10. References

Chapter 1: Our Vsion: A Need for Reappraisal

My Reflections on BAT's Smokeless World

[1] Reitsma, M.B., et al., Spatial, temporal, and demographic patterns in prevalence of smoking tobacco use and attributable disease burden in 204 countries and territories, 1990–2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet, 2021. 397(10292): p. 2337-2360 DOI: 10.1016/S0140-6736(21)01169-7

[2] Word Health Organization, WHO report on the global tobacco epidemic 2021: addressing new and emerging products. 2021. Available at: https://www.paho.org/en/node/82149 (Accessed: 22 July 2024)

Chapter 1: Our Vision: A Need for Reappraisal

Our Strategy

[1] World Health Organization, WHO report on the global tobacco epidemic 2021: addressing new and emerging products. 2021. Available at: https://www.paho.org/en/node/82149 (Accessed: 22 July 2024)

[2] Combined Annual and Sustainability Report, Building a Smokeless World. 2024, BAT. Available at: https://www.bat.com/ar2024pdf

[3] Wheaton, K., A Purposeful and Profitable Pathway to A Better Tomorrow. BAT Investor Presentation, Barclays Global Consumer Staples Conference - 5 September, 2023. Available at: https://www.bat.com/content/dam/batcom/global/main-nav/investors-and-reporting/investor-presentations/Presentation-slides-40-mb.pdf

[4] U.S. Food & Drug Administration, Nicotine is Why Tobacco Products are Addictive. Available at: https://www.fda.gov/tobacco-products/healtheffects-tobacco-use/nicotine-why-tobacco-products-are-addictive#:~:text=2-,What%20Makes%20Tobacco%20Use%20Harmful%3F,in%20some%20e%2Dcigarette%20aerosols. (Accessed: 1 August 2024).

Chapter 1: Our Vision: A Need for Reappraisal

Our Vision for a Smokeless World

[1] (P17) Combined Annual and Sustainability Report, Building a Smokeless World. 2024, BAT. Available at: https://www.bat.com/ar2024pdf

[2] Institute of Medicine Staff, Clearing the smoke: assessing the science base for tobacco harm reduction. National Academies Press, 2001. DOI: 10.17226/10029

[3] Forster, M., et al., Assessment of novel tobacco heating product THP1.0. Part 3: Comprehensive chemical characterisation of harmful and potentially harmful aerosol emissions. Regul Toxicol Pharmacol, 2018. 93:14-33. DOI: 10.1016/j.yrtph.2017.10.006

[4] Pinto, M. I., et al., Chemical characterisation of the vapour emitted by an e-cigarette using a ceramic wick-based technology. Sci Rep, 2022. 12(1):16497. DOI: 10.1038/s41598-022-19761-w

[5] Azzopardi, D., et al., Chemical characterization of tobacco-free "modern" oral nicotine pouches and their position on the toxicant and risk continuums. Drug Chem Toxicol, 2022. 45(5):2246-2254. DOI: 10.1080/01480545.2021.1925691

[6] Human D., et al., Saving Lives Like Sweden. Smoke Free Sweden 2023, 2023. Available at: https://smokefreesweden.org/wp-content/themes/smokefreesweden/assets/pdf/reports/Report_SAVING%20LIVES%20LIKE%20SWEDEN.pdf

[7] Benchikh, S., Capital Effectiveness & Our Growth Algorithm. Capital Markets Day 2024 Presentation - 16 October, 2024. Available at: https://www.bat.com/content/dam/batcom/global/main-nav/investors-and-reporting/investor-presentations/2024-cmd/presentation/10_Capital_Effectiveness_Our_Growth_Algorithm-Soraya_Benchikh.pdf

Chapter 1: Our Vision: A Need for Reappraisal

Tobacco Harm Reduction: A Need for Balance

[1] Royal College of Physicians, E-cigarettes and harm reduction: An evidence review. RCP, 2024. Available at: https://www.rcp.ac.uk/policy-andcampaigns/policy-documents/e-cigarettes-and-harm-reduction-an-evidence-review (Accessed: 29 July 2024)

[2] BAT, We need more regulation says UK’s largest vapour manufacturer. 2023. Available at: https://www.bat.com/media/press-releases/_2023/november/we-need-more-regulation-says-uk-s-largest-vapour-manufacturer (Accessed: 30 July 2024)

[3] SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Opinion on electronic cigarettes. European Commission, 2021. Available at: https://health.ec.europa.eu/system/files/2022-08/scheer_o_017.pdf

Chapter 1: Our Vision: A Need for Reappraisal

A Better Tomorrow™ for Shareholders

[1] Adjusting items, as identified in accordance with the Group’s accounting policies, represent certain items of income and expense which the Group considers distinctive based on their size, nature or incidence.

[2] Diluted earnings per share before the impact of adjusting items and inorganic adjustments, presented at the prior year’s rate of exchange. Reconciliation available at: https://www.bat.com/ar2024pdf

[3] Profit from operations before the impact of adjusting items, inorganic adjustments and translational foreign exchange. Reconciliation available at: https://www.bat.com/ar2024pdf

[4] To supplement the Group’s results presented in accordance with International Financial Reporting Standards (IFRS), the Group’s Management Board, as the chief operating decision maker, reviews certain of its results, including revenue and adjusted profit from operations, at constant rates of exchange, prior to the impact of businesses sold or held-for-sale. Although the Group does not believe that these measures are a substitute for IFRS measures, the Group does believe that such results excluding the impact of businesses sold or to be held-for-sale provide additional useful information to investors regarding the underlying performance of the business on a comparable basis and in the case of the divestment of the Group’s businesses in Russia and Belarus, the impact these businesses had on revenue and profit from operations. Accordingly, the organic financial measures appearing in this document should be read in conjunction with the Group’s results as reported under IFRS. The exits referred to in respect of other markets, including in Africa, are not deemed significant to the users’ understanding.

[5] Net cash generated from operating activities before the impact of adjusting items and dividends from associates and excluding taxes paid and net capital expenditure, as a proportion of adjusted profit from operations.

[6] Net debt excluding the impact of the revaluation of Reynolds American Inc. acquired debt arising as part of the purchase price allocation process, as a proportion of profit for the year (earnings) before net finance costs/income, taxation on ordinary activities, depreciation, amortisation, impairment costs, the Group’s share of post-tax results of associates and joint ventures, translational foreign exchange and other adjusting items. Reconciliation available at: https://www.bat.com/ar2024pdf

Chapter 1: Our Vision: A Need for Reappraisal

Shifting Gears

[1] European Environment Agency, CO2 emissions performance of car manufacturers in 2010. Available at: https://www.eea.europa.eu/dataandmaps/data/co2-cars-emission-1/monitoring-of-co2-emissions-from-1/monitoring_co2_emissions_from_new_passenger_cars_in_eu27.pdf/download (Accessed: 25 July 2024)

[2] Sky News, BMW to make new electric Mini in Oxford after securing millions in taxpayer funding. 2023. Available at: https://news.sky.com/story/bmw-to-make-new-electric-mini-in-oxford-after-securing-millions-in-taxpayer-funding-12958875 (Accessed: 19 August 2024)

[3] UK Government, Åí381m boost for EV charging as Chancellor opens West Midlands hub. Available at: https://www.gov.uk/government/news/381m-boost-for-ev-charging-as-chancellor-opens-west-midlands-hub (Accessed: 25 July 2024)

[4] BMW, 10 years of BMWi: The success story of a vision. Available at: https://www.bmw.com/en/innovation/bmw-i-10-year-anniversary.html (Accessed: 25 July 2024)

[5] BMW Group, The BMW i3 turns two. Time for an interim review. In Germany the BMW i3 has been the best-selling electric car since it was launched. In the worldwide ranking it stands third. 2015. Available at: https://www.press.bmwgroup.com/global/article/detail/T0242822EN/thebmw-i3-turns-twotime-for-an-interim-review-in-germany-the-bmw-i3-has-been-the-best-selling-electric-car-since-it-was-launched-in-theworldwide-rankingit-stands-third?language=en (Accessed: 25 July 2024)

[6] Forbes, New York Auto Show: BMWi3 Is The 2014 World Green Car Of The Year. 2014. Available at: https://www.forbes.com/sites/jimhenry/2014/04/17/bmwi3-drives-off-with-green-world-car-of-the-year-award-plus-a-surprise/ (Accessed: 25 July 2024)

[7] Auto Express, What was the UK plug-in car grant? 2022. Available at: https://www.autoexpress.co.uk/tips-advice/94376/what-uk-plug-car-grant (Accessed: 25 July 2024)

[8] BMW Group, A million times of sheer driving pleasure – electrified. 2021. Available at: https://www.bmwgroup.com/content/grpw/websites/bmwgroup_com/en/news/general/2021/1-million-electrified-vehicles.html (Accessed: 8 August 2024)

[9] United States Internal Revenue Service, Credits for new clean vehicles purchased in 2023 or after. Available at: https://www.irs.gov/creditsdeductions/credits-for-new-clean-vehicles-purchased-in-2023-or-after (Accessed: 25 July 2024)

[10] Reuters, China unveils $72 billion tax break for EVs, other green cars spur demand. 2023. Available at: https://www.reuters.com/business/autostransportation/china-announces-extension-purchase-tax-break-nevs-until-2027-2023-06-21/ (Accessed: 25 July 2024)

[11] Reuters, EU looks to Tesla, BMW and others to charge $3.5 billion battery project. 2021. Available at: https://www.reuters.com/article/technology/eulooks-to-tesla-bmw-and-others-to-charge-35-billion-battery-project-idUSKBN29V1LS/ (Accessed: 25 July 2024)

[12] Ernst and Young, Why consumers are charging towards electric vehicles. Available at: https://www.ey.com/en_uk/automotive-transportation/mobility-consumer-index-wave-3 (Accessed: 25 July 2024)

[13] BMW Group, Annual Reports 2018-2023. Available at: https://www.bmwgroup.com/en/investor-relations/company-reports.html (Accessed: 25 July 2024)

[14] BMW Group, BMW Group posts strong growth in fully-electric vehicles and upper premium segment in first half of 2024. 2024. Available at: https://www.press.bmwgroup.com/global/article/detail/T0443729EN/bmw-group-posts-strong-growth-in-fully-electric-vehicles-andupperpremium-segment-in-first-half-of-2024 (Accessed: 8 August 2024)

Chapter 1: Our Vision: A Need for Reappraisal

Winds of change

[1] McKinsey & Company, Interview with Martin Neubert, Executive Vice President and CEO of Offshore Wind at Ørsted: Ørsted’s renewable energy transformation. 2020. Available at: https://www.mckinsey.com/capabilities/sustainability/our-insights/orsteds-renewable-energytransformation (Accessed: 25 July 2024)

[2] Ørsted, In numbers: powering the world with green energy. Available at: https://orsted.com/en/who-we-are/our-purpose/powering-the-worldwith-green-energy (Accessed: 25 July 2024)

[3] Ørsted, Could our green transformation inspire yours? Available at: https://orsted.co.uk/about-us/our-company/our-green-energytransformation (Accessed: 25 July 2024)

[4] Danish Energy Agency, The Danish Energy Model. 2015. Available at: https://ens.dk/sites/ens.dk/files/Globalcooperation/the_danish_energy_model.pdf

[5] Ørsted, Company announcement: DOING Energy to change company name to .rsted. 2017. Available at: https://orsted.com/en/companyannouncement-list/2017/10/1623554 (Accessed: 25 July 2024)

[6]Ørsted investor presentation, Capital Markets Day: 2018. 2018. Available at: https://orsted.com/-/media/www/docs/corp/com/investor/cmd2018/cmd-presentation-2018.pdf

[7] Ørsted, Capital Markets Day: .rsted confirms its ambition of ~50 GW renewable capacity by 2030 and strong financial outlook. 2018. Available at: https://orsted.com/en/media/news/2023/06/20230607684111 (Accessed: 25 July 2024)

[8] Ørsted, Renewable Hydrogen., Available at: https://orsted.co.uk/energy-solutions/renewable-hydrogen (Accessed: 25 July 2024)

[9] HM Government, UK Hydrogen Strategy. 2021. p. 34. Available at: https://assets.publishing.service.gov.uk/media/64c7e8bad8b1a70011b05e38/UK-Hydrogen-Strategy_web.pdf

[10] Mayer Brown, Offshore Wind and the US Inflation Reduction Act. 2022. Available at: https://www.mayerbrown.com/en/insights/publications/2022/08/offshore-wind-and-the-us-inflation-reduction-act (Accessed: 2 August 2024)

Chapter 2: The Big Questions

Big Question 1: What is Tobacco Harm Reduction?

[1] Institute of Medicine Staff, Clearing the smoke: assessing the science base for tobacco harm reduction. National Academies Press, 2001. DOI: 10.17226/10029

[2] Bates, C., Regulation: Why less is more. E-cigarette summit, 2013. Available at: https://www.slideshare.net/slideshow/ecigarette-summit-12-novem/28364227#11 (Accessed: 4 July 2024)

[3] Russell, M. J., Low-tar medium nicotine cigarettes: a new approach to safer smoking. Br Med J, 1976. 1(6023): p.1430-1433. DOI: 10.1136/bmj.1.6023.1430 (Accessed: 30 July 2024)

[4] Human D., et al., The Swedish experience: a roadmap to a smoke free society. Smoke Free Sweden 2023, 2023. Available at: https://smokefreesweden.org/wp-content/themes/smokefreesweden/assets/pdf/reports/Report%20The%20Swedish%20Experience%20EN.pdf

[5] McNeill, A. and Munafò, M.R., Reducing harm from tobacco use. J Psychopharmacol, 2013. 27(1): p. 13-18. DOI: 10.1177/0269881112458731

[6] Fagerström, K.O. and Bridgman, K., Tobacco harm reduction: the need for new products that can compete with cigarettes. Addict Behav, 2014. 39(3): p. 507-511. DOI: 10.1016/j.addbeh.2013.11.002

[7] McNeill A., et al., E-cigarettes: an evidence update. Public Health England, 2015. Available at: https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update

[8] Balfour, D.J., et al., Balancing consideration of the risks and benefits of e-cigarettes. Am J Public Health, 2021. 111(9): p. 1661-1672. DOI: 10.2105/AJPH.2021.306416

[9] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Nicotine Pouch Market Database, Quarter 1 Report. 2024.

[10] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Heated Tobacco Market Database, Quarter 1 Report. 2024.

[11] ECigIntelligence, Regulatory & Market Intelligence for the e-Cigarette Sector, ECigIntelligence market database, July Report. 2024.

[12] Lindblom, E.N., What Is “Appropriate for the Protection of the Public Health” Under the US Tobacco Control Act?. Food Drug Law J, 2019. 74(4): p. 523-585. Available at: https://www.jstor.org/stable/27007713

[13] Hatsukami, D.K. and Carroll, D.M., Tobacco harm reduction: past history, current controversies and a proposed approach for the future. Prev Med, 2020. 140: p.106099. DOI: 10.1016/j.ypmed.2020.106099

[14] Greek Law 4715/2020, (Article 36), Available at: https://www.kodiko.gr/nomothesia/document/634794/nomos-4715-2020

[15] BAT Announcement, Scientific Decision for glo™ neo classic tobacco. 2024. ΕΠΙΣΤΗΜΟΝΙΚΗ ΑΠΟΦΑΣΗ ΓΙΑ ΤΟ glo™ neo classic tobacco – Blog (discoverglo.gr) (Accessed: 26 July 2024)

[16] PMI Science, Greek Ministry of Health approves differentiated health claims for heated tobacco products, including THS. 2023. https://www.pmiscience.com/en/smoke-free/tobacco-regulation/greece-approves-health-claims-heated-tobacco/

Chapter 2: The Big Questions

Big Question 2: What are the Desired Outcomes of THR?

[1] Balfour, D.J., et al., Balancing consideration of the risks and benefits of e-cigarettes. Am J Public Health, 2021. 111(9): p. 1661-1672. DOI: 10.2105/AJPH.2021.306416

[2] World Health Organization, Tobacco-free generations: Protecting children from tobacco in the WHO European Region. 2017. Available at: https://cdn.who.int/media/docs/librariesprovider2/euro-health-topics/tobacco/20170428_who-tobaccofreegeneration-draft09.pdf?sfvrsn=76e790c9_2&download=true

[3] Hatsukami, D.K. and Carroll, D.M., Tobacco harm reduction: past history, current controversies and a proposed approach for the future. Prev Med, 2020. 140: p. 106099. DOI: 10.1016/j.ypmed.2020.106099

[4] International and Local Tobacco Harm Reduction Experts, Report: Integrating harm reduction into tobacco control. Lives Saved. Available at: https://smokefreesweden.org/lives-saved.pdf

Chapter 2: The Big Questions

Big Question 3: What Current Progress is being made on Global THR?

[1] World Health Organization, WHO report on the global tobacco epidemic 2021: addressing new and emerging products. 2021. Available at: https://www.paho.org/en/node/82149 (Accessed: 22 July 2024)

[2] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Nicotine Pouch Market Database, Quarter 1 Report. 2024

[3] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Heated Tobacco Market Database, Quarter 1 Report. 2024

[4] ECigIntelligence, Regulatory & Market Intelligence for the e-Cigarette Sector, ECigIntelligence market database, July Report. 2024

[5] International and Local Tobacco Harm Reduction Experts, Report: Integrating harm reduction into tobacco control. Lives Saved. Available at: https://smokefreesweden.org/lives-saved.pdf

[6] World Health Organization, Tobacco in China. Available at: https://www.who.int/china/healthtopics/tobacco#:~:text=There%20are%20more%20than%20300,world%20is%20smoked%20in%20China

[7] Statistics Norway, Tobacco, alcohol and other drugs. Available at: https://www.ssb.no/en/helse/helseforhold-og-levevaner/statistikk/roykalkohol-og-andre-rusmidler (Accessed: 22 July 2024)

[8] CDC, Current Cigarette Smoking Among Adults in the United States. Available at:https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm (Accessed: 17 July 2024)

[9] Kramarow E.A. and Elgaddal N. Current Electronic Cigarette Use Among Adults Aged 18 and Over: United States, 2021. NCHS Data Brief, no 475. Hyattsville, MD: National Center for Health Statistics. 2023. DOI: 10.15620/cdc:129966

[10] NHS, Vaping myths and facts. Available at: https://www.nhs.uk/better-health/quit-smoking/vaping-to-quit-smoking/vaping-myths-and-the-facts/ (Accessed 15 July 2024)

[11] Action on Smoking and Health (ASH), Use of e-cigarettes (vapes) among adults in Great Britain. 2023. Available at: https://ash.org.uk/uploads/Use-of-e-cigarettes-among-adults-in-Great-Britain-2023.pdf?v=1691058248

[12] Global Action to End Smoking, State of Smoking and Health in Japan. Available at: https://globalactiontoendsmoking.org/research/tobacco-around-the-world/japan/ (Accessed: 17 July 2024)

[13] Euromonitor International, Market Sizes, Cigarettes – Japan, Tobacco: Euromonitor from trade sources/national statistics (Accessed 5 August 2024)

[14] Euromonitor International, Market Sizes, Heated Tobacco – Japan, Tobacco: Euromonitor from trade sources/national statistics (Accessed 5 August 2024)

Chapter 2: The Big Questions

Big Question 4: Why is THR Important to BAT?

[1] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Nicotine Pouch Market Database, Quarter 1 Report. 2024.

[2] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Heated Tobacco Market Database, Quarter 1 Report. 2024.

[3] ECigIntelligence, Regulatory & Market Intelligence for the e-Cigarette Sector, ECigIntelligence market database, July Report. 2024.

[4] Time forDesigns, The Downfall of Kodak: An Innovation Oversight. 2023. Available at: https://www.timefordesigns.com/blog/2023/11/02/the-downfall-of-kodak-an-innovation-oversight/ (Accessed: 17 July 2024)

[5] Doll, R., Cancer of the Lung. Br Med J, 1954. 2:1402. DOI: 10.1136/bmj.2.4901.1402-a

Chapter 2: The Big Questions

Big Question 5: What is BAT Doing to Address Underage Access to Tobacco and Nicotine Products?

[1] U.K. National Health Service (NHS), Young people and vaping. Available[1] U.K. National Health Service (NHS), Young people and vaping. Available at: https://www.nhs.uk/better-health/quit-smoking/vaping-to-quit-smoking/youngpeople-and-vaping/ (Accessed: 23 July 2024)

[2] Apollonio, D.E. and Glantz, S.A., Minimum ages of legal access for tobacco in the United States from 1863 to 2015. Am J Public Health, 2016. 106(7): p. 1200-1207. DOI: 10.2105/AJPH.2016.303172

[3] UK Legislation, Children Act, Part III. Juvenile Smoking. 1908. Available at: https://www.legislation.gov.uk/ukpga/1908/67/pdfs/ukpga_19080067_en.pdf

[4] U.S. Food & Drug Administration, Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised). 2020. Available at: https://www.fda.gov/media/133880/download

[5] BAT, Responsible Marketing Principles. Available at: https://www.bat.com/content/dam/batcom/global/main-nav/sustainability-esg/governance---ethics/BAT_Responsible_Marketing_Principles.pdf

[6] BAT, Responsible Marketing Code. Available at: https://www.bat.com/content/dam/batcom/global/main-nav/sustainability-esg/governance---ethics/BAT_Responsible_Marketing_Code.pdf

[7] We Card™, Available at: https://www.wecard.org/faq (Accessed: 23 July 2024)

[8] TruAge™, Available at: https://www.mytruage.org/ (Accessed: 23 July 2024)

[9] Royal College of Physicians, E-cigarettes and harm reduction: An evidence review. RCP, 2024. Available at:

https://www.rcp.ac.uk/media/n5skyz1t/e-cigarettes-and-harm-reduction_full-report_updated_0.pdf

Chapter 2: The Big Questions

Big Question 6: What is the Risk of Using Smokeless Products Compared to Smoking?

[1] AP news, Insider Q&A: FDA official on vaping’s “promise or peril”. 2022. Available at: https://apnews.com/article/science-health-public-tobaccoindustryregulation-6af0d635d7859bab914cc249ef43b6e2 (Accessed: 17 July 2024)

[2] Doll, R., et al., Mortality in relation to smoking: 50 years’ observations on male British doctors. Br Med J, 2004. 328(7455):1519. DOI: 10.1136/bmj.38142.554479.AE

[3] Nutt, D.J., et al., Estimating the harms of nicotine-containing products using the MCDA approach. Eur Addict Res, 2014. 20(5): p. 218-225. DOI: 10.1159/000360220

[4] U.S. Food & Drug Administration, CTP Director Discusses Opportunities and Considerations for Addressing Misperceptions About the Relative Risks of Tobacco Products Among Adults Who Smoke. 2023. Available at: https://www.fda.gov/tobacco-products/ctp-newsroom/ctp-directordiscusses-opportunities-and-considerations-addressing-misperceptions-about-relative (Accessed: 8 August 2024)

[5] Royal Australian College of General Practitioners (RACGP), Supporting smoking cessation: A guide for health professionals. 2014. Available at: https://extranet.who.int/ncdccs/Data/AUS_D1bib_Supporting%20smoking%20cessation.pdf

[6] McNeill, A., et al., E-cigarettes: an evidence update. Public Health England, 2015. Available at: https://www.gov.uk/government/publications/ecigarettes-an-evidence-update (Accessed: 8 August 2024)

[7] Visser, W., et al., The health risks of using e-cigarettes. National Institute for Public Health and the Environment, Ministry of Health, Welfare and Sport (The Netherlands), 2015. Available at: https://www.rivm.nl/bibliotheek/rapporten/2015-0144.pdf

[8] Glasser, A.M., et al., Overview of electronic nicotine delivery systems: a systematic review. Am J Prev Med, 2017. 52(2): p. e33-e66. DOI: 10.1016/j.amepre.2016.10.036

[9] Royal College of Physicians, Nicotine without smoke: tobacco harm reduction. RCP, 2016. Available at: https://www.rcp.ac.uk/media/xcfal4ed/nicotine-without-smoke_0.pdf

[10] Committee on Toxicity, Toxicological evaluation of novel heat-not-burn tobacco products – non-technical summary. 2017. Available at: https://cot.food.gov.uk/sites/default/files/heat_not_burn_tobacco_summary.pdf

[11] Chen, J., et al., A comparative health risk assessment of electronic cigarettes and conventional cigarettes. Int J Environ Res Public Health, 2017. 14(4): 382. DOI: 10.3390/ijerph14040382

[12] Public Health England, Evidence review of e-cigarettes and heated tobacco products 2018: executive summary. 2018. Available at: https://www.gov.uk/government/publications/e-cigarettes-and-heated-tobacco-products-evidence-review/evidence-review-of-e-cigarettesand-heated-tobacco-products-2018-executive-summary (Accessed: 18 July 2024)

[13] Eaton, D.L., et al., Public Health Consequences of E-Cigarettes. National Academies Press, 2018. DOI: 10.17226/24952

[14] Mallock, N., et al., Levels of selected analytes in the emissions of “heat not burn” tobacco products that are relevant to assess human health risks. Arch Toxicol, 2018. 92(6): p. 2145-2149. DOI: 10.1007/s00204-018-2215-y

[15] Caponnetto, P., et al., Carbon monoxide levels after inhalation from new generation heated tobacco products. Respir Res, 2018. 19:164. DOI: 10.1186/s12931-018-0867-z

[16] Simonavicius, E., et al., Heat-not-burn tobacco products: a systematic literature review. Tob Control, 2019. 28(5): p. 582-594. DOI: 10.1136/tobaccocontrol-2018-054419

[17] Académie Nationale de Médecine, L' Académie nationale de médecine rappelle les avantages prouvés et les Inconvénients Indûment allégués de la cigarette électronique (vaporette). Communique de Presse, 2019. Available at: https://www.academie-medecine.fr/wp-content/uploads/2019/12/Cigarette-e%CC%81lectronique-10-12-19.pdf

[18] U.S. Food & Drug Administration, FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway. 2019. Available at: https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobacco-heating-system-throughpremarket-tobacco-product-application-pathway (Accessed: 18 July 2024)

[19] Public Health England, Vaping in England: 2020 evidence update summary. 2020. Available at: https://www.gov.uk/government/publications/vaping-in-england-evidence-update-march-2020/vaping-in-england-2020-evidence-update-summary (Accessed: 18 July 2024)

[20] Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT), Statement on the potential toxicological risks from electronic nicotine (and non-nicotine) delivery systems (E(N)NDS – e-cigarettes). 2020. Available at: https://cot.food.gov.uk/sites/default/files/2020-09/COT%20E%28N%29NDS%20statement%202020-04.pdf

[21] Federal Public Service Health and Food Chain Safety and Environment, New Tobacco Products: Heated Tobacco Products. Belgium Superior Health Council, 2020. Available at: https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/201026_shc-9538_new_tobacco_products_vweb.pdf

[22] Slob W., et al., A Method for Comparing the Impact on Carcinogenicity of Tobacco Products: A Case Study on Heated Tobacco Versus Cigarettes. Risk Anal, 2020. 40(7): p. 1355-1366. DOI: 10.1111/risa.13482

[23] U.S. Food & Drug Administration, FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information. 2020. Available at: https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-iqos-tobacco-heating-system-reducedexposure-information (Accessed: 18 July 2024)

[24] Government of Canada, Regulatory Impact Analysis Statement. 2021. Available at: https://gazette.gc.ca/rp-pr/p1/2021/2021-06-19/html/reg2-eng.html (Accessed: 18 July 2024)

[25] German Federal Institute for Risk Assessment (BFR), Frequently asked questions about e-cigarettes. 2020. Available at: https://www.bfr.bund.de/en/frequently_asked_questions_about_e_cigarettes-130598.html (Accessed: 19 July 2024)

[26] Action on Smoking and Health (ASH), Electronic Cigarettes Fact Sheet. 2021. Available at: https://ash.org.uk/resources/view/electronic-cigarettes (Accessed: 5 August 2024)

[27] National Institute for Health and Care Excellence (NICE), Tobacco: preventing uptake, promoting quitting and treating dependence (NG209). 2021. Available at: https://www.nice.org.uk/guidance/ng209/resources/tobacco-preventing-uptake-promoting-quitting-and-treatingdependencepdf-66143723132869 (Accessed: 23 July 2024)

[28] Marques, P., et al., An updated overview of e-cigarette impact on human health. Respir Res, 2021. 22(1):151. DOI: 10.1186/s12931-021-01737-5

[29] Rijksinstituut voor Volksgezondheid en Milieu (RIVM), Nicotineproducten zonder tabak voor recreatief gebruik. 2021. Available at: https://www.rivm.nl/bibliotheek/rapporten/2020-0152.pdf

[30] U.S. Food & Drug Administration. FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency. 2021. Available at: https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-firstauthorization-its-kind-agency (Accessed: 18 July 2024)

[31] Benowitz, N.L., et al., Clinical Pharmacology of Electronic Nicotine Delivery Systems (ENDS): Implications for Benefits and Risks in the Promotion of the Combusted Tobacco Endgame. J Clin Pharmacol, 2021. 61: p. S18-S36. DOI: 10.1002/jcph.1915

[32] Balfour, D.J., et al., Balancing consideration of the risks and benefits of e-cigarettes. Am J Public Health, 2021. 111(9): p. 1661-1672. DOI: 10.2105/ajph.2021.306416

[33] Snowdon, C., et al., Vaping Works. International Best Practises: United Kingdom, France, Canada and New Zealand. Property Rights Alliance, 2021. Available at: https://www.propertyrightsalliance.org/wp-content/uploads/PRA_VapingWorks.pdf

[34] Hidayat, S. and Alayyannur, P.A., The content of harmful and potentially harmful constituents in heated tobacco product: Systematic review. J Drug Deliv Ther, 2021. 11(3-S): p. 111-120. DOI: 10.22270/jddt.v11i3-S.4830

[35] Centre for Addiction and Mental Health (CAMH) and Centre for Effective Practice (CEP), 7 tips to lower your risk when using nicotine. Available at: https://intrepidlab.ca/en/Documents/Quick%20Tips.pdf

[36] Office for Health Improvement & Disparities, Nicotine vaping in England: 2022 evidence update summary. Gov. UK, 2022. Available at: https://www.gov.uk/government/publications/nicotine-vaping-in-england-2022-evidence-update/nicotine-vaping-in-england-2022-evidence-updatesummary (Accessed: 18 July 2024)

[37] Bundesinstitut für Risikobewertung (BfR). Health Risk Assessment of Nicotine Pouches: Updated BfR Opinion No. 023/2022. 2022. DOI: 10.17590/20220204-105615

[38] U.S Food & Drug Administration, FDA Issues Marketing Decisions on Vuse Vibe and Vuse Ciro E-Cigarette Products. 2022. Available at: https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-marketing-decisions-vuse-vibe-and-vuse-ciro-e-cigarette-products (Accessed: 18 July 2024)

[39] Hu, H., et al., Heated tobacco products and circulating high-density lipoprotein cholesterol concentrations. Sci Rep, 2022. 12(1):17385. DOI: 10.1038/s41598-022-22337-3

[40] Hartmann-Boyce, J., et al. Biomarkers of potential harm in people switching from smoking tobacco to exclusive e-cigarette use, dual use or abstinence: secondary analysis of Cochrane systematic review of trials of e-cigarettes for smoking cessation. Addiction, 2023. 118(3): p. 539-545. DOI: 10.1111/add.16063

[41] BAT Announcement, ΕΠΙΣΤΗΜΟΝΙΚΗ ΑΠΟΦΑΣΗ ΓΙΑ ΤΟ glo™ neo classic tobacco. 2023. Available at: https://www.discoverglo.gr/blog/post/glo-neo-classic-tobacco (Accessed: 26 July 2024)

[42] PMI Science, Greek Ministry of Health approves differentiated health claims for heated tobacco products, including THS. 2023. Available at: https://www.pmiscience.com/en/smoke-free/tobacco-regulation/greece-approves-health-claims-heated-tobacco/ (Accessed: 24 July 2024)

[43] The Royal Australian & New Zealand College of Psychiatrists, E-cigarettes and vaporisers. 2023. Available at: https://www.ranzcp.org/clinical-guidelines-publications/clinical-guidelines-publications-library/e-cigarettes-and-vaporisers (Accessed: 19 July 2024)

[44] U.S. Food & Drug Administration, Facts about E-Cigarettes. 2023. Available at: https://www.fda.gov/news-events/rumor-control/facts-about-ecigarettes (Accessed: 24 July 2024)

[45] Institut National Du Cancer, Cigarettes électroniques : ce qu’il faut savoir. 2023. Available at: https://www.e-cancer.fr/Comprendre-prevenir-depister/Reduire-les-risques-de-cancer/Tabac/La-cigarette-electronique (Accessed: 24 July 2024)

[46] Government of Canada, Vaping and quitting smoking. 2023. Available at: https://www.canada.ca/en/health-canada/services/smoking-tobacco/vaping/quit-smoking.html (Accessed: 19 July 2024)

[47] U.K. National Health Service (NHS), Vaping to quit smoking. Available at: https://www.nhs.uk/better-health/quit-smoking/vaping-to-quit-smoking/ (Accessed: 19 July 2024)

[48] Royal College of Physicians, E-cigarettes and harm reduction: An evidence review. RCP, 2024. Available at: https://www.rcp.ac.uk/media/t5akldci/ecigarettes-and-harm-reduction_executive-summary_0_0.pdf

[49] Khouja, J.N., et al., Estimating the health impact of nicotine exposure by dissecting the effects of nicotine versus non-nicotine constituents of tobacco smoke: A multivariable Mendelian randomisation study. PLoS Genet, 2024. 20(2):e1011157. DOI: 10.1371/journal.pgen.1011157

[50] U.S. Centers for Disease Control and Prevention (CDC), Health Effects of Vaping. 2024. Available at: https://www.cdc.gov/tobacco/e-cigarettes/healtheffects.html (Accessed: 24 July 2024)

[51] Travis N., et al., The Potential Impact of Oral Nicotine Pouches on Public Health: A Scoping Review, Nicotine Tob Res, 2024. ntae131. DOI: 10.1093/ntr/ntae131

[52] Auer, R., et al., Electronic Nicotine-Delivery Systems for Smoking Cessation. N Engl J Med, 2024. 390(7): p. 601-610. DOI: 10.1056/NEJMoa2308815

[53] Vaping Facts, Our position on vaping. Ministry of Health New Zealand. Available at: https://vapingfacts.health.nz/our-position-on-vaping.html (Accessed: 19 July 2024)

[54] Beaglehole, R., and Bonita, R., Harnessing tobacco harm reduction. Lancet, 2024. 403(10426): p. 512-514. DOI: 10.1016/S0140-6736(24)00140-5

[55] Canadian Cancer Society, Tobacco Control. Available at: https://cancer.ca/en/get-involved/advocacy/what-we-are-doing/tobacco-control (Accessed: 19 July 2024)

Chapter 2: The Big Questions

Big Question 7: What is Nicotine?

[1] U.K. National Health Service (NHS), Vaping myths and the facts. Available at: https://www.nhs.uk/better-health/quit-smoking/vaping-to-quit-smoking/vaping-myths-and-the-facts/ (Accessed: 15 July 2024)

[2] Moldoveanu, S.C., et al., Nicotine analysis in several non-tobacco plant materials. Contrib Tob Nicotine Res, 2016. 27(2): p. 54-59. DOI: 10.1515/cttr-2016-0008

[3] Villanti, A.C., et al., Latent classes of nicotine beliefs correlate with perceived susceptibility and severity of nicotine and tobacco products in US young adults. Nicotine Tob Res, 2019. 21(Supplement_1): p. S91-S100. DOI: 10.1093/ntr/ntz156

[4] U.S. National Cancer Institute, How much do you agree or disagree that the nicotine in cigarettes is the substance that causes most of the cancer caused by smoking? Health Information National Trends Survey. Available at: https://hints.cancer.gov/view-questions/question-detail.aspx?nq=1&qid=1514 (Accessed: 9 August 2024)

[5] Steinberg, M.B., et al., Nicotine risk misperception among US physicians. J Gen Intern Med, 2021. 36(12): p. 3888-3890. DOI: 10.1007/s11606-020-06172-8

[6] U.S. Food & Drug Administration, Nicotine is Why Tobacco Products are Addictive. Available at: https://www.fda.gov/tobacco-products/health-effectstobacco-use/nicotine-why-tobacco-products-are-addictive (Accessed: 1 August 2024).

[7] Valentine, G. and Sofuoglu, M., Cognitive effects of nicotine: recent progress. Curr Neuropharmacol, 2018. 16(4): p .403-414. DOI: 10.2174/1570159X15666171103152136

[8] National Institute for Health and Care Excellence (NICE), Nicotine replacement therapy. 2024. Available at: https://cks.nice.org.uk/topics/smokingcessation/prescribing-information/nicotine-replacement-therapy-nrt/ (Accessed: 15 July 2024)

[9] IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, Tobacco smoke and involuntary smoking (No. 83). World Health Organization and International Agency for Research on Cancer, 2004. Available at: https://www.ncbi.nlm.nih.gov/books/NBK316407/

[10] Jenkins, R.A., et al., Mainstream and sidestream smoke. In The chemistry of environmental tobacco smoke: composition and measurement (2nd ed.), CRC Press, 2000. p 49-75. DOI: 10.1201/9781482278651

[11] Rodgman, A. and Perfetti, T.A., The chemical components of tobacco and tobacco smoke. CRC press, 2008. DOI: 10.1201/9781420078848

[12] World Health Organization and International Agency for Research on Cancer, IARC Monographs on the Identification of Carcinogenic Hazards to Humans. Available at: https://monographs.iarc.who.int/agents-classified-by-the-iarc/ (Accessed: 15 July 2024)

[13] Kim, M. M., et al., "Study title: A systematic review of RCTs to examine the risk of adverse cardiovascular events with nicotine use" Front Cardiovasc Med, 2023. 10:1111673. DOI: 10.3389/fcvm.2023.1111673

[14] Steinberg, M.B., et al., Nicotine risk misperception among US physicians. J Gen Intern Med, 2021. 36(12): p. 3888-3890. DOI: 10.1007/s11606-020-06172-8

[15] Public Health England, Health matters: stopping smoking – what works? Gov.UK, 2019. Available at: https://www.gov.uk/government/publications/health-matters-stopping-smoking-what-works/health-matters-stopping-smoking-what-works (Accessed: 15 July 2024)

[16] Royal College of Physicians, Nicotine without smoke: Tobacco harm reduction. London: RCP, 2016. Available at: https://www.drugsandalcohol.ie/25448/1/Nicotine%20without%20smoke_0.pdf

[17] Office of Health Improvement and Disparities, Smoking and tobacco: applying All Our Health. Gov. UK, 2022. Available at: https://www.gov.uk/government/publications/smoking-and-tobacco-applying-all-our-health/smoking-and-tobacco-applying-all-our-health (Accessed: 15 July 2024)

[18] BAT, Responsible Marketing Principles. Available at: https://www.bat.com/content/dam/batcom/global/main-nav/sustainability-esg/governance---ethics/BAT_Responsible_Marketing_Principles.pdf

[19] BAT, Responsible Marketing Code. Available at: https://www.bat.com/content/dam/batcom/global/main-nav/sustainability-esg/governance---ethics/BAT_Responsible_Marketing_Code.pdf

[20] World Health Organization, No level of alcohol consumption is safe for our health. 2023. Available at: https://www.who.int/europe/news/item/04-01-2023-no-level-of-alcohol-consumption-is-safe-for-our-health (Accessed:15 July 2024)

Chapter 2: The Big Questions

Big Question 8: Are Smokeless Products a Gateway to Cigarette Smoking?

[1] Shahab, L., et al., Unpacking the gateway hypothesis of e-cigarette use: the need for triangulation of individual-and population-level data. Nicotine Tob Res, 2022. 24(8): p. 1315-1318. DOI: 10.1093/ntr/ntac035

[2] Khouja, J.N., et al., Is e-cigarette use in non-smoking young adults associated with later smoking? A systematic review and meta-analysis. Tob Control, 2021. 30(1): p. 8-15. DOI: 10.1136/tobaccocontrol-2019-055433

[3] Cancer Research UK, Exploring the Evidence: The Role of E-Cigarettes in Smoking Cessation. 2018. Available at:

https://publications.cancerresearchuk.org/sites/default/files/publication-files/AP1732%20CRUK%20Meeting%20Report_FINAL.pdf

[4] Cancer Research UK, Vaping: what we know and what we don’t about e-cigarettes. 2021. https://news.cancerresearchuk.org/2021/04/26/ecigarettes-what-we-know-and-what-we-dont/ (Accessed: 24 July 2024)

[5] Vlaams Instituut Gezond Leven, Alle jongeren aan de e-sigaret? Tijd voor een diepgaande analyse van het vapegedrag van Vlaamse jongeren. Available at: https://www.gezondleven.be/files/tabak/Rapport-e-sigaret-en-jongeren.pdf

[6] Vlaams Instituut Gezond Leven, Alle jongeren aan de e-sigaret? Available at: https://www.gezondleven.be/nieuws/alle-jongeren-aan-de-esigaret (Accessed: 1 August 2024)

Chapter 2: The Big Questions

Big Question 9: What is the Role of Flavours in Smokeless Products and THR?

[1] Russell C., et al., Changing patterns of first e-cigarette flavor used and current flavors used by 20,836 adult frequent e-cigarette users in the USA. Harm Reduct J, 2018. 15:33. DOI: 10.1186/s12954-018-0238-6

[2] Action on Smoking Health (ASH), Use of e-cigarettes (vapes) among adults in Great Britain. 2023. Available at:

https://ash.org.uk/uploads/Use-of-e-cigarettes-among-adults-in-Great-Britain-2023.pdf

[3] Royal College of Physicians, The RCP responds to the government’s consultation on creating a smokefree generation and tackling youth vaping. 2023. Available at: https://www.rcp.ac.uk/policy-and-campaigns/policy-documents/the-rcp-responds-to-the-government-s-consultation-oncreating-a-smokefree-generation-and-tackling-youth-vaping/ (Accessed: 23 July 2024)

[4] BAT, You want Britain to be smoke-free by 2030. Available at: https://www.bat.com/campaigns/bat-supports-smoke-free-uk-regulators (Accessed: 23 July 2024)

[5] Mok, Y., et al., Associations between E-cigarette use and E-cigarette flavors with cigarette smoking quit attempts and quit success: evidence from a US Large, Nationally Representative 2018–2019 Survey. Nicotine Tob Res, 2023. 25(3): p. 541-552. DOI: 10.1093/ntr/ntac241

[6] Li, L., et al., How does the use of flavored nicotine vaping products relate to progression toward quitting smoking? Findings from the 2016 and 2018 ITC 4CV surveys. Nicotine Tob Res, 2021. 23(9): p. 1490-1497. DOI: 10.1093/ntr/ntab033

Chapter 2: The Big Questions

Big Question 10: Are Smokeless Products Associated with Reductions in Smoking?

[1] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Nicotine Pouch Market Database, Quarter 1 Report. 2024.

[2] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Heated Tobacco Market Database, Quarter 1 Report. 2024.

[3] ECigIntelligence, Regulatory & Market Intelligence for the e-Cigarette Sector, ECigIntelligence market database, July Report. 2024.

[4] Tobacco Free Life, History of Tobacco. Available at: https://tobaccofreelife.org/tobacco/tobacco-history/ (Accessed: 23 July 2024)

[5] World Health Organization, WHO report on the global tobacco epidemic 2021: addressing new and emerging products. 2021. Available at: https://iris.who.int/handle/10665/343287 (Accessed: 22 July 2024)

[6] The Tobacco Atlas, Product Sales. Available at: https://tobaccoatlas.org/challenges/product-sales/ (Accessed: 25 July 2024)

[7] World Bank Group, Population, total-India. Available at: https://data.worldbank.org/indicator/SP.POP.TOTL?locations=IN

(Accessed: 2 August 2024)

[8] World Bank Group, Population, total-Brazil. Available at: https://data.worldbank.org/indicator/SP.POP.TOTL?locations=BR (Accessed: 2 August 2024)

[9] Snowdon, C., et al., Vaping Works. International Best Practises: United Kingdom, France, Canada and New Zealand. Property Rights Alliance, 2021. Available at: https://www.propertyrightsalliance.org/wp-content/uploads/PRA_VapingWorks.pdf

[10] Maia E.G., et al., Trends in Prevalence of Cigarette Smoking in Brazil: 2006-2019. Am J Public Health, 2021. 111(4): p. 730-738. DOI: 10.2105/AJPH.2020.306102

[11] Worldometer, Countries in the world by population (2024). Available at: https://www.worldometers.info/world-population/population-by-country/ (Accessed: 25 July 2024)

Chapter 3: Impact of Smoking

Smoking: A Global Overview

[1] World Health Organization, WHO report on the global tobacco epidemic 2021: addressing new and emerging products. 2021. Available at: https://iris.who.int/handle/10665/343287 (Accessed: 22 July 2024)

[2] World Health Organization, WHO global report on trends in prevalence of tobacco use 2000–2030. 2024. Available at: https://iris.who.int/bitstream/handle/10665/375711/9789240088283-eng.pdf

[3] Reitsma, M.B., et al., Spatial, temporal, and demographic patterns in prevalence of smoking tobacco use and attributable disease burden in 204 countries and territories, 1990–2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet, 2021. 397(10292): p. 2337-2360 DOI: 10.1016/S0140-6736(21)01169-7

Chapter 3: Impact of Smoking

Combusting Tobacco & Cigarette Smoke

[1] International Organization for Standardization (ISO), ISO 3308:2012: Routine analytical cigarette-smoking machine – Definitions and standard conditions. 2012. Available at: https://www.iso.org/standard/60404.html

[2] International Organization for Standardization (ISO), ISO 20778:2018: Cigarettes – Routine analytical cigarette smoking machine – Definitions and standard conditions with an intense smoking regime. 2018. Available at: https://www.iso.org/standard/69065.html

[3] IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, Tobacco smoke and involuntary smoking (No. 83). World Health Organization and International Agency for Research on Cancer, 2004. Available at: https://www.ncbi.nlm.nih.gov/books/NBK316407/

[4] Jenkins, R.A., et al., Mainstream and sidestream smoke. In The chemistry of environmental tobacco smoke: composition and measurement (2nd ed.), CRC Press, 2000. p 49-75. DOI: 10.1201/9781482278651

[5] Rodgman, A. and Perfetti, T.A., The chemical components of tobacco and tobacco smoke. CRC press, 2008. DOI: 10.1201/9781420078848

[6] Baker R.R., A review of pyrolysis studies to unravel reaction steps in burning tobacco. J Anal Appl Pyrolysis, 1987. 11: p 555-573.

[7] Baker, R.R., Combustion and thermal decomposition regions inside a burning cigarette. Combust Flame, 1977. 30: p.21-32. DOI: 10.1016/0010-2180(77)90048-7

[8] Oxford English Dictionary online, Available at: https://www.oed.com/dictionary/pyrolysis_n?tab=meaning_and_use (Accessed: 28 June 2024)

[9] Baker, R.R., Product formation mechanisms inside a burning cigarette. Progr Energ Combust, 1981. 7(2): p. 135-153. DOI: 10.1016/0360-1285(81)90008-3

[10] Benowitz, N.L., et al., Nicotine chemistry, metabolism, kinetics and biomarkers. In Nicotine psychopharmacology. Springer, 2009. p. 29-60. DOI: 10.1007/978-3-540-69248-5_2

[11] Committee on Passive Smoking, Board of Environmental Studies and Toxicology and National Research Council, Environmental Tobacco Smoke: Measuring exposures and assessing health effects, National Academies Press, 1986. Available at: https://nap.nationalacademies.org/catalog/943/environmental-tobacco-smoke-measuring-exposures-and-assessing-health-effects

[12] Baker, R.R. and Proctor, C.J., The origins and properties of environmental tobacco smoke. Environ Int, 1990. 16(3): p.231-245. DOI: 10.1016/0160-4120(90)90117-O

Chapter 3: Impact of Smoking

Health Impacts of Smoking

[1] U.S. Department of Health and Human Services, The Health Consequences of Smoking: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2004. Available at: https://www.ncbi.nlm.nih.gov/books/NBK44695/ (Accessed 16 August 2024)

[2] IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, Tobacco smoke and involuntary smoking (No. 83). World Health Organization and International Agency for Research on Cancer, 2004. Available at: https://www.ncbi.nlm.nih.gov/books/NBK316407/ (Accessed 16 August 2024)

[3] Jenkins, R.A., et al., Mainstream and sidestream smoke. In The chemistry of environmental tobacco smoke: composition and measurement (2nd ed.), CRC Press, 2000. p 49-75. DOI: 10.1201/9781482278651

[4] Rodgman, A. and Perfetti, T.A., The chemical components of tobacco and tobacco smoke. CRC press, 2008. DOI: 10.1201/9781420078848

[5] American Lung Association. State of Tobacco Control, 10 of the Worst Diseases Smoking Causes. 2024. Available at: https://www.lung.org/research/sotc/by-the-numbers/10-worst-diseases-smoking-causes (Accessed 12 August 2024)

[6] World Health Organization, Chronic obstructive pulmonary disease (COPD). Available at: https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd) (Accessed 12 August 2024)

[7] World Health Organization, Cardiovascular diseases (CVDs). Available at: https://www.who.int/news-room/fact-sheets/detail/cardiovasculardiseases-(cvds) (Accessed 12 August 2024)

[8] World Health Organization, Cancer. Available at: https://www.who.int/news-room/fact-sheets/detail/cancer (Accessed 12 August 2024)

[9] Cancer Research UK, How does smoking cause cancer? Available at: https://www.cancerresearchuk.org/about-cancer/causes-of-cancer/smoking-and-cancer/how-does-smoking-cause-cancer#tobaccorefs0(Accessed 19 July 24)

[10] World Health Organization, Tobacco. Available at: https://www.who.int/news-room/fact-sheets/detail/tobacco (Accessed 1 July 2024)

[11] United States of America: Institute for Health Metrics and Evaluation (IHME), Global Burden of Disease Study 2019 (GBD 2019) Smoking Tobacco

Use Prevalence 1990-2019. Available at: https://ghdx.healthdata.org/record/ihme-data/gbd-2019-smoking-tobacco-use-prevalence-1990-2019 (Accessed 16 August 2024)

[12] Doll R., et al., Mortality in relation to smoking: 50 years’ observations on male British doctors. Br Med J, 2004. 328(7455): p. 1519. DOI: 10.1136/bmj.38142.554479.AE

Chapter 3: Impact of Smoking

Our Historical Efforts to Reduce the Risks of Smoking

[1] Doll, R. and Hill, A.B., Lung cancer and other causes of death in relation to smoking. Br Med J, 1956. 2:1071. DOI: 10.1136/bmj.2.5001.1071

[2] IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, Tobacco smoke and involuntary smoking (No. 83). World Health Organization and International Agency for Research on Cancer, 2004. Available at: https://www.ncbi.nlm.nih.gov/books/NBK316407/

[3] Jenkins, R.A., et al., Mainstream and sidestream smoke. In The chemistry of environmental tobacco smoke: composition and measurement (2nd ed.), CRC Press, 2000. p 49-75. DOI: 10.1201/9781482278651

[4] Rodgman, A. and Perfetti, T.A., The chemical components of tobacco and tobacco smoke. CRC press, 2008. DOI: 10.1201/9781420078848

[5] The Wall Street Journal, A Potentially Less Toxic Cigarette To Get a National Push by Vector. 2001. Available at: https://www.wsj.com/articles/SB1004930384516626400 (Accessed: 20 August 2024)

[6] Laugesen, M. and Fowles, J., Marlboro UltraSmooth: a potentially reduced exposure cigarette? Tob Control, 2006. 15(6): p. 430-435. DOI: 10.1136/tc.2006.016055

[7] Reuters, Philip quashes Marlboro Ultra Smooth test. 2008. Available at: https://www.reuters.com/article/world/us/philip-quashes-marlboroultra-smooth-test-idUSN23254520/ (Accessed: 20 August 2024)

[8] Dittrich, D.J., et al., Approaches for the design of reduced toxicant emission cigarettes. SpringerPlus, 2014. 3: p. 1-23. DOI: 10.1186/2193-1801-3-374

[9] Combes, R., et al., The effect of a novel tobacco process on the in vitro cytotoxicity and genotoxicity of cigarette smoke particulate matter. Toxicol In Vitro, 2012. 26(6): p. 1022-1029. DOI: 10.1016/j.tiv.2012.04.011

[10] Shepperd, C.J. et al., Changes in levels of biomarkers of exposure and biological effect in a controlled study of smokers switched from conventional cigarettes to reduced-toxicant-prototype cigarettes. Reg Toxicol Pharmacol, 2015. 72(2): p. 273-291. DOI: 10.1016/j.yrtph.2015.04.016

Chapter 3: Impact of Smoking

Epidemiology of Cessation

[1] U.S. Department of Health and Human Services, Smoking Cessation: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2020. Available at: https://www.cdc.gov/tobacco-surgeon-general-reports/reports/2020-smoking-cessation/

[2] Doll R., et al., Mortality in relation to smoking: 50 years’ observations on male British doctors. Br Med J, 2004. 328:1519. DOI: 10.1136/bmj.38142.554479.AE

[3] U.S. Department of Health and Human Services, The Health Consequences of Smoking: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2004. Available at: https://www.ncbi.nlm.nih.gov/books/NBK44695/

Chapter 3: Impact of Smoking

Nicotine Replacement Therapies

[1] Cornelius, M.E., et al., Tobacco Product Use Among Adults – United States, 2021, Morbidity and Mortality Weekly Report, 2023. 72: p. 475–483. DOI: 10.15585/mmwr.mm7218a1

[2] Global Action to End Smoking, State of Smoking and Health in the United Kingdom. Available at: https://globalactiontoendsmoking.org/research/tobacco-around-the-world/united-kingdom/ (Accessed: 22 July 2024)

[3] Garc.a-Rodr.guez, O., et al., Probability and predictors of relapse to smoking: results of the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). Drug Alcohol Depend, 2013. 132(3): p. 479-485. DOI: 10.1016/j.drugalcdep.2013.03.008

[4] Hughes, J. R., et al., Shape of the relapse curve and long-term abstinence among untreated smokers. Addict, 2004. 99(1): p. 29-38. DOI: 10.1111/j.1360-0443.2004.00540.x

[5] Gilpin, E.A., et al., Duration of smoking abstinence and success in quitting. J Natl Cancer Inst, 1997. 89(8): p. 572. DOI: 10.1093/jnci/89.8.572

[6] Institute of Medicine, Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press, 2012. DOI: 10.17226/13294

[7] U.S. Food and Drug Administration, Drug Approval Package: Chantix (Varenicline) Tablets. 2006. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021928_s000_chantixtoc.cfm (Accessed: 6 August 2008)

[8] World Health Organization, WHO Model List of Essential Medicines. 2009. Available at: https://iris.who.int/bitstream/handle/10665/70642/a95055_eng.pdf

[9] Joseph, A.M., et al., Chronic disease management for tobacco dependence: a randomized, controlled trial. Arch Intern Med, 2011. 171(21): p. 1894-1900. DOI: 10.1001/archinternmed.2011.500

[10] U.S. Food and Drug Administration, Modifications to labeling of nicotine replacement therapy products for over-the-counter human use. Federal Register, 2013. 78(63): p. 19718-19721. Available at: https://www.govinfo.gov/content/pkg/FR-2013-04-02/pdf/2013-07528.pdf

[11] World Health Organization, WHO Model List of Essential Medicines. 2021. Available at: https://iris.who.int/bitstream/handle/10665/345533/WHO-MHP-HPS-EML-2021.02-eng.pdf

[12] World Health Organization, WHO clinical treatment guideline for tobacco cessation in adults. 2024. Available at:

https://iris.who.int/bitstream/handle/10665/377825/9789240096431-eng.pdf

Chapter 3: Impact of Smoking

E-Cigarettes and Smoking Prevalence

[1] Snowdon, C., et al., Vaping Works. International Best Practises: United Kingdom, France, Canada and New Zealand. Property Rights Alliance, 2021. Available at: https://www.propertyrightsalliance.org/wp-content/uploads/PRA_VapingWorks.pdf

[2] Lindson, N., et al. Electronic cigarettes for smoking cessation. Cochrane Database Syst Rev, 2024. 1: CD010216. DOI: 10.1002/14651858.CD010216.pub8

[3] Health and Food Safety, Special Eurobarometer: Attitudes of Europeans towards tobacco and electronic cigarettes. European Commission, 2021. Available at: https://europa.eu/eurobarometer/surveys/detail/2240 (Accessed: 22 July 2024)

[4] Office of National Statistics, Adult smoking habits in the UK. 2021. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/healthandlifeexpectancies/bulletins/adultsmokinghabitsingreatbritain/2021 (Accessed: 22 July 2024)

[5] Cochrane Library, Available at: www.cochranelibrary.com (Accessed: 6 August 2024)

Chapter 4: Our Smokeless Science

Overview of Scientific Frameworks

[1] Smith, M.R., et al., Evaluation of the Tobacco Heating System 2.2. Part 1: Description of the system and the scientific assessment program. Regul Toxicol Pharmacol, 2016. 81(2): p.S17-S26. DOI: 10.1016/j.yrtph.2016.07.006

[2] Cordery, S., et al., The Product Science of Electrically Heated Tobacco Products: An Updated Narrative Review of the Scientific Literature. Cureus, 2024. 16(5): e61223. DOI: 10.7759/cureus.61223

[3] Lowe, F., et al., A framework for the assessment of reduced risk tobacco and nicotine products. Recent Adv Tob Sci, 2015. 41: p. 51-82. Available at: https://www.bat-science.com/pdfs/a-framework-for-the-assessment-of-reduced-risk-tobacco-and-nicotine-products.pdf

[4] Murphy, J., et al., Assessing modified risk tobacco and nicotine products: description of the scientific framework and assessment of a closed modular electronic cigarette. Regul Toxicol Pharmacol, 2017. 90: p. 342-357. DOI: 10.1016/j.yrtph.2017.09.008

[5] Peitsch, M.C., et al., Next-generation tobacco and nicotine products: Substantiating harm reduction and supporting tobacco regulatory science. Toxicol Res App, 2018. 2. DOI: 10.1177/2397847318773701

[6] Institute of Medicine, Clearing the smoke: Assessing the science base for tobacco harm reduction. National Academies Press, 2001. Available at: http://nap.nationalacademies.org/10029

[7] Institute of Medicine, Scientific Standards for Studies on Modified Risk Tobacco Products. National Academies Press, 2012. DOI: 10.17226/13294

[8] U.S. Food & Drug Administration, Section 911 of the Federal Food, Drug, and Cosmetic Act - Modified Risk Tobacco Products. 2018. Available at: https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/section-911-federal-food-drug-and-cosmetic-act-modified-risktobacco-products (Accessed: 2 July 2024)

[9] Margham, J., et al., Chemical composition of aerosol from an e-cigarette: a quantitative comparison with cigarette smoke. Chem Res Toxicol, 2016. 29(10): p. 1662-1678. DOI: 10.1021/acs.chemrestox.6b00188

[10] Wagner, K.A., et al., An evaluation of electronic cigarette formulations and aerosols for harmful and potentially harmful constituents (HPHCs) typically derived from combustion. Regul Toxicol Pharmacol, 2018. 95: p. 153-160. DOI: 10.1016/j.yrtph.2018.03.012

[11] Jaccard, G., et al., Comparative assessment of HPHC yields in the Tobacco Heating System THS2.2 and commercial cigarettes. Regul Toxicol Pharmacol, 2017. 90: p. 1-8. DOI: 10.1016/j.yrtph.2017.08.006

[12] Bentley, M. C., et al., Comprehensive chemical characterization of the aerosol generated by a heated tobacco product by untargeted screening. Anal Bioanal Chem, 2020. 412: p. 2675-2685. DOI: 10.1007/s00216-020-02502-1

[13] Shah, N.H., et al., Non-targeted analysis using gas chromatography-mass spectrometry for evaluation of chemical composition of E-vapor products. Front Chem, 2021. 9: 742854. DOI: 10.3389/fchem.2021.742854

[14] Rawlinson, C., et al., Chemical characterisation of aerosols emitted by electronic cigarettes using thermal desorption–gas chromatography–time of flight mass spectrometry. J Chromatogr A, 2017. 1497: p. 144-154. DOI: 10.1016/j.chroma.2017.02.050

[15] Murphy, J., et al. Assessing modified risk tobacco and nicotine products: Description of the scientific framework and assessment of a closed modular electronic cigarette. Regul Toxicol Pharmacol, 2017. 90: p. 342-357. DOI: 10.1016/j.yrtph.2017.09.008

[16] Caruso, M., et al., Screening of different cytotoxicity methods for the assessment of ENDS toxicity relative to tobacco cigarettes. Regul Toxicol Pharmacol, 2021. 125:105018. DOI: 10.1016/j.yrtph.2021.105018

[17] Miller-Holt, J., et al., In vitro evaluation of mutagenic, cytotoxic, genotoxic and oral irritation potential of nicotine pouch products. Toxicol Rep, 2022. 9: p. 1316-1324. DOI: 10.1016/j.toxrep.2022.06.008

[18] Thorne, D., et al., The genotoxicological assessment of a tobacco heating product relative to cigarette smoke using the in vitro micronucleus assay. Toxicol, 2020. 7: p. 1010-1019. DOI: 10.1016/j.toxrep.2020.08.013

[19] Clippinger, A.J., et al., Alternative approaches for acute inhalation toxicity testing to address global regulatory and non-regulatory data requirements: An international workshop report. Toxicol In Vitro, 2018. 48: p. 53-70. DOI: 10.1016/j.tiv.2017.12.011

[20] Wong, E.T., et al., Reduced chronic toxicity and carcinogenicity in A/J mice in response to life-time exposure to aerosol from a heated tobacco product compared with cigarette smoke. Toxicol Sci, 2020. 178(1): p. 44-70. DOI: 10.1093/toxsci/kfaa131

[21] Goniewicz, M.L., et al., Comparison of nicotine and toxicant exposure in users of electronic cigarettes and combustible cigarettes. JAMA Netw Open, 2018. 1(8): e185937. DOI: 10.1001/jamanetworkopen.2018.5937

[22] Gale, N., et al., Changes in biomarkers after 180 days of tobacco heating product use: a randomised trial. Intern Emerg Med, 2021. 16(8): p. 2201-2212. DOI: 10.1007/s11739-021-02798-6

[23] Fearon, I.M., et al., Nicotine pharmacokinetics of electronic cigarettes: a review of the literature. Regul Toxicol Pharmacol, 2018. 100: p.25-34. DOI: 10.1016/j.yrtph.2018.09.004

[24] Liu, J., et al., Nicotine pharmacokinetics and subjective responses after using nicotine pouches with different nicotine levels compared to combustible cigarettes and moist smokeless tobacco in adult tobacco users. Psychopharmacol, 2022. 239(9): p. 2863-2873. DOI: 10.1007/s00213-022-06172-y

[25] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research and Center for Drug Evaluation and Research, Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. 2010. Available at: https://www.fda.gov/media/71542/download

[26] D.az, L.D., et al., An international regulatory review of food health-related claims in functional food products labeling. J Funct Foods, 2020. 68:103896. DOI: 10.1016/j.jff.2020.103896

Chapter 4: Our Smokeless Science

Our Scientific Framework

[1] Lowe, F., et al., A framework for the assessment of reduced risk tobacco and nicotine products. Recent Adv Tob Sci, 2015. 41: p. 51-82. Available at: https://www.bat-science.com/pdfs/a-framework-for-the-assessment-of-reduced-risk-tobacco-and-nicotine-products.pdf

[2] Rodgman, A. and Perfetti, T.A., The chemical components of tobacco and tobacco smoke. CRC press, 2008. DOI: 10.1201/9781420078848

[3] Eaton, D., et al., Assessment of tobacco heating product THP1. 0. Part 2: product design, operation and thermophysical characterisation. Regul Toxicol Pharmacol, 2018. 93: p. 4-13. DOI: 10.1016/j.yrtph.2017.09.009

[4] Forster, M., et al., Assessment of novel tobacco heating product THP1. 0. Part 3: Comprehensive chemical characterisation of harmful and potentially harmful aerosol emissions. Regul Toxicol Pharmacol, 2018. 93: p. 14-33. DOI: 10.1016/j.yrtph.2017.10.006

[5] Margham, J., et al., Chemical Composition of Aerosol from an E-Cigarette: A Quantitative Comparison with Cigarette Smoke. Chem Res Toxicol, 2016. 29(10): p. 1662-1678. DOI: 10.1021/acs.chemrestox.6b00188

[6] Azzopardi, D., et al., Chemical characterization of tobacco-free “modern” oral nicotine pouches and their position on the toxicant and risk continuums. Drug Chem Toxicol, 2022. 45(5): p. 2246-2254. DOI: 10.1080/01480545.2021.1925691

[7] Breheny, D., et al., The in vitro assessment of a novel vaping technology. Toxicol Rep, 2020. 7: p. 1145-1156. DOI: 10.1016/j.toxrep.2020.08.016

[8] Thorne, D., et al., Assessment of novel tobacco heating product THP1.0. Part 7: Comparative in vitro toxicological evaluation. Regul Toxicol Pharmacol, 2018. 93: p. 71-83. DOI: 10.1016/j.yrtph.2017.08.017

[9] Bishop, E., et al., An approach for the extract generation and toxicological assessment of tobacco-free ‘modern’ oral nicotine pouches. Food Chem Toxicol, 2020. 145:111713. DOI: 10.1016/j.fct.2020.111713

[10] Crooks, I., et al., Evaluation of flavourings potentially used in a heated tobacco product: Chemical analysis, in vitro mutagenicity, genotoxicity, cytotoxicity and in vitro tumour promoting activity. Food Chem Toxicol, 2018. 118: p. 940-952. DOI: 10.1016/j.fct.2018.05.058

[11] Taylor, M., et al., E-cigarette aerosols induce lower oxidative stress in vitro when compared to tobacco smoke. Toxicology mechanisms and methods, 2016. 26(6): p. 465-476. DOI: 10.1080/15376516.2016.1222473

[12] Gale, N., et al., Changes in biomarkers of exposure and biomarkers of potential harm after 360 days in smokers who either continue to smoke, switch to a tobacco heating product or quit smoking. Intern Emerg Med, 2022. 17(7): p. 2017-2030. DOI: 10.1007/s11739-022-03062-1 [13] Haswell, L.E., et al., Biomarkers of exposure and potential harm in exclusive users of electronic cigarettes and current, former, and never smokers. Intern Emerg Med, 2023. 18(5): p. 1359-1371. DOI: 10.1007/s11739-023-03294-9

[14] Azzopardi, D., et al., Assessment of biomarkers of exposure and potential harm, and physiological and subjective health measures in exclusive users of nicotine pouches and current, former and never smokers. Biomark, 2023. 28(1): p. 118-129. DOI: 10.1080/1354750x.2022.2148747

[15] Jones, J., et al., A cross-category puffing topography, mouth level exposure and consumption study among Italian users of tobacco and nicotine products. Sci Rep, 2020. 10(1): 12. DOI: 10.1038/s41598-019-55410-5

[16] Bachand, A.M. and Sulsky, S.I., A dynamic population model for estimating all-cause mortality due to lifetime exposure history. Regul Toxicol Pharmacol, 2013. 67(2): p. 246-251. DOI: 10.1016/j.yrtph.2013.08.003

[17] Bachand, A.M., et al., Assessing the likelihood and magnitude of a population health benefit following the market introduction of a modified-risk tobacco product: Enhancements to the dynamic population modeler, DPM(+ 1). Risk Anal, 2018. 38(1): p. 151-162. DOI: 10.1111/risa.12819

[18] Lee, P.N., Summary of the epidemiological evidence relating snus to health. Regul Toxicol Pharmacol, 2011. 59(2): p. 197–214. DOI: 10.1016/j.yrtph.2010.12.002

[19] Lee, P.N., Epidemiological evidence relating snus to health--an updated review based on recent publications. Harm Reduct J, 2013. 10: 36. DOI: 10.1186/1477-7517-10-36

Chapter 4: Our Smokeless Science

Seeking Validation of Our Science

[1] Briggs, J. and Vallone, D., The tobacco industry’s renewed assault on science: a call for a United public health response. Am J Public Health, 2022. 112(3): p. 388-390. DOI: 10.2105/AJPH.2021.306683

[2] Godlee, F., et al., Journal policy on research funded by the tobacco industry. Br Med J, 2013. 347: f5193. DOI: 10.1136/bmj.f5193

[3] SRNT, SRNT Membership Categories. Available at: https://www.srnt.org/page/Join_Us (Accessed: 3 July 2024)

[4] Larrick, B.M., et al., An updated framework for industry funding of food and nutrition research: managing financial conflicts and scientific integrity. J Nutr, 2022. 152(8): p. 1812-1818. DOI: 10.1093/jn/nxac106

[5] Cummings, K.M., et al., The past is not the future in tobacco control. Prev Med, 2020. 140:106183. DOI: 10.1016/j.ypmed.2020.106183

Chapter 4: Our Smokeless Science

The Transition from Combustible to Smokeless Science

[1] Proctor, C.J., et al., Evaluation of an apparatus designed for the collection of sidestream tobacco smoke. Analyst, 1988. 113(10): p. 1509-1513. DOI: 10.1039/AN9881301509

[2] Proctor, C.J., 2003. Sometimes a Cigarette is Just a Cigarette, Sinclair-Stevenson, ISBN-13: 978-0954352011

[3] Institute of Medicine, Clearing the smoke: Assessing the science base for tobacco harm reduction. National Academies Press, 2001. Available at: http://nap.nationalacademies.org/10029

[4] National Research Council, Toxicity testing in the 21st century: a vision and a strategy. The National Academies Press, 2007. Available at: https://nap.nationalacademies.org/download/11970

[5] British American Tobacco (BAT), https://www.bat-science.com/ (Accessed: 7 August 2024).

[6] Murphy, J., et al., Assessing modified risk tobacco and nicotine products: description of the scientific framework and assessment of a closed modular electronic cigarette. Regul Toxicol Pharmacol, 2017. 90: p. 342-357. DOI: 10.1016/j.yrtph.2017.09.008

[7] OECD, Test No. 471: Bacterial Reverse Mutation Test. OECD Guidelines for the Testing of Chemicals. Section 4, OECD Publishing, Paris, 2020. DOI: 10.1787/9789264071247-en

[8] World Medical Organization. Declaration of Helsinki (1964). Br Med J, 1996. 313(7070):1448. DOI: 10.1136/bmj.313.7070.1448a

[9] International Council for Harmonisation of Technical Requirements for Pharmaceuticals For Human Use (ICH), Integrated Addendum to Ich E6(R1): Guideline For Good Clinical Practice E6(R2). European Medicines Agency, 2016. Available at: https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guideline

[10] See, e.g., ISRCTN registry. ISRCTN81075760: A study to examine health effect indicators when a smoker switches to using a tobacco heating product. DOI: 10.1186/ISRCTN81075760

[11] Chawla, D.S., Tobacco publishing ban for researchers at industry-owned firms. Nature, 2022. Available at:

https://www.nature.com/articles/d41586-022-00197-1 (Accessed: 5 July 2024)

[12] See ‘Our Published Tobacco Harm Reduction Science’ in the Appendices

[13] Chang, C.M., et al.; Biomarkers of Tobacco Exposure: Summary of an FDA-Sponsored Public Workshop. Cancer Epidemiol Biomarkers Prev, 2017. 26(3): p. 291-302. DOI: 10.1158/1055-9965.EPI-16-0675

[14] Proctor, C.J., Lessons from clinical studies using biomarkers of exposure to assess toxicant exposure. Presentation to Public Workshop on Biomarkers of Tobacco Exposure, FDA, Center for Tobacco Products. 2015. Available at: https://bat-science.com/pdfs/presentation-to-the-fdascenter-for-tobacco-products-public-workshop-on-biomarkers-of-exposure.pdf

Chapter 4: Our Smokeless Science

Combustion, Emissions, and Toxicological Studies

[1] IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, Tobacco Smoke and Involuntary Smoking (No. 83). World Health Organization and International Agency for Research on Cancer, 2004. Available at: https://www.ncbi.nlm.nih.gov/books/NBK316407/

[2] Jenkins, R.A., et al., Mainstream and sidestream smoke, In The chemistry of environmental tobacco smoke: composition and measurement (2nd ed). CRC Press, 2000. p. 49-75 DOI: 10.1201/9781482278651

[3] Rodgman, A. and Perfetti, T.A., The chemical components of tobacco and tobacco smoke. CRC press, 2008. DOI: 10.1201/9781420078848

[4] Baker, R.R., A review of pyrolysis studies to unravel reaction steps in burning tobacco. J Anal Appl Pyrolysis, 1987. 11: p 555-573. DOI: 10.1016/0165-2370(87)85054-4

[5] Eaton, D., et al., Assessment of tobacco heating product THP1.0. Part 2: product design, operation and thermophysical characterisation. Regul Toxicol Pharmacol, 2018. 93: p. 4-13. DOI: 10.1016/j.yrtph.2017.09.009

[6] Forster, M., et al., Assessment of novel tobacco heating product THP1.0. Part 3: Comprehensive chemical characterisation of harmful and potentially harmful aerosol emissions. Regul Toxicol Pharmacol, 2018. 93: p. 14-33. DOI: 10.1016/j.yrtph.2017.10.006

[7] Savareear B., et al., Non-targeted analysis of the particulate phase of heated tobacco product aerosol and cigarette mainstream tobacco smoke by thermal desorption comprehensive two-dimensional gas chromatography with dual flame ionisation and mass spectrometric detection. J Chromatogr A, 2019. 1603: p. 327-337. DOI: 10.1016/j.chroma.2019.06.057

[8] Savareear, B., et al., Headspace solid-phase microextraction coupled to comprehensive two-dimensional gas chromatography–time-of-flight mass spectrometry for the analysis of aerosol from tobacco heating product. J Chromatogry A, 2017. 1520: p. 135-142. DOI: 10.1016/j.chroma.2017.09.014

[9] Margham, J., et al., Chemical composition of aerosol from an e-cigarette: a quantitative comparison with cigarette smoke. Chem Res Toxicol, 2016. 29(10): p. 1662-1678. DOI: 10.1021/acs.chemrestox.6b00188

[10] Pinto, M.I., et al., Chemical characterisation of the vapour emitted by an e-cigarette using a ceramic wick-based technology. Sci Rep, 2022. 12(1):16497. DOI: 10.1038/s41598-022-19761-w

[11] Dalrymple, A., et al., Assessment of enamel discoloration in vitro following exposure to cigarette smoke and emissions from novel vapor and tobacco heating products. Am J Dent, 2018. 31(5): p. 227-233. Available at: https://pubmed.ncbi.nlm.nih.gov/30346667/

[12] Azzopardi, D., et al., Chemical characterization of tobacco-free “modern” oral nicotine pouches and their position on the toxicant and risk continuums. Drug Chem Toxicol, 2022. 45(5): p. 2246-2254. DOI: 10.1080/01480545.2021.1925691

[13] WHO, The Scientific Basis of Tobacco Product Regulation. WHO Press, 2008. https://iris.who.int/bitstream/handle/10665/43997/TRS951_eng.pdf

[14] Jaunky, T., et al., Assessment of tobacco heating product THP1.0. Part 5: In vitro dosimetric and cytotoxic assessment. Regul Toxicol Pharmacol, 2018. 93: p. 52-61. DOI: 10.1016/j.yrtph.2017.09.016

[15] Taylor, M., et al., Assessment of novel tobacco heating product THP1.0. Part 6: a comparative in vitro study using contemporary screening approaches. Regul Toxicol Pharmacol, 2018. 93: p. 62-70. DOI: 10.1016/j.yrtph.2017.08.016

[16] Thorne, D., et al., Assessment of novel tobacco heating product THP1.0. Part 7: Comparative in vitro toxicological evaluation. Regul Toxicol Pharmacol, 2018. 93: p. 71-83. DOI: 10.1016/j.yrtph.2017.08.017

[17] Murphy, J., et al., 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, 2018. 93: p. 92-104. DOI: 10.1016/j.yrtph.2017.10.001

[18] Goodall, S., et al., Evaluation of behavioural, chemical, toxicological and clinical studies of a tobacco heated product glo™ and the potential for bridging from a foundational dataset to new product iterations. Toxicol Rep, 2022. 9: p. 1426-1442. DOI: 10.1016/j.toxrep.2022.06.014

[19] Taylor, M., et al., E-cigarette aerosols induce lower oxidative stress in vitro when compared to tobacco smoke. Toxicol Mech Methods, 2016. 26(6): p. 465-476. DOI: 10.1080/15376516.2016.1222473

[20] Thorne, D., et al., The mutagenic assessment of an electronic-cigarette and reference cigarette smoke using the Ames assay in strains TA98 and TA100. Mutat, 2016. 812: p. 29-38. DOI: 10.1016/j.mrgentox.2016.10.005

[21] Azzopardi, D., et al., Electronic cigarette aerosol induces significantly less cytotoxicity than tobacco smoke. Toxicol Mech Methods, 2016. 26(6): p. 477-491. DOI: 10.1080/15376516.2016.1217112

[22] Bishop, E., et al., An in vitro toxicological assessment of two electronic cigarettes: E-liquid to aerosolisation. Curr Res Toxicol, 2024. 6:100150. DOI: 10.1016/j.crtox.2024.100150

[23] Bishop, E., et al., A contextualised e-cigarette testing strategy shows flavourings do not impact lung toxicity in vitro. Toxicol Lett, 2023. 380: p. 1-11. DOI: 10.1016/j.toxlet.2023.03.006

[24] Bishop, E., et al., An approach for the extract generation and toxicological assessment of tobacco-free ‘modern’ oral nicotine pouches. Food Chem Toxicol, 2020. 145:111713. DOI: 10.1016/j.fct.2020.111713

[25] East, N., et al., A screening approach for the evaluation of tobacco-free ‘modern oral’ nicotine products using Real Time Cell Analysis. Toxicol Rep, 2021. 8: p. 481-488. DOI: 10.1016/j.toxrep.2021.02.014

[26] Yu, F., et al., Multi-endpoint in vitro toxicological assessment of snus and tobacco-free nicotine pouch extracts. Mutat, 2024. 895: p. 503738. DOI: 10.1016/j.mrgentox.2024.503738

Chapter 4: Our Smokeless Science

Use Behaviour and Pharmacokinetic Studies

[1] Jones, J., et al., A cross-category puffing topography, mouth level exposure and consumption study among Italian users of tobacco and nicotine products. Sci Rep, 2020. 10:12. DOI: 10.1038/s41598-019-55410-5

[2] Prasad., K., et al., Emissions, puffing topography, mouth level exposure and consumption among Japanese users of tobacco heated products. Int J Sci Rep, 2022. 8(11): p. 313-322. DOI: 10.18203/issn.2454-2156.IntJSciRep20222694

[3] Prasad, K., et al., Actual use puffing topography and mouth level exposure to aerosol and nicotine for an evolving series of electronic nicotine delivery systems. Int J Sci Rep, 2022. 8(12): p. 366-76. DOI: 10.18203/issn.2454-2156.IntJSciRep20223033

[4] Edward, L., et al., A consumer use behaviour study to evaluate the average daily consumption, mouth level exposure and puffing topography of regular e-cigarette consumers across a range of e-liquid nicotine levels and flavour categories in New Zealand [unpublished manuscript].

British American Tobacco (BAT), 2024. 

[5] Digard, H., et al., Determination of Nicotine Absorption from Multiple Tobacco Products and Nicotine Gum. Nicotine Tob Res, 2013. 15(1): p. 255–261. DOI: 10.1093/ntr/nts123

[6] Digard, H., et al., Patterns and behaviors of snus consumption in Sweden. Nicotine Tob Res, 2009. 11(10): p. 1175-1181. DOI: 10.1093/ntr/ntp118

[7] Azzopardi, D., et al., Assessment of biomarkers of exposure and potential harm, and physiological and subjective health measures in exclusive users of nicotine pouches and current, former and never smokers. Biomarkers, 2023. 28(1): p. 118-129. DOI: 10.1080/1354750X.2022.2148747

[8] Slayford, S.J., and Frost, B.E., A Device to Measure a Smoker's Puffing Topography and Real-Time Puff-by-Puff “Tar” Delivery. Contrib Tob Nicotine Res, 2014. 26(2). DOI: 10.2478/cttr-2014-0011

[9] Troude, V., et al., Human mouth-level transfer rate of menthol, 1.8-cineole and nicotine from Swedish pouched snus. CORESTA SSPT meeting, Seville, 2013. Available at: https://www.coresta.org/sites/default/files/abstracts/2013_ST19_Troude.pdf

[10] Hardie, G., et al., An abuse liability assessment of the glo tobacco heating product in comparison to combustible cigarettes and nicotine replacement therapy. Sci Rep, 2022. 12(1): 14701. DOI: 10.1038/s41598-022-19167-8

[11] Kanobe, M., et al., Randomized, Crossover Studies of Abuse Liability and Nicotine Pharmacokinetics Assessment of Vuse Alto Electronic Nicotine Delivery Systems. [unpublished manuscript]. British American Tobacco (BAT), 2024

[12] McEwan, M., et al., Plasma Nicotine Pharmacokinetics of Oral Nicotine Pouches Across Varying Flavours and Nicotine Content. Contrib Tob Nicotine Res, 2023. 32(4): p. 130-139. DOI: 10.2478/cttr-2023-0016

[13] Bradford, D. C., et al., The actual use trial: A description of design principles and methods. SelfCare, 2010. 1(4): p. 117-123. Available at: https://selfcarejournal.com/wp-content/uploads/2015/09/Bradford-1.4.117-123.pdf

Chapter 4: Our Smokeless Science

Clinical: Exposure

[1] Lowe, F.J., et al., Evaluation of biomarkers of exposure and potential harm in smokers, former smokers and never-smokers. Clin Chem Lab Med, 2009. 47(3): p.311-320. DOI: 10.1515/CCLM.2009.069

[2] Burns, D.M., et al., Mandated lowering of toxicants in cigarette smoke: a description of the World Health Organization TobReg proposal. Tob Control, 2008. 17(2): p. 132-141. DOI: 10.1136/tc.2007.024158

[3] Institute of Medicine (US), Board on Population Health and Public Health Practice and Committee on Scientific Standards for Studies on Modified Risk Tobacco Products, Scientific Standards for Studies on Modified Risk Tobacco Products. National Academies Press, 2012. Available at: https://nap.nationalacademies.org/catalog/13294/scientific-standards-for-studies-on-modified-risk-tobacco-products

[4] Haswell, L.E., et al., Biomarkers of exposure and potential harm in exclusive users of electronic cigarettes and current, former, and never smokers. Intern Emerg Med, 2023. 18(5): p. 1359-1371. DOI: 10.1007/s11739-023-03294-9

[5] Azzopardi, D., et al., Assessment of biomarkers of exposure and potential harm, and physiological and subjective health measures in exclusive users of nicotine pouches and current, former and never smokers. Biomark, 2023. 28(1): p. 118-129. DOI: 10.1080/1354750X.2022.2148747

[6] Gale, N., et al., Changes in biomarkers of exposure and biomarkers of potential harm after 360 days in smokers who either continue to smoke, switch to a tobacco heating product or quit smoking. Intern Emerg Med, 2022. 17: p. 2017-2030. DOI: 10.1007/s11739-022-03062-1

Chapter 4: Our Smokeless Science

Clinical: Individual Risk

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[12] Haswell, L.E., et al., Biomarkers of exposure and potential harm in exclusive users of electronic cigarettes and current, former, and never smokers. Intern Emerg Med, 2023. 18: p. 1359-1371. DOI: 10.1007/s11739-023-03294-9

[13] Azzopardi, D., et al., Assessment of biomarkers of exposure and potential harm, and physiological and subjective health measures in exclusive users of nicotine pouches and current, former and never smokers. Biomark, 2023. 28(1): p. 118-129. DOI: 10.1080/1354750X.2022.2148747

[14] Chang, C. M., et al., Biomarkers of Potential Harm: Summary of an FDA-Sponsored Public Workshop. Nicotine Tob Res, 2019. 21(1): p. 3–13. DOI: 10.1093/ntr/ntx273

Chapter 4: Our Smokeless Science

Population Risk and Modelling

[1] Levy, D.T., et al., The Australia Smoking and Vaping Model: The Potential Impact of Increasing Access to Nicotine Vaping Products. Nicotine Tob Res, 2023. 25(3): p. 486–497. DOI: 10.1093/ntr/ntac210

[2] Rytsar, R., et al., Estimated Public Health Gains From German Smokers Switching to Reduced-Risk Alternatives: Results From Population Health Impact Modelling. Contrib Tob Nicotine Res, 2022. 31(1): p. 35-51. DOI: 10.2478/cttr-2022-0004

[3] Mzhavanadze, G., and Yanin, D., The Potential Impact of E-cigarettes on the Life-Years Lost from Conventional Smoking in the Russian Federation. J Consum Policy, 2023. 46(2): p. 253-274. DOI: 10.1007/s10603-023-09540-z

[4] Human D., et al., Saving Lives Like Sweden. Smoke Free Sweden 2023, 2023. Available at: https://smokefreesweden.org/wp-content/themes/smokefreesweden/assets/pdf/reports/Report_SAVING%20LIVES%20LIKE%20SWEDEN.pdf

[5] Council Directive 92/41/EEC of 15 May 1992 amending Directive 89/622/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products. Official Journal L158, 1992. p. 30–33. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31992L0041:EN:HTML (Accessed: 16 August 2024).

[6] World Health Organization. WHO global report: mortality attributable to tobacco. 2012. Available at: https://www.who.int/publications/i/item/9789241564434 (Accessed: 16 August 2024)

Chapter 4: Our Smokeless Science

Adverse Outcome Pathways

[1] OECD., Guidance document for the use of adverse outcome pathways in developing integrated approaches to testing and assessment (IATA). OECD Series on Testing and Assessment, No. 260, OECD Publishing, 2017. DOI: 10.1787/44bb06c1-en

[2] Society for Advancement of AOPs, AOP-Wiki. Available at: https://aopwiki.org/ (Accessed: 12 August 2024)

[3] Luettich, K., et al., An adverse outcome pathway for decreased lung function focusing on mechanisms of impaired mucociliary clearance following inhalation exposure. Front Toxicol, 2021. 3:750254. DOI: 10.3389/ftox.2021.750254

[4] Makena, P., et al., An adverse outcome pathway for the cigarette smoke-mediated oxidative stress in plaque formation. [unpublished manuscript]. British American Tobacco (BAT), 2024.

[5] Bal-Price, A., and Meek, M. E. B., Adverse outcome pathways: Application to enhance mechanistic understanding of neurotoxicity. Pharmacol Ther, 2017. 179: p. 84-95. DOI: 10.1016/j.pharmthera.2017.05.006

[6] Gale, N., et al., Changes in biomarkers of exposure and biomarkers of potential harm after 360 days in smokers who either continue to smoke, switch to a tobacco heating product or quit smoking. Intern Emerg Med, 2022. 17(7): p. 2017-2030. DOI: 10.1007/s11739-022-03062-1

Chapter 4: Our Smokeless Science

A Summary of Our 9-Step Scientific Risk Assessment Science

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[2] Institute of Medicine, Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press, 2012. DOI: 10.17226/13294

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[4] U.S. Food & Drug Administration, Modified Risk Tobacco Products. Available at: https://www.fda.gov/tobacco-products/advertising-andpromotion/modified-risk-tobacco-products (Accessed: 2 July 2024)

[5] Berman, M. L., et al., Providing a science base for the evaluation of tobacco products. Tob. Regul Sci, 2015. 1(1): p.76. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671507/

[6] Li, X., et al., Chemical analysis and simulated pyrolysis of tobacco heating system 2.2 compared to conventional cigarettes. Nicotine Tob Res, 2019. 21(1): p. 111-118. DOI: 10.1093/ntr/nty005

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[8] Bekki, K., et al., Comparison of chemicals in mainstream smoke in heat-not-burn tobacco and combustion cigarettes. J UOEH, 2017. 39(3): p. 201-207. DOI: 10.7888/juoeh.39.201

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[10] Jaccard, G., et al., Comparative assessment of HPHC yields in the Tobacco Heating System THS2. 2 and commercial cigarettes. Regul Toxicol Pharmacol, 2017. 90: p. 1-8. DOI: 10.1016/j.yrtph.2017.08.006

[11] Frege, C., et al., Assessment of single-photon ionization mass spectrometry for online monitoring of in vitro aerosol exposure experiments. Chem Res Toxicol, 2020. 33(2): p. 505-514. DOI: 10.1021/acs.chemrestox.9b00381

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[15] Mallock, N., et al., Levels of nicotine and tobacco-specific nitrosamines in oral nicotine pouches. Tob Control, 2024. 33(2): p. 193-199. DOI: 10.1136/tc-2022-057280

[16] Aldeek, F., et al., Dissolution testing of nicotine release from OTDN pouches: product characterization and product-to-product comparison. Separations, 2021. 8(1):7. DOI: 10.3390/separations8010007

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Chapter 5: Our Smokeless Products

A Better Tomorrow^™ for Consumers

[1] BAT, Responsible Marketing Principles. Available at: https://www.bat.com/content/dam/batcom/global/main-nav/sustainability-esg/governance---ethics/BAT_Responsible_Marketing_Principles.pdf

[2] BAT, Responsible Marketing Code. Available at: https://www.bat.com/content/dam/batcom/global/main-nav/sustainability-esg/governance---ethics/BAT_Responsible_Marketing_Code.pdf

Chapter 5: Our Smokeless Products

Tobacco Harm Reduction: Risk Perceptions

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[4] Denlinger-Apte, R.L., et al., Risk perceptions of low nicotine cigarettes and alternative nicotine products across priority smoking populations. Int J Environ Res Public Health, 2021. 18(10): p. 5311. DOI: 10.3390/ijerph18105311

[5] Goulette, M.R., et al., Perceptions of harmfulness of heated tobacco and nicotine vaping products compared to cigarettes, and the association of advertising exposure on harm perceptions among adults who smoke in South Korea: Cross-sectional findings from the 2020 ITC Korea Survey. Tob Induc Dis, 2023. 21:121. DOI: 10.18332/tid/170252

[6] Wackowski, O.A., et al., Smokers' sources of e-cigarette awareness and risk information. Prev Med Rep, 2015. 2: p. 906-910. DOI: 10.1016/j.pmedr.2015.10.006

[7] Tobacco Use and Dependence Guideline Panel, Treating Tobacco Use and Dependence: 2008 Update. US Department of Health and Human Service: Atlanta, GA, USA, 2008. Available at: https://www.ncbi.nlm.nih.gov/books/NBK63952/ (Accessed: 30 July 2024)

[8] Delnevo, C.D., et al., Communication Between US Physicians and Patients Regarding Electronic Cigarette Use. JAMA Netw Open, 2022. 5(4): p. e226692. DOI: 10.1001/jamanetworkopen.2022.6692

[9] Otsuka Y., et al., Awareness, Attitudes, and Concerns Regarding Heated Tobacco Products Among Physicians in Japan. J Epidemiol, 2023. 33(9): p. 441-449. DOI: 10.2188/jea.JE20210470

[10] Otsuka, Y., et al., Prevalence, knowledge, and concerns regarding the use of heated tobacco products and electronic cigarettes among young Japanese physicians. Tob Induc Dis, 2024. 22. DOI: 10.18332/tid/178508

[11] Department of Health and Social Care, Press release: Smokers urged to swap cigarettes for vapes in world first scheme’ Press Release. Gov.UK,

2023. Available at: https://www.gov.uk/government/news/smokers-urged-to-swap-cigarettes-for-vapes-in-world-first-scheme (Accessed: 30 July 2024)

[12] McNeill, A., et al., Nicotine vaping in England: an evidence update including health risks and perceptions. Office for Health Improvement and Disparities, 2022. Available at: https://assets.publishing.service.gov.uk/media/633469fc8fa8f5066d28e1a2/Nicotine-vaping-in-England-2022-report.pdf

[13] Bover Manderski, M.T., et al., Persistent misperceptions about nicotine among US physicians: results from a randomized survey experiment. Int J Environ Res Public Health, 2021. 18(14): p. 7713. DOI: 10.3390/ijerph18147713

[14] Steinberg, M.B., et al., Nicotine risk misperception among US physicians. Journal of General Internal Medicine, 2021. 36(12): p. 3888-3890. DOI: 10.1007/s11606-020-06172-8

[15] BAT, THR Perceptions Presentation, Unpublished, 1 June 2024

Chapter 5: Our Smokeless Products

Consumer Product Research

[1] World Medical Organization, Declaration of Helsinki (1964). Br Med J, 1996. 313(7070): p. 1448-1449. DOI: 10.1136/bmj.313.7070.1448a

Chapter 5: Our Smokeless Products

Social Consideration and Personal Hygiene: A Benefit of Smokeless Products

[1] Baker, R.R., and Proctor, C.J., The origins and properties of environmental tobacco smoke. Environment International, 1990. 16(3): p. 231-245. DOI: 10.1016/0160-4120(90)90117-O

[2] Forster, M., et al., Assessment of tobacco heating product THP1.0. Part 4: Characterisation of indoor air quality and odour. Regul Toxicol Pharmacol, 2018. 93: p. 34-51. DOI: 10.1016/j.yrtph.2017.09.017

[3] McAughey, J., et al. The impact of e-cigarettes and tobacco heating products on indoor air quality. J Aerosol Med Pulm Drug Deliv, 2017. 30:3 (abstract 116). DOI: 10.1089/jamp.2017.ab01.abstracts

[4] Dalrymple, A., et al., Enamel staining with e-cigarettes, tobacco heating products and modern oral nicotine products compared with cigarettes and snus: An in vitro study. 2021. Am J Dent, 34(1): p. 3-9. Available at: https://pubmed.ncbi.nlm.nih.gov/33544982/

Chapter 5: Our Smokeless Products

Responsibly Building a Smokeless World

[1] This excludes those markets that are scheduled to cease the sale of disposable devices due to regulatory bans or other market constraints.

Chapter 6: THR: A Global Transformation

Smokeless Products: Market Access

[1] Bates, C., Regulation: Why less is more. E-cigarette summit, 2013. Available at: https://www.slideshare.net/slideshow/ecigarette-summit-12-novem/28364227 (Assessed 4 July 2024)

[2] Global Tobacco Control, Heated Tobacco, Available at: https://www.globaltobaccocontrol.org/en/policy-scan/heated-tobacco/sale (Accessed 19 August 2024)

[3] BAT Internal CORA Data

[4] Global Tobacco Control, Country Laws Regulating E-Cigarettes, Available at: https://www.globaltobaccocontrol.org/en/policy-scan/e-cigarettes/sale (Accessed 19 August 2024)

[5] Global Tobacco Control, Nicotine Pouches, Available at: https://www.globaltobaccocontrol.org/en/policy-scan/nicotine-pouches/sale (Accessed 19 August 2024)

Chapter 6: THR: A Global Transformation

Introduction by Johan Vandermeulen

[1] Human D., et al, Saving Lives Like Sweden. Smoke Free Sweden, 2023. Available at: https://smokefreesweden.org/wp-content/themes/smokefreesweden/assets/pdf/reports/Report_SAVING%20LIVES%20LIKE%20SWEDEN.pdf  (Assessed 14 March 2025)

[2] See, e.g., Action on Smoking and Health (ASH), Use of e-cigarettes (vapes) among adults in Great Britain. 2024. Available at:https://ash.org.uk/uploads/Use-of-vapes-among-adults-in-Great-Britain-2024.pdf. (Assessed 14 March 2025)

Chapter 6: THR: A Global Transformation

UK: A Decade of Public Health Advocacy Positioning Vaping as a Tobacco Harm Reduction Tool

[1] McNeill A., et al., E-cigarettes: an evidence update. Public Health England, 2015. Available at: https://www.gov.uk/government/publications/ecigarettes-an-evidence-update (Accessed: 14 July 2025)

[2] BBC News, E-cigarettes could be prescribed by the NHS to help smokers quit, report says. 2015. www.bbc.co.uk/news/health-33978603

[3] Office of Health Improvement and Disparities (OHID), E-cigarettes and vaping: policy, regulation and guidance. Gov. UK, 2022. Available at: https://www.gov.uk/government/collections/e-cigarettes-and-vaping-policy-regulation-and-guidance#e-cigarettes-evidence-reviews (Accessed: 21 March 2025).

[4] Office of Health Improvement and Disparities (OHID), Nicotine vaping in England: 2022 evidence update main findings. Gov. UK, 2022. Available at: https://www.gov.uk/government/publications/nicotine-vaping-in-england-2022-evidence-update/nicotine-vaping-in-england-2022-evidence-update-main-findings (Accessed: 21 March 2025).

[5] Office for Health Improvement and Disparities (OHID), The Khan review: making smoking obsolete. Gov. UK, 2022. Available at: https://www.gov.uk/government/publications/the-khan-review-making-smoking-obsolete (Accessed: 21 March 2025)

[6] Balogun, B. and Harker, R., The smokefree 2030 ambition for England. House of Commons Library, 2023. Available at: https://commonslibrary.parliament.uk/research-briefings/cbp-9655/ (Accessed: 21 March 2025)

[7] National Institute for Health and Care Excellence (NICE), Tobacco: preventing uptake, promoting quitting and treating dependence (NG209). 2021. Available at: https://www.nice.org.uk/guidance/ng209/resources/tobacco-preventing-uptake-promoting-quitting-and-treatingdependencepdf-66143723132869 (Accessed: 21 March 2025).

[8] Action on Smoking and Health (ASH), Vaping: what you need to know. Available at: https://ash.org.uk/key-topics/vaping-what-you-need-to-know (Accessed: 06 August 2025)

[9] Royal College of Physicians, E-cigarettes and harm reduction: An evidence review. RCP, 2024. Available at: https://www.rcp.ac.uk/policy-andcampaigns/policy-documents/e-cigarettes-and-harm-reduction-an-evidence-review/ (Accessed: 21 March 25).

[10] U.K. National Health Service (NHS), Vaping to quit smoking. Available at: https://www.nhs.uk/better-health/quit-smoking/ready-to-quit-smoking/vaping-to-quit-smoking/ (Accessed: 21 March 25).

[11] U.K. National Health Service (NHS), NHS stop smoking services help you quit. Available at: https://www.nhs.uk/live-well/quit-smoking/nhs-stopsmoking-services-help-you-quit/ (Accessed: 21 March 2025).

[12] Department of Health and Social Care, Press release: “Smokers urged to swap cigarettes for vapes in world first scheme”.Gov. UK, 2023. Available: https://www.gov.uk/government/news/smokers-urged-to-swap-cigarettes-for-vapes-in-world-first-scheme (Accessed: 21 March 2025).

[13] Action on Smoking and Health (ASH), Use of vapes (e-cigarettes) among adults in Great Britain. 2024. Available at: https://ash.org.uk/uploads/Use-of-vapes-among-adults-in-Great-Britain-2024.pdf  (Accessed: 21 March 2025).

[14] Office for National Statistics (ONS), Adult smoking habits in the UK: 2023. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/healthandlifeexpectancies/bulletins/adultsmokinghabitsingreatbritain/2023  (Accessed: 21 March 2025).

[15] Eurobarometer, Attitudes of Europeans towards tobacco and related products. European Commission, 2023. Available at: https://europa.eu/eurobarometer/surveys/detail/2995 (Accessed: 14 July 2025).

[16] UK Parliament, Tobacco and Vapes Bill. Available at: https://bills.parliament.uk/bills/3879#timeline (Accessed: 14 July 2025).

[17] Department of Health and Social Care (OHID), Tobacco and Vapes Bill: creating a smoke-free UK and tackling youth vaping factsheet. Gov. UK. 2024. Available at: https://www.gov.uk/government/publications/the-tobacco-and-vapes-bill-creating-a-smoke-free-uk-and-tackling-youthvaping/tobacco-and-vapes-bill-creating-a-smoke-free-uk-and-tackling-youth-vaping (Accessed: 14 July 2025).

Chapter 6: THR: A Global Transformation

Greece’s: Progressive Strategy on Communicating Risk-Related Messages to Adult Smokers

[1] OECD, Tobacco Consumption, Measure: share of population who are daily smokers. Available at: https://data-explorer.oecd.org/vis?tm=daily%20smokers&pg=0&hc[Unit%20of%20measure]=&snb=2&vw=tb&df[ds]=dsDisseminateFinalDMZ&df[id]=DSD_HEALTH_LVNG%40DF_HEALTH_LVNG_TC&df[ag]=OECD.ELS.HD&df[vs]=1.0&dq=.A.....&pd=2010%2C&to[TIME_PERIOD]=false (Accessed: 19 March 2025)

[2] Institute for Health Metrics and Evaluation (IHME), Health by location, Greece. Available at: https://www.healthdata.org/research-analysis/health-by-location/profiles/greece (Accessed: 11 July 2025)

[3] Global Action to End Smoking, State of Smoking and Health in Greece. Available at: https://globalactiontoendsmoking.org/research/tobaccoaround-the-world/greece/ (Accessed: 11 July 2025)

[4] Smoke Free Greece. Available at: https://smokefreegreece.gr/en/smoke-free-greece/ (Accessed: 19 March 2025)

[5] Greek Law 4715/2020 (Article 36), Available at: https://www.kodiko.gr/nomothesia/document/634794/nomos-4715-2020

[6] Greek Government, National Action Plan Against Smoking. 2019. Available at: https://www.government.gov.gr/ethniko-schedio-drasis-kata-toukapnismatos-i-igia-mas-enoni/ (Accessed: 11 July 2025)

[7] Eurobarometer, Attitudes of Europeans towards tobacco and related products. European Commission, 2021. https://europa.eu/eurobarometer/surveys/detail/2240

[8] Eurobarometer, Attitudes of Europeans towards tobacco and related products. European Commission, 2024. Available at: https://europa.eu/eurobarometer/surveys/detail/2995

[9] Statista, Health Indicators Greece report 2024. Available at: https://www.statista.com/study/173878/health-indicators-greece-report/

[10] TobaccoIntelligence, Greece: Heated tobacco market snapshot, November 2024

Chapter 6: THR: A Global Transformation

Japan: A Heated Products Story

[1] Euromonitor International, Market Sizes, Cigarettes – Japan, Tobacco: Euromonitor from trade sources/national statistics (Accessed 5 August 2024)

[2] Euromonitor International, Market Sizes, Heated Tobacco – Japan, Tobacco: Euromonitor from trade sources/national statistics (Accessed 5 August 2024)

[3] Forey, B., et al., Japan in International Smoking Statistics: A collection of historical data from 30 economically developed countries (2nd ed), Oxford University Press, 2002. DOI: 10.1093/acprof:oso/9780198508564.001.0001

[4] Otsuka Y. et al., Comparison of the responses of cross-sectional web- and paper-based surveys on lifestyle behaviors of Japanese adolescents, Prev Med Rep, 2023. 36: p. 102462. DOI: 10.1016/j.pmedr.2023.102462

[5] Xu, S.S., et al., Reasons for Regularly Using Heated Tobacco Products among Adult Current and Former Adult smokers in Japan: Finding from 2018 ITC Japan Survey. Int J Environ Res Public Health, 2020. 17(21): p. 8030. DOI: 10.3390/ijerph17218030

[6] World Economic Forum, 5 Japanese innovations that changed the world. 2016. Available at: https://www.weforum.org/agenda/2016/10/5-japanese-innovations-that-changed-the-world/ (Accessed: 29 July 2024)

[7] Bloomberg, Japan: Where innovation is borderless. Available at: https://sponsored.bloomberg.com/article/jco/japan-where-innovation-is-borderless (Accessed: 29 July 2024)

Chapter 6: THR: A Global Transformation

U.S.: Our Vapour Products Story

[1] U.S. Centers for Disease Control and Prevention, National Centers for Health Statistics, National Health Interview Survey. Available at: https://www.cdc.gov/nchs/nhis/index.htm (Accessed: 28 August 2023)

[2] Bao, W., et al. Electronic Cigarette Use Among Young, Middle-aged, and Older Adults in the United States in 2017 and 2018. JAMA Intern Med, 2020. 180(2): p. 313-314. DOI: 10.1001/jamainternmed.2019.4957

[3] King, B. A., et al., Trends in awareness and use of electronic cigarettes among US adults, 2010-2013. Nicotine Tob Res, 2015. 17(2): p. 219-227. DOI: 10.1093/ntr/ntu191

[4] U.S. Food and Drug Administration, The Relative Risks of Tobacco Products. Available at: https://www.fda.gov/tobacco-products/health-effectstobacco-use/relative-risks-tobacco-products (Accessed: 7 August 2024)

[5] National Academies of Sciences, Engineering, and Medicine, Public Health Consequences of E-Cigarettes. The National Academies Press, 2018. DOI: 10.17226/24952

[6] U.S. Food and Drug Administration, FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency. 2021. Available at: https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-e-cigarette-products-marking-firstauthorization-its-kind-agency(Accessed: 29 July 2024)

[7] Based on U.S. Marlin Value Share of Total Vapor (Feb. 2022 – Apr. 2022).

[8] U.S. Food and Drug Administration, FDA Issues Marketing Decisions on Vuse Vibe and Vuse Ciro E-Cigarette Products. 2022. Available at: https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-marketing-decisions-vuse-vibe-and-vuse-ciro-e-cigarette-products (Accessed: 29 July 2024)

[9] U.S. Food and Drug Administration, FDA Authorizes Marketing of Vuse Alto Tobacco-Flavored E-Cigarette Pods and Accompanying Power Unit. 2024. Available at: https://www.fda.gov/tobacco-products/ctp-newsroom/fda-authorizes-marketing-vuse-alto-tobacco-flavored-e-cigarettepods-and-accompanying-power-unit (Accessed: 7 August 2024)

Chapter 6: THR: A Global Transformation

A Tale of Two Countries: New Zealand vs. Australia

[1] New Zealand Legislation, Smokefree Environments and Regulated Products Act 1990, Section 3A

Available at: https://www.legislation.govt.nz/act/public/1990/0108/latest/DLM3913904.html (Accessed: 23 July 2024)

[2] Ministry of Health New Zealand, Vaping facts. Available at: https://www.vapingfacts.health.nz/ (Accessed: 23 July 2024)

[3] Ministry of Health New Zealand, New Zealand’s smoking rates continue to decline. 2023. Available at:

https://www.health.govt.nz/news/new-zealands-smoking-rates-continue-to-decline (Accessed: 23 July 2024)

[4] Action on Smoking and Health (ASH), Smoking rate continues record decline to only 6.8% daily use, Māori and Pacific rates are also reduced.

Action for Smokefree 2025, 2023. Available at: https://www.ash.org.nz/smoking_rate_continues_record_decline_to_only_6_8_daily_use_m_ori_and_pacific_rates_are_also_reduced (Accessed: 23 July 2024)

[5] New Zealand Legislation, Smokefree Environments and Regulated Products Regulations 2021: Version as at 20 March 2024. 2024. Available at:

https://www.legislation.govt.nz/regulation/public/2021/0204/latest/whole.html (Accessed: 23 July 2024)

[6] Action on Smoking and Health (ASH), Vaping and young people: ASH position statement. Action for Smokefree 2025, 2023. Available at:

https://assets.nationbuilder.com/ashnz/pages/193/attachments/original/1683505972/Vaping_and_young_people_ASH_Position_Statment_May_2023.pdf (Accessed: 23 July 2024)

[7] New Zealand Legislation, Smokefree Environments and Regulated Products Regulations 2021: Version as at 21 September 2023. 2023

Available at: https://legislation.govt.nz/regulation/public/2021/0204/22.0/whole.html (Accessed: 5 August 2024)

[8] NewsGP. (2021). newsGP - Have GPs been supported for vaping to go prescription-only from October?

Available at: https://www1.racgp.org.au/newsgp/clinical/have-gps-been-supported-for-vaping-to-go-prescript

[9] Williams, R. (n.d.). Vaping plan up in smoke Leading supplier pulls out. [online]

Available at: https://readnow.isentia.com/Temp/29541-1205141376/1097584394_20260616.pdf

[10] Queensland Health, Everything you need to know about illicit tobacco and vapes. 2025.

Available at: https://www.health.qld.gov.au/newsroom/news/everything-you-need-to-know-about-illicit-tobacco-and-vapes

[11] Roy Morgan (2024). The full picture: a decade of smoking in Australia - Roy Morgan Research. [online]

Available at: https://www.roymorgan.com/findings/9937-cigarette-smoking-in-australia-press-release.

[12] Levy, D.T., et al., The Australia Smoking and Vaping Model: The Potential Impact of Increasing Access to Nicotine Vaping Products.

Nicotine Tob Res, 2023. 25(3): p. 486-497. DOI: 10.1093/ntr/ntac210

[13] The Pharmacy Guild of Australia, Vape control smoked. 2024.

Available at: https://www.guild.org.au/news-events/news/2024/vape-control-smoked (Accessed: 4 August 2024)

[14] ALIVE Advocacy. (2025). Firebombings | ALIVE Advocacy. [online] Available at: https://www.aliveadvocacymovement.com/firebombings

[15] Commins, P. (2025). Tobacco excise has passed a ‘tipping point’ and is fuelling black market, economists warn. [online] the Guardian.

Available at: https://www.theguardian.com/society/2025/jun/11/tobacco-excise-isnt-making-australians-smoke-less-and-should-be-frozen-tocurb-black-market-economists-say

Chapter 6: THR: A Global Transformation

Sweden: Soon Europe’s First ‘Smoke-free’ Country

[1] Human, D., et al., The Swedish experience: a roadmap to a smoke free society. Smoke Free Sweden 2023, 2023. Available at: https://smokefreesweden.org/wp-content/themes/smokefreesweden/assets/pdf/reports/Report%20The%20Swedish%20Experience%20EN.pdf

[2] World Health Organization, Tobacco-free generations: Protecting children from tobacco in the WHO European Region. 2017. Available at: https://cdn.who.int/media/docs/librariesprovider2/euro-health-topics/tobacco/20170428_who-tobaccofreegeneration-draft09.pdf

[3] Farsalinos, K., et al., No Smoke Less Harm. Smoke Free Sweden, 2024. Available at: https://smokefreesweden.org/No%20Smoke%20Less%20Harm.pdf

[4] Folkh.lsomyndigheten, Tobacco and nicotine use (self-reported) by age, sex and year. Percentage. Available at: http://fohm-app.folkhalsomyndigheten.se/Folkhalsodata/pxweb/en/A_Folkhalsodata/A_Folkhalsodata__B_HLV__aLevvanor__aagLevvanortobak/hlv1tobaald.px/ (Accessed: 29 July 2024)

[5] World Health Organization and International Agency for Research on Cancer, Cancer Today: Data visualization tools for exploring the global cancer burden in 2022. (Selection criteria: Age-Standardized Rate (World) per 100 000, Incidence, Both sexes, Cancer Type [Lip, oral cavity], European Union (27), age [15-85+], Available at: https://gco.iarc.who.int/today/en (Accessed: 8 August 2024)

[6] The Swedish Parliament, Excise taxes on nicotine-containing consumer products after the year 2023, 2022. Available at: https://www.riksdagen.se/sv/dokument-och-lagar/dokument/svar-pa-skriftlig-fraga/punktskatter-pa-nikotininnehallande_H9121477/(Accessed: 24 July 2024)

[7] World Health Organization and International Agency for Research on Cancer, Cancer Today: Data visualization tools for exploring the global cancer burden in 2022. (Selection criteria: Age-Standardized Rate (World) per 100 000, Mortality, Both sexes, Cancer Type [Trachea, bronchus and lung], European Union (27), age [15-85+], Available at: https://gco.iarc.who.int/today/en (Accessed: 8 August 2024)

Chapter 6: THR: A Global Transformation

Pakistan: Oral Nicotine Pouches in a LMIC

[1] Global Action to End Smoking, State of Smoking and Health in Pakistan. Available at: https://globalactiontoendsmoking.org/research/tobacco-around-the-world/pakistan/ (Accessed: 24 July 2024)

[2] Niaz, K., et al., Smokeless tobacco (paan and gutkha) consumption, prevalence, and contribution to oral cancer. Epidemiol Health, 2017. 39:e2017009. DOI: 10.4178/epih.e2017009

[3] Ahmad, F., et al., Implementing smokeless tobacco control policy in Pakistan: a qualitative study among Naswar supply chain actors. Tob Control, 2021. 30(5): p. 548-552. DOI: 10.1136/tobaccocontrol-2020-055748

[4] Hossain, M.M., et al., Malondialdehyde and heavy metal contents in Piper betel: Possible Risks of Heavy Metals in Human Health. J Food Compos Anal, 2024. 134:106540. DOI: 10.1016/j.jfca.2024.106540

[5] Saeed, M., et al., Assessment of potential toxicity of a smokeless tobacco product (naswar) available on the Pakistani market. Tob Control, 2012. 21(4): p. 396-401. DOI: 10.1136/tc.2010.042630

[6] Saeed, M., et al., Biochemical composition of a smokeless tobacco product (NASWAR) used in Pakistan. J King Saud Univ. Sci, 2024. 36(5): 103168. DOI: 10.1016/j.jksus.2024.103168

[7] Sankhla, B., et al., Genotoxic and carcinogenic effect of gutkha: a fast-growing smokeless tobacco. Addict Health, 2018. 10(1): p. 52-63. DOI: 10.22122/ahj.v10i1.537

[8] Ahmad, F., et al., Smokeless tobacco control in Pakistan. J Postgrad Med Inst, 2020. 34(3): p. 139-141. Available at: https://jpmi.org.pk/index.php/jpmi/article/view/2868 (Accessed: 24 July 2024)

[9] Stanfill, S.B., et al., Global surveillance of oral tobacco products: total nicotine, unionised nicotine and tobacco-specific N-nitrosamines. Tob Control, 2011. 20(3):e2. DOI: 10.1136/tc.2010.037465

[10] World Health Organization and International Agency for Research on Cancer. Cancer Today - Dataviz. (Query: Age-Standardized Rate (World) per 100,000, Incidence, Both sexes, age [15-85+], In 2022 Lip, oral cavity). Available at: https://gco.iarc.who.int/today/en/dataviz (Accessed: 13 August 2024)

[11] Rutqvist, L.E., et al., Swedish snus and the GothiaTek. standard. Harm Reduct J, 2011. 8:11. DOI: 10.1186/1477-7517-8-11

[12] Swedish Food Agency's regulations (LIVSFS 2012:6) on snus and chewing tobacco. Available at: https://www.livsmedelsverket.se/globalassets/om-oss/lagstiftning/snus-tuggtobak/livsfs-2022-11-kons-2012-6.pdf

[13] World Health Organization and International Agency for Research on Cancer, Global Cancer Observatory: Pakistan. 2022. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/586-pakistan-fact-sheet.pdf

[14] The Tobacco Atlas, Country Factsheets - Sweden. Available at: https://tobaccoatlas.org/factsheets/sweden/ (Accessed: 16 August 2024)

[15] The Tobacco Atlas, Country Factsheets - Pakistan. Available at: https://tobaccoatlas.org/factsheets/pakistan/ (Accessed: 16 August 2024)

[16] World Health Organization and International Agency for Research on Cancer, Cancer Today: Data visualization tools for exploring the global cancer burden in 2022. (Selection criteria: Age-Standardized Rate (World) per 100 000, Mortality, Both sexes, Cancer Type [Lip, oral cavity], Sweden, Pakistan), age [15-85+], Available at: https://gco.iarc.who.int/today/en (Accessed: 16 August 2024)

[17] World Health Organization and International Agency for Research on Cancer, Agents Classified by the IARC Monographs, Volumes 1–136. Available at: https://monographs.iarc.who.int/agents-classified-by-the-iarc/ (Accessed: 30 July 2024)

[18] Azzopardi, D., et al., Chemical characterization of tobacco-free "modern" oral nicotine pouches and their position on the toxicant and risk continuums. Drug Chem Toxicol, 2022. 45(5): p. 2246-2254. DOI: 10.1080/01480545.2021.1925691

[19] National University of Sciences & Technology (NUST), Illicit Cigarette Trade in Pakistan – Current Situation and Way Forward. 2024.

[20] Lahore University of Management Sciences (LUMS), Impact of Taxation on the Cigarette Sector in Pakistan – A Thorough Analysis. 2024. Available at: https://actalliance.pk/wp-content/uploads/2024/06/LUMS-Impact-of-Taxation-on-the-Cigarette-Sector-in-Pakistan.pdf

[21] International and Local Tobacco Harm Reduction Experts, Report: Integrating Harm Reduction into Tobacco Control. Lives Saved. Available at: https://smokefreesweden.org/lives-saved.pdf

[22] Rodu, B., and Jansson, C., Smokeless tobacco and oral cancer: A review of the risks and determinants. Crit Rev Oral Biol Med, 2004. 15(5):252-63. DOI: 10.1177/154411130401500502

Chapter 7: THR: Global Regulation

Regulation: Our Views

[1] Human D., et al, Saving Lives Like Sweden. Smoke Free Sweden 2023, 2023. Available at: Report SAVING LIVES LIKE SWEDEN_02082023_WEB.pdf (smokefreesweden.org) (Assessed: 04 July 2024)

[2] Snowdon, C., et al., Vaping Works. International Best Practises: United Kingdom, France, Canada and New Zealand. Property Rights Alliance, 2021. Available at: https://www.propertyrightsalliance.org/wp-content/uploads/PRA_VapingWorks.pdf )

Chapter 7: THR: Global Regulation

FDA Regulations 

[1] U.S. Food and Drug Administration, Premarket Tobacco Product Applications. Available at: https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications(Accessed: 26 July 2024)

[2] U.S Food and Drug Administration, PMTA Acceptance Phase Metrics. Available at: https://www.fda.gov/media/169533/download?attachment (Accessed: 31 July 2024)

[3] U.S Food and Drug Administration, Public Law: Family smoking prevention and tobacco control and federal retirement reform. 2009. Available at: https://www.govinfo.gov/content/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf

[4] U.S Food and Drug Administration, Modified Risk Granted Orders. Available at:  https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-granted-orders (Accessed: 31 August 2024)

[5] AP News, Thousands of unauthorized vapes are pouring into the US despite the FDA crackdown on fruity flavors. 2023. Available at:https://apnews.com/article/fda-vapes-vaping-elf-bar-juul-80b2680a874d89b8d651c5e909e39e8f (Accessed: 26 July 2024)

Chapter 7: THR: Global Regulation

Illicit trade in Smokeless Products and the risks of it undermining global Tobacco Harm Reduction

[1] American Lung Association, E-cigarette or Vaping Use-Associated Lung Injury (EVALI). Available at:  https://www.lung.org/lung-health-diseases/lung-disease-lookup/evali (Accessed: 31 July 2024)

[2] Triantafyllou, G.A., et al., Long-term outcomes of EVALI: a 1-year retrospective study. Lancet, 2021. 9(12), p.e112. DOI:10.1016/S2213-2600(21)00415-X

[3] ECigIntelligence, Regulatory & Market Intelligence for the e-Cigarette Sector, ECigIntelligence market database, July Report. 2024.

[4] Ulep, V.G., et al. Measuring the capacity to combat illicit tobacco trade in 160 countries. Global Health, 2021. 17, 130. DOI: 10.1186/s12992-021-00783-4

[5]AP News, 5 takeaways from the AP’s report on Chinese disposable e-cigarettes flooding the US market. 2023. Available at: https://apnews.com/article/fda-vapes-vaping-elf-bar-juul-5e45cf57dc78f6b94213047c97b10f7e (Accessed: 7 August 2024)

Chapter 7: THR: Global Regulation

Responsibly Building a Smokeless World

[1] This excludes those markets that are scheduled to cease the sale of disposable devices due to regulatory bans or other market constraints.

Chapter 8: THR: Scientific Engagement

Communicating Our Science: Peer-Reviewed Publications

[1] Office for Health Improvement & Disparities, Nicotine vaping in England: 2022 evidence update main findings, 2022. Available at: https://www.gov.uk/government/publications/nicotine-vaping-in-england-2022-evidence-update/nicotine-vaping-in-england-2022-evidence-update-main-findings (Accessed 18 July 2024)

[2] International Agency for Research on Cancer, Word Health Organization, Are e-cigarettes less harmful than conventional cigarettes? Available at: https://cancer-code-europe.iarc.fr/index.php/en/ecac-12-ways/tobacco/247-are-e-cigarettes-less-harmful-than-conventional-cigarettes

[3] Science and Technology Committee, E-cigarettes. Seventh Report of Session 2017-19. House of Commons, 2018. Available at: https://publications.parliament.uk/pa/cm201719/cmselect/cmsctech/505/505.pdf (Accessed: 26 July 2024)

Chapter 8: THR: Scientific Engagement

Selection of Tobacco Harm Reduction Stakeholders’ Views

[1] World Health Organization, Tobacco: E-cigarettes. 2024. Available at: https://www.who.int/news-room/questions-and-answers/item/tobacco-ecigarettes (Accessed: 3 July 2024)

[2] Gottlieb, S. and Zeller, M., A nicotine-focused framework for public health. N Engl J Med, 2017. 377(12): p. 1111-1114. DOI: 10.1056/NEJMp1707409

[3] Balogun, B. and Harker, R., The smokefree 2030 ambition for England. House of Commons Library, 2023. Available at: https://commonslibrary.parliament.uk/research-briefings/cbp-9655/ (Accessed: 3 July 2024)

[4] Smokefree, What is vaping? Health New Zealand. Available at: https://www.smokefree.org.nz/help-advice/learn-about-vaping (Accessed: 31 July 2024)

[5] Healthdirect, Vaping. Available at: https://www.healthdirect.gov.au/vaping (Accessed: 3 July 2024)

[6] Public Health England, Evidence review of e-cigarettes and heated tobacco products 2018: executive summary. 2018. Available at: https://www.gov.uk/government/publications/e-cigarettes-and-heated-tobacco-products-evidence-review/evidence-review-of-e-cigarettesand-heated-tobacco-products-2018-executive-summary (Accessed: 3 July 2024)

[7] Cummings, K.M., et al., The past is not the future in tobacco control. Prev Med, 2020. 140:106183. DOI: 10.1016/j.ypmed.2020.106183

Chapter 9: Our Future Outlook

Measuring BAT's Transformation

[1] Bates, C., Regulation: Why less is more. E-cigarette summit, 2013. Available at: https://www.slideshare.net/slideshow/ecigarette-summit-12-novem/28364227#11 (Accessed: 04 July 2024)

[2] World Health Organization, Tobacco-free generations: Protecting children from tobacco in the WHO European Region. 2017. Available at: https://cdn.who.int/media/docs/librariesprovider2/euro-health-topics/tobacco/20170428_who-tobaccofreegeneration-draft09.pdf?sfvrsn=76e790c9_2&download=true

[3] European Commission, Europe's Beating Cancer Plan. Available at: https://health.ec.europa.eu/system/files/2022-02/eu_cancer-plan_en_0.pdf

[4] Reitsma, M.B., et al., Spatial, temporal, and demographic patterns in prevalence of smoking tobacco use and attributable disease burden in 204 countries and territories, 1990–2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet, 2021. 397(10292): p. 2337-2360 DOI: 10.1016/S0140-6736(21)01169-7

[5] Tobaksfakta, The Swedish Government aims at Smoke Free Sweden 2025. 2016. Available at: https://tobaksfakta.se/the-swedish-government-aims-at-smoke-free-sweden-2025/. (Accessed 14 August 2024)

[6] Ramström, L., Wikmans, T., Mortality attributable to tobacco among men in Sweden and other European countries: an analysis of data in a WHO report. Tob Induc Dis., 2014.12(1):14. DOI: 10.1186/1617-9625-12-14.

[7] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Heated Tobacco Market Database, Quarter 1 Report. 2024

[8] ECigIntelligence, Regulatory & Market Intelligence for the e-Cigarette Sector, ECigIntelligence market database, July Report. 2024

[9] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Nicotine Pouch Market Database, Quarter 1 Report. 2024

Chapter 9: Our Future Outlook

Tobacco Harm Reduction: The Way Forward

[1] World Health Organization and International Agency for Research on Cancer, IARC Monographs on the Identification of Carcinogenic Hazards to Humans. Available at: https://monographs.iarc.who.int/agents-classified-by-the-iarc/ (Assessed: 15 July 2024)

[2] NHS, Vaping myths and facts. Available at: https://www.nhs.uk/better-health/quit-smoking/vaping-to-quit-smoking/vaping-myths-and-the-facts/#:~:text=Myth%202%3A%20Nicotine%20is%20very%20harmful%20to%20health&text=It%20is%20the%20many%20other,to%20help%20people%20stop%20smoking. (Accessed: 15 July 2024)

[3] AP news. Insider Q&A: FDA official on vaping’s “promise or peril”. 2022. Available at: https://apnews.com/article/science-health-public-tobacco-industry-regulation-6af0d635d7859bab914cc249ef43b6e2. (Accessed: 17 July 2024)

[4] U.S. Food & Drug Administration. CTP Director Discusses Opportunities and Considerations for Addressing Misperceptions About the Relative Risks of Tobacco Products Among Adults Who Smoke. 2023. Available at: https://www.fda.gov/tobacco-products/ctp-newsroom/ctp-director-discusses-opportunities-and-considerations-addressing-misperceptions-about-relative#:~:text=The%20survey%20found%20that%20only,cigarettes%20being%20the%20most%20harmful. (Accessed 8 August 24)

[5] McNeill A., et al., E-cigarettes: an evidence update, Public Health England. 2015. Available at: https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update.

[6] Government of Canada, Vaping and quitting smoking. 2023. Available at: https://www.canada.ca/en/health-canada/services/smoking-tobacco/vaping/quit-smoking.html. (Accessed 19 July 2024)

[7] Travis N., et al., The Potential Impact of Oral Nicotine Pouches on Public Health: A Scoping Review, Nicotine Tob Res, 2024. p. ntae131. DOI: 10.1093/ntr/ntae131

[8] Vaping Facts, Our position on vaping, Ministry of Health. Available at: https://vapingfacts.health.nz/our-position-on-vaping.html (Accessed 19 July 2024)