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Cholestin lovastatin content renders product unapproved new drug, FDA concludes.

This article was originally published in The Tan Sheet

Executive Summary

LOVASTATIN IN CHOLESTIN RELEVANT "ARTICLE" FOR DEFINING REGULATORY STATUS, FDA determines in a May 20 letter to Pharmanex outside counsel Stuart Pape (D.C. firm of Patton Boggs). The agency has concluded Cholestin is an unapproved new drug, not a dietary supplement, because it contains lovastatin, which was not "marketed as a dietary supplement or food" before the ingredient was involved in recognized clinical studies or approved for prescription drug use in 1987 as Merck's cholesterol-reducer, Mevacor.
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