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In Brief: Pharmanex

This article was originally published in The Tan Sheet

Executive Summary

Pharmanex: Submits Feb. 20 letter to FDA rebutting arguments by Merck regarding the regulatory status of Pharmanex' red yeast rice product, Cholestin. In the latest submission to the agency supporting continued dietary supplement status for the product, Pharmanex criticizes the opinion of Merck scientist Richard Monaghan that Cholestin is not produced by traditional methods and therefore does not fit within the Dietary Supplement Health & Education Act's definition of a dietary supplement. Merck has argued Cholestin unfairly competes with its Rx cholesterol-lowering drug, Mevacor ("The Tan Sheet" Feb. 9, p. 17). In other submissions to FDA, Rep. Thomas Bliley (R-Va.), chairman of the House Commerce Committee, urges the agency in a Jan. 30 letter to "respect both the language and spirit" of DSHEA in reaching its conclusions on the regulatory status of Cholestin...
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