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E-DRUG: FDA DETERMINES CHOLESTIN TO BE AN UNAPPROVED DRUG

T98-28                        
May 20, 1998                  
                              
E-DRUG: FDA DETERMINES CHOLESTIN TO BE AN UNAPPROVED DRUG
---------------------------------------------------------

U.S. Food and Drug Administration (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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