The primary barriers to removal of nicotine from cigarettes appear to be social and political, although problems such as inadequate educational, research, and treatment infrastructures also could hinder successful implementation. To effect a nicotine reduction strategy in such a way as to achieve the greatest lowering of tobacco caused disease and to minimise undesirable consequences, a variety of components must be considered.


Successful implementation of a strategy to eliminate nicotine from cigarettes requires educating both health professionals and the general public.109 110 Inadequate education about tobacco results in the propagation of lore and anecdotes regarding health effects and treatment needs. It also allows unfounded concerns as to whether tobacco abstinence will undermine the treatment of psychiatric diseases and alcohol and illicit drug addictions.94 95 111 Health professionals will need more education about how to diagnose and manage health problems that could be precipitated by nicotine withdrawal from cigarettes.109 110 112 Moreover, it is possible that, in the future, a variety of medical disorders will be treated with medications containing nicotine or nicotine analogues.113 114 There is no reason to believe that the medical benefits of nicotine use could not be derived through the use of pure nicotine containing medications without exposure to tobacco products. Similarly, a reluctance to recommend safe forms of nicotine (because of high cost, non availability, or irrational fears) to former smokers may be to the detriment of some former smokers health. Thus, it is important to educate both consumers and health professionals about the goals and realistic expectations of, and alternate strategies to, a nicotine reduction policy before and during implementation.


As nicotine levels are reduced in cigarettes, it would be useful for a wide range of tar and nicotine deliveries to be available in different brands up to the permitted ceiling, to facilitate the efforts of individuals who will want to wean themselves more rapidly from tobacco.6 46 115 As has been observed elsewhere, the seemingly wide range of choice that consumers have today is actually little more than a cigarette marketing strategy based on machine yields of cigarettes that provides relatively little variation in nicotine levels actually obtained by human cigarette smokers.6 50However, it is possible to provide consumers with meaningfully labelled cigarettes. Apparent consumer demand (approximately two thirds of American cigarette smokers currently smoke cigarettes that are rated by machines as yielding low tar and nicotine) should provide a strong product development incentive to actually provide such cigarettes.6 50

Cigarettes with nicotine levels lower than those deemed generally adequate to cause and sustain addiction could be labelled analogously to decaffeinated coffee or non alcoholic beer. In both cases, special processes have been used to remove most of the psychoactive substance normally present.

The AMA has advocated that all cigarettes be labelled as addicting (AMA Policy H 495.997, AMA Policy Compendium), as cigarettes marketed by the Liggett Group in the United States have been since 1997. Cigarettes in Canada and Australia are also labelled with rotating warnings that include the word addiction. 116 117 Even a cigarette that does not deliver readily addicting levels of nicotine could serve as the first step in the process of developing addiction to other nicotine products therefore, such cigarettes should not be exempt from an addiction warning, although it is possible that the warning might be modified for such cigarettes for example, Use of these cigarettes may lead to nicotine addiction.


Many smokers achieve and sustain tobacco and nicotine abstinence about 1.3 million or 2% to 3% of American cigarette smokers each year achieve the criterion of a year of continuous abstinence.55 Although studies have shown that about 90% of former smokers achieved abstinence without treatment support (including nicotine medications),118 the facts remain that (a) more than 90% of people who try to quit smoking relapse within a year, with most relapsing within about a week54 55 (b) behavioural and pharmacological treatment improves the odds of success90 98 119 (c) some presently unknown percentage of people who quit smoking appear to require extended nicotine maintenance to feel normal and to be fully functional at their jobs and in their ability to interact socially and (d) it is plausible that some people who have grown up under the behavioural and physiological influence of nicotine will never be fully or comfortably functional without continued nicotine administration. These observations support the conclusion that many cigarette smokers could benefit from some form of intervention to achieve abstinence from tobacco products. Unfortunately, the treatment infrastructure of our nation is woefully underdeveloped with regard to smoking cessation.14 120 124 Cigarettes are readily available to most people 24 hours per day, but access to effective smoking cessation aids is much more limited. A person might have to wait months for the start of a smoking cessation clinic group, if the service is even offered in his or her locale.

The foregoing observations suggest that the relative lack of treatment infrastructure and alternate nicotine delivery systems is a barrier to reducing nicotine from cigarettes. Treatment infrastructure needs have been discussed in detail elsewhere.115 120 127 Briefly, these needs include a mechanism to determine which treatments are effective, modes of treatment delivery, the ability to deliver treatment to those with increased need along a stepped care model, mechanisms of payment for treatment, and a means of determining which treatment modalities are worthy of government endorsement and health insurance coverage. This infrastructure would ideally be in place when the nicotine weaning policy is implemented and would probably be required for decades following implementation. It may be necessary to pace the speed of nicotine reduction to the development of adequate treatment infrastructure. In particular, people with higher levels of nicotine dependence are likely to have stronger needs for formal treatment to help them cope with the reduction of nicotine in cigarettes.90 98


Alternate forms of nicotine delivery should be at least as accessible as cigarettes.46 48 49 A major reduction of barriers to alternate forms of nicotine delivery was the marketing of nicotine patches and gum as over the counter (OTC) products, which has contributed to increased smoking cessation.128 129 130Nonetheless, restrictions on the packaging, pricing, and points of sale (gas stations and convenience stores, for example, are prohibited from selling nicotine medications), as well as other factors, mean that it is still much easier to buy a pack of 20 cigarettes (in most states costing about $2) than to purchase the minimal package size of nicotine medications (about $30 for 48 pieces of gum).46 49Whereas tobacco companies have been relatively free to manipulate taste and other sensory characteristics to maximise the appeal of their products, improving the acceptability of nicotine medications would require years of regulatory review and further testing after the product modifications had been developed and proposed to the FDA.40 45 49 131 Moreover, anything but relatively minor alterations to existing OTC nicotine delivering products could cause them to revert to a prescription only status.48 100

Regulatory approaches to medicinal forms of nicotine would clearly need to be revised in coordination with any approaches taken with tobacco products to enable the removal of nicotine from cigarettes in a timely manner.46 Similarly, although it is beyond the scop
e of this report to discuss the issue regarding other tobacco products, a nicotine reduction strategy for cigarettes implies that all forms of tobacco would be considered for such a policy and that efforts would be made to ensure that reduced access to high nicotine yielding cigarettes did not inadvertently stimulate increased use of other tobacco products. The importance of more consistent regulation across tobacco products to avoid such product substitution was discussed at the American Cancer Society s conference on cigars in June 1998, in which it was concluded that because the FDA has asserted jurisdiction over cigarettes and smokeless tobacco but not over cigars,11 12 cigars might become relatively more accessible and appealing than cigarettes and smokeless tobacco.132

A more controversial issue is the degree to which alternate nicotine delivery systems need to be competitive with cigarettes with respect to their nicotine dosing characteristics.48 49 A wide range of nicotine dosing systems are likely to be required to meet the needs of the diversity of cigarette smokers who cannot stop smoking.133 However, this does not mean that all nicotine delivering systems must be treated equally from a regulatory perspective.46 49 Although there is no question that non tobacco forms of nicotine exposure are less toxic than tobacco forms, it is also a mistake to equate all non tobacco nicotine delivery forms as equally toxic and equally addictive (or non addictive) and, therefore, requiring similar regulation.22 49 134Analgesics range from inexpensive single dose packages that can be procured in almost any retail setting (such as aspirin), to those restricted to pharmacies (certain combination analgesic medications), to those regulated under the provisions of the Controlled Substances Act, such as morphine. A similar range of nicotine delivering medications may be needed, ranging from readily available, very safe forms with a very low additive potential to much more aggressive nicotine delivering forms that might be treated as prescription substances. Such developments are technically feasible, but regulatory issues presently serve as disincentives and obstacles to the rapid development and marketing of such products.49 135


Complementary and supportive research is needed to enable the most effective implementation of a nicotine reduction approach and to implement such an approach without unintended consequences.14 40 131 136 140 Thus, there is a need for expanded research capacity and commitment at the federal level in the following areas. (a) Surveillance research that would be rapid and provide comprehensive monitoring of the use of all forms of nicotine is needed to allow midcourse policy corrections, to guide regulation, and to enable more rapid dissemination of new treatment approaches. In this regard it is worth noting that at least one major tobacco company conducts monthly consumer use and attitude tracking surveys.139 (b) Basic research on the pathophysiology and development of nicotine dependence is important, because it promises to provide a rational basis for improved prevention and treatment efforts. (c) Prevention and treatment research is needed to complement work done by the private sector to develop and evaluate new prevention and treatment approaches. (d) Regulatory research by the FDA would be critical to ensure that it could keep regulations consistent with the science underlying existing and new tobacco products and nicotine delivery systems for example, research on issues such as the means by which product modification affects nicotine dosing characteristics.

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Ex-marlboro man dies from smoking-related disease – businessweek
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