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by

Cheryl Hoard

In 1978 the German government established a committee, called Commission E, comprised of physicians, pharmacologists, toxicologists, representatives of the pharmaceutical industry and lay persons. Phytomedicines, simply called herbal remedies, are commonly used and very popular in Germany. The German government saw the need to create a process to affirm their safety and effectiveness. The Commission E evaluated data obtained from clinical trials, field studies, collections of single cases, scientific literature including facts published in the standard reference works and expertise of medical associations. Their evaluations resulted in the establishment of "reasonable certainty" of the safety and effectiveness of the herb reviewed.

Here in the USA the FDA requires "absolute certainty" for all drugs. Dr. Andrew Weil, M.D., author of Spontaneous Healing and Eight Weeks to Optimum Health, looks at conventional medicine and sees that some procedures, in use today, like angioplasty and bypass surgery are not supported by evidence and were used long before proper clinical trials were done. Dr. Weil believes "Conventional medicine...uses methods more productive of harm, so it must be held to stricter standards." The FDA classifies herbs as dietary supplements in which no direct claims can be made for their use for certain conditions. The American public is left on its own to determine what is safe and effective. Many herb leaders who were involved in the Commission on Dietary Supplement Labels (CDSL) 1997 report to President Clinton presented documentation that herbs were successfully regulated as medicines in leading European nations, particularly Germany. In the words of Dr. Varro Tyler, "The German experience has definitely shown that reasonable certainty of safety and efficacy is adequate for long-used remedies." Dr. Tyler, Dean and Distinguished Professor of Pharmacognosy Emeritus School of Pharmacy and Pharmacal Sciences, Purdue University, was one of the first American authors to report on scientific herbal information. His books are now widely read by the American public and were some of the first herb books currently used by doctors in the USA.

There are 380 monographs presented in the American Botanical Council’s The Complete German Commission E Monographs, Therapeutic Guide to Herbal Medicines. This material has recently been translated into English and can be viewed at Cheryl’s Herbs Study Center where it is now a part of our library of over 500 books. The monographs include listings of approved herbs, unapproved herbs, uses and indications, contraindications, side effects, interactions of herbs with conventional drugs, duration of administration and more.

The German market is the largest with 10 percent of pharmaceutical sales being natural remedies. The French market is the second largest with both countries experiencing positive attitudes towards herbal medicine by the medical profession, government and pharmacies. In Germany a large proportion of herbs are sold on prescription.

Sales through health food stores are predominant compared to other outlets like supermarkets and drug discount stores. Although in the more developed markets of France and Germany, most herbal sales are through pharmacies. New legislation in France actually restricts the sale of licensed herbal products to pharmacies. Generally though, European countries allow herbal remedies to be sold only in places that provide some kind of advisory service to consumers.

Some countries like Germany and France have created a system of monographs that establish a plant’s safety and efficacy. Manufacturers only have to provide proof of a product’s quality. Products containing herbs not covered by existing monographs require clinical and toxicological support as vigorous as drug approval here in the USA. Interestingly, the UK is not producing any monographs and the British herbal market has been restricted by negative attitudes of the medical profession, government and pharmacies. Their herbal sales equal 2 percent of the UK’s total pharmaceutical market.

A copy of the monographs established by the German government are available for study at Cheryl’s Herbs. Although the English translation is in book form, the monographs were originally intended to be package insert information. The German Commission E Monographs have been described as the most accurate scientific information available in the entire world on the safety and efficacy of herbs.

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