ABSTRACT
OVERVIEW OF FDA Introduction The Food and Drug Administration (FDA) is a federal agency that is part of the U.S. Department of Health and Human Services (DHHS). All food, drug, medical devices, and cosmetics legally available for animals and man in the United States are regulated under the authority provided by Congress in the Food, Drug, and Cosmetic Act of 1938 and its subsequent amendments. The act itself also established the regulatory agency that today is known as the FDA. As with many government regulations and regulatory agencies, the FDA and its regulatory authority were created in response to significant human health events. The regulatory powers granted to the FDA by Congressional Acts since 1902 vary considerably depending on the product, the potential for risk, and the evolution of the laws of the product being regulated. The FDA’s authority has evolved over many years in response to developments in scientific research, human tragedy as a result of misuse of drugs and devices, and laws enacted by Congress generally in response to public outcry of suffering from either some new malady or a misguided attempt to cure some disease entity that sometimes can appear counterintuitive because of the political nature of creating and passing such legislation.
