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

Regulatory Toxicology and Pharmacology

Volumn 93, Issue , 2018, Pages 92-104

  Murphy, James ^a   Liu, Chuan ^a   McAdam, Kevin ^a   Gaҫa, Marianna ^a   Prasad, Krishna ^a   Camacho, Oscar ^a   McAughey, John ^a   Proctor, Christopher ^a  

^a BRITISH AMERICAN TOBACCO   (United Kingdom)

Author keywords

electronic cigarettes; Next generation products; Novel tobacco products; Pre clinical assessment; Risk continuum; tobacco heating products

Indexed keywords

CIGARETTE SMOKE; NICOTINE; TOBACCO HEATING PRODUCT THP1.0; TOBACCO SMOKE; UNCLASSIFIED DRUG;

AEROSOL; ARTICLE; CARCINOGENICITY; CIGARETTE; CYTOTOXICITY; DOSIMETRY; IN VITRO STUDY; MEASUREMENT; MUTAGENICITY; PRIORITY JOURNAL; RISK ASSESSMENT; SMOKING; TOBACCO; TOXICOLOGY; ADMINISTRATION AND DOSAGE; ANALYSIS; DRUG EFFECT; ELECTRONIC CIGARETTE; HEATING; HUMAN; MUTAGENESIS; PHYSIOLOGY; PRECLINICAL STUDY; PROCEDURES;

AEROSOLS; DRUG EVALUATION, PRECLINICAL; ELECTRONIC NICOTINE DELIVERY SYSTEMS; HEATING; HUMANS; MUTAGENESIS; NICOTINE; TOBACCO PRODUCTS;

EID: 85033491521     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2017.10.001     Document Type: Article

References (62)

1. US Department of Health and Human Services, The Health Consequences of Smoking 50 Years of Progress: a Report of the Surgeon General., 2014, US Department of Health & Human Services, Centres for Disease Control and Prevention; National centre for Chronic Disease Prevention and health promotion, office on smoking and health, Atlanta, GA.
2. Adamson, J., Thorne, D., Zainuddin, B., Baxter, A., McAughey, J., Gaça, M., Application of dosimetry tools for the assessment of e-cigarette aerosol and cigarette smoke generated on two different in vitro exposure systems. Chem. Cent. J., 10, 2016, 74.
3. Azzopardi, D., Patel, K., Jaunky, T., Santopietro, S., Camacho, O.M., McAughey, J., Gaҫa, M., Electronic cigarette aerosol induces significantly less cytotoxicity than tobacco smoke. Toxicol. Methods Mech. 26 (2016), 477–491.
4. Baker, R.R., Proctor, C., The origins and properties of environmental tobacco smoke. Environ. Int. 16 (1990), 231–245.
5. Baker, R.R., Massey, E.D., Smith, G., An overview of the effects of tobacco ingredients on smoke chemistry and toxicity. Reg. Tox. Pharm. 42 (2004), 53–83.
6. Berman, M.L., Connolly, G., Cummings, M.K., Djordjevic, M.V., Hatsukami, D.K., Henningfield, J.E., Myers, M., O'Connor, R.J., Parascandola, M., Rees, V., Rice, J.M., Shields, P.G., Providing a science base for the evaluation of tobacco products. Tob. Regul. Sci. 1 (2015), 76–93.
7. Breheny, D., Adamson, J., Azzopardi, D., Baxter, A., Bishop, E., Carr, T., Crooks, I., Hewitt, K., Jaunky, T., Larard, S., Lowe, F., Oke, O., Taylor, M., Santopietro, S., Thorne, D., Zainuddin, B., Gaça, M., Liu, C., Murphy, J., Proctor, C., 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. Food Chem. Toxicol. 106 (2017), 533–546.
8. Breheny, D., Oke, T., Pant, K., Gaça, M., The comparative tumour promotion assessment of e-cigarette and cigarettes using the in vitro Bhas 42 cell transformation assay. Environ. Mol. Mutagen. 58:4 (2017), 190–198.
9. 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., Mandated lowering of toxicants in cigarette smoke: a description of the world health organisation Tobreg proposal. Tob. Control 17 (2008), 132–141.
10. Burstyn, I., Peering through the mist: systematic review of what the contaminants in electronic cigarettes tells us about health risks. BMC Public Health, 14, 2014, 18.
11. Cancer Research UK, E-cigarettes Safer than Smoking Says Long-term Study. 2017 (online) Available at: http://www.cancerresearchuk.org/about-us/cancer-news/press-release/2017-02-06-e-cigarettes-safer-than-smoking-says-long-term-study. (Accessed 6 February 2017)
12. CORESTA, Routine analytical machine for e-cigarette aerosol generation and collection – definitions and standard conditions. 2015 https://www.coresta.org/sites/default/files/technical_documents/main/CRM_81.pdf. (Accessed 20 March 2017)
13. Crooks, I., Scott, K., Dalrymple, A., Dillon, D., Meredith, C., The combination of two novel tobacco blends and filter technologies to reduce the in vitro genotoxicity and cytotoxicity of prototype cigarettes. Reg. Tox. Pharm. 71:3 (2015), 507–514.
14. Cunningham, A., Slayford, S.J., Vas, C., Gee, J., Costigan, S., Gee, K., Development, validation and application of a device to measure e-cigarette users’ puffing topography. Sci. Rep., 6, 2016, 35071.
15. D'Ruiz, C.D., Graff, D.W., Robinson, E., Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes. BMC Public Health, 16, 2016, 543, 10.1186/s12889-016-3236-1.
16. Dautzenberg, B., Bricard, D., Real-time characterization of e-cigarette use: the one million puffs study. J. Addict. Res. Ther., 6, 2015, 229.
17. Dittrich, D.J., Fieblekorn, R.T., Bevan, M.J., Rushforth, D., Murphy, J.J., Ashley, M., McAdam, K.G., Liu, C., Proctor, C.J., Approaches for the design of reduced toxicant emission cigarettes. SpringerPlus, 2014(3), 2014, 374.
18. Eaton, D., Jakaj, B., Forster, M., Nicol, J., Mavropoulou, E., Scott, J.K., Liu, C., McAdam, K.G., Murphy, J., Proctor, C.J., Assessment of tobacco heating product THP1.0. Part 2: product design, operation and thermophysical characterisation. Reg. Tox. Pharm, 2017.
19. Etter, J.F., E-cigarettes: an Alternative to Tobacco?. 2013, 10.1111/dar.12054.
20. European Parliament and the Council of the European Union Tobacco Products Directive, 2014/40/EU. 2014 http://ec.europa.eu/health/tobacco/docs/dir_201440_en.pdf. (Accessed 30 March 2017)
21. Farsalinos, K.E., Spyrou, A., Stefopoulos, C., Tsimopoulou, K., Kourkoveli, P., Tsiapras, D., Kyrzopoulos, S., Poulas, K., Voudris, V., Nicotine absorption from electronic cigarette use: comparison between experienced consumers (vapers) and naïve users (smokers). Sci. Rep., 5, 2015, 11269.
22. Food and Drug Administration, Department of Health and Human Services (2012). 77 FR 20034-Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke. 2012 Established List. Federal Register Volume 77, Issue 64 (April 3, 2012).
23. Food and Drug Administration, Guidance for Industry Modified Risk Tobacco Product Applications. Draft guidance, 2012 http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM297751.pdf. (Accessed 30 March 2017)
24. Food and Drug Administration, Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. 2016 To be published in Federal Register 5 October 2016 http://federalregister.gov/a/2016-10685. (Accessed 30 March 2017)
25. Forster, M., Mariner, D., Wright, C., Fiebelkorn, S., Yurteri, C., Liu, C., McAdam, K.G., Proctor, C.J., Assessment of tobacco heating product THP1.0. Part 3: comprehensive chemical characterisation - harmful and potentially harmful aerosol emissions. Reg. Tox. Pharm, 2017.
26. Forster, M., McAughey, J., Prasad, K., Mavropoulou, E., Proctor, C.J., Assessment of tobacco heating product THP1.0. Part 4: characterisation of indoor air quality and odour analysis. Reg. Tox. Pharm, 2017.
27. Fowles, J., Dybing, E., Application of toxicological risk assessment principles to the chemical constituents of cigarette smoke. Tob. Control 12:4 (2003), 424–430.
28. Foy, J.W., Bombick, B.R., Bombick, D.W., Doolittle, D.J., Mosberg, A.T., Swauger, J.E., A comparison of in vitro toxicities of cigarette smoke condensate from Eclipse cigarettes and four commercially available ultra low-“tar” cigarettes. Food Chem. Toxicol. 42:2 (2004), 237–243 2004 Feb.
29. Gee, J., Prasad, K., Slayford, S., Gray, A., Nother, K., Cunningham, A., Mavropoulou, E., Proctor, C.J., Assessment of tobacco heating product THP1.0. Part 8: study to determine puffing topography, mouth level exposure and consumption among Japanese users. Reg. Tox. Pharm, 2017.
30. Goniewicz, M.L., Smith, D.M., Peng, M., Jacob, P. III, Benowitz, N.L., Exposure to nicotine and selected toxicants in cigarette smokers who switched to electronic cigarettes: a longitudinal within-subjects observational study. Nicotine Tob. Res. 19:2 (2017), 160–167.
31. Haziza, C., de La Bourdonnaye, G., Skiada, D., Ancerewicz, J., Baker, G., Picavet, P., Lüdicke, F., Evaluation of the Tobacco Heating System 2.2. Part 8: 5-Day randomized reduced exposure clinical study in Poland. Regul. Toxicol. Pharmacol. 81 (2016), S139–S150.
32. Health Canada, Tobacco Reporting Regulations. 1999 http://www.hc-sc.gc.ca/tobac-tabac/legislation/reg/indust/method//index-eng.php#main. (Accessed 30 March 2017)
33. ICCVAM, Interagency Coordinating Committee on the Validation of Alternative Methods “In Vitro Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systematic Toxicity Testing”. 2006, National Institute of Health (NIH) publication No. 07–4519.
34. ICRP, International Commission for Radiological Protection Human Respiratory Tract Model for Radiological Protection, vol. 66, 1994, ICRP Publication, 1–3 Ann. ICRP 24.
35. Institute of Medicine, IOM, Scientific Standards for Studies on Modified Risk Tobacco Products. 2012, The National Academies Press, Washington, DC.
36. ISO, Cigarettes – Determination of Total and Nicotine Free Dry Particulate Matter Using a Routine Analytical Smoking Machine. 2000 BS ISO 4387:2000 + A1:2008.
37. Jaunky, T., Adamson, J., Santopietro, S., Terry, A., Thorne, D., Breheny, D., Proctor, C.J., Gaca, M., Assessment of tobacco heating product THP1.0. Part 5: in vitro dosimetric and cytotoxic assessment. Reg. Tox. Pharm, 2017.
38. Margham, J., McAdam, K.G., Forster, M., Liu, C., Wright, C., Mariner, D., Proctor, C., Chemical composition of an e-cigarette aerosol – a quantitative comparison with cigarette smoke. Chem. Res. Toxicol. 29 (2016), 1662–1678.
39. McNeill, A., Munafò M.R., Reducing harm from tobacco use. J. Psychopharmacol. 27 (2012), 13–18.
40. McNeill, A., Brose, L.S., Calder, R., Hitchman, S.C., Hajek, P., McRobbie, E-cigarettes: an Evidence Update a Report Commissioned by Public Health England., 2015 https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update. (Accessed 30 March 2017)
41. Mitova, M.I., Campelos, P.B., Goujon-Ginglinger, C.G., Maeder, S., Mottier, N., Rouget, E.G., Tharin, M., Tricker, A.R., Comparison of the impact of the Tobacco Heating System 2.2 and a cigarette on indoor air quality. Regul. Toxicol. Pharmacol. 81 (2016), 91–101.
42. Murphy, J., Assessing the risk of e-cigarettes. Pan Eur. Netw. Gov. 21 (2017), 52–55.
43. Murphy, J., Gaca, M., Lowe, F., Minet, E., Breheny, D., Gee, K., Camacho, O., Fearon, I.M., Liu, C., Wright, C., McAdam, K., Proctor, C., A modified risk tobacco and nicotine product assessment framework and the demonstration of a closed modular electronic cigarette as a potentially reduced risk product. Reg. Tox. Pharm. Submitted, 2017.
44. Nutt, D.J., Phillips, L.D., Balfour, D., Curran, H.V., Dockrell, M., Foulds, J., Fagerstrom, K., Letlape, K., Milton, A., Polosa, R., Ramsey, J., Sweanor, D., Estimating the harms of nicotine-containing products using the MCDA approach. Eur. J. Addict. Res. 20:5 (2014), 218–225.
45. OECD, Test No. 471: Bacterial Reverse Mutation Test, OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects. 1997, OECD Publishing.
46. OECD, Organisation for Economic Co-operation and Development “Guidance Document on the in Vitro BHAS 42 Cell Transformation Assay” ENV/JM/Mono(2016)1 Series on Testing & Assessment, No. 231. 2016, OECD Publishing.
47. Poynton, S., Sutton, J., Goodall, S., Margham, J., Forster, M., Scott, K., Liu, C., McAdam, K., Murphy, J., Proctor, C., A novel hybrid tobacco product that delivers a tobacco flavour note with vapour aerosol (Part 1): product operation and preliminary aerosol chemistry assessment. Food Chem. Toxicol. 106 (2017), 522–532.
48. Proctor, C.J., Lessons from clinical studies using biomarkers of exposure to assess toxicant exposure. Presentation at Biomarkers of Tobacco Exposure: a Public Workshop, Washington DC, 3rd-4th Aug 2015, 2015.
49. Rodgman, A., Perfetti, T.A., The Chemical Components of Tobacco and Tobacco Smoke. second ed., 2013, CRC Press, Boca Raton.
50. Roemer, E., Stabbert, R., Veltel, D.J., Mueller, B.P., Meisgen, T.J., Schramke, H., Anskeit, E., Elves, R.G., Fournier, J.A., Reduced toxicological activity of cigarette smoke by the addition of ammonium magnesium phosphate to the paper of an electrically heated cigarette: smoke chemistry and in vitro cytotoxicity and genotoxicity. Toxicol. Vitro 22 (2008), 671–681.
51. 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., Mainstream smoke chemistry and in vitro and in vivo toxicity of the reference cigarettes 3R4F and 2R4F. Beitr. Tab. Int. 25 (2012), 316–335.
52. Royal College of Physicians (Tobacco Advisory Group), Nicotine without Smoke-tobacco Harm Reduction, 2016, Royal College of Physicians.
53. Rustemeier, K., Stabbert, R., Haussmann, H.J., Roemer, E., Carmines, E.L., Evaluation of the potential effects of ingredients added to cigarettes. Part 2: chemical composition of mainstream smoke. Food Chem. Toxicol. 40:1 (2002), 93–104.
54. Schaller, J.-P., Keller, D., Poget, L., Pratte, P., Kaelin, E., McHugh, D., Cudazz, 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., Evaulation of the tobacco heating system 2.2. Part 2: chemical composition, genotoxicity, cytotoxicity, and physical properties of the aerosol. Reg. Tox. Pharm. 81 (2016), S27–S47.
55. Shahab, L., Goniewicz, M.L., Blount, B.C., Brown, J., McNeill, A., Alwis, U., Feng, J., Wang, L., West, R., Nicotine, carcinogen, and toxin exposure in long-term e-cigarette and nicotine replacement therapy users: a cross-sectional study. Ann. Intern Med. 166:6 (2017), 390–400.
56. Smith, M.R., Clark, B., Lüdicke, F., Schaller, J.P., Vanscheeuwijck, P., Hoeng, J., Peitsch, M.C., Evaluation of the Tobacco Heating System 2.2. Part 1: description of the system and the scientific assessment program. Reg. Tox. Pharm. 81 (2016), S17–S26.
57. Stratton, K., Shetty, P., Wallace, R., Bondurant, S., Committee to Assess the Science Base for Tobacco Harm Reduction; Board on Health Promotion and Disease Prevention; Institute of Medicine. Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction. 2001, National Academy Press, Washington, DC.
58. Taylor, M., Thorne, D., Carr, T., Breheny, D., Walker, P., Proctor, C.J., Gaca, M., Assessment of tobacco heating product THP1.0. Part 6: a comparative in vitro study using contemporary screening approaches. Reg. Tox. Pharm, 2017.
59. Thorne, D., Crooks, I., Hollings, M., Seymour, A., Meredith, C., Gaҫa, M., The mutagenic assessment of electronic-cigarettes and tobacco smoke using the Ames assay in strains TA98 and TA100. Mutat. Res. 812 (2016), 29–38.
60. Thorne, D., Breheny, D., Proctor, C.J., Gaҫa, M., Assessment of tobacco heating product THP1.0. Part 7: comparative in vitro toxicological evaluation. Reg. Tox. Pharm., 2017.
61. World Health Organization, WHO Guidelines for Indoor Air Quality: Selected Pollutants. 2010, WHO Regional Office for Europe ISBN 978 92 890 0213 4.
62. World Health Organization, Ambient (Outdoor) Air Quality and Health: Factsheet. 2016 http://www.who.int/mediacentre/factsheets/fs313/en/. (Accessed 21 September 2017)