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| so little meaningful research is conducted here. Yet federal regulations require that any herb or food for which a therapeutic claim is made be classified a drug and that any drug be proven safe and effective under FDA supervision (at an estimated cost of $100 million) before any medical information can be put on its label. "It is impossible to deny the need in the United States today for a truly rational system to promote the availability and the rational use of phytomedicinals [plant drugs]," wrote Varro E. Tyler, Ph.D., Sc.D., Lilly Distinguished Professor of Pharmacognosy at the Purdue University School of Pharmacy and Pharmacal Sciences, in his book Herbs of Choice: The Therapeutic Use of Phytomedicinals. "Unfortunately, under the present restrictions imposed on herbs and herbal labeling in this country, the means of properly utilizing this potentially helpful type of over-the-counter medicament is denied the consumer." |
| Tyler proposed several changes in federal policy (described by him as "a regulatory Tower of Babel"), including adopting the German system of phytomedicinal evaluation, citing "that advanced country's excellent experience" and "a nearly total absence of supporting data of American origin." In 1978, Germany established Commission E to evaluate the safety and efficacy of 1,400 herbal drugs made from nearly 700 plant species, using results obtained from clinical trials, collections of single cases and scientifically documented medical experience. "The findings of the German Commission E on herb safety and efficacy constitute the most accurate body of scientific knowledge on that subject available in the world today," wrote Tyler. The com- |
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