“The many innovations and technological breakthroughs [in the e-cig industry] are so rapid that it is impractical to create complete new data sets every time a product is tweaked,” said James Murphy, head of reduced risk substantiation at British American Tobacco (BAT).
Instead, he suggested that regulators could require complete data sets for entirely new products, covering issues such as toxicants in vapour, effect on cells compared to tobacco smoking, chemical stability, and likely consumer use patterns.
But they could then accept a smaller number of “more focused” studies for variants of the original product.
“Once you build the initial science package, a reduced number of tests should be sufficient to support subsequent product tweaks,” said Murphy, speaking at the Next Generation Nicotine Delivery conference in London last week.
“This would drastically impact the innovation process, the availability of new and improved products and their value as a public health tool.”
What This Means: Conceptually, Murphy’s concept of “bridging” makes eminent sense and is a logical extension of allowing anything other than wholly original science.
Even the Food and Drug Administration (FDA) in the U.S. – hardly famed for its easy-going attitude toward e-cigs – has said it will sometimes accept previous research when considering products for approval, and indeed referred overtly to bridging in guidance on premarket tobacco product applications (PMTAs) for e-cigs.
However, we can anticipate wrangling over details if Murphy’s proposal is to become a widespread reality, and much of that will focus on the question of exactly what can be safely left to previous research and what needs to be investigated afresh for each new product.
For example, it was proposed at another London conference last week – the E-Cigarette Summit – that safety studies need to be device-specific because larger quantities of oxidants are produced by higher-powered products.
– ECigIntelligence staff
Photo: Richard Dennis