In September 2001, the Public Citizen consumer group called on the FDA to ban dietary supplements containing ephedra because of the increased risk of hypertension, stroke, heart attacks and seizures. According to the group based on data, there was indication that ephedra was the “most lethal of all dietary supplements.” Found in popular weight loss aids, energy boosters and performance enhancers, ephedra was marketed as all natural and safe.
It was not until the spring of 2003 that ephedra’s deadly effects were so publicly acknowledged. At spring training, a young Baltimore Orioles pitcher, Steve Bechler, died after using a dietary supplement that contained ephedra. At the time, a health organization put the number of ephedra related deaths at 155. The ephedra death created major headlines, mainly because it involved the death of a young public figure that made a living off of strength, fitness and athletic talent.
In December 2003, the FDA said it would ban the sale of ephedra-containing products as of April 12, 2004. During the period between the ban announcement and the effective ban start date, the FDA acknowledged four more people died after taking ephedra. The Director of Public Citizen’s Health Research Group, Dr. Sidney Wolfe, issued a statement after the FDA’s ban announcement saying the delay in acting to remove ephedra from the market showed “the dangerous cowardice of FDA Commissioner Mark McClellan and HHS Secretary Tommy Thompson.”
The ephedra dangers were considered so significant that a consumer watchdog group, Public Citizen, called on the FDA to ban supplements containing ephedra in 2001. It was not until over two years after the ephedra petition was submitted to the FDA that the agency finally announced it was banning the sale of ephedra products. The delay from the time of the group’s petition, as well as the delay from the agency’s ban announcement to the effective date, resulted in more people exposed to ephedra dangers.
Ephedra is an herb that contains the stimulant ephedrine. The ephedra dangers can be deadly, including risks of heart attacks, cardiac arrhythmias, hypertension, strokes and seizures. Public Citizen described ephedra dangers as being the most lethal of all dietary supplements in its 2001 petition, based on indications from data. By the spring of 2003, one health organization estimated the number of deaths at the time to result from ephedra dangers was at 155. Between the FDA’s December 2003 ephedra ban announcement and the April 2004 ephedra ban start date, the federal agency acknowledged four more people died from ephedra dangers.
Ephedra products were highly popular, but its potential for deadly health effects resulted in the eventual ban. Mainly found in diet pills, ephedra products also included energy boosters and performance enhancers. When the FDA announced in December 2003 that an ephedra products ban would go into effect in April 2004, the agency had received reports of more than 155 deaths.
Between the ban announcement and effective start date, the FDA received four more reports of deaths because of ephedra products. The agency was criticized for failing to act sooner, and then when deciding to finally take action, allowing a lapse in time for the ban to go into effect. Critics of the FDA’s actions leading up to the ephedra products ban believed the delay in immediately implementing the ban was to allow stores that stocked ephedra products time to sell their stock.
Metabolife 356 was once a very popular diet drug made with the combination of the herbal stimulant ephedra and caffeine. The ephedra and Metabolife combination acted as a super-stimulant that speed up a person’s metabolism to burn more calories. The ephedra and Metabolife combination was considered so dangerous that individual states took action to ban the herbal stimulant in the absence of prompt FDA regulation. New York, Illinois and California decided to issue an ephedra and Metabolife ban before the FDA because of the reports of strokes, seizures and heart attacks.
As of the beginning of March 2005, Metabolife still faced hundreds of personal injury lawsuits in federal and state courts. The company has asked a federal New York judge to approve a proposed multimillion-dollar class action settlement with U.S. consumers alleging injuries from ephedra and Metabolife, and a hearing has been scheduled for the end of March 2005. Metabolife’s former chief executive, Michael Ellis, faces federal charges that he lied to the FDA regarding the safety of the ephedra and Metabolife combination.
The number of actual deaths caused by ephedra is believed to be much greater than the number that has been reported. A health organization estimated the number of deaths caused by ephedra by the spring of 2003 was 155. In December 2003, the FDA said it was banning the sale of ephedra products, which would go into effect April 12, 2004. In the four months between the FDA announcement and the ephedra ban, the agency said four more deaths caused by ephedra had been reported.
Ephedra is an herbal supplement and the FDA had limited ability to regulate the products under a 1994 act, so data relied on voluntary reports. Considering adverse drug reports are already considered to be just a small fraction of the actual number of events, the deaths caused by ephedra have been estimated to be significantly higher than reported. In 2001, when the Public Citizen consumer group issued a petition to the FDA requesting an immediate ban on ephedra, the group referred to a Texas Department of Health report that said it had received 500 adverse events related to ephedra between December 1993 and September 1995. Some people believe because of the way ephedra-containing products were marketed as being all natural and safe, some deaths caused by ephedra may have been attributed to other things.