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A Summary of Our 9-Step Scientific Risk Assessment Science

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CHAPTER 4 . OUR SMOKELESS SCIENCE

A Summary of Our 9-Step Scientific Risk Assessment Science

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Our 9-step scientific Risk Assessment Framework allows us to understand:
 

  • How the product works;
  • How the product may impact an individual;
  • How the product may impact a population, and 
  • What the effect of time may be.

 

Through our published science, we can summarise the following key conclusions for each of our Smokeless Products: glo, Vuse and Velo.

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Table 1. A summary of conclusions for our Smokeless Products from key scientific studies within our risk assessment framework.

  

Heated Products

-glo-

Vapour Products

-Vuse-

Oral Nicotine Pouches

-Velo-

Combustion studies

(see Pages 172-177)

No Combustion

Our glo products heat their consumables below 300°C, and our science has shown combustion does not occur below 300°C.

No Combustion

Our Vuse products heat its e-liquid below 200°C delivering an aerosol without combustion

No Combustion

Our Velo products are oral products that are consumed without heat.

Emissions studies

(see Pages 172-177)

90-95%

less toxicants*† ^\

>99%

less toxicants*† ^

>99%

less toxicants*† ^

Toxicology studies

(see Pages 172-177)

98%

lower genotoxic response#

90%

lower cytotoxic response#

95%

less cell stress#

>99%

lower genotoxic response#

95%

lower cytotoxic response#

>98%

less cell stress#

>99%

lower genotoxic response#

99%

lower cytotoxic response#

>98%

less cell stress#

Clinical: Exposure

(see Pages 184-189)

Statistically Significant 
Reductions in Exposure

Complete switching to glo can reduce a smoker's exposure to several harmful chemicals as compared to continued smoking.

Statistically Significant
Reductions in Exposure

Adult solus consumers of our Vuse products have lower levels of exposure to several harmful chemicals compared to adult smokers.

Statistically Significant
Reductions in Exposure

Adult solus consumers of our Velo products have lower levels of exposure to several harmful chemicals compared to adult smokers.

Clinical: Individual Risk

(see Pages 190-193)

Favourable Changes in Biomarkers of Potential Harm

Complete switching to glo

from combustible cigarettes can result in favourable changes in biomarkers of potential harm.

Favourable Differences in Biomarkers of Potential Harm

Adult solus consumers of our Vuse products have shown favourable differences in biomarkers of potential harm as compared to smokers.

Favourable Differences in Biomarkers of Potential Harm

Adult solus consumers of our Velo products have shown favourable differences in biomarkers of potential harm as compared to smokers.

Beyond our own science, there is evidence across both scientific organisations/institutes and industry that supports a scientific risk assessment framework approach with published data available (Table 2). Scientific organisations including the National Academy of Sciences, Engineering and Medicine (NASEM),[1] Institute of Medicine (IOM),[2] U.S. Food and Drug Administration (FDA),[3,4] and Tobacco Product Assessment Consortium (TobPRAC)[5], all layout frameworks as how to evaluate the risk profile of Smokeless Products.

"Evidence-based tobacco regulation requires a comprehensive scientific framework to guide the evaluation of new tobacco products and health-related claims made by product manufacturers."

 

TobPRAC[5]

Table 2. Selection of Third parties' scientific publications in areas described by the 9-step scientific Risk Assessment Framework**

  

Heated Products

Vapour Products

Oral Nicotine Pouches

Combustion Studies

Academia, China[6]

Philip Morris International[7]

Emission Studies

Regulator, Japan[8]

Philip Morris International[9, 10]

Philip Morris International[11]

Altria[12, 13]

Imperial Brands[14]

Regulator, Germany[15]

Altria[16]

Toxicological Studies

Academia, Italy[17]

Philip Morris International[18, 19]

Japan Tobacco International[20, 21]

Imperial Brands[22, 23, 24]

Academia, Italy[17]

Philip Morris International[25]

Altria[26, 27]

Altria/

Philip Morris International[28]

Imperial Brands[17, 29]

Japan Tobacco International[30]

Imperial Brands[31]

Use Behaviour

Philip Morris International[32]

Altria[33]

Altria[34, 35]

Imperial Brands[36]

Altria[37, 38]

Clinical: Pharmacokinetic Studies

Philip Morris International[39, 40]

Imperial Brands[41]

Imperial Brands[42]

Academia, U.S.[43]

Altria[44, 45]

Imperial Brands[46]

Swedish Match[47]

Clinical: Exposure

Philip Morris International[48, 49, 50]

Japan Tobacco International[51, 52]

Academia & Regulator, U.K. and U.S.[53]

Academia & Regulator, U.S[54]

Altria[55, 56]

Imperial Brands[57, 58]

Altria[59]

Clinical: Individual Risk

Philip Morris International[34, 36]

Altria[39, 40, 59]

Population Risk Post-Market Surveillance

Philip Morris International[60]

Japan Tobacco International[61]

Altria[43]

Academia, U.S.[62]

Epidemiological Modelling Data

Philip Morris International[63, 64]

Japan Tobacco International[65]

Altria[66]

Footnotes

* Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk free and are addictive.

† Our Vapour product Vuse (including Alto, Solo, Ciro and Vibe), and certain products, including Velo, Grizzly, Kodiak, and Camel Snus, which are sold in the U.S., are subject to FDA regulation and no reduced-risk claims will be made as to these products without agency clearance.

^ On average, in comparison with smoke from a scientific standard reference cigarette (approximately 9 mg tar).

# On average, in comparison with smoke from a scientific standard reference cigarette (approximately 9 mg tar)

** The allocation for illustrative purposes of the individual third parties’ scientific publications does not necessarily mean that the third parties listed follow a similar 9 step framework approach in their science.

 

References

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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

[3] U.S. Food & Drug Administration, Premarket Tobacco Product Applications. (Accessed: 26 July 2024)

[4] U.S. Food & Drug Administration, Modified Risk Tobacco Products. (Accessed: 2 July 2024)

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[31] Yu, F., et al., Preclinical assessment of tobacco-free nicotine pouches demonstrates reduced in vitro toxicity compared with tobacco snus and combustible cigarette smoke. Appl In Vitro Toxicol, 2022. 8(1): p. 24-35. DOI: 10.1089/aivt.2021.0020

[32] Roulet, S., et al., Potential predictors of adoption of the Tobacco Heating System by US adult smokers: An actual use study. F1000Res, 2019. 8: 214 DOI: 10.12688/f1000research.17606.2

[33] Noggle, B., et al., A reduced exposure heated tobacco product was introduced then abruptly taken off United States shelves: results from a tobacco harm reduction natural experiment. Harm Reduct J, 2024. 21: 84. DOI: 10.1186/s12954-024-01000-2

[34] McCaffrey, S.A., et al., Development and validation of behavioral intention measures of an E-vapor product: intention to try, use, dual use, and switch. Health Qual Life Outcomes, 2021. 19:123. DOI: 10.1186/s12955-021-01764-2

[35] Vansickel, A.R., et al., Characterization of puff topography of a prototype electronic cigarette in adult exclusive cigarette smokers and adult exclusive electronic cigarette users. Regul Toxicol Pharmacol, 2018. 98: p. 250-256. DOI: 10.1016/j.yrtph.2018.07.019

[36] Fearon, I.M., et al., Curiosity and intentions to use myblu e-cigarettes and an examination of the ‘gateway’theory: Data from cross-sectional nationally representative surveys. Drug Test Anal, 2023. 15(10): p. 1257-1269. DOI: 10.1002/dta.3450

[37] Cheng, H.G., et al., Effect of Flavored on! Nicotine Pouch Products on Smoking Behaviors: Protocol for a Sequential, Multiple Assignment, Randomized Controlled Trial. JMIR Res Protoc, 2024. 13(1): e56565. DOI: 10.2196/56565

[38] Becker, E., et al., Characterization of Ad Libitum use behavior of On! Nicotine pouches. Am J Health Behav, 2023. 47(3): p. 428-449. DOI: 10.5993/AJHB.47.3.1

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[40] Brossard, P., et al., Nicotine pharmacokinetic profiles of the Tobacco Heating System 2.2, cigarettes and nicotine gum in Japanese smokers. Regul Toxicol Pharmacol, 2017. 89: p. 193-199. DOI: 10.1016/j.yrtph.2017.07.032

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[49] Haziza, C., et al., Reduction in exposure to selected harmful and potentially harmful constituents approaching those observed upon smoking abstinence in smokers switching to the menthol tobacco heating system 2.2 for 3 months (Part 1). Nicotine Tob Res, 2020. 22(4): p. 539-548. DOI: 10.1093/ntr/ntz013

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