The U S. Food and Drug Administration is a scientific, regulatory, and public health agency that oversees items accounting for 25 cents of every dollar spent by consumers. Its jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed. The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 9,100 employees and a budget of $1.294 billion in 2001, comprising chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, and many others. About one-third of the agency’s employees are stationed outside of the Washington, D. C. area, staffing over 150 field offices and laboratories, including five regional offices and 20 district offices. Agency scientists evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs. Also, the FDA monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person. Investigators and inspectors visit more than 16,000 facilities a year, and arrange with state governments to help increase the number of facilities checked.
Beginning as the Division of Chemistry and then (after July 1901) the Bureau of Chemistry, the modern era of the FDA dates to 1906 with the passage of the Federal Food and Drugs Act; this added regulatory functions to the agency’s scientific mission. The Bureau of Chemistry’s name changed to the Food, Drug, and Insecticide Administration in July 1927, when the nonregulatory research functions of the bureau were transferred elsewhere in the department. In July 1930 the name was shortened to the present version. FDA remained under the Department of Agriculture until June 1940, when the agency was moved to the new Federal Security Agency. In April 1953 the agency again was transferred, to the Department of Health, Education, and Welfare (HEW). Fifteen years later FDA became part of the Public Health Service within HEW, and in May 1980 the education function was removed from HEW to create the Department of Health and Human Services, FDA’s current home. To understand the development of this agency is to understand the laws it regulates, how the FDA has administered these laws, how the courts have interpreted the legislation, and how major events have driven all three.States exercised the principal control over domestically produced and distributed foods and drugs in the 19th century, control that was markedly inconsistent from state to state.