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Ban on Ephedra: Protection for the Drug Co's

Although some media quote the number of deaths due to ephedra at 155, a 2003 FDA commissioned report in stated in its final ruling that only five deaths could be attributed directly to ephedra.

To put this number in perspective, about 12 to 17 million people consumed ephedra in 1999, reports the American Herbal Products Association. The Nutrition Business Journal estimated that sales of ephedra in 2002 were $1.25 billion.

Contrast this with the number of people killed each year because of pharmaceutical drugs. A study reported that in 106,000 people died in 1994 because of overmedication or adverse reactions to prescription drugs.

The ban was challenged by Utah-based Nutraceutical Corporation. They make an ephedra product with less than 10 mg of ephedra. The judge ruled, in accordance with the DSHEA, the FDA could not place the burden to prove safety on dietary supplement manufacturers as it does for drug and device makers.

Instead, the agency "must establish that (ephedra supplements) pose a significant or unreasonable risk by a preponderance of the evidence," Campbell wrote.

Campbell also said that the FDA couldn't prove this with low doses of ephedra.

Bruce Hough, President of Nutraceutical, commented the decision "is, in our view, about protecting the public’s access to safe and effective dietary supplements and in clarifying the meaning of the 1994 Dietary Supplement Health and Education Act (DSHEA). The Court’s ruling clarifies the steps FDA must take to comply with the law in its regulation of dietary supplements."

Hough continued, "The Court made it clear that FDA has authority under DSHEA to remove unsafe dietary ingredients from the market. But the Court also clarified that FDA must follow DSHEA and cannot treat dietary supplements like drugs or medical devices. The Court made other important findings, pointing out that Congress intended that dietary supplements be treated as a subset of foods and, like other foods, are "presumed to be safe."

It allows the company to resume selling its whole herb ephedra product with less than 10 mg of naturally occuring ephedrine alkaloids per daily dose.

Ephedra is a herb used for hundreds of years to treat asthma and other conditions. Because of its ability to increase metabolism, it also became popular as an ingredient in diet pills. Ephedra was taken off the market in April 2004 by the FDA after safety concerns.

One high-profile case involved Baltimore Orioles pitcher Steve Bechler. He was 23 years old when he died during spring training in February 2003. At the time, Bechler was taking diet pills containing ephedrine - the active substance in ephedra - to lose some weight. Bechler had a history of borderline high blood pressure and abnormal liver and a family history of heart disease.

Instead of jumping on ephedra, the FDA should have been after Vioxx and other arthritis drugs and their effect on the heart, and HRT and and its effect on heart disease and cancer.

 
Author Biography

Ban on Ephedra: Protection for the Drug Co's
By Bob Rutledge
 

 

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