Federal Food and Drug Administration


Food and Drug Administration established


Oldest consumer protection agency

Division of Chemistry stopped evaluating applications


Division of Chemistry stopped evaluated applications for new drugs for use in humans or animals , food and color additives, medical devices, and infant formulas.

Tainted batch of Tetanus Diphtheria antitoxins

  • 13 children and 9 babies died
  • Led to the pure and food drug act

The Pure Food and Drug Act

  • government power in state production of food and drugs
  • drugs had to meet the standards of strength, quality, and purity established by the U.S Pharmacopoeia and the National Formulary guidelines
  • labels cannot mislead the consumer
  • prohibit the additives that pose a health hazard in food

Harvey Wiley - passage of legislation for The Pure Food and Drug Act


Chief chemist changed division by established scientist authority by researching effects of chemical preservatives used in foods/drugs, exposing potential hazards

Wiley Resigned


Supreme Court said the law cannot be applied to the false therapeutic claims

Franklin D. Roosevelt

  • change FDA's authority to include both quality and identity standards for foods, drugs, and covers cosmetics and medical devices
  • FDA countered ads at this time to expose the truths of the harmful drugs

Federal Food, Drug, and Cosmetic Act

  • required many manufacturers to prove to the FDA that a drug was safe to use before marketing it
  • manufacturers had to provide directions on a drug's label for safe use
  • mandated standards for food, set tolerances for certain poisonous substances and authorize factory insepctions

Durham and Humphrey Amendment

  • distinguished categories for over the counter and prescribed drugs
  • banned carcinogenic addictives to food

Drug Abuse Control Amendments

  • establish special controls for depressant and stimulant drugs and counterfeit drugs
  • in 1968, the Drug Enforcement Administration enforced this
  • then in 1973, the FDA responsible for enforcement

Medical Device Amendments

  • allows FDA to regulate device standards for human use
  • allows FDA to recall devices that have false claims or pose a threat to humans

Orphan Drug Act

  • encourages drug companies to develop drugs for rare diseases by providing research assistance, grants, and cost incentives to manufacturers