Eskinazi.D. - Botanical Medicine Efficacy, Quality Assurance, and(2).pdf

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cover
cover
title :
Botanical Medicine: Efficacy, Quality Assurance, and
Regulation
author :
Eskinazi, Daniel.
publisher :
isbn10 | asin :
0913113832
print isbn13 :
9780913113837
ebook isbn13 :
9780585277981
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cover
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Botanical Medicine
Efficacy, Quality Assurance, and Regulation
Editor Daniel Eskinazi, D.D.S., Ph.D., L.Ac.
The Richard and Hinda Rosenthal Center
for Complementary & Alternative Medicine
Department of Rehabilitation Medicine
Columbia University College of Physicians &
Surgeons, New York, New York
Associate Editors Mark Blumenthal
American Botanical Council, Austin, Texas
Norman Farnsworth, Ph.D.
University of Illinois at Chicago
Chance W. Riggins
American Botanical Council, Austin, Texas
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Copyright © 1999 by Mary Ann Liebert, Inc., 2 Madison Avenue, Larchmont, NY 10538
ISBN: 0-913113-83-2
All rights reserved.
No part of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by
any means, electronic, mechanical, photocopying, microfilming, recording, or otherwise, without written
permission from the publisher.
Cover drawing of Sambucus nigra (elder) by Eric Yarnell, N.D.
Printed in the United States of America.
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PREFACE
The 1992 legislative language creating the Office of Alternative Medicine at the National Institutes of Health clearly
reflects a strong Congressional interest in the "investigation and validation" of alternative medicine. To achieve the
mandated goals, the Office of Alternative Medicine, in cooperation with the Food and Drug Administration, has
begun to address several regulatory issues under the aegis of the FDA. These issues may affect the research into, and
availability of, products and devices that are relevant to alternative medicine.
One of the "alternative" approaches that falls within the purview of the Office of Alternative Medicine is that of
botanical medicine. Indeed, the last decade has seen a resurgence of interest in the use of botanical products for
medicinal purposes. This interest may have been kindled by factors such as inadequate treatments of chronic
conditions, and other perceived shortcomings of the conventional health care system. Also, an increasing number of
articles in the lay and scientific press have touted the virtues of these products, and the concerns about maintaining
their availability in their natural habitat.
The role of botanicals is a rather complex one from a regulatory standpoint. These products fall within more than
one regulatory category in the United States: they may be considered foods, dietary supplements, or drugs, chiefly
depending on their intended use as defined by the products' labeling.
In 1994, the Office of Alternative Medicine invited the Food and Drug Administration to assist in the planning of a
conference on botanical products. The "Symposium on Botanicals: A Role in US Health Care?" was organized in co-
operation with the FDA, and brought together academia, industry, the United States Pharmacopeia, and agency and
government officials, both from the United States and abroad, to discuss the role and regulation of botanical
products in US health care.
The symposium was composed of five panels. Each panel was given the task of answering specific questions:
"What are botanicals and how are they currently used?" This panel discussed the use of botanical medicines in
foreign countries, and the most common uses in the United States.
"How can we know that botanicals work?" This panel discussed the relative advantages and limitations of the
traditional controlled clinical trial, as well as other methodological approaches, including single case studies and
outcomes research.
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"How can we know that these products are safe?" This panel discussed methods for assessing potential adverse
events resulting from the use of botanical products.
"How can we ensure that botanical preparations will be reliable and of good quality?" This panel discussed the
necessary steps to ensure the product's quality, purity, and reliability.
"How do regulations affect the marketplace and impact the cost of health care?" This panel addressed two issues: (1)
the economic factors impacting on the development of botanical medicine in various countries, including Europe
and the United States; and (2) the legal and regulatory issues that are relevant to the marketing of these products.
This symposium was held in Washington D.C., in December, 1994. It was attended by more than 450 participants,
many of whom viewed it as a historic event, as it brought together for the first time, in a cooperative atmosphere, the
various parties directly interested in this set of issues. The meeting aided in identifying and defining the relevant
issues. Follow-up meetings, such as several recent conferences sponsored by the Drug Information Association,
have discussed many of the issues presented at the symposium in greater detail. In addition, the FDA has formed
several internal working groups to discuss policy issues, which might result in new regulatory considerations for
botanical products.
Although the material presented here has not been significantly updated since the workshop, it is still current and
relevant, as the issues raised are still being debated in the same terms, and little further substantive progress has been
made to date.
DANIEL P. ESKINAZI, D.D.S., Ph.D., L.Ac.
FORMER DEPUTY DIRECTOR
OFFICE OF ALTERNATIVE MEDICINE
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