Research priorities and infrastructure needs of the Family Smoking Prevention and Tobacco Control Act: science to inform FDA policy.
Nicotine Tob Res
; 14(1): 1-6, 2012 Jan.
Article
in En
| MEDLINE
| ID: mdl-22184581
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Nicotiana
/
Smoking
/
Biomedical Research
/
Government Regulation
Type of study:
Guideline
/
Screening_studies
Limits:
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Nicotine Tob Res
Journal subject:
SAUDE PUBLICA
Year:
2012
Type:
Article