History of the FDA


Established with U.S. Department of Agriculture

1862 - 1940

Considered to be the oldest consumer protection agency.

Pure Food and Drug Act (Wiley Act)


Gave government power to administer and prohibit the interstate transport of unlawful food and drugs.

FDA Setback


Supreme Court ruled that regulation of drugs didn't apply to false therapeutic claims; Wiley then resigned.

FDA Changed its Authority


President Franklin Roosevelt came into office: FDA was able to apply quality and identity standards for food and drugs and prohibit false therapeutic claims for drugs which allowed them to shut down many companies.

Tennessee Drug Company


Tested a drug without following any guidelines; ended up being toxic and killed over 100 people, mostly children which enraged many.

Congress Passed the Federal Food, Drug, and Cosmetic Act


Due to the harm caused by a Tennessee Drug Company; it required manufacturers to prove to the FDA that a drug was safe for use with directions, mandated standards for food, set tolerances for certain poisonous substances, and authorized factory inspections.

Part of Federal Security Agency

1940 - 1953

Durham-Humphrey Amendment


It gave clarification between the difference of prescription and over-the-counter drugs.

Part of the Department of Health, Education, and Welfare (HEW)

1953 - Present

Kefauver-Harris Amendment


It ensured safety and effectiveness of medications in the U.S. market.

Drug Abuse Control Amendments


This was due to an increase of people abusing drugs like barbiturates.

Consumer Product Safety Commission


The FDA had control over hazardous toys, flammable fabrics, and potential poisons.

Medical Device Amendments


It allowed the FDA to recall ineffective and dangerous devices, especially in the medical field.

Orphan Drug Act


It influenced expanded research and availability of new treatments for AIDS, cancer, and genetic diseases.