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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."
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Tribune reporters Pamela Manson, Elizabeth Neff and Linda Fantin and The Associated Press contributed to this story.
Suing FDA
--BAN BANNED: A federal judge struck down the FDA ban on supplements containing ephedra, the once-popular diet aid pulled from the market after being linked to dozens of deaths.
-- WRONG RULES: The judge says the FDA wrongly treated ephedra like a drug instead of a food, and that current law presumes all food - including dietary supplements - is safe. The judge said that FDA's statement that a safe level of ephedra cannot be determined doesn't meet the burden of proof.
--TRY AGAIN: The ruling sends the matter back to the FDA and keeps it from enforcement action against the Utah supplement firms that sued the FDA.