Exploring the impact of the German Commission E.
Like the roots of an herb hidden beneath the soil’s surface, the foundations of current herb use in the United States are not immediately evident. Have you ever asked yourself why ginkgo, St. John’s wort, black cohosh, ginseng, garlic, echinacea, saw palmetto, valerian, bilberry and milk thistle are the top-selling herbs in the United States? Does some common factor draw consumers to them more than other herbs?
The simple answer is science. These herbs have more science behind them than most other herbs on the market. They also have something else in common: They are all approved as drugs in Germany. Since the late 1970s, changes in Germany’s drug regulations have required a system that registers herb products. This system requires development of information on how herbal products work (their chemistry and pharmacology), how well they work (clinical trials), and safety information based on their long history of use and any new scientific data.
Anyone who has done even cursory research into an herbal supplement or product has seen references to findings by the German Commission E. Few of us actually know what the commission is or how it is doing work that, by all rights, our own regulatory agency ought to do for the American consumer. If you’re interested in medicinal herbs — and you probably are if you’re reading this magazine — this relatively unknown working group has a great deal of influence on the choices available to you.
Germany is a place of contrast and continuity, where the past is never far from the present, embraced seamlessly as if time were nonexistent. When engaged in conversation about herbs, one is likely to hear the name Hildegard of Bingen, evoked as if the 12th-century nun were someone’s grandmother who had died just yesterday. Hildegard, author of Physica (Natural Science), the first herbal written by a woman, lived from 1098 to 1179. Her herbal was published in 1533 — a short time ago by German standards.
The therapeutic use of herbs is a longstanding tradition in Germany. A 1901 law, reaffirmed in 1961, allows for the sale of herbal medicines as drugs, giving them special status as medicinal agents, a unique situation compared with other European countries. In essence, throughout the 20th century up to the present, herbs sold with the intent of curing, alleviating or preventing disease or symptoms of illness have been allowed in the German market as drugs.
German research and herbal products have driven the U.S. market. Today, we turn to Germany for scientific information on herbs, including American medicinal plants. Much of the scientific data — chemical, pharmacological and clinical — on the best-selling herbs comes directly from German research. Many of the best-selling herb products in the United States also come from Germany.
According to Heinz Schilcher of the Institute of Pharmaceutical Biology at Berlin Independent University, one of the reasons herbal medicine has survived in Germany is because the use of herbs is considered a component of orthodox medicine, not as an alternative or complementary approach. Furthermore, he notes, an important reason for the acceptance of herbal medicine by many German physicians is the existence of the scientifically supported Commission E monographs. According to the late Varro Tyler, Ph.D., of Purdue University and author of Tyler’s Honest Herbal (Haworth, 1999), “These monographs constitute some of the most up-to-date and useful information extant on the safety and efficacy of plant drugs.”
Under German drug laws, there is a separate drug registration category for herbal medicines, also known as phytomedicines. In the United States, the very same herbs — often the same products — are regulated as “dietary supplements.” Dietary supplements are categorized as foods rather than drugs, even though they may provide the consumer with health benefits. The basis of therapeutic claims made on German herbal products is the information found in the federally sanctioned Commission E monographs. According to Tyler, “Basically, the regulations in Germany permit phytomedicines to be sold either as self-selected or prescription drugs provided there is absolute proof of safety and reasonable certainty of their efficacy.”
The German government’s counterpart to the U.S. Food and Drug Administration is the German Federal Institute for Drugs and Medical Devices. In 1976, Germany passed a law that required all medicines then on the market (including conventional drugs) to be reviewed by scientific committees. In 1978, they established a special committee on herbal remedies called the Commission E.
The Commission E is a federally appointed panel of leading experts on herbs and plant-based medicines. Members of the commission, who serve three-year terms, were proposed by various health professional associations and appointed by the Minister of Health. The initial task of the Commission E was to evaluate the safety and effectiveness of herbal remedies.
Today, the 24 members of the commission include physicians, pharmacists, pharmacologists, toxicologists, representatives of the pharmaceutical industry and lay persons, among others. About half of the members are university researchers who study the theoretical scientific basis of herbal medicines. The other half is composed mainly of health-care professionals with experience in prescribing and dispensing plant medicines. One of the perceived strengths of the commission is its ability to utilize a broad range of experience and expertise from numerous academic disciplines. According to longtime commission member Schilcher, the interdisciplinary nature of the Commission E is unique in the world.
From 1978 to 1994, the commission produced more than 300 monographs on specific herbs. The monographs include such details as the name of the herb, its constituents, indications for use, contraindications (if any), side effects (if known), interactions with other drugs (if known), dosage, method of dosing and the general properties or therapeutic value of the herb or herb product. The purpose of the monographs was to serve as the basis for product inserts or information on product panels. The results from the commission findings were published in the German Federal Gazette (Bundesanzeiger), the equivalent of our Federal Register. A total of 380 monographs covering 360 plant species are represented in the published monographs, which include those on single herbs and combination products.
The Commission E created the text for the monographs by reviewing relevant scientific information or the relevant experience of product use known to commission members. Because a bibliography is not part of the published monographs, it is not always clear exactly what information was used to reach a decision. Information considered for evaluating herbal monographs included literature on long-term traditional use of an herb, which can reveal a pattern of relative safety and presumed effectiveness. Chemical data revealed information on analysis of the botanical and its known active components and their relative quantities. Pharmacological and toxicological literature was used to corroborate traditional data. Starting in the 1980s, controlled clinical studies became increasingly important as sources of information. Because many herbal products have been used in Germany for many decades, market experience and epidemiological data were reviewed by the commission, if available and relevant. Given the long experience of herb use in Germany and the fact that several commission members are practitioners, the commission also considered case reports from clinical experience. Finally, unpublished data submitted by manufacturers was sometimes used.
The monographs have been updated periodically as new information on any aspect of a plant product, its intended medicinal use or safety becomes available. The monographs fall into two basic categories: Positive Monographs include accepted uses of a particular herb or plant part; Negative Monographs are published on herbs deemed harmless but considered ineffectual for medicinal purposes due to lack of scientific evidence of their therapeutic effectiveness, or whose use may be unacceptable due to possible toxicity.
Since 1994, the Commission E has not been involved in producing any new monographs. Its role has shifted to reviewing registration submissions for new plant-based medicines to be made available by prescription. It also continues to review and update data on the registration of nonprescription plant medicines. This work is carried out as part of an ongoing process under German law, whereby manufacturers are required to periodically renew licenses for the sale of well-established plant medicines. Recently, the Commission E issued guidance to the German Federal Institute for Drugs and Medical Devices that may in the future require manufacturers to carry out specific studies to determine how their products may interact with conventional drugs.
The complete text of the German Commission E monographs was translated and published in English by the Austin, Texas-based American Botanical Council in 1998. The work is called The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. (Now available on our website, www.herbsforhealth.com.) The project, initiated by Mark Blumenthal, executive director of the American Botanical Council and an Herbs for Health editorial adviser, took more than six years to complete.
As “harmonization” of drug laws proceeds in European Union nations, the Commission E monographs serve as the foundation for other regulatory and monograph systems emerging in various parts of the world. The European Scientific Cooperative on Phytotherapy uses the monographs as the basis for review of scientifically accepted uses of herbal medicine throughout the European Union. The World Health Organization draws on the Commission E’s work to develop a new series of herbal monographs that help regulatory agencies worldwide develop guidance for their own drug regulations. No doubt they will continue to impact the U.S. market as new regulations are considered for herbal medicines.
Steven Foster is lead editorial adviser of Herbs for Health and is the author of 14 books, including the Peterson Field Guide to Western Medicinal Plants and Herbs, with Christopher Hobbs (Houghton Mifflin, 2002).