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This paper aims to describe the various government measures that regulate the market for novel tobacco harm reduction products (THRPs), with an emphasis on e-cigarettes [electronic nicotine delivery systems (“ENDS”)], and evaluates the public health impact of excise taxes levied on these products.

The paper reviews the economic research on the impact ENDS. Using cited evidence, the paper compares the tax treatment of ENDS and cigarettes and provides a simulation of potential lives that can be saved under alternative tax treatment of ENDS.

ENDS are considerably less harmful than cigarettes. Imposing the same tax burden on them (per unit of “harm”) as on cigarettes leads to poorer health outcomes. Differential tax treatment of ENDS will encourage more cigarette smokers to switch to ENDS and could save millions of lives worldwide.

Country experiences with regulatory measures on ENDS are limited to those with high THRP penetration. The paper’s simulation analysis used evidence from a limited number of studies. Rigorous economic analysis is needed to understand how ENDS could save lives and could prevent expected one billion premature deaths by the end of this century.

The paper uses research evidence in its analysis of the impact that the differential taxation of cigarettes and ENDS would have. It also provides a rough estimate of the number of lives that could be saved if more smokers who are trying to quit can make the switch to ENDS.

This article aims to provide an informed overview of the current policy and upcoming e‐cigarette legislation, and their impact on the potential for harm reduction in the tobacco products arena in the USA. The article argues in favor of reasonable regulatory options supportive of harm reduction, and which take into consideration the realities of the emerging US e‐cigarette market.

The authors consider the recent refocus on harm reduction potential in the e‐cigarettes, which are growing in popularity but will be soon subject to potentially very restrictive regulation. This article provides an overview of selected, relevant provisions of the US tobacco product regulatory framework as it may soon apply to e‐cigarettes, not only for the benefit of the tobacco harm reduction debate, but also to global stakeholders, as well.

FDA needs strong leadership to avoid current political pressures to label all tobacco products as equally dangerous, vilify nicotine and deny a reasonable approach to harm reduction that promotes the benefits of reduced risk as a legitimate approach to better health. Admittedly, more research is needed before a final assessment can be made on the population‐level health benefits of e‐cigarettes.

This article provides an informed view of US e‐cigarette industry regulatory challenges by two industry regulatory experts, and an overview of possible e‐cigarette regulatory outcomes in the USA, in light of the US Food and Drug Administration announcement that such regulation is to be expected shortly.