William Scanlon, Nye Stevens
Description
In June Ô97, the FDA published a proposed rule that would establish a dosing regimen, require warning state., and affect other aspects of product labe
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ling 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 FDA's proposed rule, and the agency's adherence to the regulatory analysis require. for fed. rulemaking. Examines scientific evidence, and FDA's past use of and internal guidance on AERs in rulemaking.
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