A leading senator took the Food and Drug Administration to task Wednesday for failure to act on the potentially dangerous food supplement ephedra.
“Either the law is bad, the resources are not being given to you or there is no will to deal with this threat,” said Sen. Richard J. Durbin, chairman of the Senate Governmental Affairs Committee’s oversight panel.
His comments came just over a month after the Bush Administration outraged doctors by delaying action on ephedra by launching a new safety review of the herbal stimulant.
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.
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.
Karen Ruiz of San Clemente, Calif., told the subcommittee she had tried to report her experience with ephedra to the FDA but got “lost in the shuffle.”
Ruiz said that she began taking the supplement in 1996 to lose weight and within a few days began experiencing manic episodes that required sedation and lengthy hospital treatment.
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.
And 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.