title: Providing a Science Base for the Evaluation of Tobacco Products.
abstract: OBJECTIVE
  Evidence-based tobacco regulation requires a comprehensive scientific framework to guide the evaluation of new tobacco products and health-related claims made by product manufacturers.
  
  
  METHODS
  The Tobacco Product Assessment Consortium (TobPRAC) employed an iterative process involving consortia investigators, consultants, a workshop of independent scientists and public health experts, and written reviews in order to develop a conceptual framework for evaluating tobacco products.
  
  
  RESULTS
  The consortium developed a four-phased framework for the scientific evaluation of tobacco products. The four phases addressed by the framework are: (1) pre-market evaluation, (2) pre-claims evaluation, (3) post-market activities, and (4) monitoring and re-evaluation. For each phase, the framework proposes the use of validated testing procedures that will evaluate potential harms at both the individual and population level.
  
  
  CONCLUSIONS
  While the validation of methods for evaluating tobacco products is an ongoing and necessary process, the proposed framework need not wait for fully validated methods to be used in guiding tobacco product regulation today.
authors.affiliation: The Ohio State University College of Public Health, Columbus, OH.
authors.forename: Micah L
authors.initials: ML
authors.lastname: Berman
authors.affiliation: Northeastern University Bouvé College of Health Sciences, Boston, MA.
authors.forename: Greg
authors.initials: G
authors.lastname: Connolly
authors.affiliation: Medical University of South Carolina Hollings Cancer Center, Charleston, SC.
authors.forename: K Michael
authors.initials: KM
authors.lastname: Cummings
authors.affiliation: National Cancer Institute, Division of Cancer Control and Population Sciences, Bethesda, MD.
authors.forename: Mirjana V
authors.initials: MV
authors.lastname: Djordjevic
authors.affiliation: University of Minnesota Tobacco Use Research Center, Minneapolis, MN.
authors.forename: Dorothy K
authors.initials: DK
authors.lastname: Hatsukami
authors.affiliation: The Johns Hopkins University School of Medicine, Bethesda, MD.
authors.forename: Jack E
authors.initials: JE
authors.lastname: Henningfield
authors.affiliation: Campaign for Tobacco-Free Kids, Washington, DC.
authors.forename: Matthew
authors.initials: M
authors.lastname: Myers
authors.affiliation: Roswell Park Cancer Institute, Buffalo, NY.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: O'Connor
authors.affiliation: National Cancer Institute, Division of Cancer Control and Population Sciences, Bethesda, MD.
authors.forename: Mark
authors.initials: M
authors.lastname: Parascandola
authors.affiliation: Harvard School of Public Health, Boston, MA.
authors.forename: Vaughan
authors.initials: V
authors.lastname: Rees
authors.affiliation: Georgetown University Lombardi Comprehensive Cancer Center, Washington, DC.
authors.forename: Jerry M
authors.initials: JM
authors.lastname: Rice
authors.affiliation: The Ohio State University Comprehensive Cancer Center, Columbus, OH.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Shields
keywords: FDA; Modified Risk Tobacco Products (MRTPs); Potential Reduced Exposure Products (PREPs); Tobacco; chemistry; clinical trials; epidemiology; health claims; surveillance; toxicology