Public Interest Group Asks FDA to Ban Ephedra Supplements

Public Interest Group Asks FDA to Ban Ephedra Supplements

WASHINGTON--The Public Citizen Health Research Group (www.citizen.org),founded by Ralph Nader, asked the federal government to ban the sale andproduction of ephedrine alkaloid dietary supplements and send out an immediateadvisory concerning the possible health risks associated with these products.Written by Sidney Wolfe, M.D., Amer Ardati (the groups director and researchassociate, respectively) and Ray Woosley, M.D., Ph.D., from the University ofArizona Medical Center, the letter was sent to Health and Human ServicesSecretary Tommy Thompson asking him to implement these requests for ephedrinealkaloids, which include ma huang, ephedra, ephedrine, pseudoephedrine andmethylephedrine.

The letter reported that FDAs Center for Food Safety and Applied Nutritions(CFSAN) Special Nutritionals Adverse Event Monitoring System showed thatephedrine alkaloid supplements were associated with more reports of death,myocardial infarctions, cardiac arrhythmias, hypertension, stroke and seizureevents than all other dietary supplements combined. It also cited that there wasa sharp increase in adverse event reporting for ephedra users from 1997through 1999 at the American Association of Poison Control Centers. However, aspokesperson at the Ephedra Education Council (EEC) (www.ephedrafacts.com)stated that, according to the councils statistics, there was also a largeincrease in ephedra users during that time period.

The letter detailed that ephedrine alkaloid products may lead to kidneystones and hepatitis. The letter also suggested ephedrine may also initiate orexacerbate autoimmune conditions (such as toxic shock syndrome) becauseephedrine may act in a fashion similar to pseudoephedrine, which has been linkedto autoimmune function.

The authors also addressed the economic impact of these suggested actions.The only potential loss of income is to the manufacturers and distributors ofephedrine alkaloid dietary supplements, they wrote. Potentially, therewill be savings on the productivity of citizens who otherwise would have beeninjured by ephedrine alkaloid dietary supplements.

Wolfe and his associates concluded in the letter to Thompson that, Fromthe perspective of defending the public health, you must be willing to take onthis drug (ephedra)-pushing part of the dietary supplement industry.

Its important that we acknowledge that ephedra is not a benignsubstance, and that there is needs to be some government regulatory overview onthis substance, said Michael McGuffin, president of the American HerbalProducts Association (AHPA) (www.ahpa.org).We agree with Public Citizen that there needs to be a change in theregulatory approach to this ingredient. Where we disagree is that we wouldntremove it from the market, we would see to it that it was properly labeled,which we asked FDA to do last October. However, they responded 181 days laterthat this was too complex an issue to provide a response at this time.

Both McGuffin and EEC consultant Steven Karch, M.D., believed that thescience Public Citizen used to support its letter was off base. Im surethe letter was well-intended, but it was based on very bad science, Karchsaid. Ive read all of the adverse reports that [Public Citizen] has, andthe reports dont have the data to support the authors conclusions. By themcondemning ephedra products, theyre dismissing reasonably good evidence thatthis ingredient helps in weight loss. However, with the American HeartAssociations Web site saying that 40 percent of Americans are overweight,even a 10-pound weight loss decreases your risk profile.