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Pharmanex

This article was originally published in The Tan Sheet

Executive Summary

Export of Cholestin and bulk red yeast rice either as a food or drug should be permitted, firm says in Oct. 10 petition for reconsideration of FDA's Sept. 10 export request denial. Nu Skin division cites purchase order from Nu Skin Japan for red yeast rice inventory, all of which was imported before a Salt Lake City federal judge's March 30 decision upholding FDA's ruling that product is an unapproved new drug. Given that Pharmanex has stopped marketing Cholestin in the U.S., firm "would have no reason to deviate from its intention to export the remaining inventory," Pharmanex says, adding bulk red yeast rice should not be considered a drug component "given its use as a food in the countries of export"
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