Role of testing standards in smoke-free product assessments

Belushkin, Maxim; Esposito, Marco; Jaccard, G.; Jeannet, Cyril; Korneliou, Alexandra; Djoko, Donatien Tafin

doi:10.1016/j.yrtph.2018.06.021

Cited by 19 publications

(20 citation statements)

References 57 publications

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“…For cigarettes, the applied analytical smoking machine regime followed the specifications of the ISO intense smoking regime (ISO 2018a) modifications. For eHTPs, the same regime was used for the generation of their aerosols, because it is the regime that has been most widely used for such products (Belushkin et al 2018) and is the regime currently recommended for their assessment (CORESTA 2020). The puff number per product unit was determined.…”

Section: Hphc Yield Determinationmentioning

confidence: 99%

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

et al. 2020

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Health risk associated with the use of combustible cigarettes is well characterized and numerous epidemiological studies have been published for many years. Since more than a decade, innovative non-combusted tobacco products have emerged like heated tobacco products (HTP) or electronic cigarettes (EC). Long-term effects of these new products on health remain, however, unknown and there is a need to characterize associated potential health risks. The time dedicated to epidemiological data generation (at least 20 to 40 years for cancer endpoint), though, is not compatible with innovative development. Surrogates need, therefore, to be developed. In this work, non-cancer and cancer risks were estimated in a range of HTP and commercial combustible cigarettes based upon their harmful and potentially harmful constituent yields in aerosols and smoke, respectively. It appears that mean lifetime cancer risk values were decreased by more than one order of magnitude when comparing HTPs and commercial cigarettes, and significantly higher margin of exposure for non-cancer risk was observed for HTPs when compared to commercial cigarettes. The same approach was applied to two commercial ECs. Similar results were also found for this category of products. Despite uncertainties related to the factors used for the calculations and methodological limitations, this approach is valuable to estimate health risks associated to the use of innovative products. Moreover, it acts as predictive tool in absence of long-term epidemiological data. Furthermore, both cancer and non-cancer risks estimated for HTPs and ECs highlight the potential of reduced risk for non-combusted products when compared to cigarette smoking.

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Section: Hphc Yield Determinationmentioning

confidence: 99%

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

et al. 2020

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“…The proposed normalization approaches for the assessment of robustness for HPHC reduction included the transformation of HPHC yields into aerosol/smoke HPHC concentrations, and the representation of HPHC yields in relation to the observed nicotine yields. The concept for the use of aerosol/smoke concentrations is based on the arithmetical division of the HPHC yields by the total amount of aerosol generated, as described by BELUSHKIN et al (5) addressing the role of testing standards in smoke-free product assessments. The latter approach would be entirely appropriate for comparing a product containing no nicotine with a nicotine-containing product, whereby HPHC yields are normalized in accordance with the total volume of aerosol delivered, and not with the amount of nicotine delivered.…”

Section: Resumementioning

confidence: 99%

Robustness of HPHC Reduction for THS 2.2 Aerosol Compared with 3R4F Reference Cigarette Smoke Under High Intensity Puffing Conditions

Goujon

Kleinhans

Maeder

et al. 2020

Contributions to Tobacco &Amp; Nicotine Research

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SummaryIn the absence of standards specific for testing the reduction robustness of the levels of harmful and potentially harmful constituents (HPHCs), the aerosol from the THS 2.2, a heated tobacco product, was compared with the mainstream smoke of the 3R4F reference cigarette over a broad range of machine-smoking regimes. The average reduction and the introduced concept of threshold limits of robust reduction were derived from HPHC concentrations, in mass per tobacco-stick normalized per total puff volume, to propose an alternative for the assessment of products where nicotine-adjusted yields would be inappropriate. In addition, this study explores the influence of 3R4F reference cigarette filter ventilation, and discusses the roles of temperature and precursors in the present context of robustness of HPHC reduction. Fifty-four HPHCs were analyzed under multiple regimes in THS 2.2 aerosol and 3R4F cigarette smoke. The average reduction of HPHC concentrations compared across all regimes characterized the robustness. Threshold limits of reduction of individual HPHCs were statistically determined across all regimes. The results observed under Health Canada Intense (HCI) and more intense regimes indicated that on average the reductions in HPHCs levels investigated in THS 2.2 aerosol were more than 90% and that the majority of the 54 HPHCs investigated in THS 2.2 aerosol showed more than 90% reduction. The robustness of THS 2.2 in maintaining the levels of reduction of representative HPHCs, whatever the puffing regime, can be quantified. The mass of HPHC per tobacco-stick normalized per total puff volume is a valuable approach to compare the robustness of the performance of a product over a large range of puffing conditions. Our findings will greatly complement the assessment for robustness of current and future similar products where classical approaches would present limitations.

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“…89 Standardized methodologies and interlaboratory trial results are also available for other constituents as industry standards through CORESTA, the Centre for Scientific Research Relative to Tobacco, with a number of methods presently in development phase within the ISO technical committee in charge of tobacco and tobacco products, such as for carbonyls and volatile compounds. 56 The relative abundance of HPHCs in CS and their amenability to measurement using routine analytical equipment has facilitated the development of standard procedures. The relatively low levels of constituents in HNB aerosols is a significant technical challenge to the development of efficient analytical methods.…”

Section: Aerosol Hphc Analysesmentioning

confidence: 99%

“…57 Comparing products on a per-puff basis necessitates an estimate of the number of puffs per day for both the cigarettes and the HNB tobacco product. 56,162 Using nicotine concentration as a normalization parameter in comparative studies of CS constituents has been recommended by the TobReg (2nd report). 3 HNB tobacco products aim at delivering similar amounts of nicotine per puff to the consumer as a puff of CS would deliver.…”

Section: Dose-range-finding Studiesmentioning

confidence: 99%

State-of-the-art methods and devices for the generation, exposure, and collection of aerosols from heat-not-burn tobacco products

Boué

Goedertier

Hoeng

et al. 2020

Toxicology Research and Application

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Tobacco harm reduction is increasingly recognized as a promising approach to accelerate the decline in smoking prevalence and smoking-related population harm. Potential modified risk tobacco products (MRTPs) must undergo a rigorous premarket toxicological risk assessment. The ability to reproducibly generate, collect, and use aerosols is critical for the characterization, and preclinical assessment of aerosol-based candidate MRTPs (cMRTPs), such as noncombusted cigarettes, also referred to as heated tobacco products, tobacco heating products, or heat-not-burn (HNB) tobacco products. HNB tobacco products generate a nicotine-containing aerosol by heating tobacco instead of burning it. The aerosols generated by HNB products are qualitatively and quantitatively highly different from cigarette smoke (CS). This constitutes technical and experimental challenges comparing the toxicity of HNB aerosols with CS. The methods and experimental setups that have been developed for the study of CS cannot be directly transposed to the study of HNB aerosols. Significant research efforts are dedicated to the development, characterization, and validation of experimental setups and methods suitable for HNB aerosols. They are described in this review, with a particular focus on the Tobacco Heating System version 2.2. This is intended to support further studies, the objective evaluation and verification of existing evidence, and the development of scientifically substantiated HNB MRTPs.

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Role of testing standards in smoke-free product assessments

Cited by 19 publications

References 57 publications

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

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

Robustness of HPHC Reduction for THS 2.2 Aerosol Compared with 3R4F Reference Cigarette Smoke Under High Intensity Puffing Conditions

State-of-the-art methods and devices for the generation, exposure, and collection of aerosols from heat-not-burn tobacco products

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