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Adulturated red yeast rice

This article was originally published in The Tan Sheet

Executive Summary

FDA threatens enforcement action against two firms selling red yeast rice supplements adulterated with lovastatin - the active ingredient in Merck's Rx cholesterol-lowering drug Mevacor. Consumers should not purchase or consume Swanson Healthcare Products' Red Yeast Rice and Red Yeast Rice/Policosonal Complex or Sunburst Biorganics' Cholestrix since FDA testing revealed the presence of the statin, which can cause harmful side-effects such as muscle weakness and kidney issues and may interact with other medications, FDA announces Aug. 9. The agency determined the adulterated supplements are unapproved new drugs, sent warning letters to the companies marketing the products and threatens to employ enforcement actions, such as seizure of illegal products and criminal prosecution if the companies fail to resolve the violations immediately, according to the warning letters. In January 2005, Source Naturals received a courtesy letter from FDA for the same problem (1"The Tan Sheet" Jan. 24, 2005, In Brief)...
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