FDA Rules Cholestin a Drug

FDA has ruled that Cholestin, a red yeast product marketed in the U.S. as a dietary supplement for lowering cholesterol, is a drug and should be regulated. Pharmanex, the California company that sells the product, has been asked to submit a Citizen Petition requesting a decision on its regulatory status, which would open the process to public comment. At issue is whether red yeast contains a regulated substance, lovastatin, a cholesterol-lowering drug belonging to Merck & Co. and sold under the name Mevacor. Pharmanex has sued FDA, accusing the agency of mounting a head-on attack against the Dietary Supplement Health and Education Act of 1994.