FDA Bans Ephedra

By Ellen Kuwana Neuroscience for Kids Staff Writer April 16, 2004 US FDA Bans the Herbal Supplement Ephedra The Chinese call it ma-huang. The makers of ephedra, an over-the-counter herbal supplement, call it a way to increase metabolism and energy. The US FDA calls it unsafe, stating that it poses "an unreasonable risk of illness or injury." As of April 12, 2004, it is banned from sale in the US. Natural Does NOT Equal Safe: The Effects on Your Body The active ingredient in ephedra is ephedrine, a natural chemical from a plant. Ephedrine is similar to adrenaline, the substance your body produces in a "fight-or-flight" crisis. These stimulants (such as amphetamines) excite your central nervous system, increase your heart rate, and raise your blood pressure. Adrenaline and ephedrine cause your blood to pump to your muscles, so that you could fight off an attacker, or run away from a predator. Imagine being really scared. Your heartbeat sounds loud. Your breathing is rapid. Your pupils are dilated. You are alert and ready to react. That is the effect of adrenaline...and ephedrine. These effects, though, can stress your body to the point that it overheats (called heat stroke, when your core body temperature exceeds 104oF), sustains nerve damage, or, worse, triggers a stroke, heart attack, or even sudden death. Ephedra Contributes to the Death of a Baseball Player Ephedra was brought to the public's attention after 23-year-old Baltimore Orioles pitcher Steve Belcher died in February of 2003. After taking ephedra tablets for weight loss, he suffered a heat stroke during practice. Researchers Conclude Ephedra is Dangerous The FDA commissioned an independent research organization, the RAND Corporation, to study ephedra and report any adverse effects. They concluded that ephedra caused a 2- to 3-fold increase in health problems such as depression, anxiety, insomnia, vomiting, heartburn and heartbeat irregularities. The researchers counted 15,951 cases in which a medical problem had been reported to the manufacturer either by a doctor or by the user. Of these, 283 were classified as "severe" and included 5 deaths, 11 strokes, 5 heart attacks and 4 seizures. Three states (California, New York and Illinois) and most major league sports teams have banned the use of ephedra. (Source: Science News, April 12, 2004.) Burden of Proof With prescription drugs, a manufacturer has to prove that medicine is safe and brings about the advertised effects. Supplements, however, do not fall under such strict laws. (Ephedrine, when manufactured in a lab, is regulated as a drug by the FDA!) Since 1994, the FDA has had to prove that a supplement is harmful; manufacturers do not have to prove that the supplement is safe and effective. Thus, the FDA does not have much power to regulate herbal products. It is up to the consumer to research what is safe. It is also important to tell your doctor what supplements you are taking, because though they may be "natural," they also may adversely interact with prescription drugs. (Remember, many poisons are "natural," too!)

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A study concluded that ephedra does not enhance athletic performance and is not effective for short-term weight loss. (Journal of the American Medical Association, March 26, 2004.) Approximately 1 million children ages 12-17 have tried "performance-enhancing" supplements, many of which contained ephedra. (Blue Cross and Blue Shield Association's Healthy Competition Foundation survey, August 2001.) Ephedra sales, in part because high insurance rates caused a decline in manufacturing, fell from $1.28 billion in 2002 to $510 million in 2003. ("US to Prohibit Supplement Tied to Health Risks," New York Times, December 31, 2003.) The FDA ban excludes ephedra use by traditional Asian practitioners such as acupuncturists and herbalists. Insurance costs, however, are causing a decline in how often ma-haung (ephedra) is used. ("Despite FDA Ban, Ephedra Won't Go Away," New York Times, February 17, 2004.)