Assessing modified risk tobacco and nicotine products: Description of the scientific framework and assessment of a closed modular electronic cigarette

Abstract

Cigarette smoking causes many human diseases including cardiovascular disease, lung disease and cancer. Novel tobacco products with reduced yields of toxicants compared to cigarettes, such as tobacco-heating products, snus and electronic cigarettes, hold great potential for reducing the harms associated with tobacco use. In the UK several public health agencies have advocated a potential role for novel products in tobacco harm reduction. Public Health England has stated that "The current best estimate is that e-cigarettes are around 95% less harmful than smoking" and the Royal College of Physicians has urged public health to "Promote e-cigarettes widely as substitute for smoking". Health related claims on novel products such as 'reduced exposure' and 'reduced risk' should be substantiated using a weight of evidence approach based on a comprehensive scientific assessment. The US FDA, has provided draft guidance outlining a framework to assess novel products as Modified Risk Tobacco Products (MRTP). Based on this, we now propose a framework comprising pre-clinical, clinical, and population studies to assess the risk profile of novel tobacco products. Additionally, the utility of this framework is assessed through the pre-clinical and part of the clinical comparison of a commercial e-cigarette (Vype ePen) with a scientific reference cigarette (3R4F) and the results of these studies suggest that ePen has the potential to be a reduced risk product.

Cancer potencies and margin of exposure used for comparative risk assessment of heated tobacco products and electronic cigarettes aerosols with cigarette smoke

“…The aerosol chemical characterization is only one part of the full product assessment of HTPs and ECs (Murphy et al 2017;Peitsch et al 2018) as potential reduced risk alternatives to continued cigarette smoking. The full assessment of such products includes other pre-clinical tests, such as in vitro assays, in vivo testing in animal models, and clinical studies (Murphy et al 2017;Smith et al 2016). Effectively, an average mean reduction against HPHCs measured in cigarette smoke does not represent a corresponding reduction of risk for a consumer switching from cigarettes to HTPs or ECs.…”

The in vitro assessment of a novel vaping technology

“…Scientific frameworks have been proposed [ 13 , 14 ] for the assessment of e-cigs and other next generation tobacco and nicotine products, to help establish a comprehensive data set to evaluate the reduced risk potential of these products. These frameworks include the analytical evaluation of aerosol emissions and data on the toxicological and biological effects of aerosol exposure at an individual and population level, to enable a weight of evidence-based assessment of the potential risk associated with product use.…”

Nicotine products relative risk assessment: a systematic review and meta-analysis

“…Nicotine delivery has been the subject of significant innovation since the 1950s with the development of novel products that are designed to rapidly deliver nicotine to the user while significantly reducing the risks associated with exposure to toxins emitted by combustible products 5 . These next generation products include heat-not-burn/heated tobacco (HNB) devices, electronic cigarettes, snus and nicotine replacement therapy 5,6 . There is a large body of evidence in the scientific literature that proves the detrimental effects of combustible tobacco products on the health of their users, and this is widely accepted by public health authorities.…”

“…There is a large body of evidence in the scientific literature that proves the detrimental effects of combustible tobacco products on the health of their users, and this is widely accepted by public health authorities. However, there is currently no consensus, that is based on the available scientific evidence, regarding the relative risks associated with the full spectrum of nicotine products, particularly the next generation/reduced risk products 6 .…”