United States of America. The Food and Drug Administration has decided that Cholestin (Pharmanex): a product promoted as a dietary supplement intended to affect cholesterol levels: is not a dietary supplement but is instead an unapproved drug under the terms of the Federal Food, Drug and Cosmetics Act. This decision means that Cholestin may not be legally sold in the United States.
The FDA based its decision on the fact that Cholestin: a product made from a fungus fermented on rice (red yeast rice): contains lovastatin, an active ingredient in the approved prescription drug Mevacor used to lower cholesterol levels. Lovastatin was never marketed as a dietary supplement before its approval as a drug.
Reference: FDA Talk Paper T98-28 dated 20 May 1998. [http://www.fda.gov/bbs/topics]