U.S. Seeks Tough Warning Labels for Ephedra

FDA wants word 'death' included; critics want ban

FRIDAY, Feb. 28, 2003 (HealthDayNews) -- The government will seek tougher warning labels for the popular weight-loss supplement ephedra, which has been linked to more than 100 deaths.

"We will propose and seek public comment on a brand-new strong warning label on any ephedra product that will continue to be marketed," Health and Human Services Secretary Tommy Thompson said at a press conference Friday. "This label will include a warning about possible death."

The possibility of an outright ban on the herb by the U.S. Food and Drug Administration, which regulated nutritional supplements, is still on the table, Thompson added.

The announcement, coming two weeks after the death of baseball pitcher Steve Bechler, drew immediate criticism.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group in Washington, D.C., called the FDA's refusal to ban ephedra products "cowardly."

It "comes in the face of clear, unequivocal evidence of the dangers of these products," he said in a statement. "The legal standard, under the Dietary Supplement Health and Safety Act (DSHEA) of unreasonable risk of harm when used at the recommended dose, is clearly met."

Industry representatives, however, praised the announcement.

"Overall, we're extremely pleased that the FDA and HHS are taking action to resolve this public controversy," said John Hathcock, vice president for nutritional and regulatory science at the Council for Responsible Nutrition, a trade group based in Washington, D.C. "We have petitioned for action as much as a year and a half ago to compose warning labels and restrictions of dosage."

"We view this essentially as good news for consumers because the products are still on the market," says Wes Siegner, legal counsel for the Ephedra Education Council in Washington, D.C. "We've been asking the FDA for federal warning labels for the products for a long time, and we now have that."

Ephedra-containing products have been tied to more than 100 deaths, including Bechler, the Baltimore Orioles pitcher who died of heatstroke at spring training two weeks ago.

Ephedrine, the active ingredient in the herb called ephedra, increases metabolic rate, heat production, and the risk of heatstroke. Earlier this month, a group of San Francisco researchers claimed that ephedra is the most dangerous herbal product on the market. They based their statement on data collected from poison control centers.

Thompson also announced the early release of a Rand Corp. report on ephedra that had been commissioned by the government.

The report, a review of existing literature, said "the evidence suggests a link between these products and catastrophic events such as sudden death, heart attack, or stroke," but it nevertheless called for more research on the topic.

"It is more likely than not that there is a relationship, although the available evidence falls short of the conventional level of scientific proof," said Dr. Paul Shekelle, who headed the study, said in a statement.

The report also found that ephedra did contribute to moderate weight loss of about two pounds per month. However, Thompson said, "there was no evidence of sustainability of that weight loss, and achieving that weight loss would require taking more milligrams than the FDA would recommend."

The FDA regulates nutritional supplements (including ephedra) differently than either "conventional" foods or drugs, both prescription and over-the-counter. Under the terms of DSHEA, the manufacturer is responsible for making sure a dietary supplement is safe before putting it on the market. The FDA can take action only if something goes wrong after that point.

Because of these burden-of-proof regulations, the government has found it difficult to take products off the market.

Thompson decried the system at the press conference.

"It is surprising to me that drugs have to prove their safety in order to get approved and, for dietary supplements, we have to prove that they are unreasonably unsafe for us to take them off the market," he said.

"The burden is on the FDA to show through science that dietary supplements such as ephedra should not be on the market," he added. "This is contrary to pharmaceuticals, where the burden is on the manufacturers to prove the drug is safe."

This is just the latest chapter in an ongoing saga over ephedra. In 1997, the FDA failed to restrict certain dosages of the substance.

A month-long public comment period is required now before the agency can mandate any warnings.

The Council for Responsible Nutrition, for one, intends to make its voice heard.

"We will fully evaluate the new scientific evidence to adjust our thinking commensurate with the science to see if we should change our opinion," Hathcock said. "We don't know the answer to that yet, but we're certainly going to evaluate and almost certainly will comment in writing."

And Siegner added, "Obviously, the FDA is also asking for comments about unreasonable risks, but I think that's clearly answered by the Rand report. It says there are lots of reports and lots of press but basically zero evidence that there's a connection between ephedra and significant adverse effects."

More information

Go to the Food and Drug Administration to learn about today's action. Click here to read a summary of the Rand report on ephedra.

Get the industry's side from the Ephedra Education Council.

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