The Transition from Combustible to Smokeless Products Science

Biotran III laboratory equipment display and old smoking testing machine setup
17 September 2024
CHAPTER 4 . OUR SMOKELESS SCIENCE

The Transition from Combustible to Smokeless Products Science

Portrait of Tim Nestor, Executive Vice President, US R&D, RAI Service Company

We’re in the eighth decade of our Research & Development within the BAT Group.

 

Tim Nestor

Executive Vice President, U.S. R&D, RAI Services Company

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Traditionally and in addition to efforts to reduce the risk associated with tobacco products, companies' research focused on areas such as understanding the products or measuring tobacco and smoke,[1] while academic researchers focused on medical studies relating to the harm caused by cigarette smoking.[2] Tobacco and nicotine science was typically published in specialist tobacco- or combustion-related scientific journals and presented at scientific conferences.

 

The 21st century saw a new wave of Tobacco Harm Reduction (THR) interest that changed the landscape.[3] There became a need to publish data on new categories of products, including Heated Products, Vapour Products, and Oral Nicotine Pouches, to contribute to the scientific understanding of how they performed chemically and toxicologically. This coincided with cross-industry and government efforts to develop new ways of testing products that did not involve the use of animals.[4]

 

At BAT, we recruited scientists with a range of expertise and set out a new programme of research, seeking to publish in widely read and often medical-based peer-reviewed journals.

 

To substantially increase transparency, we opened our R&D facilities to host scientific conferences; developed a dedicated science website, www.bat-science.com, and began publishing Science and Technology reports on research intentions and findings.[5] We also set out risk assessment frameworks covering chemistry, toxicology, consumer use, and clinical studies, to assess whether new products could deliver on their harm reduction potential.[6] It became essential to develop partnerships with Contract Research Organisations (independent laboratories used by a range of industrial and academic researchers) and ensure the use of internationally-recognised research approaches on toxicology[7] and ethical ways to conduct clinical studies.[8,9] Details are also published on publicly accessible trials websites[10] so that anyone can follow the subsequent findings.

 

Tobacco and nicotine science continues to have its critics, and some journals have banned the publication of such research.[11] Others have accepted our research, subject to the rigorous scientific procedures of peer-review by independent scientists.[12] Publication rate, particularly on THR issues, has dramatically accelerated over the past decade and our researchers are now invited to speak at expert workshops such as those held by the U.S. FDA Center for Tobacco Products.[13,14]

The Growth of the BAT Group’s R&D

1953

Reynolds R&D, U.S.


1956

BAT R&D, UK


2007

Souza Cruz R&D, Brazil


2021

BAT Innovation Centre, Italy


2022

KBio Biotech, U.S.


2022

BAT Innovation Centre, China


2024

BAT Innovation Centre, UK



References

[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