Comparative assessment of HPHC yields in the Tobacco Heating System THS2.2 and commercial cigarettes
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There has been a sustained effort in recent years to develop products with the potential to present less risk compared with continued smoking as an alternative for adult smokers who would otherwise continue to smoke cigarettes. During the non-clinical assessment phase of such products, the chemical composition and toxicity of their aerosols are frequently compared to the chemical composition and toxicity of the smoke from a standard research cigarette – the 3R4F reference cigarette. In the present study, it is demonstrated that results of these analytical comparisons are similar when considering commercially available cigarette products worldwide. A market mean reduction of about 90% is observed on average across a broad range of harmful and potentially harmful constituents (HPHC) measured in the aerosol of a candidate modified risk tobacco product, the Tobacco Heating System 2.2 (THS2.2), compared against the levels of HPHC of cigarettes representative of selected markets; this mean reduction is well in line with the reduction observed against 3R4F smoke constituents in previous studies.
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Anonymous, 2013. Reference products used in tobacco and smoke analyses. Tob. J. Int. 2/2013, 150e154.
Belushkin, M., Jaccard, G., Kondylis, A., 2015. Considerations for comparative tobacco product assessments based on smoke constituent yields. Regul. Toxicol. Pharmacol. 73 (1), 105e113.
Belushkin, M., Piade, J.-J., Chapman, S., Fazekas, G., 2014. Investigating predictability of toxicological assessments of cigarettes: Analysis of 7 years of regulatory submissions to Canadian regulatory authorities. Regul. Toxicol. Pharmacol. ISSN: 0273-2300 68 (2), 222e230. http://dx.doi.org/10.1016/ j.yrtph.2013.12.009.
Bodnar, J.A., Morgan, W.T., Murphy, P.A., Ogden, M.W., 2012. Mainstream smoke chemistry analyses of samples from the 2009 US cigarette market. Regul. Toxicol. Pharmacol. 64, 35e42.
Bombick, D.W., Putnam, K., Doolittle, D.J., 1998. Comparative cytotoxicity studies of smoke condensates from different types of cigarettes and tobaccos. Toxicol. Vitro 12 (3), 241e249.
Burns, D.M., Dybing, E., Gray, N., Hecht, S., Anderson, C., Sanner, T., O'Connor, R., Djordjevic, M., Dresler, C., Hainaut, P., Jarvis, M., Opperhuizen, A., Straif, K., 2008. Mandated lowering of toxicants in cigarette smoke: a description of the World Health Organization TobReg proposal. Tob. Control 17 (2), 132e141.
Coggins, C.R.E., Gaworski, C.L., 2008. Could charcoal filtration of cigarette smoke reduce smoking-induced disease? A review of the literature. Regul. Toxicol. Pharmacol. 50 (3), 359e365.
Dittrich, D.J., Fieblekorn, R.T., Bevan, M.J., Rushforth, D., Murphy, J.J., Ashley, M., McAdam, K.G., Liu, C., Proctor, C.J., 2014. Approaches for the design of reduced toxicant emission cigarettes. SpringerPlus 3 (1), 1e23.
Eldridge, A., Betson, T.R., Gama, M.V., McAdam, K., 2015. Variation in tobacco and mainstream smoke toxicant yields from selected commercial cigarette products. Regul. Toxicol. Pharmacol. 71 (3), 409e427.
Eldridge, A.C., McAdam, K.G., Betson, T.R., Gama, M.V., Proctor, C.J., 2017. Impact assessment of WHO TobReg proposals for mandated lowering of selected mainstream cigarette smoke toxicants. Regul. Toxicol. Pharmacol. 86, 332e348.
FDA, 2012. Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke: Established List. US Food and Drug Administration. http:// www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ ucm297786.htm.
Ghosh, D., Jeannet, C., 2014. An improved cambridge filter pad extraction meth- odology to obtain more accurate water and “tar” values: in situ Cambridge filter pad extraction methodology. Beitrage zur Tabakforschung International/Con- tributions Tob. Res. 26 (2), 38e49.
Haziza, C., de La Bourdonnaye, G., Merlet, S., Benzimra, M., Ancerewicz, J., Donelli, A., Baker, G., Picavet, P., Ludicke, F., 2016a. Assessment of the reduction in levels of exposure to harmful and potentially harmful constituents in Japanese subjects using a novel Tobacco Heating System compared with conventional cigarettes and smoking abstinence: a randomized controlled study in confinement. Regul. Toxicol. Pharmacol. 81, 489e499.
Haziza, C., de La Bourdonnaye, G., Skiada, D., Ancerewicz, J., Baker, G., Picavet, P., Ludicke, F., 2016b. Evaluation of the Tobacco Heating System 2.2. Part 8: 5-Day randomized reduced exposure clinical study in Poland. Regul. Toxicol. Pharmacol. 81 (Suppl. 2), s139es150.
Health Canada, 1999. In: Health Canada (Ed.), Official Method-T115. Determination of Tar, Nicotine and Carbon Monoxide in Mainstream tobacco Smoke. Tobacco Control Programme, Modified: 2007-11-28. Ottawa, Canada.
Health Canada 2000. Canadian Ministry of Justice: Tobacco Reporting Regulations. SOR/200e273. Registration 2000-06-26. Part 3: Emissions from designated tobacco products.
Hearn, B.A., Ding, Y.S., Vaughan, C., Zhang, L., Polzin, G., Caudill, S.P., Watson, C.H., Ashley, D.L., 2010. Semi-volatiles in mainstream smoke delivery from select charcoal-filtered cigarette brand variants. Tob. Control 19 (3), 223e230.
International Organization for Standardization, 2000. Cigarettes e Determination of Total and Nicotine-free Dry Particulate Matter Using a Routine Analytical Smoking Machine. ISO 4387, Geneva, Switzerland.
Ludicke, F., Picavet, P., Baker, B., Haziza, C., Poux, V., Lama, N., Weitkunat, R., 2017b. Effects of switching to the Tobacco Heating System 2.2 menthol, smoking abstinence, or continued cigarette smoking on biomarkers of exposure: a randomized, controlled, open-label, multicenter study in sequential confinement and ambulatory settings (Part 1). Nicotine Tob. Res. http://dx.doi.org/10.1093/ ntr/ntw287.
Margham, J., McAdam, K., Forster, M., Liu, C., Wright, C., Mariner, D., Proctor, C., 2016. Chemical composition of aerosol from an e-cigarette: a quantitative comparison with cigarette smoke. Chem. Res. Toxicol. 29:1662e1678.
McAdam, K., Eldridge, K.A., Fearon, I.M., Liu, C., Manson, A., Murphy, J., Porter, A., 2016. Influence of cigarette circumference on smoke chemistry, biological ac- tivity, and smoking behaviour. Regul. Toxicol. Pharmacol. 82, 111e126.
Oldham, M.J., Haussmann, H.J., Gomm, W., Rimmer, L.T., Morton, M.J., McKinney, W.J., 2012. Discriminatory power of standard toxicity assays used to evaluate ingredients added to cigarettes. Regul. Toxicol. Pharmacol. 62 (1), 49e61.
Pazo, D.Y., Moliere, F., Sampson, M.M., Reese, C.M., Agnew-Heard, K.A., Walters, M.J., Holman, M.R., Blount, B.C., Watson, C.H., Chambers, D.M., 2016. Mainstream smoke levels of volatile organic compounds in 50 U.S. Domestic cigarette brands smoked with the ISO and canadian intense protocols. Nicotine Tob. Res. 18, 1886e1894.
Piade,J.J.,Jaccard,G.,Dolka,C.,Belushkin,M.,Wajrock,S.,2015.Differencesin cadmium transfer from tobacco to cigarette smoke, compared to arsenic or lead. Toxicol. Rep. 2, 12e26.
Piade, J.J., Wajrock, S., Jaccard, G., Janeke, G., 2013. Formation of mainstream cigarette smoke constituents prioritized by the World Health Organization - yield patterns observed in market surveys, clustering and inverse correlations. Food Chem. Toxicol. 55, 329e347.
Proctor, C., Shepperd, C., McAdam, K., Elridge, A., Meredith, C., 2014. Integrating chemical, toxicological and clinical research to assess the potential of reducing health risks associated with cigarette smoking through toxicant regulation. In: Tobacco Science Research Conference, vol. 2014.
Rickert, W.S., Trivedi, A.H., Momin, R.A., Wright, W.G., Lauterbach, J.H., 2007. Effect of smoking conditions and methods of collection on the mutagenicity and cytotoxicity of cigarette mainstream smoke. Toxicol. Sci. 96 (2), 285e293.
Roemer, E., Schramke, H., Weiler, H., Buettner, A., Kausche, S., Weber, S., Berges, A., Stueber, M., Muench, M., Trelles-Sticken, E., Pype, J., Kohlgrueber, K., Voelkel, H., Wittke, S., 2012. Mainstream smoke chemistry and in vitro and in vivo toxicity of the reference cigarettes 3R4F and 2R4F. Beitrage zur Tabakforschung International/Contributions Tob. Res. 25 (1), 316e335.
Roemer, E., Stabbert, R., Rustemeier, K., Veltel, D.J., Meisgen, T.J., Reininghaus, W., Carchman, R.A., Gaworski, C.L., Podraza, K.F., 2004. Chemical composition, cytotoxicity and mutagenicity of smoke from US commercial and reference cigarettes smoked under two sets of machine smoking conditions. Toxicology 195 (1), 31e52.
Sarkar, M., Kapur, S., Frost-Pineda, K., Feng, S., Wang, J., Liang, Q., Roethig, H., 2008. Evaluation of biomarkers of exposure to selected cigarette smoke constituents in adult smokers switched to carbon-filtered cigarettes in short-term and long- term clinical studies. Nicotine Tob. Res. 10 (12), 1761e1772.
Schaller, J.P., Keller, D., Poget, L., Pratte, P., Kaelin, E., McHugh, D., Cudazzo, G., Smart, D., Tricker, A.R., Gautier, L., Yerly, M., Reis Pires, R., Le Bouhellec, S., Ghosh, D., Hofer, I., Garcia, E., Vanscheeuwijck, P., Maeder, S., 2016. Evaluation of the Tobacco Heating System 2.2. Part 2: chemical composition, genotoxicity, cytotoxicity, and physical properties of the aerosol. Regul. Toxicol. Pharmacol. 81 (Suppl. 2), s27es47.
Schramke, H., Meisgen, T.J., Tewes, F.J., Gomm, W., Roemer, E., 2006. The mouse lymphoma thymidine kinase assay for the assessment and comparison of the mutagenic activity of cigarette mainstream smoke particulate phase. Toxicology 227 (3), 193e210.
Shin, H.J., Sohn, H.O., Han, J.H., Park, C.H., Lee, H.S., Lee, D.W., Hwang, K.J., Hyun, H.C., 2009. Effect of cigarette filters on the chemical composition and in vitro biological activity of cigarette mainstream smoke. Food Chem. Toxicol. 47 (1), 192e197.
Siu, M., Mladjenovic, N., Soo, E., 2013. The analysis of mainstream smoke emissions of Canadian 'super slim' cigarettes. Tob. control 22:e10.
Smith, M.R., Clark, B., Luedicke, F., Schaller, J.P., Vanscheeuwijck, P., Hoeng, J., Peitsch, M.C., 2016. Evaluation of the Tobacco Heating System 2.2. Part 1: description of the system and the scientific assessment program. Regul. Toxicol. Pharmacol. 81 (Suppl. 2), s17es26.
World Health Organization, 2015. WHO Study Group on Tobacco Product Regulation: Report on the Scientific Basis of Tobacco Product Regulation. WHO Technical Report Series, n. 989,.
Yauk, C.L., Williams, A., Buick, J.K., Chen, G., Maertens, R.M., Halappanavar, S., White, P.A., 2012. Genetic toxicology and toxicogenomic analysis of three cigarette smoke condensates in vitro reveals few differences among full-flavor, blonde, and light products. Environ. Mol. Mutagen. 53 (4), 281e296.
Lee, P.N., Forey, B.A., Fry, J.S., Hamling, J.S., Hamling, J.F., Sanders, E.B., Carchman, R.A., 2009. Does use of fluecured rather than blended cigarettes affect international variation in mortality from lung cancer and COPD? Inhal. Toxicol. 21 (5), 404e430.
Ludicke, F., Baker, G., Magnette, J., Picavet, P., Weitkunat, R., 2017a. Reduced exposure to harmful and potentially harmful smoke constituents with the Tobacco Heating System 2.1. Nicotine Tob. Res. 19 (2), 168e175.
