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The National Academy of Sciences Monograph on

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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 Pharmacognosy – PowerPoint PPT presentation

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Title: The National Academy of Sciences Monograph on


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)
    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

9
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