Health Warning Label Proposed for Ephedra

Times Staff Writer

The federal government moved to crack down on ephedra Friday, proposing a label warning that the herbal stimulant may contribute to heart attacks, strokes and even death.

Officials stopped short of banning the adrenaline-like herb, saying federal law limits their authority to restrict sales of dietary supplements.

But they began soliciting from the public new evidence of ephedra’s health risks to determine whether products containing the compound posed a “significant risk of illness or injury” -- the standard required by law to support a ban of a dietary supplement.


They also accused 26 companies that market ephedra supplements of making “false and misleading claims” about their products’ capacity to build muscle mass and boost athletic performance. The Food and Drug Administration warned the companies that it would seize their products if they did not stop making such claims.

Officials cited a long-awaited Rand Corp. study as the basis for Friday’s announcement, but they were also responding to public demand for government action that has been building since the Feb. 17 death of Baltimore Orioles pitcher Steve Bechler. Several professional and college athletes who took ephedra products have died in recent years.

“I would not take this, I would not give it to my family, and I don’t know why anyone would take the risk,” Health and Human Services Secretary Tommy G. Thompson said Friday, expanding on remarks he made after Bechler’s death.

By leaving ephedra products on store shelves and in medicine cabinets and locker rooms across the country, the Bush administration ensured that the years-long battle between ephedra makers and consumer advocates would continue for several more months, if not longer.

For nine years, the FDA has received reports -- totaling more than 1,400 and including news of more than 80 deaths -- of serious side effects suffered by people taking ephedra products. Citing those reports, consumer groups and lawmakers have called on the government to ban the products.

Friday’s limited actions demonstrated the entrenched power of the dietary supplement industry -- expressed in a 1994 law that severely limits government regulation of such products. The industry has contributed heavily to the election campaigns of the members of Congress who sponsored the 1994 law.


The industry publicly praised the government’s latest steps.

“The actions taken today by [the Department of Health and Human Services] and FDA will ensure that responsible adults who desperately need weight-loss options will have continued access to safe and beneficial ephedra products,” the Ephedra Education Council said in a statement. The group said it “has always supported regulation of ephedra products based on science.”

Ephedra’s critics were bitterly disappointed, if not surprised, by the Bush administration’s actions. “This is a weak and inadequate response to a serious public health problem,” said Rep. Henry A. Waxman (D-Los Angeles).

Government officials, indicating they favored a ban, all but promised future action.

“This is not the end of the story,” Thompson said.

Dr. Mark McClellan, commissioner of the FDA, expressed even stronger support for government limits on ephedra sales and suggested that he favored action sooner rather than later.

While Friday’s actions “lay the legal groundwork for further legal action ... I believe the FDA has the basis [now] to take further action,” McClellan said.

An herbal stimulant derived from the Chinese plant ma huang, ephedra acts much like adrenaline. Taken in pill form, it boosts the heart rate and increases metabolism. An ephedra extract, ephedrine, is commonly used in over-the-counter decongestants -- regulated by the FDA -- to open nasal passages.

Some 15 million consumers take ephedra products annually. Industry officials say the pills are an important weapon in the nation’s battle against obesity.


Consumer advocates, including Public Citizen’s Health Research Group and the Center for Science in the Public Interest, said serious side effects have been associated with ephedra. In addition to heart attack, stroke and death, side effects include high blood pressure, dehydration, heatstroke and anxiety-related disorders. Along with some lawmakers, including Waxman and Sen. Richard Durbin (D-Ill.), consumer advocates have called for a government ban.

Fueling the ephedra controversy are conflicting scientific studies of the herb’s safety and effectiveness. The industry cites one group of studies to argue that ephedra products are safe; ephedra critics list the thousands of “adverse event reports,” as well as other studies, to argue the stimulant it is not.

The Rand study, commissioned by the Department of Health and Human Services in 2001, was intended to sort out claims and lay the groundwork for a definitive study that would be conducted by the National Institutes of Health.

But on Friday, few could agree on what the 300-plus-page Rand report said.

Thompson and McClellan said the Rand report found “no evidence” to support claims that ephedra boosted athletic performance and only limited evidence that it facilitated weight loss.

Wes Siegner Jr., an attorney representing the industry, called the Rand report “an affirmation of the science. There is very clear clinical data here that people can lose weight on these products.”

Dr. Paul Shekelle, the lead author of the Rand report, said his study proved definitively that ephedra could cause anxiety, sweating, nausea and other mild side effects. And while it’s “much more likely than 50-50 that the use of ephedra is related to” more serious effects such as heart attack and death, he said this conclusion could not be stated with scientific certainty.


The 1994 Dietary Supplement Health and Education Act requires the government to meet not only a scientific but also a legal standard before it can order such products off the market.

To survive an inevitable legal challenge to an ephedra ban, the government would have to prove that ephedra products posed an “imminent hazard” or a “significant or unreasonable risk to public health and safety.”

McClellan used the latter phrase several times Friday to describe the state of scientific understanding of ephedra’s effects. He also said warning labels, which he said could be ready well before the end of the year, would go on the front of whatever ephedra products “might remain on the market.”