Prompted by a growing record of health problems, including the death of a 16-year-old high school athlete, a U.S. senator renewed his call on Tuesday for a ban on the dietary supplement ephedra.
The current evidence indicates “ephedra is not a safe product and should be taken off the market,” said Sen. Richard Durbin, D-Ill., at a hearing of his subcommittee on oversight of government management, restructuring, and the District of Columbia.
Durbin said he was motivated to spotlight the ephedra issue after reading about the death of a Lincoln, Ill., teenager named Sean Riggins who died on Sept. 3 after suffering a heart attack. The county coroner who handled Riggins’ case told the subcommittee the boy had apparently died from ephedrine use.
The boy, healthy and athletic, had no other drugs or other unusual substances in his system. Nor did he have any cardiovascular conditions, said Charles Fricke, the Logan County coroner. “It is our opinion that the acute myocardial infarct in this individual is consistent with the effects of ephedrine,” Fricke said.
The family later discovered their son had used a product readily available over-the-counter in convenience stores and gas stations called Yellow Jackets, an herbal remedy promoted to be a performance enhancer that contains ephedra, kola nut extract — a source of caffeine — and other herbal ingredients. The Yellow Jackets packet, which both Fricke and Durbin held up during the hearing, warns that selling it to a minor is illegal. Yet minors rarely are asked to show identification for herbal remedies, which are sold for just a few dollars everywhere from mini-marts to health food stores.
“The problem with ephedra, in my opinion, is that these kids don’t understand it’s a drug,” Kevin Riggins, the father of Sean Riggins, said during emotional testimony. “This herbal supplement killed my son, and I’m just afraid it’s going to happen again.”
Riggins added, “It’s called a dietary supplement, an herbal supplement. That’s just semantics. It’s a drug. Garlic is an herb. Bay leaf is an herb. I’ve never heard of anyone dying from bay leaf.”
On Monday, the Food and Drug Administration announced it had issued a cyber letter to an Internet promoter of Yellow Jackets named Xoch Linnebank in the Netherlands. The FDA letter stated Yellow Jackets is promoted as an alternative to controlled substances and warned Linnebank that continued sales to U.S. citizens could be illegal.
“Consumers should not purchase or use these or similar products available through the Internet or elsewhere,” the FDA deputy commissioner, Dr. Lester M. Crawford, said in a statement. “FDA will continue its efforts to protect American consumers from dangerous and fraudulent Internet companies who would sell illegal products that present risks to public health.”
The only representative from the supplement industry was Lanny Davis, the attorney representing Metabolife, a San Diego company that sells weight-loss supplements containing ephedra. Metabolife is under investigation by the U.S. Department of Justice for failing to turn over records of consumers reporting adverse side effects ranging from heart attack and stroke to psychiatric symptoms and seizures. Justice Department officials are investigating whether Metabolife withheld information from the Food and Drug Administration about serious side effects reported to the company by consumers who used its ephedra products.
“The record here is damning for Metabolife,” Durbin said. “Metabolife’s actions contradict their glossy PR statements.”
Davis told the subcommittee Metabolife is only marketed to adults and added the company wants to work with the government in to “clean this situation up the industry” and “get rid of the bad apples like Yellow Jackets.” Davis also claimed, however, that ephedra had not been linked conclusively to the serious side effects reported by consumers.
Although the industry was put in the hot seat, other panelists also blamed the FDA for failing to protect consumers adequately.
Bill Jeffrey, national coordinator for the Centre for Science in the Public Interest at Carleton University in Ottawa, Ontario, testified the FDA and Health Canada the Canadian federal health department have had access to the same body of evidence regarding dietary supplements, including ephedra. Canada has banned ephedra products as have many countries in Europe.
When asked why the U.S. government has failed to act, Jeffrey replied: “Either the DSHEA law (the 1994 Dietary Supplement Health and Education Act) has completely undermined the authority of the FDA or the FDA believes American lives are cheaper than Canadian lives.”
Sidney Wolfe, director of Health Research Group at Public Citizen, a Washington, D.C., consumer watchdog group, said the U.S. military has reported 33 deaths between 1997 to present among active-duty members who used ephedra. As a result, the military issued memos in July 2002 warning ephedra products should be removed from military posts, he said.