Regulating Natural Health Products

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Science  05 Apr 2002:
Vol. 296, Issue 5565, pp. 46-47
DOI: 10.1126/science.296.5565.46b

In his recent editorial “The future of medicine” (11 Jan., p. 233), C. Everett Koop calls attention to the growing use of alternative medicine and the need to prove the efficacy and safety of dietary supplements. He is correct when he compares the current situation to the snake oil days of a century ago that led to passage of the Pure Food and Drug Act of 1906. However, in 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), in response to a massive lobbying effort by the natural products industry. This law exempts the manufacturers of dietary supplements from having to prove safety or efficacy before marketing. The burden of proof is thus on the Food and Drug Administration (FDA) to show that something is not safe, and to do this, the FDA must rely on an inefficient system of voluntary reporting of adverse events. The net result of this is a relatively unregulated industry that was estimated to have sales of $17.1 billion in 2000 (1).

Koop calls upon the “natural products industry to work with medical research, including the FDA” to assure safety and efficacy. While this is certainly something that should happen, it is naïve to think that it will occur in the absence of regulatory requirements. Although many in the industry support the FDA's proposed Good Manufacturing Practices (which address only issues of quality control), the industry has no incentive to voluntarily fund research that might reveal that some products are neither safe nor effective.

Congress must repeal or amend the DSHEA to give the FDA the power to regulate nutritional supplements by requiring scientific proof of efficacy and safety. Until that happens, it is essential that adequate resources be made available to the FDA and the Federal Trade Commission to enforce existing rules covering claims made on labels and in other advertising. Manufacturers should also be required to label all dietary supplements with a toll-free number and a Web URL for reporting adverse events directly to the FDA (2).

References and Notes

In his editorial, Koop discusses the importance of applying scientific and regulatory tests to the use of herbal and nutritional remedies. Recent findings about St. John's wort, an herbal product used to treat a variety of ailments, including depression, raise a related issue of concern. St. John's wort has been found to interfere with the effectiveness of a wide variety of commonly used drugs (1). For example, it causes a rapid reduction in the level of the immunosuppressant cyclosporine, with attendant danger of transplant rejection (2), and a reduction in the level of an anti-HIV protease inhibitor, indinavir (3). A major ingredient of St. John's wort, hyperforin, binds to a transcription factor (the PXR protein), activating synthesis of an enzyme (cytochrome P450 3A4), which then degrades a wide variety of drugs, including not only cyclosporine and indinavir, but also the active ingredient of birth control pills. The existence of this pathway, whose normal purpose is to protect the body from noxious chemicals, is well documented in recent molecular studies (4, 5).

I agree with Koop that there may well be roles for alternative and complementary therapies in health care. It is crucial, however, that in the efforts to realize this potential, these remedies do not cause unintended damage to approved therapeutic agents.

All FDA-approved drugs are required to list precautions such as potential interactions with other drugs. It is disappointing that the bottle of St. John's wort that I recently purchased locally at a major nutritional products store contained only the most perfunctory of precautions on the label about possible interactions with drugs (“If you are taking medication, consult a healthcare professional before using this product.”). Furthermore, this store was unable to provide any literature warning of possible interference with drugs.

It is noteworthy that the 2002 edition of the Physicians' Desk Reference (6) contains specific recommendations against co-administration of indinavir and St. John's wort and describes the interaction between cyclosporine and St. John's wort. Given the widespread use of St. John's wort, it might be advisable for the herbal remedy and nutrition industry to provide comparable explicit warnings and information.

References and Notes

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