The Food and Drug Administration (FDA) is the oldest comprehensive consumer protection agency in the U.S. federal government, tracing its modern regulatory functions to the passage of the 1906 Pure Food and Drugs Act.
“The Food and Drug Administration (FDA) is a government agency that’s in place to protect public health. It does this by ensuring the safety, effectiveness, and security of many products you use every day,” says GoodRx Health.
The FDA officially says it's responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
The FDA also provides accurate, science-based health information to the public.
“The Food and Drug Administration (FDA), the United States’ regulatory agency for food, medical, and an array of other products, is a critical part of U.S. public health infrastructure,” says the Council on Foreign Relations (CFR) .
FDA Regulates Foods, Cosmetics, Medications and More
The FDA says it's responsible for:
- Protecting the public health by assuring that foods (except for meat from livestock, poultry, and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary, and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.
- Protecting the public from electronic product radiation.
- Assuring cosmetics and dietary supplements are safe and properly labeled.
- Regulating tobacco products.
- Advancing public health by helping to speed product innovations.
“Foods, cosmetics, medications, and more are regulated by the FDA. Each has to meet specific requirements — either before and/or after — they’re available to the public,” explains GoodRx Health. “The FDA is responsible for approving new medications before they hit the market. This ensures they’re safe and effective for their intended use.”
FDA's responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.
History of the FDA
Since 1848 the federal government has used chemical analysis to monitor the safety of agricultural products -- a responsibility inherited by the Department of Agriculture in 1862 and later by the FDA.
Dr. Harvey Washington Wiley, chief chemist of the USDA Bureau of Chemistry was the driving force behind the passage of the 1906 Pure Food and Drug Act, a law that the FDA says took nearly 25 years to craft and “prohibited interstate commerce in adulterated and misbranded food and drugs.”
Wiley became the head of the Pure Food and Drug Act enforcement in the early years.
Here is a timeline for the history of the FDA and its predecessors:
- 1862: President Lincoln appointed a chemist, Charles M. Wetherill, to serve in the new Department of Agriculture. This was the beginning of the Bureau of Chemistry, the processor of the FDA.
- 1883: Dr. Harvey becomes chief chemist, expanding the Bureau of Chemistry’s food adulteration studies. Dr. Wiley earned the nickname of the “Crusading Chemist” and later “Father of the Pure Food and Drugs Act.”
- 1902: The Biologics Control Act is passed to ensure the purity and safety of serums, vaccines, and similar products used to prevent or treat diseases in humans.
- 1906: The original Food and Drugs Act was passed by Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods, drinks, and drugs. On the same day, the Meat Inspection Act was passed.
- 1907: First Certified Color Regulations, requested by manufacturers and users, list seven colors found suitable for use in foods.
- 1913: The Gould Amendment requires that food package contents be "plainly and conspicuously marked on the outside of the package in terms of weight, measure, or numerical count."
- 1914: The Harrison Narcotic Act requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.
- 1927: The Bureau of Chemistry is reorganized into two separate entities. Regulatory functions are located in the Food, Drug, and Insecticide Administration, and nonregulatory research is located in the Bureau of Chemistry and Soils.
- 1930: The name of the Food, Drug, and Insecticide Administration is shortened to Food and Drug Administration (FDA) under an Agricultural Appropriations Act. That same year, the McNary-Mapes Amendment authorizes FDA standards of quality and fill-of-container for canned food, excluding meat and milk products.
- 1938: The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions:
o Extending control to cosmetics and therapeutic devices.
o Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation.
o Eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases.
o Providing that safe tolerances be set for unavoidable poisonous substances.
o Authorizing standards of identity, quality, and fill-of-container for foods.
o Authorizing factory inspections.
o Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions.
- 1939: First Food Standards issued (canned tomatoes, tomato purée, and tomato paste).
- 1940: FDA transferred from the Department of Agriculture to the Federal Security Agency, with Walter G. Campbell appointed as the first Commissioner of Food and Drugs.
- 1949: FDA publishes guidance to industry for the first time. This guidance, "Procedures for the Appraisal of the Toxicity of Chemicals in Food," came to be known as the "black book."
- 1953: Federal Security Agency becomes the Department of Health, Education, and Welfare (HEW).
- 1962: Kefauver-Harris Drug Amendments passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to the FDA the effectiveness of their products before marketing them.
- 1968: Reorganization of federal health programs places FDA in the Public Health Service. Animal Drug Amendments place all regulation of new animal drugs under one section of the Food, Drug, and Cosmetic Act.
- 1969: FDA begins administering Sanitation Programs for milk, shellfish, food service, and interstate travel facilities, and for preventing poisoning and accidents. These responsibilities were transferred from other units of the Public Health Service.
- 1970: Drug Abuse Prevention and Control Act replaces previous laws and categorizes drugs based on abuse and addiction potential compared to their therapeutic value.
- 1971: PHS Bureau of Radiological Health transferred to FDA. Its mission: protection against unnecessary human exposure to radiation from electronic products in the home, industry, and the healing arts.
- 1973: Regulation of Biologics--including serums, vaccines, and blood products--is transferred from NIH to FDA. Also, the Consumer Product Safety Commission created by Congress; takes over programs pioneered by the FDA under the 1927 Caustic Poison Act, 1960 Federal Hazardous Substances Labeling Act, 1966 Child Protection Act, and PHS accident prevention activities for the safety of toys, home appliances, etc.
- 1976: Medical Device Amendments were passed to ensure the safety and effectiveness of medical devices, including diagnostic products. The amendments require manufacturers to register with the FDA and follow quality control procedures. Some products must have pre-market approval by the FDA; others must meet performance standards before marketing.
- 1982: FDA publishes first Red Book (successor to 1949 "black book"), officially known as Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food.
- 1988: The Food and Drug Administration Act of 1988 officially establishes the FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate, and broadly spells out the responsibilities of the Secretary and the Commissioner for research, enforcement, education, and information.
- 1992: Nutrition facts, basic per-serving nutritional information, are required on foods under the Nutrition Labeling and Education Act of 1990. Based on the latest public health recommendations, the FDA and the Food Safety and Inspection Service of the Department of Agriculture recreated the food label to list the most important nutrients in an easy-to-follow format.
- 1995: FDA declares cigarettes to be "drug delivery devices." Restrictions are proposed on marketing and sales to reduce smoking among young people.
- 1997: Food and Drug Administration Modernization Act reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to accelerate the review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.
- 2011: The Food Safety and Modernization Act (FSMA) provides the FDA with new enforcement authorities related to food safety standards, gives the FDA tools to hold imported foods to the same standards as domestic foods, and directs the FDA to build an integrated national food safety system in partnership with state and local authorities.
FDA Has a Very Broad Regulatory Scope
The scope of the FDA’s regulatory authority is very broad.
The FDA's responsibilities are closely related to those of several other government agencies.
In general, FDA regulates:
- Foods, including:
o Dietary supplements
o Bottled water
o Food additives
o Infant formulas
o Other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products)
- Drugs, including:
o Prescription drugs (both brand-name and generic)
o Non-prescription (over-the-counter) drugs
- Biologics, including:
o Vaccines for humans
o Blood and blood products
o Cellular and gene therapy products
o Tissue and tissue products
- Medical Devices, including:
o Simple items like tongue depressors and bedpans
o Complex technologies such as heart pacemakers
o Dental devices
o Surgical implants and prosthetics
- Electronic Products that give off radiation, including:
o Microwave ovens
o X-ray equipment
o Laser products
o Ultrasonic therapy equipment
o Mercury vapor lamps
- Cosmetics, including:
o Color additives found in makeup and other personal care products
o Skin moisturizers and cleansers
o Nail polish and perfume
o Veterinary Products, including:
- Veterinary Products, including:
o Pet foods
o Veterinary drugs and devices
- Tobacco Products, including:
o Cigarette tobacco
o Roll-your-own tobacco
o Smokeless tobacco
o E-cigarettes (tobacco and non-tobacco derived nicotine)
The CFR says that criticisms of the agency “center on the extent of its regulatory powers and the risk that FDA officials could be swayed by the powerful pharmaceutical lobby. The agency has in particular taken heat over its part in approving the drugs at the center of the national opioid epidemic. Its work has also come into the spotlight amid the COVID-19 pandemic, as the FDA is tasked with reviewing all potential vaccines and treatments for the new coronavirus disease.”