Tuesday, December 30, 2003

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."
Fed. R. Evid. 702: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.