For Immediate Release
December 30, 2003
Contact:
Joan Eve Quinn
914-378-2436
—Badly Needed Ban is Long Overdue; Stronger Federal Oversight of Unsafe Supplements Urged; Consumers Should Avoid All Weight-Loss and Energy-Boosting Supplements, including “Ephedra-Free” Products—
Yonkers, NY—December 30, 2003–Consumers Union (CU), the independent nonprofit publisher of Consumer Reports magazine, praised the FDA on Tuesday for taking action to ban dietary supplements containing ephedra.
As reported in the January issue of Consumer Reports, ephedra, an herbal substance also known as “ma huang,” is a dangerous heart and central nervous system stimulant similar in effect to amphetamines and speed. The FDA has received at least 16,961 adverse event reports regarding ephedra supplements, including reports of heart attacks, strokes, seizures and fatalities.
“We commend the FDA for taking strong action to remove supplements containing ephedra from the marketplace,” states Marvin M. Lipman, M.D., Chief Medical Adviser for CU. “A national ban on ephedra products is badly needed to protect consumers from serious potential side effects, including heart attacks, seizures, strokes and deaths.”
“There is compelling evidence to justify a national ban on ephedra, because it poses an unreasonable risk to public health, under recommended conditions of use,” Dr. Lipman said. “If ephedra were a prescription drug instead of an herbal supplement, it would likely have been removed from the market a long time ago.”
In 1995, Consumer Reports magazine published a list of five supplements that according to the FDA can cause serious harm to consumers – chaparral, ephedra, comfrey, lobelia, and yohimbe. Nine years later, all five of these supplements are still being marketed and sold.
“While we strongly support the FDA’s action to ban ephedra, we also feel that this action is long overdue,” Dr. Lipman said. “We also need to change the system that allowed untested ephedra products to be widely marketed and sold, and continues to allow other hazardous products to be sold, despite widespread evidence of safety problems.”
CU strongly supports Senate Bill 722, introduced by Sen. Richard Durbin, that would enhance FDA’s authority to ban dietary supplements that are stimulants and untested steroid equivalents. SB 722 would also require manufacturers to report adverse events for dietary supplements, and enhance the FDA’s authority to compel submission of additional safety information for supplements deemed to pose serious hazards to consumers. CU also supports HR 3377, introduced by Rep. Susan Davis, Rep. John Dingell and Rep. Henry Waxman, that would enhance FDA’s authority to ensure supplements are safe and require manufacturers to report adverse events.
Over the last three years, CU has advocated for a national ban on ephedra, and worked for statewide bans in New York, Illinois and California. CU has also written twice to Secretary of Health and Human Services Tommy Thompson urging a national ban on supplements containing ephedra. In October, Charles Bell, programs director for CU, testified before the Senate Commerce Committee urging stronger federal oversight of dietary supplements, and the passage of Senate Bill 722.
“We hope that the Bush administration and Congress will work together to provide the FDA with enhanced authority and funding to act quickly when it receives reports regarding unsafe supplements and untested steroid equivalents,” Bell said. “Ephedra is the poster child for a failed policy. The federal government should not permit dietary supplements to be sold without adequate pre-market safety testing, and manufacturers should be required to report all adverse events promptly to the FDA.”
Consumer Reports has strongly urged consumers to avoid all weight-loss and energy-boosting supplements, including those that are touted as “ephedra-free.” As pointed out in the January Consumer Reports article, herbal supplements that are touted as ‘ephedra-free’ are not necessarily safe. Some include stimulants, such as bitter orange, that may effect the body in ways similar to ephedra. There is no pre-market safety evaluation for these products, so consumers have no assurance that the problems seen with ephedra supplements will not be repeated if they switch to ephedra-free products. Further, these medications may interact unfavorably with other medicines that consumers are taking. To prevent possible problems, Consumer Reports strongly urges consumers not to take dietary supplements without first discussing the use of specific products with their doctor.
For more information, see:
“Ephedra Heart Dangers in Disguise,” and “Ephedra-Free: But is it safe?” Consumer Reports, January 2004, page 22, available on the web at:
www.ConsumerReports.org/co/ephedra
Consumers Union “Ban Ephedra” page
http://www.consumersunion.org/supplements/ephedra.htm
10/28/03 Senate Commerce Committee testimony
http://www.senate.gov/~commerce/hearings/testimony.cfm?id=976&wit_id=2750
Consumers Union, publisher of Consumer Reports magazine, is an independent nonprofit testing, educational and information organization serving only the consumer. We are a comprehensive source of unbiased advice about products and services, personal finance, health, nutrition and other consumer concerns. Since 1936, our mission has been to test products, inform the public and protect consumers.