• Where data or assessment methods are deficient for evaluating a product and/or product category, identify information needs for addressing key uncertainties and present evaluations.

  • Assess the performance of the evidence-based model for evaluating the selected product categories and identify next steps for further refinement of the model.

  • In assessing health consequences, consider both the risks and the beneficial aspects of product use, and where applicable and feasible, consider the potential impact on population health if beneficial product use is curtailed through risk reduction strategies.

  • In reviewing selected scientific literature, the committee shall consider the scientific literature broadly, to include, as appropriate, social science and economic literature, grey literature, and regulatory policy literature.

The committee will not recommend specific FDA activities or regulatory strategies, because those choices will entail policy judgments that transcend scientific and technologic considerations.

The committee has prepared a brief letter report that describes the conceptual model and methods.

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