FDA Cholestin Drug Determination Remanded For Utah Court Review
This article was originally published in The Tan Sheet
Executive Summary
A Utah federal judge must decide if FDA was arbitrary and capricious in determining Pharmanex' Cholestin red yeast rice supplement constitutes a drug, a Denver federal appeals court states in a July 21 opinion.
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Cholestin Red Yeast Rice Shipments Halted Pending FDA Talks
Pharmanex suspended U.S. shipments of Cholestin April 2 following a federal court decision affirming FDA's determination that the red yeast rice product is a drug, not a dietary supplement.
Cholestin Red Yeast Rice Shipments Halted Pending FDA Talks
Pharmanex suspended U.S. shipments of Cholestin April 2 following a federal court decision affirming FDA's determination that the red yeast rice product is a drug, not a dietary supplement.