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 UIC
Distinguished Professor College of
Pharmacy University of Illinois at
Chicago November 2, 2004
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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

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Rationale for Framework

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

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Rationale for Framework

• The framework was developed based on current law
  as described in DSHEA

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Rationale for Framework

• Vulnerable Groups and Prevalence of Use
• Application of the framework

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Categories of Scientific Information Used

• Human data
• Historical use
• Clinical studies
• Epidemiological studies
• Animal data
• Related substances
• In vitro data

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Interactions

• Types of interactions
• Predictability

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Case Studies Using Prototype Safety Monographs

• Glucosamine
• Melatonin
• Chromium picolinate
• Saw Palmetto
• Shark cartilage
• Chaparral

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