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http://www.nytimes.com/2005/04/15/health/15ephedra.html
ASHINGTON, April 14 - A federal judge in Utah on Thursday struck down a Food and Drug Administration ban on the herbal supplement ephedra, an adrenaline-like stimulant linked to dozens of deaths.
The ruling, by Judge Tena Campbell of Federal District Court, calls into question whether the F.D.A. can enforce its ban on ephedra anywhere in the United States, though the ruling's immediate effect is restricted to Utah. It also prompted calls on Capitol Hill for legislation to crack down on the supplements industry.
Saying that the drug agency had failed to prove that ephedra at low doses was dangerous, and that it lacked the authority to ban the substance without such proof, Judge Campbell called for the F.D.A. to devise new rules for ephedra.
Bruce Hough, president of the Nutraceutical Corporation, the company that brought the suit, said that it had no immediate plans to resume the sale of ephedra, which was pulled off the market a year ago this week.
He said that the company, which is based in Park City, Utah, brought the suit to check the agency's oversight of nutritional supplements.
"We didn't file this lawsuit because of ephedra," said Mr. Hough. "We filed it because the F.D.A. established rules that could cause problems to the rest of our business."
A spokeswoman for the F.D.A. said that the agency was still evaluating the ruling. No determination has been made about an appeal.
Dr. Julian Bailes, chairman of neurosurgery at West Virginia University School of Medicine, said the ruling was "a green light to abuse this substance again."
Dr. Bailes's research established a link between ephedra and heat-stroke deaths among young athletes. Ephedra has been linked to more than 80 deaths, though estimates vary.
More adverse reactions were reported from the use of ephedra than from the use of all other herbal supplements combined, Dr. Bailes said.
Judge Campbell stated in her ruling that the F.D.A. had failed to prove that low doses of ephedra were dangerous. In fact, she found, the agency was caught in a bind. It suspected that all doses of ephedra posed a risk, suggesting that further research would have been unethical.
Unable to determine a safe dose of ephedra, the agency banned them all.
That, however, is not legal, Judge Campbell ruled. A 1994 law championed by Senator Tom Harkin, a Democrat of Iowa, and Senator Orrin G. Hatch, a Republican of Utah, shields makers of herbal and nutritional supplements from strict adherence to F.D.A. rules that require drug makers to prove that their products are safe and effective.
Instead, the law defines nutritional supplements as food, which is assumed to be safe unless federal regulators can prove otherwise. After all, "if food producers were required to show a benefit as a precondition to sale, the sale of foods such as potato chips might be prohibited," Judge Campbell wrote.
Because the research on ephedra is incomplete, the drug agency could not prove that low doses of the supplement were unsafe. And because the burden of proof under the 1994 law is the agency's, its ban was illegal, the judge wrote.
"The statement that a safe level cannot be determined is simply not sufficient to meet the government's burden," Judge Campbell ruled.
A major push to ban ephedra came after it was cited as a factor in the death of Steve Bechler, a 23-year-old pitcher with the Baltimore Orioles who collapsed during a workout at Fort Lauderdale Stadium on Feb. 16, 2002, and died the next day.
On Thursday, Tom Glavine, a pitcher for the New York Mets, said that he doubted that Judge Campbell's ruling would lead players to start using ephedra again. "Guys understand the concerns and the potential risks involved with ephedra," Mr. Glavine said. "I don't see anyone running and saying, 'Let's do it again now. This is a great idea.' "
Rob Manfred, Major League Baseball's executive vice president for labor relations and human resources, said baseball would not lift its own ban on ephedra. The National Football League and the National Basketball Association also ban its players from using ephedra.
Safety advocates have long complained that the law governing herbal and nutritional supplements allows their manufacturers to sell potentially dangerous products with little federal oversight.
Advocates of the law say that it provides needed protection for the companies that cannot afford to undertake the enormous expense involved in underwriting the clinical trials to prove that their products are safe and effective.
Senator Edward M. Kennedy, Democrat of Massachusetts, said that Thursday's ruling showed that the 1994 law needed to be changed. At the time, Mr. Kennedy tried to include a provision that would prohibit supplements that presented a "reasonable possibility of harm."
"If F.D.A. can't take a supplement as dangerous as ephedra off the market, then Congress needs to change the law to allow it to do so," Mr. Kennedy said through a spokeswoman.
But Mr. Hatch said that "the history of ephedra regulation has been tortured, and I do not believe it is a good example of how the government should resolve dietary supplement safety."
He concluded that consumers "should have access to safe products."
Steven M. Mister, president of the Council for Responsible Nutrition, a Washington-based trade association for the dietary supplement industry, said that the ruling should not lead to "inappropriate conclusions" about the need to change the law.
ASHINGTON, April 14 - A federal judge in Utah on Thursday struck down a Food and Drug Administration ban on the herbal supplement ephedra, an adrenaline-like stimulant linked to dozens of deaths.
The ruling, by Judge Tena Campbell of Federal District Court, calls into question whether the F.D.A. can enforce its ban on ephedra anywhere in the United States, though the ruling's immediate effect is restricted to Utah. It also prompted calls on Capitol Hill for legislation to crack down on the supplements industry.
Saying that the drug agency had failed to prove that ephedra at low doses was dangerous, and that it lacked the authority to ban the substance without such proof, Judge Campbell called for the F.D.A. to devise new rules for ephedra.
Bruce Hough, president of the Nutraceutical Corporation, the company that brought the suit, said that it had no immediate plans to resume the sale of ephedra, which was pulled off the market a year ago this week.
He said that the company, which is based in Park City, Utah, brought the suit to check the agency's oversight of nutritional supplements.
"We didn't file this lawsuit because of ephedra," said Mr. Hough. "We filed it because the F.D.A. established rules that could cause problems to the rest of our business."
A spokeswoman for the F.D.A. said that the agency was still evaluating the ruling. No determination has been made about an appeal.
Dr. Julian Bailes, chairman of neurosurgery at West Virginia University School of Medicine, said the ruling was "a green light to abuse this substance again."
Dr. Bailes's research established a link between ephedra and heat-stroke deaths among young athletes. Ephedra has been linked to more than 80 deaths, though estimates vary.
More adverse reactions were reported from the use of ephedra than from the use of all other herbal supplements combined, Dr. Bailes said.
Judge Campbell stated in her ruling that the F.D.A. had failed to prove that low doses of ephedra were dangerous. In fact, she found, the agency was caught in a bind. It suspected that all doses of ephedra posed a risk, suggesting that further research would have been unethical.
Unable to determine a safe dose of ephedra, the agency banned them all.
That, however, is not legal, Judge Campbell ruled. A 1994 law championed by Senator Tom Harkin, a Democrat of Iowa, and Senator Orrin G. Hatch, a Republican of Utah, shields makers of herbal and nutritional supplements from strict adherence to F.D.A. rules that require drug makers to prove that their products are safe and effective.
Instead, the law defines nutritional supplements as food, which is assumed to be safe unless federal regulators can prove otherwise. After all, "if food producers were required to show a benefit as a precondition to sale, the sale of foods such as potato chips might be prohibited," Judge Campbell wrote.
Because the research on ephedra is incomplete, the drug agency could not prove that low doses of the supplement were unsafe. And because the burden of proof under the 1994 law is the agency's, its ban was illegal, the judge wrote.
"The statement that a safe level cannot be determined is simply not sufficient to meet the government's burden," Judge Campbell ruled.
A major push to ban ephedra came after it was cited as a factor in the death of Steve Bechler, a 23-year-old pitcher with the Baltimore Orioles who collapsed during a workout at Fort Lauderdale Stadium on Feb. 16, 2002, and died the next day.
On Thursday, Tom Glavine, a pitcher for the New York Mets, said that he doubted that Judge Campbell's ruling would lead players to start using ephedra again. "Guys understand the concerns and the potential risks involved with ephedra," Mr. Glavine said. "I don't see anyone running and saying, 'Let's do it again now. This is a great idea.' "
Rob Manfred, Major League Baseball's executive vice president for labor relations and human resources, said baseball would not lift its own ban on ephedra. The National Football League and the National Basketball Association also ban its players from using ephedra.
Safety advocates have long complained that the law governing herbal and nutritional supplements allows their manufacturers to sell potentially dangerous products with little federal oversight.
Advocates of the law say that it provides needed protection for the companies that cannot afford to undertake the enormous expense involved in underwriting the clinical trials to prove that their products are safe and effective.
Senator Edward M. Kennedy, Democrat of Massachusetts, said that Thursday's ruling showed that the 1994 law needed to be changed. At the time, Mr. Kennedy tried to include a provision that would prohibit supplements that presented a "reasonable possibility of harm."
"If F.D.A. can't take a supplement as dangerous as ephedra off the market, then Congress needs to change the law to allow it to do so," Mr. Kennedy said through a spokeswoman.
But Mr. Hatch said that "the history of ephedra regulation has been tortured, and I do not believe it is a good example of how the government should resolve dietary supplement safety."
He concluded that consumers "should have access to safe products."
Steven M. Mister, president of the Council for Responsible Nutrition, a Washington-based trade association for the dietary supplement industry, said that the ruling should not lead to "inappropriate conclusions" about the need to change the law.
