rating symbols in a cluttered on-package environment. Based on the evidence reviewed in the preceding chapters, the committee determined that the type of nutrition rating symbol system most likely to be successful in enabling healthier food choice and purchase decisions will be: • s imple, understanding does not require specific or sophisticated nutritional knowledge; • i nterpretive, nutrition information is provided as guidance rather than as specific facts; • o rdinal, nutritional guidance is offered through a scaled or ranked approach; and • s upported by communication with readily remembered names or identifiable symbols.

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73 A MODEL FOP SYMBOL SYSTEM CHARACTERISTICS OF A MODEL FOP SYMBOL SYSTEM In addition to the three outcomes of an effective FOP system, the committee identified eight characteristics that are essential to the success of an FOP system. These characteristics are: 1. One simple, standard symbol translating information from the NFP on each product into a quickly and easily grasped health meaning, making healthier options unmistakable. “Health meaning” refers to the extent to which a product contains reasonable amounts of three nutrient components (saturated and trans fats, sodium, and added sugars) considered harmful to health when consumed in excess or above a certain threshold. All information currently on the NFP would remain on the NFP. The committee suggested adding, on the FOP, a simple summary symbol offering nutritional guidance on that information. 2. Displaying: a. Calories in common household measure serving sizes, and b. Zero to three nutritional “points.” The more points, the more the food or beverage helps consumers avoid less healthy levels of nutrients identified as being associated with diet-related health risks. Specifically, a food or beverage product could earn one point for an acceptable level of sodium, one for an acceptable level of saturated and trans fats, and/or one point for an acceptable level of added sugars. Saturated and trans fats are considered together to facilitate communication about limiting consumption of foods containing solid fats (USDA, 2010). If a food or beverage product contains any one of the nutrient components of concern in amounts exceeding specified criteria limits, then the product would not be eligible for points (see examples and discussion of points below). A similar system could be developed for shelf tags for unpackaged or bulk items such as fruits and vegetables as well as packaged goods. 3. Appearing on all grocery products allowing consumers to compare food choices across and within categories. If all products displayed the FOP symbol system, then it would be easier for consumers to make healthier food choices both within and across food categories. If, however, consumers come to perceive products not displaying the FOP symbol system as less healthy alternatives, then they would in essence “use” the system even if it did not appear on all products; 4. Appearing in a consistent location across products. Chapter 4 discusses the benefits of minimizing processing time. Chapter 6 discusses the benefits of characteristics that capture consumer attention, including color and contrast. If symbols are placed on a consistent, as opposed to unpredictable, FOP location, then it will take less time for consumers to process the information; 5. Practical to implement because the FOP symbol system is consistent with nutrition labeling regulations. FDA and the U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service have developed extensive regulations for nutrition labeling, determining labeled serving sizes and explicit and implied nutrient content claims, and declaring ingredient content. These regulations were developed based on science and with public input from an array of interested parties through a formal rulemaking process and are publicly available; 6. Integrated with the NFP so that the FOP symbol system and the NFP are mutually reinforcing. A FOP symbol system and the NFP can be integrated by placing a check, star, or other indicator inside or next to the NFP adjacent to the nutrition component earning the point. In this way, those who are interested can easily see what component(s) earned a point. When the NFP is displayed in the basic vertical format, 2 it is possible to place the check or other indicator just outside the box (see examples in Figures 7-1 through 7-3). However, when the NFP is displayed in a tabular format3 or linear format4 it is not possible to place the check or other indicator just outside the box and adjacent to the name of the nutrient earning the point. Accordingly, it would be preferable to consistently have the check or other indicator inside the box for all NFP formats. The committee recognizes that current regulations would need to be modified to allow a 2 21 CFR 101.9(d)(12). 3 21 CFR 101.9(j)(13)(iii) or 101.9(j)(13)(ii)(A)(1). 4 21 CFR 101.9(j)(13)(ii)(A)(2).

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74 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS check or other indicator within the NFP. Rulemaking to provide for such a modification could accompany rulemaking to establish an FOP system; 7. Providing a nonproprietary, transparent translation of nutrition information into health meaning. Ease of compliance and enforcement requires publicly available and standardized nutrition criteria. An FOP nutrition rating symbol system that displays earned nutrient points based on criteria consistent with labeling regulations is nonproprietary, transparent, and can easily be monitored for compliance; and 8. Made prominent and useful to consumers through an ongoing and a frequently refreshed program of promotion integrating the efforts of all concerned parties. Brands invest in frequent consumer communications that maintain the power and salience of their brand sym - bols. Without that continual, frequent communication, any symbol can fade from interest and exert less and less influence on choice (Hasher and Zacks, 1984; Romaniuk and Sharp, 2004; Wixted, 2004). Similarly, without fre - quent communication from the brand to the consumer, any FOP symbol system will fade from interest and become less and less useful in helping consumers make healthier choices. A readily remembered name or “brand” for the FOP symbol would facilitate communication to consumers by increasing its salience and encouraging its use. This need for the FOP system dovetails with the objectives of many governmental and nongovernmental organizations and food manufacturers that are interested in helping consumers make healthier choices and reduce diet-related chronic disease risk—USDA, FDA, the Centers for Disease Control and Prevention (CDC), the American Heart Association, the American Diabetes Association, the American Dietetic Association, and the Grocery Manufac - turer’s Association, among others. Integrating the efforts of these concerned parties behind the FOP system can contribute dramatically to its ability to increase healthier food choices by consumers. In addition, a well-designed FOP symbol system would also stimulate competition among food and beverage companies to provide the consumer with the most desirable options that do not lead to or contribute to diet-related chronic disease. A well-designed FOP symbol system should be a competitive opportunity. Examples of FOP Symbols The committee commissioned two graphic designers to produce examples of FOP symbols that incorporate to varying degrees the communication and design concepts discussed above. The examples in Figures 7-1 through 7-3 illustrate different visual interpretations of FOP symbol systems for food product packages. Each figure displays a series of four hypothetical food product packages showing the two-component symbol system of calories per serv - ing (expressed in household measures) and a nutrient component rating symbol. Each system is also displayed in three “usage” samples: the FOP symbol, a shelf tag, and the NFP with a tie-in to the FOP symbol. It is important to note that the committee does not endorse any particular design or product; these examples are presented for illustrative purposes only. The committee encourages regulators and industry stakeholders to engage in a process of selecting and designing an effective FOP symbol system based on the committee’s recommendations, and incor- porating effective design elements such as color and contrast (see Chapters 6 and 9 for additional information). APPROACH TO EVALUATING PRODUCTS FOR FOP POINTS When developing the approach to evaluating food products the committee considered the eight characteristics described in the previous section for a model FOP system as well as factors that would influence its assessment of food products. This section describes the approach and discusses the overall strengths and limitations of potential nutritional criteria as well as of each nutrient category. A model FOP symbol system displays calories and serving size information, as described by characteristic 2a, and indicates acceptable levels of saturated and trans fats, sodium, and added sugars in food and beverage products. It also excludes products from earning points for acceptable amounts of these nutrient components if any one component exceeds a specified limit (described by characteristic 2b). Products are ineligible for FOP points if one (or more) of the nutrient components is present in an amount that exceeds a specified limit. Additionally, a model FOP symbol system must be consistent with nutrition labeling regulations as described by characteristics

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System 1 150 190 100 150 calories calories calories calories per 16 chips per 1 Cup per slice per bar 150 190 100 150 150 190 100 calories calories calories 150 calories per 16 chips per 1 Cup per slice per bar POTATO calories calories calories calories per 16 chips per 1 Cup per slice per bar snack time 150 190 100 150 calories calories calories calories per 16 chips per 1 Cup per slice per bar RAISIN POTATO CHIPS POTATO CHIPS POTATO CHIPS POTATO CHIPS UNIT PRICE UNIT PRICE UNIT PRICE UNIT PRICE $ $ $ $ 0.23 0.23 0.23 0.23 $ $ $ $ PER OUNCE PER OUNCE PER OUNCE PER OUNCE 150 150 150 150 POTATO CHIPS POTATO CHIPS POTATO CHIPS POTATO CHIPS calories calories calories calories per 16 chips per 16 chips per 16 chips per 16 chips UNIT PRICE UNIT PRICE UNIT PRICE UNIT PRICE 1.50 1.50 1.50 1.50 POTATO CHIPS POTATO CHIPS POTATO CHIPS POTATO CHIPS $ $ $ $ UNIT PRICE UNIT PRICE UNIT PRICE UNIT PRICE BRAN 0.23 0.23 0.23 $ $ $ 0.23 $ $ $ $ $ PER OUNCE PER OUNCE PER OUNCE PER OUNCE 150 150 150 (680 g) Natural calories calories calories 0.23 calories 0.23 0.23 0.23 $ $ $ $ PER OUNCE PER OUNCE PER OUNCE PER OUNCE per 16 chips per 16 chips per 16 chips per 16 chips 150 150 150 1.50 1.50 1.50 1.50 150150 NET WT 1 LB 8 OZ calories calories calories calories per 16 chips per 16 chips per 16 chips per 16 chips 1.50 1.50 1.50 1.50 POTATO CHIPS POTATO CHIPS POTATO CHIPS POTATO CHIPS UNIT PRICE UNIT PRICE UNIT PRICE UNIT PRICE $ $ $ $ 0.23 0.23 0.23 0.23 $ $ $ $ PER OUNCE PER OUNCE PER OUNCE PER OUNCE 150 150 150 150 calories calories calories calories per 16 chips per 16 chips per 16 chips per 16 chips 1.50 1.50 1.50 1.50 5-1.4 OZ (40g) Bars NET WT 7 OZ (200g) FLAKES NET WT 25.5 OZ (1 LB 9.5 OZ)(723 g) NET WT. 6 OZ. (168g) Product 150 190 100 150 calories calories calories calories per 16 chips per 1 Cup per slice per bar System Detail Nutrition Facts POTATO CHIPS OAT AND PEANUT BUTTER BAR RAISIN BRAN FLAKES 100% WHOLE WHEAT BREAD UNIT PRICE UNIT PRICE UNIT PRICE UNIT PRICE $ $ $ $ 0.23 0.36 0.13 0.19 $ $ $ $ PER OUNCE PER OUNCE PER OUNCE PER OUNCE 150 150 190 100 calories calories calories calories per 16 chips per bar per 1 Cup per slice 1.50 2.50 3.39 4.49 Shelf Tag FIGURE 7-1 Front-of-package symbol system example 1. 75 POTATO CHIPS POTATO CHIPS POTATO CHIPS POTATO CHIPS UNIT PRICE UNIT PRICE UNIT PRICE UNIT PRICE $ $ $ $ 0.23 0.23 0.23 0.23 $ $ $ $ PER OUNCE PER OUNCE PER OUNCE PER OUNCE 150 150 150 150 calories calories calories calories per 16 chips per 16 chips per 16 chips per 16 chips 1.50 1.50 1.50 1.50

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System 2 76 calories per 16 chips calories per 1 cup calories per bar calories per slice 150 190 150 100 calories per 16 chips calories per 1 cup calories per 1 cup calories per bar calories per bar calories per 16 chipscalories per slice calories per slice 150 190 190 150 150 150 100 100 POTATO snack time calories per 16 chips calories per 1 cup calories per bar calories per slice 150 190 150 100 RAISIN BRAN (680 g) Natural NET WT 1 LB 8 OZ 5-1.4 OZ (40g) Bars NET WT 7 OZ (200g) FLAKES NET WT 25.5 OZ (1 LB 9.5 OZ)(723 g) NET WT. 6 OZ. (168g) Product calories per 16 chips calories per 1 cup calories per bar calories per slice 150 190 150 100 System Detail Nutrition Facts POTATO CHIPS OAT AND PEANUT BUTTER BAR RAISIN BRAN FLAKES 100% WHOLE WHEAT BREAD UNIT PRICE UNIT PRICE UNIT PRICE UNIT PRICE $ $ $ $ calories per 16 chips calories per 1 cup calories per bar calories per slice 150 190 150 100 0.23 0.36 0.13 0.19 $ $ $ $ PER OUNCE PER OUNCE PER OUNCE PER OUNCE 1.50 2.50 3.39 4.49 Shelf Tag FIGURE 7-2 Front-of-package symbol system example 2.

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System 3 100 190 150 150 calories calories calories calories per slice per 1 cup per bar per 16 chips 100 100 190 190 150 150 150 150 calories calories calories calories calories calories calories calories per slice per slice per 1 cup per 1 cup per bar per bar per 16 chips per 16 chips POTATO snack time 100 190 150 150 calories calories calories calories per slice per 1 cup per bar per 16 chips RAISIN BRAN (680 g) Natural NET WT 1 LB 8 OZ 5-1.4 OZ (40g) Bars NET WT 7 OZ (200g) FLAKES NET WT 25.5 OZ (1 LB 9.5 OZ)(723 g) NET WT. 6 OZ. (168g) Product 100 190 150 150 calories calories calories calories per slice per 1 cup per bar per 16 chips System Detail Nutrition Facts POTATO CHIPS OAT AND PEANUT BUTTER BAR RAISIN BRAN FLAKES 100% WHOLE WHEAT BREAD UNIT PRICE UNIT PRICE UNIT PRICE UNIT PRICE $ $ $ $ 190 150 150 0.23 0.36 0.13 0.19 $ $ $ $ calories calories calories calories PER OUNCE PER OUNCE PER OUNCE PER OUNCE per slice per 1 cup per bar per 16 chips 1.50 2.50 3.39 4.49 100 Shelf Tag 77 FIGURE 7-3 Front-of-package symbol system example 3.

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78 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS BOX 7-1 Definition of Terms Used in Setting Nutritional Criteria Front-of-Package (FOP) point: A point that indicates that a critical nutrient component met its defined eli- gibility and qualifying criteria for inclusion in the FOP symbol system. Nutrient content claims: Claims on food package labels that characterize and describe the level of a nutri- ent or dietary substance in the product. Disclosure level: The threshold amount at which certain nutrients, including saturated fat and sodium, in products must be disclosed when making nutrient content claims. Disqualifying level: The threshold amount at which certain nutrients, including saturated fat and sodium, in products disqualify a product from making health claims. Daily Value (DV): Reference values established by the Food and Drug Administration (FDA) and used in nutrition labeling. DV are based on recommended daily intake levels of nutrients needed for health. Percent DV: Percentages found on the Nutrition Facts panel on food labels that put the amount of nutrients in the product in the context of a total diet. Reference Amounts Customarily Consumed (RACC): The amount of a food customarily consumed per eating occasion by persons in a population group as determined by FDA. RACC is used as the regulatory basis for determining labeled serving sizes on the Nutrition Facts panel. 5 and 7. A model FOP system requires a clear, systematic procedure for determining whether a given product earns zero, one, two, or three points, and the criteria used to assess products for points should balance restrictive - ness with practicability. An FOP system will function among a variety of constraints and resources, which offer both guidance and complexity. Box 7-1 describes and defines the terms used in setting nutritional criteria. When developing the approach to evaluating food products the committee considered the following factors: • Evaluation of a convenience sample of food and beverage products against relevant criteria for nutrition labeling, nutrient content and health claims, and ingredient labeling related to saturated fat, trans fat, sodium, and added sugars; • Consideration of recommendations in the Dietary Guidelines for Americans (USDA, 2010) and products that have been determined based on their nutritional value to be eligible for use in federal food programs such as the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); 5 and • Identification of potential options for addressing discrepancies between product ratings based on current regulations and dietary recommendations and WIC eligibility. Appendix E lists 95 products6 and their relevant nutrition information that were evaluated by the commit - tee. Nutrition and ingredient information was obtained from the NFP on product labels, manufacturers’ websites, an online database of NFPs and ingredient statements,7 and the USDA Food and Nutrient Database for Dietary Studies, 3.0 (ARS, 2008). Each is only one of many examples of products within a product category and may not be representative of all products in its category. Each product is considered an individual food under FDA regula - tions, as compared to main dishes and meal products. Current regulations for nutrient content claims are consistent across all product categories of individual foods and differ from regulations for main dishes and meal products to 5 Available online: http://www.fns.usda.gov/wic/benefitsandservices/foodpkgregs.htm (accessed March 15, 2011). 6 It is Institute of Medicine (IOM) policy to not use brand names of products. 7 Available online: http://www.peapod.com/ (accessed on various dates throughout 2010 and 2011).

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79 A MODEL FOP SYMBOL SYSTEM recognize that each type of product makes a different relative contribution to the total diet. The committee did not evaluate mixed dishes (a category of individual foods), main dishes, and meal products because of the complexity of the task and resource constraints. Approach to Evaluating Nutrients to Limit in an FOP Symbol System The committee notes that no one FOP symbol system, including its underlying nutrition criteria, is flawless. The proposed approach for evaluating nutrients to limit in an FOP symbol system addresses the purposes and has the strengths and limitations listed in Box 7-2 and discussed in the evaluation of nutritional criteria. A much more extensive evaluation of foods and beverages against potential criteria is needed to fully identify the strengths and limitations of the proposed approach and current regulations. The committee considered the diversity of the food supply as well as the nutrient content of individual foods. Because of this diversity there will always be particular foods or food categories that do not appear to appropriately qualify, or not qualify, for earned “points.” Although criteria based on existing labeling regulations are transparent and nonproprietary, the described approach would require modifications or exemptions to existing regulations and the development of new regulations to implement the model FOP symbol system. NUTRITIONAL CRITERIA The committee determined that an FOP symbol system should not inadvertently promote products that contain amounts of saturated and trans fat, sodium, or added sugars that are inconsistent with Dietary Guidelines recom- mendations. Therefore, the committee developed a two-step process for evaluating products that, first, assesses products for eligibility for FOP points (see Figure 7-4), and, second, evaluates products for points. Step 1: Eligible or not? Eligibility criteria determine whether a product may earn FOP points for saturated and trans fats, sodium, or added sugars. If the product contains an amount of one or more of the stated nutri - ent components that is not consistent with Dietary Guidelines recommendations, then it is ineligible for FOP points. Step 2: If eligible, for how many points? If a product is eligible for FOP points, then qualifying criteria determine whether the product earns zero, one, two, or three FOP points. The qualifying criteria in general are more restrictive than the eligibility criteria. In Step 1, a food or beverage can be excluded from earning FOP points for saturated and trans fats, sodium, and added sugars because the amount of any one of those components is considered “too high,” that is, it contains an amount of saturated fat, trans fat, sodium, and/or added sugars and that is inconsistent with Dietary Guidelines recommendations. For example, a product “high” in sodium but containing no or low levels of saturated and trans fat and added sugars would not be eligible for FOP points. Such a product should be excluded from earning FOP points for saturated and trans fats and added sugars even if the amounts of these nutrient components otherwise meet qualifying criteria. In the second step, a food or beverage that meets the eligibility criteria can then be evalu - ated for FOP points for saturated and trans fats, sodium, and added sugars. These steps are illustrated in Figure 7-4. Eligibility Criteria The committee outlined a potential approach to setting eligibility criteria that would use nutrient levels set by FDA that define the point at which a food product can make a health claim or nutrient content claim. FDA defines these “disclosure/disqualifying” criteria as no more than 20 percent of the Daily Value (DV) for certain nutrients (see Glossary for definition) whose consumption in excess “can lead to a diet inconsistent with dietary guidance for maintaining good health.”8 Accordingly, FDA has set >20 percent DV as the threshold amount at which certain 8 58 FR 2478 at 2494; January 6, 1993.

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80 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS BOX 7-2 Purposes, Strengths, and Limitations of the Described Approach for Evaluating Nutrients to Limit in the Model Front-of-Package (FOP) Symbol System Purposes The model FOP symbol system: • P rovides consumers with prominent calorie content information • P rovides prominent serving size information • P rovides targeted information related to saturated and trans fats, sodium, and added sugars • F acilitates consumers’ comparisons of nutritional value within food categories • F acilitates consumers’ comparisons of nutritional value across most food categories Encourages manufacturers to reformulate products Strengths The model FOP symbol system: • argets nutrients of public health concern T • rovides a measure of the relative amount of saturated and trans fats, sodium, and added sugars P by assigning points when a product contains qualifying amounts of these nutrients • valuates nutrient amounts consistent with science-based regulations E • pplies one set of nutritional criteria across all or most product categories similar to current regula- A tions, with certain exceptions where technically needed • acilitates compliance with recommendations from the Dietary Guidelines for Americans F • llows compliance to be monitored, either by chemical analysis of nutrient levels or by review of A the ingredient list Limitations In the approach to evaluating products: • any foods that are consistent with the recommendations of the Dietary Guidelines for Americans M or that are eligible for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) exceed the disclosure level for saturated fat. • ost foods, including those that are consistent with the recommendations of the Dietary Guidelines M for Americans or that are WIC-eligible, do not meet criteria for “low saturated fat.” • o disclosure level or regulatory criteria defines “low” for trans fat. N • ost foods, including those that are consistent with the recommendations of the Dietary Guidelines M for Americans or that are WIC-eligible, do not meet criteria for “low sodium.” • o disclosure level or regulatory criteria exists for “low” added sugars. N Many of these attributes were among those identified and used by the Phase I committee to evaluate exist- ing types of FOP symbol systems (IOM, 2010a). nutrients, including saturated fat and sodium, in individual foods must be disclosed when making nutrient content claims (disclosure levels)9 or which disqualify a product from making health claims (disqualifying levels). 10 The committee believes that >20 percent DV is an appropriate eligibility criterion for saturated fat and sodium for an 9 21 CFR 101.13(h). 10 21 CFR 101.14(a)(4).

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81 A MODEL FOP SYMBOL SYSTEM Eligibility Criteria Qualifying Criteria Eligibility criteria met Qualifying criteria met in all three areas in any three areas Saturated Saturated Added Added and Trans Fat Sodium Sugar Sodium Sugar Fat FIGURE 7-4 Evaluation criteria for a front-of-package symbol system. FOP system. Disclosure/disqualifying levels for main dishes (>30 percent DV) and meal products (>40 percent DV) could also be used as eligibility criteria for these types of products. FDA has not defined disclosure/disqualifying levels for trans fat and added sugars in part because of the absence of the type of quantitative information from authoritative scientific groups on which the agency could support the establishment of a Daily Reference Value.11 However, in accordance with dietary guidance that recom- Figure 7-4 mends that trans fat intake be kept as low as possible, especially by limiting foods that contain synthetic sources of trans fat (IOM, 2005; USDA, 2010, p. 21), R02048 trans fat content can be evaluated when determining a product’s whether it qualifies for an FOP point for saturated and trans fats (see Qualifying Criteria for FOP Points). A prod- unlalterable raster image, uct’s added sugars content can be evaluated for eligibility based on the approach described below. does not match provided ms. copy 11 68 FR 41434; July 11, 2003.

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86 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS TABLE 7-5 Saturated Fat Content of Selected Example Products Compared to Criteria for “Low in Saturated Fat” and Content of Trans Fat and Partially Hydrogenated Vegetable Oil Saturated Fat Not Contains Percent of Low Labeled TFA and g/LS g/RACC calories Producta SFAb PHVOc Serving Sugar cookies 4 (40 g) 1 <1 7 x Chocolate chip cookies 1 pkg (42 g) 3 2.1 13 x x Snack crackers 9 (32 g) 2 1.9 12 x x Breakfast bar 1 bar (40 g) 2 2 12 x Toaster pastry 1 pastry (52 g) 2 1.5 9 x Milk, 1% fat 1 cup (240 mL) 1.5 1.5 12 x Ricotta cheese, part skim 0.25 cup (62 g) 4 3.5 36 x Egg 1 large (50 g) 1.5 1.5 19 x Olive oil 1 tbsp (15 mL) 2 2 15 x Peanut oil 1 tbsp (14 g) 2.5 2.5 19 x Soybean oil 1 tbsp (14 g) 2 2 15 x Margarine, soft 1 1 tbsp (14 g) 2 2 26 x Margarine, soft 2 1 tbsp (14 g) 2.5 2.5 28 x Margarine, soft 3 1 tbsp (14 g) 1.5 1.5 17 x Mayonnaise 1 tbsp (13 g) 1.5 1.7 15 x Salad dressing, regular 1 2 tbsp (30 g) 2.5 2.5 16 x Salmon fillets, frozen raw 4 oz (114 g) 1.5 1.4 7 x Salmon fillets, raw 3 oz (85 g) 2.6 3.4 13 x Salmon steaks, raw 3.5 oz (99 g) 1 1.1 6 x Salmon, canned 0.25 cup (60 g) 1.5 1.4 12 x Chicken thighs, raw boneless skinlessd 4 oz (114 g) 5 5 19 x Walnuts, shelled 0.25 cup (30 g) 2 2 9 x Peanut butter 2 tbsp (32 g) 3 3 14 x NOTES: LS = labeled serving size, PHVO = partially hydrogenated vegetable oil, pkg = package, RACC = reference amounts customarily consumed, SFA = saturated fat, TFA = trans fat. a P roducts followed by numbers represent different brands. b C ontains >1 g saturated fat per RACC and/or >15% of calories from saturated fat. c C ontains ≥ 0.5 g t rans fat per LS and PHVO in ingredients statement. d P oultry is regulated by the U.S. Department of Agriculture; chicken thighs were included for illustrative purposes only. Extensive computer modeling is needed to compare the saturated fat content of a wide variety of products against various criteria to determine which approach results in products appropriately earning an FOP saturated fat point. Qualifying Criteria for Sodium FOP Points FDA has defined criteria for “low sodium” and “healthy” claims that characterize the amount of sodium in a product, which could potentially be used to qualify a product for an FOP sodium point (Table 7-6). Table 7-7 lists several example products that were evaluated against the sodium criteria for “low” claims (≤140 mg per RACC) and “healthy” claims (≤480 mg per RACC). Mayonnaise, a soft margarine, and peanut butter were included in this analysis even though they exceeded the disclosure/disqualifying level for saturated fat and therefore would not be eligible for evaluation for an FOP sodium point unless exempted by FDA. Of the example products listed,22 only seven met the criteria for “low sodium” but all met the sodium criteria for “healthy.” Thus, qualifying criteria for an FOP sodium point based on the criteria for a “healthy” claim may be more realistic than one based on “low sodium.” Qualifying criteria based on “healthy” sodium would allow 22 The peanut butter example contains added salt and added sugars, but some peanut butters do not contain added salt and added sugars.

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87 A MODEL FOP SYMBOL SYSTEM TABLE 7-6 Criteria for Nutrient Content Claims That Characterize the Amount of Sodium Lowa Healthyb Product ≤140 mg per RACC ≤480 mg per RACC and LS foodsc Individual (or per 50 g if RACC is small) (or per 50 g if RACC is small) ≤140 mg per 100 g ≤600 mg per LS Main dishes and meal products NOTES: LS = labeled serving size, RACC = reference amounts customarily consumed. A small RACC is ≤30 g or ≤2 tablespoons. a 21 CFR 101.61(b)(4) and 101.61(b)(5). b 21 CFR 101.65(d)(2)(ii). c Includes seafood and game meat. TABLE 7-7 Sodium Content of Selected Example Foods That Meet the Sodium Criteria for “Low” and/or “Healthy” Sodium mg per Producta Lowb Healthyc Labeled Serving LS RACC 50 g 100% whole wheat bread 1 slice (43 g) 170 198 NA no yes Graham crackers 8 pieces (31 g) 180 174 290 no yes Animal crackers 13 pieces (30 g) 75 75 125 yes yes Breakfast bar 1 bar (40 g) 105 105 NA yes yes Shredded wheat cereal 1 cup (49 g) 0 0 NA yes yes Toasted oat cereal 1 cup (28 g) 160 NA 286 no yes Crisped rice cereal 1.25 cup (33 g) 190 NA 288 no yes Oatmeal, old-fashioned 0.5 cup (40 g) 0 0 NA yes yes Oatmeal, instant plain 1 package (25 g) 75 120 NA yes yes Oatmeal, instant with fruit and nuts 1 package (37 g) 190 282 NA no yes Chocolate milk, 1% fat 1 cup (240 mL) 150 150 NA no yes Yogurt, plain nonfat 1 cup (227 g) 190 188 NA no yes Margarine, soft 1 1 tbsp (14 g) 100 100 357 no yes Margarine, soft 2 1 tbsp (14 g) 90 90 321 no yes Margarine, soft 3 1 tbsp (14 g) 85 85 304 no yes Mayonnaise 1 tbsp (13 g) 70 81 269 no yes Salad dressing, regular 1 2 tbsp (30 g) 260 260 433 no yes Salad dressing, light 1 2 tbsp (31 g) 290 280 468 no yes Salad dressing, light 2 2 tbsp (32 g) 290 272 453 no yes Tuna fish, solid white in water ~0.25 cup (55 g) 190 190 NA no yes Kidney beans, canned 0.5 cup (130 g) 360 360 NA no yes Peanut butter 2 tbsp (32 g) 130 130 203 no yes Soups, “healthy” 0.5 cup (120 mL) 410 410 NA no yes Mixed vegetable juice, regular 1 can (5.5 oz) 330 480 NA no yes Mixed vegetable juice, low sodium 1 can (5.5 oz) 80 116 NA yes yes Tomato juice, low sodium 8 fl oz (240 mL) 140 140 NA yes yes Tomatoes, canned 0.5 cup (121 g) 220 236 NA no yes NOTES: LS = labeled serving size, NA = the small RACC rule does not apply, RACC = reference amounts customarily consumed. a Products followed by numbers represent different brands. b Contains ≤140 mg per RACC, or per 50 g if RACC is small. 21 CFR 101.16(b)(4). c Contains ≤480 mg per RACC and LS, or per 50 g if RACC is small. 21 CFR 101.65(d)(2)(ii).

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88 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS TABLE 7-8 Potential Qualifying Criteria for a Front-of-Package Added Sugars Point for Individual Foods Total Sugars Content Condition and/or Rationale Meets criteria for “sugar free”a 0 g on NFP ≥0.5 g per RACC Products with no ingredient recognized as added sugars listed in the ingredients statementb ≤6 g per ounce Breakfast cereals that meet the WIC requirement for sugarsc ≤5 g per RACC Products with an ingredient recognized as added sugars except for canned products containing tomatoes and/or other vegetables and yogurt products and substitutesd ≤10 g per RACC Canned products with tomatoes and other vegetables that contain naturally occurring sugars as well as an ingredient recognized as added sugarse ≤20 g per RACC Yogurt products and substitutes that contain a low calorie sweetener and an ingredient recognized as added sugarsf NOTES: LS = labeled serving size, NFP = Nutrition Facts panel, RACC = reference amounts customarily consumed, WIC = Special Supple- mental Nutrition Program for Women, Infants and Children. a Contains <0.5 g sugars per RACC and LS. 21 CFR 101.60(c)(1). b Applies to products containing only naturally occurring sugars such as fruits, fruit juices, and milk. c Contains no more than 21.2 g sucrose and other sugars per 100 g of dry cereal. Available online: http://www.fns.usda.gov/wic/benefitsandservices/ foodpkgregs.htm (accessed March 15, 2011). d This would qualify WIC-eligible peanut butters and canned mature legumes. The latter contains small amounts of added sugars to prevent stress resulting from the canning process; however, WIC does not specify what constitutes a small amount of sugar. The 5 g represents 20 calories or 1 percent of 2,000 calories. Available online: http://www.fns.usda.gov/wic/benefitsandservices/foodpkgregs.htm (accessed March 15, 2011). e WIC requirements allow small amounts of sugars to be added to vegetables that are naturally sugar-containing during the canning process to prevent stress resulting in membrane rupture; however, WIC does not specify what constitutes a small amount of sugar. The 10 g represents 40 calories or 2 percent of 2,000 calories. Available online: http://www.fns.usda.gov/wic/benefitsandservices/foodpkgregs.htm (accessed March 15, 2011). f Half the sugar should come from milk as estimated from the protein and lactose contents of plain yogurt and products expected to be covered by this criterion. more foods that are consistent with the Dietary Guidelines recommendations and/or are WIC-eligible to earn an FOP sodium point, as well as foods that have been specially formulated to meet regulations for a “healthy” claim such as some soups and vegetable juices. The qualifying criteria also provide a more realistic target for product reformulation and new product development. A limitation is that products that pass the eligibility criteria for sodium would automatically qualify for a sodium point based on “healthy,” because the cut-off for qualifying for an FOP sodium point based on “healthy” is the same as the cut-off for eligibility based on the disclosure amount. This limitation could be addressed by reduc - ing the qualifying cut-off for sodium over time as part of an overall strategy to reduce sodium in the food supply. Qualifying Criteria for Added Sugars Although added sugars are not declared in the NFP, the committee identified an approach for determining whether a product qualifies for an FOP point for added sugars. The approach uses FDA’s claim criteria for “sugar free” and “no added sugars,” as well as the amount of total sugars declared on the NFP in conjunction with specific conditions. Potential criteria and associated rationale or conditions for individual foods are listed in Table 7-8. Criteria for meal products and main dishes could be developed and evaluated based on a similar approach. FDA regulations provide for claims of “no added sugars” and “without added sugars” if no sugar or sugar- containing ingredient is added during processing. FDA defines “added sugars” as sugars or other ingredients added during processing or packaging that functionally substitute for sugars, such as fruit juice concentrates, jams, and jellies, and including ingredients that may functionally increase the sugars content of a food, such as enzymes. 23 The Dietary Guidelines list the following as examples of added sugars: anhydrous dextrose, brown sugar, con - 23 21 CFR 101.60(c)(2).

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89 A MODEL FOP SYMBOL SYSTEM TABLE 7-9 Sugars Content of Selected Example Foods That Do and Do Not Meet Potential Front-of-Package Criteria for Added Sugars Total Sugars Added Meets g/LS g/RACC Producta Criteriab Labeled Serving Sugars 100% whole wheat bread 1 slice (43 g) 4 4.6 yes yes Graham crackers 8 pieces (31 g) 8 7.7 yes no Animal crackers 13 pieces (30 g) 8 8 yes no Breakfast bar 1 bar (40 g) 9 9 yes no Toasted oat cereal 1 cup (28 g) 1 1.1 yes yes Sweetened toasted oat cereal 1 cup (28 g) 9 9.6 yes no Oatmeal, instant plain 1 package (25 g) 0 0 yes yes Oatmeal, instant with fruit, nuts 1package (37 g) 11 16 yes no Milk, 1% fat 1 cup (240 mL) 12 12 no yes Chocolate milk, 1% fat 1 cup (240 mL) 25 25 yes no Yogurt, plain nonfat 1 cup (227 g) 18 18 no yes Yogurt, sweetened 1, fat free, LCS 1 container (170 g) 14 18.5 yes yes Yogurt, sweetened 2, fat free 1 cup (225 g) 33 33 yes no Yogurt, sweetened 3, low fat 2.25 oz (64 g) 10 35 yes no Yogurt, sweetened 4, low fat 4 oz (113 g) 16 32 yes no Yogurt, sweetened 5, low fat 1 container (113 g) 13 26 yes no Salad dressing, light 1 2 tbsp (31 g) 2 2 yes yes Orange juice, 100% 8 fl oz (240 mL) 22 22 no yes Grape juice, 100% 1 bottle (10 oz) 49 39 no yes Kidney beans, canned 0.5 cup (130 g) 2 2 yes yes Peanut butter 2 tbsp (32 g) 3 3 yes yes Tomato soup, “healthy” 0.5 cup (120 mL) 10 10 yes yes Tomatoes, canned 0.5 cup (121 g) 3 3 no yes Stewed tomatoes, canned 0.5 cup (126 g) 7 7 yes yes NOTE: LCS = low calorie sweetener, LS = labeled serving size, RACC = reference amounts customarily consumed. a Products followed by numbers represent different brands. b See Table 7-8 for criteria. fectioner’s powdered sugar, corn syrup, corn syrup solids, dextrin, fructose, high-fructose corn syrup, honey, invert sugar, lactose, malt syrup, maltose, maple syrup, molasses, nectars (e.g., peach nectar, pear nectar), pancake syrup, raw sugar, sucrose, sugar, white granulated sugar, cane juice, evaporated corn sweetener, fruit juice concentrate, crystal dextrose, glucose, liquid fructose, sugar cane juice, and fruit nectar (USDA, 2010, p. 75). A selection of example products evaluated against potential qualifying criteria for added sugars is listed in Table 7-9. Peanut butter was included in the analysis even though it exceeded the disclosure/disqualifying level for saturated fat and would be excluded from earning FOP points unless exempted by FDA. Not earning an added sugars point are the following products: Graham and animal crackers; a breakfast bar; sweetened toasted oat cereal; instant oatmeal with added sugars, fruit, and nuts; chocolate-flavored milk; and four sweetened yogurts. Products with added sugars that would earn an FOP point include 100 percent whole wheat bread, a toasted oat cereal, a yogurt sweetened with an added sugar and low calorie sweetener, a light salad dressing, canned kidney beans, peanut butter, a tomato soup that meets the criteria for “healthy,” and canned stewed tomatoes. Because the amount of total sugars would vary among products that qualify for an added sugars point, total sugars in the NFP could be footnoted with a statement such as “Contains no added sugars” or “Contains a qualifying amount of added sugars.” The latter is depicted for 100 percent whole wheat bread in Figures 7-1 through 7-3. OVERALL PRODUCT EVALUATION After evaluating a limited number of foods and beverages against current regulations for nutrient content claims, the committee identified potential eligibility and qualifying criteria for individual foods (Table 7-10) and

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90 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS TABLE 7-10 Potential Criteria for a Front-of-Package Symbol System for Individual Foods Nutritional Eligibility Criteriaa Qualifying Criteriab Component ≤4 g per RACC and LS; ≤2 g per RACCd Saturated fat ≤4.5 g per RACC and per 100 g for seafood and game meatse or per 50 g if RACC is smallc ≤3.5 g per RACC for mixed dishes not measurable with a cupf Trans fat <0.5 g per LS, or ≥0.5 g per LS and product does not contain PHVO ≤480 mg per RACC and LS; ≤480 mg per RACC and LS; or per 50 g if RACC is small Sodium or per 50 g if RACC is small Added sugars Products not categorized as sugars, “Sugar-free,” “No added sugars,” or total sugars content with sweets, and beveragesg specified conditionsh NOTES: LS, labeled serving, PHVO, partially hydrogenated vegetable oil, RACC, reference amounts customarily consumed. A small RACC is ≤30 g or ≤2 tablespoons. a Products that meet all eligibility criteria may be evaluated for a front-of-package point for saturated and trans fats, sodium, and added sugars. b Products that meet the qualifying criteria for a given nutritional component earn an FOP point for that component. To earn an FOP saturated and trans fats point, products must meet the qualifying criteria for both fats. c Some oils, foods containing oils, nuts, foods containing nuts, and seafood and game meats that exceed the saturated fat disclosure/disqualifying level could be exempted based on Food and Drug Administration (FDA)-defined criteria. d Criteria based on 10 percent Daily Value (DV) to be determined by FDA. e Saturated fat criteria for “lean” seafood and game meats. f Saturated fat criteria for “lean” mixed dishes not measurable with a cup. g USDA Food and Nutrient Database for Dietary Studies (USDA, 2008, pp. 93-100). Examples include regular soda, energy drinks, sports drinks, fruit drinks, candy, sugars, and honey. h Qualifying sugars criteria include the following: • roduct meets “sugar free” claim criteria, or P • roduct contains ≥5 g sugars per LS with no ingredient recognized as added sugars listed in the ingredients statement, or P • roduct meets WIC sugars requirement for breakfast cereals, or P • roduct contains ≤5 g total sugars per RACC and an ingredient recognized as added sugars except for canned products containing toma- P toes and/or other vegetables and yogurt products and substitutes, or • anned products that contain ≤10 g total sugars per RACC and tomatoes and/or other vegetables that contain naturally occurring sugars C as well as an ingredient recognized as added sugars, or • ogurt products and substitutes that contain ≤20 g total sugars per RACC, a low calorie sweetener, and an ingredient Y recognized as added sugars. Half the total sugars should come from milk as estimated from the protein and lactose contents of plain yogurt and products expected to be covered by this criterion. for main dishes and meat products (Table 7-11). The qualifying criteria in general are more restrictive than the eligibility criteria. For example, the eligibility criterion for saturated fat is no more than 4 g per RACC (or per 50 g if the RACC is small), and the qualifying criterion is no more that 2 g per RACC. Thus, products that contain more than 4 g per RACC would not be eligible to receive FOP points, those that contain 4 g or less but more than 2 g per RACC would not qualify for a saturated fat point (but could possibly qualify for sodium and/or added sugars FOP points), and those that contain less than or equal to 2 g per RACC would qualify for a saturated fat point if they also met the criterion for trans fat. The criteria are not committee recommendations. Rather, the committee views the criteria as starting points for the extensive computer modeling that is needed to determine if the potential criteria are consistent with appro - priate ratings for saturated and trans fats, sodium, and added sugars across a wide variety of foods and beverages, main dishes, and meal products. The criteria should balance restrictiveness with practicability. Criteria that are too restrictive may prevent foods and beverages that are consistent with the Dietary Guidelines recommendations and/ or that are WIC-eligible from displaying FOP points, as well as be a disincentive to product reformulation and new product development. For example, it is challenging for many products to meet “low sodium” criteria for a variety of reasons, including consumer acceptance, shelf life, and microbiological safety (IOM, 2010b). Manufacturers may be more motivated to reformulate “high sodium” products to attain the current sodium criteria for “healthy”

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91 A MODEL FOP SYMBOL SYSTEM TABLE 7-11 Potential Nutritional Criteria for a Front-of-Package Symbol System for Main Dishes and Meal Products Nutritional Eligibility Criteriaa Qualifying Criteriab Component ≤6 g per LS for main dishesc ≤4.5 g per 100 g and per LSd Saturated fat ≤8 g per LS for meal productsc Trans fat 0 g per LS, or ≥0.5 g per LS and does not contain PHVO ≤720 mg per LS for main dishese ≤600 mg per LSe Sodium ≤960 mg per LS for meal productse Added sugars Products not categorized as Sugars, Sweets, and “No added sugars” plus total sugars content with Beveragesf specified conditions to be determined by FDA NOTES: FDA = Food and Drug Administration, LS = labeled serving size, PHVO = partially hydrogenated vegetable oil. a P roducts that meet all eligibility criteria may be evaluated for a front-of-package point for saturated and t rans fats, sodium, and added sugars. b P roducts that meet the qualifying criteria for a given nutritional component earn an FOP point for that component. To earn an FOP saturated and trans fats point, products must meet the qualifying criteria for both saturated fat and trans fat. c D isclosure/disqualifying level. d S aturated fat criteria for lean main dishes and meals. e S odium criterion for “healthy” claim. f U SDA Food and Nutrient Database for Dietary Studies ( USDA, 2008, pp. 93-100). Examples include regular soda, energy drinks, sports drinks, fruit drinks, candy, sugars, and honey. than to lower levels that may be unacceptable to consumers. The qualifying amount for sodium could be reduced over time as part of an overall strategy to reduce sodium in the food supply. Under the two-step approach for evaluating products, manufacturers have two incentives for improving prod - uct formulations. One incentive is to lower saturated fat and/or sodium below current FDA disclosure levels to enable the product’s eligibility to earn FOP points. Manufacturers of products potentially eligible for FOP points, i.e., products that do not exceed the FDA disclosure/disqualifying levels for saturated fat and sodium and are not a Sugars, Sweet, or Beverage with added sugars, will have an incentive to formulate products to meet qualifying criteria for saturated and trans fats and/or added sugars and therefore earn FOP points. Table E-2 (Appendix E) lists the potential FOP points earned for all the example foods and beverages evaluated by the committee; points for the bakery product examples are provided in Table 7-12 for illustrative purposes. The product examples in Appendix E were evaluated against all criteria in Table 7-10 except for the potential qualify- ing criteria for saturated fat, in which case the criteria for “low saturated fat” were used. The 100 percent whole wheat bread example earned three FOP points. The animal and graham cracker examples earned two FOP points, for saturated and trans fats and for sodium. The snack cracker example also earned two FOP points, one each for sodium and added sugars. The soup cracker example earned no FOP points because its sodium content exceeded the FDA disclosure/disqualifying level for sodium, disqualifying it entirely. If the soup cracker were reformulated to reduce the sodium content to below the disclosure/disqualifying level for sodium, then it would earn three FOP points. The other bakery product examples earned one FOP point, for sodium. Many of the products listed in Table E-2 that are consistent with dietary recommendations and/or are WIC- eligible would not be eligible to earn FOP points because they exceed the disclosure/disqualifying level for satu - rated fat and/or do not meet the criteria for “low” saturated fat. This especially was the case for some oils, nuts, foods containing nuts or oils, and salmon, which are relatively lower in saturated fat and higher in mono- and polyunsaturated fats. As suggested in Table 7-10, FDA should consider exemptions and/or alternative eligibility criteria to the saturated fat disclosure/disqualifying level for such products and qualifying criteria for saturated fat based on 10 percent of the DV per RACC. Seafood, including salmon, and game meats could be evaluated for both eligibility and qualification based on criteria for “lean.” The three 100 percent fruit juices evaluated by the committee would earn three FOP points. These products contain no saturated or trans fats, no or very little sodium, 22 to 39 g of total sugars (all naturally occurring), and

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92 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS TABLE 7-12 Front-of-Package Points for Examples of Bakery Products Evaluated Against Potential Eligibility and Qualifying Criteria SFA/TFAa Product Sodium Added sugars FOP Points ü ü ü Bread, 100 percent whole wheat 3 ü ü Animal crackers 2 ü ü Graham crackers 2 ü ü Snack crackers 2 ü Oat and peanut butter bar 1 ü Sugar cookies 1 ü Chocolate chip cookies 1 ü Toaster pastry 1 0b (ü ) (ü ) (ü ) Soup crackers NOTES: SFA = saturated fat, TFA = trans fat. (ü) = Product would have earned points for SFA/TFA, sodium, and added sugars if it had not been excluded because of sodium content. a Products were evaluated against the criteria listed in Table 7-10 except that “low saturated fat” was used instead of ≤2 g per reference amounts customarily consumed. b Product exceeds the disclosure/disqualifying amount for sodium. 110 to 160 calories per 8 fluid ounces (Table E-1). Concern has been raised about the over-consumption of 100 percent fruit juices, especially among children, because of their high energy content (AAP, 2001, 2006, p. 551). The Dietary Guidelines recommend an increase in fruit intake (p. 34) and recognize that 100 percent fruit juices can be part of a healthy diet; however, because 100 percent fruit juices lack dietary fiber and can contribute extra calories when consumed in excess, the Dietary Guidelines recommend that the majority of the fruit come from whole fruit (USDA, 2010, p. 36). The declaration of calorie content on the FOP will help consumers recognize the high energy content of 100 percent fruit juices. Concern also has been raised about the added sugars content of breakfast cereals marketed to children (Batada et al., 2008; Bell et al., 2009), and the committee recognized that some FOP systems have been criticized in relation to their rating of sugar-sweetened cereals. With the FOP system proposed by the committee, consumers will be able to quickly distinguish among cereals. Cereal manufacturers have gradually reduced the amount of added sugars in cereals advertised to children. Specifically, the sugar content in many cereals has been reduced from 12 to 15 grams to 10 or 11 grams per serving, and some manufacturers have indicated their intent to reduce added sugars to below 10 grams.24 The reduced levels still exceed the sugars requirement for WIC eligibility (no more than 6 grams of sucrose and other sugars per 1 ounce dry cereal), which has been proposed as a possible qualifying criterion for FDA to consider. The three sweetened breakfast cereals evaluated by the committee were not WIC-eligible, as two contained 12 g added sugars per ounce and one contained 9 g per ounce (Table E-3). Although not earning an added sugars point, the three cereals would earn two FOP points, one for saturated and trans fats and one for sodium. ALIGNMENT WITH THE REGULATORY ENVIRONMENT Points for saturated and trans fats, sodium, and added sugars that are displayed in a FOP symbol system would be implied nutrient content claims.25 However, the eligibility and qualifying criteria for the FOP system described in this chapter are not entirely consistent with current regulations for nutrient content claims. Some, but not all, of these inconsistencies are discussed below. As it develops and tests an FOP symbol system, FDA will need to address inconsistencies between potential criteria and current regulations in addition to performing 24 The Children’s Food & Beverage Advertising Initiative in Action: A Report on Compliance and Implementation During 2009, p. 9. Available online: http://www.bbb.org/us/storage/0/Shared%20Documents/BBBwithlinks.pdf (accessed July 7, 2011). 25 21 CFR 101.13(b)(2).

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93 A MODEL FOP SYMBOL SYSTEM extensive computer modeling to assess a variety of foods and beverages, main dishes, and meal products against potential eligibility and qualifying criteria. As an example of inconsistency between the proposed criteria and current regulations, saturated fat and sodium disclosure/disqualifying levels are eligibility criteria only when used as disqualifying amounts for health claims. When pertaining to nutrient content claims, foods that exceed disclosure/disqualifying levels are only required to bear a statement disclosing that the nutrient exceeding the specified level is present in the food, e.g., “See nutrition information for [saturated fat and/or sodium] content.” Other inconsistencies include that current FDA regulations for nutrient content claims for individual foods are consistent across all product categories, e.g., the criteria for “low saturated fat” are the same for breakfast cereals, grain-based desserts, dairy products, vegetable oils, salad dressings, nuts, and seafood. As such, nutrient content claims for saturated fat do not provide exemptions for oils, nuts, foods containing oils and nuts, or certain types of seafood (e.g., salmon)—foods whose consumption is recommended by the Dietary Guidelines. Current regula- tions for saturated fat claims also do not require a product to contain less than 0.5 g trans fat per labeled serving; however, they do require declaration of the amount of monounsaturated and polyunsaturated fats in the NFP and thus provide a source of such information for consumers. Current FDA regulations for “no added sugars” do not make exemptions for otherwise healthful foods that contain a small amount of added sugars, such as WIC-eligible breakfast cereals, whole wheat bread, peanut butter, and canned vegetables, or for yogurts that contain both added sugars and a low calorie sweetener. “No added sugars” and the amount of total sugars per labeled serving are not qualifying criteria for saturated fat or sodium content claims; nor are entire categories of foods and beverages excluded from making saturated fat or sodium content claims because of added sugars content. In order for the FOP symbol to appear on as many products as possible, a similar approach for evaluating foods containing saturated fats or sodium, e.g., meat and poultry products should be assessed. In doing so, USDA would need to address some regulatory issues that currently deviate from FDA’s regulations. For example, USDA does not currently require trans fat to be listed on nutrition labels, but information on the amount of trans fat in a serving is needed to determine whether a product exceeds the qualifying criteria. In addition, because USDA regulations do not include disclosure/disqualifying levels, regulations to implement an FOP symbol system would need to include those or other such levels determined by the agency to be appropriate for setting eligibility and qualifying criteria. Finally, as with all regulatory actions, public input must be solicited on an FOP symbol system and its nutri - tional criteria. SUMMARY AND CONCLUSIONS This chapter described the characteristics of a model FOP symbol system and presented an approach for devel - oping criteria for and evaluating the amount of saturated and trans fats, sodium, and added sugars in foods and beverages consistent with these characteristics. Successful FOP symbol systems do not provide specific nutrient information but rather offer consumers guidance based on that information and give some idea of the healthful - ness of the choice on an ordinal scale. Because of public concern about overweight and obesity, an FOP symbol system should display calories per serving expressed in a common household measure consistent with the NFP. Criteria for evaluating products for saturated and trans fats, sodium, and added sugars content should proceed in a two-step process: 1. Determine whether a product may earn FOP points, based on eligibility criteria that determine whether the product contains an amount of one or more of the stated nutrient components that is not consistent with the Dietary Guidelines recommendations. If a product’s level of even one nutrient component exceeds the criteria threshold, then the product is ineligible for FOP points and would carry only calories per serving size. 2. Determine whether a product that meets the eligibility criteria earns FOP points for one or more of the following: saturated and trans fats, sodium, and/or added sugars based on qualifying criteria that assess acceptably low amounts.

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94 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS BOX 7-3 Limitations Associated with Criteria for Limits on Nutrient Components in a Front-of-Package (FOP) Symbol System Based on Current Regulations and Potential Solutions Saturated Fat • isclosure/disqualifying level as the basis for exclusion from earning FOP points is too restrictive D for many products that are consistent with the Dietary Guidelines recommendations and/or are eligible for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). A solution would be to exempt certain products from Food and Drug Administration (FDA)-based eligibility criteria. • Low” criteria as the basis for qualifying for an FOP point are too restrictive for most product catego- “ ries, especially products that are consistent with the Dietary Guidelines recommendations and/or are WIC-eligible. A solution would be to develop qualifying criteria based on 10 percent Daily Value (DV) per Reference Amounts Customarily Consumed (RACC) for individual foods and on “lean” for seafood and game meats. • xamples of products that are adversely affected by the disclosure/disqualifying level and/or criteria E for “low” include some oils, nuts, foods containing oils and nuts (such as salad dressings, mayon- naise, soft margarines, and peanut butter), 1 percent milk, eggs, and salmon. Trans Fat • o regulatory criteria exist for “low” or “high” amounts. A solution would be to qualify products based N on the trans fat declared in the Nutrition Facts panel and the absence or presence of a partially hydrogenated vegetable oil in the ingredients list. Sodium • Low sodium” criteria are overly restrictive as qualifying criteria for most products on the market. A “ solution would be to qualify products based on “healthy” criteria. • or individual foods, there is no gap between the FDA disclosure/disqualifying levela and the F “healthy” criteria.b As a result, “healthy” may appear too lenient as a qualifying criterion, at least for some products. This is not the case for main dishes and meal products, which have a significant gap between disclosure and “healthy” levels. A solution for individual foods would be to lower the criteria for “healthy” as a national sodium reduction initiative proceeds. Added sugars • o regulatory criteria exist for “low” or “high” amounts, and no analytical methods are available for N monitoring compliance. Evaluation must rely on claim criteria for “sugar free” and “no added sugars” as well as the amount of total sugars declared in the Nutrition Facts panel in conjunction with food specifications. • 00 percent fruit juices do not contain added sugars but do contain a relatively high amount of 1 naturally occurring sugars, and juices can contribute to extra calories when consumed in excess. FOP declaration of calories will help to make consumers aware of the high energy content, even as the FOP points indicate the juices to be a relatively healthy beverage. • resweetened cereals that do not meet the WIC sugar requirement could earn up to two FOP P points, one for saturated and trans fats and one for sodium. Consumers will be able to identify cereals that do and do not earn an FOP point for added sugars. a Sodium disclosure/disqualifying level is >480 mg per RACC and labeled serving (LS), or per 50 g if RACC is small. Sodium “healthy” criteria is ≤480 mg per RACC and LS, or per 50 g if RACC is small. b

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95 A MODEL FOP SYMBOL SYSTEM The criteria for evaluating nutrients to limit through an FOP symbol system should be based on FDA label - ing requirements and therefore transparent and nonproprietary and the FOP symbol system should be integrated with the NFP so the two can be mutually reinforcing. Current FDA regulations will require modifications and/or exemptions, and new regulations will need to be developed along with food group specifications to find an appro - priate balance between restrictiveness and practicality. The approach described in this chapter has strengths and limitations (listed in Box 7-2 and Box 7-3). No one FOP symbol system, including its underlying nutrition criteria, is flawless. Nonetheless, the committee believed that development of an FOP symbol system based on the model and approach described here can be achieved, with extensive computer modeling and solicitation of public input. REFERENCES AAP (American Academy of Pediatrics, Committee on Nutrition). 2001. The use and misuse of fruit juice in pediatrics. Pedi- atrics 107:1210-1213. AAP. 2006. Dietary recommendations for children and adolescents: A guide for practitioners. Pediatrics 117:544-559. ARS (Agricultural Research Service, U.S. Department of Agriculture). 2008. USDA Food and Nutrient Database for Dietary Studies, 3.0. Available online: http://www.ars.usda.gov/services/docs.htm?docID=12089 (accessed May 19, 2011). Batada, A., M. Dock Seitz, M. G. Wootan, and M. Story. 2008. Nine out of 10 food advertisements shown during Saturday morning children’s television programming are for foods high in fat, sodium, or added sugars, or low in nutrients. Journal of the American Dietetic Association 108:673-678. Bell, R. A., D. Cassady, J. Culp, and R. Alcalay. 2009. Frequency and types of foods advertised on Saturday morning and weekday afternoon English- and Spanish-language American television programs. Journal of Nutrition Education and Behavior 41:406-413. Hasher, L., and R. T. Zacks. 1984. Automatic processing of fundamental information: The case of frequency of occurrence. American Psychologist 39:1372-1388. IOM (Institute of Medicine). 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: The National Academies Press. IOM. 2010a. Front-of Package Nutrition Rating Systems and Symbols: Phase I Report. Washington, DC: The National Acad- emies Press. IOM. 2010b. Strategies to Reduce Sodium Intake in the United States. Washington, DC: The National Academies Press. Romaniuk, J., and B. Sharp. 2004. Conceptualizing and measuring brand salience. Marketing Theory 4:327-342. USDA (U.S. Department of Agriculture). 2008. Food and Nutrient Database for Dietary Studies, 3.0. Beltsville, MD: U.S. Department of Agriculture, Agricultural Research Service, Food Surveys Research Group. USDA. 2010. Dietary Guidelines for Americans. Washington, DC: U.S. Government Printing Office. USDA. 2011. Dietary Guidelines for Americans, 2010. Available online: http://www.cnpp.usda.gov/DGAs2010-PolicyDocument. htm (accessed April 2, 2011). Wixted, J. T. 2004. The psychology and neuroscience of forgetting. Annual Review of Psychology 55:235-269.

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