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Health Agencies Update
August 21, 2002

Dietary Supplement Framework

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Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002American Medical Association

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JAMA. 2002;288(7):823. doi:10.1001/jama.288.7.823

Although consumer interest in dietary supplements has exploded into a $15 billion-a-year industry, the many shelves of bottles remain virtually unregulated. Under the Dietary Supplement Health and Education Act of 1994, the products are assumed to be safe unless the Food and Drug Administration (FDA) proves otherwise.

Reflecting rising interest in regulation of these products, and at the request of the FDA, the Institute of Medicine has devised a framework for evaluating the safety of dietary supplements. "Ideally, a critical safety evaluation for each dietary supplement could be completed," write the authors of Proposed Framework for Evaluating the Safety of Dietary Supplements. However, the lack of resources to study hundreds of products means that the FDA would have to prioritize. New ingredients would be high on the list, as would those with suspected or reported links to adverse events. The report is available at

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