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.
BACKGROUND: Red yeastrice (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.