Importance of a sound evidence base to inform Food and Drug Administration regulation of tobacco products: Input from the NIH

FDA can reduce tobacco caused death and suffering by comprehensively regulating the use of all tobacco products if its regulatory scheme is based on the latest scientific evidence. The National Institutes of Health, including its constituent institutes, is well-positioned to support and conduct necessary research that will best inform FDA regulation. This presentation highlights existing NIH research to assist FDA, including: evaluating “modified risk” products, how they're used, by whom in what circumstances; evaluating all medications used to treat nicotine dependence, and the effectiveness of other therapies, interventions or cessation aids; and surveillance and monitoring trends in tobacco use. The presentation also addresses types of behavioral research that NIH supports to fill gaps in evidence to address FDA staff questions, or that will become critical if FDA obtains regulatory authority. NIH will contribute knowledge regarding evidence-based interventions, educational strategies, industry marketing and promotional efforts, policy interventions, tobacco use prevention and cessation, use of industry documents to identify their priorities and attempts to interfere with public health programs or policies. Research on the role of important tobacco control policies, including adopting and implementing comprehensive clean air laws and sizable tobacco excise taxes, in increasing smoking cessation attempts and successes, and protecting non-smokers will benefit FDA's efforts to regulate tobacco products, based on how they are ultimately used by consumers. The unparalleled research infrastructure and capacity at NIH, in coordination with efforts by other HHS components, ensures that FDA staff have full access to current evidence to successfully implement comprehensive tobacco regulations.