History of the FDA


FDA Establishment

May 15, 1862

The Division of Chemistry became established under the Department of Agriculture on May 15, 1862. This organization included chemists, physicians, veterinarians, pharmacists, microbiologists, and lawyers.

Transition from Division of Chemistry to Bureau of Chemistry

July 1, 1901

The branch of the Division of Chemistry was renamed to the Bureau of Chemistry. The role of the Bureau of Chemistry was to evaluate applications for new drugs for the use in humans or animals, food and color additives, medical devices, and infant formulas.

Tainted Batch of Tetanus Diphtheria Antitoxins


FDA failed to approve tetanus shots which led to the deaths of thirteen children and nine babies.

Pure Food and Drug Act (1906)


Harvey Wiley, the chief chemist of the Division of Chemistry led the first passage of major legislation; the Pure Food and Drug Act of 1906. This new agency was created to make more changes of its authority.

President Theodore Roosevelt Signed the Pure Food and Drug Act

June 1906

President Theodore Roosevelt signed the Pure Food and Drug Act of 1906 which administered and prohibited interstate transport of unlawful foods and drugs.

FDA Setback


The Supreme Court said that the regulation of drugs did not apply to false therapeutic claims. This attempt was to prove that drug companies intended to defraud the consumer. The Supreme Court ruling undermined the Wiley Act which led to manufacturers winning court cases.

Harvey Wiley Resigned


Harvey Wiley resigned from the Bureau of Chemistry which led to the branch to focus more on drug regulations.

Transition from Pure Food and Drug Act to Food, Drug, and Insecticide Administration


The Pure Food and Drug Act was renamed to the Food, Drug, And Insecticide Administration

Transition from Food, Drug, and Insecticide Administration to FDA

July 1930

The agency of Food, Drug, and Insecticide Administration renamed to the Food and Drug Administration (FDA) on July 1930.

Tennessee Drug Company


The Tenseness Drug Company advertised a new sulfanilamide elixir to children. This solvent contained antifreeze and was not tested; which led to the death of one hundred people.

Congress Passed Federal Food, Drug, and Cosmetic Act


Congress passed the federal Food, Drug, and Cosmetic Act to prove to the FDA that manufacturers produced safe drugs before marketing. Manufacturers also needed to provide directions on drug labels, mandated standards for foods, set tolerances for certain poisonous substances and authorized factory inspections.

FDA Under U.S. Department


The FDA remained under the U.S. Department of Agriculture until July 1940 when the agency moved to the new Federal Security Agency.

Ban of Carcinogenic Additives

1950 - 1959

Other laws were passed to ban carcinogenic additives to foods

Prescription Drugs Vs. Over-the-Counter


The Durham-Humphrey Amendment was enacted to clarify prescriptions vs. over-the-counter drugs.

FDA Oversight


The FDA allowed for greater oversight to ensure safety and effectiveness of veterinary drugs and additives to animal feed.

The Sedative Drug, Thalidomide

1960 - 1969

The drug Thalidomide, predominantly used as a sedative in Europe, was found to cause severe birth defects. This drug was never approved for use in the U.S..

Kefauver-Harris Amendment


The Kefauver-Harris Drug Amendments ensured safety and effectiveness of medications in U.S. market.

Drug Abuse Control Amendments


The Drug Abuse Control Amendments was enacted to control over amphetamines (barbiturates).

Drug Enforcement Administration (DEA)


The organization, the Drug Enforcement Administration delegated the Drug Abuse Control Amendments of 1965.

Consumer Product Safety Commission


The FDA created the Consumer Product Safety Commission which included hazardous toys, flammable fabrics and potential poisons in consumer products.

Medical Device Amendments


The Medical Device Amendments allowed the FDA to regulate and approve of medical devices and recall ineffective or dangerous devices.

Orphan Drug Act


The Orphan Drug Act was enacted to influence research and availability of new treatments for AIDS, cancer and genetic diseases.