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Vitamins, minerals, amino acids, enzymes, botanicals (herbal medicines), and certain components or derivatives of animal foods (organ and glandular tissues) were classified as dietary supplements by the Dietary Supplement Health and Education Act of 1994. This federal law exempts these drug entities from the safety and efficacy requirements and regulations that manufacturers and marketers of prescription and over-the-counter drugs must observe (for example, preclinical animal studies, premarketing controlled clinical trials, postmarketing surveillance). A product label may make health claims provided that it also bears a disclaimer stating that the product is not sold for the prevention, diagnosis, treatment, or cure of any disease. For many nutraceuticals, little or no experimental information is available as to efficacy, side-effects, and drug interactions. Because these medicines cannot be patented, pharmaceutical manufacturers have little incentive to c conduct research on their properties, beneficial or harmful. The U.S. Food and Drug Administration must show that a nutraceutical is unsafe before it can be removed from the market. But because federal legislation provides no mechanism for the observation or mandatory reporting of adverse events such as hypersensitivity, hepatic or renal toxicity, suppression of bone marrow, fetal harm, or drug interactions, nutraceuticals are largely secure from federal ban. No federal agency maintains oversight or control of the potency or purity of herbal products. Random studies suggest that these products vary widely in potency (sometimes containing none at all of the labeled ingredient) and may often be adulterated with other agents or contaminated with pesticides. Surveys show that 10-30% of the U.S. population use herbal remedies at least occasionally, but that more than 50% of these fail to disclose such use during routine medical history-taking (for example, before surgery). More than 50% of amateur and professional athletes and bodybuilders use stimulants, protein supplements, and hormones. Among the more popular herbals are echinacea, garlic, ginkgo, ginseng, kava, St. John's wort, and valerian. Widely used agents not derived from botanical sources include androstenedione, creatinine, DHEA, glucosamine, melatonin, pregnenolone, minerals (for example, chromium, manganese, zinc), and vitamins. Virtually all these have significant potential for adverse side-effects or harmful interaction with other drugs.
nutraceuticalAny food or part thereof with medicinal or health benefits, which includes vitamins and herbal products.
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