Murphy, J., Lowe, F., Fearon, I., Camacho, O., Minet, E.
Tobacco Science Research Conference (TSRC)
A FRAMEWORK FOR THE ASSESSMENT OF REDUCED-RISK TOBACCO AND NICOTINE PRODUCTS
Cigarette smoking is a cause of many human diseases including cardiovascular disease, lung disease and cancer [US Department of Health and Human Services 2014]. The use of novel tobacco and nicotine products with reduced yields of toxicants compared to cigarettes, such as tobacco-heating products, low toxicant oral smokeless products (eg, snus) and electronic cigarettes, hold great potential for reducing the harm associated with tobacco use. Currently, however, this harm reduction potential has yet to be scientifically substantiated and the US Food and Drug Administration (FDA), is the only national regulator to have provided a draft framework with which to assess novel tobacco and nicotine products for their harm reduction potential via their Modified Risk Tobacco Product directive [FDA 2012a]. In this paper we describe a framework for the assessment of such products that includes four key assessment phases: stewardship science, exposure reduction, individual risk reduction and population risk reduction. This integrated approach proposes the use of pre-clinical, clinical and population studies to assess the risk reduction potential of new products at the individual and population level.