What do we need to know about active ingredients?

1
What do we need to know about active ingredients?

• Workshop 1

2
Discussion focus--Botanicals

• Question
• Are traditional nutritional and pharmacological
  approaches applicable to herbal supplements?
• Multiple biologically active substances in
  products
• Multiple biological activity endpoints

3
Identifying meaningful components

• Meaningful Components that produce a biological
  effect
• Identification of meaningful components should
  precede study of their bioavailability
• Analytical chemistry databases inadequate for
  botanicals

4
Analytical database development

• NAPRALERT, IBIDSgood sources, need to expand
  knowledge base internationally
• USDA databases as models

5
Reference materials

• Standardized products needed for research
• Dietary fiber fish oil standard products as
  models
• Industry should collaboratively
  developnonproprietary, best first guess as to
  efficacy/safety
• USP certification

6
Clinical trials

• Need standard reference products
• Use classical approach (Phase I, II, etc..)
• Determine priorities for clinical trials
• Selection criteria?
• Extent of use
• Efficacytarget major public health issues
• Safety

7
Bioassays

• potential screening tools
• use with caution
• No substitute for clinical studies

8
Biomarkers

• Little progress to date
• May be useful

9
Summary

• Identification of meaningful (bioactive)
  components should be the main focus
• Bioavailability may be a key determinant of
  bioactivity
• Need for standard reference materials
• Clinical studies should be based on these 3
  research areas