U.S. Food and Drug Administration ( FDA ) and The Products It Regulates

Abstract

Abstract The U.S. Food and Drug Administration (FDA) is the primary federal government agency that is responsible for protecting and promoting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biologics, medical devices, food, dietary supplements, cosmetics, tobacco, and products that emit radiation. To achieve this mission, the FDA balances the twin goals of assuring products are safe and effective and encouraging innovation and new product entry into the market. As a science‐based institution, the FDA also reviews clinical research, monitors the marketing practices of regulated‐industry to assure the public gets accurate, science‐based information, and interacts with international bodies with the goal of reducing the burden of regulation and harmonizing regulatory requirements. The FDA's organization currently consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency. Functionally, the FDA is comprised of six product centers: the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Veterinary Medicine (CVM), the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Tobacco Products (CTP). The FDA also has an office dedicated to research and multiple offices focused on global regulatory operations and policy. Collectively these Centers oversee the development, manufacture, promotion and distribution of drugs, biologics, veterinary products, medical devices, foods, dietary supplements, cosmetics, and tobacco in the United States under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations. This article provides a historical summary of the legal framework in which the FDA operates, discusses the FDA's organization and role, highlights the regulatory requirements for each of the product types the FDA regulates, and ends with a general discussion of the FDA's enforcement powers.