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The National Academy of Sciences Monograph on “Dietary Supplements: A Framework for Evaluating Safety”

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

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The National Academy of Sciences Monograph on “Dietary Supplements: A Framework for Evaluating Safety”

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

  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): http://books.nap.edu/catalog/10882.html

  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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