FDA Proposes Strong Warning Label for Ephedra
The FDA is seeking public comment on the warning labels and said they could be in place in a matter of months.
“Throughout America, there continue to be tragic incidents that link dietary supplements containing ephedra to serious health problems in consumers that use these products,” Health and Human Services Secretary Tommy Thompson said Friday.
“I would not take this, not give it to my family. And I don’t know why anyone would take these products,” Thompson said.
Thompson said an outright ban was still being considered.
“Dietary supplements containing ephedra may present a significant and unreasonable risk of illness and injury,” he continued.
The FDA action came less than two weeks after a medical examiner in Florida said the heatstroke death of Baltimore Orioles pitcher Steve Bechler was probably linked to his use of ephedra. The FDA, which has reports of at least 100 deaths linked to ephedra supplements, had been under pressure from doctors for years to ban the herb, but Bechler’s death renewed the scrutiny.
The agency said it had warned 24 companies that market the amphetamine-like stimulant to athletes and bodybuilders that there is no scientific evidence that ephedra helps athletic performance, signaling the possibility of a bigger crackdown.
The FDA also released results of a long-awaited ephedra review by the Rand Corporation, which concluded the herb probably has caused some deaths while giving users very little weight-loss benefit.
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 the use of other stimulants such as caffeine, and they’re particularly risky if the user has certain underlying medical conditions such as heart disease.
A recent study published online by the Annals of Internal Medicine found that even through ephedra represents less than 1 percent of the herbal supplement market, it accounted for 64 percent of adverse reactions to such supplements that were reported to poison control centers.
Anticipating the announcement, a leading ephedra manufacturer, Metabolife International, issued a statement condemning “irresponsible marketing practices” that result in athletes misusing the product and called for limited government regulations such as banning sales to minors. Metabolife is taken by 2.5 million Americans and contains a combination of ephedra and caffeine.
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.
The FDA first proposed stronger warning labels for ephedra in 1997. It reopened that proposal for public comment Friday, a step required before the agency can mandate the warnings. The proposal suggests every ephedra bottle list death, heart attacks and strokes as potential side effects, caution consumers about exercise and caffeine, and list groups of people who are especially vulnerable to bad reactions and should never use the herb.
The FDA said Friday it will also seek public comment on whether ephedra poses enough risk to justify banning the dietary supplement — leaving in question just how big a crackdown the agency intends.
“The standard for regulating the safety of dietary supplements is largely untested, but we are committed to finding the right public health solution,” said FDA Commissioner Mark McClellan.