Dietary Supplement or Drug: FDA decides - September 4, 2007

Sometimes the difference between a Drug and a Dietary Supplement is in the dosage. Read this excerpt from a recent Warning Letter.

You promote Cholestrix as a dietary supplement. Your website states, "Sunburst's Cholestrix is made from a specially concentrated red yeast rice extract which is standardized to contain 1.35% of naturally occurring lovastatin. Just 2 capsules per day provide 10mg. of natural lovastatin." Lovastatin is the active pharmaceutical ingredient in Mevacor and its generic counterparts, which are FDA-approved drugs to treat patients with primary hypercholesterolemia.

Traditional red yeast rice does not contain more than trace amounts of lovastatin, if any. Because Cholestrix contains red yeast rice with enhanced or added lovastatin, and bears a claim about the "powerful cholesterol fighting" benefits supplied by this ingredient, it cannot be marketed as a dietary supplement.

Read the entire Warning Letter and a similar Warning Letter issued by FDA last month to Swanson Health Products Inc. and Sunburst Biorganics. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

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