Why the FDA banned ephedra

Published: March, 2004

In December 2003, the U.S. Food and Drug Administration announced it was banning the sale of products containing ephedra. This announcement heralded the first time the agency has banned an herbal supplement. Its decision was based on extensive research involving more than 16,000 reports of adverse health effects from products containing ephedra. These studies clearly indicate that ephedra is dangerous. And it can kill. Roughly 155 deaths have been blamed on the amphetamine-like stimulant, including the 2003 death of 23-year-old Baltimore Orioles pitcher Steve Bechler.

Ephedra occurs naturally in the Chinese herb ma huang and contains ephedrine and pseudoephedrine, stimulants that can constrict blood vessels. In low doses, they act as decongestants, but in higher doses, they can raise blood pressure. The stimulant effect contributes to the herb's effectiveness as an appetite suppressant, especially when combined with caffeine, aspirin, or both. Its claims for promoting weight loss as well as for increasing energy and alertness led athletes and average gym goers alike to take ephedra products.

A variety of studies associate ephedra use with cardiovascular problems, including high blood pressure, palpitations, and heart attacks. Side effects of the herb include heart palpitations, nausea, and vomiting. More than 800 dangerous reactions have been reported - among them, heart attacks, strokes, seizures, and sudden death. Psychosis, insomnia, and heatstroke have also been reported.

The supplement has been conclusively linked to cases of healthy adults suddenly falling ill or even dying after taking it. According to a study in the Annals of Internal Medicine, ephedra products make up only 1% of herbal supplement sales in the U.S. , but they are responsible for 62% of herb-related reports to poison-control centers.

Manufacturers have insisted that studies prove their product is safe when used properly. But several scientists said that it is impossible to prove whether ephedra is safe based on these studies because they screen out participants who have health problems - the people most likely to be hurt by the supplement.

Herbal products can be as powerful as prescription drugs, but unfortunately, under the 1994 Dietary Supplement Health and Education Act (DSHEA), companies don't have to prove that an herbal or dietary supplement will do what's claimed, or even that it contains what it's supposed to. That's because under the act, substances classified as dietary supplements are not "drugs." As a result, because ephedra is an herb, U.S. law permitted over-the-counter sales of the supplement until the FDA could prove a clear danger to public health.

Some people who think ephedra helped them lose weight are looking to new herbs and natural extracts to replace the banned dietary supplement. Topping the list of new ingredients is caffeine. Some products deliver the buzz of at least three cups of coffee in one dose. They don't all mention caffeine on the label; consumers may have to learn herbal aliases such as guarana and green tea to ensure they don't get caffeine jitters by taking multiple supplements.

Although we have more - and growing - research data on complementary and alternative health care, findings regarding safety, effectiveness, and mechanism of action are often limited or controversial. What's more, most herbs and supplements have not been adequately tested for interactions with other herbs or supplements, drugs, or foods. It will take a lot of additional scientific scrutiny to really understand how these substances work in the body, and how we might harness their properties for use in promoting health. Until then, as always, buyer beware.

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