What do we need to know about active ingredients?

Workshop #1

Discussion focus--Botanicals Question— Are traditional nutritional and

pharmacological approaches applicable to herbal supplements?

Multiple biologically active substances in products

Multiple biological activity endpoints

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

Analytical database development NAPRALERT, IBIDS—good sources,

need to expand knowledge base internationally

USDA databases as models

Reference materials Standardized products needed for

research Dietary fiber & fish oil standard

products as models Industry should collaboratively

develop—nonproprietary, best first guess as to efficacy/safety

USP certification

Clinical trials Need standard reference products Use classical approach (Phase I, II,

etc..) Determine priorities for clinical trials Selection criteria?

Extent of use Efficacy—target major public health

issues Safety

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

Biomarkers Little progress to date May be useful

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