FDA Issues Ephedra AlertJan 9, 2004 | The Beam
Food and Drug Administration officials have issued a consumer alert on the safety of dietary supplements containing ephedra that calls for consumers to immediately stop buying and using ephedra products.
Besides issuing an alert, FDA officials are notifying manufacturers that they intend to publish a final rule stating dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the effect of banning the sale of these products as soon as it becomes effective, 60 days after publication.
"FDA will publish a final rule as soon as possible that will formalize its conclusions that dietary supplements containing ephedrine alkaloids present unreasonable risks to those who take them for any reason," said Tommy G. Thompson, health and human services secretary.
"[The action] puts companies on notice of our intentions, and it tells consumers that the time to stop using ephedra products is now," said Thompson.
"We are taking action today to notify Americans about the unreasonable risk of ephedra as currently marketed in dietary supplements," said Dr. Mark B. McClellan, FDA commissioner. "Our action is based on diligent and thorough work by the agency as required by the challenging legal standard in the dietary supplement law.
"We worked hard to obtain and review all the available evidence about the risks and benefits of ephedra, including its pharmacology, studies of ephedra's safety and effectiveness, adverse event reports, and reviews by independent experts," said McClellan.
In February, a jury in Austin, Texas, determined that ephedra use was at least 50-percent to blame for the death of 24-year-old Charles Bryant Scurlock II, of Round Rock, Texas. Scurlock collapsed and later died after a two-mile run for an Army National Guard physical fitness test in 1999. The jury awarded $1 million to the plaintiffs.
In September 2002, the Air Force surgeon general issued a revised policy covering dietary supplements containing ephedra that strongly discouraged the use of such supplements and highlighted associated risk factors.
In November 2002, the Air Force's surgeon general issued a notice to airmen on the potential risks associated with dietary supplements containing ephedra following the death of a young airman. These medical notices are released by the AFMS clinical quality management division to disseminate lessons learned from medical incident investigations and other pertinent events.