New Labeling Program Delivers Safety Information for Herbal Products
TX, 1 March 2003
Note: Many stories challenging the safety of herbal supplements
have appeared in the media over the past year. While most attention
has focused on ephedra, concerns have also been raised about
other supplements (such as kava).
sources claim these concerns mean that Americans should change
the regulatory framework for herbs established by the Dietary
Supplement Health and Education Act of 1994 (DSHEA) and adopt
the same pre-market screening required for pharmaceutical drugs.
herbal supplements are based on centuries of safe use by health
professionals. Until the development of modern pharmaceuticals
over the course of the past several decades, many of these botanicals
were part of mainstream Western medicine.
SupplementQuality.com agrees with the Supreme Court that a better
solution to problems arising from potentially misleading information
is to provide more information, instead of imposing a "father
knows best" approach that would effectively end public access
to many useful supplements.
this goal of providing more information, SupplementQuality.com
welcomes news from the American Botanical Council that they
have developed a program for providing comprehensive and accurate
safety information where it is most needed: on the label.
American Botanical Council (ABC) announces a new program to provide
quality, science-based safety information for commercial herbal
products. The Safety Labeling Program (SLP) is designed to help
manufacturers provide a range of safety data on product labels for
the benefit of both consumers and healthcare professionals.
general, we do not believe there is a safety problem with herbs,"
says Mark Blumenthal, founder and executive director of ABC. "However,
we think it is important to provide consumers and health professionals
with accurate guidelines for the responsible use of herbal products."
an independent third party, ABC conducts research on a particular
herb, and provides the data in a format called Safety Information
Sheets (SIS). Selected herbs are currently available and more will
be added over time as needed. ABC licenses use of the SIS, along
with the ABC name and logo, to manufacturers who adapt the SIS into
text for their standard label, including new accordion-style labels,
peel-out labels, as a package insert, or on the panel of a box.
SIS presents a rational interpretation of the literature on the
safety aspects of a particular herbtogether with accurate,
useful information on contraindications, adverse effects, potential
interactions with prescription and over-the-counter drugs, pregnancy
and lactation warnings, and other guidelines. A draft version of
each SIS is sent to expert reviewers whose comments are researched
and may be included in the SIS. Before the product can display the
ABC name and logo, ABC reviews the manufacturer's proposed label
text to ensure its accuracy and that it is an adequate reflection
of the information contained in the SIS.
is the first time that the American Botanical Council has allowed
its name on a commercial herb product," Blumenthal notes. "We hope
to see an increase in confidence about herbal products now that
consumers have access to the safety information they have requested."
primary source of information in the SIS is The ABC Clinical
Guide to Herbs, a soon-to-be-published reference book that includes
comprehensive monographs, abbreviated clinical overviews, patient
information sheets, and extensive references for 29 of the most
commonly used herbs and 13 proprietary products and herb combinations.
Relevant information in the SIS will be updated on an as-needed
basis, and the updated sheets will be forwarded to participating
manufacturers so that they may revise their product labels.
Resource Herbs, manufactured by Pharmavite Corporation, developed
the program with ABC and will be the first manufacturer to participate
in the program. ABC's safety information will appear on millions
of Nature's Resource labels this year.
American Botanical Council is one of the leading nonprofit educational
and research organizations disseminating science-based information
promoting the safe and effective use of medicinal plants and phytomedicines.
This member-sponsored organization also publishes the peer-reviewed
journal HerbalGram, and offers a variety of educational publications
covering herb research and regulation for the benefit of the general
public and ABC's members.
Botanical Council (ABC).