These types of tests could be used together to help support healthrelated claims such as ‘ reduced risk ’ compared to conventional cigarettes for e-cigarettes , as well as for other innovative next generation products , like tobacco heating products “ This is a very new consumer category and both consumers and regulators rightly want as much information as possible about the products available ,” according to Dr David O ’ Reilly , Group Scientifi c and R & D Director at British American Tobacco . “ We believe a science-based approach is vital to gathering the evidence needed to demonstrate the reduced-risk potential of e-cigarettes and other products , which is why testing products like Vype ePen in this way is so important . We intend for this to be the fi rst of many applications of our scientifi c assessment framework ,” he said . We have applied these tests to Vype ePen and over a period of eighteen months or so have published the results of 17 different published studies ( a collation of these study results will also be published soon in a peer-reviewed scientifi c publication ). The tests used can be divided into three groups of studies : preclinical , clinical and population studies .
• Preclinical studies :
Pre-clinical studies are basically all those done before moving into the clinic for human studies . The simplest test involves passing smoke and vapour through a fi lter that traps particles . These tests are routinely done with the same kind of cigarettes , a so-called 3R4F reference cigarette , produced by the University of Kentucky . This ensures that when comparing results from different groups in different institutions , you are always comparing like with like . The results , which can be seen in Figure 1 , are quite startling . On the left , you can see a fi lter pad through which e-cigarettes were puffed . The used pad is almost indistinguishable from an un-used fi lter pad . By contrast , on the right , you can see a pad through which the same number of cigarettes has been puffed . This simple example gives an indication that the vapour produced by Vype ePen e-cigarette is likely to be much ‘ cleaner ’ and compositionally much simpler than the smoke produced by a burning cigarette .*
for the 9 types of harmful components which the World Health Organisation recommends to reduce in cigarette smoke , our results suggest that there are around 95 % less of those toxicants in Vype ePen vapour than in smoke from the reference cigarette .* Further tests in the pre-clinical phase suggested that this vapour has either a much-reduced or zero biological impact on human cells in the laboratory , compared to conventional cigarette smoke , depending on the test used . For example , certain tests suggest that Vype ePen vapour does not damage DNA , even at doses 28 times that of equivalent smoke exposure . Other tests look at gene expression , cell viability , tumour promotion and endothelial dysfunction ( how easily the inside of blood vessels healed ). In each case , e-cigarette vapour had little or no measurable impact .*
Cigarette smoke
EC aerosol
Figure 2 : Chemical analysis of cigarette smoke and e-cigarette smoke
• Clinical Studies :
The clinic is where human studies happen . Here we can look at many things , including , for example , how well an e-cigarette can deliver nicotine to a consumer . An e-cigarette is after all no good as a harm reduced product if people who would otherwise be smoking don ’ t want to use it . It needs to be a satisfying alternative to a cigarette . ePen
3R4F
Figure 1 : Filter pads with Vype ePen aerosol ( left ) and smoke from reference cigarettes 3R4F ( right )
A more sophisticated test involves analysing whether certain chemicals are present in the e-cigarette vapour and the smoke . The results obtained can be seen in Figure 2 . These results also reveal the relatively simple composition of the Vype ePen vapour compared to conventional cigarette smoke ( Figure 2 ) – fewer peaks means fewer compounds . When testing the Vype ePen
Figure 3 . Pharmacokinetic data illustrating blood nicotine profile for e-cigarette compared to commercial cigarettes and a cig-a-like e-cigarette .
One way to assess how effi ciently nicotine is delivered is to measure changes in nicotine concentration in the blood over a period of time . We have done this and found that Vype ePen vapour effectively delivers nicotine in a manner similar to a conventional cigarette and more effectively than an older generation cig-a-like e-cigarette ( Figure 3 ).
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