April 17, 2000 (West Lafayette, Ind.) -- All is not well in herbal America.
Today about one-third of the adult population in the United States uses herbal products, a retail market that has swelled to nearly $4 billion a year.
Yet in this mostly unregulated area of medicine, there is no way consumers can be assured that what is on the label is actually in the package, other than the reputation of the producer. Anyone can call him- or herself an herbalist and offer advice. The fact is most herbal-based books, pamphlets, and Internet sources are filled with exaggeration and are designed to sell products, not to inform accurately.
This is a scandalous situation.
Herbs have pharmaceutical properties and should be treated with respect and caution. Consider the conventional drug digitalis, derived from the foxglove plant. For decades it was valued here as a remedy for congestive heart failure, and is still widely used for that purpose in other parts of the world. But if it is misused, it can kill.
Under the 1994 Dietary Supplement Health and Education Act, however, herbs are classified as supplements rather than drugs. This has two important results: On the one hand, manufacturers cannot make any claim as to the ability of an herb to prevent illnesses or treat symptoms. On the other hand, there are no requirements that they produce a product that meets set standards for uniformity and consistency. Under this weak law, consumers have nowhere to turn for help.
In the past, the Food and Drug Administration (FDA) was unwilling to compromise and create a regulatory process that makes sense for herbs, insisting instead that herbal remedies undergo the same costly clinical study protocol required of pharmaceutical substances -- an impossible situation for herbal manufacturers. The cost of bringing a new synthetic drug to market in the United States runs about $350 million. Because herb producers can't patent their natural products -- which have been used for centuries -- they could never recoup the cost of getting FDA approval.
It is time for the United States to combine common sense with good science and begin regulating herbal products much the way Germany does. There, "reasonable" amounts of proof are accepted as evidence of efficacy for plant-based medications, allowing these products to become an integral part of mainstream medicine. I believe herbal manufacturers could get satisfactory evidence for the efficacy of each herb through two well-designed, placebo-controlled studies -- costing at most a few million dollars instead of hundreds of millions.
Consumers, if given the choice, prefer products with the government's seal of approval. In time, herbal manufacturers might lose customers to their competitors if they didn't seek -- and get -- FDA approval for their products.
Granted, it would take vast change within the FDA -- and very likely federal legislation -- to revamp the way this nation treats herbal medicine. But I remain an optimist. After all, for much of recent history, natural drug products were scorned by professionals and the public alike. Now they are highly valued, with good reason, by a very large segment of the population.
Varro Tyler, PhD, is a distinguished professor emeritus of pharmacognosy (pharmaceutical biology) at Purdue University and dean of pharmacy emeritus. He is the author of more than 30 books on medicinal herbs.
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