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. 2015 Apr;1(1):76-93.
doi: 10.18001/TRS.1.1.8.

Providing a Science Base for the Evaluation of Tobacco Products

Micah L Berman  1 , Greg Connolly  2 , K Michael Cummings  3 , Mirjana V Djordjevic  4 , Dorothy K Hatsukami  5 , Jack E Henningfield  6 , Matthew Myers  7 , Richard J O'Connor  8 , Mark Parascandola  4 , Vaughan Rees  9 , Jerry M Rice  10 , Peter G Shields  11
Affiliations

Providing a Science Base for the Evaluation of Tobacco Products

Micah L Berman et al. Tob Regul Sci. 2015 Apr.

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.

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

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Figures

Figure 1
Figure 1
Tobacco products may be conceptually considered as conventional, existing products; PREPs; or—after sufficient scientific evaluation—a reduced exposure product. After further evaluation and full implementation of the proposed Conceptual Framework, a product might be considered a reduced harm product. This figure is not meant to imply a classification scheme.
Figure 2
Figure 2
The Conceptual Framework proposed in this report comprises four components. Each component includes an overall goal and a list of the specific types of data needed to evaluate whether the goal for that phase has been met. Additional detail and figures for each component, contexts and pitfalls can be found in the full report as supplemental material.
See this image and copyright information in PMC

References

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