DSHEA reconsideration
This article was originally published in The Tan Sheet
Executive Summary
Editorial in Dec. 21 New England Journal of Medicine reiterates call for more stringent oversight of dietary supplements. "It is time for Congress to legislate a holistic approach to drug regulation and to amend [DSHEA] to close the loophole" that allows ingredients such as ephedrine alkaloids to be sold as supplements, former FDA Division of Metabolic & Endocrinologic Drug Products drug reviewer Alexander Fleming, Ingenix Pharmaceutical Services, asserts. The editorial accompanies two studies published in the journal: the Hemorrhagic Stroke Project, which reports a link between PPA-containing OTC cough/cold products and hemorrhagic stroke, and the University of California at San Francisco review of ephedrine alkaloid AEs
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Editorial in Dec. 21 New England Journal of Medicine reiterates call for more stringent oversight of dietary supplements. "It is time for Congress to legislate a holistic approach to drug regulation and to amend [DSHEA] to close the loophole" that allows ingredients such as ephedrine alkaloids to be sold as supplements, former FDA Division of Metabolic & Endocrinologic Drug Products drug reviewer Alexander Fleming, Ingenix Pharmaceutical Services, asserts. The editorial accompanies two studies published in the journal: the Hemorrhagic Stroke Project, which reports a link between PPA-containing OTC cough/cold products and hemorrhagic stroke, and the University of California at San Francisco review of ephedrine alkaloid AEs. |