'Too risky'

Government announces ban on herbal supplement ephedra

Steve Bechler's heatstroke in February was linked ephedra, which also has been blamed for more than 150 other deaths. AP/The Baltimore Sun, Gene Sweeney, Jr.

WASHINGTON (AP) -- The Bush administration is banning the sale of ephedra early next year and urged consumers Tuesday to immediately stop using the herbal stimulant linked to the death of Baltimore Orioles pitcher Steve Bechler.

Ephedra has been blamed for 155 deaths and dozens of heart attacks and strokes, and the NFL, NCAA and International Olympic Committee banned its use. Major League Baseball did not.

The government's first ban on a dietary supplement comes eight years after the Food and Drug Administration began receiving reports that ephedra could be dangerous.

"The time to stop taking these products is now," Health and Human Services Secretary Tommy Thompson said. "They are simply too risky to be used."

Ephedra once was hugely popular for weight loss and body building. But it can cause life-threatening side effects even in seemingly healthy people who use the recommended doses, because the amphetamine-like stimulant speeds heart rate and constricts blood vessels. It is particularly risky for anyone with heart disease or high blood pressure or people engaging in strenuous exercise.

The ban isn't immediate because federal rules require certain paperwork steps that mean the earliest it could take effect would be March. But the FDA wrote 62 current and former manufacturers on Tuesday that, "we intend to shut you down," said Commissioner Mark McClellan.

"There are companies out there who've profited by misleading Americans about the benefits of ephedra, even as they put Americans' health at risk," McClellan said. "Any responsible manufacturer and retailer should stop selling these products as soon as possible."

Thompson said he was announcing the upcoming ban now so that people making New Year's resolutions to lose weight won't be tempted to try ephedra.

"Ephedra raises your blood pressure and stresses your system," McClellan added. "There are far better, safer ways to get in shape."

Critics called the ban long overdue.

Sales already have plummeted because of publicity about the herb's dangers, which peaked after Bechler's ephedra-related death in February. The Nutrition Business Journal estimates $500 million worth of ephedra was sold this year, down from $1.3 billion in 2002.

Three states -- New York, Illinois and California -- have passed their own bans. Most retail chains have quit selling ephedra-containing products, and only a handful of major ephedra producers still are in business to supply Internet sellers. Even market leader Metabolife International suspended ephedra sales last month, citing ambiguities in state laws.

"It's a dead product, and unfortunately it has become a dead product over the backs of a lot of dead people when the FDA could have acted before," said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.

Wolfe petitioned the government for a ban in 2001, when the agency had reports of 81 deaths. That number now is 155; also, FDA has reports of more than 16,000 health complaints from ephedra users.

"It was unfortunately only with the tragic death of a high-profile athlete that this started to get the attention that was due," added Dr. Mark Estes of the New England Medical Center in Boston, who called FDA unresponsive to years of physician complaints.

Others welcomed FDA's crackdown.

"It won't bring Steve back, but it will help and protect other people," said Pat Bechler, the baseball player's mother. Her husband Ernie recently urged Congress to pass a ban, saying, "Please don't let my son die in vain."

The FDA said it couldn't act any sooner because of a federal law that lets dietary supplements sell over the counter without any requirements that they prove to be safe. To curb supplement sales, the FDA must prove a clear danger to public health -- something Thompson called "a tremendous burden of proof" that Congress should rethink.

Ephedra makers insisted their products are safe if used correctly, but so far aren't saying if they'll sue to block the ban.

"Millions of consumers throughout the United States have used ephedra dietary supplements as a safe, inexpensive and effective means by which to support weight loss," San Diego-based Metabolife said.

Questions about the herb ephedra and its ban

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. 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 in some conditions. 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 weight control, building muscle and boosting energy. FDA's power to regulate the dietary supplements is more limited than for prescription drugs. The agency can ban risky supplements only after gathering evidence of injury.

Q: Why is ephedra now being banned by the FDA?

A: After years of studying, the FDA has concluded that continued sale and use of products containing ephedra "pose an unreasonable health risk." There have been about 1,000 reports of serious health complications from the use of ephedra and at least 100 deaths. The herb already was banned in three states and by the NFL, NCAA and International Olympic Committee. A 23-year-old pitcher for the Baltimore Orioles who died suddenly was taking ephedra.

Q: Do companies making or selling ephedra products have a right to appeal the FDA order?

A: Yes, they can sue. FDA officials said they are ready for the new ephedra rule to be challenged in court.

Q: Is the FDA evaluating other dietary supplements?

A: Yes. Officials said that other products are being looked at, but no immediate action is expected. An FDA publication lists a number of herb supplement ingredients with "possible health hazards," including chaparral, comfrey, willow bark and wormwood.