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Law Topics > Injuries > Ephedra Recall
In December 2003, The U.S. Food and Drug Administration in cooperation with the Department of Health and Human Services announced their intention to publish a final rule stating that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The FDA finalized the ban on February 6, 2004, and the sale of dietary supplements containing ephedra became illegal on April 12, 2004.
A recent report in the New England Journal of Medicine cited ephedra (which is related to ma huang, alkaloids ephedrine, pseudoephedrine, norpseudoephedrineas, squaw tea and Mormon tea) as the cause of hundreds of “adverse events” in people taking the substance. The study found that side effects of ephedra can include insomnia, nervousness, rapid heartbeat, high blood pressure, heart attack, seizure, stroke, and death. The researchers reported that ephedra left several of those in the study permanently injured and killed at least three. Ephedra may cause other health problems in addition to those listed above.
A 1994 Federal law has made it much more difficult for the FDA to effectively regulate ephedra. Many hope that the information contained in this new study will assist the FDA in its regulatory efforts regarding the substance. In addition, the consumer watchdog group Public Citizen recently petitioned the FDA to ban all products that contain ephedra or ephedrine.
Heating the debate on the safety of ephedra, several studies say the supplement is beneficial. More than 20 physicians recently asked Health and Human Services Secretary Tommy Thompson to allow the continued sale of ephedra supplements because they believe ephedra products are safe and beneficial when used as directed. Please review this report on the physicians’ fight to keep ephedra on the market. A study conducted by researchers at Harvard University and Columbia University also found ephedra safe and effective.
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