Ephedra ruling may spur probe of supplements
This is an archived article that was published on sltrib.com in 2005, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

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.

But Hatch says: The law governing the industry does not need changing
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