March 21, 2003
Senator Deborah Ortiz, Chair
Senate Health and Human Services Committee
California State Senate
P.O. Box 942848
Sacramento, CA 94248-0001
Dear Senator Ortiz :
Consumers Union, nonprofit publisher of Consumer Reports magazine, was among the first to warn the public about the dangers of the dietary supplement ephedra, in a 1995 article. We have called on the Food and Drug Administration (FDA) to ban ephedra in dietary supplements and we strongly support Senator Jackie Speier's two pieces of legislation, SB 582 and SB 779, both of which protect consumers from the potential dangers of ephedra. SB 582 would ban the sale of ephedra in California, and SB 779 would require California's ephedra manufacturers and distributors to make quarterly reports to the California Department of Health Services of all adverse event reports made to them by consumers.
In February, the 23-year-old pitcher for the Baltimore Orioles, Steve Bechler, who had been taking an ephedra product (Xenadrine RFA-1), died of heatstroke in Florida spring training. On March 13, 2003, Broward County medical examiner Dr. Joshua Perper said that toxicology tests confirmed that "significant amounts" of the over-the-counter supplement containing ephedra led to the heatstroke, along with other factors. While ephedra is banned by the NFL, the NCAA and the International Olympic Committee, use of the substance is allowed in professional baseball. Consumers Union recently called upon Commissioner Bud Selig to ban the use of ephedra in Major League Baseball.
The FDA recently proposed new labels for ephedra products that would list death, heart attacks, and strokes as possible side effects. However, the FDA's failure to ban this product is derelict and demands more stringent state and local legislative action.
From January 1993 through October 2000, the FDA received almost 1400 reports of adverse events linked to herbal supplements containing ephedra, including 81 deaths, 32 heart attacks, 62 reports of cardiac arrhythmia, 91 reports of hypertension, 69 strokes, and 70 seizures. Complaints to the FDA about ephedra made up 42 percent of all dietary supplement complaints and 59 percent of all reported deaths. According to a recent analysis by the American Association of Poison Control Centers, the risk for an adverse reaction to ephedra is over 100 times higher than the risk associated with other herbal supplements.
The New York Times reported on February 20th that U.S. Secretary of Health and Human Services Tommy Thompson, when asked by reporters to comment on ephedra, replied, "I wouldn't use it, would you?" The Secretary's remarks suggest that he is fully aware of the dangers of ephedra. So why isn't his agency doing more to protect people? A mere warning label is not enough.
Consumers Union believes that dietary supplements containing ephedra offer dubious health benefits while posing serious health risks to consumers, particularly to young people, who use ephedra for its amphetamine-like or speed-like effects on the body. Because the Dietary Supplement Health and Education Act of 1994 treats dietary supplements as "foods" instead of "drugs," herbs like ephedra are not subject to pre-market safety testing before they show up on grocery shelves and on the Internet.
Consumers Union has long held that ephedra, a powerful stimulant that acts like amphetamines in the body, should be considered a drug, and therefore, subject to pre-market safety testing. We applaud Senator Speier for her continuing commitment to carry legislation that protects consumers from the dangers of ephedra. We urge you and your committee to support SB 582 and SB 779.
Sincerely,
Elisa Odabashian
Senior Policy Analyst
Consumers Union West
Coast Regional Office
cc: Andrea Margolis, Consultant
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