FDA Orders Sales Ban On Ephedra
Supplement linked to health concernsDec 31, 2003 | Kansas City Star Already sagging in sales because of perceived health risks, the weight-loss herbal supplement ephedra will be banned in 60 days, the Food and Drug Administration announced Tuesday.
Ephedra, linked to heart ailments, is “simply too risky to be used,'' said Tommy Thompson, secretary of health and human services. He advised people to stop using it immediately.
Consumer groups lauded the ban but said it should have occurred long ago. Companies that make or sell ephedra products maintained they were safe, and Thompson said he expected a lawsuit in an attempt to block the ban.
In the Kansas City area, most nutrition stores and weight-loss centers contacted Tuesday said use of ephedra had dropped sharply in the last year or two because of reported risks.
Ephedra is promoted by manufacturers as good for weight control, building muscles and increasing energy. But its chemicals also can affect heart rate and increase blood pressure, studies show.
The FDA sent letters to 62 manufacturers Tuesday urging them to stop dispensing ephedra, even though the sales ban will not take effect for 60 days after publication in the Federal Register to allow time for congressional review.
“We have long been urging the FDA to take decisive action because it's been a product creating negative publicity that has washed over the whole diet supplement industry,” said Judy Blatman of the Council for Responsible Nutrition, which represents 80 dietary product makers. “It has hurt consumer confidence.”
Public Citizen, a consumer advocacy group, petitioned the FDA to ban ephedra more than two years ago because of a reported 81 ephedra-linked deaths, a number that has since almost doubled. The ban is far too late, the group said.
“This is an inexcusable dereliction of responsibility by an agency that has acted more like an ephedra sales extension agency than the public-health agency it is supposed to be,” said Sidney Wolfe, director of the Public Citizen Health Research Group.
A leading manufacturer of ephedra products, in a statement issued Tuesday, said the supplement was safe, though the company said it should not be used by minors or by athletes trying to improve performance.
“Millions of consumers throughout the United States have used ephedra dietary supplements as safe, inexpensive and effective means by which to support weight loss,” said Jan Strode, spokeswoman for Metabolife International Inc.
Strode said the company would “carefully consider its options” regarding the ban when the final rules are published in the Federal Register. The San Diego company suspended sales of ephedra last month pending clarification of a California ban on the supplement, Strode said.
The owner of a store in Overland Park that sells 30 to 50 bottles of ephedra products monthly was displeased with the ruling but said it won't put him out of business.
“If you're going to take a product like that, you have to do it responsibly,” said Russell Wood of Fit 4 Less. “…This is just the government telling you what's best for you.”
The FDA has been concerned about ephedra for some time, and last February it ordered warning labels to be placed on products that contain it. The order came 11 days after Baltimore Orioles pitcher Steve Bechler died of heat stroke that a medical examiner linked in part to his use of ephedra.
“A lot of times when people are desperate and want to lose weight, they are looking for quick fixes,'' said Kristi Widmar, public relations manager for the Weight Watchers International Inc. regional office in Kansas City. “It's kind of an eye-opener for them to realize, ‘Boy, this isn't as safe as I thought. If the federal government doesn't believe in it, maybe I shouldn't either.' ”
Not many stores carry ephedra in the Kansas City area, according to interviews with store owners.
“There is just too much negative media out there, and we don't like to associate ourselves with that,” said Paul Bennett, of Harvest Moon Natural Foods in Olathe.
Bennett said ephedra products once made up 5 percent to 10 percent of all supplement sales and that a lot of customers were upset when he no longer carried them.
The Nutrition Business Journal has reported that ephedra product sales of about $1.4 billion last year could drop to $300 million to $500 million this year. Ephedra is banned in three states — Illinois, California and New York.
“They're almost impossible to get,” said Larry Maples, owner of the Muscle Matrix store in Olathe. Ephedra is tempting to athletes but is banned by the National Collegiate Athletic Association, National Football League and minor league baseball. It is not banned in Major League Baseball, the National Hockey League or National Basketball Association.
High school coaches have tried to keep athletes from using ephedra. Four years ago, Olathe East High School suspended 15 athletes for using Ripped Fuel, which contains ephedra.
“I believe it is a dangerous substance,” Olathe East varsity football coach Jeff Meyers said. “I'm glad it's being outlawed.”