Regulatory Approaches and Implementation of Minimally Addictive Combusted Products.

introductionA joint meeting was held by the World Health Organization (WHO) and the Convention Secretariat of the WHO Framework Convention on Tobacco Control to examine the potential effects of a regulatory policy to reduce nicotine in cigarettes to minimally addictive levels. This paper reviews the feasibility of and approaches to implementing a nicotine product standard.

methodsPrior WHO reports on this topic were consulted and a systematic review of the scientific literature was conducted. The paper was reviewed by the participants at the aforementioned meeting and their feedback was incorporated.

resultsThe nicotine dose most likely to consistently reduce smoking behavior and dependence is ≤0.4 mg nicotine/g tobacco. An immediate rather than a gradual nicotine reduction approach appears to be more beneficial. Smokers are likely to seek nicotine from alternate sources (e.g., nicotine replacement therapies, e-cigarettes) or potentially, the illegal market. As such, the availability of alternative products, as well as strong policies against illegal markets, can potentially mitigate unintended consequences. An effectively reduced nicotine regulation must be imbedded in a comprehensive and strong tobacco control program that includes public education and surveillance. Barriers and challenges to implementing a nicotine product standard exist, particularly in low-capacity countries.

conclusionsNot all countries will have the capacity to implement a regulation to reduce nicotine in cigarettes (and preferably other combusted tobacco products) to minimally addictive levels. However, for the countries that choose to implement it, such a policy could potentially dramatically reduce the burden of tobacco use. IMPLICATIONS FOR TOBACCO REGULATORY SCIENCE: Article 9 of the Framework Convention on Tobacco Control provides signatory governments the authority to implement a product standard for reducing nicotine in tobacco products to minimally addictive levels. This product standard has the potential to result in a dramatic reduction in cigarette and other combusted tobacco use and therefore, smoking-caused mortality and morbidity. This article describes the growing scientific evidence to support nicotine regulation in cigarettes, potential regulatory approaches and describes the infrastructure and tobacco control policies needed to implement a reduced nicotine product standard.