TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 003 (Symposium)

The role of non-combusted products in tobacco harm reduction

FLORA W.; GOGOVA M.; SARKAR M.A.
Altria Client Services LLC, Richmond, VA, USA

Today, FDA has regulatory authority over all tobacco products. FDA acknowledges that there is a continuum of risk for tobacco products and distinguishes between the harm associated with combustible versus non-combustible products. A harm-reduction strategy that informs adult smokers about reduced-risk products, subject to FDA oversight, will complement, not compete, with proven prevention and cessation strategies. This approach should focus on reducing tobacco-related morbidity and mortality among the population of adults who continue to use tobacco products by empowering them to make an informed decision to choose a product proven to be lower on the continuum of risk. That is why we invest in developing a portfolio of non-combustible tobacco products. We've been concentrating on three product platforms. These include smokeless and other oral nicotine containing products, e-vapor, and heated tobacco products. We believe adult smokers unable or unwilling to quit are more likely to completely switch from cigarettes if they can choose from a variety of acceptable alternative tobacco products. Of course, we can only compete in the marketplace with products authorized by the FDA and we can only communicate reduced harm or risk claims if FDA grants authorization to a Modified Risk Tobacco Product Application (MRTPA). As manufacturers, it is critical to develop a variety of innovative reduced harm tobacco products that are acceptable alternatives to conventional cigarettes for adult smokers, transparently provide extensive science and evidence about these products, and, with FDA authorization, bring them to market. FDA and the broader public health must provide reasonable regulatory pathways, unbiased scientific assessments, collaborative research, and science and evidence based differential risk communications about these products. A diverse market of FDA-authorized, non-combustible products with accompanying modified risk claims will enable informed decisions for adult cigarette consumers to choose products proven to be lower on the continuum of risk and thus is an extremely important step in advancing tobacco harm reduction in the U.S.