FDA criticised for failure to act on ephedra
week when a US senator attacked the department for refusing to move
on legislation on the herbal supplement ephedra. Trade bodies still
insist however that the herb can be used safely.
A leading US senator criticised the country's Food and Drug Administration this week for failing to act on the controversial herbal supplement ephedra, according to a report by the Associated Press.
"Either the law is bad, the resources are not being given to you or there is no will to deal with this threat," Senator Richard J. Durbin, chairman of the Senate Governmental Affairs Committee's oversight panel, said.
In June the US government outraged doctors by delaying action on ephedra and instead 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 did have a plan to deal with ephedra but lacked enough data, which was currently being collected. He added that the use of food supplements was growing rapidly and represented a "significant challenge" for the agency.
However, Durbin stressed that there was mounting evidence about the danger of the product and no action had yet been taken.
A year ago Canada warned consumers not to use ephedra and it has been banned by the International Olympic Committee, National Football League and National Collegiate Athletic Association.
However, in the US ephedra is sold as a food supplement, and therefore the 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. So far it has only 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 was clearly risky to some people, the FDA's statistics were sloppy.
This prompted the FDA to work on warning labels instead while consumer group Public Citizen petitioned for a ban.News in June that the Department of Health and Human Services had ordered a review of all scientific reports on ephedra's safety came as another surprise. Results are due in the autumn.
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 was voluntary.
"For the year 1999, we found that the FDA received 460 reports compared to 13,000 reports that poison control centres reported receiving nationwide related to dietary supplements," Mangano said.
The Council for Responsible Nutrition, a trade association for the dietary supplement industry, has submitted a written testimony to the subcommittee, claiming it commissioned Cantox Health Sciences to perform a study on ephedra, which was concluded in December 2000. The report found that ephedra was safe under the recommended conditions of use that specify a total daily dosage of 90 mg.
The organisation said that the Cantox Report evaluated all the available data including that from the now peer-reviewed study conducted by Columbia and Harvard University and published in the International Journal of Obesity that found ephedra both safe and beneficial for weight loss.
However according to the Associated Press, Durbin has found at least one product on sale in the United States which contains 325 milligrams of ephedra.
Consumer groups are now lobbying the FDA to change its system to review reports of bad reactions to supplements.
