FDA Press
Release: Rockville, Maryland,
May 20,
1998
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.
