title: Review of red yeast rice content and current Food and Drug Administration oversight.
abstract: BACKGROUND
  Red yeast rice (RYR) is a commonly used dietary supplement for the management of dyslipidemia. In 2007, the Food and Drug Administration (FDA) issued a consumer warning to avoid RYR products because they may contain unauthorized drug (lovastatin) and also implemented Current Good Manufacturing Practices (CGMP) requiring that proper controls be in place by dietary supplement companies to ensure products are manufactured and processed in a consistent manner and produce high-quality products that are not adulterated with impurities or contaminants and are accurately labeled.
  
  
  OBJECTIVE
  To assess the FDA oversight of companies manufacturing RYR products and review the labeled content of available RYR products.
  
  
  METHODS
  The FDA was audited through the Freedom of Information Act, we requested answers to a series of questions concerning their oversight of companies manufacturing RYR products. The labeled content of each RYR product listed in the Natural Medicines Comprehensive Database (NMCD) was tabulated and summarized. Statin-related product warnings and if product certification and verification by an independent laboratory had been performed were documented.
  
  
  RESULTS
  The FDA had no information on the number of RYR manufacturers and their compliance with CGMP regulations. A total of 101 products containing RYR were reviewed. No product could be confirmed as passing any independent laboratory verification testing. Nearly one-half (42.6%) of the RYR product labels contained statin-related warnings (ie, potential for muscle pain or weakness, etc).
  
  
  CONCLUSIONS
  Currently, the FDA is not regulating manufacturers of RYR products and as a result, many of these products may contain monacolin K and toxins such as citrinin.
authors: Oregon State University/Oregon Health & Science University College of Pharmacy, Pharmacy Practice, Portland, OR 97239, USA.
authors: Lindsey
authors: L
authors: Childress
authors: Andrea
authors: A
authors: Gay
authors: Atanaz
authors: A
authors: Zargar
authors: Matthew K
authors: MK
authors: Ito
mesh_terms: D001688:Biological Products / Q000032:analysis* / Q000627:therapeutic use; D002953:Citrinin / Q000032:analysis; D019587:Dietary Supplements / Q000032:analysis; D033161:Government Regulation; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000032:analysis; D006949:Hyperlipidemias / Q000178:diet therapy; D008148:Lovastatin / Q000032:analysis; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C117343:red yeast rice; D002953:Citrinin; D008148:Lovastatin