Herbal Supplement Update: News from the Herb Research Foundation

New research on St Johns Wort calls concerns about side effects and interactions into question, and the Courts uphold claims on folic acid supplement labels, despite FDA protests.

| May/June 2001

For almost twenty years, the Herb Research Foundation (HRF) has been providing the public and health practitioners with solid scientific information on the safe and effective use of herbs for maintaining and improving health. Our affiliation with Herbs for Health magazine goes back to the magazine’s inception. As president of the HRF, I’m pleased to welcome you to the HRF section of Herbs for Health. Here you will find the latest news and views on the science, business, and regulation of herbs for health. We hope you enjoy this new addition and encourage you to visit HRF on the web at www.herbs.org, or e-mail us at info@herbs.org.

Remember all the fuss last year about potential herb/drug interactions with St. John’s wort? This subject led to warnings from medical professionals and regulators and became the number-one topic on which the press questioned the foundation. Much of the speculation was based on a single study led by Stephen Piscitelli, M.D., of the National Institutes of Health. The study showed that the herb speeded up the liver’s metabolism of the immune suppressant cyclosporine (for organ transplant patients) and the protease inhibitor indinavir (for HIV patients). He claimed this happened because St. John’s wort increased the activity of the liver enzyme system that clears these and many other drugs from the bloodstream. Because this enzyme system also metabolizes birth control pills, Piscitelli did a talk-show tour to promote his theory about the “miracle babies” that could result if St. John’s wort caused birth control failures. There was never any direct evidence of such an interaction.

Surprise: The latest study by the same research team revealed that St. John’s wort does not affect the metabolism of carbamazapine, an anticonvulsant drug that is metabolized by the very same enzyme system in the liver. The bottom line? This finding calls into question the automatic assumption that St. John’s wort will interact with birth control pills—or the dozens of other drugs metabolized by this pathway.

Regulatory update

A federal court in the District of Columbia has ruled against the U.S. Food and Drug Administration (FDA) and in favor of expanded free speech rights for companies selling folic acid supplements. This is viewed as an important case because it indicates that the courts won’t allow the FDA to prevent companies from presenting truthful information. The impact will likely extend far beyond folic acid supplements.

The FDA’s position was that supplement companies should not be allowed to say that folic acid supplements containing 0.8 mg of folic acid are more effective in preventing birth defects than foods high in this nutrient. In a previous decision, the court of appeals ruled there was credible evidence that the claim was true, that the FDA had been “arbitrary and capricious” in denying the claim, and that their standard of evidence is undefined.

The FDA responded by denying the claim again without reviewing any new evidence, saying it was “inherently misleading.” The court disagreed, and in a sharp rebuke, U.S. District Court Judge Gladys Kessler wrote that the FDA “simply failed to comply with the constitutional guidelines,” and “at best misunderstood and at worst deliberately ignored highly relevant portions” of the court decision against it. Kessler then dismantled the FDA’s arguments, pointing out that while the courts usually do not rule on scientific evidence, in this case even a cursory reading of the evidence goes against the FDA. She wrote that there is evidence that 0.8 mg is better than 0.4 mg, that there is no evidence to the contrary, that numerous authorities including the Centers for Disease Control and Prevention agree that folic acid in supplements is better absorbed than that in food, and that cooking and canning destroys folic acid, further supporting the superiority of supplements.

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