Appeals Court Rules FDA Can Regulate Cholestin As A DrugAppeals Court Rules FDA Can Regulate Cholestin As A Drug

DENVER--An appeals court issued an opinion on July 21 that would once again allow the Food and Drug Adminstration (FDA) to regulate cholestin, a dietary supplement that lowers cholesterol, as a drug. Cholestin is produced by Pharmanex Inc., a division of Nu Skin Enterprises Inc.

In 1999, the FDA banned the import of a red yeast powder containing the active compound mevinolin, which is used to make cholestin. The FDA found that mevinolin was identical to a synthetic drug called Mevachor, which is marketed by Merck & Co. It maintained that it should be classified as an unapproved drug and proceeded to ban the powder.

Last May, U.S. District Court Judge Dale Kimball (Utah) determined that the FDA's ban was illegal under DSHEA, and that Pharmanex's Cholestin fit the definition of a "dietary supplement." Therefore, he ruled, it could not be regulated by the agency as a drug. According to Kimball's interpretation of the law, the FDA can regulate finished products as drugs, but not the ingredients of finished products.

On July 21, the 10th Circuit Court of Appeals in Denver said that Kimball's ruling was in error and restored the FDA's ability to regulate Cholestin as a drug. It said the law's intent was ambiguous, and although it was "lingustically possible," it determined that the FDA interpretation [that the definition applied to ingredients and finished products] was "not arbitrary, capricious, or manifestly contrary to the statute." Therefore, to apply a single interpretation--that it applies only to finished products--"would be to restrict its scope so as to render it a meaningless limitation."

It also found that "deference is particularly appropriate in the instant case, which involves important questions of public health and safety." Due to this deference, there are still unresolved arguments, so the case will be sent back to district court. For more information, visit www.nuskin.com or http://www.courts.state.co.us/ctappeals/coacas00.htm, where it should be listed with other Denver appeals court case announcements.