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6
Changing the Regulatory Landscape

The first prong of the committee’s blueprint for reducing tobacco use, set forth in Chapter 5, envisions strengthening traditional tobacco control measures. If the plan set forth in Chapter 5 is successfully implemented and sustained, it could have a significant impact on tobacco use; but even an optimistic projection leaves prevalence at 10 percent in 2025, and a more realistic projection might be 15 percent. The main argument presented in this chapter is that a more substantial long-term impact requires a change in the current legal framework of tobacco control to a new, innovative regulatory approach that takes into account the unique history and characteristics of tobacco.

Over the past two decades, tobacco control policy has developed incrementally as the nation has moved step-by-step from a laissez-faire legal system embedded in a smoking culture to a system with coherent antismoking policy grounded in public health. Incremental reforms, however, will not end the nation’s tobacco problem. A more fundamental shift must occur. It is time for Congress and other policy makers to change the legal structure of tobacco policy, thereby laying the foundation for a strategic initiative to end the nation’s tobacco problem, that is, reducing tobacco use to a level that is insignificant from a public health standpoint. In this chapter, the committee sets forth the blueprint for a new regulatory approach.

Currently (and under the interventions of the blueprint outlined in Chapter 5), the implicit model of tobacco control is demand reduction combined with reactive efforts to prevent the tobacco industry from impeding demand-reducing policies. This leaves in place the supply side (the product and its existing channels of distribution) as well as all the existing



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Ending the Tobacco Problem: A Blueprint for the Nation 6 Changing the Regulatory Landscape The first prong of the committee’s blueprint for reducing tobacco use, set forth in Chapter 5, envisions strengthening traditional tobacco control measures. If the plan set forth in Chapter 5 is successfully implemented and sustained, it could have a significant impact on tobacco use; but even an optimistic projection leaves prevalence at 10 percent in 2025, and a more realistic projection might be 15 percent. The main argument presented in this chapter is that a more substantial long-term impact requires a change in the current legal framework of tobacco control to a new, innovative regulatory approach that takes into account the unique history and characteristics of tobacco. Over the past two decades, tobacco control policy has developed incrementally as the nation has moved step-by-step from a laissez-faire legal system embedded in a smoking culture to a system with coherent antismoking policy grounded in public health. Incremental reforms, however, will not end the nation’s tobacco problem. A more fundamental shift must occur. It is time for Congress and other policy makers to change the legal structure of tobacco policy, thereby laying the foundation for a strategic initiative to end the nation’s tobacco problem, that is, reducing tobacco use to a level that is insignificant from a public health standpoint. In this chapter, the committee sets forth the blueprint for a new regulatory approach. Currently (and under the interventions of the blueprint outlined in Chapter 5), the implicit model of tobacco control is demand reduction combined with reactive efforts to prevent the tobacco industry from impeding demand-reducing policies. This leaves in place the supply side (the product and its existing channels of distribution) as well as all the existing

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Ending the Tobacco Problem: A Blueprint for the Nation incentives for attracting more consumers and selling more cigarettes. A more ambitious strategy would ask these questions: Can anything be done to substantially curtail the availability of tobacco products? Can anything be done to change tobacco products to make them less hazardous? Is it possible to bring the industry’s incentives into closer alignment with the public health goals of tobacco control? No existing regulatory statute provides a model for tobacco products because there is no other lawful product for which the declared public goal is to suppress its use altogether. A new legal regime, new models, and new policy paradigms are needed. The challenge, then, is to craft a policy framework that is aligned with the unique aim of tobacco control policy: to substantially reduce, if not eliminate, the use of this unusually damaging product without replicating the problems associated with the prohibition of alcohol in the 1920s and with the contemporary prohibitions of illegal drugs (e.g., widespread noncompliance, violent black markets, corruption, and high rates of arrest). In this chapter and Chapter 7, the committee offers several ideas for more fundamental change. FEDERAL REGULATORY AUTHORITY IS NEEDED It is clear that the U.S. Congress has the constitutional authority to enact national legislation bearing on all domains of tobacco control, including banning the distribution and use of tobacco products, analogous to the authority that it exercises over controlled substances such as peyote and marijuana. The pertinent policy questions are (1) whether Congress should exercise its constitutional authority (by prescribing national rules or by delegating the authority to do so to a federal agency, such as the Food and Drug Administration [FDA]), or, conversely, whether it should allow the states to exercise primary authority to regulate the production, distribution, marketing, and use of tobacco; and (2) if Congress does exercise federal regulatory authority in any of these domains, whether it should leave any room for supplemental state regulation and, if so, within what constraints. The committee believes that the time has come for Congress to exercise its acknowledged authority to regulate the production, marketing, and distribution of tobacco products while freeing the states to supplement federal action with their own measures that aim to suppress tobacco use and that are compatible with federal law. Relationship Between Federal and State Tobacco Regulation Setting aside the complexities of a complicated body of federal law, Congress has essentially three options: (1) state control, in which the federal government leaves regulation in a particular domain to the states (and,

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Ending the Tobacco Problem: A Blueprint for the Nation depending on state law, to localities); (2) federal preemption, in which the federal government has complete regulatory control and precludes any state regulation in the area; and (3) complementary regulation, in which the federal government establishes regulations on a particular subject but does not exclude the states from also establishing regulations. Under the third approach, the federal action typically establishes minimum requirements for the whole country (the basic requirements) while allowing the states to adopt more stringent regulations. Familiar examples of these three approaches include the state regulation of the retail distribution of alcohol, federal preemption of the state regulation of employee benefit plans under the Employee Retirement and Income Security Act, and complementary regulation of controlled substances. At present, tobacco regulation in the United States is characterized by plenary state control except in the federally preempted domain of information or warnings “based on smoking and health,” as defined in the 1969 Cigarette Labeling Act. The preemption language adopted by the Congress has been construed broadly by the U.S. Supreme Court to preempt “failure to warn” product liability suits under state tort law and direct state or local regulation of tobacco advertising, as well as the obviously preempted area of mandated warnings on packages or in advertisements (Cipollone v. Liggett Group I1992;505 U.S. 504; Lorillard Tobacco Company v. Reilly 2001;533 U.S. 525). Whether federal regulation is needed and, if so, whether and to what extent the federal regulatory statute should preempt compatible state regulation are complex inquiries involving highly contextual judgments. However, the general contours of the analysis can be summarized succinctly. On the one hand, a decision to preempt state regulation in favor of exclusive federal authority may impose an overly rigid and inefficient uniform nationwide approach that is contrary to public preferences in many jurisdictions, especially when the benefits and costs from regulation vary considerably across jurisdictions. For example, a state with no tobacco farmers to protect may want to impose stricter regulations than a tobacco-growing state, or a state with a large Hispanic population might want to insist on labels in both English and Spanish. As another example, because the prevalence of smoking varies by as much as threefold among the states, the voters in a state with more smokers may find public smoking regulations more oppressive than the voters in another state with fewer smokers. Nationwide rules can be especially inefficient when it comes to regulatory matters that fall almost exclusively within a state’s geographic boundaries. Thus the regulation of smoking in public places is primarily a local matter, with individual business establishments and local governments bearing the brunt of the compliance costs. The same might also be said for restrictions on point-of-sale advertising, including the in-store placement of

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Ending the Tobacco Problem: A Blueprint for the Nation placards and the proximity of external store window signs to schoolyards. Consider in this respect a hypothetical national ban on certain activity (such as the sale of alcohol) within a certain radius of a school. What seems like a perfectly reasonable distance, say, 1,000 yards, would have a very different impact on lawful access to alcohol in a dense urban area, where the ban might cover an entire city, than it would in a less densely populated suburban or rural area. Finally, the imposition of a nationwide approach can increase the costs of a regulatory error, especially when there is uncertainty over the most appropriate form of regulation and when the scientific evidence and business environment are changing. As these observations suggest, there are many reasons why regulation of retail distribution, marketing, and use of tobacco should presumptively be left to state regulation and, to the extent that federal regulation is adopted in these domains, that supplementary state regulation should be permitted as long as it is compatible with the federal regulatory objectives. However, in some contexts, there are strong arguments for a national regulatory approach, and perhaps for national uniformity. One such context is the regulation of commercial products for which there is a national market and where the regulated products are easily transported across state lines. For example, if there are substantial differences in regulatory standards from one state to another, strong incentives would exist for people to purchase less heavily regulated products in one state and sell them in a state with more demanding regulatory requirements, thereby potentially undermining the latter state’s regulatory objectives, creating a black market, and possibly attracting the participation of criminal syndicates. Another concern that sometimes arises in situations involving diverse state regulation of product characteristics is inefficiency attributable to the need for manufacturers to comply with 50 different requirements. A third consideration is the need for continuing oversight and research by experts, as is often the case in environmental protection. Regulation of pharmaceutical products, where national standards have prevailed since adoption of the Pure Food and Drugs Act of 1906, is pertinent illustration of a strong national regulatory interest, potentially high costs to state-by-state variations, and need for ongoing regulatory oversight. Over time, the Congress has tended to both increase the scope of federal regulatory authority and precluded additional state regulation in areas in which the FDA has acted. Explicit statutory preemption has been adopted in connection with FDA regulation of medical devices, over-the-counter drugs, and cosmetics. As will be explained below, the committee favors strong regulation of tobacco product characteristics, packaging, labeling, and promotion and distribution. The colossal failure of the tobacco market to produce accurate information regarding the health effects of tobacco products and

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Ending the Tobacco Problem: A Blueprint for the Nation to produce adequate incentives for companies to develop less hazardous products, the national scope of the problem, and the need for creating and sustaining regulatory expertise argue strongly for national regulation. The residual question is whether supplemental, compatible state regulation should be permitted. In the committee’s view, a uniform national approach preempting state regulation altogether makes the most sense in relation to regulations governing tobacco product design and labeling, as well as in relation to marketing through national media. A uniform national approach makes the least sense in relation to the retail distribution, local marketing, and consumption of tobacco. Federal regulation may not be needed in some of these areas at all, but even if federal regulations are adopted, the federal rules should set the floor, and supplemental state regulation should be permitted. In this latter respect, the current federal preemption provision unduly constrains the prerogatives of the states in regulating the local marketing of tobacco products. Recommendation 23: Congress should repeal the existing statute preempting state tobacco regulation of advertising and promotion “based on smoking and health” and should enact a new provision that precludes all direct state regulation only in relation to tobacco product characteristics and packaging while allowing complementary state regulation in all other domains of tobacco regulation, including marketing and distribution. Under this approach, federal regulation sets a floor while allowing states to be more restrictive. This approach was embodied in the proposed “Family Smoking Prevention and Tobacco Control Act” (S. 625 and HR 1008), introduced on February 15, 2007, by Senators Kennedy and Cornyn with 29 other Senators and Congressmen Waxman, Davis, and Palone. This will be referred to as the proposed Tobacco Control legislation in this report. Any federal statute preempting direct state regulation of the product and its packaging should not preempt any private or public causes of action, in state or federal courts, based on a failure to warn consumers about any risks (of which the company was aware) not covered by the federally prescribed warnings or based on claims of fraud or conspiracy. Congress should make its intentions regarding the narrow scope of preemption clear in the legislative record. EMPOWERING FDA TO REGULATE TOBACCO In 1994, the Institute of Medicine (IOM) report Growing Up Tobacco Free urged Congress to adopt a regulatory framework for tobacco products and to empower a federal regulatory agency to implement it:

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Ending the Tobacco Problem: A Blueprint for the Nation Congress should confer upon an administrative agency the authority to regulate the design and constituents of tobacco products whenever it determines that such regulation would reduce the prevalence of dependence or disease associated with use of the product or would otherwise promote the public health. The agency should be specifically authorized to prescribe ceilings on the yields of tar, nicotine, or any other harmful constituent of a tobacco product (IOM 1994, p. 246-247). Soon after the IOM report was released, the FDA surprised many observers by claiming that Congress had already given the agency the authority to regulate cigarettes as nicotine delivery devices under the Food, Drug, and Cosmetic Act (FDCA) and by issuing a rule regulating the marketing and distribution of cigarettes to youth. Eventually, the U.S. Supreme Court rejected the FDA’s position, ruling that the FDCA did not authorize the FDA to regulate tobacco products and striking down the 1996 FDA Tobacco Rule (FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 2000). Since the U.S. Supreme Court’s decision, proposals have been pending in the Congress to authorize the FDA to regulate tobacco products. The version pending at the time of the final version of the committee’s report is the proposed Tobacco Control legislation, which would give the FDA wide-ranging authority over the manufacture, distribution, and promotion of tobacco products with a few exceptions, which will be described below. The power granted to FDA in the proposed Tobacco Control legislation is even more extensive than that envisioned in Chapter 8 of Growing Up Tobacco Free (IOM 1994). Under the proposed Tobacco Control legislation: The 1996 FDA Tobacco Rule relating to youth access and marketing to youth would be revived. FDA would have broad authority to promulgate tobacco product standards whenever such a standard is found to be “appropriate for protection of the public health,” taking into consideration “the risks and benefits to the population as a whole, including users and non-users of tobacco products.” (The bill embodies the principles relating to products purporting to reduce exposure to toxins and to reduce disease risk developed by the IOM in Clearing the Smoke [2001].) Legally required package warnings would be strengthened immediately and FDA would have the authority to revise these requirements upon finding “that such a change would promote greater public understanding of the risks associated with tobacco.”

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Ending the Tobacco Problem: A Blueprint for the Nation FDA would have authority to “restrict … the sale and distribution of a tobacco product if the Secretary [of the U.S. Department of Health and Human Services] determines that such regulation would be appropriate for the protection of the public health.” FDA would be empowered to restrict the advertising and promotion of tobacco products “to the full extent permitted by the First Amendment” upon finding “that such regulation would be appropriate for the protection of the public health.” Each of these topics is discussed below. Overall, however, the committee reiterates the view taken by two previous IOM committees (IOM 1994, 2001): broad federal regulatory authority over the manufacture, distribution, marketing, and use of tobacco products is an essential element of a comprehensive public health approach to tobacco control.1 Congress does not have the institutional capacity to monitor and respond to ongoing innovations in product design (especially those purporting to reduce exposure to tobacco-related toxins), or to changes in marketing or patterns of consumption, whereas FDA personnel are well-positioned to gather the necessary information and to make evidence-based scientific judgments about the likely public health consequences of alternative regulatory approaches. Overall, the potential benefits of agency regulation in this context seem to far outweigh its potential costs. Specifically, the committee does not agree with the view expressed by some tobacco control advocates that empowering FDA to regulate the manufacture, distribution, promotion, and use of tobacco products necessarily “legitimizes” these products or that it will unavoidably lead to the “regulatory capture” of the agency by the tobacco industry. Other objections to the federal regulation and to particular features of the proposed Tobacco Control legislation are discussed below in the specific contexts in which they arise. Recommendation 24: Congress should confer upon the FDA broad regulatory authority over the manufacture, distribution, marketing, and use of tobacco products. A REGULATORY PHILOSOPHY The ultimate regulatory goal is to reduce smoking-related mortality and morbidity to a level that is acceptable to a well-informed American public. 1 The committee assumes that the FDA will be the agency empowered to regulate tobacco products. If Congress decides to confer regulatory authority on another agency, recommendations addressed to FDA should be understood to refer to whatever agency has regulatory authority.

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Ending the Tobacco Problem: A Blueprint for the Nation Under the present circumstances, given what is known about the health consequences of tobacco use, reducing the prevalence of smoking and the level of per-capita cigarette consumption are reasonable proxies for reducing harm. In the context of other health and safety regulations, the goal of reducing cigarette consumption to a socially acceptable level might mean reducing it to the lowest feasible level or the level at which the social costs of trying to reduce it further exceed the public health benefits of doing so. Either way, feasibility is a significant constraint on the regulatory measures that can sensibly be adopted. Most importantly, a total prohibition against tobacco manufacture and distribution is not a realistic option at present or for the foreseeable future. The United States now has 44.5 million adult smokers (CDC 2005), the vast majority of whom are addicted to the nicotine in cigarette smoke. If it were possible to prevent smoking initiation altogether, it might be feasible to embrace a nicotine maintenance approach, under which tobacco products would be lawfully available only by prescription to people who are addicted to nicotine. However, the experience with marijuana and other illegal drugs demonstrates that prohibition does not eliminate initiation even when there is no lawful market for a psychoactive drug, and it is implausible to expect that tobacco products lawfully available to more than 40 million addicts would not spill over into a large “gray” market that would sustain ongoing initiation, especially by young people. Nor is it plausible that the billions of cigarettes produced for the international market would not find their way into the United States.2 The challenge, then, is to frame a policy for tobacco production and distribution within the context of a regulated market. What should be the aims of the regulatory agency over the short term? In the committee’s view, the following aims should guide tobacco policy for the foreseeable future: Undertake significant and sustained efforts to reduce the rate of initiation of smoking Maximize the options available to addicted smokers to help them quit or reduce their risk Prevent people from becoming addicted to tobacco products if they use them Reduce the risks of using tobacco products to the users and to others 2 Although prohibition accompanied by prescription-only cigarettes for already addicted smokers might reduce smoking initiation, the committee anticipates that the costs of enforcing such an approach would be substantial and would exceed the potential public health gains. However, such an approach may be worthy of consideration at some future time, especially if it is combined with the nicotine reduction concept sketched in Chapter 7. Innovative strategies of this kind should be explored by the tobacco policy research office recommended in that chapter.

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Ending the Tobacco Problem: A Blueprint for the Nation Policies designed to achieve these aims must be formulated and implemented on the basis of a careful consideration of their potential effectiveness and potential costs. A key factor is the need to avoid creating a substantial black market and its associated costs. The remainder of this chapter sets forth several elements of the comprehensive regulatory strategy that should supplement the traditional tobacco control approaches described in Chapter 5. Specifically: Tobacco product characteristics should be regulated to protect the public health. Messages on tobacco packages should promote health. The retail environment for tobacco sales should be transformed to promote the public health. New models for regulating the retail market should be explored. The federal government should mandate industry payments for tobacco control and should support and coordinate state funding. Tobacco advertising should be further restricted. Targeting of youth by tobacco manufacturers for any purpose should be banned. Youth exposure to smoking in movies and other media should be reduced. Surveillance and evaluation should be enhanced. TOBACCO PRODUCT CHARACTERISTICS SHOULD BE REGULATED As noted above, the proposed Tobacco Control legislation would grant FDA the authority to regulate tobacco products. FDA was selected because it is the only existing regulatory agency with expertise both in scientific and health issues and in product regulation. The authority that would be conferred on FDA for tobacco regulation in the proposed Tobacco Control Legislation parallels in many ways current FDA authority for the regulation of drugs, although different regulatory criteria are needed. Requiring tobacco products to be “safe” is not an available option, of course, and prohibition of the existing products is not a feasible regulatory strategy. Overall, the regulatory standard should be to “protect the public health” by reducing initiation, promoting cessation, preventing relapse, reducing consumption, and reducing product hazards. This standard incorporates its own limitation because it will require the agency to evaluate the likely consumer responses to any proposed regulation, including the likelihood of product substitution and the creation of black markets that could nullify the anticipated public health benefits of the regulation.

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Ending the Tobacco Problem: A Blueprint for the Nation FDA regulates many consumer products, including drugs and foods, and the agency has many tools at its disposal that can be deployed in tobacco regulation. FDA regulation serves to inform consumers about the constituents of the products that they consume and to enhance the safety of these products. FDA can require existing and new products to meet toxicant exposure standards and can promote new standards and make products less hazardous. FDA can also ensure that the claims made about products are truthful and are not misleading. If FDA is authorized to regulate tobacco products, the task should be undertaken in the context of a comprehensive framework that includes the regulation of novel tobacco products and other nicotine delivery products, the delivery of tobacco smoke constituents, and the regulation of medications used to treat tobacco addiction. The need for a tobacco regulatory authority is illustrated by the history of the low yield cigarette, which has been described in detail in a recent IOM report and in National Cancer Institute (NCI) Monograph 13 (IOM 2001; NCI 2001). In brief, low-yield cigarettes were developed after scientific evidence indicated that cigarette tar contributed to cancer. Low-tar cigarettes were implicitly promoted by the tobacco industry as a way to reduce the health risks of smoking. A large majority of smokers believe that low-yield cigarettes were less harmful, and many have switched to low-yield cigarettes rather than quit smoking (Kozlowski et al. 1998). However, because of the engineering characteristics of the cigarettes and the tendency of the smokers to maintain their desired levels of nicotine in their bodies, smokers easily compensate for low-yield cigarettes by smoking more intensively and by smoking more cigarettes (NCI 2001). One strategy used to decrease cigarette tar delivery was to change tobacco blends. However the tobacco contained higher levels of nitrogenous chemicals that resulted in the generation of larger amounts of NNK, a tobacco-derived substance that is known to be a pulmonary carcinogen. The ultimate result of the shift to low-yield cigarettes was no reduction of toxic exposures and no impact on smoking-related disease risks. Unfortunately, however, low yield cigarettes were promoted for more than 30 years before it was publicly understood that they have no beneficial effect on smoking-related risk (NCI 2001). Evidence introduced in the U.S. Department of Justice Racketeering Influenced and Corrupt Organization (RICO) suit against the tobacco manufacturers indicated that for many years company scientists and company officials had internal information indicating that “light” cigarettes might not deliver lower doses of toxicants and that such cigarettes delivered lower dosages to machines than they did to human smokers (NCI 2001). Moreover, tobacco company researchers had information that the tar from a “light” cigarette might be qualitatively more toxic on a milligram-per-milligram basis than the tar from a regular filtered cigarette. However, public health professionals and officials in other government agencies failed to appreciate

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Ending the Tobacco Problem: A Blueprint for the Nation the seriousness of the problem for several reasons. First, lacking the information possessed by tobacco manufacturers, they mistakenly assumed that smoking machines could accurately gauge the relative toxicity of cigarettes. They underestimated the complexity of the cigarette product and the ability of manufacturers to change the product in ways not reflected in the machine-based measurements. Second, lacking complete information about smoker compensation possessed by tobacco manufacturers, they underestimated the behavioral inclination of smokers to maintain their desired levels of nicotine intake. As a result of industry deception, there was a massive regulatory failure, as nothing was done to control how these products were marketed. The best way to prevent such a sequence of events from occurring again is to have a regulatory body that can systematically assess toxic exposures, make judgments about potential risks from tobacco products, regulate industry claims about the products to ensure that they are accurate and not misleading, set minimum standards, and provide relevant surveillance to determine actual human exposures and risks. This is particularly important because a number of tobacco companies are developing and marketing tobacco products that are intended to reduce the harm from smoking and presumably will be promoted as such. Goals of Tobacco Product Regulation The regulation of tobacco product characteristics can be seen as having two primary goals (IOM 2001). One is to reduce the harm from the continued use of tobacco products. This might be achieved by reducing the toxic emissions from cigarettes or the toxic constituents of smokeless tobacco. Reducing toxic exposures would potentially lower the risk and severity of disease in people who continue to smoke. It is essential, however, that the federal government assure that consumers are informed about what is and what is not known about the risks of using products that result in reduced toxic exposures (reduced exposure products). Moreover, regulators must take steps to reduce the likelihood that the availability of reduced-exposure products will increase initiation or reduce the number of users who quit. The danger that the marketing of reduced-exposure products could lead to an increase in smoking prevalence by altering risk perceptions about smoking is one of the greatest challenges that the FDA will need to address. The second goal of regulating tobacco product characteristics is to reduce consumption. The most promising way of reducing consumption through product regulation would be to make cigarettes less addictive, thereby making quitting easier and preventing initiating smokers from becoming addicted. Another promising strategy is the development of new medications for the treatment of nicotine addiction. To the extent that harm

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Ending the Tobacco Problem: A Blueprint for the Nation The constitutionality of the proposed restriction is not free from doubt, since it curtails the freedom of tobacco companies to communicate with young people for any purpose.7 However, the proposal does not ban all communication with minors, and the mere exposure of minors to advertising would not be a violation of the proposed ban. Instead, the restriction bans “targeting” of young people (conduct that is also banned by the MSA when it is explicitly promotional). The committee’s proposal extends the MSA ban to all targeting of youth, based on the presumption that any communications that target young people are highly likely to reflect a promotional motivation. Any legislation seeking to implement this restriction could certainly allow room for a company to prove that a specific communication had a legitimate purpose and did not have the purpose or effect of promoting tobacco use. On the basis of this analysis and on the unique history of tobacco company efforts to promote youth smoking, the committee believes that the proposed restriction would survive a constitutional challenge. YOUTH EXPOSURE TO SMOKING IN MOVIES AND OTHER MEDIA SHOULD BE REDUCED One of the biggest challenges of modern life for parents is to minimize the exposure of their children and impressionable teens to images and messages in the media that encourage or even glorify unhealthy and risky behaviors. Although the values of a free and open society preclude strong measures to cleanse the cultural environment of images and messages that are unfit for children, properly tailored legal restrictions on the time, place, and manner of display of such images and messages are permissible. The fact remains, however, that the authority of the state in this area is limited. These observations highlight the heavy responsibility borne by the entertainment media for formulating and enforcing industry regulations to facilitate parental efforts to protect their children from potentially harmful exposures to images and messages that tend to promote unhealthy (indeed, unlawful) behavior. A recent IOM/National Research Council report on underage drinking reviewed the evidence bearing on depictions and messages encouraging or glorifying drinking and urged stronger industry self-regulation backed up by monitoring of media content by the federal government (IOM/NRC 2004). This committee believes that a similar approach is needed regarding youth exposure to smoking in the entertainment media, especially in the movies. The scientific literature on smoking in the movies is reviewed by Halpern-Felsher and Cornell in Appendix H, and the following material is drawn 7 Committee member Cass Sunstein doubts the constitutionality of the proposed restriction and does not endorse it.

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Ending the Tobacco Problem: A Blueprint for the Nation from that review. Depictions of smoking in the movies doubled in the 1990s, bringing exposure rates closer to those observed in the 1950s (Glantz et al. 2004). Although recent data suggest that depictions of smoking in the movies declined from 2000 to 2004 (Worth et al. 2006), youth exposure to smoking in the movies remains high. In addition to its inclusion in R-rated movies, smoking can readily be observed in many movies rated appropriate for youth, including movies rated G, PG, and PG-13 (Charlesworth and Glantz 2005). Studies that have used content analysis have documented that smoking was portrayed in approximately 87 percent of movies produced from 1988 to 1997 (Dalton et al. 2002), in 77 percent of movies in 2004 (Worth et al. 2006), and in more than 66 percent of children’s animated movies released between 1937 and 1997 (Goldstein et al. 1999). Healthcare professionals and tobacco control advocates are concerned that youth exposure to smoking in the movies will have an impact on adolescents’ attitudes toward smoking as well as smoking behavior itself (Charlesworth and Glantz 2005; Sargent 2005; Worth et al. 2006). These concerns are consistent with social cognitive theory, which indicates that adolescents are especially vulnerable to social modeling influences on behavior, including risky behaviors such as the use of tobacco and other drugs (Akers and Lee 1996; Bandura 1986). Research investigating the impact of youth exposure to smoking in movies has yielded three important findings: Exposure to depictions of smoking in movies is associated with more favorable attitudes toward smoking and characters who smoke, and these positive views are particularly prevalent among youth who themselves smoke. As the information in the previous section demonstrates, there is little doubt that youth are being exposed to smoking in the media, including movies, television, magazines, and newspapers, and that such exposures influence youth smoking-related perceptions. Exposure to smoking in movies increases the risk for smoking initiation. Cross-sectional and longitudinal studies provide clear support that youth report greater susceptibility and intentions to smoke and are more likely to actually try smoking following exposure to smoking in the movies and on television. Furthermore, even after controlling for other factors known to be associated with adolescent smoking intention and tobacco use, studies show a clear dose effect, whereby greater exposure to smoking in the movies is associated with a greater chance of smoking. Studies have not yet been conducted to determine whether such a relationship between viewing smoking in the movies and tobacco use continues after initial tobacco use (Sargent 2005).

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Ending the Tobacco Problem: A Blueprint for the Nation The increased risk for smoking initiation as a result of exposure to smoking in the movies can be reduced by antismoking advertisements and parental restriction of which movies their children watch. On the basis of these findings, the committee encourages the entertainment industries to formulate and implement a set of strategies to limit and monitor youth exposure to smoking in the movies, television programming, and videos and to combat the effect of tobacco exposure on youth’s smoking attitudes and behaviors. These strategies should both guide and educate the movie industry about the evidence linking smoking in the movies and adolescent tobacco use (Dalton et al. 2003; Sargent et al. 2005), as well as spark a cogent discussion within the movie industry and between the movie industry and policymakers. A ratings board, which is appointed by the president of the Motion Picture Association of America (MPAA), decides on the ratings assigned to each movie. Currently, such ratings are based on the extent to which there is violence, language, nudity, sensuality, and drug abuse in the film. Tobacco use is not considered. Assigning films with tobacco use a mature (R) rating increases the likelihood that parents will restrict their children’s access to such films, a strategy that has been shown to reduce the rate of smoking initiation (Dalton et al. 2002; Sargent et al. 2004, 2003). The effects of youth viewing of smoking in the movies were found to be reduced among youth who first viewed an antismoking advertisement (Edwards et al. 2004; Pechmann and Shih 1999). Investigations of the effectiveness of antismoking advertisements with adolescents indicate strategies that are effective in reducing the influence of the viewing of smoking depictions in the media in general and that can be applied to smoking depictions in the movies as well. Goldman and Glantz (1998) showed that messages that are aggressive, delegitimize the tobacco industry, deglamorize smoking, and portray the negative effects of secondhand smoke were the most effective at changing perceptions about the normality of smoking and reducing cigarette consumption (Goldman and Glantz 1998). The results of a recent study of a specific antismoking advertising campaign (the truth­® campaign) echoes those findings. That study found that this counter-industry media campaign was effective in increasing negative beliefs and attitudes about the tobacco industry and were associated with lower receptivity to protobacco advertising and less progression of smoking intention and behavior (Hershey et al. 2005). Recommendation 37: The Motion Picture Association of America (MPAA) should encourage and facilitate the showing of anti-smoking advertisements before any film in which smoking is depicted in more than an incidental manner. The film rating board of the MPAA

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Ending the Tobacco Problem: A Blueprint for the Nation should consider the use of tobacco in the movies as a factor in assigning mature film ratings (e.g., an R-rating indicating Restricted: no one under age 17 admitted without parent or guardian) to films that depict tobacco use. This recommendation urges the MPAA to take smoking into account “as a factor” in its rating system; it does not suggest, categorically, that all movies with smoking receive an R-rating. The objective is to encourage directors and producers to take into account the possible impact of displays of smoking on a teenage audience and give serious consideration whether depicting characters smoking contributes to the artistic aims of the film or is needed for historical or cultural accuracy. Independent oversight of the industry’s standards and strategies is warranted. Such oversight of industry accountability should be facilitated through public monitoring and awareness of industry practices. Accordingly, the committee recommends that the U.S. Department of Health and Human Services be authorized and funded to monitor these media practices and report to Congress and the public. This approach echoes a similar recommendation made by the IOM Committee on Preventing and Reducing Underage Drinking in 2004 (IOM/NRC 2004). Recommendation 38: Congress should appropriate the necessary funds to enable the U.S. Department of Health and Human Services to conduct a periodic review of a representative sample of movies, television programs, and videos that are offered at times or in venues in which there is likely to be a significant youth audience (e.g., 15 percent) in order to ascertain the nature and frequency of images portraying tobacco use. The results of these reviews should be reported to Congress and to the public. SURVEILLANCE AND EVALUATION SHOULD BE ENHANCED Central to successful tobacco control is surveillance for antismoking program design and outcomes. An in-depth discussion of the elements of surveillance for tobacco control is included in Clearing the Smoke (IOM 2001). CDC offers the following definition of surveillance: “Public health surveillance is the ongoing, systematic collection, analysis, and interpretation of health data essential to the planning, implementation, and evaluation of public health practice, closely integrated with the timely dissemination of these data to those who need to know” (Thacker and Berkelman 1988). The extent of tobacco control activity surveillance depends on the goals of the program, the breadth of control activities and methods, the size of the geographic area being evaluated, the availability and accuracy of data

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Ending the Tobacco Problem: A Blueprint for the Nation elements being sought, and the amount of funding available to conduct surveillance procedures. Surveillance for tobacco use takes several forms. Most frequently, surveillance is underpinned by assessing tobacco use through household surveys. Such surveys, usually conducted by telephone, often include cigarette smoking behaviors; the intensity, amount and patterns of smoking; the brands of cigarettes and other tobacco products consumed; the sources of tobacco purchase or other acquisition; smoking history; personal smoking cessation attempts and the source and methods of such attempts; indicators of tobacco dependence, tobacco-related consultations as part of interactions within the health care system; family and peer use of tobacco; exposure to formal tobacco education programs during schooling; and environmental exposures to tobacco smoke, including venues where smoking occurs and where it is banned. Survey information may be obtained from dedicated tobacco use surveys or at least in part through multipurpose surveys that may contain additional relevant health and behavioral information. Household surveys have certain limitations, including less than full and possibly biased participation rates, a high respondent time burden, limited access to minors, the recurring need to demonstrate valid responses, and substantial costs. Validation studies are conducted periodically to determine the accuracy of personal reports and may be supplemented by the use of tests for biological markers of tobacco use. More critically, however, many elements of tobacco control programs cannot be comprehensively determined from household information, and information must be derived from other sources. School-based surveys may be required to monitor adolescent tobacco use. Internet-based surveys may also be valuable, as they reduce the time burden for respondents. Tobacco use among special populations, such as prisoners, patients with major mental illnesses, and homeless people, usually require special institutional surveys and sampling procedures and often require the collection of more detailed informed consent. Surveillance of healthcare professional practices pertaining to tobacco-related education and smoking cessation may best be ascertained through reviews of medical records or the presence of institutional clinical guidelines that are themselves periodically evaluated. Data on the commercial distribution and sales of tobacco and tobacco control products often provide considerable insight into control efforts and can also be used to validate population survey information. Monitoring of jurisdictional environmental regulations and compliance with those regulations, tobacco use in the media and countermarketing activities, seizures of illegal tobacco products smuggled into the United States, the delivery of school-based antismoking educational programs, the resources being spent on community-based tobacco control efforts (public and private), the enforcement of youth-access restrictions, and the activities and management of community-based tobacco control

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Ending the Tobacco Problem: A Blueprint for the Nation programs themselves are all examples of important surveillance activities occurring outside of household surveys. Yet another important element of a national control program is toxicological assessment of the contents of tobacco products, both in the distributed product and after the product is burned or other tobacco-containing products are used. Finally, although it may be a long-term endeavor, surveillance for tobacco-related disease outcomes is a critical component of evaluations of tobacco control programs. Such surveillance may take many forms, but most jurisdictions are able to conduct surveillance on the occurrence of smoking-related cancers. Nevertheless, a comprehensive discussion of surveillance elements and methods is beyond the scope of this document. General guidance for constructing a local and state surveillance program can be found in materials prepared by CDC. The basic elements of existing tobacco control efforts, based on best-practice elements (CDC 1999), provide important guidance to the elements of tobacco control surveillance. However, many state and local control programs have surveillance programs in place and have tailored these programs to their special activities, such as surveillance in workplaces, eating, and drinking establishments, college campuses, urban public places and motor vehicles. Most importantly, surveillance programs allow assessment of the progress that tobacco control programs have made. In turn, surveillance findings are used to drive changes in program activities, direction, and intensity. Recommendation 39: State tobacco control agencies should conduct surveillance of tobacco sales and use and the effects of tobacco control interventions, in order to assess local trends in usage patterns; identify special groups at high risk for tobacco use; determine compliance with state and local tobacco-related laws, policies, and ordinances; and evaluate overall programmatic success. Recommendation 40: The Secretary of HHS, through FDA or other agencies, should establish a national comprehensive tobacco surveillance system to collect information on a broad range of elements needed to understand and track the population impact of all tobacco products and the effects of national interventions (such as attitudes, beliefs, product characteristics, product distribution and usage patterns, and marketing messages and exposures to them). SUMMARY This chapter recommends a fundamental change in the current legal framework of tobacco control: a new, innovative regulatory approach that

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Ending the Tobacco Problem: A Blueprint for the Nation takes into account the unique history and characteristics of tobacco and its uses. Under the plan envisioned by the committee, the federal government would assume broad regulatory responsibility for tobacco control to augment the traditional state-centered tobacco control approaches described in Chapter 5. Because a total prohibition against the manufacture and distribution of tobacco products is not a realistic option for the foreseeable future, the new legal structure for tobacco control must be framed within the context of a regulated market. Accordingly, Congress should confer upon the FDA broad regulatory authority over the manufacture, distribution, marketing, and use of tobacco products. Such a broad federal regulatory authority would free the states to supplement federal action with their own measures that aim to suppress tobacco use and that are compatible with federal law. Within this general framework, the committee recommends federal regulation of tobacco product characteristics and product packaging, aggressive state regulation of the retail environment to promote public health objectives, implementation of a federal tobacco control funding plan to coordinate state funding and reduce the wide range of state excise tax rates, and strong state and federal measures to reduce tobacco advertising and promotion and otherwise reduce initiation of tobacco use by youth. REFERENCES AAPHP (American Association of Public Health Physicians). 2007. American Association of Public Health Physicians. Web Page. Available at: http://www.aaphp.org/WebLinks/stakeholders.html; accessed May 11, 2007. Akers RL, Lee G. 1996. A longitudinal test of social learning theory: adolescent smoking. Journal of Drug Issues 26(2):317-343. Ashley MJ, Cohen J, Ferrence R. 2001. “Light” and “mild” cigarettes: who smokes them? Are they being misled? Canadian Journal of Public Health 92(6):407-411. Bandura A. 1986. Social Foundations for Thought and Action: A Social-Cognitive Model. Englewood Cliffs, NJ: Prentice Hall. Basil MD, Basil DZ, Schooler C. 2000. Cigarette advertising to counter New Year’s resolutions. Journal of Health Communication 5(2):161-174. Benowitz NL, Henningfield JE. 1994. Establishing a nicotine threshold for addiction. The implications for tobacco regulation. New Engand Journal of Medicine 331(2):123-125. Borland R, Yong HH, King B, Cummings KM, Fong GT, Elton-Marshall T, Hammond D, McNeill A. 2004. Use of and beliefs about light cigarettes in four countries: findings from the International Tobacco Control Policy Evaluation Survey. Nicotine and Tobacco Research 6(Suppl 3):S311-S321. CDC (Centers for Disease Control and Prevention). 1999. Best Practices for Comprehensive Tobacco Control Programs—August 1999. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. CDC. 2005. Cigarette smoking among adults—United States, 2004. MMWR (Morbidity and Mortality Weekly Report) 54(44):1121-1124.

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