FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
T98-28                        Print Media:        301-827-6242
May 20, 1998                  
                              Consumer Media:     800-532-4440

FDA DETERMINES CHOLESTIN TO BE AN UNAPPROVED DRUG

FDA today announced its decision that Cholestin, 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. Cholestin is manufactured by Pharmanex, Inc. Of Simi Valley, California.

Today's decision is the culmination of an extensive administrative proceeding, underway since November 1997, to determine the regulatory status of Cholestin. FDA's decision follows the consideration of hundreds of comments submitted to the agency, and three separate meetings with Pharmanex, Inc. to discuss this matter.

FDA based its decision on the fact that Cholestin contains lovastatin -- an active ingredient in the approved prescription drug Mevacor used to lower cholesterol levels. Under the terms of the Federal, Food, Drug and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act of 1994, Cholestin is not a dietary supplement because lovastatin was not "marketed as a dietary supplement or food" before FDA approved Mevacor as a drug.

The law is intended to maintain incentives for companies to establish the clinical safety and efficacy of drug products. FDA believes that today's decision furthers that result.

Pharmanex has indicated its intent to challenge FDA's decision in Court. A hearing on the matter has been scheduled for June 15, 1998, in the United States District Court for the District of Utah.

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