A Summary of Our 9-Step Scientific Risk Assessment Science

CHAPTER 4 . OUR SMOKELESS SCIENCE

A Summary of Our 9-Step Scientific Risk Assessment Science

Words by

Scientist using pipette in laboratory

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.

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


No Combustion

Our glo devices heat their consumables below 400°C, delivering an aerosol without combustion.

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.


90-95%

fewer toxicants*†#

99%

fewer toxicants*†#

>99%

fewer toxicants*†#


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 Clinical: Exposure section

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 Clinical: Individual Risk section

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 Changes 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 Changes 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)[51], Institute of Medicine (IOM)[118], U.S. Food and Drug Administration (FDA)[119],[120],and Tobacco Product Assessment Consortium (TobPRAC)[121], 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[121]

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[122]

Philip Morris International[123]


Emission Studies

Regulator, Japan[124]

Philip Morris International[11],[12]

Philip Morris International[145]

Altria[10],[13]

Imperial Brands[146]

Regulator, Germany[165]

Altria[166]


Toxicological Studies

Academia, Italy[16]

Philip Morris International[20],[125]

Japan Tobacco International[125, 127]

Imperial Brands[128-131]

Academia, Italy[16]

Philip Morris International[147]

Altria/Philip Morris International[148-150]

Imperial Brands[128],[131],[146]

Japan Tobacco International[17]

Imperial Brands[167]


Use Behaviour

Philip Morris International[132],[133]

Altria[134]

Altria[151-153]

JUUL/Altria[154]

Imperial Brands[155]

Academia, U.S.[168],[169]

Academia, U.S. & Canada[170]

Altria[171],[172]


Clinical: Pharmacokinetic Studies

Philip Morris International[135],[136]

Academia, U.S.[156]

Imperial Brands[46]

Japan Tobacco International[158]

Imperial Brands[159]

Academia, U.S.[173]

Altria[22],[174]

Imperial Brands[175]

Swedish Match[176]


Clinical: Exposure

Philip Morris International[137],[138]

Japan Tobacco International[139-141]

Academia & Regulator, U.K. and U.S.[160]

Academia & Regulator, U.S[21]

Altria[153],[161],[162]

Imperial Brands[163],[164]

Altria[177]


Clinical: Individual Risk

Philip Morris International[142]

Altria[153],[158],[159]

Altria[178]


Population Risk Post-Market Surveillance

Philip Morris International[133],[142],[143]

Japan Tobacco International[141],[144]

Imperial Brands[155]

Academia, U.S.[165]


Epidemiological Modelling Data

Philip Morris International[142],[143]

Japan Tobacco International[144]

Altria[152]

Swedish Match[179]


Footnotes

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

† Products sold in the U.S., including Vuse, Velo, Grizzly, Kodiak, and Camel Snus, 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)

** 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

A full list of references for this page can be found in the section 11. References.

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