FDA plans ban on ephedra.

Byline: Tim Christie The Register-Guard

Federal regulators announced plans Tuesday to ban ephedra products and urged Americans trying to shed a few pounds for the new year to stay away from the popular nutritional supplement with an amphetaminelike kick.

"The time to stop taking this product is now," Health and Human Services Secretary Tommy Thompson said in declaring the government's first-ever ban of a dietary supplement. "They are just too risky to use."

The timing of the announcement was made deliberately to deter dieters from turning to ephedra to help fulfill New Year's resolutions to lose weight, Thompson said.

The U.S. Food and Drug Administration concluded that ephedra products pose "an unreasonable risk" of illness and injury to consumers.

FDA Commissioner Mark McClellan said manufacturers should pull their products from shelves now and not wait for the ban to take effect in March.

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

But the announcement spurred some people to race to local suppliers to stock up on the supplement, also used by athletes looking for an energy boost.

At Discount Sports & Nutrition in Eugene, Paul Buel fielded a steady stream of phone calls from customers. One caller wanted to buy 20 cases of an ephedra sports drink, he said.

Ephedra supplements account for 10 percent to 15 percent of his overall sales, he said. "It's going to hurt business, but people will move on to other things," he said. "But it's tough to replace ephedrine."

The FDA said its decision followed a comprehensive review of ephedra's pharmacology, clinical studies of its safety and effectiveness, analysis of more than 16,000 adverse reactions among consumers and other reports.

Agency officials said the review found little evidence that ephedra was effective except for short-term weight loss, and confirmed suspicions that ephedra raised blood pressure and otherwise stressed the circulatory system.

Those reactions have been linked to heart ailments and strokes, even in outwardly healthy people taking recommended doses.

Roughly 155 deaths have been blamed on ephedra, including that of Baltimore Orioles pitcher Steve Bechler, who played for South Medford High School.

``It won't bring Steve back, but it will help and protect other people,'' said Pat Bechler, the baseball player's mother.

"I mean, to get this off the market and to save other people's lives is just amazing to us," said Bechler's father, Ernie Bechler.

He recalled his testimony to Congress last summer: "Please don't let my son die in vain."

Publicity about the herb's dangers, which peaked after Bechler's death last winter, caused sales of ephedra supplements to plummet. The Nutrition Business Journal estimates $500 million worth of ephedra was sold this year, down from $1.3 billion in 2002.

Despite its stimulant effect, ephedra is classified as a nutritional supplement by the federal government, meaning it gets the same regulatory scrutiny as food.

Prescription drugs must undergo rigorous, costly clinical testing to prove they're safe and effective before they can be sold to the public. But under a 1994 law, supplements are presumed safe and must be found to be harmful before the FDA can take them off the market.

Before the FDA action, the substance was already banned by three states, the NCAA, the NFL and the International Olympic Committee. Several retail chains, including supplement giant General Nutrition Centers, have stopped selling ephedra products.

In Eugene, Buel said he plans to continue selling the supplement until his stock runs out. He's convinced ephedra is safe - when used as directed, he said.

"I've yet to run into anybody who's had serious side effects," he said. "Unfortunately, a few people abuse it and mess it up for everybody."

At Wynant's Family Health Foods, a family-owned store in Springfield, assistant manager Greg Daily said he's not surprised by the government ban, noting that many companies have already reformulated their products, substituting stimulants such as caffeine or guarana for ephedra.

But some people can't handle the massive doses of caffeine in the new products, he said. "People say they can't take it anymore because it makes them shaky," he said.

Some fitness clubs, such as Gold's Gym in Eugene, still sell the supplement, but others have stopped. The 24-Hour Fitness club in Gateway lost about a third of its total drink sales when it took ephedra products off its shelves about a year ago, said David Scott, the store's operations manager.

But the club now sells ephedra-free drinks and pills that are as effective as ephedra at increasing metabolism and energy levels, he said.

Some consumers groups and critics say the federal ban came too late.

The consumer advocacy group Public Citizen urged remaining manufacturers to recall all ephedra products still on store shelves.

A supplement industry group, the Council for Responsible Nutrition, said it didn't oppose a ban, noting that few companies still make the stimulant.

"We think the reputable players have found so much controversy and difficulty in this marketplace that they've decided to get out of it," said the group's John Hathcock.

But some ephedra marketers decried the ban.

``Cold medicine kills more people a year than ephedra does," said Robert Mackenzie, owner of MaxOutBody.com, a Web site that has sold at least $300,000 in ephedra since July. "If you overindulge in anything ... you're going to have the same kind of problem."

The Associated Press contributed to this report

EPHEDRA FACTS

Ephedra, a plant also known as ma huang, has been used for thousands of years in Chinese medicine.

Ephedra contains two alkaloids, ephedrine and pseudoephedrine, which can combat congestion and ease breathing.

Ephedra, a stimulant, speeds the body's metabolism, boosts energy and raises a person's heart rate.

Ephedra is found in 200 dietary supplements sold over the counter, though many manufacturers have begun marketing ephedra-free products.

CAPTION(S):

Paul Buel of Discount Sports & Nutrition in Eugene says ephedra products make up 10 percent to 15 percent of sales.