Research Priorities and Infrastructure Needs of the Family Smoking Prevention and Tobacco Control Act: Science to Inform FDA Policy
Open Access
- 19 December 2011
- journal article
- research article
- Published by Oxford University Press (OUP) in Nicotine & Tobacco Research
- Vol. 14 (1), 1-6
- https://doi.org/10.1093/ntr/ntr057
Abstract
A new law in the United States gives the Food and Drug Administration (FDA) wide latitude to regulate tobacco products for the first time. Given the need for science to serve as a foundation for FDA actions, it is critical that a scientific review of the literature relevant to the proposed legislation be undertaken by experts in the field of nicotine and tobacco research in order to develop research priorities. This paper describes an initiative that was implemented to identify research opportunities under “The Family Smoking Prevention and Tobacco Control Act” and summarizes the conclusions and future directions derived from that initiative. Multiple research and surveillance needs were identified, such as characterization of biomarkers and increased analysis of risk perception. It was also recognized that science will play a critical role in policy determinations such as what constitutes “substantial equivalence” and that there will be considerable infrastructure needs (e.g., laboratories for product testing). Science must drive FDA's decision making regarding tobacco regulation. This article provides a summary of research opportunities identified through literature reviews related to various provisions of the new law. However, the science required by the law requires a transdisciplinary approach because of its complexity, so one of the challenges facing the FDA will be to connect the silos of research in recognition that the “system” of tobacco regulation is greater than the sum of its parts.Keywords
This publication has 4 references indexed in Scilit:
- The Use of Epidemiological Evidence in the Compensation of VeteransAnnals of Epidemiology, 2010
- Criteria for evaluating tobacco control research funding programs and their application to models that include financial support from the tobacco industryTobacco Control, 2009
- Systems Thinking to Improve the Public's HealthAmerican Journal of Preventive Medicine, 2008
- The Tobacco Epidemic in the United StatesAmerican Journal of Preventive Medicine, 2007