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Food and Drugs Administration (FDA)

The Food and Drugs Administration (FDA) is an agency of the United States Department of Health and Human Services. It controls the safety of food, drugs and related blood products, cosmetics and veterinary products in the United States.

The FDA emerged from President Theodore Roosevelt’s Pure Food and Drug Act in 1906. This attempted to stop manufacturers and grocers adding cheap, sometimes poisonous, ingredients to food to make production cheaper. The American Medical Association (AMA) joined forces with the pure food lobby and argued that medicines also required control and regulation.

The Act was strengthened in 1912 to prohibit false claims of drugs’ effectiveness. This resulted in the collapse of the patent medicine industry. Drug regulation originally took place under the Department of Agriculture’s Bureau of Chemistry. The FDA became a separate agency in 1930.

The FDA now regulates quality and safety control over all food sold in the United States. It also licenses all drugs in the US. Any drug developed by a pharmaceutical company needs FDA approval for clinical trials before it is made available to patients.

The FDA has been attacked for unnecessarily delaying approval of drugs, including certain live-saving HIV/AIDS drugs. However, in thalidomide’s case a delay may have prevented people being disabled.

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External links:


PJ Hilts, Protecting America's health: the FDA, business, and one hundred years of regulation (New York: Alfred A. Knopf, 2003)

L Lasagna, ‘Congress, the FDA, and new drug development’, Perspectives in Biology and Medicine, 32 (1988-89), p 322

B F Shearer and B S Shearer (eds), Notable Women in the Life Sciences: a biographical dictionary (Westport: Greenwood Press, 1996)