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After 4 years of litigation, and prior rulings in Pharmanex's favor, the Utah Federal District Court on April 2, 2001 ruled in favor of the FDA. Consequently, Cholestin can no longer be sold as a dietary supplement within the United States. The FDA has assured us that this ruling will also apply to Red Yeast Rice products sold by other companies.
It should be stressed that the FDA has never challenged the safety and efficacy of Cholestin. Indeed, there have been no reports of harm or injury to any Cholestin consumers during six years of sales and Cholestin is still freely available in our international markets. Pharmanex is considering several options, including the possibility of an appeal, pending final discussions with the FDA, and developing new products or ingredients that will preserve the Cholestin brand equity.
While we are obviously disappointed with the court decision, it actually reaffirms Pharmanex's commitment to clinically proven high quality, effective products. We will continue to develop and launch only those products that truly benefit the health and well-being of our customers.
Commentary:
Pharmanex is recommending their Cardio Formula as a substitute. It contains policosanol, made from beeswax. Initial studies have shown that policosanol is comparable to Cholestin in maintaining cholesterol levels. It has not shown good evidence in lowering cholesterol. I am continuing to review studies as they come out.
Cardio Formula consists of vitamin E, folic acid, vitamin B6, vitamin B12, garlic, fish oil, policosanol, and white willow bark extract. All of these ingredients have been shown to promote cardiovascular health, so Cardio Formula certainly be helpful in promoting cardiovascular health. Unfortunately, I do not, at this time, find that it is as effective in lowering cholesterol levels.
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