Online History of the FDA

Events

United States Pharmacopoeia

1820

Established 1820
Set standards for drugs regarding strength, quality, and purity
Established these standards
Made rules such as the label could not mislead the consumer, and all ingredients must be plainly listed

Food and Drug Administration

1862

Oldest consumer protection agency in USA
Remained under the authority of the US department of Agriculture
1940 became part of the Federal Security Agency
1953 transferred to the Department of Health, Education, and Welfare
1968 Placed under the authority of US PHS
1980 moved to US department of Health and Human Services

FDA's Division of Chemistry

1900

Consists of staff from several divisions (chemists, physicians, veterinarians, pharmacists, microbiologists, lawyers)
1901 remained the Bureau of Chemistry
Used to evaluate applications for new drugs for use in humans or animals, food and color addition, medical devices, infant formulas (1901)
Harvey WIley changed the direction of the division

Pure Food and Drug Act of 1906

1906

First passage of major legislation
Gave the government the power to administer and prohibit the interstate transport of unlawful foods and drugs

Change in Authority

1933

FDA was allowed to include both quality and identity standards for food and drugs
Had the right to inspect factories and control advertisements

Federal Food, Drug, and Cosmetic Act of 1938

1938

Required manufacturers to prove to the FDA that a drug was safe for using before marketing it
Had the power to set standards for foods, set tolerances for certain poisons, and authorized factory inspections
Gave authority to enforce standards

Durham- Humphrey Amendment

1951

Clarified what constituted a prescription drug versus an over-the-counter drug

Drug Abuse Control Amendments of 1965

1965

FDA was given more control of potentially addictive agents such as amphetamines, barbiturates, etc - Control was eventually delegated to DEA in 1968

Consumer Product Safety Commission

1972

Regulation which provides: federal control over hazardous toys; flammable fabrics; and potential poisons.

Medical Device Amendments

1976

Allowed the FDA to regulate and approve medical devices and recall ineffective or dangerous devices

Orphan Drug Act

1983

Influenced expanded research and availability of new treatments for acquired immunodeficiency syndrome, cancer, and genetic diseases

Present Day FDA

2017

Continues its mission to ensure public safety, including the oversight of dietary supplements, misleading claims or adulterated misbranded