# Presentation: 076842

## Botanical Research Centers:NIEHS Interests

- Elizabeth A. Maull, Ph.D.
- Program Administrator, NIEHS

## Historical 

- 1998 – National Toxicology Program held a Workshop on Herbal Medicines
- Recommendations
- More research on herbals
- A call for industry to identify and standardize product ingredients
- Increase consumer education

## National Toxicology Program Efforts

- Herbs and active or toxic ingredients of herbs nominated and selected for study by NTP
- Criteria – widespread human exposure
- Assessments preformed by NTP
- Acute high dose effects
- Chronic low dose effects
- Reproductive toxicity
- Neurotoxicity
- Immunotoxicity

## National Toxicology Program Efforts (cont.)

- Of special interest to the NTP:
- Potential for herb/herb or herb/drug interactions
- Responses of sensitive subpopulations
- Pregnant women
- Developing fetus
- Young
- Elderly

## NIEHS Focus for BRC Recompetition 

- Centers structured around a central scientific theme
- Research projects that complement ongoing National Toxicology Program efforts

## NIEHS Focus for BRC Recompetition

- Agriculturally related issues
- Biologically related issues

## Agriculturally Related Issues

- Identification of environmental factors influencing the concentration of bioactive constituents
- Localization of bioactive ingredients within the plant
- Development of “fingerprinting” technologies
- Identify the plant source of a botanical
- Detection of adulterations of botanicals

**Notes:**
Environmental factors:  impact of harvest time; soil type; optimal growing conditions; use fertilizers
Also interested in post harvest conditions; for example the impact of storage time on the concentrations of bioactive ingredients; the effects of processing on bioactive compounds

## Biologically Related Issues

- Mechanisms of action of bioactive ingredients
- Identification of targets for botanicals (molecular, cellular, organ)
- Identification of interactions (antagonistic or synergistic) with other botanical components
- Potential botanical/botanical or botanical/drug interactions

## Biologically Related Issues (cont.)

- Pharmacokinetic / pharmacodynamic analyses of botanicals
- Study the role of botanicals as regulators of genetic pathways or epigenetic events
- Identify and validate biomarkers of botanical intake or biological effects

**Notes:**
Pharmacokinetics: ADME; the action of drugs in the body over a period of time including the processes of ADME
Pharmacodynamics: the study of biochemical and physiological effects of drugs with their chemical structure; also, such effects on the actions of a particular drug or drugs
MOA including correlation of actions and effects of drugs with chemical sturcture
Epigenetic – refers to factors affecting the development or function of an organism other than primary sequence of target genes.
Biology- any change in an organism brought about by alterations in action of genes

## Botanicals of Interest (NTP)http://ntp-server.niehs.nih.gov/htdocs/liason/factsheets/HerbMedFacts.pdf

**Aloe vera gel**
**Black cohosh**
**Bladderwrack**
**Blue green algae extract**
**Comfrey**
***Echinacea purpurea***** Ephedra**
***Ginkgo biloba***** extract**

**Ginseng and ginsenosides**
**Goldenseal**
**Green tea extract**
**Kava kava extract**
**Milk thistle extract**
**Pulegone**
**Senna**
**Thujone**

## Elizabeth A. Maull, Ph.D.

**Elizabeth A. Maull, Ph.D.**
**Program Administrator**
**Susceptibility and Population Health Branch**
**National Institute of Environmental Health Sciences**
**T: (919) 316-4668**
**F: (919) 316-4606**
**E: maull@niehs.nih.gov**