Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids

Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids

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Overview

Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids by William Scanlon, Nye Stevens

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.

Product Details

ISBN-13: 9780788187988
Publisher: DIANE Publishing Company
Publication date: 07/28/2000
Pages: 79

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