Online History of the FDA


United States Pharmacopoeia

  • 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

  • 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

Approx. 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

  • 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

  • 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

  • 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

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

Drug Abuse Control Amendments of 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

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

Medical Device Amendments

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

Orphan Drug Act

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

Present Day FDA

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