Wary consumers are beginning to shy away from diet preparations containing ephedra, with U.S. sales of some of the most popular brands falling 30% or more over the last year. But some researchers and lawmakers worry that without a change in federal law, untested substitutes will take their place.
Concern about ephedra has grown in recent months with a series of deaths among professional athletes who had been taking ephedra weight-loss products. Most recently, one diet aid containing ephedra, Xenadrine RFA-1, was blamed in part for the death of Baltimore Orioles pitching prospect Steve Bechler, who died of heat exhaustion in training camp Feb. 17.
The government wants to force dietary supplement manufacturers to start using a new warning label that says ephedra can trigger heart attacks and strokes, sometimes causing death. The Food and Drug Administration has announced it is exploring the possibility of a ban -- a step that Canadian health authorities took early last year.
Regardless of the reason, ephedra sales have declined dramatically in recent months.
Data newly compiled by Information Resources Inc., a company that collects sales data directly from the bar-code scanners at cash registers in supermarkets, drugstores and mass merchandising outlets nationwide, show U.S. sales of Metabolife 356, Metabolife International Inc.'s signature product, have fallen by 30% over the last year. Metabolite which boasts of its similarity to Metabolife in its advertising, saw sales plummet 48% last year.
The Dutch conglomerate that owns GNC, the worldwide chain of 5,300 stores devoted solely to items such as vitamins, dietary products and herbs, earlier this month blamed its lackluster 2002 corporate results on a $40-million drop in ephedra-product sales in the United States last year.
Industry officials, however, say ephedra supplements are safe when taken as directed on their labels, and blame declining sales on public misunderstanding caused by news coverage of ephedra-linked deaths. The industry points out that millions of Americans take their products every year without suffering any adverse health effects.
Although Metabolife firmly stands behind its ephedra-based product, it recently has begun heavily promoting a new "ephedra-free" product.
"Metabolife is developing ephedra-free products simply to offer consumers additional choices," said Metabolife spokeswoman Jan Strode. "The new products provide an alternative, particularly for those consumers who have been confused and misinformed by inaccurate public information being circulated about dietary supplements."
Medical researchers who helped build the government's case against ephedra -- and lawmakers at the forefront of years-long efforts to ban the substance -- worry that the loosely regulated dietary supplement industry will turn to untested substitutes if ephedra is banned.
"I have no doubt that there are scores of plant pharmacologists working to find something else they can throw into these dietary supplements," said Dr. Christine A. Haller, the UC San Francisco medical researcher who 2 1/2 years ago coauthored the FDA's first authoritative study on the dangers of consumer products containing ephedra.
Haller is in the middle of a study of Citrus aurantium, or "bitter orange," a Chinese botanical that has become the key ingredient in the "ephedra-free" versions of some of the most widely sold diet and pep pills -- Dexatrim, Ripped Fuel, Stacker 2, and Xenadrine. Haller said little is known about Citrus aurantium but that its effects resemble those of phenylpropanolamine, a diet pill ingredient the FDA banned two years ago.
"I think many of us in the research community believe that if ephedra goes away, this bitter orange extract will certainly become the major herbal ingredient in herbal weight-loss products," Haller said. "And who knows what else is down the road?"
Dr. Billy Joe Gurley, a University of Arkansas Medical School professor who has studied dietary supplements, said a key ingredient of bitter orange, synephrine, is chemically very similar to ephedrine, the major component of ephedra.
"So, for all intents and purposes, they're just substituting a horse for a zebra," Gurley said.
Haller and Gurley are critical of federal laws that set different regulatory standards for drugs and dietary supplements. Although drugs must be proven safe and effective before they can be put on the market, dietary supplements are treated like food. The FDA must prove that a supplement is dangerous before it can be ordered off the market.
Unless the present law is amended to impose some pre-market safety requirements, "we're going to have this constant stream of potentially dangerous products out there that we're trying to catch up on and ban as we go along," Haller said.
"Rather than focusing on just this one bad player, ephedra, we need to address this whole issue," Haller said.
Critics of the law on dietary supplements have some allies in Congress.
"It is clearly time for Congress to ... strengthen the law so that there is greater regulatory oversight of dietary supplements," said Rep. Henry A. Waxman (D-Los Angeles).
To that end, Sen. Richard Durbin (D-Ill.) plans to introduce legislation that would change the way the FDA treats dietary supplements that contain stimulants or steroids, a spokesman said.
The bill essentially would require that dietary supplements containing stimulants or steroids be proven safe before they are marketed or sold.