FDA History-Alyssa Deguzman


FDA's Division of Chemistry


evaluate applications for new drugs for use in humans or animals, food and color additives, medical devices, and infant formulas

Pure Food and Drug Act


First passage of major legislation passed by Wiley. Made new changes in authority. Name changed to Food, Drug, Insecticide Administration

Harvey Wiley

Approx. 1906

Changed direction of division, established scientific authority by researching effects of chemical preservatives used in production of foods and drugs, exposed potential hazards in products, focused on consumer safety

Supreme Court Case that undermined the Wiley Act


Supreme Court determined that the law enforcing regulation of drugs did not apply to false therapeutic claims

Franklin D. Roosevelt

1933 - 1945

New presidential administration changed the authority of the FDA to include both quality and identify standards for food and drugs, prohibition of false therapeutic class for drugs

Post Office Department and Federal Trade Commission


in charge of ensuring safety of cosmetics and medical devices

Federal Food, Drug, Cosmetic Act


Required manufacturers to prove to the FDA that a drug was safe before marketing it. Manufacturers had to provide directions on drug's label. Mandated standards for foods. set tolerances for certain poisonous substances and authorized factory inspections

FDA has more Responsibility


FDA became in charge of ensuring the safety of cosmetics and medical devices

Kefauver-Harris Amendment


Revolutionary in scope for ensuring safety and effectiveness of medications in US market

Drug Abuse Control Amendments


Gives FDA control over barbiturates and addictive agents

Medical Devices Amendments


Allowed FDA to regulate and approve devices to recall ineffective and dangerous devices

Orphan Drug Act


Targeted rare diseases and influenced expanded research and availability of new treatments for acquired immunodeficiency syndrome, cancer and genetic diseases