The Bush administration moved on Tuesday to ban the dietary supplement ephedra, which federal regulators first recognized as a potential danger six years ago.
The struggle to ban the herbal stimulant–which has been linked to 155 deaths–has underscored the scant oversight regulators have over the multibillion dollar dietary supplement business. More than a dozen other supplements that the U.S. Food and Drug Administration has deemed potentially hazardous remain on the market, including products linked to liver disease and neurological damage.
Administration officials who announced the ephedra decision conceded that it took too long to pull the stimulant–a move that the American Medical Association and consumer group Public Citizen had urged for years.
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Officials blamed the delay on a controversial 1994 law that forbids the FDA from regulating dietary supplements as it would normal drugs.
Although the vast majority of dietary supplements are safe, including the common vitamins used by more than half of Americans, the case of ephedra has revealed a gap in the FDA’s safeguards.
The ephedra ban is set to take effect 60 days after regulators publish their decision, though U.S. Secretary of Health and Human Services Tommy Thompson said consumers should stop using the supplement immediately. He said the ban was timed in part to get word out before people begin post-holiday diets.
“[Ephedra products] are simply too risky to be used, whether by people who want to lose weight, or by elite athletes seeking to enhance their performance, or by youngsters who want to be like these athletes,” Thompson said.
Illinois became the first state to ban ephedra last May.
At its height of popularity the stimulant was used by an estimated 12 million people. Ephedra, which boosts the body’s metabolism and promotes weight loss, has been used as a diet drug and by athletes seeking extra energy.
The supplement became a target of controversy after the deaths of several high-profile athletes who used it, including Northwestern University cornerback Rashidi Wheeler, who died during a workout in 2001. Baltimore Orioles pitcher Steve Bechler died in February while taking ephedra to lose weight.
The consumer group Public Citizen called for an ephedra ban soon after Wheeler’s death, citing dozens of similar deaths linked to the product.
Dr. Sidney Wolfe, head of health research at Public Citizen, said the Bush administration’s delay in ordering a ban was an “inexcusable dereliction of responsibility,” even considering the barriers set by the 1994 dietary supplement law.
“They have to answer the question of why they didn’t act two years ago, when they had more than enough evidence,” Wolfe said.
The FDA first proposed restricting ephedra in 1997 based on safety concerns, but government advisers concluded that the agency had not collected enough evidence to act under the 1994 dietary supplement law. Wolfe and many other experts said it will be impossible to ensure the long-term safety of dietary supplements without changes to that legislation.
The Dietary Supplement Health and Education Act of 1994 exempted supplement makers from having to prove the safety and efficacy of their products–a requirement that all modern pharmaceuticals must pass before being approved.
“If a product is a drug, it cannot go on the market until the manufacturer tests it and presents data, and then we get to decide,” associate FDA commissioner Bill Hubbard said. “For dietary supplements, it’s the reverse. The manufacturer has to present nothing.”
Instead, the 1994 law placed the burden on the FDA to prove that supplements are unsafe–an extremely difficult standard to meet. The FDA also cannot require supplement makers to do pre-market testing or provide the agency with reports of health problems linked to supplements.
“That act for all intents and purposes circumvented the FDA,” said Bill Gurley, a professor of pharmaceutical sciences at the University of Arkansas College of Pharmacology. Gurley, who performed some of the earliest studies critical of ephedra, had called for its removal since the late 1990s.
HHS Secretary Thompson said Tuesday that he would like to see the law changed, at least to give the FDA authority to see adverse incident reports. Wolfe and some lawmakers have said the entire act should be repealed.
Sen. Dick Durbin (D-Ill.) has introduced legislation that would hold manufacturers responsible for proving a product’s safety.
“Ephedra really told the story,” Durbin said Tuesday. “The current system is inadequate. They were selling a dangerous product.”
In the meantime the FDA maintains a list of supplements that have been linked to illness or injury, but which the agency is largely powerless to ban.
Those products include wormwood, once an ingredient in the alcoholic drink absinthe, which was banned in most countries because of links to brain damage. Wormwood still is sold as a dietary supplement for its purported ability to treat intestinal ailments.
Another such product is chaparral, a traditional medicine used in teas for “blood purifying” properties. The FDA says it has been linked to potentially irreversible liver disease.
Less is known about the supplement synephrine, also known as bitter orange, which has been billed as a safer alternative to ephedra. Experts say it’s impossible to gauge its safety without more studies–which the FDA cannot mandate.
Dietary supplement makers are eager to escape the pall that ephedra has cast over the industry, though they say broad regulation is not the answer. While maintaining that ephedra is safe when used properly, some industry officials expressed relief at the news of a ban.
“We needed an end to this controversy,” said Judy Blatman, spokeswoman for the Washington-based Council for Responsible Nutrition, a supplement trade group.
Blatman pointed out that the market for ephedra has virtually disappeared in the last year, as controversy mounted and insurance rates rose for ephedra producers. Indeed, the leading makers of dietary supplements such as Metabolife International Inc., have removed ephedra-based supplements from their product lines.
“We decided to suspend sales until further clarification of ambiguities in the recently passed California law governing the sale of ephedra,” company spokeswoman Jan Strode said.
Strode said the company wanted to wait for the FDA to release the rationale behind the ruling before deciding whether to challenge the ban in court.
“We are going to review all our options,” she said.
The ban has sent some ephedra distributors scrambling.
Javier Scalini, owner of AllStar Health in Santa Ana, Calif., said he may consider offering a promotion to boost sales of ephedra before the ban goes into effect.
“We have 60 days to sell,” said Scalini, who still has back stock from before many ephedra manufacturers discontinued the product last spring.
FDA officials said the ban will go into effect 60 days after the completion of a new rule governing ephedra, which is in the final stages of official review.
Some families of ephedra users whose deaths were linked to the drug said a ban was the only sensible solution.
“It’s a bittersweet ending,” said Pat Bechler, mother of Orioles pitcher Steve Bechler, who died at age 23. “It’s too bad it wasn’t done before Steve had to pay with his life.”
The ban is little comfort to Kevin Riggins of Lincoln, Ill., whose son Sean, a high school football player, died last year while taking ephedra. Riggins said he is pushing for tougher regulations such as pre-market study of supplements and better monitoring of adverse events.
“There are a lot of dead people now,” Riggins said. “If they had taken action when they should have, Sean would still be alive.”
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Ephedra at the center of controversy
The Food and Drug Administration has announced a ban on the dietary supplement ephedra, which has come under heavy scrutiny in recent years.
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EPHEDRA FACTS
USES: Primarily sold as a weight-loss aid and to boost energy and sports performance. Studies suggest it only provides short-term weight loss. Also used to treat respiratory problems.
HEALTH RISKS: Adrenaline-like stimulant raises blood pressure and increases the risk of heart problems and stroke. More than 150 deaths and about 1,000 reports of serious health problems have been linked to ephedra.
BANNING EPHEDRA: FDA rules treat dietary supplements with natural ingredients, such as ephedra, differently from man-made drugs. Drug companies must prove that their products are safe, whereas the FDA must prove that a supplement is unsafe in order to ban it.
Ephedra sinica: The herb, also called ma huang, that provides the active ingredient in ephedra.
EPHEDRA TIMELINE
1994: A new federal law allows dietary supplements to be sold over-the-counter with little oversight unless the FDA can prove a clear public health risk.
1997: Manufacturers block an FDA effort to restrict sales of ephedra and require a warning label, saying that the agency lacks proof that it is dangerous.
SEPT. 2001: Following the death of NFL player Korey Stringer, the league bans ephedra. The NCAA and International Olympic Committee later follow suit. The Major League Baseball Players Association bans the stimulant for minor leaguers.
AUG. 2002: The Justice Department begins an investigation into whether Metabolife International lied about ephedra’s safety.
FEB. 17, 2003: Baltimore Orioles pitcher Steve Bechler collapses and dies during spring training. The medical examiner rules that ephedra is a contributing factor.
FEB. 28: The FDA orders that products with ephedra must include a label warning of the risk of heart attack, stroke or death.
MAY 26: Illinois becomes the first state to ban ephedra. California follows in October and New York in November.
DEC. 30: The FDA announces a ban on ephedra, effective after 60 days.
OTHER SUPPLEMENTS WITH HEALTH RISKS
The following are used for everything from weight loss to reducing inflammation.
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Herbal ingredient Possible health hazards
Chaparral Liver disease
Comfrey Obstructed blood flow to the liver, possibly fatal
Dieter’s teas Nausea, diarrhea, vomiting, stomach cramps
Germander Liver disease, possibly fatal
Lobelia
(Indian Tobacco) Respiratory problems, rapid heartbeat,
low blood pressure; possibly coma and
death at higher doses
Willow bark Reye syndrome, a potentially fatal disease associated
with aspirin intake in children with chickenpox or
flu-like symptoms; allergic reaction in adults
Wormwood Neurological symptoms, numbness in legs and arms,
delirium, paralysis
Source: Food and Drug Administration, Associated Press, KRT
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