Birth rate
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NGP user
(never smoker)
Former NGP user
(never smoker)
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smoking
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NGP to dual use
Initiate smoking
Initiate dual use
Initiate smoking
Current smoker
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NGP dual user
Quit
Smoker to dual use
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smoking
NGP to dual use
Switch to NGP
Quit smoking
Initiate NGP
Former NGP
dual user
NGP user
(smoking history)
Dual use to NGP
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Former smoker
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(smoking history)
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Figure 4: Population Effects Model Schematic
• Population studies: Dossier
E-cigarettes haven’t been around for a very long time so there isn’t
a lot of information on how their widespread, long-term availability
might impact a population, as opposed to an individual.
To test this theory, we have developed computer models that
use the information we have today, such as who is likely to use
an e-cigarette: a smoker, an ex-smoker, a non-smoker, etc. This
model tests various scenarios over decades (how complicated
this can get can be seen in Figure 4).
Using this model, our studies indicate that the wide availability
of an e-cigarette such as Vype ePen can have an overall harm
reduction effect because more people may quit smoking or not
start at all when e-cigarettes are widely available. Taken together, these results form the basis of a comprehensive
dossier of scientifi c data that lay the groundwork for establishing
this product’s reduced-risk potential compared to cigarettes*.
A dossier like this can take years to create – years of testing and
years of analysing data.
But this category is very fast moving, and there are new and
potentially improved products appearing all the time. If a dossier
like this were to become a requirement for every iteration of
every type of product for which such a dossier has already been
created, this would drastically slow down the rate of progress and
the variety of devices and e-liquids on the market. This would not
be good for or acceptable to vapers and would not be good for
harm reduction.
We think the framework of tests that we have created could help
provide datasets for product families so that the whole process
does not need to be repeated for every new generation of the
same product. This would help get new products developed,
assessed and brought to market more quickly.
It is important that this kind of testing be done. Consumers and
regulators want this kind of information. It is also important,
however, that innovators can continue to innovate and that vapers
continue to be excited about and get what they want from their
vaping products.
In 2012, the US Food and Drug Administration provided draft
guidance for companies wishing to introduce novel reduced-
risk tobacco products to the US market place. A dossier of
scientifi c evidence would be required to support any submission
for such a Modifi ed Risk Tobacco Product Application.
* Scientists at British American Tobacco tested and compared emissions from a Vype ePen e-cigarette and a reference conventional cigarette in laboratory tests.
These results do not necessarily mean that the Vype ePen produces less adverse health effects than tobacco products.
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