Cholestin suit
This article was originally published in The Tan Sheet
Executive Summary
A decision is expected in late February or early March following oral arguments heard Jan. 7 in Pharmanex' lawsuit against FDA regarding the regulatory status of Cholestin, a red yeast rice product marketed by the company as a dietary supplement for healthy cholesterol. Salt Lake City, Utah federal court Judge Dale Kimball heard the arguments presented on behalf of the company by Williams & Connelly attorney Richard Cooper. The suit was filed by the company to challenge FDA's decision that the product is an unapproved new drug ("The Tan Sheet" May 25, 1998, p. 1)