Cholestin label revisions under discussion at Pharmanex include new cholesterol claims.
This article was originally published in The Tan Sheet
Executive Summary
CHOLESTIN LABEL REVISIONS UNDER DISCUSSION AT PHARMANEX include statements on the principal display panel that the product "lowers total cholesterol" and "inhibits production of cholesterol in body" and no longer that it "reduces LDL `bad' cholesterol," "reduces triglycerides" and "increases HDL `good' cholesterol." A mock-up of the possible changes is included in an Oct. 29 submission to FDA. The filing requests suspension of enforcement action against Cholestin while Pharmanex petitions the agency to reverse its conclusion that the product is an unapproved new drug and not a dietary supplement.