The safety assessment process--setting the scene: an FDA perspective.

Abstract

The process by which the US Food and Drug Administration (FDA) evaluates the safety/hazard potential of the products under its purview has evolved from a constellation of scientific research achievements in toxicology and related areas and a succession of historical events, some tragic, which encouraged dramatic changes in the oversight and regulation of foods, drugs, and cosmetics. The process is science based and has, over the years, achieved significant success in protecting human health. The authority by which the FDA provides pre- and postmarketing oversight of the products it regulates is established in the Federal Food, Drug, and Cosmetic Act, which has been amended extensively to broaden FDA's authority to include different products and product classes and to include oversight of safety and efficacy, greater stringency regarding reporting requirements, and enforcement processes. The structure of the agency, which comprises six regulatory components and a principal multidisciplinary research facility, is both practical and functional, providing regulatory oversight, regulatory guidance to industry, and fundamental and applied research. FDA's participation in different national and international scientific initiatives has helped bring focus to the prioritization, standardization, validation, and globalization of testing strategies and methodologies and the practical and widespread application of these initiatives to the regulation of consumer products. The agency is a leading advocate of alternative methods that refine procedures using animals to limit pain and distress, reduce and replace animal use in research and testing as scientifically appropriate and feasible, and have the potential to yield data comparable with or better than that obtained from conventional methods. The current scientific and technological advances and the rapidity with which they emerge offer new opportunities for the scientific community, industry, and regulatory authorities to alter current toxicological practices and promote the use of validated, reliable, and relevant alternative methods.