Why The Need For The EEC?
FDA is planning to release a new set of Adverse Event Reports (AERs). AERs are reports of individuals who have had any type adverse health event while consuming a particular product, regardless of whether the event was caused by that product. FDA recognizes, because it is ordinarily not possible to establish a causal link between an adverse event and a particular product, that AERs cannot be the basis for a scientifically valid risk determination. Industry leaders realized, based on the manner in which FDA publicized past AERs, that there was a need to provide the American public through the media accurate information concerning the use of ephedra products.
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