Tag: reduced-risk products

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BAT scientists propose new framework for assessing reduced-risk products

| November 4, 2015

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.”

PMI and Altria to cooperate on e-cigs

| December 22, 2013

Philip Morris International and Altria Group have established a strategic framework to commercialize reduced-risk products and e-cigarettes. Under the terms of a set of licensing, supply and cooperation agreements, Altria will make available its e-cigarette products exclusively to PMI for commercialization outside the United States and PMI will make available two of its candidate reduced-risk tobacco products exclusively to Altria for commercialization in the United States.

The companies expect PMI’s products in the U.S. to be regulated as Modified Risk Tobacco Products. Any commercialization would be subject to Food and Drug Administration (FDA) authorization.

The agreements also provide for cooperation on the scientific assessment and regulatory engagement and authorization related to these products with the FDA, and for a similar framework for e-cigarettes with the relevant regulatory authorities in international markets. In addition, the agreements provide for the sharing of improvements to the existing generation of products.

“PMI firmly believes that reduced-risk tobacco products, as well as e-cigarettes, represent an important step toward achieving the public health goal of harm reduction, a potential paradigm shift for the industry and a significant growth opportunity for the company,” said PMI CEO André Calantzopoulos.

“Further to our plans for international test market introduction of our candidate reduced-risk products as of the second-half of 2014, this agreement establishes a roadmap for commercialization in the U.S., subject to FDA authorization. At the same time, it provides us with a platform to accelerate our entry into international e-cigarette markets while we continue to develop future versions,”