The Regulation of Dietary Supplements in the United States
USA
Aug 04, 2022
s it legal to make health claims for a product sold in the United States without being required to prove those claims? Yes, but only if those claims relate to dietary supplements, not drugs. The world of dietary supplement regulation is quite unlike any other. First, dietary supplements are not drugs, but "food" in the regulatory scheme. The US Food and Drug Administration has no authority to approve or deny approval to manufacturers for the marketing of dietary supplements. There is, however, a general prohibition against marketing drugs that are "adulterated or misbranded." The author discusses information for pharmacists relative to this topic.
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Australia
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FDA new guidance on "New Dietary Ingredient Notification Procedures and Timeframes"
USA
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ANVISA revises pre-market control system
Brazil
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FDA updates directory of ingredients used in dietary supplements
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