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7 Cards in this Set
- Front
- Back
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dietary supplement
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-legally classified as food products
-treated differently by the FDA |
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OTC
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-over the counter drugs
-a drug is a product intended for use in the diagnosis, cute, mitigation, treatment, or prevention of disease |
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Dietary Supplement Health and Education Act (DSHEA)
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-1994
-passed in part due to pressure on Congress from the supplement industry in response to indication that the FDA was planning to expand regulation of dietary supplements -defined supplements and set regulations for safety and labeling |
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Saint-John's-Wort
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-many take it for its suggested ability to improve mood, reduce anxiety, and induce sleep
-classified as a dietary supplement, it is regulated more like a food than a drug |
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GRAS
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"generally recognized as safe"
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GRAE
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-"generally recognized as effective"
-a reasonable expectation that the pharmocological effect of the drug will provide clinically significant relief of the type claimed in a significant proportion of the target population |
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GRAHL
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-"generally recognized as honestly labeled"
-more than 100,000 OTC products on the market contain fewer than 1,000 total active ingredients |
