This work is licensed under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Institute of Medicine Committee to Assess the Science Base for Tobacco Harm Reduction: Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction; edited by K. Stratton, P. Shetty, R. Wallace, and S. Bondurant, National Academy Press, Washington, DC, USA, 2001.Institute of Medicine Committee to Assess the Science Base for Tobacco Harm ReductionClearing the Smoke: Assessing the Science Base for Tobacco Harm Reductionedited byStrattonK.ShettyP.WallaceR.BondurantS.National Academy PressWashington, DC, USA2001Search in Google Scholar
Royal College of Physicians: Nicotine Without Smoke: Tobacco Harm Reduction; Royal College of Physicians, London, UK, 2016. Available at https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction (accessed March 2022).Royal College of PhysiciansNicotine Without Smoke: Tobacco Harm ReductionRoyal College of PhysiciansLondon, UK2016Available at https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction (accessed March 2022).Search in Google Scholar
McNeill, A., L.S. Brose, R. Calder, L. Bauld, and D. Robson: Evidence Review of E-Cigarettes and Heated Tobacco Products 2018: A Report Commissioned by Public Health England; Public Health England, London, UK, 2018. Available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/684963/Evidence_review_of_e-cigarettes_and_heated_tobacco_products_2018.pdf (accessed February 2022).McNeillA.BroseL.S.CalderR.BauldL.RobsonD.Evidence Review of E-Cigarettes and Heated Tobacco Products 2018: A Report Commissioned by Public Health EnglandPublic Health EnglandLondon, UK2018Available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/684963/Evidence_review_of_e-cigarettes_and_heated_tobacco_products_2018.pdf (accessed February 2022).Search in Google Scholar
The National Academies of Sciences, Engineering, Medicine: Consensus Study. Public Health Consequences of E-Cigarettes; National Academies Press, Washington, DC, USA, 2018. DOI: 10.17226/24952The National Academies of Sciences, Engineering, MedicineConsensus StudyPublic Health Consequences of E-CigarettesNational Academies PressWashington, DC, USA201810.17226/2495229894118Open DOISearch in Google Scholar
Takahashi, Y., Y. Kanemaru, T. Fukushima, K. Eguchi, S. Yoshida, J. Miller-Holt, and I. Jones: Chemical Analysis and In Vitro Toxicological Evaluation of Aerosol From a Novel Tobacco Vapor Product: A Comparison With Cigarette Smoke; Regul. Toxicol. Pharmacol. 92 (2018) 94–103. DOI: 10.1016/j.yrtph.2017.11.009TakahashiY.KanemaruY.FukushimaT.EguchiK.YoshidaS.Miller-HoltJ.JonesI.Chemical Analysis and In Vitro Toxicological Evaluation of Aerosol From a Novel Tobacco Vapor Product: A Comparison With Cigarette SmokeRegul. Toxicol. Pharmacol.2018929410310.1016/j.yrtph.2017.11.00929158044Open DOISearch in Google Scholar
Eaton, D., B. Jakaj, M. Forster, J. Nicol, E. Mavropoulou, K. Scott, C. Liu, K. McAdam, J. Murphy, and C.J. Proctor: Assessment of Tobacco Heating Product THP1.0. Part 2: Product Design, Operation and Thermophysical Characterisation; Regul. Toxicol. Pharmacol. 93 (2018) 4–13. DOI: 10.1016/j.yrtph.2017.09.009EatonD.JakajB.ForsterM.NicolJ.MavropoulouE.ScottK.LiuC.McAdamK.MurphyJ.ProctorC.J.Assessment of Tobacco Heating Product THP1.0. Part 2: Product Design, Operation and Thermophysical CharacterisationRegul. Toxicol. Pharmacol.20189341310.1016/j.yrtph.2017.09.00929080851Open DOISearch in Google Scholar
Schaller, J.-P., D. Keller, L. Poget, P. Pratte, E. Kaelin, D. McHugh, G. Cudazzo, D. Smart, A.R. Tricker, L. Gautier, M. Yerly, R. Reis Pires, S. Le Bouhellec, D. Ghosh, I. Hofer, E. Garcia, P. Vanscheeuwijck, and S. Maeder: Evaluation of the Tobacco Heating System 2.2. Part 2: Chemical Composition, Genotoxicity, Cytotoxicity, and Physical Properties of the Aerosol; Regul. Toxicol. Pharmacol. 81 (2016) S27–S47. DOI: 10.1016/j.yrtph.2016.10.001SchallerJ.-P.KellerD.PogetL.PratteP.KaelinE.McHughD.CudazzoG.SmartD.TrickerA.R.GautierL.YerlyM.Reis PiresR.Le BouhellecS.GhoshD.HoferI.GarciaE.VanscheeuwijckP.MaederS.Evaluation of the Tobacco Heating System 2.2. Part 2: Chemical Composition, Genotoxicity, Cytotoxicity, and Physical Properties of the AerosolRegul. Toxicol. Pharmacol.201681S27S4710.1016/j.yrtph.2016.10.00127720919Open DOISearch in Google Scholar
Smith, M.R., B. Clark, F. Lüdicke, J.P. Schaller, P. Vanscheeuwijck, J. Hoeng, and M.C. Peitsch: Evaluation of the Tobacco Heating System 2.2. Part 1: Description of the System and the Scientific Assessment Program; Regul. Toxicol. Pharmacol. 81 (2016) S17–S26. DOI: 10.1016/j.yrtph.2016.07.006SmithM.R.ClarkB.LüdickeF.SchallerJ.P.VanscheeuwijckP.HoengJ.PeitschM.C.Evaluation of the Tobacco Heating System 2.2. Part 1: Description of the System and the Scientific Assessment ProgramRegul. Toxicol. Pharmacol.201681S17S2610.1016/j.yrtph.2016.07.00627450400Open DOISearch in Google Scholar
U.S. Food and Drug Administration (FDA): Modified Risk Orders. IQOS System Holder and Charger; FDA, Silver Spring, MD, USA, 2020. Available at https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-orders (accessed February 2022).U.S. Food and Drug Administration (FDA)Modified Risk OrdersIQOS System Holder and ChargerFDASilver Spring, MD, USA2020Available at https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-orders (accessed February 2022).Search in Google Scholar
U.S. Food and Drug Administration (FDA): Guidance for Industry. Modified Risk Tobacco Product Applications. Draft Guidance; FDA, Silver Spring MD, USA, 2012. Available at https://www.fda.gov/media/83300/download (accessed February 2022).U.S. Food and Drug Administration (FDA)Guidance for IndustryModified Risk Tobacco Product Applications. Draft GuidanceFDASilver Spring MD, USA2012Available at https://www.fda.gov/media/83300/download (accessed February 2022).Search in Google Scholar
U.S. Food and Drug Administration (FDA): Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products. Guidance for Industry and Food and Drug Administration Staff; FDA, Silver Spring, MD, USA, 2011. Available at https://www.fda.gov/-regulatory-information/search-fda-guidance-documents/section-905j-reports-demonstrating-substantial-equivalence-tobacco-products (accessed February 2022)U.S. Food and Drug Administration (FDA)Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products. Guidance for Industry and Food and Drug Administration StaffFDASilver Spring, MD, USA2011Available at https://www.fda.gov/-regulatory-information/search-fda-guidance-documents/section-905j-reports-demonstrating-substantial-equivalence-tobacco-products (accessed February 2022)Search in Google Scholar
Midha, K.K. and G. McKay: Bioequivalence: Its History, Practice, and Future; AAPS J. 11 (2009) 664–670. DOI 10.1208/s12248-009-9142-zMidhaK.K.McKayG.Bioequivalence: Its History, Practice, and FutureAAPS J.20091166467010.1208/s12248-009-9142-z278207619806461Open DOISearch in Google Scholar
Schlage, W.K., B. Titz, A. Iskandar, C. Poussin, M. Van der Toorn, E.T. Wong, P. Pratte, S. Maeder, J.P. Schaller, P. Pospisil, S. Boué, G. Vuillaume, P. Leroy, F. Martin, N.V. Ivanov, M.C. Peitsch, and J. Hoeng: Comparing the Preclinical Risk Profile of Inhalable Candidate and Potential Candidate Modified Risk Tobacco Products: A Bridging Use Case; Toxicol. Rep. 7 (2020) 1187–1206. DOI: 10.1016/j.toxrep.2020.09.004SchlageW.K.TitzB.IskandarA.PoussinC.Van der ToornM.WongE.T.PratteP.MaederS.SchallerJ.P.PospisilP.BouéS.VuillaumeG.LeroyP.MartinF.IvanovN.V.PeitschM.C.HoengJ.Comparing the Preclinical Risk Profile of Inhalable Candidate and Potential Candidate Modified Risk Tobacco Products: A Bridging Use CaseToxicol. Rep.202071187120610.1016/j.toxrep.2020.09.004750237832995294Open DOISearch in Google Scholar
Proctor, C.: Assessment of Tobacco Heating Product THP1.0. Part 1: Series Introduction; Regul. Toxicol. Pharmacol. 93 (2018) 1–3. DOI: 10.1016/j.yrtph.2017.09.010ProctorC.Assessment of Tobacco Heating Product THP1.0. Part 1: Series IntroductionRegul. Toxicol. Pharmacol.2018931310.1016/j.yrtph.2017.09.01028989081Open DOISearch in Google Scholar
Jaunky, T., J. Adamson, S. Santopietro, A. Terry, D. Thorne, D. Breheny, C. Proctor, and M. Gaça: Assessment of Tobacco Heating Product THP1.0. Part 5: In Vitro Dosimetric and Cytotoxic Assessment; Regul. Toxicol. Pharmacol. 93 (2018) 52–61. DOI: 10.1016/j.yrtph.2017.09.016JaunkyT.AdamsonJ.SantopietroS.TerryA.ThorneD.BrehenyD.ProctorC.GaçaM.Assessment of Tobacco Heating Product THP1.0. Part 5: In Vitro Dosimetric and Cytotoxic AssessmentRegul. Toxicol. Pharmacol.201893526110.1016/j.yrtph.2017.09.01628987911Open DOISearch in Google Scholar
Forster, M., S. Fiebelkorn, C. Yurteri, D. Mariner, C. Liu, C. Wright, K. McAdam, J. Murphy, and C. Proctor: Assessment of Novel Tobacco Heating Product THP1.0. Part 3: Comprehensive Chemical Characterisation of Harmful and Potentially Harmful Aerosol Emissions; Regul. Toxicol. Pharmacol. 93 (2018) 14–33. DOI: 10.1016/j.yrtph.2017.10.006ForsterM.FiebelkornS.YurteriC.MarinerD.LiuC.WrightC.McAdamK.MurphyJ.ProctorC.Assessment of Novel Tobacco Heating Product THP1.0. Part 3: Comprehensive Chemical Characterisation of Harmful and Potentially Harmful Aerosol EmissionsRegul. Toxicol. Pharmacol.201893143310.1016/j.yrtph.2017.10.00629080848Open DOISearch in Google Scholar
Thorne, D., D. Breheny, C. Proctor, and M. Gaça: Assessment of Novel Tobacco Heating Product THP1.0. Part 7: Comparative In Vitro Toxicological Evaluation; Regul. Toxicol. Pharmacol. 93 (2018) 71–83. DOI: 10.1016/j.yrtph.2017.08.017ThorneD.BrehenyD.ProctorC.GaçaM.Assessment of Novel Tobacco Heating Product THP1.0. Part 7: Comparative In Vitro Toxicological EvaluationRegul. Toxicol. Pharmacol.201893718310.1016/j.yrtph.2017.08.01729080850Open DOISearch in Google Scholar
Taylor, M., D. Thorne, T. Carr, D. Breheny, P. Walker, C. Proctor, and M. Gaça: Assessment of Novel Tobacco Heating Product THP1.0. Part 6: A Comparative In Vitro Study Using Contemporary Screening Approaches; Regul. Toxicol. Pharmacol. 93 (2018) 62–70. DOI: 10.1016/j.yrtph.2017.08.016TaylorM.ThorneD.CarrT.BrehenyD.WalkerP.ProctorC.GaçaM.Assessment of Novel Tobacco Heating Product THP1.0. Part 6: A Comparative In Vitro Study Using Contemporary Screening ApproachesRegul. Toxicol. Pharmacol.201893627010.1016/j.yrtph.2017.08.01629080849Open DOISearch in Google Scholar
Murphy, J., C. Liu, K. McAdam, M. Gaça, K. Prasad, O. Camacho, J. McAughey, and C. Proctor: 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; Regul. Toxicol. Pharmacol. 93 (2018) 92–104. DOI: 10.1016/j.yrtph.2017.10.001MurphyJ.LiuC.McAdamK.GaçaM.PrasadK.CamachoO.McAugheyJ.ProctorC.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 StudiesRegul. Toxicol. Pharmacol.2018939210410.1016/j.yrtph.2017.10.00129080852Open DOISearch in Google Scholar
Gee, J., K. Prasad, S. Slayford, A. Gray, K. Nother, A. Cunningham, E. Mavropoulou, and C. Proctor: Assessment of Tobacco Heating Product THP1.0. Part 8: Study to Determine Puffing Topography, Mouth Level Exposure and Consumption Among Japanese Users; Regul. Toxicol. Pharmacol. 93 (2018) 84–91. DOI: 10.1016/j.yrtph.2017.08.005GeeJ.PrasadK.SlayfordS.GrayA.NotherK.CunninghamA.MavropoulouE.ProctorC.Assessment of Tobacco Heating Product THP1.0. Part 8: Study to Determine Puffing Topography, Mouth Level Exposure and Consumption Among Japanese UsersRegul. Toxicol. Pharmacol.201893849110.1016/j.yrtph.2017.08.00528822877Open DOISearch in Google Scholar
21, Forster, M., J. McAughey, K. Prasad, E. Mavropoulou, and C. Proctor: Assessment of Tobacco Heating Product THP1.0. Part 4: Characterisation of Indoor Air Quality and Odour; Regul. Toxicol. Pharmacol. 93 (2018) 34–51. DOI: 10.1016/j.yrtph.2017.09.017ForsterM.McAugheyJ.PrasadKMavropoulouE.ProctorC.Assessment of Tobacco Heating Product THP1.0. Part 4: Characterisation of Indoor Air Quality and OdourRegul. Toxicol. Pharmacol.201893345110.1016/j.yrtph.2017.09.01728989082Open DOISearch in Google Scholar
Health Canada: Official Method T-115 – Determination of “Tar”, Nicotine and Carbon Monoxide in Mainstream Tobacco Smoke; Health Canada, Ottawa, Canada, 1999.Health CanadaOfficial Method T-115 – Determination of “Tar”, Nicotine and Carbon Monoxide in Mainstream Tobacco SmokeHealth CanadaOttawa, Canada1999Search in Google Scholar
World Health Organization (WHO): Report on the Scientific Basis of Tobacco Product Regulation – TRS 1015; Study Group on Tobacco Product Regulation, World Health Organization, Geneva, Switzerland, 2019.World Health Organization (WHO)Report on the Scientific Basis of Tobacco Product Regulation – TRS 1015; Study Group on Tobacco Product RegulationWorld Health OrganizationGeneva, Switzerland2019Search in Google Scholar
Adamson, J., T. Jaunky, D. Thorne, and M.D. Gaça: Characterisation of the Borgwaldt LM4E System for In Vitro Exposures to Undiluted Aerosols From Next Generation Tobacco and Nicotine Products (NGPs); Food Chem. Toxicol. 113 (2018) 337–344. DOI: 10.1016/j.fct.2018.02.005AdamsonJ.JaunkyT.ThorneD.GaçaM.D.Characterisation of the Borgwaldt LM4E System for In Vitro Exposures to Undiluted Aerosols From Next Generation Tobacco and Nicotine Products (NGPs)Food Chem. Toxicol.201811333734410.1016/j.fct.2018.02.00529421647Open DOISearch in Google Scholar
Bishop, E., L. Haswell, J. Adamson, S. Costigan, D. Thorne, and M. Gaça: An Approach to Testing Undiluted E-Cigarette Aerosol In Vitro Using 3D Reconstituted Human Airway Epithelium; Toxicol. In Vitro 54 (2019) 391–401. DOI: 10.1016/j.tiv.2018.01.010BishopE.HaswellL.AdamsonJ.CostiganS.ThorneD.GaçaM.An Approach to Testing Undiluted E-Cigarette Aerosol In Vitro Using 3D Reconstituted Human Airway EpitheliumToxicol. In Vitro20195439140110.1016/j.tiv.2018.01.01029355593Open DOISearch in Google Scholar
Azzopardi, D., L.E. Haswell, G. Foss-Smith, K. Hewitt, N. Asquith, S. Corke, and G. Phillips: Evaluation of an Air-Liquid Interface Cell Culture Model for Studies on the Inflammatory and Cytotoxic Responses to Tobacco Smoke Aerosols; Toxicol. In Vitro 29 (2015) 1720–1728. DOI: 10.1016/j.tiv.2015.06.016AzzopardiD.HaswellL.E.Foss-SmithG.HewittK.AsquithN.CorkeS.PhillipsG.Evaluation of an Air-Liquid Interface Cell Culture Model for Studies on the Inflammatory and Cytotoxic Responses to Tobacco Smoke AerosolsToxicol. In Vitro2015291720172810.1016/j.tiv.2015.06.01626096598Open DOISearch in Google Scholar
Costigan, S. and C. Meredith: An Approach to Ingredient Screening and Toxicological Risk Assessment of Flavours in E-Liquids; Regul. Toxicol. Pharmacol. 72 (2015) 361–369. DOI: 10.1016/j.yrtph.2015.05.018CostiganS.MeredithC.An Approach to Ingredient Screening and Toxicological Risk Assessment of Flavours in E-LiquidsRegul. Toxicol. Pharmacol.20157236136910.1016/j.yrtph.2015.05.01826026505Open DOISearch in Google Scholar