Evidence From the Scientific Assessment of Electronic Cigarettes and Their Role in Tobacco Harm Reduction

Abstract

Summary While smoking remains a main global cause of preventable morbidity and mortality, a potential inflection point has arrived where it could become possible for non-combustible nicotine products to displace cigarettes and reduce risk for smokers who transition completely from smoking. These have proven consumer satisfaction and are now widely and increasingly available globally. One of the most prominent of these nicotine products are electronic cigarettes (ECs), which are used daily by millions of current and former smokers. The category is not without controversy as these products are not risk free and can cause nicotine dependence. The differing interpretation of science assessing ECs has transpired into inconsistent regulation and product standards, providing an environment for its fragmented manufacturing base which allows for variable product quality and in turn, product quality variability has impacted on how they are viewed. In this review, we assess published scientific evidence to evaluate whether, on balance, ECs fulfil a tobacco harm reduction role by reducing health risks relative to smoking and providing a viable alternative for smokers while having limited appeal to non-smokers.

Preliminary toxicological assessment of heated tobacco products: A review of the literature and proposed strategy

“…Table 1 includes 10 publications that describe generalized principles, strategies, and frameworks for the overall product assessment of MRTPs [2] , [29] , [4] , [8] , [58] , [59] , [33] , [60] , [61] , [73] . These include three from tobacco-industry authors [58] , [59] , [8] , two from academic institutes [2] , [29] , and four representing commissioned work on request from the official organizations World Health Organization [73] , the US Institute of Medicine as commissioned by the FDA [33, 61] , and the Tobacco Product Assessment Consortium (TobPRAC) commissioned by the US National Cancer Institute [4] . The other publication was from the Life Sciences Research Office (LSRO) and commissioned by PMI [60] .…”

“… Proposes a 7 step approach of which steps 1 (characterization of the product) and step 5 (evaluation of direct health effects) parallel PTA. [8] (BAT) Electronic cigarettes (EC) Overall assessment of e-cigarettes for public health impact.exposure 6 step process for product stewardship includes purity standards; exclusion of CMR d and respiratory allergens; toxicological risk assessment on e-liquid and aerosol, with potential bridging approach. a Products as described within the publication; b TobPRAC = Tobacco Product Assessment Consortium; c HPHC = harmful and potentially harmful constituents; d CMR = carcinogenicity, mutagenicity, and reproductive toxicity …”

“…Specifically, aerosol chemistry analysis and in vitro assays for cytotoxicity and genotoxicity were commonly recommended. Several studies have also noted the necessity to perform these assessments under conditions of actual use, with reference to either selecting an appropriate puffing regimen for the generation of the aerosol [8] , or to compare activities using a range of different aerosol generation regimes to evaluate the potential for different chemical or toxicological effects to be noted under extreme conditions [58] , [59] , [60] , [61] , [73] .…”

A Practical Framework for Novel Electronic Nicotine Delivery System Evaluation: Chemical and Toxicological Characterization of JUUL2 Aerosol and Comparison with Reference Cigarettes

“…To assist in compliance with the growing body of standards and established regulatory frameworks and to support the evaluation of potential health-related claims, we propose in this paper a simplified framework to guide manufacturers on the characterization and assessment of new/modified products before introduction to the market. While other product evaluation frameworks have been proposed, these frameworks may include recommendations such as clinical trials, long-term surveillance, and population modeling studies or involve comprehensive systems toxicology assessments [ 63 , 64 , 65 , 66 ]. These frameworks add valuable analyses but are less suited for early assessments of novel tobacco products and do not emphasize the thorough chemical analysis required for their evaluation.…”

Evaluation of behavioural, chemical, toxicological and clinical studies of a tobacco heated product glo™ and the potential for bridging from a foundational dataset to new product iterations

“…As was seen with vaping products [15] , there is a rapid early-stage innovation cycle as the products are developed and evolve to become satisfactory alternatives to smoking cigarettes. There are now multiple iterations of the glo™ device that vary in size, weight and the technology used for heating that are used with a range of tobacco consumables that vary by size, the weight of tobacco used and flavours.…”