Court Rules That FDA Can Regulate Pharmanex’s Cholestin – (08-28-00)

Court Rules That FDA Can Regulate Pharmanex’s Cholestin

This battle has been waging for awhile. A natural product derived from red Chinese yeast rice has been shown to lower cholesterol levels. Keep a close eye on this one–it could have major implications on the supplement market if the FDA and the pharmaceuticals win.

NEW YORK, Jul 25 (Reuters Health) – Pharmanex’s cholesterol-fighting formula Cholestin is subject to US Food and Drug Administration (FDA) regulation as a drug product, the 10th US Circuit Court of Appeals ruled on Friday. However, the FDA asserts that Cholestin is a drug because it contains a substance chemically identical to lovastatin, the active ingredient in Merck’s Mevacor, which is an approved prescription therapy for lowering cholesterol. As a drug, Cholestin cannot legally be marketed without an approved New Drug Application, the agency maintains. Pharmanex has argued that mevinolin, the ingredient that the agency equates with lovastatin, is actually a significantly different substance. Mevinolin is naturally occurring, while lovastatin is synthetically isolated, purified and crystallized, according to the company.