In June 97, the FDA published a proposed rule that would establish a dosing regimen, require warning state., & affect other aspects of product labeling for dietary supp. (DS) containing ephedrine alkaloids (EA). FDA based its rule on a number of adverse events reports (AER) it received that indicated that some health problems could have been assoc. with use of DS containing EA. This report examines: the scientific basis for FDAs proposed rule, & the agencys adherence to the regulatory analysis require. for fed. rulemaking. Examines scientific evidence, & FDAs past use of & internal guidance on AERs in rulemaking.
|Publisher:||DIANE Publishing Company|