FDA pressed for fast action on herbal supplement ephedra

WASHINGTON -- A leading senator took the Bush Administration to task Wednesday for its failure to act on the potentially dangerous food supplement ephedra.

"Today I am asking the Secretary of Health and Human Services to determine whether the dietary supplement ephedra poses an 'imminent hazard' to the public's health, and if so, use his authority to suspend sales of the product in the U.S. until we can ensure that it is safe," said Sen. Richard J. Durbin, chairman of the Senate Governmental Affairs Committee's oversight panel.

"This is a strong step, but one that must be taken if we are serious about protecting the health and well-being of our citizens," the Illinois Democrat said.

His comments came just over a month after the administration outraged doctors by delaying action on ephedra, instead launching a new safety review of the herbal stimulant.

Durbin spoke at the end of a Senate hearing called to examine the validity of claims made for weight-loss supplements and the government's system of oversight for the supplements.

The food supplement industry has grown explosively in recent years and is on track to reach $19 billion in sales this year, Durbin said.

Joseph A. Levitt, director of the FDA's Center for Food Safety and Applied Nutrition, said the agency does have a plan to deal with ephedra but lacks enough data, which is currently being collected.

Challenge for agency

The use of food supplements is growing rapidly and represents a "significant challenge" for the agency, Levitt said.

Durbin retorted: "Evidence keeps piling on about the danger of this product. Proposed rules are fine, but nothing has been done."

Canada a year ago warned consumers not to use ephedra and it has been banned by the International Olympic Committee, National Football League and National Collegiate Athletic Association.

Because ephedra, made from herbs, is sold as a food supplement, U.S. law does not require its manufacturers to prove safety, meet standard drug manufacturing rules or provide any specific warning labels.

To remove a supplement from the market, the FDA has to prove it is dangerous. It has blocked sales of synthetic ephedra.

Three years ago, citing death reports, the agency attempted to bar certain high doses of ephedra. Industry protests killed the move, and a General Accounting Office report said that while ephedra clearly was risky to some people, the FDA's statistics were sloppy.

So FDA officials reanalyzed and began working toward warning labels. The consumer group Public Citizen petitioned for a ban.

But instead of deciding on either option, the Department of Health and Human Services in June surprised the medical community and hired Rand Corp. to review all scientific reports on ephedra's safety.

Results are due this fall, when the National Institutes of Health will determine what additional research is needed.

Michael F. Mangano, principal deputy inspector general of the department, noted that the FDA's system for supplement makers to report customers who suffer bad reactions to their products is voluntary.

"For the year 1999, we found that FDA received 460 reports compared to 13,000 reports that poison control centers reported receiving nationwide related to dietary supplements," Mangano said.

In written testimony submitted to the subcommittee, the Council for Responsible Nutrition, a trade association of the dietary supplement industry, contended that it had commissioned a study that showed ephedra is safe under the recommended uses with a daily dose of 90 milligrams.

Durbin noted that at least one product on sale in the United States is a pill containing 325 milligrams of ephedra.

Michael McGuffin, president of the American Herbal Products Association, said in testimony that members of his group engage in self-regulation, recommending business and safety practices.

The Consumer Healthcare Products Association issued a statement urging improvements in the FDA's system for learning of bad reactions to products and calling on the agency to establish standards for good manufacturing practices.