Reduced nicotine product standards for combustible tobacco: building an empirical basis for effective regulation

Prev Med. 2014 Nov;68:17-22. doi: 10.1016/j.ypmed.2014.06.020. Epub 2014 Jun 23.


Introduction: Both the Tobacco Control Act in the U.S. and Article 9 of the Framework Convention on Tobacco Control enable governments to directly address the addictiveness of combustible tobacco by reducing nicotine through product standards. Although nicotine may have some harmful effects, the detrimental health effects of smoked tobacco are primarily due to non-nicotine constituents. Hence, the health effects of nicotine reduction would likely be determined by changes in behavior that result in changes in smoke exposure.

Methods: Herein, we review the current evidence on nicotine reduction and discuss some of the challenges in establishing the empirical basis for regulatory decisions.

Results: To date, research suggests that very low nicotine content cigarettes produce a desirable set of outcomes, including reduced exposure to nicotine, reduced smoking, and reduced dependence, without significant safety concerns. However, much is still unknown, including the effects of gradual versus abrupt changes in nicotine content, effects in vulnerable populations, and impact on youth.

Discussion: A coordinated effort must be made to provide the best possible scientific basis for regulatory decisions. The outcome of this effort may provide the foundation for a novel approach to tobacco control that dramatically reduces the devastating health consequences of smoked tobacco.

Keywords: Addiction; Cigarettes; Harm reduction; Nicotine; Regulatory science; Tobacco.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.
  • Review

MeSH terms

  • Government Regulation
  • Humans
  • Mental Disorders / psychology
  • Nicotine / administration & dosage
  • Nicotine / adverse effects
  • Nicotine / chemistry*
  • Randomized Controlled Trials as Topic
  • Smoking Cessation
  • Smoking* / adverse effects
  • Smoking* / legislation & jurisprudence
  • Smoking* / psychology
  • Tobacco / adverse effects
  • Tobacco / chemistry*
  • Tobacco Industry* / legislation & jurisprudence
  • Tobacco Products / standards*
  • United States
  • United States Food and Drug Administration


  • Nicotine