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U.S. Department of Health and Human Services

About FDA

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Background

The origins of the Food and Drug Administration can be traced back to 1862, when President Lincoln appointed chemist Charles M. Wetherill to head the Chemical Division in the new U. S. Department of Agriculture. In the following decade Wetherill's successor as chief chemist of the USDA, Peter Collier, began working on the ubiquitous problem of food adulteration. Harvey W. Wiley replaced Collier in 1883, leading the division as it grew into the Bureau of Chemistry in 1901. The bureau was charged to enforce the first comprehensive federal statute of its kind, the Federal Food and Drugs Act, when that law was passed in 1906.

In 1927 Congress authorized the formation of the Food, Drug, and Insecticide Administration from the regulatory wing of the Bureau of Chemistry; the name of the agency was shortened to the Food and Drug Administration in 1930. FDA left the Department of Agriculture in 1940 for the Federal Security Agency, which was created a year earlier. In 1953 FDA joined the Department of Health, Education, and Welfare after Congress established that department to assume certain functions of FSA. In 1968 the agency became part of the Public Health Service within HEW. When the education function was removed from HEW to create a separate department, HEW became the Department of Health and Human Services in 1980.

FDA's responsibilities derive from statutes that date back to the early twentieth century. Harvey Wiley fought long and hard to unify disparate interest groups behind a federal law to deal with serious problems in the food and drug supply. Through Wiley's crusading, the support of the General Federation of Women's Clubs, the work of muckraking journalists, the efforts of state and local food and drug officials, cooperation from the American Medical Association and the American Pharmaceutical Association, and the impact of Upton Sinclair's The Jungle, a novel depicting the filth of the meat packing industry, Congress approved one of the landmarks of Progressive era legislation in 1906, the Food and Drugs Act. Among other provisions, this law charged the Bureau of Chemistry to control--albeit to a lesser extent than Wiley and others had hoped--adulterated and misbranded drugs and food in interstate commerce.

FDA initiated a movement to replace the problematical aspects of the 1906 act during the nascent New Deal. Again, the support of women's groups, journalists, and others was important to the final passage of a bill, as was the repercussion from a toxic preparation of the wonder drug, sulfanilamide. So-called Elixir Sulfanilamide employed an untested solvent for the drug, diethylene glycol, and eventually it killed over a hundred people, most of whom were children. The 1938 Food, Drug, and Cosmetic Act, which remains the basic law we have today, featured many provisions lacking in the 1906 Act. For example, it mandated that all new drugs be proved safe before marketing, therapeutic devices and cosmetics become subject to regulation, and standards of identity and quality be instituted for foods. The law also formalized FDA's ability to conduct factory inspections.

Over the following decades numerous amendments and other acts broadened FDA's responsibilities considerably. These include a mandate for agency testing of insulin and antibiotics; regulation of chemical pesticides and food and color additives; distinction between prescription and nonprescription medications; regulation of drug efficacy; ensuring of good manufacturing practices; control of prescription drug advertising; regulation of therapeutic agents of biological origin; and oversight of nutrition labeling. The realities of enforcing such broad statutes requires FDA's interaction with a variety of political, economic, and social interests. Today, as in the past, FDA strives above all else to safeguard the health and well being of the American people.

 

Selected Federal Food, Drug, Cosmetic, and Device Laws

Name of Law Date
Vaccine Act February 27, 1813
Drug Importation Act June 26, 1848
Tea Importation Act March 3, 1883
Food and Drug Importation Act August 30, 1890
Tea Importation Act March 2, 1897
Food Importation Act March 1, 1899
Biologics Control Act July 1, 1902
Pure Food and Drugs Act June 30, 1906
Meat Inspection Act June 30, 1906
Sherley Amendment August 23, 1912
Federal Trade Commission Act September 26, 1914
Harrison Narcotic Act December 17, 1914
Federal Food, Drugs, and Cosmetic Act June 25, 1938
Miller Amendment June 24, 1948
Durham-Humphrey Amendment October 26, 1951
Factory Inspection Amendment August 7, 1953
Miller Pesticides Amendment July 22, 1954
Food Additives Amendment September 6, 1958
Pesticide Chemicals Amendment June 29, 1960
Color Additive Amendment July 12, 1960
Kefauver-Harris Drug Amendments October 10, 1962
Drug Abuse Control Amendments July 15, 1965
Child Protection Act November 3, 1966
Vitamins and Mineral Amendments April 22, 1976
Medical Device Amendments May 28, 1976
Saccharin Study and Labeling Act November 23, 1977
Orphan Drug Act January 4, 1983
Safe Medical Devices Act October 27, 1990
Nutrition Labeling and Education Act November 8, 1990
Mammography Quality Standards Act October 27, 1992
Prescription Drug User Fee Act October 29, 1992
Dietary Supplement Health and Education Act October 25, 1994
Food and Drug Modernization Act November 21, 1997
Food and Drug Administration Amendments Act of 2007 January 4, 2007
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