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FDA Says Red Yeast Supplements Illegally Contain Lovastatin

August 24th, 2007 by Barry - Admin BioPharmArena

FDA this week warned two companies to immediately stop promoting and selling red yeast products that contain the cholesterol-lowering drug lovastatin.

A warning letter was issued Tuesday to Sunburst Biorganics of Baldwin, New York, for the company’s Cholestrix red rice and yeast extract product. FDA issued a letter the next day to Swanson Health Products of Fargo, North Dakota, for the company’s Red Yeast Rice and Read Yeast Rice/Policosanol dietary supplements.

According to FDA, Swanson’s products, if taken as advertised on the company’s website, provide more than 5 mg of lovastatin daily, or half the lowest-recommended daily dose of FDA-approved formulations of the drug.

FDA stated that Sunburst’s product, Cholestrix, is advertised as containing “1.35% of naturally occurring lovastatin,” with two tablets daily providing 10 mg of the drug.

Read more …..

Medicalnewstoday.com

Posted in News, Regulatory Affairs |

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