Ephedra Court Ruling Rekindles Debate

bbsadmin

Herb's safety and FDA's power to regulate it at issue, experts say

By Steven Reinberg
When a U.S. District Court judge in Salt Lake City lifted the year-old FDA ban on ephedra Thursday, she also re-ignited a debate on both the supplement's safety and the U.S. Food and Drug Administration's power to regulate it.

Judge Tena Campbell ruled that the Food and Drug Administration had not proven that dosages of 10 milligrams (mg) or less of ephedrine-alkaloid dietary supplements (EDS) -- a dosage threshold set by the agency -- were dangerous. According to Campbell's ruling, the FDA did not at the time of the ban have sufficient data to determine what a safe level of EDS might be.

In addition, the ruling noted that the burden of proof for the danger of any supplement falls on the government, not on the maker of the supplement.

Last year's ban would therefore "be directly contrary to the statutory language placing the burden of proof on the government and to the intent of Congress in regulating dietary supplements as food," Campbell wrote in her decision. The court has sent the matter back to the FDA for further evaluation.

As of now, the FDA hasn't decided how to respond to this ruling. "FDA interprets the ruling to mean that the order banning ephedra remains in effect as to higher doses of these products. The court ruling spoke to the plaintiff's product at the lower doses," FDA spokeswoman Kimberly Rawlings said Friday.

"FDA, at this point, is considering all its options with respect to what our next steps will be," she added.

One expert agreed that the evidence for banning low-dose ephedra just isn't there.

"The worry is that people that used to want to take 50 mg or 60 mg will take lots of the 10 mg," said Dr. Paul Shekelle, an assistant professor of family medicine at UCLA and a member of a task force on ephedra convened by the nonprofit Rand Corporation and sponsored by the U.S. Agency for Healthcare Research and Quality.

"But the evidence on ephedra use is so slim that to try to make a decision that it's safe or not safe based on a 10 mg dose is not possible," he added. "The problem is you are talking about something that is available over-the-counter."

Dr. Sidney M. Wolfe, the director of the Public Citizen Health Research Group, is upset by the ruling and what he believes is a basic misunderstanding of the science involved.

"The concept that a drug that kills people at one dose is going to be safe at a lower dose just because there hasn't been very much study at the lower dose is ridiculous," he said.

Wolfe believes many people are sensitive to ephedra, an amphetamine-like herb, even at low doses. "There are people who will have high blood pressure, increased pulse rates, strokes and heart attacks, at the lower dose," he said.

Wolfe hopes the FDA will appeal the ruling. He said Campbell's decision also doesn't allow the FDA to take into consideration the risks and benefits of ephedra. "The fact that it [ephedra] doesn't work at all at lower does is irrelevant" in her ruling, he said.

To deal with this problem, Wolfe believes laws should be changed to define over-the-counter supplements as drugs, which the FDA can then regulate. "Pharmacologically, ephedra is active, so the fact that it's derived from natural sources is completely irrelevant in terms of safety or effectiveness," he said.

Chuck Bell, the program director at Consumers Union, agreed that ephedra needs to be regulated. "We would not want to see the reintroduction of ephedra into the marketplace, so we hope the FDA will do everything it can to keep the product off the market," he said.

He also wants to see current laws amended, so the burden of proof for the safety of supplements falls on the manufacturer, not on the FDA. Bell noted that New York, Illinois and California have all banned ephedra. "At least in these states, these low-dose supplements would not be sold," he said.

But not everyone agrees ephedra needs to be banned.

"Although I do believe ephedra has serious safety risks in high doses, more than most herbs and supplements, I do not think it should be banned from the market," said Dr. Ray Sahelian, an alternative medicine expert from Los Angeles, and author of Mind Boosters and Natural Sex Boosters.

For Sahelian it comes down to a matter of freedom. "The possibility of rare cases of harm that occur from ephedra is a risk a free society has to take to allow access to different products," he said. "If we were to eliminate anything that could harm the public, we would have to disallow sodas, donuts, and even skiing and parachute jumping."


The FDA initiated the ephedra ban in February 2004. The lawsuit sparking this week's ruling was brought by Nutraceutical Corp. and Solaray Inc. of Park City, Utah, a nutritional supplement manufacturer.

"The object of the lawsuit was to get the FDA to go back to the statute, which regulates us as a subset of food, not as a drug," said Bruce Hough, president of Nutraceutical Corp. "We really didn't give a hoot about the ephedra, that's [just] a catalyst for doing the lawsuit."

The reason for the suit, according to Hough, was that company officials felt the FDA had overstepped the bounds of the law. "They banned ephedra in all its supplement forms, but they didn't ban it in foods like teas," he said.

For Hough there were two basic issues. First, there's no evidence that ephedra at low doses is harmful. Second, "being a food, we are presumed to be safe -- just like any other food, like peanuts and strawberries, which have probably killed thousands of people."

The whole problem surrounding ephedra is based on media hype, Hough said. The bottom line for Hough is that dietary supplements like his products should be treated as subset of foods, not drugs.

Hough, however, wouldn't say what benefit his company's products, including ephedra, might offer consumers. "I wouldn't tell you that because it's not in our purview to say," he said.

Ephedrine, the active ingredient in ephedra, increases metabolic rate, bodily heat production and the risk of heatstroke. A group of San Francisco researchers had claimed that ephedra was the most dangerous herbal product on the market, based on data collected from poison-control centers.

More than 155 deaths have been linked to ephedra, according to Public Citizen's Health Research Group, including the 2003 death of 23-year-old Baltimore Orioles pitcher Steve Bechler. Bechler's death resulted in a slew of negative publicity that, in turn, contributed to declining sales of ephedra products.

"I feel very strongly the FDA must appeal this decision," said Dr. David L. Katz, an associate clinical professor of public health and director of the Prevention Research Center at Yale University School of Medicine. "It's a very dangerous slippery slope; ephedra is definitely a bad actor."

From nccam.nih.gov