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New Labeling Program Delivers Safety Information for Herbal Products
Austin TX, 1 March 2003

Editor's 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).

Some 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.

However, 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.

Thus, 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.

To 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.

The 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.

"In 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."

As 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.

The SIS presents a rational interpretation of the literature on the safety aspects of a particular herb—together 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.

"This 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."

The 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.

Nature's 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.

About ABC

The 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.


American Botanical Council (ABC).end-of-story




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