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In response to the increased use of medicinal herbs by the U.S. population, the NIEHS/National Toxicology Program (NTP) has recently received an increased number of nominations of herbal preparations for study, both from the general public and from other Federal agencies. Reviews of the literature available on the nominated herbs show that the exposed population is in the millions.
According to the President's Commission on Dietary Supplements, some 1,500 to 1,800 botanicals are sold in the U.S. as dietary supplements or ethnic traditional medicines. The data indicate that herbal medicines are the fastest growing component in the U.S. pharmaceutical market. These formulations are being widely consumed for both treatment and prevention of a variety of health- related problems.
Many of the herbal preparations on the market today offer significant relief from, or prevention of, adverse health conditions, and some of our best known and most valuable drugs (aspirin, digitalis, quinine) are of botanical origin. However, there is concern for the lack of standardization of herbal preparations for content and efficacy. Published analyses of some herbal preparations have shown great disparities in the concentrations of herb per dose and even greater variance in the concentrations of the active
ingredient. Data describing possible adverse health effects associated with heavy or prolonged use of medicinal herb formulations is limited or nonexistent. Thus, the number of persons exposed, the variability of the material on the market, and the lack of knowledge regarding the toxicology of some of these compounds suggest a need for additional research. Since the FDA is prohibited by law from requiring any kind of safety or efficacy testing from supplement manufacturers, the NTP has a clear mandate to perform this kind of testing in the interest of public health.
The NTP, with the support of the NIH Office of Dietary Supplements, the HHS Office of Disease Prevention and Health Promotion, the FDA Office of Special Nutrition, and the Society for the Advancement of Women's Health Research, organized a workshop to seek expert assistance to identify the most relevant and obvious research needs on the safety and efficacy of medicinal herbs. A further objective was to coordinate U.S. research on medicinal herbs with that of other nations in which their use, beneficial effects, and formulation are better characterized and standardized. A coordinated research program focusing on the botanicals of greatest public health importance could be undertaken incorporating the recommendations of this and future workshops.
Recommendations from this workshop spanned the responsibility of a number of Federal agencies. Those with particular relevance to the NIEHS include: the need to identify the toxicity of herbs and the dose at which toxicity occurs; the need to understand the interactions between different herbs and the adverse consequences of herbal combinations; and the need to identify sensitive subpopulations such as the fetus, children, and the aged. The NIEHS/NTP already has plans to begin rodent studies of some herbal products for which there is no long-term data.