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Research priorities and infrastructure needs of the Family Smoking Prevention and Tobacco Control Act: science to inform FDA policy
- Source :
- Nicotinetobacco research : official journal of the Society for Research on Nicotine and Tobacco. 14(1)
- Publication Year :
- 2011
-
Abstract
- Introduction 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. Methods 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. Results 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). Conclusions 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.
- Subjects :
- Biomedical Research
Consensus
MEDLINE
Legislation
Smoking Prevention
Order (exchange)
Environmental health
Political science
Tobacco
Humans
Health policy
business.industry
United States Food and Drug Administration
Health Policy
Research
Tobacco control
Smoking
Public Health, Environmental and Occupational Health
Product testing
Foundation (evidence)
Public relations
United States
Risk perception
Population Surveillance
Government Regulation
Drug and Narcotic Control
business
Subjects
Details
- ISSN :
- 1469994X
- Volume :
- 14
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Nicotinetobacco research : official journal of the Society for Research on Nicotine and Tobacco
- Accession number :
- edsair.doi.dedup.....9eb8b732fa5df5134cc4216646fc775f