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23 September 2002
Herbal Supplement Warning

A string of recent Food and Drug Administration (FDA) warnings and recalls on herbal products has left researchers, physicians and health advocates concerned that consumers are wasting money and taking unknown health risks with every herbal pill they pop.

"You know more about what is in a bag of Doritos than what's in an herbal product touted to treat and prevent disease," said David J. Kroll, PhD, an adjunct associate professor of medicine at Duke University Medical Center, "When it comes to herbs, the consumer is unprotected and essentially on their own. There's no guarantee these products are safe or effective."

The Dietary Supplement Health and Education Act (DSHEA), passed in 1994, does not include an FDA requirement that manufacturers of herbs and other dietary supplements prove their products are safe or effective before they hit the shelves. The Act encourages disclosure of information to consumers, but the lack of research requirements give herbal makers the freedom to make general health claims on their labels. For example, a product can advertise that it has a calming effect but not that it can be used to treat anxiety disorders. Consequently, some manufacturers make unsubstantiated treatment claims leaving countless consumers confused about what these "all-natural" products can and can not do for their health.

"Labels often don't give accurate or complete information in part because the FDA is given no teeth to enforce claims made by the manufacturer," says Dr. Kroll who is also a pharmacologist in the Natural Products Laboratory at Research Triangle Institute in North Carolina, a non-profit research organization.

While experts say most herbs are safe when taken as directed, a series of recent reports underscore the potential ramifications of such loose regulation. Death, liver damage, seizures, heart attacks and stroke have all occurred as a result of using a small number of herbal products, according to FDA alerts and advisories. Such adverse events can be caused by herbal products interacting with other medicines, allergies, impurities, and dangerously high doses.

Few herbs have caused the stir of ephedra, or ma huang, an herb taken by millions of Americans annually for weight-loss and body building. A 2001 study published in the New England Journal of Medicine concluded the herb could cause high blood pressure, heart problems, stroke, seizures and death. And the FDA has reports of 100 deaths among ephedra users.

Yet manufacturers adamantly claim the reports do not prove the product is risky and ephedra-containing products remain on the market. Because of the 1994 law, the burden of proof falls on the FDA to show a product is dangerous and regulatory action has proved difficult.

Three years after unsuccessfully attempting to ban high doses and require warning labels, the controversial sales continue. In June of this year, the federal government initiated a new safety review and two months later, the Justice Department announced they were conducting a criminal investigation into whether a leading ephedra seller lied about the safety of this dietary supplement. Meanwhile, Canada has warned consumers against using ephedra and the International Olympic Committee, National Football League and National Collegiate Athletic Association have all banned its use.

Other herbs have also been recently linked to health risks. Results of a small study on St. John's wort, a popular product thought to alleviate signs of depression, suggest the supplement can dramatically interfere with a common chemotherapy drug called irinotecan. Researchers from the Netherlands found that when cancer patients took irinotecan and St. John's wort together, the blood levels of irinotecan decreased by 42 percent compared to when using irinotecan alone. The study was published in the August 2002 issue of the Journal of the National Cancer Institute.

Like many of the known risks of herbal medicines, these hazards were revealed after the products went on the market. "If safety testing were required before marketing, we would know many of these things before consumers suffer adverse reactions and death," says Dr. Kroll, "In these unfortunate cases, the consumer was the guinea pig."

While FDA-mandated safety and efficacy testing would benefit consumers, Dr. Kroll believes it will be a long time coming. For this to become a reality, Congress would have to pass legislation giving the FDA new authority over dietary supplements. "With national security, Iraq and biological weapons competing for the attention of Congress and FDA, I don't think there will be enough public pressure in the near future to force a change," says Dr. Kroll.

Pressure from trade and consumer groups alike, however, seem to be having a positive effect on some manufacturers. For example, the Council for Responsible Nutrition, a trade association of the dietary supplement industry, encourages members to meet certain levels of manufacturing standards. "The industry now recognizes that a few bad apples can spoil things for more ethical companies," says Dr. Kroll. "As a result, the trade organizations are trying to weed out and distance themselves from the lesser manufacturers."

To encourage improvement in standards, the United States Pharmacopeia (USP) has introduced the Comprehensive Dietary Supplement Verification Program. The Program involves USP certification that supplement products: contain the ingredients stated on the label in the declared amount and strength; are within limits for contaminants such as heavy metals, pesticides and microbes; will be absorbed into the body according to USP criteria; and have been manufactured using safe and controlled procedures.

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