Advertisement

Review of red yeast rice content and current Food and Drug Administration oversight

Published:September 27, 2012DOI:https://doi.org/10.1016/j.jacl.2012.09.003

      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).

      Conclusion

      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.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Clinical Lipidology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Becker D.J.
        • Gordon J.
        • Halbert S.C.
        • French B.
        • Morris P.B.
        • Rader D.J.
        Red yeast rice versus placebo in dyslipidemic, statin-intolerant patients enrolled in a therapeutic lifestyle program: a randomized, controlled trial.
        Ann Intern Med. 2009; 150: 830-839
        • Halbert S.C.
        • French B.
        • Gordon R.Y.
        • et al.
        Tolerability of red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice daily) in patients with previous statin intolerance.
        Am J Cardiol. 2010; 105: 198-204
      1. The 2009 Supplement Business Report. Boulder, CO: Nutrition Business Journal; 2009:44.

        • Bogsrud M.P.
        • Ose L.
        • Langlet G.
        • et al.
        HypoCol (red yeast rice) lowers plasma cholesterol—a randomized placebo controlled study.
        Scand Cardiovasc J. 2010; 44: 197-200
        • Endo A.
        • Kurodoa M.
        Citrinin, an inhibitor of cholesterol synthesis.
        J Antibiot (Tokyo). 1976; 29: 841-843
        • Sabater-vilar M.
        • Maas R.F.M.
        • Fink-Gremmels J.
        Mutagenicity of commercial Monascus fermentation products and the role of citrinin contamination.
        Mutation Red. 1999; 444: 7-16
        • Liu J.
        • Zhang K.
        • Shi Y.
        • Grimsgaard S.
        • Alraek T.
        • Fonnebo V.
        Chinese red yeast rice (Monascus purpureus) for primary hyperlipidemia: a meta-analysis of randomized controlled trials.
        Chin Med. 2006; I4
        • Lu Z.
        • Kou W.
        • Du B.
        • et al.
        Effects of Xuezhikang, an extract from red yeast Chinese rice, on coronary events in a Chinese population with previous myocardial infarction.
        Am J Cardiol. 2008; 101: 1689-1693
      2. Dietary Supplement Health and Education Act of 1994, Public Laq 103–417, 103rd Congress. General Dietary Supplement Labeling. Chapter I. Available at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/DietarySupplementlabelingguide/ucm070519.htm#1-1. Accessed March 3, 2012.

      3. US Food and Drug Administration. FDA issues dietary supplements final rule. FDA News. Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide. Available at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/SmallBusinessesSmallEntityComplianceGuides/ucm238182.htm. Accessed March 3, 2010.

        • Pearson T.A.
        Commentary: lipid-lowering therapy in low risk patients.
        JAMA. 1998; 179: 1659-1661
        • Gordon R.Y.
        • Cooperman T.
        • Obermeyer W.
        • Becker D.J.
        Marked variability of monacolin levels in commercial red yeast rice products: buyer beware.
        Arch Intern Med. 2010; 170: 1722-1727
        • Heber D.
        • Lembertas A.
        • Lu Q.Y.
        • Bowerman S.
        • Go V.L.
        An analysis of nine proprietary Chinese red yeast rice dietary supplements: implications of variability in chemical profile and contents.
        J Altern Complement Med. 2001; 7: 133-139
        • Woo J.J.
        Adverse event monitoring and multivitamin-multimineral dietary supplement.
        Am J Clin Nutr. 2007; 85: 323S-324S
        • Timbo B.B.
        • Ross M.P.
        • McCarthy P.V.
        • Lin C.T.
        Dietary supplements in a national survey: prevalence of use and reports of adverse events.
        J Am Diet Assoc. 2006; 106: 1966-1974
      4. Natural Medicines Comprehensive Database [Internet Database]. Stockton, CA: Therapeutic Research Faculty. Updated periodically.

        • Hsu P.
        Natural Medicines Comprehensive Database.
        J Med Libr Assoc. 2002; 90: 114
      5. United Stated Pharmacopeia Verified Dietary Supplements. Rockville, MD: United States Pharmacopeia; Updated periodically.

      6. ConsumerLab.com. White Plains, NY: ConsumerLab.com, LLC; Updated periodically.

      7. National Sanitation Foundation. Ann Arbor, MI: NSF International; Updated periodically.

      8. Natural Products Association. Washington, DC: Natural Products Association; Updated periodically.

        • Product information
        Mevacor (lovastatin).
        Merck & Co., Inc., Whitehouse Station, NJMay 2010
        • Cohen J.D.
        • Brinton E.A.
        • Ito M.K.
        • Jacobson T.A.
        Understanding Statin Use in America and Gaps in Patient Education (USAGE): An internet-based survey of 10,138 current and former statin users.
        J Clin Lipidol. 2012; 6: 208-215
        • Bakhai A.
        • Rigney U.
        • Hollis S.
        • Emmas C.
        Co-administration of statins with cytochrome P450 3A4 inhibitors in a UK primary care population.
        Pharmacoepidemiol Drug Saf. 2012; 21: 485-493