Dempsey, R.; Rodrigo, G.; Vonmoos, F.; Gunduz, I.; Belushkin, M.; Esposito, M.
Heated tobacco products (HTP) have become increasingly common in many countries worldwide. The principle of heating tobacco, without combustion, to produce a nicotine-containing aerosol with remarkably reduced levels of other known toxins, compared to combusted tobacco cigarettes, is now well established. As these products are intended as alternatives to traditional combusted products, during the early stages of their development, it is important for manufacturers to ensure that the design of the product does not lead to any unintentionally increased or new risk for the consumer, compared to the traditional products that consumers seek to replace. There is limited guidance from tobacco product regulations concerning the requirements for performing such preliminary toxicological assessments. Here, we review the published literature on studies performed on HTPs in the pursuit of such data, outline a proposed approach that is consistent with regulatory requirements, and provide a logical approach to the preliminary toxicological assessment of HTPs.
PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts to develop and assess products that have the potential to reduce individual risk and population harm associated with tobacco use. This site is for use by scientists, the public health and regulatory communities, and other stakeholders with an interest in tobacco policy. The purpose of this site is not for advertising or marketing. It is not intended for use by consumers.
Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. Our RRPs are smoke-free products that produce an aerosol that contains far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.