The United States Food and Drug Administration (FDA) is a federal agency of the U.S. government, operating under the Department of Health and Human Services (HHS). It is responsible for protecting and promoting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radiation. The agency was formally established on June 30, 1906, with the passage of the Pure Food and Drug Act. This act was a response to public outcry over unsafe foods and medications, notably spurred by Upton Sinclair's novel The Jungle, which exposed unsanitary conditions in the meatpacking industry. The original act solved the problem of misbranded or adulterated food and drugs by prohibiting their shipment in interstate commerce.
The FDA's primary mechanism for operation is enforcing the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938, which replaced the 1906 statute and remains the foundational law. The FD&C Act significantly increased federal authority by mandating pre-market review for the safety of all new drugs and authorizing factory inspections. Key provisions include requiring scientific proof of drug effectiveness and safety before marketing, a requirement added by the Kefauver–Harris Drug Amendments of 1962. The FDA connects to other major U.S. laws, such as the Public Health Service Act, which gives it authority over vaccines and serums.
Recently, the FDA has undergone changes, including the launch of the National Priority Voucher program to accelerate reviews of certain new drugs. The agency has also published more than 200 complete response letters (CRLs) for drug and biological products approved between 2020 and 2024 to increase transparency in its decision-making process. Proposed changes in the Fiscal Year 2027 budget include creating a new clinical trial initiation pathway and permanently reauthorizing the Rare Pediatric Disease Priority Review Voucher. The core mission of ensuring product safety and efficacy, however, has stayed the same since its inception.