Abstract

The Food and Drug Administration (FDA) is the primary federal scientific and regulatory government agency that monitors drug, biologic, medical device, food, veterinary and cosmetic products. FDA is organized into five distinct centers, each with its own rules and regulations. This article discusses FDA's traditional regulatory mission of consumer protection and how its decisional processes have changed over time as a result of the explosion of advances within analytical chemistry and toxicology. Because no compound is completely safe, FDA must regularly assess the intended use of a product and whether the level of risk is acceptable. The article also summarizes the legislation that sets the boundaries of FDA's authority and lays out the administration's organization and responsibilities.