The U.S. Food and Drug Administration (FDA) is a federal public health agency charged with ensuring the safety, effectiveness, and accurate labeling of foods, human and veterinary drugs, vaccines and other biologics, medical devices, cosmetics, tobacco products, and radiation‑emitting electronic products; it operates within the United States Department of Health and Human Services and oversees products that account for roughly 20–25% of U.S. consumer spending. According to the FDA, “about 25 cents of every dollar” spent by American consumers involves FDA‑regulated products. Food and Drug Administration; Executive Summary: Strategic Plan for Regulatory Science. (fda.gov)

History

The federal government’s food and drug oversight traces to 19th‑century chemical analyses within the Department of Agriculture’s Bureau of Chemistry, culminating in the 1906 Pure Food and Drugs Act, which prohibited interstate commerce in adulterated and misbranded food and drugs and laid the foundation for the first comprehensive consumer‑protection regime; the agency took its present name in 1930. FDA History; Pure Food and Drug Act | Britannica. (fda.gov)

A series of crises and reforms led to the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938, which required premarket safety for drugs, authorized factory inspections, and established standards for foods and cosmetics; the law remains the FDA’s primary statutory authority and has been amended repeatedly. The 1938 Food, Drug, and Cosmetic Act | FDA; Federal Food, Drug, and Cosmetic Act. (fda.gov)

Legal authority and major statutes

Key amendments to the FD&C Act and related laws have defined modern regulatory practice:

• –The Food Additives Amendment of 1958 established a premarket safety framework for food additives and codified the GRAS (generally recognized as safe) concept, along with the Delaney Clause for carcinogenic additives. Food Additives Amendment of 1958. (en.wikipedia.org)
• –The Kefauver–Harris Drug Amendments of 1962 mandated substantial evidence of efficacy in addition to safety for drugs and strengthened inspection and informed consent requirements. Kefauver–Harris Amendment. (en.wikipedia.org)
• –The Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch–Waxman Act) created the abbreviated new drug application (ANDA) pathway for generics while balancing patent and exclusivity provisions. Hatch‑Waxman Letters | FDA; 40th Anniversary of the Generic Drug Approval Pathway | FDA. (fda.gov)
• –The Prescription Drug User Fee Act (PDUFA) of 1992 authorized FDA to collect user fees to support timely human drug and biologics review, subject to periodic five‑year reauthorizations. PDUFA Legislation and Background | FDA. (fda.gov)
• –The Dietary Supplement Health and Education Act (DSHEA) of 1994 classified dietary supplements as foods and limited FDA’s premarket authorities, placing primary responsibility on firms for safety and labeling; FDA acts post‑market against adulterated or misbranded products. FDA 101: Dietary Supplements; Information for Consumers on Using Dietary Supplements | FDA. (fda.gov)
• –The Family Smoking Prevention and Tobacco Control Act of 2009 established FDA’s Center for Tobacco Products (CTP) and empowered the agency to regulate the manufacture, distribution, and marketing of tobacco products. Family Smoking Prevention and Tobacco Control Act – Overview | FDA. (fda.gov)
• –The FDA Food Safety Modernization Act (FSMA) of 2011 shifted the nation’s food safety system toward prevention, risk‑based inspections, and strengthened import oversight. Food Safety Modernization Act (FSMA) | FDA; Federal/State Integration and the FSMA | FDA. (fda.gov)
• –The 21st Century Cures Act of 2016 advanced patient‑focused drug development, modernized clinical trial design, expanded real‑world evidence use, and created expedited programs such as RMAT and Breakthrough Devices. 21st Century Cures Act | FDA. (fda.gov)
• –The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expanded FDA’s cosmetics oversight, including facility registration, product listing, records access, and mandatory recall authority. MoCRA | FDA. (fda.gov)

Organization and headquarters

FDA is led by the Commissioner of Food and Drugs and is headquartered at the White Oak campus, 10903 New Hampshire Avenue, Silver Spring, Maryland, with additional offices across the United States and selected international locations to support inspections and import oversight. Food and Drug Administration; White Oak Campus Information | FDA. (fda.gov)

The agency’s principal product centers and offices include the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Tobacco Products (CTP), Center for Veterinary Medicine (CVM), the unified Human Foods Program (HFP), the National Center for Toxicological Research (NCTR), and the Office of Inspections and Investigations (OII, FDA’s field operations for inspections, investigations, and imports). Center for Tobacco Products | FDA; National Center for Toxicological Research | FDA; Human Foods Program – FY 2025 Priority Deliverables | FDA; Office of Inspections and Investigations | FDA. (fda.gov)

Regulatory scope

Foods: FDA regulates approximately 80% of the U.S. food supply, focusing on preventive controls, hazard analysis, labeling (including Nutrition Facts), and chemical and microbiological safety across domestic and imported foods; by contrast, the U.S. Department of Agriculture’s Food Safety and Inspection Service regulates meat, poultry, and certain egg products. Human Foods Program – FY 2025 Priority Deliverables | FDA; FSIS – About FSIS. (fda.gov)

Drugs and biologics: CDER and CBER evaluate investigational and marketing applications for prescription, generic, and over‑the‑counter drugs, as well as vaccines, blood components, and gene and cell therapies, applying standards of safety, efficacy, and manufacturing quality; PDUFA user fees support timely reviews. PDUFA Legislation and Background | FDA; Food and Drug Administration | Britannica. (fda.gov)

Medical devices and radiation‑emitting products: CDRH oversees premarket pathways (510(k), De Novo, PMA), quality systems, postmarket surveillance, and safety for a spectrum of devices and radiation‑emitting electronics. FDA Center for Devices and Radiological Health. (en.wikipedia.org)

Tobacco products: CTP implements the 2009 Tobacco Control Act, including premarket pathways (PMTA, SE, MRTP), product standards, youth marketing restrictions, and compliance and enforcement programs. Family Smoking Prevention and Tobacco Control Act – Overview | FDA; Center for Tobacco Products | FDA. (fda.gov)

Cosmetics: Under MoCRA (2022), FDA now requires facility registration and product listing, has records‑access and mandatory recall authority, and is developing GMP regulations and standardized testing for asbestos in talc‑containing cosmetics. MoCRA | FDA; FDA Proposes Talc Asbestos Testing Rule. (fda.gov)

Dietary supplements: DSHEA defines supplements as a category of food; FDA does not pre‑approve supplements for safety or efficacy but can act against adulteration, misbranding, or unlawful claims and requires specific label elements including a Supplement Facts panel. FDA 101: Dietary Supplements; Dietary Supplements | FDA. (fda.gov)

Field operations, imports, and laboratories

FDA’s Office of Inspections and Investigations (OII) conducts domestic and foreign inspections, investigations, import screening, and criminal enforcement in collaboration with U.S. and international partners; OII reports screening of all FDA‑regulated imported products using risk‑based tools and manages the FDA Emergency Operations Center. Office of Inspections and Investigations | FDA; Import Systems | FDA. (fda.gov)

The National Center for Toxicological Research (NCTR) in Jefferson, Arkansas, is FDA’s primary intramural research center dedicated to regulatory science supporting product‑center decision‑making (for example, predictive toxicology, bioinformatics, and safety signal detection). National Center for Toxicological Research | FDA. (fda.gov)

Emergency authorities and medical countermeasures

Under section 564 of the FD&C Act, the Emergency Use Authorization (EUA) mechanism permits the FDA—following the appropriate HHS determination—to authorize unapproved medical products or unapproved uses of approved products in emergencies involving serious or life‑threatening diseases, when statutory criteria are met and no adequate, approved, and available alternatives exist. Emergency Use Authorization | FDA. (fda.gov)

Budget and workforce

In March 2024, the FDA requested $7.2 billion for FY 2025 to enhance food safety and nutrition, medical product safety, supply‑chain resilience, mission support, and infrastructure modernization, reflecting a proposed increase over FY 2023 enacted levels; FDA also relies on user fees authorized by statutes such as PDUFA. FDA Seeks $7.2 Billion… (FY 2025) | FDA; PDUFA Legislation and Background | FDA. (fda.gov)

Interagency coordination

FDA coordinates extensively with other federal and state partners. For example, USDA’s FSIS regulates meat, poultry, and certain egg products while FDA regulates most other foods; the agencies collaborate on cross‑cutting issues such as human food made with cultured animal cells and import controls. Importing Meat, Poultry & Egg Products to the United States | FSIS; Food Safety Acts | FSIS. (fsis.usda.gov)

Recent organizational modernization

On October 1, 2024, FDA implemented the largest reorganization in its modern history, creating a unified Human Foods Program and restructuring field operations under OII to improve risk‑based oversight, elevate nutrition, and further realize FSMA’s preventive vision. FDA’s Unified Human Foods Program… Goes into Effect | FDA; FDA Modernization Efforts…. (fda.gov)