Evaluation of the Tobacco Heating System 2.2. Part 1: Description of the system and the scientific assessment program

Abstract

This publication introduces a series of eight other publications describing the non-clinical assessment and initial clinical study of a candidate modified risk tobacco product (MRTP) - the Tobacco Heating System 2.2 (THS2.2). This paper presents background information on tobacco harm reduction, to complement the approaches aimed at increasing smoking cessation and reducing smoking initiation to reduce the morbidity and mortality caused by cigarette smoking. THS2.2 heats tobacco without combustion, and the resulting formation of harmful and potentially harmful constituents (HPHC) is greatly reduced compared with cigarette smoke. Assessment of the THS2.2 aerosol in vitro and in vivo reveals reduced toxicity and no new hazards. Additional mechanistic endpoints, measured as part of in vivo studies, confirmed reduced impact on smoking-related disease networks. The clinical study confirmed the reduced exposure to HPHCs in smokers switching to THS2.2, and the associated transcriptomic study confirmed the utility of a gene expression signature, consisting of only 11 genes tested in the blood transcriptome of subjects enrolled in the clinical study, as a complementary measure of exposure response. The potential of THS2.2 as an MRTP is demonstrated by the assessment and additional publications cited in this series.

The sbv IMPROVER Systems Toxicology computational challenge: Identification of human and species-independent blood response markers as predictors of smoking exposure and cessation status

“…The tobacco heating system (THS)2.2, uses an electrically heated system [33], and pMRTP uses a fast-lighting carbon tip as heat source [24]. …”

Heat-not-burn tobacco products: concerns from the Italian experience

“…Most safety data on this new tobacco product come from research conducted by the tobacco industry 2. The few independent toxicological studies confirm that HNBs release harmful and potentially harmful substances, although at reduced levels as compared with conventional cigarettes 1 3 4.…”

iQOS: evidence of pyrolysis and release of a toxicant from plastic

“…The function of the polymer-film filter is to cool the aerosol,3 thus, it would seem that the polymer composing the film should be heat resistant, although, ε-caprolactone, also known as polycaprolactone, tends to have a low-melting point which is thickness dependent 24. The intensity of the heat produced by the iQOS, under both cleaned and uncleaned conditions, was sufficient to melt the polymer-film filter, even though it was not in direct contact with the heater.…”

“…However, there are still a number of conventional (combustible) cigarette smokers who would welcome a cigarette-like tobacco-containing/nicotine-containing product that is devoid of or has a significantly reduced toxicity compared with conventional cigarettes 1. To appeal to this demographic, Philip Morris International (PMI) has released a new product called the iQOS (I quit original smoking), which is a ‘heat-not-burn’ system,3 as an alternative to conventional cigarettes and EC. The iQOS system uses a flange, called the ‘heater’, which is composed of a silver, gold, platinum, ceramic coating,4 to heat a rolled, cast-leaf sheet of tobacco impregnated with glycerin, thereby creating an aerosol without combustion 3.…”

“…To appeal to this demographic, Philip Morris International (PMI) has released a new product called the iQOS (I quit original smoking), which is a ‘heat-not-burn’ system,3 as an alternative to conventional cigarettes and EC. The iQOS system uses a flange, called the ‘heater’, which is composed of a silver, gold, platinum, ceramic coating,4 to heat a rolled, cast-leaf sheet of tobacco impregnated with glycerin, thereby creating an aerosol without combustion 3. This aerosolisation process is proposed to reduce the user’s exposure to toxic and carcinogenic chemicals produced by the combustion of tobacco 5 6.…”