Food and Drug Administration
Overview
The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
History
The FDA's origins can be traced back to the appointment of Lewis Caleb Beck in the Patent Office around 1848 to carry out chemical analyses of agricultural products, a function that the newly created Department of Agriculture inherited in 1862. Although it was not known by its present name until 1930, the FDA was officially formed in 1906 with the passage of the Federal Food and Drugs Act.
Organization and Structure
The FDA is an agency within the Department of Health and Human Services and reports to the Secretary of Health and Human Services. It is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. The 21st and current Commissioner is Dr. Stephen Hahn.
Functions and Responsibilities
The FDA's primary focus is enforcing the Federal Food, Drug, and Cosmetic Act. The agency ensures safety of all food except for meat, poultry, and certain egg products; ensures safety and efficacy of pharmaceuticals, biological products, and medical devices; and ensures the safety of cosmetics and radiation-emitting products. The FDA also enforces other laws and regulations related to these areas, and conducts research into the same.
Regulatory Programs
The FDA carries out its regulatory functions through several programs, including the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the National Center for Toxicological Research.
Criticisms and Controversies
The FDA has been criticized for its regulatory decisions, its process for approval of drugs and medical devices, its oversight of food safety, and its relationship with the pharmaceutical industry. Some critics argue that the FDA's regulatory decisions are influenced by political and economic considerations, rather than by scientific evidence.