• James Murphy, Marianna Gaca, Frazer Lowe, Emmanuel Minet, Damien Breheny, Krishna Prasad, Oscar Camacho, Ian M Fearon, Chuan Liu, Christopher Wright, Kevin McAdam, and Christopher Proctor.
• British American Tobacco, R&D Centre, Southampton, SO15 8TL, United Kingdom. Electronic address: james_murphy@bat.com.
• Regul. Toxicol. Pharmacol. 2017 Nov 1; 90: 342-357.

AbstractCigarette 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 The US FDA, has provided draft guidance outlining a framework to assess novel products as Modified Risk Tobacco Products (MRTP).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.Copyright © 2017 British American Tobacco Ltd. Published by Elsevier Inc. All rights reserved.

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