FDA use of Cholestin marketing, manufacture to resolve status "reasonable" -- agency.
This article was originally published in The Tan Sheet
Executive Summary
FDA RELIANCE ON CHOLESTIN MARKETING, MANUFACTURING TO DETERMINE STATUS of the product as an unapproved new drug "is a reasonable application" of the Dietary Supplement Health & Education Act, the agency maintains in a June 9 memorandum filed in Salt Lake City federal court. The memorandum responds to Pharmanex' motion for a preliminary injunction that would lift an FDA ban on imports of red yeast rice for the production of Cholestin.