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3 Actions by Federal Agencies: A Focus on Foods and Beverages Key Presenter Messages • The Federal Trade Commission has been examining the self- regulation of marketing practices by the food industry and is working on nutritional standards for food marketed to chil- dren and adolescents. • The Food and Drug Administration has been implementing the federal menu labeling law, updating the Nutrition Facts label, defining dietary guidance statements, and considering a front- of-package labeling system. • Although their reach and budgets are limited, federal agencies have many potential ways to help prevent childhood obesity. Three speakers at the workshop described actions taken by the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) to alter some of the factors that contribute to childhood obesity in the United States. Although there are limits on the authority of federal agencies to regulate the manufacture, marketing, and consumption of foods and bever- ages, legislation also gives them unique leverage points for combating the obesity epidemic. 13

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14 LEGAL STRATEGIES IN CHILDHOOD OBESITY PREVENTION INITIATIVES BY THE FEDERAL TRADE COMMISSION The FTC is involved in helping to prevent childhood obesity in several ways, including public education and the enforcement of regulations, said David Vladeck, director of the FTC’s Bureau of Consumer Protection. In his presentation, Vladeck focused on two major initiatives—one directed at food marketing and the other at nutritional standards. In 2008 the FTC released a groundbreaking report on food and bever- age marketing to children based on 2006 data (FTC, 2008). Previously, no government agency had been able to document as thoroughly and precisely the dollars spent on the wide array of marketing techniques being used to promote foods and beverages to children. By using its powers of com- pulsory process, which give the agency the legal authority to compel the provision of certain kinds of information, the FTC was able to amass an unprecedented data set on these techniques. Based on these data, the FTC made several key recommendations: • All food and beverage companies should adopt and adhere to meaningful nutrition-based standards for marketing their products to children under 12. • These nutrition-based standards should not apply just to television, radio, print, and Internet advertising but cover the full range of marketing activities directed at children, including packaging and in-store promotions. • All companies should cease in-school marketing and promotion of foods and beverages that fail to meet meaningful nutritional standards. • Media and entertainment companies should institute their own self-regulatory programs. In its study, the FTC did not address the question of whether there is a link between food marketing to children and childhood obesity rates. However, in a comprehensive survey of the then-available research on the relationship between food advertising on television and requests for, pref- erences for, and consumption of the advertised products by children and adolescents, the Institute of Medicine (IOM) concluded that there is strong evidence that television advertising influences food and beverage requests, preferences, and short-term consumption by children aged 2 to 11 (IOM, 2006). The evidence with respect to adolescents and to a relationship with long-term consumption patterns was not as strong. The IOM study did not draw a conclusion about the causal relationship between television advertis- ing and adiposity in children and adolescents, although the two are clearly associated, said Vladeck. He noted that additional research has occurred

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15 ACTIONS BY FEDERAL AGENCIES in this area since 2006 and that updating this literature is warranted if not already under way. In its 2008 report, the FTC also committed to conducting a follow-up study a few years later. That follow-up study has now begun. On August 23, 2010, the FTC sent a second round of compulsory process orders to 48 companies, including most of the original 44 companies. These orders sought similar but expanded information about marketing activities and expenditures for calendar year 2009, as well as nutritional information on the foods marketed to children. The timing of this follow-up study is propitious, said Vladeck. In 2006, efforts by the industry to self-regulate its activities in this area were in their formative stages. By the close of 2009, the industry had 3 years of experi- ence with self-regulation. In its forthcoming report, the FTC will be able to document not only the dollars spent on marketing but also the nutritional properties of the advertised products. In this way, it will be able to measure the extent to which self-regulation has achieved its stated goal of changing the nutritional landscape of food marketing to children. The second initiative Vladeck described is a joint undertaking of the FTC, the FDA, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture. The Congress has charged an interagency working group with recommending nutritional standards for foods to be marketed to children and adolescents. The group has been preparing a notice proposing a set of nutritional standards—a large and complex task, according to Vladeck. When the proposal is published, the group will seek public comment, “and the more comment the better,” he said, since “we have struggled with some of these issues.” The proposed standards will not be regulations, Vladeck emphasized. Rather, the voluntary cooperation of the food industry will be sought in using the standards to raise the nutritional bar for foods marketed to children and bring greater uniformity to the standards companies follow. Regulators and Congress “have made the decision to give self-regulation a chance,” said Vladeck. INITIATIVES BY THE FOOD AND DRUG ADMINISTRATION As the agency responsible for regulating the labeling of most food products on the market, the FDA is involved in many activities with a connection to childhood obesity. Barbara Schneeman, director, Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, FDA, described four specific initiatives: implementing the federal menu labeling law, updating the Nutrition Facts label, defining dietary guidance statements, and considering a front-of-package labeling system or systems.

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16 LEGAL STRATEGIES IN CHILDHOOD OBESITY PREVENTION Federal menu labeling law: The Affordable Care Act of 2010 created a requirement for nutrition information on menus, menu boards, and vend- ing machines. This requirement applies to chain restaurants with 20 or more locations and similar retail food establishments. They must disclose calorie content on menus and menu boards, make additional nutrition information available upon request, and provide a statement on the menu or menu board about the availability of that additional information. They also must provide calorie information for most self-service items and foods on display. The law applies as well to vending machine companies that own or operate 20 or more vending machines. If the Nutrition Facts informa- tion for products in the machines is not readily available to consumers, the calorie information for those products must be disclosed. Since Americans on average now consume about a third of their total calories outside the home, Schneeman said, labeling of these foods has become an increasingly important issue. In July 2010 the FDA issued a Federal Register notice seek- ing research and expert opinion on menu labeling, in response to which it received 873 comments. In that same month, the agency published a Fed- eral Register notice regarding restaurants that may not be covered by the federal law but are covered by state or local requirements and could choose to be covered by the federal law. In August the FDA published a guidance document explaining the preemptive effect of the new law, along with draft guidance on the provisions of the law that were effective immediately. At the time of the workshop, the agency was working to finalize its implemen- tation guidance for the new law, with a statutory deadline of March 23, 2011, for publishing the proposed regulations. Nutrition Facts label: The FDA has been working to update the Nutri- tion Facts label that since 1994 has been mandated to appear on most packaged food in the United States. The label includes information on serving size, calories, and nutritional content based on daily values. The agency plans to issue proposed regulations regarding the prominence of the calorie information, updated daily value information, and updated serving size information for certain products. Additional issues on which the FDA is working involve the declaration for carbohydrates, the utility of the footnote that appears on the label, and the inclusion of nutrients of public health value. Dietary guidance statements: The FDA is working on the dietary guid- ance statements used in food labeling, which relate to general dietary pat- terns and practices that promote health. An example is: “Substitute higher fat snacks with fruits and vegetables for a quick alternative.” The use of these statements by manufacturers is voluntary, but the FDA wants to provide guidance on conditions under which it is appropriate to use such statements on food products, Schneeman said. The FDA also believes that it would be beneficial to define these types of statements more clearly.

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17 ACTIONS BY FEDERAL AGENCIES Front-of-package labeling: Finally, the FDA wants to develop a front- of-package labeling system or systems that consumers will notice, under- stand, and use to make healthier food choices. This labeling also should encourage consumers to make more use of the Nutrition Facts label. Front- of-package labeling can be divided roughly into two categories: information based on nutrients, and numeric or symbolic summary symbols. The latter might include a logo; a numeric or symbolic rating (such as multiple stars); or a system based on red, yellow, and green highlighting. An example of what has been studied is a shorter version of Nutrition Facts, which the FDA has termed Nutrition Tips. The agency also has tested the provision of nutritional information through a rating on the front of the package or through the use of a term such as “healthy.” The IOM has been studying front-of-package labeling, and Schneeman said the FDA is following this work carefully to learn how such labeling can be most effective. At the time of the workshop, the Office of the Assistant Secretary for Planning and Evaluation also was carrying out a study on labeling that would help inform the FDA’s actions. According to Schneeman, the FDA wants “to make sure that we have the right information, so as we move forward with guidance, we are coming up with something that we know will be of value to consumers.” In addition to the above initiatives, the FDA is involved in food label- ing in other ways. For example, in February 2010 it sent warning letters to 17 companies about misleading claims on the front of packages. The agency also is actively involved with other agencies in the development of the Dietary Guidelines for Americans and in efforts addressing the market- ing of foods to children. Michael Landa, acting director, Center for Food Safety and Applied Nutrition, FDA, spoke more broadly about the FDA’s role in preventing childhood obesity. The agency issues and enforces regulations requiring various types of label disclosure. It enforces a general prohibition against labeling that is false or misleading. Also, it engages in some educational activities, although its budget for such activities is limited. The FDA’s underlying goal, Landa said, is to determine how to motivate people to follow healthful diets. How can labels be designed and applied so that people will understand, pay attention to, and use them? “Most of our efforts are geared to providing information to help consumers construct and follow healthful diets,” he said. “You have to get that right. You have to get it in language that people understand, but also in language that they can and will use.” The FDA also oversees the way industry uses health claims. For exam- ple, the agency authorizes by regulation a particular kind of health claim. “The paradigm is, ‘consumption of X may help reduce Y,’” said Landa. “Those [claims] are pretty tightly controlled.” In contrast, the FDA is still

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18 LEGAL STRATEGIES IN CHILDHOOD OBESITY PREVENTION involved in litigation involving health claims not supported by “significant scientific agreement,” a statutory standard based on publicly available data of a certain quality. Courts have ruled against the FDA’s attempts to ban such claims and have asked whether they could be qualified through the use of a disclaimer. The FDA has objected to the use of such qualified health claims, but the courts have ruled that the First Amendment does not allow the agency to ban the formulation and use of at least some such claims by companies. “Much of the litigation has been over what that formulation is,” said Landa. Finally, Landa expressed the opinion that one of the primary reasons for the increased use of seatbelts was education of elementary school chil- dren. “At least when my son was in elementary school, heaven help the driver or passenger in a car if he did not have his seatbelt on.” To prevent childhood obesity, Landa said, the government will need to devote “a good deal of energy, time, money, and thought to education.” DISCUSSION During the discussion period, Bruce Silverglade, Center for Science in the Public Interest, asked Landa about a different kind of health claim, which takes the form of “consumption of X helps maintain a healthy Y.” Landa replied that the FDA has no premarket control over these so-called structure–function claims; the law does not require that companies notify the FDA before such claims are made. The regulatory tool available to the FDA in these cases is the statute barring interstate commerce in food prod- ucts that bear false or misleading labeling. The law states that companies should have substantiation to support structure–function claims. But the FDA, unlike the FTC, does not have compulsory process power to force a company to submit the evidence it has. The FDA can search the published literature to see whether it contains evidence supporting the claim, but even if it does not, this does not mean that data supporting the claim do not exist. Silverglade also asked Vladeck whether the FTC needs evidence con- cerning causation to make a claim that a product’s labeling is deceptive. Vladeck replied that the FTC does not take the position that causality or materiality is a necessary element of a claim. It remains a point of conten- tion whether a company can defend against a claim by proving that no one was affected—that is, that the claim is immaterial. As an example, Vladeck noted that the FTC sent letters to companies about their use of omega-3 fatty acids in marketing claims, and many of the companies changed the claims. “If there were litigation over any of those claims,” he said, “we could have established that these claims were material to purchas- ing decisions.”

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19 ACTIONS BY FEDERAL AGENCIES Several workshop participants discussed the extent to which legal strat- egies should differ for products that are not necessary to life, such as tobacco, and those that are necessary to life, such as food. Teret pointed out that some people in the advocacy and legal communities believe that the ultimate goal should be to eliminate the manufacture and smoking of cigarettes, whereas no one would make that claim about food or the use of motor vehicles. Thus legal strategies and legal goals must be appropriate to the type of product, he suggested. A finer-grained analysis could consider particular kinds of foods, such as calorie-dense foods, he said. Vladeck emphasized that just because a product is necessary does not mean that the law cannot be used to effect change. He noted that many successful public health initiatives have involved necessary products. The introduction of the air bag (discussed in Chapter 2) is a good example. No one was going to argue that we should eliminate all motor vehicles. . . . The argument is that you needed to effect change.” Schneeman pointed out that those who formulated the 2005 Dietary Guidelines struggled with the issue of necessary and unnecessary consump- tion. One way to analyze food consumption is to calculate how many “discretionary calories” a person can consume without gaining weight, although some object to this term. A person who engages in low to mod- erate levels of physical activity has a relatively limited number of calories from which to gain necessary nutrients without becoming obese, and thus must consume nutrient-dense foods. Yet many Americans consume more calories than they can burn without meeting their nutrient needs. “That is part of the dilemma of how we think of food. Yes, it is necessary, but how should we be thinking of it in terms of meeting our nutrient needs?” The advisory committee working on revising the Dietary Guidelines has been examining the concept of nutrient-dense foods, Schneeman said. Scott Faber of the Grocery Manufacturers Association (whose presen- tation at the workshop is summarized in the next chapter) observed that a glass of 2 percent milk is not an inherently dangerous product like a gun. The regulatory approach taken toward milk therefore should be different from that taken toward certain other commercial products. Moreover, applying the same regulatory approach to all foods is problematic because it is difficult to draw the line between necessary and unnecessary calories. For example, one person’s list of discretionary foods would be different from another’s. Furthermore, such distinctions would be difficult to imple- ment given the many thousands of food items in the marketplace. Thus, said Faber, setting limits on manufacturers is a complex undertaking that may not be the best approach to the problem. In response to a question about preventing childhood obesity in com- munities of color, specifically in Hispanic communities, Vladeck noted that the FTC is an antifraud agency and not a public health agency. However,

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20 LEGAL STRATEGIES IN CHILDHOOD OBESITY PREVENTION it does carefully monitor Spanish-language media for misleading claims directed to Hispanic communities. Schneeman pointed out that the FDA has provisions for the dual labeling of food products in Spanish and Eng- lish. The agency also has outreach and education programs for Hispanic communities. For example, the Spot the Block program has a component aimed at getting Spanish-speaking communities to make greater use of the Nutrition Facts label. Similarly, Landa said that the front-of-package labeling initiative will include a public education campaign focused on par- ticular groups and using multiple languages. “We understand that there are different communities that will use these labels differently, and we need to structure our public education campaign accordingly,” he said. In response to a question about how the FDA can enforce the menu labeling provisions for companies that fail to comply, Landa suggested that the enforcement tools available to the agency are not a good fit with the regulations. The agency can seize products, issue injunctions for failures to comply, or prosecute, but it lacks the authority to seek civil monetary penal- ties. If states issue laws that are identical to federal requirements, the state laws will not be preempted, and the states can then use whatever enforce- ment mechanisms are available to them. “My own view,” said Landa, “is that the enforcement mechanism that would work in this circumstance is a fine, under some minimal administrative process that met the requirements of constitutional due process. But we don’t have that authority.” Joseph Thompson, a member of the IOM’s Standing Committee on Childhood Obesity Prevention, asked whether federal agencies view child- hood obesity as an epidemic and therefore deserving of special treatment, or as a new issue that should be tackled through regular processes. For example, the outbreak of H1N1 influenza was treated as an epidemic and led to the expenditure of hundreds of millions of dollars to buy vaccines of uncertain efficacy. Vladeck responded that labeling childhood obesity an epidemic would not necessarily be crucial to the FTC’s actions. The agency already views the situation as critical and is devoting “extraordi- nary resources” to address it. In its most recent study of food marketing, for example, the FTC asked 48 companies for enormous amounts of data involving many hundreds of products. “This is a massive undertaking,” said Vladeck. Landa said that the increasing prevalence of childhood obesity has not changed how the FDA uses its statutory tools but has created a strong sense of urgency. For example, the agency has issued three guidance documents on menu labeling in the past 8 months, each of which represents consider- able effort since the statutes are not necessarily clear, and the process for issuing such documents can be cumbersome. Schneeman observed that the FDA has entered into an increasing number of partnerships with other federal agencies to accelerate progress on the issue.