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.
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 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."
This book contains all monographs published by Commission E between 1983 and
1995, including all revisions (incorporated into the monographs). It also
includes extensive indexes of therapeutic data (uses, contraindications, side
effects, drug interactions, etc.), plus chemical and taxonomic cross-references
(English, Latin, German, and pharmacopeial names), excerpts from European
regulatory literature, glossary of terms, and general index.