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Manufacturers Want to Combine Nonprescription Drugs, Herbs

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July 7, 2000 (Washington) -- If your life is complicated by the many choices of over-the-counter drugs and herbal supplements now available in your pharmacy or supermarket, just wait. Things are likely to get even more confusing.

Manufacturers of over-the-counter (OTC) drugs want to combine herbal supplements with their drugs and create entirely new products. If and when these new products appear, they will create even more choices in the pharmacy.

Fortunately, the FDA is trying to get ahead of the problem. It has asked drug companies to voluntarily set aside any plans they may have for combining herbal supplements with OTC drugs until the agency has a chance to develop a regulatory policy for these substances. Usually, the large drug companies agree to such requests by the FDA so long as their competitors do.

OTC drug ingredients and labels are regulated by the FDA under a well-defined system that requires data to back up any claims, strict manufacturing processes to assure quality, and new studies to prove the drugs are effective for any new uses. Herbal supplements, on the other hand, are basically unregulated. The FDA can go after an herbal supplement only after it has been shown to cause harm. Supplements may make label claims so long as they do not promise to cure or treat diseases. And there are no real standards yet for the manufacture of herbal supplements.

Increasingly, there are calls within the medical community for a change in the 1994 law that permits herbal supplements to be sold with this minimum regulation. Former FDA Commissioner David A. Kessler urged such a change in a recent editorial in The New England Journal of Medicine.

The FDA asked for the moratorium on combining OTC drugs with supplements in a letter responding to an inquiry from lawyers representing an unnamed drug company that was considering making such a product.

The FDA letter was pointed: "The addition of a new ingredient to a legally marketed drug product could affect the safety and efficacy of the drug component," it said. "In addition ... consumers may believe that both components have been subjected to the more stringent drug regulatory requirements when, in fact, only the drug component may have been reviewed by the agency for safety and effectiveness."

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