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.
Keywords: FDA; Modified Risk Tobacco Products (MRTPs); Potential Reduced Exposure Products (PREPs); Tobacco; chemistry; clinical trials; epidemiology; health claims; surveillance; toxicology.