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~ DRAFT ~ Future Strategies for the Chan:ging Cigarette . Introduction and Objectives During the past three decades cigarettes have changed dramatically in their make-up. Over 90 percent of the cigarettes now sold in the United States are filter tipped, compared with 1.4 percent in 1952. Tar and nicotine yields have decreased significantly to the point where .803. In the past, when the overwhelming majority of cigarette brands yielded over 15 mg. of tar and the sales weighted average cigarette was in 1982, the sales weighted average tar of U.S. cigarettes was below 14 mg. and the market share of cigarettes yielding 15 mg. or less tar ("low tar cigarettes") was over 60 percent. In addition, the carbon monoxide yields of these cigarettes have shown a strong association with lower tar, with a correlation coefficient of one with over 20 mg. of tar, Lhe term "low tar" was a useful way of differentiat- ing cigarettes with varying yields of tar and nicotine. However, today's average cigarette is a "low tar" cigarette. And, while industry analysts believe the enormous growth in the market share for these cigarettes may taper off, changes in this "average" cigarette will continue as long as consumer demand and sales competition remain active. In order to reach these lower yields of tar, nicotine and carbon monoxide, ~ cigarette manufacturers have made major changes in the cigarette product W V, 41 itself through a variety of technological and manufacturing changes as well ~n Cl? as through reductions in the amount of tobacco used in each cigarette. ~ Cigarette paper has been made more porous, the types of tobacco used have been modified and the nature and extent of additives have been changed signi- ficantly. The nature of these changes is considered priveleged information

2 by the cigarette companies. The majority of the changes are not fully understood by research scientists outside the cigarette companies or by public health officials. The health effects or relative risks posed -by these changes are also not fully understood. As the 1981 Surgeon General's Report showed, the scientific evidence available to evaluate these changes is severely limited except with resepct to lung cancer. At the same time that the "average" cigarette has been undergoing a dramatic transformation, the federal government and the voluntary health agencies have encouraged the use of lower tar and nicotine cigarettes by those smokers who cannot quit. And the cigarette companies have devoted an increasingly larger percentage of their enormous advertising outlays to promoting the use of those products. The effects on the smoker of this encouragement and of the changes in the product are also not fully understood. There are very strong indications that smokers use the cigarettes differently, taking more puffs, smoking more cigarettes or changing the way they hold the cigarette to increase the delivery of tar nd nicotine. There is also strong and unsettling evidence that smokers believe that the new products have removed any risk from smoking. The Federal Trade Commission Staff Report on the Cigarette Advertising Investigation discussed the results of a survey conducted for the Tobacco Institute by the Roper Organization: C W V)- In the 1980 Roper study, respondents were presented with the following ~ false statement: "It has been proven that smoking low-tar, low-nicotinev cigarettes does not significantly increase a person's risk of disease CL` over that of a non-smoker." More than one out of three -- 360 -- of ~ smokers said they knew or thought this was true, while another 321% of the smokers said they didn't know if it was true or not. This evidence suggests that many smokers falsely believe that smoking is not dangerous to them if they smoke low-tar and low-nicotine cigarettes. 0

C 3 In light of all of these factors, the Working Group on Future Strategies for the Changing Cigarette met for the purposes of examining the ;issues arising from the dramatic changes in the cigarette and considering what corresponding changes may be needed in public health policies, programs and research. Major Issues Addressed The lack of aoaressive leadership and direction in responding to the changing cigarette and its potential health effects. There was consensus in the group that to some extent, the federal agencies responsible for dealing with the changing cigarette, and the voluntary health agencies as well, have been overwhelmed by the changes which have occurred in the past ten years. There is a pressing need for a strong non-governmental focal point, capable of ensuring that necessary research is being carried out and that the cigarette is subjected to continuous surveillance and monitoring. Reliance on government agencies to carry out such functions aggressively and consistently was deemed unrealistic, given the need for quick response to rapid changes in the product and governments' susceptibility to political interests. The need for concerted private voluntary sector action in influencing public policy and achieving specific policy goals was also cited as a critical aspectt of the leadership issue. The reorientation of the National Interagency Council on Smoking and Health as a Washington based, public policy oriented coalition was discussed extensively. 03646591 A third aspect of the leadership issue which was considered equally important was the need for a strengthened, active and vital federal government presence

.i - 4 - through the Office on Smoking and Health. This aspect was seen as a comple- ment to the private focal point, but would not preclude the need for the private sector effort. The lack of information about the changes in the cigarette and the inability of the government and the voluntary agencies to conduct surveillance of these chanaes. Discussion focused on the limitations of the Department of Health and Human Services and the Federal Trade Commission in establishing the necessary mechanisms, either through regulation or surveillance, to determine the nature of changes in the cigarette. There was also a lengthy discussion about the lack of an effective central point either within or outside of government where surveillance could be carried out, using a variety of existing and new methodologies. The lack of research, completed or in progress, to fill the substantial gaps in knowledQe about the health effects and relative risks posed by the changing cigarette. Considerable discussion was devoted to assessing both the adequacy of research already in the literature, as well as ongoing research, to provide definitive judgments regarding the effects of the changing cigarette on heart disease, chronic obstructive pulmonary disease and pregnancy and infant health. There was consensus that the findings of the 1981 Surgeon General's Report should serve as the base against which all of the groups' recommendations should be weighed. - The apparent public misperception that lower tar and nicotine cigarettes pose little or no risk. 03646592

5 There was considerable concern expressed over the results of the Tobacco Institute survey described in the FTC Report. In addition, many members of the group were deeply concerned about the ability of the cigarette manufac- turers to use the statements of groups such as this to the advantage of their efforts to sell lower tar and nicotine products. Strong support was voiced for a major public information effort aimed at correcting the misperception. The inadeauacy of the existing tar and nicotine testing methodology as a measure of the actural delivery of harmful constituents to the smoker. There was consensus that the methodology used by the FTC and the cigarette companies to measure the tar and nicotine yields of cigarettes does not provide an accurate or adequate measure of the actual delivery to the smoker. The methodology provides a useful index of relative yield among the more than 175 different brands, but the changes in the product and probable corresponding changes in smoking behavior make the "FTC method" severely limited as the only available parameter. A variety of parameters were discussed including metabolic measures. The need to establish guidelines for the further reduction of selected smoke constituents. There was general.agreement about the need to establish some type of guide- line to encourage the industry to further reduce selected constituents. However, there was concern over the possibility of creating an apparent endorsement of a specific level of constituent yield as the ideal or accept- able cigarette. It was agreed that any such guideline should utilize new parameters for constituent delivery rather than the FTC method.

.. 6 The potential risks posed by additives. The group considered the issue of additives in the broader context of the need for surveillance and monitoring of the changes taking place in the cigarette. There was agreement that some type of disclosure of additives currently in use is essential and that some form of regulation of future additives needs to be established, along lines comparable to the food and drug industries. Recommendations and Actions Needed To increase our understanding of the possible health consequences and to provide consumers with adequate information on the changing cigarette, the group recommended a broad based approach to developing the necessary resources, political support and public awareness. Such an approach requires the creation of a national center for smoking and health with the expansion of the knowledge base on the changing cigarette as its first priority. This strategy must have as its base an affirmation of the conclusions of the 1981 Surgeon General's Report which stated: 1. There is no safe cigarette and no safe level of consumption. 2. Smoking cigarettes with lower yields of tar and nicotine reduces the risk of lung cancer and, to some extent, improves the smoker's chance for longer life, provided there is no compensatory increase in the amount smoked. However, the benefits are minimal in compar- ~ ison with giving up cigarettes entirely. The single most effec- G,W tive way to reduce hazards of smoking continues to be that of ~ quitting entirely. ~ c~1t 3. It is not clear what reductions in risk may occur in the case of ~ diseases other than lung cancer. The evidence in the case of cardiovascular disease is too limited to warrant a conclusion, nor is there enough information on which to base a judgement in the case

7 of chronic obstructive lung disease. In the case of smoking's effects on the fetus and newborn, there is no evidence that changing to a lower tar and nicotine cigarette has any effect at all on reducing risk. In addition, the strategy must include a major-public information program to inform consumers of the limitations in reduced risk reflected by the Surgeon General's conclusions. This campaign must address the major gaps in knowledge regarding the changing cigarette identified by the Federal Trade Commission Staff Report. The recommendations considered most important and steps needed for their implementation are as follows: , Create a non-governmental national center on smoking to conduct surveillance of the changing cigarette and to coordinate research; develop a national public information program to fill gaps in knowledge about the relative risks of the changing cigarette. To begin creation of a national center; convene a planning committee from ACS, AHA, ALA; arrange for preparation of a feasibility study, organizational plan, and funding plan; launch center prior to January, 1983. To launch the public information program a joint governmental/voluntary agency committee should be established. Emphasis should be placed on includ- ing ing a changing cigarette warning in the Hatch bill, and physicians should be ~ MP given additional information on the relative risks of the changing cigarette. ~ CD C11 Establish three top priority actions to follow accomplishment of the above: a Develop new parameters to measure cigarette smoke delivery and human exposure, b Study human health effects of the changing cigarette on smokers and involuntary smokers; c Support Senator Hatch's legislation with emphasis on requiring a warning on the changing cigarette and disclosure of constituents on packs and in ads.

c 6 c A national advisory group on delivery of smoke constituents should be estab- lished and convened as soon as possible. In the research area, research proposals in coronary heart disease, chronic obstructive pulmonary disease and pregnancy effects should be actively solicited. The American Heart Association, American Lung Association and the American Cancer Society should communicate with Senator Hatch immediately to urge inclusion of a legisla- tively mandated warning on cigarette packs regarding the limitations of the changing cigarette. In addition to the creation of the national center and its accompanying recommendations, the full listing of the group's recommendations includes: Develop realistic parameters for measuring and monitoring cigarette smoke delivery of various constituents through both machine measurements and human exposure. Develop a reference cigarette with lower tar and nicotine for use in research. Place major emphasis in all smoking research on the health effects changing cigarette, especially brands with very low yie s. Conduct qualitative analyses of the tar delivered by the-changing cigarette. Conduct research into dosimetry, pharmacokinetics, physiologic and metabolic effects of the changing cigarette. Conduct high priority epidemiologic studies of cardiovascular disease effects of the changing cigarette. and pulmonary Conduct high priority studies of the effects of these cigarettes on children and reproductive aged women. Initiate a major public information campaign on the relative risks of the changing ciQarette. Require disclosure in advertising and packaging of the yields of tar, tine and carbon monoxide.

f 9 Require rotational warnings in advertising and on packages concerning the changing cigarette. Encourage physicians to become more involved with assisting their patients to give up smoking and with informing them of the relative risks of the chanqinq cigarette. Utilizing newly developed parameters for measuring cigarette smoke delivery, establish governmental or voluntary agency guidelines for reducing the delivery of selected smoke constituents with appropriate warnings on the limitations of the data base. Monitor and set standards for the reduction of sidestream smoke emissions from the changing cigarette.. It 40