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FDA seeks Pharmanex Cholestin citizen petition requesting status decision.

This article was originally published in The Tan Sheet

Executive Summary

CHOLESTIN REGULATORY STATUS WARRANTS "PUBLIC SCRUTINY," FDA says in a Sept. 30 letter to the Washington, D.C. law firm Patton Boggs, outside counsel to the product's marketer, Pharmanex. The letter reiterates the agency's previously stated opinion that Cholestin is a drug, not a dietary supplement, but adds the issues involved "warrant public scrutiny and input before the agency issues a final decision in this matter." Pharmanex has been marketing Cholestin since early 1997 as a dietary supplement that helps to lower cholesterol.
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