Providing a Science Base for the Evaluation of Tobacco Products
Peter G. Shields, MD, Greg Connolly, DMD, MPH, K. Michael Cummings, PhD, Mirjana V. Djordjevic, PhD, Dorothy K. Hatsukami, PhD, Jack E. Henningfield, PhD, Matthew Myers, JD, Richard J. O'Connor, PhD, Mark Parascandola, PhD, Vaughan Rees, PhD, Jerry Rice, PhD, and Mitchell Seller, JD
- Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, 20057
- Division of Public Health Practice, Harvard School of Public Health, Boston, MA 02115
- Department of Health Behavior, Roswell Park Cancer Institute, Buffalo, NY, 14263
- Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, 20892
- University of Minnesota Tobacco Use Research Center, Minneapolis, MN 55414
- Pinney Associates, Bethesda, MD 20814
- Campaign for Tobacco-Free Kids, Washington, DC 20005
Context: Tobacco control efforts and product regulation require an independent scientific evaluation of tobacco products, including their design, use and harmful effects to the individual and population.
Objective: The National Cancer Institute (NCI) contracted the Tobacco Product Assessment Consortia (TobPRAC) to develop a scientific framework for evaluating tobacco products.
Design: An iterative process ensued involving TOBPRAC investigators, consultants, a workshop of independent scientists and public health experts, and written reviews. The recommendations for the framework are not intended to substitute for, or pre-empt, and legal standards, but can be used to facilitate those actions.
Results: A Conceptual Framework for the scientific evaluation of products worldwide, independednt of any specific regulatory environment, has four main components involving pre-market, pre-claims, post-market and monitoring evaluations. It includes the use of validated test procedures with particular emphasis on human studies, and a weight of scientific evidence review and risk assessment for population effects. Several pitfalls for implementing a Framework are discussed.
Conclusions: This paper provides a scientific framework for evaluating all tobacco products. Current knowledge gaps preclude the validation and full implementation of the Framework at this time, although there is value in implementing parts of it. This Framework also helps to categorize and prioritize a research agenda and infrastructure needs.
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