A novel hybrid tobacco product that delivers a tobacco flavour note with vapour aerosol (Part 2): In vitro biological assessment and comparison with different tobacco-heating products

Abstract

This study assessed the toxicological and biological responses of aerosols from a novel hybrid tobacco product. Toxicological responses from the hybrid tobacco product were compared to those from a commercially available Tobacco Heating Product (c-THP), a prototype THP (p-THP) and a 3R4F reference cigarette, using in vitro test methods which were outlined as part of a framework to substantiate the risk reduction potential of novel tobacco and nicotine products. Exposure matrices used included total particulate matter (TPM), whole aerosol (WA), and aqueous aerosol extracts (AqE) obtained after machine-puffing the test products under the Health Canada Intense smoking regime. Levels of carbonyls and nicotine in these matrices were measured to understand the aerosol dosimetry of the products. The hybrid tobacco product tested negative across the in vitro assays including mutagenicity, genotoxicity, cytotoxicity, tumour promotion, oxidative stress and endothelial dysfunction. All the THPs tested demonstrated significantly reduced responses in these in vitro assays when compared to 3R4F. The findings suggest these products have the potential for reduced health risks. Further pre-clinical and clinical assessments are required to substantiate the risk reduction of these novel products at individual and population levels.

Potential predictors of adoption of the Tobacco Heating System by U.S. adult smokers: An actual use study

“…The substantial reduction in toxic emission and subsequent body exposure have been established by the THS manufacturer (PMI) and competitors 20– 35 . Though a few studies have brought contradictory evidence 36, 37 , the weight of evidence produced by independent studies, including FDA laboratory tests, confirms PMI’s findings on the substantial reduction of major carcinogens 17, 29, 38– 42 . While prevalence data are still sparse, evidence from Japan, where IQOS was first launched, suggest a steady increase in awareness and use of IQOS between 2015 and 2017 43, 44 .…”

Cancer potencies and margin of exposure used for comparative risk assessment of heated tobacco products and electronic cigarettes aerosols with cigarette smoke

“…Our observations for combustible cigarettes are comparable to the results obtained by Fowles and Dybing (2003), who mentioned 1,3-butadiene, acrylonitrile, acetaldehyde, and benzene among the five main contributors. This difference in major contributors may be explained by the changes in product design between cigarettes and HTPs, in particular the much lower temperature applied to tobacco for HTPs when compared to cigarettes (Breheny et al 2017;Smith et al 2016;Eaton et al 2018), which result in significant changes in product emission characteristics (Simonavicius et al 2019). It may, however, be confusing to have acrylamide and ethylene oxide appearing as main contributors to cancer risk for HTPs, as these substances' yields are often below LOQ in their aerosols.…”

Mainstream smoke constituents and in vitro toxicity comparative analysis of 3R4F and 1R6F reference cigarettes

“…It has been regularly used as a monitor in collaborative tests organized for the analysis of MS constituents [[1], [2], [3]], or in the frame of methods development [[4], [5], [6], [7], [8], [9]], as a comparator for analyses performed for cigarettes [4,[10], [11], [12], [13], [14], [15]] or heated tobacco products [[16], [17], [18], [19], [20], [21], [22], [23]]. It has also been used as a comparator for toxicological in vitro assays for cigarettes [[24], [25], [26], [27]] or novel tobacco products and e-cigarettes [20,26,[28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38]] and in vivo toxicological studies [[39], [40], [41], [42], [43], [44], [45], [46]]. The stock for 3R4F reference cigarette is, however, depleting.…”