Assessment of tobacco heating product THP1.0. Part 9: The placement of a range of next-generation products on an emissions continuum relative to cigarettes via pre-clinical assessment studies

Regul Toxicol Pharmacol. 2018 Mar:93:92-104. doi: 10.1016/j.yrtph.2017.10.001. Epub 2017 Oct 25.

Abstract

This series of nine papers described the operation and pre-clinical assessment of a tobacco heating product THP1.0. This last paper contextualises the pre-clinical assessment data on THP1.0 with data from other next generation products relative to cigarette smoke. The tobacco and nicotine risk continuum is a concept that ranks products according to their potential harm, with cigarettes at the highest risk extreme and Nicotine Replacement Therapy at the least risky extreme. Data generated in pre-clinical studies on THP1.0 and a range of Next Generation Products (NGPs) may provide some initial indication of potential ranking of these products, although importantly, data from such studies are limited and cannot take into consideration several important aspects for risk such as long term product use patterns. In each of the studies, the responses to the emissions from THP1.0 were substantially reduced relative to cigarette smoke. Additionally, responses from THP1.0 were very similar to those from the other NGP emissions. A comparison of the results clearly showed the emissions from all the NGPs were considerably lower than those from cigarettes and all in around the same emissions level. These results show that THP1.0 could have the potential to be a reduced risk product compared to cigarettes, though further studies assessing the exposure, individual and population risk reduction profile would be required to substantiate this potential.

Keywords: Next-generation products; Novel tobacco products; Pre-clinical assessment; Risk continuum; electronic cigarettes; tobacco heating products.

MeSH terms

  • Aerosols / administration & dosage
  • Aerosols / analysis*
  • Drug Evaluation, Preclinical / methods
  • Electronic Nicotine Delivery Systems / methods*
  • Heating / methods*
  • Humans
  • Mutagenesis / drug effects
  • Mutagenesis / physiology
  • Nicotine / administration & dosage
  • Nicotine / analysis*
  • Tobacco Products / analysis*

Substances

  • Aerosols
  • Nicotine