| Overview of Federal Food, Drug, and Cosmetic Act |
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| Congress passed the Federal Food, Dug, and Cosmetic Act (FDCA) in 1938. The FDCA set up the Food and Drug Administration (FDA) to enforce the Act. The goals of the FDCA were to assure that foods are pure and safe to eat, that drugs and medical devices are safe and effective, and that cosmetics are safe. The FDCA banned adulterated and misbranded food from interstate commerce. The FDCA also regulates the labeling and packaging of foods, drugs, medical devices, and cosmetics. Under the FDCA, the FDA was given authority to adopt regulations dealing with food, drug, medical device, and cosmetic safety. This article discusses important amendments to the FDCA. More... |
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| The Food and Drug Administration's 2004 Initiatives for Dietary Supplements |
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| Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA), giving the Food and Drug Administration (FDA) power to adopt specific standards for dietary supplements. Dietary supplements include vitamins, minerals, herbs, botanicals, amino acids, and nutraceuticals. More... |
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| Toxic Shock Syndrome Litigation |
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| Toxic Shock Syndrome (TSS) is a serious, sometimes fatal disease, caused by a toxin produced by certain types of bacteria. TSS first emerged in the late 1970s and early 1980s. It showed up in women using highly absorbent menstrual tampons. The symptoms of the disease include high fever, a red rash, muscle ache, nausea, vomiting and/or diarrhea, seizures, headache, and organ failure. Studies by the Center for Disease Control and by several state health departments show that a statistically significant link exists between tampon use and TSS. Certain brands of super-absorbent tampons were withdrawn from the market in the 1980s.More... |
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| FDA and the Recall Process |
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| The U.S. Food and Drug Administration (FDA) is responsible for monitoring adverse product experiences. If a product is deemed defective by the FDA, the FDA is authorized to request that members of industries regulated by the FDA recall the product. The FDA is also authorized to mandate product recalls under certain circumstances. More... |
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| The FDA Modernization Act of 1997 |
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| In 1997, Congress passed legislation amending the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biological products. The new legislation, called the Food and Drug Administration Modernization Act, reduces the approval time for drugs and medical devices while maintaining patient safety. In addition, the Modernization Act provides the U.S. Food and Drug Administration (FDA) with additional resources to devote to expediting the drug and medical device review process.More... |
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