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Dietary supplements, medicine: Understanding the difference
By Ruth Sorrelle, MPH

The death of Steve Bechler, a pitcher with the Baltimore Orioles who died this month from heat exhaustion associated with a weight-loss drug that contained ephedrine, revealed a major deficiency in the way such “natural” compounds are regulated. In 1994, the Dietary Supplement and Health Education Act defined herbs and other botanicals as dietary supplements, seriously altering the way in which the claims of such compounds could be regulated by the U.S. Food and Drug Administration.

As Donald Marcus, MD, a professor at Baylor College of Medicine and his colleague Arthur P. Grollman, MD of the State University of New York at Stony Brook pointed out in a recent New England Journal of Medicine article, these botanical and herbal medicine are usually considered ‘safe’ by the public because they are natural and have been used for many years. However, in recent years, with increased use of these preparations, their toxicities have become more apparent.

“In the past year alone, the Food and Drug Administration was compelled to issue warnings about nephrotoxic, hepatotoxic and carcinogenic effects associated with botanical products containing kava, comfrey and aristolochic acid – all herbal remedies used widely in the United States and Europe,” they wrote.

Many of these compounds are crude and unpurified. They are not consistent in terms of composition or in potency and are not required to prove that they are under current laws. Some have been found to contain prescription medications or heavy metals. In addition, such preparations can interact with prescription medications that individuals may be taking at the time. The extent to which such interactions occur is unknown because the 1994 federal law does not require reporting of adverse events associated with these products.

Marcus and Grollman want the rules changed. They want the manufacturers of dietary supplements to be subject to many of the same requirements as drug makers. In particular, they want manufacturers of dietary supplements to prove that their products do not provide a substantial risk of injury to those who take them. They also want mandatory reporting of adverse events to the FDA.

It is important to realize that there are always exceptions to the rule. Prescription medications undergo rigorous testing and yet unwanted side effects frequently appear after the drug is allowed on the market.

The same is true for dietary supplements. Nothing is totally safe. The difference is that some approved drugs are subjected to careful surveillance while botanicals, herbs and dietary supplements are not. Drugs makers have to prove their product’s safety and effectiveness. Manufacturers of dietary supplements face no requirements in this area.

At present, taking herbal and botanical preparations is a matter of caveat emptor – buyer beware.

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