The Food and Drug Administration (FDA) reopened for 30 days the comment period for a proposed rule entitled ``Dietary Supplements Containing Ephedrine Alkaloids'' that published in the Federal Register of June 4, 1997 (62 FR 30678) (the June 1997 proposal). In that document, FDA proposed a number of requirements relating to dietary supplements containing ephedrine alkaloids, including a requirement for a warning statement on the product label.

Since publication of the June 1997 proposal, new scientific evidence has come to light concerning health risks associated with the use of dietary supplements containing ephedrine alkaloids. FDA is reopeningthe comment period to receive comment on this new evidence, as well as on the warning statement it is now considering for dietary supplements containing ephedrine alkaloids. FDA also intends to consider, to the extent possible, whether in light of current information FDA should determine that dietary supplements containing ephedrine alkaloids present a ``significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.''

Available for download below (PDF) are the final comments submitted to FDA by CRN on April 3, 2003 on ephedra.

CRN ephedra comments 04.03.03 (PDF)