Scientists at British American Tobacco (BAT) have proposed a new scientific framework that could be used to assess the reduced-risk potential of nicotine and tobacco products currently being developed.
The new assessment framework employs a four-stage process that uses lab-based and clinical tests along with real-world observations of individual and population perception and use, according to BAT.
“We propose that this assessment framework will help us build the required evidence base to demonstrate that novel tobacco and nicotine products can deliver a net population health gain in comparison to cigarette smoking,” Dr. James Murphy, head of reduced-risk substantiation at BAT told delegates at the Tobacco Science Research Conference (TSRC), in Naples, Florida, USA, in September.
The first step in the process is the characterization of the product, which includes laboratory-based testing. This is followed by clinical testing to determine whether toxicant reductions measured in the laboratory are observed in consumers when the products are used. The third step is to determine what impact, if any, this reduction in toxicants will have on a person’s individual risk as well as the collective risk of the population using the products.
According to BAT, in contrast to modified cigarettes, innovative new tobacco and nicotine products have significantly reduced toxicant levels.
“We have observed reductions of 90 percent and more in the levels of certain toxicants present in these new tobacco and nicotine products and these are manifesting reductions when the aerosols are applied to in vitro tests, which can mimic some key disease processes and endpoints,” said Murphy. “These early-stage results demonstrate that in comparison to reduced toxicant prototype cigarettes, these new products have a greater potential to demonstrate disease relevant changes in humans—tests that we plan to do over the next 12-18 months.”