7
Conclusions and Plans for Phase II

Previous chapters have documented the proliferation of nutrition rating systems and symbols that has taken place in U.S. and international markets in recent years. Each of the systems is intended to promote the purchase and consumption of more nutritious foods and to help consumers make purchasing decisions on the basis of nutrition information quickly and accurately, but these systems vary greatly in the particular details of their purpose, symbols, formats, and criteria used. In this chapter the committee presents its conclusions, made on the basis of available information and its judgment, about how FOP systems might be best structured in the future. For the first phase of the committee’s work, the primary focus was the nutrition science underlying these systems. This focus is reflected in the conclusions presented here. This chapter also describes plans for a second phase of work that will consider consumer use and effectiveness of FOP systems and symbols to improve dietary practice and improve health.

TARGET AUDIENCE

Conclusion 1: Front-of-package rating systems and symbols would be best geared toward the general population.

The committee concluded that the target population for FOP rating systems should be the general population, for several reasons. The majority of the U.S. population is now overweight or obese, and the prevalence of chronic diseases and behaviors that increase the risk for chronic diseases are both at high levels (Ford et al., 2007, 2008). Thus there is an urgent need for a majority of the population to make healthier food choices. Furthermore, past nutrition labeling efforts, such as the Nutrition Facts panel, have used the general population as the intended audience (Taylor and Wilkening, 2008), so maintaining the general population as the audience for FOP rating systems will maintain consistency with other nutrition labeling now present on foods.

While FOP criteria and symbols would be best geared toward the general population, the committee recognizes that specific subpopulations (e.g., those with diet-related chronic disease, lower-income populations, minority populations, parents, and primary food purchasers) may benefit from information campaigns on FOP labeling that are specifically designed to address their particular health needs and to capture their attention. Such a campaign would be consistent with the IOM (2006) report suggesting a marketing campaign to educate parents about sound nutritional choices for their families. No such national campaign has been launched since that report.



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7 Conclusions and Plans for Phase II Previous chapters have documented the proliferation of nutrition rating systems and symbols that has taken place in U.S. and international markets in recent years. Each of the systems is intended to promote the purchase and consumption of more nutritious foods and to help consumers make purchasing decisions on the basis of nutri - tion information quickly and accurately, but these systems vary greatly in the particular details of their purpose, symbols, formats, and criteria used. In this chapter the committee presents its conclusions, made on the basis of available information and its judgment, about how FOP systems might be best structured in the future. For the first phase of the committee’s work, the primary focus was the nutrition science underlying these systems. This focus is reflected in the conclusions presented here. This chapter also describes plans for a second phase of work that will consider consumer use and effectiveness of FOP systems and symbols to improve dietary practice and improve health. TARGET AUDIENCE Conclusion 1: Front-of-package rating systems and symbols would be best geared toward the general population. The committee concluded that the target population for FOP rating systems should be the general population, for several reasons. The majority of the U.S. population is now overweight or obese, and the prevalence of chronic diseases and behaviors that increase the risk for chronic diseases are both at high levels (Ford et al., 2007, 2008). Thus there is an urgent need for a majority of the population to make healthier food choices. Furthermore, past nutrition labeling efforts, such as the Nutrition Facts panel, have used the general population as the intended audi - ence (Taylor and Wilkening, 2008), so maintaining the general population as the audience for FOP rating systems will maintain consistency with other nutrition labeling now present on foods. While FOP criteria and symbols would be best geared toward the general population, the committee rec - ognizes that specific subpopulations (e.g., those with diet-related chronic disease, lower-income populations, minority populations, parents, and primary food purchasers) may benefit from information campaigns on FOP labeling that are specifically designed to address their particular health needs and to capture their attention. Such a campaign would be consistent with the IOM (2006) report suggesting a marketing campaign to educate parents about sound nutritional choices for their families. No such national campaign has been launched since that report. 

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0 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS An appropriately designed system might be useful for determining products that may be marketed to children, an issue that can be revisited in Phase II. PURPOSES Conclusion 2: The committee supports the goal and purposes of front-of-package systems announced by the Food and Drug Administration in April 2010 and concludes that the most useful primary purpose of front-of-package rating systems and symbols would be to help consumers identify and select foods based on the nutrients most strongly linked to public health concerns for Americans. An ideal system would allow consumers to identify the amount of calories per serving and the serving size as well to compare and evaluate amounts of targeted nutrients present in different products both within and across food categories. Such a system may also encourage food and beverage manufacturers to reformulate products to meet nutrient criteria targeted by FOP systems. Two system types could fulfill these purposes—nutrient-specific systems and summary indicator systems based on nutrient thresholds in which all food categories had the same nutrient thresholds. NUTRITION INFORMATION TO INCLUDE As discussed above, the variation in FOP systems has led to numerous questions, including how sound the criteria are that are used to determine which products are the more nutritious choices. The committee considered these and a number of other questions in its review of existing systems. In developing conclusions on nutrients that should be included or excluded and options for setting criteria, the committee weighed potential conclusions against the guiding principles in Chapter 1. Conclusions 3 through 5 reflect the committee’s assessment of which pieces of nutrition information it would be reasonable to include or exclude from FOP systems at the current time. Conclusion 3: Regardless of system type, it would be useful to declare calorie and serving size information prominently in front-of-package symbols. As discussed in Chapter 4, obesity and overweight, which are caused by calorie consumption in excess of energy expenditure, are now a critical public health concern that affects the population. Given that overweight and obesity pose an increased risk for numerous diseases and morbidities, the 2010 Dietary Guidelines Advisory Committee encourages all Americans to know their energy needs as a means of avoiding inappropriate weight gain (DGAC, 2010). Including total calories in nutrition rating system symbols could be one tool for emphasizing the importance of calories in the American diet. In addition, such information might help consumers select lower- calorie foods, consume lower quantities of higher-calorie foods, and track the number of calories consumed per day and the relative contribution of various foods consumed. Including a more prominent display of calories within nutrition rating symbols would also provide consistency between packaged and restaurant foods. The Patient Protection and Affordable Care Act, 1 signed into law in March 2010, amends the Food, Drug, and Cosmetic Act to require chain restaurants to provide access to nutrition informa - tion for standard menu items. Restaurants with 20 or more outlets are required to post calories on menus, menu boards (including drive-thrus), and food display tags. Similarly, vending machines operated by large distributors are required to have calorie information displayed for vended products. Including calories on FOP systems for packaged foods could complement these new requirements. Providing serving size information would also give context to the amount of food associated with the calories per serving displayed as part of an FOP symbol. Serving size information in an easy-to-understand format consistent with current dietary practices may help consumers do a better job of visualizing appropriate serving sizes and put their servings into the context of the other foods and beverages they are consuming. 1 Patient Protection and Affordable Care Act. Public Law 111-148, Title IV, Subtitle C, Sec. 4205; March 2010.

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 CONCLUSIONS AND PLANS FOR PHASE II Displaying serving sizes would best be accomplished by using household measures that would be easy for the consumer to understand. U.S. authoritative bodies, consumer research groups, health professionals, and the food industry have long held that nutrient amounts should be expressed per serving rather than per 100 g, as is used in some other countries (Usmanova and Thor, 2003). Furthermore, there is some evidence that consumers find it helpful when a clear definition of a serving is provided. Research conducted during the development of the MyPyramid Food Guidance System found that most focus group participants believed that using household measures (e.g., cups or tablespoons) would be more effective than simply using the word “servings” because the household measures are more commonly understood (Britten et al, 2006). Household measures are also commonly used in the Nutrition Facts panel, so displaying serving size information in household measures would maintain consistency with this other tool for consumers. In addition, the committee identified several related approaches as being potentially important for enhancing accuracy, comparability, and consumer understanding of the relative contribution a product might provide towards daily caloric intake. These approaches include adding calories per package and the number of servings per pack - age and providing context for how the calories per serving relate to daily caloric needs (e.g., the proportion of a 2,000-calorie diet that a serving of a particular product provides). Consumer research may help determine whether one or more pieces of this additional information might be helpful in assisting consumers to visualize serving size and in increasing consumer awareness of the calorie contributions of the products they consume. The committee also recognized that the Reference Amounts Customarily Consumed (RACCs) used for defining labeled serving sizes in the Nutrition Facts panel may not reflect the larger portions of food consumed today. Conclusion 4: The most critical nutritional components to include in front-of-package nutrition rating systems are calories, saturated fat, trans fat, and sodium. As stated in the committee’s guiding principles (see Chapter 1), the committee considers it critical that FOP rating systems focus on the nutritional components that are most strongly associated with the diet-related health risks affecting the greatest number of Americans, such as obesity, cardiovascular disease, hypertension, type 2 diabetes, and certain types of cancer. Calories, saturated fat, trans fat, and sodium are four of the most critical nutritional components affecting these health risks, and they are also overconsumed in the American diet (see Chapter 4). As previously described, calories are the most critical nutritional component to address in reducing obesity and its various co-morbidities, including coronary heart disease (CHD) and stroke, type 2 diabetes, meta - bolic syndrome, and certain types of cancer. Reducing sodium intake can reduce blood pressure, which in turn can reduce an individual’s risk of stroke and cardiovascular disease events. Decreasing saturated and trans fat intake may decrease the risk of cardiovascular disease. Given the adverse health effects of excess calories, saturated fat, trans fat, and sodium intakes, including these components in nutrition rating systems could have important ben - efits to public health by helping Americans chose foods with lower levels of these nutrients of concern. Calories, saturated fat, trans fat, and sodium should not be viewed in isolation, however. It is important to understand not only whether labeling to encourage the choice of similar products with less of these components is effective in meeting that goal, but also whether such labeling encourages alternate food choices and, if so, the relative nutrient profile of those alternate choices. Conclusion 5: There is insufficient evidence at this time to suggest that including the following nutrients would be useful in all types of front-of-package rating systems or symbols: total fat, cholesterol, total carbohydrate, total or added sugars, protein, fiber, vitamins, and minerals other than sodium. It may not be essential or useful to include in all types of FOP systems a number of the nutrients that cur- rently appear on the Nutrition Facts panel or in existing FOP system criteria. Many factors led to the conclusion that certain nutrients might not be included in FOP system criteria at this time, including the relative importance of these nutrients to the most pressing diet-related public health concerns, the potential for some nutrients to track with other nutrients that are considered important to include in FOP rating systems, and challenges in measuring

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 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS compliance for some nutrients. This issue is particularly important considering the limited space available on food labels and shelf tags to present nutrition information, especially for FOP symbols that display information on individual nutrients. It is important to recognize that even though it might be best to exclude these nutrients from FOP system criteria, monitoring their intake is still important in assembling a diet that is consistent with optimal health out - comes. The point, however, is that other tools may be more appropriate for accomplishing goals for some of these nutrients, freeing up FOP systems to focus on the most critical public health concerns. For example, the Food, Drug and Cosmetic Act requires that information on total fat, cholesterol, total carbohydrate, total sugar, protein, fiber, and many vitamin and mineral contents appear on the Nutrition Facts panel. This information can be used by individuals who want or need to monitor intakes of these nutrients (e.g., individuals who need to monitor iron intake). Mandatory fortification of commonly consumed foods with vitamins or minerals that are lacking in the diet is another tool that is more suited to meeting certain public health needs for particular nutrients, and educa - tion campaigns are yet another. Reasons for excluding each of the nutrients listed above from FOP systems are provided in the sections that follow. Total Fat Because of the lack of data supporting an association between fat in the diet and either body weight or health outcomes, it is difficult to conclude that including total fat in FOP systems would be useful. Total fat includes mono- and polyunsaturated fats, which are associated with beneficial health outcomes, as well as saturated and trans fats, which are nonessential and associated with adverse health outcomes. The lack of evidence supporting an associa - tion with total fat and health and the heterogeneity in the total fat composition of a food product make it difficult to characterize total fat content as a positive or negative attribute in many types of nutrition rating systems. Furthermore, recent dietary guidance encourages the consumption of unsaturated oils in order to displace saturated and trans fats in the diet, making it important that Americans not be discouraged from consuming all forms of fat. Yet, there is some evidence that consumers continue to be confused about the various types of fats and that many continue to avoid even beneficial fats. The 2010 IFIC Food and Health Survey found that close to a third of Americans are attempting to decrease their intake of mono- and polyunsaturated fats (IFIC, 2010). Since many consumers have a negative view of all types of fat, it is likely that these consumers may avoid all products showing higher levels of total fat content in FOP systems that include nutrient-specific information, and this may not always be the desired behavior. Cholesterol While cholesterol remains a concern for certain subpopulations, overconsumption of cholesterol is not as significant a problem for the general population as overconsumption of saturated fat, trans fat, and sodium, so there is less need to include cholesterol in FOP system criteria. Furthermore, saturated fat criteria may help address most major sources of cholesterol. The major source of cholesterol in the diet is animal products, primarily meat and dairy. These foods are also typically sources of satu - rated fats. Since saturated fats are important to include in FOP systems, most foods that are “high” in cholesterol would already be rated poorly because of their saturated fat content. Therefore, it may not be necessary to include specific cholesterol criteria in order to help consumers chose lower-cholesterol foods. For some systems, such as those displaying nutrient amounts per serving, excluding cholesterol from the FOP symbol may help to reduce label clutter, leading consumers to focus more on nutrients of greater public health concern. Total Carbohydrates Like total fat, total carbohydrates consist of multiple components with various physiological functions. Carbohydrates as a class include a variety of compounds including monosaccharides (e.g., fructose), disaccharides (e.g., sucrose or table sugar), starch, fiber, pectins, and gums. These compounds vary greatly in their physiologi -

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 CONCLUSIONS AND PLANS FOR PHASE II cal function. The consumption of some carbohydrates, such as fiber, is encouraged, while consumption of other carbohydrates, such as added sugars (e.g., sucrose, high-fructose corn syrup) is discouraged. Because of the varied physiological functions that carbohydrates take on, it would be difficult in many types of nutrition rating systems to characterize the total carbohydrate content of an individual food as either a positive or a negative attribute. Total Sugars Consensus about the amount of total sugars that can be consumed in a healthy diet is still lacking. Beyond a role in dental caries and as a contributor to calories, identifying additional potential adverse effects of sugars on health outcomes remains elusive. Furthermore, total sugars include those naturally present in fruits, vegetables, and dairy products, which are generally considered foods to encourage. Thus, it is difficult to conclude that including total sugars in FOP systems could at this time address issues of public health concern or that such inclusion would not result in adverse dietary pattern outcomes. Added Sugars It might be plausible to include added sugars information on FOP labeling, mainly because the consumption of added sugars has increased, and this increase has contributed to the overall increase in total calories in Americans’ diets. A number of reports have recommended limits on the intake of added sugars, including Nutrition Standards for Foods in Schools (IOM, 2007) and the Report of the Joint WHO/FAO Expert Consultation on Diet, Nutrition and the Preention of Chronic Diseases (WHO/FAO, 2003). The Dietary Guidelines for Americans and other fed- eral nutrition guidance call on Americans to reduce the intake of added sugars, and surveys show that consumers are concerned about added sugars in foods (HHS/USDA, 2005; IFIC, 2009). However, a number of concerns and barriers exist for including added sugars in FOP rating systems. Based on the literature, there is a lack of scientific evidence and agreement about what adverse effects added sugars have on health outcomes independent of total sugar, with the exceptions that added sugars, whether in solid or liquid form, contribute extra calories which could lead to weight gain and obesity and that current sugar intakes exceed amounts consistent with consuming recommended intakes of essential nutrients. Because of the lack of scientific evidence and agreement on whether added sugars adversely affect health outcomes beyond contributing to calories, the committee concluded that the emphasis should be on calories rather than added sugars per se. A relatively small number of food categories—regular soft drinks, sugar and candy, grain-based desserts (cookies, cakes, and pies), and fruit drinks (fruitades and fruit punch)—provide over 70 percent of the added sugars in the American diet (Guthrie and Morton, 2000). Recommendations to reduce consumption of these specific types of food combined with including calories in FOP rating systems would be one approach to reducing added sugars in the American diet without requiring the inclusion of added sugars in FOP rating systems, and this approach would also maintain the current emphasis on the importance of calories. Another concern about including only added sugars and not total sugars in FOP systems is that it would under- represent the sugars content of foods high in naturally occurring sugars, thus misleading consumers who may need to be aware of total sugars, such as individuals with diabetes, those trying to control their weight, or parents trying to limit children’s sugars intake. For example, 100 percent fruit juice contains naturally occurring sugars but can easily be over-consumed and can contribute to energy imbalance; thus, it has been recommended that such juices be consumed in moderation (AAP, 2001). Inclusion of added sugars content in FOP systems also raises several challenges and concerns related to maintaining consistency with the Nutrition Facts panel, which was a guiding principle of the committee’s decision- making process. The Nutrition Facts panel on foods and beverages currently gives the amount of total sugars in a serving, but it does not distinguish whether the sugars were added to the food or occur naturally. Barriers to including added sugars on the Nutrition Facts panel have included both the state of nutrition science surrounding added sugars and various compliance monitoring concerns. As discussed in Chapter 6, distinguishing between added and naturally occurring sugars in food products presents analytical challenges. Lacking a regulatory com - pliance method, the only apparent solution to this analytical gap would be for food manufacturing companies to

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 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS share proprietary product formulations with the Food and Drug Administration (FDA) or a government-approved third-party auditor in order to differentiate and verify the amount of added sugars. Given the proprietary nature of most food formulations, some food manufacturers may resist sharing such information and oppose the inclusion of added sugars on the Nutrition Facts panel or in FOP information. In 1999, the Center for Science in the Public Interest, with support from a number of health and consumer organizations, petitioned FDA to require that added sugars be included on the Nutrition Facts panel (CSPI, 1999). Such labeling would make it possible for consumers to know how much has been added to foods such as yogurt, ice cream, puddings, flavored milks, breakfast cereals, and baked goods. It has been suggested that added sugars could be listed in grams in order to be consistent with total sugars (Krebs-Smith, 2001) and that FDA should establish a Daily Reference Value for added sugars and require a mandatory disclosure of added sugars in both grams per serving and percent Daily Value (CSPI, 1999). It will be important in the future to reevaluate whether added sugars content can or should be included in the Nutrition Facts panel. However, given the lack of scientific consensus concerning the adverse effects of added sugars (apart from their caloric contributions), and because monitoring levels of added sugars is not feasible, including added sugars on the Nutrition Facts panel may be a difficult task. Until these issues can be resolved and added sugars can be included in the Nutrition Facts panel, it seems premature to include added sugars in FOP systems. Protein Protein is currently not a nutrient of public health concern. Given that one of the guiding principles identified by the committee was that FOP systems should focus on those nutrients or food components that are most strongly associated with the diet-related health risks affecting the greatest number of Americans, it does not seem useful to include protein in the criteria of such systems at this time. Fiber, Vitamins, and Minerals (Other Than Sodium) While it is widely recognized that a healthful diet contains adequate amounts of various vitamins, minerals, and fiber, deciding whether to include information on them in FOP systems must take into account the lack of critical public health need for many of these nutrients, concerns over fortification, and the limited space for FOP symbols. For example, while the evidence for highlighting specific types of fiber is not as robust as that for the so-called negative nutrients, physiologic benefits and nutrients present in fiber-containing foods are recognized. Thus encouraging consumption of these foods is important, and the committee recognizes that increasing fruit and vegetable intake is a core recommendation of the Dietary Guidelines for Americans. Manufacturers also have mechanisms such as nutrient content and, in some cases, health claims to highlight positive nutrients. Thus, given the issues of space, need to focus on public health priorities, and availability of other tools, the committee concluded that including fiber on every type of FOP system was not essential. There are also measurement and definitional issues with fiber that complicate its use in FOP systems. For many vitamins and minerals there is no overarching public health need for the general population to increase intake. In fact, the 2010 Dietary Guidelines Advisory Committee found vitamin D, calcium, and potassium to be the only vitamins and minerals for which Americans have insufficient intake and were of public health con - cern (DGAC, 2010). Even for those vitamins, minerals, and fiber for which there is a public health need to increase intake, inclu - sion in FOP systems may not be the best means for achieving this goal. As described in Chapter 6 in the section on the role of fortification, including these nutrients in FOP systems could lead to practices such as excessive or inappropriate uses of fortification that may not be beneficial to consumers, or it could inadvertently drive consumers away from high-quality food choices that do not contain significant amounts of these nutrients. Similar fortification concerns arise for fiber, and there are also concerns regarding the definition of fiber, the health benefits of novel fibers that have been developed in recent years, and the fact that the 2010 Dietary Guidelines Advisory Committee stressed that fiber in the diet should come from incorporating more whole grains, fruits, vegetables, and legumes into the diet (DGAC, 2010). These potential adverse consequences, coupled with the risk of label clutter for some

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 CONCLUSIONS AND PLANS FOR PHASE II systems, imply that including these nutrients in FOP rating systems may not be an ideal tool for increasing con - sumption. This should not be taken to imply that the committee has minimized the importance of addressing public health concerns about shortfall nutrients in the U.S. diet, but it is instead recognition that encouraging consumers to eat a diet rich in shortfall nutrients may require other tools, depending on the type of FOP labeling. For example, there may be the possibility of using nutrient content claims (e.g., good source of calcium) and other claims as tools for calling attention to nutrients on specific products types. POTENTIAL QUALIFYING AND DISQUALIFYING NUTRIENT CRITERIA Given the gaps in scientific data noted above, the ongoing consumer research by FDA and others, and the plans for examination of consumer use of FOP labeling in the second half of the committee’s work, it is premature at this time to draw conclusions on the exact types of FOP symbols and systems that might be the most useful in informing consumers and facilitating dietary changes. The second phase of this study will consider consumer understanding and use of FOP symbols with the goal of helping to draw additional conclusions concerning which systems and symbols might be most helpful. Because of the diversity of system types, the committee was unable to identify a set of criteria that could be used for all FOP systems. However, the committee did examine how criteria might be set for various system types, and it believes that these considerations might serve as a basis for setting future FOP criteria once consumer research and testing results can determine which formats are most appropriate. Furthermore, the committee notes that future modeling work could help determine if the criteria were set in such a way that the types and quantities of products labeled facilitate recognition of FOP systems by consumers. In addition, modeling could be used to determine if choices made based on the criteria would be likely to improve food choices and lead to diets that are consistent with current dietary guidance. The sections that follow describe the committee’s thoughts on how criteria might be set for various system types. For each of the potential systems, the committee identified ways in which criteria might be set for calories, saturated fat, trans fat, and sodium, i.e., the nutrients that the committee concluded were most important to include in FOP systems. Conclusion 6: Based on the committee’s review, several options exist for setting criteria for two types of rating systems (nutrient-specific information and a summary indicator based on nutri - ent thresholds), but further testing of consumer use and understanding is required to assess their overall viability. The committee identified multiple options for setting criteria for two of the system types it had defined. For nutrient-specific information systems it identified four options for setting criteria, while two options were identi - fied for a summary indicator based on threshold systems. These options are described in the following sections. Other system types, including food group information systems and summary indicators based on algorithms, did not have readily apparent options for setting criteria. The challenges for setting criteria for these types of systems are also described in the sections that follow. Nutrient-Specific Information Several types of nutrient-specific information systems are possible. Some, such as calories per serving and claim-based icons (e.g., “low sodium” symbols), are factual statements, and the claim-based symbols are already subject to labeling regulations. On the other end of the spectrum of nutrient-specific information systems are those systems that use colors or words to indicate that a food is “high,” “medium,” or “low” in a specific nutrient. These systems require more work to establish criteria because existing labeling regulations do not establish “medium” levels, and “low” and “high” levels have not been established for all nutrients of interest. The committee identified four options for displaying calories, saturated fat, trans fat, sodium, and serving size which depend on the amount of information considered to be of most use to consumers.

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 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS Option : Amount per Sering The first option would be a simple, declarative statement (see Box 7-1). This would bring calories, saturated fat, trans fat, and sodium to more prominent locations for faster reading of some of the key information that is already part of the Nutrition Facts panel. To maintain consistency with the Nutrition Facts panel, the nutrients would need to be stated in the same units (calories, grams, or milligrams) and based on the same serving size as the Nutrition Facts panel. Because saturated fat and trans fat (so-called solid fats) are both fats of concern, these components could be combined to reduce the number of individual components that would need to be understood by consumers and to save valuable space on the front of food labels. The committee recognizes that doing so would be inconsistent with the Nutrition Facts panel and, therefore, would not be in accordance with one of the guiding principles intended to assist the committee in identifying a potential FOP system. Still, the benefits to the consumer and the food industry, in addition to health educators by minimizing one of the complexities in nutrition education programs, make it worth considering (IOM, 2003). The two types of fats are listed one after another and indented under total fat in the Nutrition Facts panel. Consumer research could be conducted to determine how consumers would respond to the summation of the two amounts under a single heading on the FOP label. In addition, to avoid the need for consumers to look at the Nutrition Facts panel in order to determine the serving size, the symbol could include the product serving size in terms of common household measurements. Option : Amount Within the Context of a Daily Diet The second option would display calories, saturated fat, trans fat, and sodium in the context of the daily diet by displaying the %DV provided per serving (see Box 7-2). Daily Values currently exist for some but not all nutrients of interest. A Daily Value for calories does not exist, but the %DV could be based on a 2,000-calorie diet, which is consistent with the Nutrition Facts panel and is currently being done by at least one food manufacturer on FOP labeling. Providing a Daily Value for calories was discussed by FDA in its 2004 report entitled Calories BOX 7-1 Nutrient-Specific Information Option 1: Nutrient Amounts per Serving Declaration of: • Calories • Saturated fat + trans fat (g) • Sodium (mg) • Serving size BOX 7-2 Nutrient-Specific Information Option 2: Nutrient Amounts Within the Context of a Daily Diet Declaration of: • %DV of calories based on a 2,000-calorie/day diet • %DV of saturated fat + trans fat (using Daily Value for saturated fat as basis for calculation) • %DV of sodium • Serving size NOTE: Calories, grams of saturated + trans fats, and milligrams of sodium could also be displayed.

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 CONCLUSIONS AND PLANS FOR PHASE II BOX 7–3 Nutrient-Specific Information Option 3: Characterization of the Amount of Nutrients in Foods—“Low” Levels Only • Declaration of calories • Characterization of saturated fat + trans fat as “low” when appropriate • Characterization of sodium as “low” when appropriate • Declaration of serving size NOTE: Grams of saturated + trans fats and milligrams of sodium as well as %DVs for saturated + trans fats, sodium, and calories could also be displayed; %DV for calories is based on 2,000 calories/day. TABLE 7-1 FDA-Regulated Criteria for “Low” Calories, Saturated Fat, and Sodium Nutrient Content Claims Individual Food Main Dishes and Meals Calories 40 calories or less per RACC (and per 50 g if RACC is small) 120 calories or less per 100 g Saturated Fat 1 g or less per RACC + 15% or less calories from 1 g or less per 100 g + less than 10% of calories from saturated fat saturated fat Sodium 140 mg or less per RACC (and per 50 g if RACC is small) 140 mg or less per 100 g Count: Report of the Working Group on Obesity (FDA, 2004) and in an April 4, 2005, advance notice of proposed rulemaking.2 Using this, a 200-calorie serving, for example, would contribute 10 percent of the Daily Value for calories. Like calories, trans fat does not have a Daily Value. However, similar to the suggestion in Option 1, grams of trans fat could be combined with grams of saturated fat, and the %DV could then be calculated on the basis of the combined quantity, using the Daily Value for saturated fat. This approach was taken for nutrition labeling in Canada.3 Without new rulemaking to amend current nutrition labeling regulations to provide for a declaration of the %DV of saturated and trans fat combined, this option would result in a value that would, when trans fats are present, differ from the %DV declared on the Nutrition Facts panel for saturated fat. To address the lack of a Daily Value for trans fat and because Daily Values have not been not updated as new IOM Dietary Reference Intakes have been established and are considered by some to be out of date, labeling systems based on Daily Values would benefit from updating. This would ensure that the systems are based on the most accurate informa - tion known about the nutrient quantities that should be consumed for optimal health. This type of system could also display information on calories, grams of saturated and trans fat, and milligrams of sodium if this was found to be useful to consumers. Option : Characterization of the Amount of Nutrients in Foods—“Low” Leels Only The third option would characterize the amount of various nutrients per serving, identifying whether a serving of food contained “low” amounts of saturated fat, trans fat, and sodium (see Box 7-3). The indication of “low” might be displayed as the word “low,” as a green light, or some combination of the two. Information on the amounts and %DV of saturated and trans fats and sodium contributed by the food might also be present. For this option, the regulated definitions for “low” could be used as the criteria for saturated fat, again combining saturated and trans fats as described in Option 2 (see Table 7-1). While the regulated criteria for “low” could be used for sodium as well, if FDA adopts the recommendations of the recent IOM report Strategies to Reduce Sodium Intake (IOM, 2 70 FR 17008. 3 Available online: http//www.hc-sc.ca/fn-an/label-etiquet/nutrition/cons/inl_main-eng.php (accessed September 17, 2010).

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 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS BOX 7-4 Nutrient-Specific Information Option 4: Characterization of the Amount of Nutrients in Foods—“High,” “Medium,” and “Low” Levels • Declaration of calories • Characterization of saturated fat + trans fat as “high”/“medium”/“low” • Characterization of sodium as “high”/“medium”/“low” • Declaration of serving size NOTE: Grams of saturated + trans fats and milligrams of sodium as well as %DVs for saturated + trans fats, sodium, and calories could also be displayed; %DV for calories is based on 2,000 calories/day. TABLE 7-2 FDA-Regulated Disclosure Levels for Saturated Fat and Sodium Individual Fooda Main Dishb Mealb Saturated Fat 4g 6g 8g Sodium 480 mg 720 mg 960 mg a Per RACC, per labeled serving, or for foods with small RACC, per 50g. b Per labeled serving. 2010), it may be necessary to adjust the criteria for “low.” If the IOM recommendations to gradually reduce the amount of sodium in foods are adopted, the criteria for “low” could be adjusted with each stepwise reduction in the level of sodium considered to be Generally Recognized as Safe. If Option 3 is used, it would be useful to dis - play calories and possibly a %DV for calories (based on a 2,000-calorie-per-day diet). However, there was some question about the utility of including an indication of “low calorie.” The FDA definition of “low” is 40 calories per RACC. Since few foods, even those considered as part of a healthy diet, contain 40 calories or less per RACC, characterizing calorie levels in this way could have the unintended consequence of discouraging the consumption of otherwise nutritious foods. Option : Characterization of the Amount of Nutrients in Foods—“High,” “Medium,” and “Low” Leels The fourth option would be similar to Option 3 but would further characterize the relative amounts of nutrients by including indicators of “medium” and “high” (see Box 7-4). This might be displayed using words or traffic light colors, or both. For saturated and trans fats and sodium, the same criteria described in Option 3 could be used to identify “low” contents. For “high” criteria, it may be possible to use disclosure statement criteria. FDA regulations require that disclosure statements be placed adjacent to claims on food packages when another nutrient in the food exceeds certain prescribed levels. (USDA regulated meat and poultry product labels are not subject to this requirement.) Disclosure statements are intended to alert consumers that some nutrients in the food may increase the risk of a disease or health-related condition.4 For example, a food that is “low” in saturated fat but “high” in sodium is required to have the statement “See nutrition information for sodium content” if a “low saturated fat” claim is made. Table 7-2 displays the current disclosure levels for saturated fat and sodium. These levels could be used for “high” criteria, with “medium” levels being defined as all nutrient levels between “low” and “high” criteria. 4 Available online: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ FoodLabelingGuide/ucm064908.htm (accessed June 23, 2010).

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 CONCLUSIONS AND PLANS FOR PHASE II As described in previous options, trans fat content could be added to the saturated fat content, and the combined total could be rated against the saturated fat regulations. On the other hand, characterizing calorie contents in the same way that saturated fat, trans fat, and sodium are characterized under this option could have unintended consequences. Small differences in caloric intake can result in a weight change over time. Thus, even consumers who were trying to consume a healthy diet by consuming most foods within the “medium” range for calories could gain weight, particularly if foods were within the upper range of the “medium” criteria and were consumed multiple times per day. Furthermore, no disclosure statement levels exist for calories, which would create additional complications for setting criteria if an effort was made to characterize calorie levels. Despite these concerns, calories remain important for such labeling systems and could be included by providing the number of calories per serving or a %DV for the calories per serving based on a 2,000-calories-per-day diet. Summary Indicators Based on Nutrient Thresholds The committee concluded that two options might be reasonable for developing a nutrient threshold-based summary indicator. As discussed above, these systems would be based on the content of calories, saturated fat, trans fat, and sodium and would include a declaration of serving size. The two options would be to (1) set the same criteria across all foods or (2) develop different criteria across food categories in order to make the criteria more or less stringent based on the characteristic attributes of the food category. For either system, the setting of criteria would benefit from modeling studies to ensure that an adequate number of foods qualify within each category and to ensure that the resulting ratings make sense from the perspectives of both nutrition science and dietary guidance. Option : Set Criteria Across All Food Categories A summary indicator based on the same criteria across all food categories would make it possible to com - pare foods across the supermarket. For example, apple slices would be rated against the same criteria as potato chips, as is currently possible using existing nutrient content claims defined by FDA and the U.S. Department of Agriculture. For FOP systems, products qualifying for the use of a summary indicator (summary symbol) on packaging or shelf tags would need to meet multiple criteria requirements including providing information on calories and serving size and meeting specified levels for saturated fat, trans fat, and sodium (see Box 7-5). Criteria could be similar to those proposed in Option 3 for nutrient-specific information systems but result in a single symbol rather than a “low” characterization for each nutrient. However, setting criteria in this manner would likely result in certain food categories having very few foods that qualify for a summary symbol. Since consumers would see a single summary symbol rather than a characterization of the levels of individual nutrients (as in Options 3 and 4 for the BOX 7-5 Summary Indicator Option 1: Same Criteria Across All Food Categories Set criteria for all foods with requirements for: • Declaration of calories as part of the symbol • Declaration of serving size as part of the symbol • Specified threshold for saturated fat used across all food categories • Specified threshold for trans fat used across all food categories • Specified threshold for sodium used across all food categories

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0 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS nutrient-specific information), there might be some additional flexibility to set less stringent qualifying levels of saturated fat and sodium without having to worry about inconsistencies with criteria for “low” nutrient content claims. The committee did not have sufficient resources or data to propose what these less stringent levels might be. However, the committee expects that parties interested in developing such a system could model the effects that various criteria would have on which foods qualify. Option : Set Separate Criteria by Food Categories A summary indicator based on separate criteria for various food categories would be valuable for comparing products within a food category (see Box 7-6). For example, breakfast cereals, snack foods, and meats could each be considered separate food categories and thus have their own nutrient criteria. The downside of this option would lie in the difficulty of comparing foods across categories because of differences in qualifying criteria. To develop this type of summary symbol system, it would be necessary to determine the number of distinct food categories that are reasonable and to determine criteria for saturated fat, trans fat, and sodium for each cat- egory. The committee assumes that in this type of system, the criteria for certain nutrients would be less stringent in some categories than in others so that a sufficient number of products would qualify for the symbol in each category. For example, the sodium criteria for a soup category might be more lenient than for a breakfast cereal category. There may be a role for calorie criteria in this type of summary indicator system, but further modeling would be needed to determine the usefulness of such a requirement. Given the complexity of the Phase I task, the importance of a timely Phase I report, and data shortfalls, the committee was unable to develop conclusions on the food categories and category-specific nutrient criteria that would be needed for such a system. However, the committee expects that parties interested in developing such a system could model the effects of various food categories and criteria. Summary Indicators Based on Algorithms The committee concluded that algorithm-based ratings would not constitute an ideal system for the purposes of characterizing or rating only calories, saturated fat, trans fats, and sodium. This is because an algorithm-based system would need to assume that the effects of saturated fat, trans fat, and sodium are additive for overall health outcomes, which is not the case. Furthermore, the use of algorithms to rate the quality of foods based on these nutrients could have adverse effects on the goal of promoting a high-quality diet. For example, a food that is “low” in saturated fat may still contribute a large amount of sodium. But by the nature of an algorithm, the resulting score for this product could be similar to a product with moderate levels of both nutrients, leaving consumers unable to recognize that, by eating the first food, they would need to limit the amount of sodium they consume from other sources. This could result in overconsumption of certain nutrients over the course of the day, particularly if BOX 7-6 Summary Indicator Option 2: Separate Criteria by Food Categories Set varied criteria for different food categories with requirements for: • Declaration of calories as part of the symbol • Declaration of serving size as part of the symbol • Category-based thresholds for saturated fat • Category-based thresholds for trans fat • Category-based thresholds for sodium

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 CONCLUSIONS AND PLANS FOR PHASE II multiple foods were consumed that received better scores due to one nutrient being extremely low when another nutrient content was not as favorable. Food Group Information The committee also concluded that FOP symbols based on food group information would not provide suf - ficient information about nutrients of concern. Such systems generally provide only information on the percentage of recommended food group intake (e.g., 10 percent of daily vegetables or 30 percent of daily dairy needs). Such information could be useful to consumers in terms of the number of servings they need to consume per day, but it does not characterize the nutritional quality of the food. This could make some foods receive good ratings even though they are not “low” in saturated fat, trans fat, or sodium. For example, a pasta dish with a full serving of vegetables might supply a high percentage of daily vegetable needs but also be “high” in sodium and saturated fat because of a heavy cream sauce. Therefore, such systems are most likely insufficient for addressing the major nutrient concerns that exist in the United States. PLANS FOR PHASE II During the first phase the committee was challenged by the task of considering advantages and disadvantages of various approaches and the nutrition criteria that underpin the FOP graphic representations without the benefit of an examination of consumer research. Such a focus, however, did enable the committee to focus singularly on the criteria that undergird symbols and to draw conclusions for exploration in the second phase in the context of consumer behavior research. During the second phase, an ad hoc committee will continue the overall activity to the review and make recommendations about front-of-package nutrition rating systems and symbols by shifting to an emphasis on understanding which systems and symbols are most effective with consumers. The committee will draw on the first phase report as it considers: (1) which systems and symbols are most effective with consumer audiences and best promote health, (2) how to maximize their use, and (3) the potential benefits of a single, standardized front-label food guidance system regulated by the Food and Drug Administration. Thus, in addition to the expertise resident in the first phase committee, the second phase committee will include additional expertise about how consumers make sense of nutrition and other health information. The committee’s approach to its task will be multifaceted and will include gathering information from rel - evant consumer behavior literature and experts in relevant fields, including research on FOP undertaken by FDA; deliberating on issues relevant to the task; and then drafting its report. As evidenced by the questions below, the committee will be attentive to research related to consumer literacy and numeracy, as well as usability of labels by various subgroups in the population, including children and adolescents. The committee does not plan to undertake its own consumer research. Modeling to understand which foods would receive favorable ratings with various criteria options and to ensure that the resulting ratings encourage a diet that is consistent with dietary guidance is desirable. Ultimately, any system will need to be field tested to ensure that it results in more nutritious food choices among the Ameri - can public. During Phase II the committee intends to explore available modeling from the literature, and identify questions, target audience, and study designs for such modeling based on understandings from its review of the consumer literature. Given the timeframe and financial resources, the ability to conduct substantial modeling during the study process may be limited. There are a number of questions whose answers have and will continue to enhance the committee’s understand - ing of FOP system development and use to convey information accurately and affect purchase choices and eating behavior. Some were posed to developers and administrators of FOP systems during preparations for, and as part of, the Phase I workshop, and the committee will reexamine them. These are shown in Chapter 1, Box 1-2. Questions will also be posed as part of the committee’s workshop on Consumer Behaior Research and Front of Package Nutri- tion Rating Systems and Symbols—What do consumers know, understand, and use? This workshop is an important component of the committee’s information gathering. It is expected that the workshop will be held in conjunction

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 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS with the initial second phase meeting of the committee in order to best inform the committee’s deliberations. The workshop will include presentations on consumer information on FOP systems and symbols and additional consumer research issues. Time will be made available for public comment on issues in the course of the workshop. Presenters about recent consumer behavior research will be asked to describe briefly their research methods and samples, including populations and subpopulations studied, and then to address such questions as: • What are the limitations of your work and how generalizable are your results? • What does your work show about clutter and other factors that influence attention to and comprehension of FOP? • What does your work show about differences among demographic or other populations and what are varia - tions in response to the FOP by children, adolescents, people who do not speak English, people with low health literacy and those with low incomes? • What kinds of diet and health outcomes did you explore and what did you find? • If your work focused more generally on food labeling, what are implications of your work for FOP? • What do you think should be on FOP? Additional issues of particular importance to the committee are consumer literacy and numeracy, population subgroups, new technologies, consumer use of back of panel and relevance for FOP, and relationship of labeling to product reformulation. These topics will be explored at the workshop and subsequently considered by the com - mittee during its deliberations. The committee will seek answers to questions such as the following through the workshop and subsequent literature analysis: • What is known about health literacy and numeracy and its distribution in the population? • What are the implications for developing an FOP system? • What should the committee consider related to the health literacy of the American populations and sub - groups as it considers FOP labeling? • For example, what is the best way to communicate to the consumer using FOP? What factors need to be considered for individuals with low health literacy and numeracy? • How much information is too much? • Are there variations in response to the Nutrition Facts panel by subgroups—children, adolescents, non- English speakers, individuals with low incomes? • What is the vision of the future related to new consumer technologies? • What does the committee need to consider so that its recommendations are timely and will not be outdated quickly? • Has nutrition labeling affected product reformulation? • What should the committee pay particular attention to in considering FOP labeling and its potential for influence on product reformulation? In addition to the information learned through the workshop, the committee’s deliberations will be informed by examination of evidence related to the effects of health information from product packaging and point of pur- chase displays on consumer perceptions, decisions, and behaviors. General information and information related to specific nutrients, if available, will be sought. As was the case with the Phase I review of nutrition rating systems, international research on consumer aspects of use of symbols will be reviewed, including that conducted in the United Kingdom. The report of the second phase is due late summer 2011. CONCLUDING REMARKS After reviewing a number of existing systems and examining the roles that FOP nutrition rating systems and symbols have the potential to play, clear conclusions can be drawn in some areas, but questions remain in others. It is clear that no system is perfect—each has strengths and limitations that must be weighed against the primary and secondary purposes of FOP systems. For the most part, systems have not been field tested in order to provide data

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 CONCLUSIONS AND PLANS FOR PHASE II on whether the stated goals of the system are achieved. Given current public health needs, it was the judgment of this committee that a limited number of nutrition components most closely related to prominent health conditions may have the potential to be of most benefit when reported with an FOP system. Phase II offers an opportunity to explore these conclusions in the context of consumer behavior. If the options identified by the committee are supported by the consumer research and ultimately adopted, adjustments to nutrition labeling regulations for FDA-defined claim criteria, Daily Values, and/or RACCs may be useful to ensure consistency and allow an appropriate number of products to qualify for FOP symbols. The committee’s guiding principles stress the need for maintaining consistency with existing nutrition labeling regula - tions. To comply with this principle, in many cases it would be best if criteria were continually anchored to the most recent version of the Dietary Guidelines for Americans and current consensus reports. The committee recognizes that calls have been made to update nutrition labeling regulations, including Daily Values and RACCs. It would be useful if FDA developed a formalized process that would trigger an automatic reassessment of system nutrient criteria when changes are made in the dietary recommendations on which the system is based. This could include updates to FOP system criteria. Once the scientific integrity of a potential FOP system has been verified, research will be needed to determine the most effective way of presenting the ratings to consumers and evaluating the system after it is adopted. Some such research is being conducted by the FDA, academic institutions, and industry and can factor into future FOP system development and adjustments. 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