Strategic Priority V

Promote and facilitate tobacco regulatory science and tobacco prevention research.

Rationale

The Tobacco Regulatory Science Program (TRSP) was established by the NIH in response to the historic passage of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Act gave the U.S. Food and Drug Administration (FDA) authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health. Such regulations must be built on a strong scientific base, but that base is insufficient for many tobacco products. For example, to develop effective regulations, the FDA needs research to better characterize product ingredients and their effects on consumption and health and to better characterize marketing strategies and their effects on purchasing patterns. The NIH has the infrastructure for the solicitation, review, and management of research and several NIH ICs have long supported tobacco related research as part of their missions. The FDA’s Center for Tobacco Products (CTP) has expertise in tobacco regulatory science and the resources to support research that is responsive to the FDA’s regulatory authority. With the creation of TRSP, the FDA provides resources that the NIH uses to support a diverse portfolio of research that can inform the development of regulations.

As the tobacco-focused program within the ODP, TRSP also monitors NIH investment and facilitates collaboration across NIH ICs for ODP-led opportunities to address research gaps in tobacco prevention that complement the FDA-supported program of tobacco regulatory research.

Objectives for FY 2019–2023

1. Serve as primary liaison to the CTP scientific leadership to help identify, develop, characterize, and address tobacco regulatory research priorities and monitor scientific progress of funded research.
2. Serve as a resource and provide training in tobacco regulatory science for the FDA and NIH program, review, and grants management staff, and to the extramural community.
3. Create opportunities for extramural investigators and federal scientific staff to discuss priority topics and share research results in tobacco regulatory science.
4. Oversee and lead NIH ICs and grant recipients in complying with policies unique to the NIH-FDA partnership in tobacco regulatory science.
5. Facilitate development of resources and research opportunities to address gaps in tobacco prevention intervention, measurement, and methodology.