Public debate regarding the desirability of the proposed settlement has highlighted the thorny issues of regulatory design. Is the best course, for example, to follow the logic of progressively reducing nicotine exposure? What criteria should govern the regulatory agency's decision to initiate, implement, or terminate such a strategy? In what way should the agency take into account the emergence of a black market for illicit tobacco products? Some leaders of the public health community have criticized the criteria set forth in the proposed settlement on the grounds that they would unduly constrain FDA authority compared with the authority now conferred by the Food, Drug, and Cosmetics Act. Others have pointed out that the courts may not uphold FDA's assertion of jurisdiction over tobacco products. They have also argued that the criteria outlined in the proposed settlement provide a suitable starting point for congressional deliberation and the drafting of legislation.

The board cannot resolve this debate, and it does not intend to try to do so. The board does, however, urge Congress and the executive branch to take the necessary steps to ensure that possible strategies for regulating the design and constituents of tobacco products are given careful and systematic study. FDA's authority must be broad enough to allow it to protect the public health on the basis of scientific knowledge as it accumulates. Under some possible regulatory initiatives, an adequate scientific foundation already exists. Studies clearly indicate, for example, that smokers adapt to cigarettes labeled and machine-tested as low in nicotine by inhaling more often or more deeply.23 Informational requirements regarding tar and nicotine yield could be changed in light of actual human exposures from tobacco products, for example cigarette labeling that takes account of smoking behavior and not just machine-determined yield. On some issues, such as nicotine reduction, regulation must await new research or access to the results of studies now available only to private tobacco firms. In other areas, new information should be available in the coming years. Proposals for long-term nicotine maintenance using FDA-approved nicotine products will require further research. Studies of antidepressant and antiopiate drugs to enhance cessation are also promising, but not enough studies have been completed to reach firm conclusions. Yet the success of treating tobacco dependence and consumer acceptance may well indicate whether regulation of nicotine in tobacco products is a viable option. As another example, some states are experimenting with higher age limits for legal tobacco sales. Such experiments should be encouraged, because the results can help guide national policy. Some regulatory decisions, however, cannot be made until entirely new studies are designed and carried out, and their results are analyzed.

SUPPORT STATE AND LOCAL TOBACCO CONTROL EFFORTS

Current attention to tobacco control follows many years of innovative work at the state and local levels initiated by governments and private organizations. States such as California and Massachusetts have mounted effective public education campaigns, supported research, encouraged local nonsmoking ordinances, restricted some forms of advertising and promotion, and implemented other tobacco control measures. These efforts are funded by increases in state excise taxes on tobacco products. Such increases have



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Public debate regarding the desirability of the proposed settlement has highlighted the thorny issues of regulatory design. Is the best course, for example, to follow the logic of progressively reducing nicotine exposure? What criteria should govern the regulatory agency's decision to initiate, implement, or terminate such a strategy? In what way should the agency take into account the emergence of a black market for illicit tobacco products? Some leaders of the public health community have criticized the criteria set forth in the proposed settlement on the grounds that they would unduly constrain FDA authority compared with the authority now conferred by the Food, Drug, and Cosmetics Act. Others have pointed out that the courts may not uphold FDA's assertion of jurisdiction over tobacco products. They have also argued that the criteria outlined in the proposed settlement provide a suitable starting point for congressional deliberation and the drafting of legislation. The board cannot resolve this debate, and it does not intend to try to do so. The board does, however, urge Congress and the executive branch to take the necessary steps to ensure that possible strategies for regulating the design and constituents of tobacco products are given careful and systematic study. FDA's authority must be broad enough to allow it to protect the public health on the basis of scientific knowledge as it accumulates. Under some possible regulatory initiatives, an adequate scientific foundation already exists. Studies clearly indicate, for example, that smokers adapt to cigarettes labeled and machine-tested as low in nicotine by inhaling more often or more deeply.23 Informational requirements regarding tar and nicotine yield could be changed in light of actual human exposures from tobacco products, for example cigarette labeling that takes account of smoking behavior and not just machine-determined yield. On some issues, such as nicotine reduction, regulation must await new research or access to the results of studies now available only to private tobacco firms. In other areas, new information should be available in the coming years. Proposals for long-term nicotine maintenance using FDA-approved nicotine products will require further research. Studies of antidepressant and antiopiate drugs to enhance cessation are also promising, but not enough studies have been completed to reach firm conclusions. Yet the success of treating tobacco dependence and consumer acceptance may well indicate whether regulation of nicotine in tobacco products is a viable option. As another example, some states are experimenting with higher age limits for legal tobacco sales. Such experiments should be encouraged, because the results can help guide national policy. Some regulatory decisions, however, cannot be made until entirely new studies are designed and carried out, and their results are analyzed. SUPPORT STATE AND LOCAL TOBACCO CONTROL EFFORTS Current attention to tobacco control follows many years of innovative work at the state and local levels initiated by governments and private organizations. States such as California and Massachusetts have mounted effective public education campaigns, supported research, encouraged local nonsmoking ordinances, restricted some forms of advertising and promotion, and implemented other tobacco control measures. These efforts are funded by increases in state excise taxes on tobacco products. Such increases have

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also become law in Arizona, Hawaii, and Oregon. As noted previously, Alaska and Hawaii have each raised the state excise tax on cigarettes to $1.00, with Washington and New Jersey approaching that level. Maine, Wisconsin, and Utah are mounting new tobacco control programs. Much of the action in tobacco control has been and will continue to occur at the state, county, and community levels. The federal government must support state and local infrastructure for tobacco control. Many increases in nonfederal excise taxes and restrictions on advertising, promotion, and levels of exposure to environmental tobacco smoke depend on the actions of state and local governments. Bans on smoking in public places and in workplaces not only reduce environmental tobacco exposure to nonsmokers, but have also proven to be powerful interventions to enhance cessation and to reduce the dose exposure among smokers. The vast majority of progress on this front has taken place at the state and local levels. Counteradvertising and public education have also been largely state and local efforts, although they would likely be more effective if implemented nationally. All of these are elements of tobacco control efforts and complement federal measures. Success at the federal, state, and local levels has depended in part on funding not only government efforts, but also nongovernment organizations that can hold federal, state, and local governments to account. This pattern of funding should be designed into future tobacco control programs. For now, attention is focused on the terms of the proposed national settlement. If the settlement is translated into legislation, it should provide funding for state and local tobacco control efforts. If no settlement results, however, state and local efforts will nonetheless likely remain the bulwark of tobacco control. Most federal support comes from the ASSIST program of the National Cancer Institute (NCI) and the IMPACT program of the Centers for Disease Control and Prevention (CDC). California and Massachusetts fund the largest state programs. States that are part of the ASSIST program spend less, but more per state and with more intensive interventions than IMPACT states. In effect, for the past few years, states have engaged in a dose-response test of tobacco control. Evidence from that experiment was presented at the July 1997 IOM workshop; it showed that the program impact roughly parallels the intensity (dose) of tobacco control efforts. California and Massachusetts have the largest programs and greater decrements in tobacco consumption than ASSIST states, which in aggregate show a 7-10 percent greater reduction in consumption than IMPACT states (i.e., all others). These programs are reviewed in the 1994 IOM report, which recommended that federal support for state efforts be increased to the level of ASSIST in all states, with the increase in funding that would entail. This is, in essence, a recommendation to implement ASSIST as a universal program, based on its demonstration in one third of the states. The new evidence reinforces the 1994 recommendation. It is time to apply the lessons of ASSIST nationwide. Implementing the transition has several implications. First, it is important that the program content of ASSIST be carried forward as it is expanded. This includes retaining program elements as well as drawing on the expertise of those at NCI, in the ASSIST states, and in the nongovernmental organizations that have made it a success. Second, it entails a