Recent surveys have revealed that nearly one-third of adults in the United States use herbal remedies as part of their health regimens, and that the retail market for these products exceeds $3.2 billion annually. Herbal remedies are sold as dietary supplements in the United States. But, under reasonable regulations, their sale as drugs — as products for which the establishment of quality standards and therapeutic uses is appropriate — should be allowed.
The big stumbling block to the lawful sale of herbal remedies as drugs is the cost of generating “proof of efficacy.” Only those “new chemical entities” that meet rigorous standards are approved by the Food and Drug Administration for use as drugs. Companies that would market herbal supplements as drugs are bound by these same standards, regardless of how long the botanical substance has been in medical use. Figures vary, but many pharmaceutical companies estimate the cost of obtaining proof of efficacy to be as high as $500 million per drug. Recovering such an expense would be unfeasible in the case of an unpatentable herbal remedy.
But there is a sound way to improve the utility of herbal remedies to American consumers: The FDA could arrange for a review of the findings of Germany’s Commission E. Commission E is an independent panel of experts that, for more than 15 years, under the aegis of the German equivalent of the FDA, investigated some 300 herbs in terms of safety and efficacy. Then, independent FDA-convened American experts could review the conclusions of Commission E regarding the 200 herbs it ultimately approved and determine which conclusions are applicable to American conditions. The cost of such a review would be small.
I do not know whether public pressure will induce such an event in the next 10 to 20 years, but I certainly hope it will.

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