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.
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning