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US regulation of less risky cigarettes – A world first
Regulatory Toxicology and Pharmacology 55 (2009) 247–248
Contents lists available at ScienceDirect
Regulatory Toxicology and Pharmacology journal homepage: www.elsevier.com/locate/yrtph
Editorial
US regulation of less risky cigarettes – A world first q Newly enacted US legislation offers the first world example of cigarette regulation based on relative risks to health.1 The innovating, consequential, and morally compelling feature of the law is a recognition that less hazardous cigarettes are feasible and should be advertised according to risk reduction claims certified by the Food and Drug Administration (FDA). This feature spurns nearly 40 years of disappointing prohibitionist policies, in favor of a more tolerant, humane, and successful public health approach. The new law is not without flaws, for several contradictions crept in to appease multiple stakeholders, many of whom have been long opposed to the notion of risk reduction. What ultimately emerges from these contradictions, will determine whether the legislation truly benefits public health and serves as a positive template for legislation around the world. Earlier, the law was sought as an instrument of abolition, but that goal soon appeared many decades distant. The official count of US smokers has leveled off around 50 million, and is probably higher on account of a thriving black market. In 2000 the World Bank was projecting that the growing world population of smokers might topple 1.5 billion within a decade. A global tobacco police was never an option, governments worldwide have been long addicted to massive tax revenues from tobacco, and effective prohibition remains unlikely. Enter in 2001 a report of the Institute of Medicine (IOM) of the National Academy of Sciences. It concluded that nicotine is safe at the levels experienced by smokers, and that less hazardous cigarettes can be realized by keeping nicotine and reducing other toxic components of smoke, to the point where a ‘‘regression of risk. . .might eventually bring a smoker to a risk equal to some lower level of lifetime exposure to conventional products.”2 The report dealt a capital blow to prohibitionist policies, a redoubled blow because the feasibility of less hazardous cigarettes had been proved since the late ‘70s at the US National Cancer Institute and elsewhere, only to be smothered by the antismoking crusade intent to force a ‘‘smoke free America by the year 2000.” Are the crusaders responsible for hundreds of millions of deaths that could have been prevented worldwide by an earlier introduction of less hazardous smokes? Crusaders attempted to cover up the IOM report, but the authority and truth of that message could not be contained. Seizing the opportunity, the late Senator Ted Kennedy and Congressman
Henry Waxman began consulting converging interests. Antismokers ostensibly endorsed the IOM prescriptions, hoping to divert public attention from the gruesome implications of their opposition to risk reduction. They ended up lacing the law with contradictions against risk reduction, such as prohibition of additives, appeals for nicotine elimination, advertising restrictions, grisly package labeling, and others. The tobacco industry weighed in with a deservedly tarnished image, and was fractured by a concern that regulation might shift market shares and favor consolidations. Eventually, the law passed in midyear 2009. Risk reduction is the core innovation of the law The 2001 report of the IOM shapes the innovating structure of the law. Although smoking entails mixed signals and rewards, the report concluded that nicotine is essential, because cigarettes without nicotine do not sell. The report also distanced nicotine from hard drug addictions, observing that nicotine does not cause derangement or anti-self or anti-social violence, but rather favors good socialization, good behavior, and enhanced personal performance. Importantly, the Institute found that nicotine is safe at the doses experienced by smokers, echoing prior conclusions of the Food and Drug Administration and regulators worldwide, which have long permitted free over-the-counter sales of nicotine patches and gums at dose that can exceed what smokers obtain from cigarettes. Endorsing a large body of science, the report concurred ‘‘. . .it is the cigarette constituents and pyrolysis products other than nicotine that are primarily responsible for the morbidity and mortality associated with smoking.”3 Because the epidemiologic record clearly shows that risks are proportional to the doses of smoke inhaled, the Institute’s report concluded that cigarettes can be made less hazardous by ‘‘. . .retaining nicotine at pleasurable or addictive levels while reducing the more toxic components of tobacco...”4 On this point, the IOM agrees with the scientific evidence that smokers can inhale no more than a self-limiting amount of nicotine regardless of its concentration in smoke, for beyond that amount smoking becomes unpleasant and aversive. Thus, simply doubling the concentration of nicotine would cut in half the doses and risks of smoking. Even greater reductions are within technical reach, with the prospect of truly spectacular health gains for 1.5 billion smokers worldwide. Constraints of reduced risk products
q
An abridged version of this article was published in Regulation, The Cato Institute, Washington, DC. Fall 2009. 1 Public Law 111-31. June 22, 2009. http://frwebgate.access.gpo.gov/cgi-bin/ getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ031.111. 2 Clearing the smoke: assessing the science base for tobacco harm reduction. Institute of Medicine, National Academy of Sciences. National Academy Press, Washington DC, 2001. http://books.nap.edu/openbook.php?isbn=0309072824, p. 164. 0273-2300/$ - see front matter Ó 2009 Elsevier Inc. All rights reserved. doi:10.1016/j.yrtph.2009.08.012
Besides delivering nicotine, cigarette smokes also provide taste and aroma, and the all-important function of buffering the harsh 3 4
Ibid. p.113. Ibid. p. 29.
248
Editorial / Regulatory Toxicology and Pharmacology 55 (2009) 247–248
and unpleasant characteristics of nicotine. Thus, increasing the concentration of nicotine and reducing other smoke components is bound to compromise traditional tastes and aromas, and to heighten the harshness of nicotine. Notoriously fastidious, smokers would find challenges in less hazardous cigarettes. Safe additives can overcome acceptability deficits, and the IOM recognizes that reduced risk cigarettes will ‘‘involve substantial changes in types of tobacco, in additives, or in curing, blending, or processing of the tobacco”.5 The law itself foresees the need of additives, yet it also mandates that ‘‘. . . a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.”6 The exclusion is odd, because the flavors listed are legally recognized as safe, and are widely used. Contrary to the main trust of the law, the exclusion was introduced at the behest of antismoking interests, worried that flavors and aromas would make cigarettes more pleasant. Yet, being acceptable is a necessary attribute of less hazardous smokes, suggesting that the exclusion will have to be reconsidered. Just as well, it should not be a constructive precedent when similar legislation will be considered around the world. Technicalities of risk reduction From the available evidence, a smoke containing only nicotine and buffers barely sufficient to quench its harshness would achieve the ultimate risk reduction. Devices that deliver such a smoke present relatively modest technical challenges, but arguably would no longer be cigarettes. They could hardly appeal to most smokers, also because the IOM and the law acknowledge that less hazardous items will have to be marketed along traditional ones, to prevent the sudden expansion of illegal markets. By contrast, the modifications of traditional smokes to higher nicotine concentrations and less of other components, present significant technical challenges, if they are to match acceptability expectations. This would entail a gradual reduction of combustible mass, a supplementation of nicotine, and the addition of acid buffers to attenuate the nicotine’s harshness. Alone, such devices could not match the composite buffers of traditional smokes and their flavors and aromas, thus calling for safe additives to restore acceptability. Once more, the law’s prohibition of additives represents a major hindrance, although desirable traits could be genetically engineered in new tobacco varieties, possibly overcoming strict definitions of additives.
all tobacco-related products are carefully regulated so that exposure reduction and risk reduction claims are supported by adequate scientific evidence and are not false or misleading.”7 But the report also admonishes ‘‘. . .the regulatory process should not discourage or impede scientifically grounded claims of reduced exposure, as long as steps are taken to ensure that consumers are not mislead into believing (in the absence of sound evidence) that smoking the modified product is (or is likely to be) less hazardous than smoking the conventional product. How the complex of claims and caveats associated with [reduced risk products] can best be articulated in labeling is one of the major challenges facing the regulatory agency. On the one hand, the public health is not well served by the continued use of poorly defined terms such as ‘‘light,” ‘‘low tar,” or other phrases that imply a benefit when none has been proven to exist. On the other hand, neither is the public health served if smokers are discouraged by unduly cautionary language from using a new product with the potential for real risk reduction.” Therefore, ‘‘acceptable restrictions on potential exposure or harm reduction products might be stringent, although not severe enough to put the industry out of business.”8 As things shape up, however, it is inevitable that intensive tests and documentations, and costly service fees mandated by the law, will weed out small producers and will promote consolidation of the industry. Promising as it is, the success and viability of the newborn law is not guaranteed, for the IOM warns of a ‘‘. . .continuing ambivalence among some health officials about the wisdom of embracing harm reduction as a public health policy.”9 The Institute plainly cautions that the development of the regulatory program should not be entrusted to antismoking crusaders, for they have a record of poor judgment in their fatal hostility to less hazardous smokes, and in their deceitful demonizing of passive smoking.10 Initial messages from the FDA have not been reassuring on this count, but the recent nomination of Dr. Lawrence Deyton to head the program is an auspicious move, provided he could persuade Dr. Margaret Hamburg, his boss and FDA Commissioner, that turning regulation into an instrument of prohibition would be contrary to the law, to the IOM’s vision, and ultimately to public health. Clearly, the program should seek stronger means to persuade smokers to quit and youngsters not to smoke, but experience tells that progress in this effort will drag slowly over many decades to come. Over a billion smokers, on the other hand, are with us now and for the foreseeable future, making it just as important and more pressing to provide them with the reduced risk products the IOM and the law contemplate. Anything less would restate a callous death sentence, quite at odds with the ‘‘first do no harm” imperative of a public health agency. Gio Batta Gori * The Health Policy Center, 6704 Barr Road, Bethesda, MD 20816, United States E-mail address: [email protected]
Forecasting the regulatory climate The IOM ‘‘. . .strongly recommends that new legislation be enacted to ensure that the labeling, advertising, and promotion of
7
Ibid. p. 216. Ibid. p. 218 & 54. 9 Ibid. p. 203. 10 Antismoking crusaders have used public and corporate funds for an array of specious epidemiologic reports, all of which rest their risk assessments on the preposterous assumption that study subjects could recall, with exact and reliable numerical quantifications, the cumulative summary of their individual exposures to passive smoking over the prior 60–70 years of their lives. * The author was formerly deputy director of the Division of Cancer Cause and Prevention at the National Cancer Institute, where he also directed the Smoking and Health Program aimed at developing less hazardous cigarettes. For the latter, he received the US Public Health Service Superior Service Award in 1976. In the past, he also advised the cigarette industry on such and allied matters. 8
5 6
Ibid. p. viii. Ibid. Sec. 907 (a)(1)(A).
Contents lists available at ScienceDirect
Regulatory Toxicology and Pharmacology journal homepage: www.elsevier.com/locate/yrtph
Editorial
US regulation of less risky cigarettes – A world first q Newly enacted US legislation offers the first world example of cigarette regulation based on relative risks to health.1 The innovating, consequential, and morally compelling feature of the law is a recognition that less hazardous cigarettes are feasible and should be advertised according to risk reduction claims certified by the Food and Drug Administration (FDA). This feature spurns nearly 40 years of disappointing prohibitionist policies, in favor of a more tolerant, humane, and successful public health approach. The new law is not without flaws, for several contradictions crept in to appease multiple stakeholders, many of whom have been long opposed to the notion of risk reduction. What ultimately emerges from these contradictions, will determine whether the legislation truly benefits public health and serves as a positive template for legislation around the world. Earlier, the law was sought as an instrument of abolition, but that goal soon appeared many decades distant. The official count of US smokers has leveled off around 50 million, and is probably higher on account of a thriving black market. In 2000 the World Bank was projecting that the growing world population of smokers might topple 1.5 billion within a decade. A global tobacco police was never an option, governments worldwide have been long addicted to massive tax revenues from tobacco, and effective prohibition remains unlikely. Enter in 2001 a report of the Institute of Medicine (IOM) of the National Academy of Sciences. It concluded that nicotine is safe at the levels experienced by smokers, and that less hazardous cigarettes can be realized by keeping nicotine and reducing other toxic components of smoke, to the point where a ‘‘regression of risk. . .might eventually bring a smoker to a risk equal to some lower level of lifetime exposure to conventional products.”2 The report dealt a capital blow to prohibitionist policies, a redoubled blow because the feasibility of less hazardous cigarettes had been proved since the late ‘70s at the US National Cancer Institute and elsewhere, only to be smothered by the antismoking crusade intent to force a ‘‘smoke free America by the year 2000.” Are the crusaders responsible for hundreds of millions of deaths that could have been prevented worldwide by an earlier introduction of less hazardous smokes? Crusaders attempted to cover up the IOM report, but the authority and truth of that message could not be contained. Seizing the opportunity, the late Senator Ted Kennedy and Congressman
Henry Waxman began consulting converging interests. Antismokers ostensibly endorsed the IOM prescriptions, hoping to divert public attention from the gruesome implications of their opposition to risk reduction. They ended up lacing the law with contradictions against risk reduction, such as prohibition of additives, appeals for nicotine elimination, advertising restrictions, grisly package labeling, and others. The tobacco industry weighed in with a deservedly tarnished image, and was fractured by a concern that regulation might shift market shares and favor consolidations. Eventually, the law passed in midyear 2009. Risk reduction is the core innovation of the law The 2001 report of the IOM shapes the innovating structure of the law. Although smoking entails mixed signals and rewards, the report concluded that nicotine is essential, because cigarettes without nicotine do not sell. The report also distanced nicotine from hard drug addictions, observing that nicotine does not cause derangement or anti-self or anti-social violence, but rather favors good socialization, good behavior, and enhanced personal performance. Importantly, the Institute found that nicotine is safe at the doses experienced by smokers, echoing prior conclusions of the Food and Drug Administration and regulators worldwide, which have long permitted free over-the-counter sales of nicotine patches and gums at dose that can exceed what smokers obtain from cigarettes. Endorsing a large body of science, the report concurred ‘‘. . .it is the cigarette constituents and pyrolysis products other than nicotine that are primarily responsible for the morbidity and mortality associated with smoking.”3 Because the epidemiologic record clearly shows that risks are proportional to the doses of smoke inhaled, the Institute’s report concluded that cigarettes can be made less hazardous by ‘‘. . .retaining nicotine at pleasurable or addictive levels while reducing the more toxic components of tobacco...”4 On this point, the IOM agrees with the scientific evidence that smokers can inhale no more than a self-limiting amount of nicotine regardless of its concentration in smoke, for beyond that amount smoking becomes unpleasant and aversive. Thus, simply doubling the concentration of nicotine would cut in half the doses and risks of smoking. Even greater reductions are within technical reach, with the prospect of truly spectacular health gains for 1.5 billion smokers worldwide. Constraints of reduced risk products
q
An abridged version of this article was published in Regulation, The Cato Institute, Washington, DC. Fall 2009. 1 Public Law 111-31. June 22, 2009. http://frwebgate.access.gpo.gov/cgi-bin/ getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ031.111. 2 Clearing the smoke: assessing the science base for tobacco harm reduction. Institute of Medicine, National Academy of Sciences. National Academy Press, Washington DC, 2001. http://books.nap.edu/openbook.php?isbn=0309072824, p. 164. 0273-2300/$ - see front matter Ó 2009 Elsevier Inc. All rights reserved. doi:10.1016/j.yrtph.2009.08.012
Besides delivering nicotine, cigarette smokes also provide taste and aroma, and the all-important function of buffering the harsh 3 4
Ibid. p.113. Ibid. p. 29.
248
Editorial / Regulatory Toxicology and Pharmacology 55 (2009) 247–248
and unpleasant characteristics of nicotine. Thus, increasing the concentration of nicotine and reducing other smoke components is bound to compromise traditional tastes and aromas, and to heighten the harshness of nicotine. Notoriously fastidious, smokers would find challenges in less hazardous cigarettes. Safe additives can overcome acceptability deficits, and the IOM recognizes that reduced risk cigarettes will ‘‘involve substantial changes in types of tobacco, in additives, or in curing, blending, or processing of the tobacco”.5 The law itself foresees the need of additives, yet it also mandates that ‘‘. . . a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.”6 The exclusion is odd, because the flavors listed are legally recognized as safe, and are widely used. Contrary to the main trust of the law, the exclusion was introduced at the behest of antismoking interests, worried that flavors and aromas would make cigarettes more pleasant. Yet, being acceptable is a necessary attribute of less hazardous smokes, suggesting that the exclusion will have to be reconsidered. Just as well, it should not be a constructive precedent when similar legislation will be considered around the world. Technicalities of risk reduction From the available evidence, a smoke containing only nicotine and buffers barely sufficient to quench its harshness would achieve the ultimate risk reduction. Devices that deliver such a smoke present relatively modest technical challenges, but arguably would no longer be cigarettes. They could hardly appeal to most smokers, also because the IOM and the law acknowledge that less hazardous items will have to be marketed along traditional ones, to prevent the sudden expansion of illegal markets. By contrast, the modifications of traditional smokes to higher nicotine concentrations and less of other components, present significant technical challenges, if they are to match acceptability expectations. This would entail a gradual reduction of combustible mass, a supplementation of nicotine, and the addition of acid buffers to attenuate the nicotine’s harshness. Alone, such devices could not match the composite buffers of traditional smokes and their flavors and aromas, thus calling for safe additives to restore acceptability. Once more, the law’s prohibition of additives represents a major hindrance, although desirable traits could be genetically engineered in new tobacco varieties, possibly overcoming strict definitions of additives.
all tobacco-related products are carefully regulated so that exposure reduction and risk reduction claims are supported by adequate scientific evidence and are not false or misleading.”7 But the report also admonishes ‘‘. . .the regulatory process should not discourage or impede scientifically grounded claims of reduced exposure, as long as steps are taken to ensure that consumers are not mislead into believing (in the absence of sound evidence) that smoking the modified product is (or is likely to be) less hazardous than smoking the conventional product. How the complex of claims and caveats associated with [reduced risk products] can best be articulated in labeling is one of the major challenges facing the regulatory agency. On the one hand, the public health is not well served by the continued use of poorly defined terms such as ‘‘light,” ‘‘low tar,” or other phrases that imply a benefit when none has been proven to exist. On the other hand, neither is the public health served if smokers are discouraged by unduly cautionary language from using a new product with the potential for real risk reduction.” Therefore, ‘‘acceptable restrictions on potential exposure or harm reduction products might be stringent, although not severe enough to put the industry out of business.”8 As things shape up, however, it is inevitable that intensive tests and documentations, and costly service fees mandated by the law, will weed out small producers and will promote consolidation of the industry. Promising as it is, the success and viability of the newborn law is not guaranteed, for the IOM warns of a ‘‘. . .continuing ambivalence among some health officials about the wisdom of embracing harm reduction as a public health policy.”9 The Institute plainly cautions that the development of the regulatory program should not be entrusted to antismoking crusaders, for they have a record of poor judgment in their fatal hostility to less hazardous smokes, and in their deceitful demonizing of passive smoking.10 Initial messages from the FDA have not been reassuring on this count, but the recent nomination of Dr. Lawrence Deyton to head the program is an auspicious move, provided he could persuade Dr. Margaret Hamburg, his boss and FDA Commissioner, that turning regulation into an instrument of prohibition would be contrary to the law, to the IOM’s vision, and ultimately to public health. Clearly, the program should seek stronger means to persuade smokers to quit and youngsters not to smoke, but experience tells that progress in this effort will drag slowly over many decades to come. Over a billion smokers, on the other hand, are with us now and for the foreseeable future, making it just as important and more pressing to provide them with the reduced risk products the IOM and the law contemplate. Anything less would restate a callous death sentence, quite at odds with the ‘‘first do no harm” imperative of a public health agency. Gio Batta Gori * The Health Policy Center, 6704 Barr Road, Bethesda, MD 20816, United States E-mail address: [email protected]
Forecasting the regulatory climate The IOM ‘‘. . .strongly recommends that new legislation be enacted to ensure that the labeling, advertising, and promotion of
7
Ibid. p. 216. Ibid. p. 218 & 54. 9 Ibid. p. 203. 10 Antismoking crusaders have used public and corporate funds for an array of specious epidemiologic reports, all of which rest their risk assessments on the preposterous assumption that study subjects could recall, with exact and reliable numerical quantifications, the cumulative summary of their individual exposures to passive smoking over the prior 60–70 years of their lives. * The author was formerly deputy director of the Division of Cancer Cause and Prevention at the National Cancer Institute, where he also directed the Smoking and Health Program aimed at developing less hazardous cigarettes. For the latter, he received the US Public Health Service Superior Service Award in 1976. In the past, he also advised the cigarette industry on such and allied matters. 8
5 6
Ibid. p. viii. Ibid. Sec. 907 (a)(1)(A).