Pharmanex files preemptive suit against FDA over Cholestin.
This article was originally published in The Tan Sheet
Executive Summary
PHARMANEX SEEKING COURT DECLARATION THAT CHOLESTIN CHOLESTEROL CLAIMS are acceptable under the Dietary Supplement Health & Education Act in a lawsuit filed against FDA in Salt Lake City, Utah federal court April 7. The company filed the suit after being informed by FDA in a meeting earlier the same day that the agency is interested in pursuing regulatory action against the product as an unapproved new drug. The suit is an attempt to preempt such action.