Last week, Health and Human Services Secretary Tommy G. Thompson announced that the Food and Drug Administration would soon outlaw U.S. sales of diet products containing stimulants derived from the Ephedra sinica plant. He timed the pronouncement to anticipate the start of the perennial diet season: New Year’s Day.
FDA researchers have just concluded a review of available evidence on risks and benefits of ephedra-based products, the nation’s most popular diet aids. The scientists found that the alkaloids–stimulants that include ephedrine–in these over-the-counter products “present an unreasonable risk of illness or injury.” Thompson announced that FDA was sending letters to 62 supplement makers, notifying them that it would publish a final rule banning ephedra products “as soon as possible.” The supplements’ prohibition would go into effect 60 days after the final rule appears in the Federal Register.
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In the meantime, said Thompson, consumers “should stop buying and using ephedra products right away, and FDA will make sure consumers are protected by removing these products from the market as soon as the rule becomes effective.”
Some of the companies that received Thompson’s letter could take a big economic hit. Last year, Janet Heinrich of Congress’s General Accounting Office analyzed ephedra marketing and safety. In her report, she noted that “as many as 3 billion servings of ephedra are sold each year in the United States” (See Diet Pills: It’s Still Buyer Beware).
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Handwriting was on the wall
Ephedrine, an alkaloid made by Ephedra plants, is chemically related to adrenaline, the powerful fight-or-flight stimulant produced by the human body. Both chemicals raise heart rate and blood pressure. Several other alkaloids in Ephedra plants are weaker cousins of ephedrine. By revving up heart rate, these natural compounds can make the body work harder–burning extra calories along the way.
How strong a stimulant punch a supplement packs depends on the harvested plant, because different weather, cultivation, and insect presence in the field can affect a plant’s production of alkaloids. Moreover, herbal products use various concentrations of ephedra alkaloids–and many manufacturers boost their products’ stimulant activity by adding caffeine.
Depending on the health of the individual taking these products, ephedra can jump start a sluggish metabolism–or push it beyond what the heart can safely handle. As it turns out, many people have abused ephedra products, figuring that if a little is good, more would be better. In other cases, people with heart problems may have inadvertently courted disaster by overstimulating their circulatory system with ephedra.
The result: horror stories. Athletes have developed heart problems–and some have died–after taking ephedra-based dietary supplements to shed weight gained during the off-season. Moms who used ephedra-based diet aids to slim down after a pregnancy have suffered symptoms ranging from personality changes to seizures. Middle-age couch potatoes who turned to ephedra have endured side effects including permanent nerve damage, strokes, and heart attacks.
Last March, a review of ephedra diet products in the Journal of the American Medical Association concluded that although the supplements could offer some people modest weight loss, “existing evidence about harm is strong enough to say it outweighs any chance of benefit” (SN: 4/12/03, p. 237: Available to subscribers at Weight-loss pill carries risks). FDA posted key aspects of the report on its Web site.
Seven months later, FDA’s associate commissioner for regulatory affairs, John M. Taylor, testified to a Senate committee about ephedra products. He noted that his agency had formally begun a reanalysis of whether ephedra-based dietary supplements might warrant regulation. He noted that some 30,000 people or organizations had sent comments to FDA–a mountain of information that the agency was sifting through. While studying the products’ safety, FDA was also investigating potentially false claims that manufacturers had been making about their products: chiefly, that ephedrine-containing products would boost athletic performance. Subsequently, the agency moved against 26 firms that had made such claims.
Taylor also noted that FDA was particularly concerned about the use of ephedra diet aids by athletes, because those individuals stress their hearts through strenuous exercise. Ephedra products pose “special risks” to athletes while offering them “little or no identified benefit,” he said.
Why didn’t FDA act sooner?
Although ephedrinelike alkaloids work like drugs, Congress exempted from the strict FDA regulations compounds derived from plants for use in herbal products. The rules for such dietary supplements instead put the burden of proof on the government to establish that a product presents an “unreasonable risk of illness or injury.”
It’s taken a long time for the agency to accumulate such evidence for ephedra. Complicating FDA’s efforts is the fact that the agency can’t require studies of safety or effectiveness of dietary supplements, as it can for prescription drugs. Indeed, FDA can’t even compel supplement makers to collect and turn over reports of harmful side effects from their products.
FDA initially tried to regulate ephedra products in 1997, but the move was blocked by critics–including the General Accounting Office–arguing that federal officials had failed to make the case that the supplements were dangerous when used as directed.
Now, considerably more evidence of ephedra’s dangers exists. As soon as possible, Thompson vowed last week, FDA will formally publish its findings “that dietary supplements containing ephedrine alkaloids present unreasonable risks to those who take them for any reason.”
Manufacturers are already hawking alternatives in health food stores and on the Internet, many of the products being derived from green tea. As crazy as that might sound, Swiss scientists have isolated a natural antioxidant in the tea–a compound with the unwieldy name epigallocatechin gallate, or EGCG–that boosts the body’s metabolism. Men taking a capsule of the compound burned 80 more calories in a day than they did when getting an inert look-alike pill (SN: 1/1/00, p. 11: Available to subscribers at The brew for a slimmer you).
There isn’t such a precise figure for the result of taking ephedra as directed. But if either supplement’s effect is on the order of only 80 calories a day, remember that that’s less than the energy contained in a single cookie or a few bites of cake. So dieters might be better off simply keeping their hands out of the cookie jar and the candy dish.