Over the next several years, our companies intend to pursue FDA authorization of superior branded products that offer reduced risk alternatives to adult tobacco consumers.
For example, we're supporting Philip Morris International's (PMI) efforts to submit FDA applications on an electronically-heated tobacco product. We have entered an agreement with PMI that gives Philip Morris USA the exclusive rights to market and distribute this product in the U.S. if the FDA grants PMI’s Modified Risk Tobacco Product application, which is now pending with the agency.
Advancing the Science
Science and evidence are the foundation for developing potentially reduced-harm products. As regulated companies, we're required by law to demonstrate to the FDA that a product is less harmful to individual consumers as well as to the population as a whole before making any reduced-risk statements.
To support this effort, we established a rigorous scientific framework based on FDA's guidance to evaluate potentially reduced-harm tobacco products.
This framework helps us generate important data, like clinical research, perception and behavior studies to support reduced risk product applications by:
- measuring harmful and potentially harmful compounds;
- evaluating the product's health effects;
- researching how adult tobacco consumers use the product and their understanding of its risk; and
- substantiating that the product is unlikely to appeal to unintended audiences.
Sharing Our Research
It's important to contribute to the scientific understanding of tobacco harm reduction.
We share the results of our scientific studies with the FDA and others through peer-reviewed journals, conference presentations and one-on-one meetings. Since 2009, our scientists have published more than 100 peer-reviewed articles related to harm reduction in numerous scientific journals.
Our research is also available on a website intended for scientists and the public health and regulatory communities. This website offers information to help these stakeholders learn more about our approach and provide their perspective on the work we do.
There is growing evidence that e-vapor products may be less risky than traditional combustible cigarettes for smokers who switch entirely from cigarettes to e-vapor. Unlike traditional cigarettes, which involve burning tobacco and inhaling smoke, e-vapor products create an aerosol from a nicotine solution that is heated. This difference has led many in public health to note the reduced-risk potential for individual consumers:
"Although it is not possible to estimate the long-term health risk associated with e-cigarettes precisely, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure." – Royal College of Physicians, "Nicotine without the smoke: tobacco harm reduction," April 2016
To date, however, the FDA has not reached any conclusions as to e-vapor products generally as a category of product, nor has it ruled on any application from an e-vapor manufacturer seeking authorization for a claim.