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FDA Rolling Out Ephedra Warning Labels

Mar 1, 2003 | AP

Every bottle of ephedra will soon bear stern warnings that the popular herb can cause heart attacks or strokes, even kill, the Bush administration says.

The move, however, didn't satisfy consumer advocates who had pushed for an immediate ban of the amphetamine-like stimulant.

The Food and Drug Administration announced the warning labels Friday as part of a series of steps aimed at building the case for more restrictions on the controversial dietary supplement.

The FDA stopped short of an immediate ban of the herb, used for weight loss and as an athletic performance booster. Despite reports of at least 100 deaths linked to ephedra use, the agency said it has not compiled enough proof of danger to stand up in court under a 1994 law that severely limits federal safety oversight of dietary supplements.

"This is not the end of the story," said Health and Human Services, Secretary Tommy Thompson. The FDA is "building the case for further regulatory action under the law."

Meanwhile, Thompson advised people, especially athletes and exercise enthusiasts, not to take the herb. The advice came two weeks after the latest high-profile death of an ephedra user, Baltimore Orioles pitcher Steve Bechler.

"I would not take this, I would not give it to my family and I don't know why anyone would take these products," Thompson said. He pointed to an administration-commissioned Rand Corp. review that found ephedra does nothing to enhance sports performance and causes only temporary loss of a few pounds. "Why take the risk?"

Consumer advocates and some members of Congress called the FDA's action a cowardly step that will cost lives.

"How many more deaths will it take before this agency does its job?" asked Janelle Mayo Duncan of Consumers Union.

Thompson "needs to show the courage to ban this product and be willing to stand up to protect American families," said Sen. Richard Durbin, D-Ill., who listed, by name, several ephedra users who have died since he began urging Thompson to stop sales six months ago.

"Frankly, he should be a lot more afraid of the deaths and injuries from ephedra than of facing attorneys in court," Durbin added.

The American Medical Association praised Friday's action but said more was needed. "The new steps announced today represent real progress toward what we hope will ultimately be a ban on ephedra dietary supplements in the United States," said AMA trustee Ron Davis.

Sen. Orrin Hatch, R-Utah, said, "Today's announcement appears to be a reasonable, if long overdue, step in designing science-based rules pertaining to the use of a product about which public concern has been expressed for many, many years." Hatch was one of the authors of the 1994 law.

The House Energy and Commerce Committee promised hearings on whether a ban was necessary, and the consumer advocacy group Public Citizen said it was considering suing FDA to force a ban.

Ephedra manufacturers expressed relief that FDA didn't ban their products, and said they wouldn't fight the new warning labels even though they had lobbied intensely for far weaker ones.

An industry spokesman argued the Rand study actually proved ephedra works for weight loss, and that Thompson's negative interpretation bowed to the critics.

"I respect that Secretary Thompson is under a lot of political pressure, and a lot of that has to do with reports in the press and rush to judgment in the Bechler case," said Wes Siegner, general counsel for the Ephedra Education Council.

The FDA also on Friday warned 24 companies that target ephedra to athletes and bodybuilders to stop that marketing within 15 days.

Ephedra has been linked to life-threatening side effects even when used by outwardly healthy people at recommended doses — because it speeds heart rate and constricts blood vessels.

Those effects can be exacerbated by exercise and use of other stimulants such as caffeine, and they're particularly risky if the user has certain underlying medical conditions such as heart disease, said FDA Commissioner Mark McClellan.

Canada has long warned consumers not to use ephedra, and it is banned in the Olympics. In the United States, it has been banned in professional football, college athletics and, just this week, minor-league baseball.

Because ephedra is an herb, U.S. law lets manufacturers sell it over-the-counter with little oversight to ensure safety. The FDA must prove a clear danger to public health to curb sales. Manufacturers blocked a 1997 FDA attempt to restrict sales of certain dosages and to put warning labels on the herb by arguing the agency lacked enough proof of danger.

The FDA proposed those steps again. After a 30-day comment period, it plans within months to order a large warning on the front of every ephedra bottle that death, heart attacks and strokes are possible side effects, and that certain people should avoid the pills.

Also up for comment are proposed dosage restrictions, and whether ephedra poses the kind of risk necessary for a ban.

Ephedra's active ingredient is a chemical called ephedrine that, when produced synthetically, the FDA stringently regulates. It is allowed only in small doses in certain cold drugs.

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