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.

James Bogash

For more than a decade, Dr. Bogash has stayed current with the medical literature as it relates to physiology, disease prevention and disease management. He uses his knowledge to educate patients, the community and cyberspace on the best way to avoid and / or manage chronic diseases using lifestyle and targeted supplementation.







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Category: Cholesterol
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