The federal government yesterday strongly warned people against using ephedra and said it would seek new ways to regulate the dietary supplement, including warning labels and, possibly, a ban on ephedra products in the marketplace.
"I would not take this, I would not give it to my family, and I don't know why anybody would take these products," said Health and Human Services Secretary Tommy G. Thompson. Asked at a news conference whether his remarks meant that he would seek an outright ban on ephedra, Thompson said, "You can read into that anything you want to."
Thompson said he intended to seek new restrictions on ephedra use and proposed prominent display of a label on bottles and packages that warned that "heart attack, stroke, seizure and death have been reported after consumption of ephedra products."
Thompson said his actions were prompted by release of a long-awaited report on ephedra commissioned by the department from the Rand Corp. His announcement marked the first federal action on ephedra since the death from heat stroke on Feb. 17 of Baltimore Orioles pitcher Steve Bechler after a spring training workout. Bechler had an ephedra supplement in his locker.
The Rand report found that ephedra, a powerful natural stimulant sold in thousands of weight-loss and energy-enhancing products, had only limited use as a short-term diet aid and no demonstrable effect on athletic performance.
Despite Thompson's belligerent and, at times, outright hostile comments on ephedra, it was not clear how far the government could go in regulating ephedra. Previous attempts to restrict its use have failed. Critics of the supplement said Thompson's presentation was weak and inconclusive, and maintained that he should have declared ephedra an "imminent health hazard" and banned it immediately.
"I'm encouraged by the fact that he's announced action today," said Sen. Richard J. Durbin (D-Ill.), a longtime ephedra opponent. "But I have been urging action for six months, and what he has offered as a response to the Rand study is less than necessary. The secretary should stick his neck out when that's required."
Industry representatives reacted cautiously to Thompson's announcement. Annette Dickinson, acting director of the Council for Responsible Nutrition, said she intended to study the Rand report, and questioned whether new regulation of ephedra was needed, as "current law has not been demonstrated to be inadequate."
Much of the debate on ephedra has centered in recent years on "current law" -- the 1994 Dietary Supplement Health and Education Act -- which regulates vitamins, minerals, botanicals and other dietary supplements taken by millions of Americans.
Many supplements are healthful or harmless, but ephedra, an herb known in China for thousands of years as ma huang, is pharmacologically active as a powerful stimulant. In its synthetic form, ephedrine has long been used in decongestants and as an asthma treatment.
But herbal ephedra has gained a huge following in the United States in the past15 years; it was promoted first as a "natural high" thrill drug, and later as a weight-loss aid and workout enhancer. The industry sells more than 3 billion doses of ephedra every year.
Under the 1994 act, drafted with the industry's participation, herbal ephedra and other supplements can be sold without pre-market screening for harmful side effects, companies have no obligation to report bad reactions to them, and the Food and Drug Administration must prove a supplement is dangerous before pulling it from the market. By contrast, drug companies must prove a product is safe before they can sell it.
The FDA, which Thompson oversees as part of his department, has had no success in regulating ephedra, and in 1997 abandoned a proposed regulation to impose restrictions on its use when a congressional report questioned the reliability of its data. "The burden is very, very high," Thompson said yesterday. "Drugs have to prove their safety; we have to prove dietary supplements are unreasonably unsafe."
Under Thompson's plan, the FDA will reopen debate on the 1997 rule, citing information from 17,000 new reports of dangerous side effects -- most of them gathered from ephedra companies in court cases.
Thompson explained that using the old rule as a vehicle will allow quicker action on the new regulations and warning label. If this approach fails to achieve a desired result -- which he did not describe -- Thompson said, "Congress should take a look," presumably to target ephedra specifically with new legislation or to seek overall modifications to the 1994 law.
Ephedra opponents dismissed Thompson's approach as unnecessary temporizing. Sidney M. Wolfe, director of Public Citizen's Health Research Group, insisted that Thompson had the authority under the law to pull ephedra from the market as an "imminent health hazard," a designation used in the past only when batches of contaminated supplements cause a sudden outbreak of serious illness.
Durbin dismissed Thompson's apparent reluctance to invoke this standard, saying "he should be more afraid of the dangers of ephedra than of facing the industry lawyers in court." Durbin said he had tried "everything" he could to get Thompson to take action on ephedra, but nothing happened "until this Baltimore Oriole pitcher dropped dead, and it became a big national issue."