Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on211 Ephedrine Alkaloids

摘要

The dietary supplement industry estimates that as many as 2 billion doses of211u001edietary supplements containing botanical ephedrine alkaloids are consumed each 211u001eyear in the United States. In June 1997, the Food and Drug Administration (FDA) 211u001epublished a proposed rule that would establish a dosing regimen, require warning 211u001estatements, and affect other aspects of product labeling for dietary supplements 211u001econtaining ephedrine alkaloids. FDA determined that its proposed rule on dietary 211u001esupplements containing ephedrine alkaloids was an economically significant rule 211u001eand, therefore, was required to conduct a cost-benefit analysis pursuant to the 211u001erequirements in Executive Order 12866.