
FDA Moves to Ban Ephedra
By Benj Vardigan CONSUMER HEALTH INTERACTIVE  Editor's note: On Dec. 30, 2003, US Health and Human Services Secretary Tommy G. Thompson announced that the government planned to ban the sale of pills containing ephedra in early 2004, and he urged consumers to stop taking the herbal stimulant immediately. The ban took effect on April 12, 2004. Several years of court battles followed, but ultimately the ban was left intact. Thompson's action to ban ephedra came after years of criticism from consumers and researchers who have documented cases of heart attacks, high blood pressure, and strokes associated with ephedra. While products like the sports drink Extreme Ripped Force no longer contain ephedra, some supplement manufacturers have replaced it with bitter orange, a substance that may carry the same risks as ephedra. Our award-winning, two-part series below published in 2000 was one of the early articles alerting readers to the dangers of ephedra. December 30, 2003 | In a precedent-setting action, US Health and Human Services Secretary Tommy G. Thompson announced today that the government plans to ban the sale of pills containing ephedra. "The time to stop using these products is now," Thompson said. "They are simply too risky to be used, whether by people who want to lose weight or by elite athletes seeking to enhance their performance, or by youngsters who want to be like these athletes." Thompson's comments were partly in reference to the death in February of Baltimore Orioles pitcher Steve Bechler, who collapsed after taking a supplement containing ephedra. Many people traditionally kick off the new year by starting weight-loss programs, which is why he made the announcement now, Thompson said. Ephedra is an herbal stimulant found in many weight loss and fitness supplements, as well as Chinese medicines. The proposed ban comes after years of growing criticism from both consumers and from researchers, who have called the supplement one of the most dangerous on the market. More than 1,000 reports of serious health problems have been filed with the Food and Drug Administration, including at least 150 deaths and numerous incidents of heart attacks, stroke, and dangerous spikes in high blood pressure. "With the holiday season and with the new year coming up with new resolutions, some people have put on some extra weight, and they'll be looking for ways in order to lose weight in the coming weeks and months and making resolutions to that effect," Thompson said. FDA Commissioner Mark B. McClellan said the agency has sent letters to 62 manufacturers notifying them of the ban, in order to "make sure consumers are protected by removing these products from the market as soon as the rule becomes effective." The FDA ban takes effect April 12, 2004. History of health risks
In a series of investigative reports dating back to 1999, Consumer Health Interactive has documented how this dietary supplement -- marketed for years as an innocent weight-loss alternative to diet drugs and as a healthy muscle builder for fitness enthusiasts -- caused serious injuries and deaths among unsuspecting users. The active ingredient in ephedra is ephedrine, a stimulant that's a chemical cousin of amphetamine. Manufacturers contended that these medicines were safe when taken as directed. Sold on the Internet and in health food stories and gyms acrss the country, ephedra became the supplement of choice for many youthful gym members. As energy and weight-loss pills, sports drinks, or muscle-building supplements with names like Ripped Fuel, Ultra Ripped Capsules, Metabolife, Inferno, Extreme Ripped Force, Pure Ephedrine, and Ripped to the Max, the products promised to help people drop pounds, build muscle, and increase stamina during workouts. Some ephedra products -- Speed Stack, Stacker 2, Ephedra White Cross, Truckers' Paradise, and BURN IT UP! Herbal Blend -- were also sold as a legal, mind-altering alternative to speed. In addition, ephedrine is found in Chinese medicines and considered safe in many decongestants, which are not affected by the ban. Yet widespread reports of adverse reactions plagued the supplement, many from young users who had no previous problems with their health. Few ephedra products mentioned the possible health problems associated with the stimulant, but over the last decade researchers were busy documenting its risks. Several years ago, we interviewed two physicians at the University of California at San Francisco who were investigating reports of ephedra-linked injuries. They reported at the time that nearly a third of 140 cases reported to the FDA between July 1997 and March 1999 -- including three deaths -- were "definitely or probably linked to the use of ephedrine." Their study, published in 2000 in the New England Journal of Medicine, reported that another third of the cases may have been caused by products containing ephedra, according to researchers Neal L. Benowitz and Christine A. Haller. Another critic of ephedra interviewed in our previous investigation is Bill Gurley, PhD, a University of Arkansas pharmacy science professor. In May 2000, he published a study in a leading pharmacy journal that sharply criticized the manufacturing and labeling practices of many companies producing ephedra supplements. Today, responding to the proposed ban on ephedra, he told Consumer Health Interactive that the FDA's action may save lives. "It's sad that it's taken the FDA this long, but a ban is better than no ban, and it's better late than never," Gurley said. "It's about time." Also lauding the ban was Barb Michal, who founded the Michigan organization HEAT (Halt Ephedrine Abuse Today) following her 24-year-old son Kristopher's death of heart failure in 1997 after taking a synthetic ephedrine supplement. "This is a red letter day for the consuming public," she said. "The industry is finally being brought to task." Ephedra-free sports supplements
Some manufacturers say they disagree with the FDA's decision. San Diego-based Metabolife International Inc. "strongly believes in the science supporting the safety and efficacy of dietary supplements that contain ephedra when used as directed," according to a statement issued by the company in response to the government's ban. However, Metabolife and many other supplement manufacturers already have ephedra-free versions of their fitness products on the market. And even before the proposed federal ban, sports supplements containing ephedra were outlawed by California, Illinois, and New York, as well as the International Olympic Committee, the National Football League, and the National Collegiate Athletic Association. Some national retail chains, including General Nutrition Centers, also recently stopped selling products containing ephedra. Although it was an unusual move for the FDA to ban ephedra, Thompson noted that the agency may look at other hazardous supplements on the market. -- Benj Vardigan is a senior editor at Consumer Health Interactive. In 2000, he won an Outstanding Young Journalist award from the Northern California chapter of the Society of Professional Journalists for his investigative series on the hazards of ephedra. Click here to read our investigative series on ephedra.
References Interview with Bill Gurley, PhD, professor of pharmaceutical sciences at the University of Arkansas College of Pharmacy
Interview with Barb Michal, founder of HEAT (Halt Ephedrine Abuse Today), a nonprofit Michigan corporation
Haller, C.A.; Benowitz, N. L. "Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids." New England Journal of Medicine, Dec. 21, 2000
Questions and Answers about FDA's Actions on Ephedra Dietary Supplements. Dec. 30, 2003. Food and Drug Administration. http://www.fda.gov/oc/initiatives/ephedra/december2003/qa.html
Letter to companies marketing ephedra dietary supplements. Food and Drug Administration. http://www.fda.gov/oc/initiatives/ephedra/december2003/warningltr.html
"FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra." United States Department of Health and Human Services press release. Dec. 30, 2003. http://www.hhs.gov/news/press/2003pres/20031230.html
Mayo Clinic. Ephedra (Ephedra sinica)/Ma huang. September 2005. http://www.mayoclinic.com/health/ephedra/NS_patient-ephedra
Mayo Clinic. Bitter Orange Weight Loss Supplements: Do They Work? November 29, 2005. http://www.mayoclinic.com/health/bitter-orange/AN01218
First published December 30, 2003
Last updated January 16, 2008
Copyright © 2003 Consumer Health Interactive
|