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No need for FDA approval before producing or selling; Does not need to be proven safe or effective; Comply with the Dietary Supplement Current Good Manufacturing Practices (CGMPs); No rules on serving size or amount in dietary supplements |
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Definition
Manufacturer required to submit to FDA all serious adverse event reports |
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Increase FDA's enforcement powers of the Food, Drug, and Cosmetic Act. Illegal to advertise claims not be allowed on supplement labels |
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Definition
Dietary Supplement Health and Education Act (DSHEA) passed |
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