FDA Bans Ephedra
Today's NYT reports on the Food and Drug Administration's issuance of a consumer alert advising that "dietary supplements containing ephedra present an unreasonable risk of illness or injury, and should not be consumed." The FDA has sent letters to manufacturers advising them that FDA intends to promulgate a final rule that will ban sales of ephedra, effective 60 days from its publication.
The FDA is particularly emphatic about the strength of its evidence that ephedra is unsafe. According to the agency's consumer alert: "[T]he FDA gathered and thoroughly reviewed a prodigious amount of evidence about ephedra's pharmacology; clinical studies of ephedra's safety and effectiveness; newly available adverse events reports; the published literature; and a seminal report [summarized here] by the RAND Corporation, an independent scientific institute. The FDA also reviewed tens of thousands of public comments on the agency's request in February, 2003 for information about ephedra-associated health risks." Some of that evidence is discussed in an FDA White Paper issued in February 2003.
To date, ephedra has been blamed for some 155 deaths, nationwide. "The time to stop taking this product," says HHS Secretary Tommy Thompson, "is now."
The FDA is particularly emphatic about the strength of its evidence that ephedra is unsafe. According to the agency's consumer alert: "[T]he FDA gathered and thoroughly reviewed a prodigious amount of evidence about ephedra's pharmacology; clinical studies of ephedra's safety and effectiveness; newly available adverse events reports; the published literature; and a seminal report [summarized here] by the RAND Corporation, an independent scientific institute. The FDA also reviewed tens of thousands of public comments on the agency's request in February, 2003 for information about ephedra-associated health risks." Some of that evidence is discussed in an FDA White Paper issued in February 2003.
To date, ephedra has been blamed for some 155 deaths, nationwide. "The time to stop taking this product," says HHS Secretary Tommy Thompson, "is now."
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