The Vype Dossier

Proving the reduced-risk potential of an e-cigarette

By Marina Murphy

We are all well-aware of how fast-paced and dynamic the vapor category is. New and better products are being developed all the time, and while innovation is certainly key, it must be correctly balanced with ensuring quality and safety. Consumers are rightly concerned over quality and safety, and such concern is often cited as one of the biggest barriers to moving to vaping. That is why much of British American Tobacco’s (BAT) research effort focuses on ensuring high standards of quality. The company also spends a lot of time developing tests to assess our products relative to conventional cigarettes to establish their potential to be reduced-harm.

This effort has now resulted in what is the most comprehensive scientific data set to date for an e-cigarette, Vype ePen. This data set helps establish the potential for Vype ePen to be reduced-risk compared with cigarettes and represents the kind of testing that could be used to assess the potential of other next-generation products.

It is this kind of information that the U.S. Food and Drug Administration wants to see when a company submits a modified-risk tobacco product (MRTP) application to introduce novel reduced-risk tobacco products to the U.S. market.

Testing, testing

The Vype data set was created using results collected from a series of scientific tests that BAT specifically developed to assess its products.

The company’s scientists tested everything from how people use Vype ePen—which includes looking at the minutiae of how often they puff, how deeply and for how long—to the content of the vapor and what that vapor does to cells in the lab.

In each case, the scientists compared Vype vapor and what it does to smoke and what it does. The results of any one of these tests on its own is important, but they don’t tell the whole story. But when you take them all together, you start to get a feel for the big picture. This picture reveals a real potential for this product to have a reduced health risk compared with traditional cigarettes.

This ties in with the assessment of several high-profile public health authorities, such as NHS Health Scotland, the Royal College of Physicians and Public Health England, who believe e-cigarettes are likely to offer in the order of a 95 percent reduced health risk compared with conventional cigarettes.

BAT’s tests demonstrate the relatively simple composition of Vype ePen vapor compared with conventional cigarette smoke (Figure 1). There are around 95 percent fewer toxicants in Vype ePen vapor, and the vapor has a much-reduced or no biological impact on human cells* in the laboratory, compared with conventional cigarette smoke, depending on the test used (Figure 2).

Tests in the clinic, which involve humans, revealed that Vype ePen vapor delivers nicotine to the consumer as efficiently as cigarette smoke. This suggests that this product could be a satisfactory alternative to a cigarette. A reduced-harm product is no good if nobody wants to use it. And BAT used predictive modeling to demonstrate that making e-cigarettes available can have an overall harm reduction effect on a population because more smokers will quit.

Taken together, these results form the basis of a comprehensive dossier of scientific data that lay the groundwork for establishing the potential of Vype ePen to have a reduced-risk potential compared with cigarettes. The results were published in the peer-reviewed journal Regulatory Toxicology and Pharmacology.

“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,” said David O’Reilly, group scientific and R&D director at BAT. “We intend for this to be the first of many applications of our scientific assessment framework,” he said.