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