Activity

Ranking FDA Product Categories Based on Health Consequences, Phase I

Type:: Consensus Study
Topics:: Biomedical and Health Research, Food and Nutrition, Public Health
Boards:: Executive Office, Board on Environmental Studies & Toxicology

Activity Description

An expert committee is tasked to develop and apply an evidence-based conceptual model and methods to rank product categories within the broad types of products addressed by programs of the U.S. Food and Drug Administration (FDA). The conceptual model and methods focus on ranking product categories according to the potential ranges of magnitude of various health consequences to U.S. users of the products at individual and population levels, taking both adverse and beneficial effects into consideration.

The study will be conducted in two phases. For phase I, the committee began by selecting, in consultation with HHS and FDA, categories of products within FDA mandates for human and veterinary drugs, biologics, medical devices, foods, cosmetics, and products that emit radiation. The committee reviewed selected scientific literature bearing on adverse and beneficial health consequences related to these product categories. It developed a scientific conceptual framework for potential use in guiding product category rankings based on expert judgments and related analysis of the types and potential ranges of magnitude of health consequences to U.S. users of the products. For more information