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Pharmanex v. Shalala

This article was originally published in The Tan Sheet

Executive Summary

Oral arguments are scheduled for May 10 before a Denver federal appeals court on whether Cholestin may be marketed as a dietary supplement. FDA is appealing a Salt Lake City federal judge's decision reversing the agency's determination the red yeast rice supplement containing lovastatin, the same ingredient in Merck's cholesterol-reducer Mevacor, is a drug

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Mason Stands By Cholesterol, Migraine Claims Despite "Courtesy" Letter

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Mason Stands By Cholesterol, Migraine Claims Despite "Courtesy" Letter

Eight supplement makers received FDA "courtesy" letters recently regarding their structure/function claims for cholesterol reduction, the latest in a string of such letters targeting cholesterol claims. One of the firms, Mason Vitamins, is standing by its claims in spite of the March 23 advisory letter from FDA saying they are unapproved drug claims.

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