FDA Takes Strong Action Against EphedraDec 30, 2003 | CNN
At a press conference Tuesday, Health and Human Services Secretary Tommy Thompson announced plans to ban the weight-loss aid ephedra, citing adverse health affects, saying, "I am pleased that we are able to take this strong action against ephedra."
Although 4 individual states have already banned, or partially banned the sale of ephedra, Tuesday's announcement marks a new role for the FDA: It's the first time U.S. officials have attempted to block the sale of an over-the-counter nutritional supplement a move some in Washington had been working on for years.
FDA Commissioner Mark McClellan calls the move the "result of a long hard road."
The road has been long not only for government officials, but also for families who've lost loved ones, including that of Baltimore Orioles pitcher Steve Bechler, who's heat stroke death last February was attributed to the use of ephedra by medical examiners.
Last July, Bechler's mother gave emotional testimony before the House Energy and Commerce Committee, urging the government to ban ephedra on behalf of her son and others who had died while taking the supplement.
"He was 23 years old, married for two months with a child on the way. Now he has a daughter that will never know how great her daddy was. How many Steve Bechlers or Sean Riggins have to die to prove that these are not safe?," she said in her testimony.
Sean Riggins' father also testified after, he says, his 16-year-old son took ephedra to enhance his athletic abilities.
"September 3rd of last year, Sean had a heart attack and died in our home. The cause: ephedra," Riggins' father told the congressional committee.
According to the FDA, some 155 deaths can be attributed to ephedra.
The Department of Health and Human Services says ephedra, an herbal supplement, poses several health dangers, including heart attacks, strokes, seizures, and death.
But some ephedra marketing companies disagree with this assessment.
The FDA notified 62 companies that market products containing ephedra of the planned ban, including the San Diego-based Metabolife, the most widely sold supplement. Metabolife, which also sells ephedra-free products, said it "respectfully disagrees" with the FDA decision and will "carefully consider its options."
"If it was dangerous and had been shown it was dangerous, it would have already been taken off the market," said Richard Kreider of the Ephedra Education Council.
Some organizations have already banned the use of ephedra products, including the NCAA, the International Olympic Committee and the NFL. Following Steve Bechler's death, the FDA had proposed having warning labels put on the front of ephedra products. Even the American Medical Association and other medical groups called for a ban of the supplement.
But it was still legal to buy and sell. So why the unprecedented move to ban it?
Dietary supplements aren't regulated like drugs; they don't have to get prior approval from the FDA.
"The law requires us to go through a very, much of a scientific finding. When a pharmaceutical company wants to put a drug on the market, they have to prove its efficacy and safety, but nutrition and food supplement drugs don't have to go through that process," explained Secretary Thompson.
Tuesday's ruling came after months of scientific analysis by the FDA, who said they studied over 16,000 adverse incidents reports. The law is now in the final administrative process and is expected to be completed in a few weeks, after which, stores would have 60 days to remove ephedra products from their shelves.