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Bridging approach to regulation needed to keep to e-cigarette innovations coming

November 17, 2016

A regulatory mechanism that allows for a bridging approach between different variants of e-cigarettes and other next generation products is required to maintain the rate of breakthrough innovations.

'Despite their short history, products like electronic cigarettes have gone through many changes and can now be categorized in multiple generations,' Dr James Murphy, Head of Reduced Risk Substantiation at British American Tobacco said today. But, he said, 'The many innovations and technological breakthroughs that allow for this rate of development are so rapid that it is impractical to create complete new data sets every time a product is tweaked. This would drastically impact the innovation process, the availability of new and improved products and their value as a public health tool,' he said.

Murphy was giving a keynote speech today at the at the Next Generation Nicotine Delivery conference in London.

Murphy said that although a complete data set should be required for the initial product, a reduced number of key studies should be sufficient for subsequent novel product variants.

He described the tests that could be used to help create the foundational datasets for the initial product - These tests could focus on, for example, measuring toxicants in the vapour; the impact of the vapour on lung cells and other cells in biological tests compared to cigarette smoke, ensuring that the product remains stable over time and that consumers are not likely to use more of the newer product.

'Once you build the initial science package, a reduced number of tests should be sufficient to support subsequent product tweaks, Murphy said. 'A smaller number of more focused tests could then be developed to assess product variants compared to the original product.'

'Manufacturers should be able to provide useful data to support their products,' Murphy argued adding that 'this could have multiple benefits in minimising the use of human subjects; developing efficient, intelligent testing strategies; reducing the burden on the regulator and enabling a more efficient route for the assessment of these products to realise their potential of reducing risk.'

Many in the public health community believe that e-cigarettes represent an historic opportunity to save millions of lives and drastically reduce the public health burden of smoking-related diseases. Public Health England, an executive body of the UK Department of Health, recently published a report saying that the current expert estimate is that using e-cigarettes is around 95% safer than smoking cigarettes, although more research is needed. The Royal College of Physicians have said that the public can be reassured that e-cigarettes are much safer then smoking and that they should be widely promoted as an alternative to conventional cigarettes.

R&D at British American Tobacco

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