Nicotine Reduction Strategy: State of the science and challenges to tobacco control policy and FDA tobacco product regulation.

Nicotine addiction is the proximate cause of disease and death from cigarette smoking. In 1994, we proposed reducing the nicotine content of cigarettes to non-addicting levels to reduce the risk of youth becoming addicted smokers and promoting quitting in established smokers. In 2009, the Family Smoking Prevention and Tobacco Control Act provided the authority to FDA to reduce nicotine levels as appropriate to benefit public health. Over the past 15 years, considerable research has determined that nicotine reduction is feasible and safe, resulting in reduced nicotine dependence with little evidence of compensatory over-smoking. The availability of acceptable non-combusted form of nicotine would provide support and enhance acceptability of nicotine reduction in tobacco. Most recently, the FDA promulgated a nicotine-based regulatory framework, which includes nicotine reduction combined with ready availability of noncombustible nicotine products. Nicotine reduction could contribute to a virtual end to the use of cigarette smoking, with enormous benefits to public health.