Regulatory bridging approach needed to keep e-cigarettes innovations coming

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Regulatory bridging approach needed to keep e-cigarettes innovations coming
News release

05 April 2016

A regulatory mechanism that allows for a bridging approach between different variants of e-cigarettes and other next generation products is needed.

‘Innovation in these product categories is so rapid that it is impractical to create complete new data sets every time a product is tweaked,’ Dr Chris Proctor, Chief Scientific Officer at British American Tobacco told a workshop on biomarkers at the FDA Center for Tobacco Products today.  ‘This would drastically impact the innovation process, the availability of new and improved products and their value in tobacco harm reduction,’ he said.  Proctor proposes that a complete data set should be required for the initial product, but a reduced number of key studies be performed on subsequent novel product variants.  Proctor described biomarkers of potential harm as key to creating foundational datasets that would allow for more focused, smaller numbers of tests to assess product variants compared to the original product.

Many innovations and technological breakthroughs mean that, despite their short history, products like electronic cigarettes have gone through many changes and can now be categorized in multiple generations. Biomarkers of potential harm are biological compounds that predict disease potential.  The mechanism that describes how smoking related diseases occur can be illustrated using what is called an Adverse Outcome Pathway (AOP).  An AOP uses existing knowledge to link key events at a cellular level which results in an adverse outcome eg. Cardiovascular disease. 

By establishing the key events for smoking-related diseases, it is possible to identify human and in vitro biomarkers to evaluate the reduced risk potential of novel nicotine and tobacco products in comparison to cigarette smoking.  The integration of these biomarkers along an AOP will enable the assessment of the reduced risk potential of novel tobacco and nicotine products.

‘Once you build the initial science package, a reduced number of tests should be sufficient to support subsequent product tweaks, Proctor said.  These tests could focus on, for example, ensuring that there is no increase in toxicants in the vapour; that the product remains stable over time, that the reduced risk potential of the products has not been altered and that consumers are not likely to use more of the newer product. 

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.

‘We should be able to rely on manufacturers to provide useful data to support their products,’ Proctor said.  Many in the public health community believe that e-cigarettes represent an historical 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 e-cigarettes are 95% safer than cigarettes and that they are an important tool to help smokers quit altogether.  That e-cigarettes are safer than conventional cigarettes is a view that is also supported by other groups, such as Action on Smoking and Health and Cancer Research UK.



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