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The National Academy of Sciences Monograph on “Dietary Supplements: A Framework for Evaluating Safety” Norman R. Farnsworth, Ph.D. Research Professor of.

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Presentation on theme: "The National Academy of Sciences Monograph on “Dietary Supplements: A Framework for Evaluating Safety” Norman R. Farnsworth, Ph.D. Research Professor of."— Presentation transcript:

1 The National Academy of Sciences Monograph on “Dietary Supplements: A Framework for Evaluating Safety” Norman R. Farnsworth, Ph.D. Research Professor of Pharmacognosy UIC Distinguished Professor College of Pharmacy University of Illinois at Chicago November 2, 2004

2 Rationale for Framework The Institute of Medicine was requested by the FDA to develop a framework for evaluation of the safety of dietary supplement ingredients Prepublication copy and Hardcover (soon):

3 Rationale for Framework The final framework included methods for prioritizing and evaluating safety based on existing information available to FDA and others

4 Rationale for Framework The framework was developed based on current law as described in DSHEA

5 Rationale for Framework Vulnerable Groups and Prevalence of Use Application of the framework

6 Categories of Scientific Information Used Human data –Historical use –Clinical studies –Epidemiological studies Animal data Related substances In vitro data

7 Interactions Types of interactions –Predictability

8 Case Studies Using Prototype Safety Monographs Glucosamine Melatonin Chromium picolinate Saw Palmetto Shark cartilage Chaparral

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