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[Definitie:] "An ergogenic aid is any substance or phenomenon that enhances performance."
(Wilmore and Costill) 
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1 6 - 0 4 - 2 0 05 Ephedra ban lifted by judge in Utah
Judge backs Utah firm's suit, lifts ban
By Glen Warchol
and Robert Gehrke
A Utah supplement maker predicts diet pills containing ephedra will be back on the shelves in a matter of days after a federal judge in Salt Lake City struck down the Food and Drug Administration's ban on the controversial ingredient. Kelly Harvey, president of Murray-based TSN Labs Inc., was unabashed in his delight in U.S. District Judge Tena Campbell on Thursday ruling that the FDA had no evidence to prove supplements with 10 milligrams of ephedra or less per day were too risky.
"I'm going to spend the rest of the day reading the judge's ruling," he said. "Then I'm going to call my manufacturer and give him a new formulation. I'm going to give my label makers a call and order labels. I'm going to be back on the shelves [with ephedra] in five days." Ruling on a lawsuit filed last year by Park City-based Nutraceutical Corp., Campbell said the FDA's process in banning ephedra violated the law by shifting the burden of proof from the government to supplement manufacturers. Unlike drug manufacturers, supplement makers do not have to prove their products are safe before marketing them. Campbell, who sent the ban back to the FDA for possible reworking, blocked any enforcement action against Nutraceutical Corp. for selling supplements containing 10 milligrams or less of ephedra per daily dose. Nutraceutical President Bruce Hough said the lawsuit had little to do with ephedra and more to do with forcing the FDA to follow the rules Congress set down for it. He said Nutraceutical interprets the ruling to mean the company is allowed to start selling ephedra supplements again, but added it is too soon to say whether it will put its own products back on the market. It is unknown whether the government will appeal or seek a stay of the decision. "We're going to have to review this ruling to make any determination on what action the government will take," said Charles Miller, a spokesman for the Department of Justice. Sidney Wolfe, of Public Citizen's Health Research Group, called Campbell's ruling misguided. "The idea that when you're below a certain dose ephedra is safe is a ridiculous idea," Wolfe said. "That a court would arrive at a decision like this is reason enough for Congress to repeal the dietary-supplements law." Other supplement makers said Campbell's ruling is unlikely to affect their product lines or marketing. Salt Lake City-based Weider Nutrition International, which had been hit with three ephedra-related lawsuits before the ban, has not made any products containing ephedra since July 2002. "We haven't got any plans to change that, notwithstanding the judge's ruling," senior corporate counsel Todd Crowley said. Nutritional-supplement giant Neways in Salem has no interest in ephedra, spokesman Rick Evans said. "We never sold ephedra-containing products before the ban and we don't intend to go in that direction." The ephedra controversy exploded in April 2003 after a medical examiner ruled the heatstroke death of Baltimore Orioles pitcher Steve Bechler was probably linked to his use of an ephedra-based diet pill. Prior to that, the supplement industry had fought off even labels warning ephedra could cause heart attacks and strokes. By February 2004, the FDA - saying more than 150 deaths may have been linked to the herb - banned ephedra-containing products. Utah is at the center of the controversy because it is home to the self-described "Silicon Valley of the supplement industry." Dietary supplements are a $2.5 billion business in Utah, where 80 to 100 companies operate, according to the Utah Natural Products Alliance. A second Utah connection is Republican Sen. Orrin Hatch who championed the Dietary Supplement Health and Education Act (DSHEA) in 1994. Under the law, widely known as the Hatch Act, supplements can only be pulled if the FDA proves they pose "significant or unreasonable risks." The supplement industry has contributed heavily to Hatch's campaign fund since 1994. In 1999, Hatch went on to challenge scientific support for an FDA proposal to limit ephedra sales to 8-milligram doses. After Bechler's death brought the risks of ephedra to the public, however, even Hatch supported a "prompt federal review" of ephedra. On Thursday, Hatch said the history of ephedra regulation has been "tortured." "I do not believe it is a good example of how the government should resolve dietary supplement safety," he said in a statement. "No one - not the FDA, the supplement industry, nor the public - has been satisfied by how ephedra has been regulated. Millions of people have used the product with satisfaction, but there is no doubt the product has had some serious problems." Hatch emphasized that while Campbell's ruling calls into question how the FDA applied the law in the case of ephedra, "the court did not question the fundamental structure of DSHEA, only how the FDA had applied it." U.S. Rep. Henry A. Waxman, D-Calif, a leader in calling for the ephedra ban, said Campbell took "too limited a view" of FDA's authority over supplements. "I hope and expect that FDA's ban will be upheld on appeal," Waxman said. "If it is not, it will clearly be time for Congress to revisit DSHEA and give FDA the authority it needs to protect American consumers from dangerous supplements." TSN Labs' Harvey said the biggest hurdle for companies wishing to resume ephedra sales will be reformulating their supplements to meet the 10 milligrams per day maximum. But Wolfe of Public Citizen's Health Research Group offered a different view: "One stroke, one heart attack, one death and this company [Nutraceutical] will go under and that's as it should be. No other companies are going to be stupid enough to put this back on the market."
Decision worries health specialists
Carey Hamilton
Health and nutrition experts are worried about U.S. District Judge Tena Campbell's repeal of the ephedra ban.
Wayne Askew, director of the Division of Nutrition in the University of Utah's College of Health, said he was surprised by the ruling.
"I think the FDA made a prudent decision, given the preponderance of scientific evidence the FDA had," he said. "The FDA action was a step in the right direction in making the dietary supplement industry more responsible and in promoting safety."
While ephedra has been used for centuries, originally by Eastern cultures, Askew said he is concerned about people being able to buy it without knowing potential risks. "Ephedra should be prescribed under the care and guidance of a physician. If people can buy it over the counter, they think it's not dangerous, and they may take too much," he said.
Nanna Meyer, a sports dietician and physiologist at The Orthopedic Specialty Hospital in Murray, gives nutrition guidance to athletes, some of whom have eating disorders. She also teaches sports nutrition at the U. and works with college athletes.
"This drug has to be taken off the market, especially for sports performance in athletes," Meyer said. "Ephedra should not be consumed by athletes."
Some athletes take ephedra because it makes them more alert, improves mood and helps them breathe better, because it dilates the bronchial tissues, she said. "It's also misused and abused a lot in sports for weight loss," Meyer said. "Even at a low dose, the public can take as many of them as they want. People want a quick fix to lose weight, but ephedra can be fatal."
2 4 - 0 4 - 2 0 0 5 Ephedra ruling may spur probe of supplements
By Robert Gehrke
WASHINGTON - The dietary supplement industry thought it had put the prickly issue of ephedra to rest when the government banned the stimulant last year, but a ruling by a federal judge in Utah threatens to blow it wide open and provoke Congress to clamp down on the herbal remedies.
"My feeling is it ultimately will not be seen as being in the best interest of the industry," said Loren Israelsen, executive director of the Utah Natural Products Alliance. "Even if nobody was happy with the decision to ban ephedra, it brought closure to a contentious issue and sometimes things are best left closed."
Critics have already seized on the ruling, arguing that if the Food and Drug Administration can't pull a dangerous product like ephedra off the market after it was linked to dozens of cases of heart problems, strokes and deaths, then it is time to rewrite the law regulating such substances.
But Sen. Orrin Hatch, who wrote the Dietary Supplement Health and Education Act of 1994 (DSHEA), says the only change that is needed is administrative: The FDA needs to use the enforcement power it has been given and provide sound science to back it up.
"Nobody has shown me the need to change [the law]," Hatch said in an interview. "It gives the FDA enough power to solve these problems if they do it the right way. I blame much of the criticism of DSHEA on the law not being fully implemented or enforced."
It is a well-rehearsed position for the senator who uses herbal products himself - mainly multivitamins - and has been consistently, unwaveringly in the corner of the supplement industry.
As recently as last year he fought to keep a supplement used by bodybuilders from being banned along with another substance in the steroid family, androstenedione. Hatch said he demanded an exemption for DHEA (dehydroepiandrosterone) because supplement users, including those taking it as an anti-aging pill, otherwise would have rallied against the bill and ensured its defeat. The industry has repaid his loyalty with nearly $350,000 in campaign contributions since 1999 - including tens of thousands of dollars from companies that had marketed ephedra products. His son, Scott Hatch, is also a lobbyist for the dietary supplement industry.
Hatch said the money makes no difference in how he approaches issues. "Everybody who knows me knows campaign contributions do not make decisions for me," he said. "I've had a record of doing what I believe is right."
Dietary supplements are a $2.5 billion business in Utah, with between 80 and 100 companies manufacturing and marketing the products.
In banning ephedra in 2004, the FDA cited dozens of cases where the herb, a stimulant that was once used by more than 12 million dieters, had been linked to deaths, strokes and other serious health problems.
On April 14, one year and two days after the ban was announced, U.S. District Judge Tena Campbell ruled that the FDA had not done its homework to adequately prove that, at low doses, ephedra posed a "significant or unreasonable risk of illness or injury," as required by the law. Hatch recommended Campbell's appointment to the bench in 1995 by then-President Clinton.
The senator said the FDA's failure to base its 2004 ban on sound, reliable science led to Campbell's ruling, a decision that he said "troubles him." He anticipates that the government will appeal it. A continued legal fight could block renewed ephedra sales while the case is pending.
A spokesman for the Department of Health and Human Services said the agency believes it acted appropriately in banning ephedra, but no decision had been made on an appeal.
If the FDA's ban is not upheld, California Democratic Rep. Henry Waxman said in a statement that "it will clearly be time for Congress to revisit DSHEA and give FDA the authority it needs to protect American consumers from dangerous supplements."
Sen. Edward Kennedy, D-Mass., said opponents of DSHEA saw the problems with the law from the outset and fought to strengthen it.
"Many of us thought that there ought to be a different standard than we had at the time, but we got rolled by the industry, and I think it's certainly something we'll have to take a look at," Kennedy said.
It's that backlash from Washington that has Israelsen concerned that Campbell's ruling has revived a dead issue. "DSHEA is better served, our industry is better served, if ephedra remained a closed issue," Israelsen said. "This will again make members of Congress argue that DSHEA should be amended or repealed."
Israelsen said none of the members of his organization plans to put an ephedra product on the market, but if there is a demand, someone will step up to meet it.
"I think we have to be realistic that there will be ephedra products on the market very soon," he said.
Hatch said he doesn't want to see any dangerous products on the market, but he also doesn't want to see the industry overregulated, which he said could raise costs and keep beneficial supplements out of the hands of millions of people who use them.
He said a hands-off approach is warranted because the supplements don't pose the same problems as pharmaceuticals. In ephedra's case, he said the herb was used for generations as an effective weight loss aid.
"Everyone knows it increases blood pressure if someone doesn't abide by dosage standards. In those cases where people died, there were underlying illnesses and problems that I'm not sure you can" blame on ephedra, he said.
In a speech to representatives from the dietary supplement industry this month, Hatch outlined two areas in which he would like to see changes:
First, he wants the FDA to issue its Good Manufacturing Practices guidelines to ensure the quality of products on the market. They have been years in coming.
Second, he and Sen. Richard Durbin, D-Ill., are crafting a bill to require companies to report to the FDA adverse reactions to supplements. Those reports are now voluntary, making problems hard to track.
The Institute of Medicine of the National Academies of Science has also recommended amending DSHEA to impose stricter "seed-to-shelf" quality control, strengthen labeling requirements and mandate adverse event reporting. But Sidney Wolfe of the watchdog group Public Citizen, whose petition to the FDA eventually led to the ban, said DSHEA has been "a disaster" and should be repealed.
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