U.S. Intends to Ban Diet Aid Ephedra

WASHINGTON —  The Bush administration said Tuesday that it would ban ephedra, the popular herbal derivative used for weight loss, in what would be the federal government’s first prohibition of a dietary supplement.

After years of debate, federal officials said they have conclusive medical proof that the amphetamine-like stimulant -- also used to enhance athletic performance -- presents an “unreasonable risk” even when used as directed. Ephedra has been blamed for heart attacks, strokes and at least 155 deaths.

“Today’s action tells consumers that the time to stop using these products is now,” Tommy G. Thompson, the secretary of Health and Human Services, said at a Washington news conference.

Officials expect to issue a rule in several weeks imposing the ban, which would then take effect in 60 days. In the meantime, the Food and Drug Administration is sending letters to 62 manufacturers asking them to halt sales of products containing ephedra.

Ephedra is an herbal version of pseudoephedrine, a drug used in many over-the-counter cold and allergy remedies. Ephedra is used by dieters to promote weight loss and by athletes, in what last year was a $1.3-billion market, according to the San Diego-based Nutrition Business Journal. The substance is derived from the Asian herb ma huang, and contains a mixture of chemicals, including ephedrine, that increase blood pressure and heart rate.

The debate about ephedra intensified this year with the death of Baltimore Orioles pitcher Steve Bechler, 23, who had used it. His widow has filed a $600-million lawsuit against the manufacturer of a supplement containing ephedra, Xenadrine RFA-1, which was found by a coroner to have been a “significant” factor in Bechler’s death.

California, New York and Illinois banned the supplement this year. Major manufacturers, including Metabolife International Inc. of San Diego, had already halted sales.

Years of concerns about the supplement have led to a new generation of ephedra-free products. Their popularity, experts and consumer groups say, indicates public demand and the industry’s ability to satisfy it, and also suggests more challenges for regulators.

U.S. officials said the government’s ban is likely to be quickly challenged in court by current and former manufacturers. Many manufacturers maintain that ephedra is safe if properly used. They may file suit to try to avoid legal liability and in an effort to prevent the FDA from establishing a precedent that could be used against other supplements.

“Our concern is: What’s next for the FDA?” said Jeff McCarrell, chief executive of Nutrex Research Inc., a company that sells supplements that contain ephedra, in an interview televised on MSNBC. “Is this a continued antisupplement movement, or a pro-drug movement?”

The ban is likely to set off a new battle in Congress over whether there should be tougher regulation of dietary supplements, which are overseen less rigorously than drugs under a controversial 10-year-old federal law. Although drugs can’t be sold until makers prove their safety and efficacy, supplement manufacturers have a free hand unless health officials can prove the products are unsafe after they are on the market -- a much tougher burden of proof.

Thompson urged Congress this summer to rewrite the law and to require manufacturers to acknowledge potential side effects of dietary supplements.

“We have a tremendous burden of proof in order to take supplements off of the market,” Thompson said at Tuesday’s news conference. “We have to prove scientifically that they’re unsafe. That’s a completely different burden of proof that FDA has.”

Consumer advocacy groups and some lawmakers have complained for years that the supplement industry -- a heavy contributor to congressional political campaigns -- has had dangerously lax regulation. On Tuesday, critics argued that the ban was long overdue, considering that there have been more than 16,000 “adverse event” reports from consumers, and more than 100 deaths allegedly linked to ephedra.

Rep. Henry A. Waxman (D-Los Angeles) said in a statement that Thompson’s actions “are welcome, but long overdue. Major medical groups, consumer protection organizations and health experts in Congress have been urging the administration to act for years.” He said the law regulating supplements must be changed “to give the FDA the authority to move quickly to protect consumers from unsafe dietary supplements like ephedra.”

In comments to reporters, Thompson and Mark B. McClellan, the FDA commissioner, defended the government’s actions, pointing out that the law required them to build a case and did not require manufacturers to disclose information on illnesses or give the government a way to compel clinical studies of supplements’ effects.

By weighing research and more than 10,000 public comments, McClellan said, government officials believe they have laid a legal foundation that will enable them “not only to take ephedra products off the market, but to keep them off.”

“We’re crossing every T and dotting every I,” Thompson said. “The worst thing in the world would be to short-circuit it and then have that be the reason for a judge to throw it out of court.”

Thompson said he believed that Congress would reconsider regulation of supplements, adding that he would consider it a “giant step forward” if lawmakers amended the law to require manufacturers to report “adverse actions” to supplements.

The officials said that by taking this step, they had laid a legal foundation for handling other unsafe products. “We’re going to review all of our dietary supplements on a one-by-one basis -- we continue to do that,” Thompson told MSNBC after the news conference. “If we see that there are other dietary supplements that need further action by the FDA, we will do that.”

The FDA reports to Thompson.

Thompson stopped short of saying that he intended to push for regulatory reform on supplements when Congress reconvenes next year. And although McClellan said he would be monitoring other supplements that include ephedra substitutes, another FDA official said the ban does not signal a general government crackdown on supplements.

The FDA has wrestled with the issue for years. The agency proposed dosage limits on ephedra in 1997, then withdrew them three years later when the General Accounting Office, the congressional research arm, said the FDA didn’t have evidence to back up its recommendation.

The FDA commissioned an outside study on ephedra in 2000, and another, by Rand Corp. researchers, in 2002. The Rand report, which came out in February, linked ephedra to a variety of symptoms, but found that many of the reports filed with the FDA on the substance were inadequate as proof.

Trade groups expressed concern that the ban would lead to tightened regulation.

Judy Blatman, a communications vice president for the Council for Responsible Nutrition, an industry group, said Congress shouldn’t make “an emotional decision” to toughen enforcement, since the ban shows that the current law works. “There doesn’t need to be a fundamental change, if the law is fully enforced,” she said.

Products with ephedra have been sold by dozens of companies, but Blatman said that in the last year, the largest makers have halted sales in the face of dwindling demand and soaring insurance premiums.

In August, 2002, Metabolife International’s sales slumped after it disclosed to the FDA that customers had reported nearly 15,000 “adverse events” in the previous five years.

Russell Shreck, chief executive of Metabolife, insisted that the product was safe when used according to instructions.

“Anyone who has read our label knows that we go to great lengths to inform our customers about the proper use of our products,” he told Associated Press. He said the label made it clear that the products shouldn’t be used by minors, and that people with medical conditions should consult a doctor.

Thompson said that ephedra accounted for about 5% of dietary supplement sales, but about 45% of “adverse events.”

The American Medical Assn., which has called for a ban since 2000, said it strongly supports the action. In a statement, the association said that the substance’s risks include seizure, stroke, psychiatric problems, heart attack and death.

A cosponsor of the 1994 law on supplements, Sen. Orrin G. Hatch (R-Utah), said in a statement the FDA’s action “reassures me that it will now be a priority of FDA and the Department of Health and Human Services to police the marketplace and apply acceptable scientific safety standards.”

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Ephedra Q&A;

Q: What is ephedra?

A: Ephedra is a plant with varieties growing in Asia, Australia, Europe and North America. It is called ma huang in China, where it has been used for 4,000 years to treat respiratory infections. A wild variety in the U.S. Southwest was used medicinally by early settlers to brew “Mormon tea” or “squaw tea.” Typically, the whole plant is powdered and used in pills or other preparations.

Q: What is the medical action of ephedra?

A: Ephedra contains two alkaloids, ephedrine and pseudoephedrine. These compounds can combat congestion and ease breathing. But the chemicals in ephedra also affect the heart and can cause a serious rise in blood pressure. A synthetic ephedrine is used in a very limited way in a small number of drugs prescribed for respiratory infections.

Q: What is the most common use of ephedra?

A: Ephedra has been found in about 200 dietary supplements sold over the counter. Ephedra has been promoted at health food stores. Manufacturers and retailers have claimed the herb is good for controlling weight, building muscle and boosting energy. The Food and Drug Administration’s power to regulate dietary supplements is more limited than for prescription drugs. The agency can ban risky supplements only after gathering evidence of injury.

Source: Associated Press

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Ephedra products

These popular products contain ephedra extracts, though many are also available in ephedra-free forumlas.

Metabolife, Ripped Fuel, Diet Fuel, Stacker 3, NaturalTRIM, Hydroxycut, Xenadrine RFA-1, Metab-O-Lite, Metabolift, Truckers Luv It, Yellow Jackets.

Source: University of Arkansas College of Pharmacy

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Timeline

Major events related to ephedra:

1994: Law is passed allowing dietary supplements to be sold with little oversight unless the FDA can prove a clear danger to public health.

1997: The FDA proposes a rule mandating specific warning labels and prohibiting combining the herb with other stimulants.

September 2001: The National Football League becomes the first major U.S. professional sports league to ban the supplement. It is also banned by the National Collegiate Athletic Assn. and the International Olympic Committee. The Major League Baseball Players Assn. later bans ephedra for players with minor league contracts.

August 2002: The Justice Department begins conducting a criminal investigation into whether manufacturer Metabolife International Inc. lied about the safety of ephedra.

Feb. 17, 2003: Steve Bechler, a 23-year-old pitcher for the Baltimore Orioles, dies of heatstroke one day after collapsing during spring training in Fort Lauderdale, Fla. The medical examiner later says ephedra contributed to the death.

Feb. 28: The FDA orders labels put on products with ephedra warning of the possibility of heart attack, stroke or death. The agency says it will reexamine a ban.

May 2: Nutritional supplement retailer General Nutrition Centers announces it will stop selling products containing the supplement.

May 26: Illinois becomes the first state to ban ephedra. California follows in October and New York in November.

June: The federal government begins building a case that could lead to the supplement’s ban.

July 1: The Federal Trade Commission announces that two companies that promoted ephedra-based supplements will repay customers $370,000 to resolve federal charges of deceptive advertising.

July 17: The widow of Orioles pitcher Bechler sues the manufacturer and the distributor of a dietary supplement containing ephedra for $600 million. The lawsuit also seeks a ban on the sale of ephedra-based products.

July: FDA chief Mark B. McClellan tells House members the agency is considering a ban on ephedra. Health and Human Services Secretary Tommy G. Thompson urges Congress to rewrite a law that rolled back dietary-supplement regulations and to require manufacturers to tell the FDA about potential side effects.

Dec. 30: The Bush administration announces it will ban ephedra from the marketplace because of concerns about its effects on health. The ban would take effect 60 days after publication of a rule imposing the ban. Publication is expected in several weeks.

Source: Associated Press