title: Tobacco regulatory science: research to inform regulatory action at the Food and Drug Administration's Center for Tobacco Products.
abstract: The U.S. Food and Drug Administration (FDA) promotes the development of regulatory science to ensure that a strong evidence base informs all of its regulatory activities related to the manufacture, marketing, and distribution of tobacco products as well as public education about tobacco product constituents and effects. Toward that end, the FDA's Center for Tobacco Products (CTP) provides funding for research studies with scientific aims that fall within its defined regulatory authority. However, given their traditional biomedical focus on basic and applied research, some researchers may not understand the principles of regulatory science or the types of studies CTP funds. The purpose of this paper is (1) to clarify the definition of regulatory science as a distinct scientific discipline, (2) to explore the role of tobacco regulatory science in order to help researchers understand the parameters and types of research that can be funded by CTP, and (3) to describe the types of research efforts that will inform the FDA's public health framework for tobacco product regulation.
authors.affiliation: Office of Science, Center for Tobacco Products, U.S. Food and Drug Administration, Rockville, MD.
authors.forename: David L
authors.initials: DL
authors.lastname: Ashley
authors.affiliation: Office of Science, Center for Tobacco Products, U.S. Food and Drug Administration, Rockville, MD cathy.backinger@fda.hhs.gov.
authors.forename: Cathy L
authors.initials: CL
authors.lastname: Backinger
authors.affiliation: Office of Science, Center for Tobacco Products, U.S. Food and Drug Administration, Rockville, MD.
authors.forename: Dana M
authors.initials: DM
authors.lastname: van Bemmel
authors.affiliation: Office of Science, Center for Tobacco Products, U.S. Food and Drug Administration, Rockville, MD.
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Neveleff
mesh_terms: D003132:Commerce; D033161:Government Regulation; D006801:Humans; D040541:Marketing; D011634:Public Health / Q000331:legislation & jurisprudence*; D012106:Research; D012907:Smoking; D019460:Tobacco Industry / Q000331:legislation & jurisprudence*; D062789:Tobacco Products / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration