A senator chided the Food and Drug Administration for not taking some action to block the sales of diet supplements containing ephedra, an herb that has been linked in many reports with heart attacks, high blood pressure and even death.
Sen. Richard Durbin, D-Ill., chairing a Senate subcommittee hearing, said Tuesday that even though there have been thousands of reports linking ephedra with serious medical complications, companies continue to sell it to children and the FDA has taken little action.
“We have mountains of evidence that this drug is not safe and these manufacturers are being irresponsible about their marketing practices,” said Durbin. “Ephedra is not safe and should be taken off the market.”
But a lawyer representing Metabolife International Inc., an ephedra supplement maker, disputed the criticism, saying his company’s product is safe and effective when used by adults who follow the dosage directions.
And an FDA official, Lester M. Crawford, said his agency this week blocked the sale of one ephedra product, Yellow Jackets, which has been advertised as a substitute for street drugs. He said the agency also is pressing to inspect a New Jersey plant where Yellow Jackets are made.
Durbin said one of his constituents , 16-year-old Sean Riggins, a football player in Lincoln, Ill. died of a heart attack last month after taking Yellow Jackets, a caffeine-rich combination of ephedra and kola bean extract. Durbin said the death came a month after he had written a letter to Health and Human Services secretary Tommy Thompson asking that the FDA take action against the sale of ephedra products.
“When I sent that letter, Sean Riggins was still alive,” Durbin told Crawford. “Why hasn’t there been a good faith effort to order suspension (of sales of the supplement)? The clear and prudent thing is to take this off the shelf. This is a killer.”
“The burden is on us,” replied Crawford, a deputy FDA commissioner. “Once we take an action, we have to be able to sustain it.”
He said the agency has “stepped up our efforts,” but it needs to complete a study before it can take action that might lead to a suspension of ephedra products.
Crawford said the FDA on Monday did stop imports of Yellow Jackets, which are blamed for Riggins’ death, because a Dutch firm was touting the pills on a Web site as a substitute for street drugs. He said FDA took the action based on illegal marketing, not ephedra safety.
FDA inspectors were denied admission when they tried to inspect a New Jersey plant where Yellow Jackets are made and the agency is seeking a court order to gain access, Crawford said.
Under a 1994 federal law, the FDA cannot regulate dietary supplements the same way it does pharmaceuticals. The agency requires drug manufacturers to prove their products are safe and effective. But the burden of proof is reversed for dietary supplements. Before a dietary supplement can removed from the market, the FDA must prove it is not safe.
Crawford said the FDA is still working on rules that would regulate the diet supplement industry, but they have gone through extensive changes over the years since the law was passed. “In a worst case,” he said, it could take four more years before they are in force.
There are ways for Thompson to suspend sales of the supplements, said Crawford, but he described the process as “a long and tortuous road.”
Durbin said there have been thousands of adverse health reports linked to ephedra, along with studies in the New England Journal of Medicine and at the Mayo Clinic connecting ephedra with heart attacks, strokes and high blood pressure.
The senator said Metabolife once claimed it had received no reports of adverse health effects from its products, but last month the company gave the FDA copies of more than 13,000 such reports, including three deaths, 20 heart attacks and 24 strokes.
But Lanny Davis, a Washington lawyer representing Metabolife, said conclusions about the adverse health events are based on “unverified telephone calls.” Scientific studies show that “when used as directed by adults,” the Metabolife ephedra supplement is “safe and effective,” he said.
Davis denied repeatedly that there is scientific proof of ephedra causing harm, noting, “We need science, not junk science.”
He said Metabolife favors FDA regulations that would ban promoting ephedra products as “street drug” alternatives, limit sales to adults, mandate warning labels and require reporting of adverse health events.
Witnesses testified that young people, particularly athletes, buy the ephedra supplements because the products are promoted to improve performance or to control weight. Ephedra is known to constrict blood vessels, raising blood pressure and pulse rates. Among some young people, the drug is used to stay alert after long study sessions or to sharpen reflexes on the ball field, witnesses said.