An Overview Of Herbal Medicine
Medicinal herbs are some of our oldest medicines and their
increasing use in recent years is evidence of a public interest in
having alternatives to conventional medicine. Herbal medicines
currently account for one of the fastest growing markets in U.S.
pharmacies and constitute a multi-billion dollar industry. Market size
is predicted to approximately double between 1997 and 2001. Although
approximately 1500 botanicals are sold as dietary supplements or ethnic
traditional medicines, herbal formulations are not subject to FDA
premarket toxicity testing to assure their safety or efficacy.
In response to concerns regarding the use and efficacy of medicinal
herbs and to recent nominations of these products for study by the NTP,
a workshop on herbal medicines was organized to address research needs.
This workshop was sponsored by the NTP in conjunction with the NIH Office of Dietary Supplements, the DHHS Office of Disease Prevention and Health Promotion, the FDA
Office of Special Nutrition, and the Society for the Advancement of
Women?s Health Research and held 23-24 September 1998 in Raleigh, NC.
Its objectives were to discuss the use, safety, and possible
health-related problems associated with the use of medicinal herbs;
identify how other countries evaluate and regulate medicinal herbs;
establish the NTP?s role in determining their long-term safety; and
recommend areas for research. A broader objective of the meeting was
the focus and coordination of U.S./International research efforts.
Recommendations from the workshop include a call for more research,
identification and standardization of product ingredients by industry,
and increased consumer education through package inserts.
In follow-up to this workshop, the NTP staff is working with the NIH
Office of Dietary Supplements, the FDA, the academic community, and
others to further define and implement research that addresses
deficiencies in our knowledge about herbal medicines and their
potential toxicities. Several herbs and active or toxic ingredients
found in some herbs have been nominated and selected for study by the
NTP. These studies will focus on characterization of potential adverse
health effects including reproductive toxicity, neurotoxicity, and
immunotoxicity as well as those associated with acute high dose
exposure and chronic exposure to lower doses. In addition, special
attention will be given to the potential for herb/herb and herb/drug
interactions and the responses of sensitive ssubpopulations (e.g.
pregnant women, the young, the developing fetus, the elderly, etc). NTP
studies include both traditional toxicological research and molecular
mechanistic considerations. Comments from the public and others
regarding NTP
Research in this area is welcome and should be forwarded to the NTP Liaison and Scientific Review Office.
Herbs and Active or Toxic Ingredients for Study by the NTP
Golden Seal - Second or third most popular medicinal herb used in this country
Comfrey - Herb consumed in teas and as fresh leaves for salads; contains pyrrolizidine alkaloids, which are known to be toxic
Ginkgo - Among the five or six most frequently used medicinal herbs
Echinacea - Most commonly used medicinal herb in the United States
Berberine - An active ingredient in golden seal
Thujone - A toxic compound of worm wood
Pulegone - A toxic compound found in pennyroyal
Aleo vera - 7th most widely used herb, used as both a dietary supplement and component of cosmetics
Ginseng and gensenosides - 4th most
widely used medicinal herb, gensenosides are thought to be the active
ingredients. Ginseng has been associated with a number of adverse
health effects.
Kava.html">Kava Kava - Reported to be the 5th most
widely used medicinal herb, has psychoactive properties and sold as a
calmative and antidepressant
Milk Thistle Extract - A medicinal herb promoted for the treatment of liver disease that is becoming increasingly popular.
For further information contact the NTP Liaison Office at:
919-541-0530 Fax: 919-541-0295 liaison@starbase.niehs.nih.gov
Medicinal herbs are some of our oldest medicines and their
increasing use in recent years is evidence of a public interest in
having alternatives to conventional medicine. Herbal medicines
currently account for one of the fastest growing markets in U.S.
pharmacies and constitute a multi-billion dollar industry. Market size
is predicted to approximately double between 1997 and 2001. Although
approximately 1500 botanicals are sold as dietary supplements or ethnic
traditional medicines, herbal formulations are not subject to FDA
premarket toxicity testing to assure their safety or efficacy.
In response to concerns regarding the use and efficacy of medicinal
herbs and to recent nominations of these products for study by the NTP,
a workshop on herbal medicines was organized to address research needs.
This workshop was sponsored by the NTP in conjunction with the NIH Office of Dietary Supplements, the DHHS Office of Disease Prevention and Health Promotion, the FDA
Office of Special Nutrition, and the Society for the Advancement of
Women?s Health Research and held 23-24 September 1998 in Raleigh, NC.
Its objectives were to discuss the use, safety, and possible
health-related problems associated with the use of medicinal herbs;
identify how other countries evaluate and regulate medicinal herbs;
establish the NTP?s role in determining their long-term safety; and
recommend areas for research. A broader objective of the meeting was
the focus and coordination of U.S./International research efforts.
Recommendations from the workshop include a call for more research,
identification and standardization of product ingredients by industry,
and increased consumer education through package inserts.
In follow-up to this workshop, the NTP staff is working with the NIH
Office of Dietary Supplements, the FDA, the academic community, and
others to further define and implement research that addresses
deficiencies in our knowledge about herbal medicines and their
potential toxicities. Several herbs and active or toxic ingredients
found in some herbs have been nominated and selected for study by the
NTP. These studies will focus on characterization of potential adverse
health effects including reproductive toxicity, neurotoxicity, and
immunotoxicity as well as those associated with acute high dose
exposure and chronic exposure to lower doses. In addition, special
attention will be given to the potential for herb/herb and herb/drug
interactions and the responses of sensitive ssubpopulations (e.g.
pregnant women, the young, the developing fetus, the elderly, etc). NTP
studies include both traditional toxicological research and molecular
mechanistic considerations. Comments from the public and others
regarding NTP
Research in this area is welcome and should be forwarded to the NTP Liaison and Scientific Review Office.
Herbs and Active or Toxic Ingredients for Study by the NTP
Golden Seal - Second or third most popular medicinal herb used in this country
Comfrey - Herb consumed in teas and as fresh leaves for salads; contains pyrrolizidine alkaloids, which are known to be toxic
Ginkgo - Among the five or six most frequently used medicinal herbs
Echinacea - Most commonly used medicinal herb in the United States
Berberine - An active ingredient in golden seal
Thujone - A toxic compound of worm wood
Pulegone - A toxic compound found in pennyroyal
Aleo vera - 7th most widely used herb, used as both a dietary supplement and component of cosmetics
Ginseng and gensenosides - 4th most
widely used medicinal herb, gensenosides are thought to be the active
ingredients. Ginseng has been associated with a number of adverse
health effects.
Kava.html">Kava Kava - Reported to be the 5th most
widely used medicinal herb, has psychoactive properties and sold as a
calmative and antidepressant
Milk Thistle Extract - A medicinal herb promoted for the treatment of liver disease that is becoming increasingly popular.
For further information contact the NTP Liaison Office at:
919-541-0530 Fax: 919-541-0295 liaison@starbase.niehs.nih.gov
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