Pharmanex seeks high-level FDA meeting after Cholestin ingredient import detention.
This article was originally published in The Tan Sheet
Executive Summary
FDA TAKES IMPORT DETENTION APPROACH TO CHOLESTIN REGULATORY STATUS: the agency's San Pedro, Calif. district office detained a shipment to Pharmanex of Chinese red yeast June 11 on the basis that the substance "appears to be an unapproved new drug," according to the notice of detention. Red yeast, containing naturally occurring HMG-CoA reductase inhibitors including lovastatin, is the proprietary ingredient in Cholestin, a dietary supplement.