Enacting a regulation to lower the nicotine levels in cigarettes to minimally addictive levels in the U.S. may "substantially reduce" tobacco-related mortality, according to an analysis published March 15 in the New England Journal of Medicine.

In July 2017, the U.S. Food and Drug Administration (FDA) announced a regulatory plan to explore lowering the nicotine level in cigarettes to improve the rate of smoking-related diseases and mortality in the U.S. To assess the potential risks and benefits prior to enacting such a regulation, Benjamin J. Apelberg, PhD, MHS, the Center for Tobacco Products, FDA, et al., used a simulation model derived from empirical evidence and expert opinion to estimate the effect the regulation could have on the prevalence of tobacco use, tobacco-related mortality and life-years gained.

The authors established a projection period from 2016 through 2100 to simulate a baseline scenario that predicted the future use of cigarettes and non-combusted tobacco products and compared the baseline scenario with a scenario incorporating the anticipated effects of the policy. The model included data points accounting for population, births, migration, mortality and tobacco-use behavior, among others.

Results showed that approximately five million additional smokers would quit smoking within a year of implementation of the policy. That number would increase to 13 million additional former smokers within five years of implementation. In subsequent years within the policy scenario, the difference in smoking prevalence would continue to grow because of sustained increases in cessation and decreases in initiation of cigarette use.

Since a sustained decrease in the rate of smoking initiation is expected, it is projected that the cumulative number of persons dissuaded from ever starting to smoke would continue to increase over time. The authors further estimated that by 2060, 16 million persons who would have otherwise initiated smoking, would not start because of the policy.

"Despite inherent uncertainty, the data from our model contribute to a growing base of evidence about the role of nicotine reduction that can inform the development of policy with respect to tobacco products, including an assessment of the risks and benefits to the population as a whole," the authors conclude. "Our findings show that reducing the nicotine level in cigarettes has the potential to substantially reduce the enormous burden of smoking-related death and disease. We estimate that a nicotine product standard for cigarettes in the U.S. could save millions of lives and tens of millions of life-years over the next several decades."

Keywords: ACC Advocacy, Tobacco, Smoke, Uncertainty, Prevalence, Expert Testimony, United States Food and Drug Administration, Tobacco Products, Smoking, Tobacco Use, Behavior, Addictive, Risk Assessment

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