Hypericum, Herbs, and Health Policy
We turn this chapter over to an expert in the field of law and nutritional supplements, Mary Elizabeth Conn, J.D., M.B.A. She is an Assistant Professor of Business Law at the University of San Diego and has a private practice as a trial attorney. She is currently serving as Special Deputy Trial Counsel for the State Bar of California.
We are grateful to Professor Conn for her permission to publish her paper, "Hypericum, Herbs, and Health Policy."
Hypericum perforatum has been used for thousands of years by traditional healers as a botanical medicine. In Germany, hypericum is used to treat first and foremost, mild to moderate depression as well as anxiety and sleep disorder. In Germany, approximately three million prescriptions for hypericum are issued and almost 66 million daily doses of hypericum preparations are consumed annually.
Germany's Commission E is a special scientific committee of Bundesgesundheitsamt (Federal Department of Health), an independent division of the German Federal Health Agency. Since 1978 Commission E has actively engaged in collecting data on herbal medicines, evaluating their safety and efficacy and publishing the results in Bundesanzeiger, a publication similar to the Federal Register, in the form of brief monographs. Each monograph includes either a positive or negative assessment of whether a particular herb is safe and effective for over-the-counter use. The labeling of herbal products is based on the Commission's cautions and, when appropriate, an acknowledgment that a particular herb's efficacy may not be proven. Each monograph outlines the herb's action in the body, whether the medicinal (botanical) plant is free from side effects, the contraindications, as well as noting the proper schedule for its various dosage forms.
Commission E is comprised of a panel of experts specializing in the various aspects of medicinal plant research and use, including physicians, pharmacists, pharmacologists, toxicologists, representatives of the pharmaceutical industry, and consumers. The Commission requests studies from manufacturers in addition to information obtained from animal research, human clinical trials if available, epidemiological studies, historical usage information, clinical experience of physicians, and the subjective evaluations by patients. The panel of experts reviews the information and the Commission makes a judgment based on the results. The Commission's criteria for giving any herbal medicine its approval are that the herb must be absolutely proven to be safe and shown to be reasonably effective. Commission E's monograph lists Hypericum perforatum as an approved herb.
Commission E has published 312 monographs which cover 286 individual herbs and various herbal combinations. The German monographs have been recently translated into English and will be published by the American Botanical Council in the fall of 1996. The American Botanical Council is a nonprofit herb research and educational organization based in Austin, Texas. These monographs represent the most comprehensive and up-to-date herb information in the world.
In Canada, the Health Protection Branch convened an Expert Advisory Committee on Herbs and Botanical Preparations to study the labeling of herbal products in 1984. The Committee issued a report in 1986, recommending the establishment of a new class of remedies to be designated "Folklore Medicines." The Report of the Expert Advisory Committee on Herbs and Botanical Preparations sent to the Minister of National Health and Welfare led to significant developments by the Health Protection Branch. Regulatory procedures were established that permitted health claims to be made for herbs on the basis of information readily available in standard reference sources such as pharmacopeias, pharmacology books, or supportive references in general scientific and clinical literature. The Canadian regulatory system allows for the labeling of herbal medicines to inform the consumer regarding therapeutic uses of certain products as well as issuing regulations for proper dosage amounts.
The laws and regulations governing the sale and labeling of herbal medicines in the United States is the Food and Drug Administration (FDA), a division of the Department of Health and Human Services. The FDA is the federal agency that administers and enforces the Federal Food, Drug, and Cosmetic Act of 1938, (FFDCA) as amended. This Act provides the basis for the regulation of much of the testing, manufacture, distribution, and sale of food, drugs, cosmetics, and medical devices sold to the public. The FDA's social objective is to protect consumers health and well-being by preventing the dissemination of unsupported or insubstantial scientific information on food and dietary supplement labeling.
Extensive scientific research in the German-speaking countries has yielded a great deal of information on Hypericum perforatum and its effect on mild to moderate depression and anxiety. In comparison with other countries, the United States has done very little research on whole plant or crude plant extracts as medicinal agents. In the United States a plant cannot be patented. American pharmaceutical companies screen plants for biological activity and then the active compounds are isolated. If the active compounds are proven to be powerful enough, the drug companies will begin the process for a new drug application to procure FDA approval -- an expensive and arduous process. Because of prohibitive costs and an absence of patent protection, very little incentive exists for the drug companies to actually engage in this arduous process.
In order to facilitate the use of vitamins, minerals, herbs, and botanicals to combat nutritional deficiencies and disease, portions of the FDCA, were amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA). The basic purpose of the DSHEA amendments to the FDCA is to ensure that the public has over-the-counter access to "dietary supplements," which include vitamins, minerals, amino acids, herbs and botanicals. In passing DSHEA, Congress made certain findings of fact related to the health of the American consumer, and specifically found that a rational federal regulatory framework was needed to supersede the current regulatory approach to dietary supplements. In order to accomplish this, DSHEA precludes the FDA from regulating "dietary supplements" as a "drug" solely because of any statements on the products labeling regarding claims that the product can treat or affect a nutritional deficiency or disease -- unless the FDA determines that the product is not safe.
There is, however, still no formal way to evaluate health claims for herbs short of going through the new drug application process -- a multimillion dollar commitment which is not cost effective for most herb companies. A rational federal regulatory system for the evaluation of therapeutic claims is not likely to materialize before the year 2000. DSHEA mandates that a seven-member committee of experts, appointed by the President, provide recommendations on how to evaluate health claims on supplement labels, including herbs. Under the provisions of DSHEA the panel will have two years to present its recommendations. The FDA will have another two years to formally draft the regulations. Presently, the labeling for dietary supplements must include only truthful, non-misleading, scientifically backed "statements of nutritional support" and "structure and function claims," which describe how a supplement alters the structure or function of the body.
It is hoped that in the FDA's efforts to understand medicinal herbs they will look to the efforts of other countries such as Germany's Commission E, and the Canadian regulatory system as a guide to drafting sensible regulation. Until such time, the American Botanical Council's English translation of the Commission E monographs can be used to empower consumers and also as a guide by pharmacists and health care professionals to help patients determine which herb should be taken for their specific health needs as well as address approved therapeutic uses, contraindications, safety data, dosage recommendations, and other pertinent information. Moreover, this could be used as a guide for the FDA in establishing labeling requirements for herbs in this country. Perhaps the United States might follow European policies that may make it more economically feasible for American companies and universities to research and develop herbs as medicines. Perhaps hypericum will lead the way.
Mary Elizabeth Conn, J.D., M.B.A.
P.O. Box 9005-502
La Mesa, California 91944
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Copyright © 1996 by Harold H. Bloomfield, M.D. and Peter McWilliams
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