April 24, 2008

2 Min Read
Ephedra Rule May Threaten DSHEA

Weight loss products that contain ephedra aren't dangerous enough to warrant a wholesale ban. But the federal government likely will require them to bear a "black-box" warning on the label, and some industry observers are worried about the implications for the Dietary Supplements Health and Education Act.

"The supplements industry in general and the ephedra people ought not treat this as the end of the line," said regulatory expert Marc Ullman, a partner in the New York law firm Ullman, Shapiro & Ullman.

On Feb. 28, the U.S. Food and Drug Administration released the long awaited RAND Corp. review of the safety and efficacy of ephedrine alkaloids contained in dietary supplements and said it would develop a strong new warning label for ephedra products.

Although the RAND report concluded ephedra supplements are useful for short-term weight loss and athletic performance enhancement, and that there was insufficient evidence to determine the relative danger of the supplement, Health and Human Services Secretary Tommy Thompson said "there continue to be serious questions about the risks surrounding this particular dietary supplement."

The FDA will collect public comment on the issue until April 7. The agency also said it is attempting to determine whether "the current system of regulating ephedra's safety is adequate."

Industry consultant Suzanne Shelton said this language opens the door to a review—and perhaps repeal—of DSHEA.

"I don't think we should revisit DSHEA and I don't think we should go along with revising DSHEA," Shelton said. "We should insist they enforce the law."

Currently, the FDA does not review herbal supplements for safety or efficacy, but it does have authority to prohibit sale of a supplement that "presents a significant or unreasonable risk of injury."

Though there have been several deaths attributed to the improper use of ephedra weight loss supplements—including the spring training death of Baltimore Orioles pitching prospect Steve Bechler—the FDA has left regulation of the products up to individual states and counties.

"They won't exercise the law because to do so would prove the lie in the claim that DSHEA has tied their hands," Ullman said.

For many natural products retailers, the ephedra issue may soon be moot. Several large supplements companies have dropped their ephedra products and some insurers are refusing to cover stores that carry them.

Mary Mulry, director of product development and standards for Wild Oats Markets Inc., said stores under the Henry's and Sun Harvest nameplate recently dropped their ephedra weight loss products; Wild Oats markets never carried them. "We just felt the liability was too great to be carrying these products for weight loss, so we discontinued them along with androstenedione."

Nutrition Business Journal estimates sales of weight loss products containing both herbal and synthetic ephedra reached $1.3 billion, or about 31.1 percent of all herbal supplements sales in 2001. Sales of ma huang, the natural ephedra, were about $58 million, or about 1.4 percent of total herb sales.

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