Federal Court Weakens FDA's Ephedra Ban

FDA Can't Ban Low-Dose Ephedra, Court Says

From the WebMD Archives

April 15, 2005 -- The FDA can't ban low-dose ephedraFDA can't ban low-dose ephedra, a federal judge ruled yesterday.

Ephedra is an herbal supplement also known as ma huang. The FDA's ban on ephedra was announced with great fanfare in a December 2003 news conference by Tommy Thompson, then secretary of Health and Human Services.

The ban was based on the FDA's conclusion that ephedra users risk heart attack, stroke, and sudden deathFDA's conclusion that ephedra users risk heart attack, stroke, and sudden death. These risks, the FDA said, far outweigh any benefit ephedra might have.

Ephedra, a highly popular herbal supplement, has been used as a weight loss drug. It's also been used to enhance athletic performance -- a use that had tragic consequences. In 2003, 23-year-old Baltimore Orioles pitcher Steve Bechler died after taking the supplement. Public outcry over the death helped spur the FDA ban.

Now Judge Tena Campbell of the U.S. District Court in Utah has ruled that federal law prohibits the FDA from banning a dietary supplement based on weighing its risks against its benefits. The ruling specifically prevents the FDA from banning products that contain 10 milligrams or less of ephedraThe ruling specifically prevents the FDA from banning products that contain 10 milligrams or less of ephedra.

The FDA is considering its options, an FDA spokesperson tells WebMD. The agency is taking the view that the ruling applies only to products containing 10 milligrams or less of ephedra, and that it does not prevent the FDA from banning higher-dose ephedra products.

The Council for Responsible Nutrition, a dietary supplement industry group, agrees with the FDA's interpretation, according to a statement by Steven M. Mister, CRN president and CEO.

"This ruling ... should not be misinterpreted as a complete overturn of the ephedra ban," Mister says in a news release.

Chuck Bell, programs director for Consumers Union, the publisher of Consumer Reports, says he worries that low-dose ephedra products may not be safe.

"Because of the absence of quality controlabsence of quality control in many segments of the supplement industry, the amount of ephedra in a given product may vary," Bell tells WebMD. "And they may have other ingredients, such as caffeine, that give you powerful stimulation even though they have only 10 milligrams of ephedra. We would continue to be worried about it."

FDA Authority Questioned

But the ruling may have far wider implications. It finds that a 1994 law -- the Dietary Supplement Health and Education Act or DSHEA -- requires the FDA to treat dietary supplements as foods rather than as drugs.

Drug makers must prove that their products are safe and effective. But supplement makers -- as long as they don't claim that their products treat specific diseases -- don't have to prove a thing. DSHEA makes it the FDA's job to prove a supplement is unsafe.

"Under present law, a dietary supplement, as with any food, is presumed to be safe. Food producers are not required to establish a benefit before sale," Campbell's ruling notes [Italics in the original].

The ruling came in a legal challenge to the FDA ban by ephedra maker Nutraceutical.

The court "clarified that FDA must follow DSHEA and cannot treat dietary supplements like drugs or medical devices," Nutraceutical President Bruce Hough says in a news release. "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.''presumed to be safe.'

A longtime critic of DSHEA is Stephen Barrett, MD, a retired psychiatrist who operates the Quackwatch web site. Quackwatch strongly advocates evidence-based medicine and is highly critical of claims made by some supplement manufacturers.

"DSHEA is an absolute license for the supplement industry to do anything it pleases," Barrett tells WebMD. "A number of people have been harmed by ephedra, and the FDA can't ban it. The FDA should tell the public, 'We don't have the tools we need to protect you.'"

The CRN's Mister strongly disagrees.

"The standard of DSHEA that companies may not market dietary supplements that pose a significant or unreasonable risk of illness or injury is not questioned by yesterday's decision," he says.

Consumer Union's Bell says DSHEA still leaves the FDA with the power it needs to ban ephedra. But he agrees with Barrett that stronger laws are needed to protect consumers.

"Our concern is the broader implications of this ruling for other dangerous supplements," Bell says. "We would like to see DSHEA amended to make manufacturers demonstrate the safety of their products if safety questions have been raised."

Show Sources

SOURCES: United States District Court for the District of Utah Central Division, Nutraceutical Corp. and Solaray Inc. vs. Lester Crawford, DVM, acting commissioner, U.S. Food and Drug Administration, Case No. 2:04CV409 TC. Stephen Barrett, MD, Quackwatch Inc. Chuck Bell, programs director, Consumers Union. News release, Council for Responsible Nutrition. News release, Nutraceutical Corp. News release, Consumers Union. Dietary Supplement Health and Education Act of 1994, Public Law 103-417. FDA web site.
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