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Will Nicotine-Free Cigarettes Be Mandated By The FDA?

In the previous posting I discussed the possibility of FDA requiring that no tobacco products be allowed to emit Carbon Monoxide. While appealing in its simplicity, such a strategy may have problems in that it could be interpreted as a ban on a whole class (or classes) of tobacco products, which the legislation does not allow.

Another strategy might be to reduce the harm from tobacco by lowering the nicotine content/delivery of cigarettes down to the level at which they are no longer addictive. A form of this strategy was proposed in the 1990’s by leading tobacco researchers Professor Neal Benowitz, and Professor Jack Henningfield. The FDA legislation singles out nicotine as the only chemical that cannot be reduced to zero, but this allows FDA the right to reduce the nicotine delivery of tobacco products down to a level just above zero at which they would no longer be addictive.

Although people could debate and study precisely what level of nicotine delivery is non-addictive, in reality it would not be at all difficult to define a level that would be so lacking in reinforcement as to be insufficient to perpetuate addictive use. For example, one could require that no cigarettes are capable of providing the user with a venous blood nicotine level higher than 4 ng/ml, whether from chain-smoking a number of cigarettes, or from smoking a whole pack throughout the day. For cigarettes to meet this criterion would not require them to be nicotine-free, but it would require them to deliver a per-cigarette boost in venous blood nicotine of less than 2 ng/ml (as compared to a typical boost of 10-20 ng/ml from a typical cigarette). This low level of nicotine delivery would not be sufficiently reinforcing for the vast majority of users. If alternative nicotine delivery products such as nicotine replacement therapy, smokeless tobacco products and possibly e-cigarettes were allowed to remain on the market with their normal (or possibly even increased) nicotine delivery then highly addicted smokers would transition onto these products as the nicotine delivery of their cigarettes is cut.

One of the primary aims of this strategy is to get to the point where young people will no longer become addicted to cigarettes.

So long as very low nicotine delivery cigarettes remain available, this strategy should be consistent with the legislation, and so long as plenty of smoke-free nicotine delivery products remain available it should not cause major problems of nicotine withdrawal, even if it is implemented relatively swiftly.

Of course, although in these days of FDA regulation there is talk that now tobacco policy can be driven by science rather than politics. While there is now a much more direct role for science than we had before the legislation, that does not mean that politics do not play a part. In the end, money counts, and right now the federal government and the states have become somewhat reliant on revenue from tobacco (primarily cigarette) taxes to come close to balancing budgets. If that revenue source was suddenly taken away (or even gradually) then there is a risk that the political world may interfere with the science-based public health strategy. For that reason I would recommend that the same nicotine reduction strategy not be applied to smokeless tobacco products. Rather, these should be regulated with a toxin reduction strategy to ensure they are minimally harmful, while maintaining the ability to deliver adequate amounts of nicotine to satisfy smokers’ addiction. These products would continue to be taxed at a relatively high rate and would take on the tax burden vacated by smoked products (which would no longer deliver adequate amounts of nicotine to be the lead product). In this way, the financial consequences for the states need not be so severe that the cigarette nicotine reduction strategy would be called to a halt. This dual track strategy also allows the tobacco industry to stay in business. There will be a greatly increased demand for low-toxin medium-high nicotine-delivery smokeless tobacco products, along with a greatly reduced demand for very-low-nicotine cigarettes and cigars. The companies will have to change fairly drastically to producing products that no longer cause hundreds of thousands of cases of lung cancer and COPD each year. But this is precisely the purpose of the FDA legislation: to regulate tobacco in a manner that prioritizes public health.

This post, Will Nicotine-Free Cigarettes Be Mandated By The FDA?, was originally published on by Jonathan Foulds, Ph.D..

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