CORESTA Congress, Berlin, 2016, Plenary Session, APSTW 01

What is the rationale behind TobReg’s "Global nicotine reduction strategy"?

HENNINGFIELD J.E.
Pinney Associates, Bethesda, MD, U.S.A.; The Johns Hopkins University School of Medicine, Division of Behavioral Biology, Department of Psychiatry and Behavioral Sciences, Baltimore, MD, U.S.A.

In 1994 Benowitz and Henningfield proposed a regulatory strategy to reduce the nicotine content of cigarettes to levels that would greatly reduce the risk that smoking could lead to addiction or that such cigarettes could readily sustain addiction. The Food and Drug Administration (FDA) determined that such a strategy merited consideration and further research. A 1998 report commissioned by the American Medical Association (AMA) to Henningfield et al. summarized conditions necessary to implement such a strategy. The AMA endorsed the concept. One condition was ready access to alternative forms of nicotine. This strategy was discussed at several World Health Organisation (WHO) TobReg meetings with little consensus (e.g. WHO SACTob, 2003). Increasing requests for evaluation by parties to the WHO Framework Convention on Tobacco Control (FCTC) converged with implementation of FDA regulation (2009) and the emergence of electronic nicotine delivery systems (ENDS) as a nicotine delivery alternative that might make nicotine reduction viable. With the FDA putting millions of dollars into research, data began to emerge to provide the basis for evaluation by TobReg and the topic was addressed at the 2013 TobReg meeting with initial recommendations released in a report to the FCTC Conference of Parties in 2014, and published as a WHO TobReg Advisory Note in 2015. The report calls for additional research and discusses several conditions to enable the implementation of such a strategy with an explicit caution that “the strategy is not recommended in the absence of developed capacity for market surveillance and product testing” and by implication other conditions discussed in the report. Additional rationale and research since TobReg’s evaluation will be discussed in this presentation. Conditions considered vital by TobReg to minimize unintended consequences will also be discussed.