Why requiring low-nicotine cigarettes is still ill-advised

Will a low-nicotine cigarette work for people who love to smoke? From www.shutterstock.com

Global policymakers will soon consider a policy of requiring that only reduced-nicotine cigarettes can be manufactured or sold. This may sound good, but as someone who has studied tobacco for decades, I believe it is premature to deploy this as a tool to improve global health.

The Framework Convention on Tobacco Control in 2003 was the first international treaty created by the World Health Organization. Some 180 countries have ratified it; the U.S. has not.

In 2015 WHO’s expert committee published an advisory report that promotes, with caveats, a global consideration of “a policy for limiting the sale of cigarettes to brands with a nicotine content that is not sufficient to lead to the development and/or maintenance of addiction.”

These recommendations will be discussed at the Conference of the Parties (COP7) in India, Nov. 7-12. This event is not well-suited to deal with the many caveats and may instead pick and choose the most politically alluring elements of the strategy.

First, the quality of supporting evidence on the effects of requiring low-nicotine cigarettes is poor.

Second, there are possible negative effects of banning traditional cigarettes related to the creation of black markets and ill effects on high-risk users.

Last, before deploying such a requirement, it is now judged to be critical to have satisfying and less-harmful sources of nicotine available. This prior need for alternative nicotine/tobacco products is yet to be fulfilled around the world. Also, it is not appreciated by all proponents of the low-nicotine strategy – especially those who have not followed its evolution.

Safer, alternative nicotine/tobacco products are now part of the strategy as elaborated by the WHO expert committee, which included one of the original authors, and elsewhere by another original author of the nicotine-reduction strategy.

A way around an all-out ban

Since the end of alcohol prohibition in the United States, policymakers have avoided outright prohibition of popular recreational drugs. Possible costs in crime, enforcement, punishments, restrictions on adult consumers and black markets have caused many to not favor bans.

In 1994, two prominent researchers, Neal Benowitz and Jack Henningfield, proposed a novel hypothesis regarding tobacco use. If a nicotine threshold for addiction could be identified – with the further requirement that the nicotine content of all cigarettes be below that threshold – then this would help resolve the smoking and health problem.

Nicotine addiction could thereby be banned, without having to ban cigarettes! Youth who smoked would not become addicted. Even established smokers could not sustain their addiction. The need for supplemental nicotine products was not then mentioned as an issue.

The 1994 low-nicotine strategy included no supplemental nicotine from other products.

Other experts thought the low-nicotine proposal was ill-advised. The currently recommended low-nicotine cigarette contains “only trace” levels of nicotine.

Imagine if, by regulation, all beer must only have trace levels of alcohol. Beer drinkers would consider that their preferred product had been banned and think that this regulation struck at the heart of the product.

Would beer be as popular with trace amounts of alcohol? From www.shutterstock.com

Authorities have been encouraged by being able to achieve regulations that the industry opposed (e.g., higher taxes, bans on public smoking). The difference here is that none of these measures attack the fundamental nature of the product. While paying more or exiting a bar to smoke, smokers still light up uncompromised cigarettes.

While smokers might “walk a mile” for cigarettes, smokers might not extend an arm for trace-nicotine cigarettes.

AMA, FDA support the strategy

Nonetheless, the low-nicotine cigarette gained influential support.

In the U.S., the American Medical Association and the Food and Drug Administration have both thrown their support behind the strategy of a low-nicotine cigarette. The AMA offered a formal resolution in 1998, and the 2009 law giving the FDA authority over cigarettes included the nicotine-reduction strategy as a centerpiece. Part of the 2009 law said FDA could reduce nicotine, provided levels weren’t taken to zero.

For research, the FDA contracted for trace-nicotine cigarettes that were genetically engineered using a patented process. It has invested tens of millions of dollars on research on the cigarette.

The law also requires that any regulation considers negative effects from contraband markets. Also, it should be noted that, although the FDA law explicitly allows for graphic-warning labels on all cigarettes, legal action has derailed such labels. This was influenced by FDA’s own cost/benefit analyses.

A closer look at the complex law, which was supported by Altria®, raises doubt about whether mandatory trace-nicotine cigarettes are practicable.

Research not convincing

The most extensive study to date produced only “preliminary short-term data…suggesting” some changes in nicotine exposure and dependence. The study participants had no severe mental illnesses or alcohol or other substance issues, except for marijuana. Other research on the effects of these cigarettes in high-risk groups was limited by very small samples (for example, only six individuals with affective disorders) and “no assessment of chronic exposure” to only these cigarettes.

This is important because smoking is much more common among substance users and mentally ill individuals than in the general population. And the nicotine may provide a kind of self-medication.

A subsequent paper from this project makes it clear that dissatisfaction with these cigarettes was the major predictor of cheating by smoking conventional cigarettes, and this was found in the large majority (78 percent) of participants.

Indeed the dissatisfaction with very low-nicotine cigarettes is central to the problem.

The trace-nicotine model no longer a ‘nicotine’ end-game strategy

While initially in 1994 the nicotine-reduction strategy said nothing about supplemental nicotine, the model in the hands of its leading scientific proponents (and creators) has evolved to require that less-harmful nicotine sources be provided:

“The key to successful cigarette nicotine reduction is likely to lie with providing readily available, consumer-acceptable non-combusted forms of nicotine to support shifting the source of nicotine from cigarettes to a non-combusted product…We recommend that regulations regarding e-cigarettes and other ANDS [alternative nicotine delivery systems] focus on toxicity, safety and limiting youth uptake, but do not disrupt features that make them viable alternative to cigarette smoking.”

The evolved approach should spur the AMA, FDA and WHO to advance safer, satisfying forms of nicotine products before, if ever, trying to ban traditional cigarettes.

Countries confused over safer tobacco/nicotine products

The WHO conference in India will also discuss vape, and their inclinations have not been nearly as supportive as those of others. The world is in chaos concerning regulations and support for less-harmful, satisfying forms of nicotine/tobacco.

Snus, or smokeless, manufactured tobacco. From www.shutterstock.com

Although the evidence is clear that manufactured smokeless tobacco in the U.S. or Sweden is much less harmful to health than cigarettes, authorities have shown reluctance to provide this information to American consumers.

A product that produces no lung cancer or other respiratory disease, which accounts for the majority of smoking deaths, has been estimated to be at least 90 percent less dangerous than cigarettes.

Swedish smokeless tobacco, or snus, is banned in the European Union (except for Sweden). A national U.S. survey found that only 9 percent appreciated that smokeless tobacco was safer than cigarettes.

Other countries have banned e-cigarettes (Australia) or nicotine in e-cigarettes (Canada), while others have been clear in supporting the constructiveness of vaping. New FDA regulations constrain the development of e-cigarettes.

One manufacturer (NJOY) has declared bankruptcy, citing pressures arising from FDA legislation. Sound, public health-promoting regulations need to be in place globally to support safer, satisfying alternatives to cigarettes, before, if ever, taking any further steps to banning traditional cigarettes.

Optional very low-nicotine cigarettes have been promoted in the past, but were commercial failures. We need more experience in motivated smokers using such cigarettes in open markets. What patterns of longer-term multiple-product use might develop alongside trace-nicotine cigarettes (which are fully toxic)?

Comprehensive policies

Modern efforts can decrease smoking to historic lows. Mandatory trace-nicotine cigarettes might never be needed or even desirable, especially if comprehensive efforts continue to decrease smoking. The availability of less-harmful products has been associated with drops in smoking and not increases.

Comprehensive tobacco control programs should discourage the use of combustible products and maximize use of less harmful products such as smokeless tobacco products or vape by those who are not prevented from or able to quit using all of these products.

It may take a while for those who imprinted on the purity of the 1994 nicotine reduction model (with no place for additional nicotine) to accept that the evolved model now requires a vibrant availability of less-harmful, consumer-satisfying, noncombusted products.

Without these changes, the model unarguably is a cigarette prohibition and ill-advised. AMA, FDA and WHO should now tackle first things first.

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