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In the last quarter of the 19th century many attempts were made to enact a national food and drug law. Gradually a coalition developed, including farmers, food processors, state officials, physicians, women's club members, and muckraking journalists. Pressure from this powerful lobby together with public alarm over unhygienic conditions in Chicago's meat-packing plants revealed in Upton Sinclair's novel, The Jungle, and confirmed by government investigators, finally pushed Congress to enact, in l906, both a meat inspection law and the Food and Drugs Act. The law forbade adulteration and misbranding of foods, drinks, and drugs in interstate commerce but contained few specific requirements to insure compliance. Technological changes and adverse court decisions soon made it obsolete.
Thirty years later a drug tragedy in which over 100 people were killed by a poisonous solvent used to dissolve the wonder drug sulfanilamide, greatly dramatized the need to broaden existing legislation and ensure product safety before marketing. The following year Congress passed and President Franklin D. Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act of 1938 which, with major amendments in the last 50 years contains the basic law of the land. Among numerous new provisions, it required manufacturers to provide scientific proof of a new drug's safety before it could be marketed and made dangerous or falsely labeled cosmetics and therapeutic devices illegal.
Enforcement of these laws is the mission of the Food and Drug Administration (FDA), established originally as the Bureau of Chemistry in the Department of Agriculture. Today, as a major regulatory agency of the Public Health Service, the FDA ensures consumers that foods are safe and wholesome; prescriptions and nonprescription medicines, animal drugs, and biologic drugs are safe and effective for their labeled uses; cosmetics are harmless; medical devices are safe; all these products are honestly and accurately labeled and packaged; and that radiation from electronic products does not pose a consumer hazard.
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U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894 National Institutes of Health Department of Health & Human Services Copyright, Privacy, Accessibility Last updated: 27 April 1998 |