SUMMARY OF IMPORTANT POINTS
Overview of the Food and Drug Administration

  • The FDA is the nation’s oldest consumer protection agency;


  • The FDA has the dual function of law enforcement and scientific research;


  • The FDA’s primary concern is the protection of the American consumer;


  • The FDA regulates food, medicinal products, cosmetics, radiation-emitting products, and the nation's blood supply.
FDA Regulatory Duties


Five types of activities describe the FDA’s regulatory duties:

  • New product review and approval;


  • Post-marketing surveillance;


  • Setting standards and writing regulations;


  • Scientific research;


  • Regulatory enforcement and corrective action.


The FDA evaluates scientific data for safety and efficacy to determine whether it will approve or disapprove of new drugs, biologics, and complex medical devices. A pivotal part of the approval process is determining whether the resulting benefits outweigh the risks associated with the use of the product.
Establishment of the FDA

  • In 1862, President Lincoln appoints a chemist by the name of Charles M. Wetherill, to serve in the new Department of Agriculture. This led to the beginning of the Bureau of Chemistry, which is the predecessor to the Food and Drug Administration.

  • In 1883, Dr. Harvey W. Wiley becomes the chief chemist and expands the Bureau of Chemistry's studies on food adulteration. Because of his belief in a federal law to protect the public, he was known as the "Crusading Chemist" and "Father of the Pure Food and Drugs Act."

  • In 1930, the name “Food and Drug Administration (FDA)” is formally established.

  • In 1988, the FDA becomes an official agency of the Department of Health and Human Services (DHHS).