Introduction to Herbs The American Approach

{Excerpts from The Complete German Commission E Monographs with editors notes in ()}

Increased use of herbal medicines in the United States requires a thorough review of appropriate methods to evaluate them for safety and therapeutic benefits. Some experts have called for reformed regulations to ensure that these products be labeled with adequate directions for use and reasonable information regarding their benefits and potential risks. ( Other interest have denounced any governmental influence, fearing interference in their get-rich-quick mixtures with dubious and untried ingredients.)

This Introduction covers aspects of the market for herbal products in the U.S., including consumer attitudes and market statistics. A review of the current regulatory situation is also presented, with focus on the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the difficulty in obtaining over-the-counter (OTC) drug status for well-researched herbs and phytomedicines. Considerable coverage is made of the market situation for herbs and phytomedicines and the strong proactive consumer demand for and acceptance of natural products, especially those perceived to benefit health, from simple herbal teas for treatment of minor illnesses to tonics that are believed to enhance wellness in the present and to prevent serious illnesses.

Herbs and phytomedicines are experiencing explosive growth in pharmacies and other mass-market retail outlets. An estimated 30 percent of American adults - 60 million - are reported to be using herbs and phytomedicinal products, spending an estimated $3.24 billion in 1996. These high rates of sales growth and the potential profits have drawn the interest of the investment banking community, where it is said that the herb sector of the dietary supplement market represents one of the biggest financial investment opportunities since the advent of the high-technology industry.

The change in social attitudes toward natural medicine ensures continued growth in herb use well into the future. As these products become a more integral part of American culture, increased efforts will be required in evaluating the quality, overall safety, potential benefits and effectiveness, and appropriate therapeutic and clinical guidelines for their responsible use.

The current regulatory system under DSHEA allows products( but does not require) to be labeled to communicate to consumers the potential safety problems that may be associated with the product. The new law now permits manufacturers to publish potential side effects, contraindications appropriate for some users and, if needed, additional special warnings. Section 6 of the law allows "statements of nutritional support" and statements about how the product affects the "structure and function" of the body. However, a product cannot make a statement that is deemed "therapeutic" or imply that it is useful to diagnose, treat, cure, or prevent any disease. Herbal products are not permitted labeling that contains a drug claim, except for a few herb products that are approved for over-the- counter drug use. A recent report by the President's Commission for Dietary Supplement Labels has suggested that the U.S. Food and Drug Administration (FDA) establish an expert panel to review herbs for potential OTC approval. A petition by European and American phytomedicine manufacturers has requested that FDA allow well-researched European phytomedicines the status of old drugs so they would not have to be evaluated by the prohibitively costly new drug application process. FDA has not responded to this petition, partly due to its discomfort with herbs and the lack of an appropriate mechanism to deal with herbs.

Feasible models for regulatory reform can be found in Europe, particularly Germany, where herbs and phytomedicines are accepted and integrated into medicine and pharmacy. In 1978 the German Ministry of Health established Commission E, a panel of experts charged with evaluating the safety and efficacy of the herbs available in pharmacies for general use. The Commission (Kommission in German) reviewed over 300 herbal drugs. Results were published by the German Federal Health Agency (now Federal Institute for Drugs and Medical Devices) in the form of monographs in the Bundesanzeiger, the German Federal Gazette. A total of 380 monographs were published (254 approved; 126 unapproved), plus 81 revisions. These monographs provide guidelines for the general public, health practitioners, and companies applying for registration of herbal drugs. In general, they do not contain standards for assaying the quality and purity of herbal drugs found in either the European Pharmacopoeia or the German Pharmacopoeia (Deutsches Arzneibuch). The process followed by Commission E resulted in what has been called by Prof. Varro E. Tyler "the most accurate information available in the entire world on the safety and efficacy of herbs and phytomedicines."  The Complete German Commission E Monographs may be purchased from our Book Store.-

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