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Question:
Are red yeast rice supplements legally permitted to contain statins, like lovastatin, since these are drugs?

Answer:
Red yeast rice naturally contains lovastatin and related statin (or monacolin) compounds which can dramatically lower LDL ("bad") cholesterol. The statins are produced by a special yeast as it digests rice (creating a red color). In fact, it was from yeast cultures that lovastatin (also known as monacolin K) was originally discovered and later marketed as the brand name drug Mevacor. The regulatory problem is that a dietary supplement label cannot indicate that it contains a drug, nor list the amount of that drug. So, while red yeast rice can be legally sold as a supplement, the amount of lovastatin cannot appear on the label — otherwise it could be subject to removal from the market as an unauthorized drug. Technically, it is not even legal for a supplement to contain a drug, so some red yeast rice supplements do not contain lovastatin, despite the fact that it should, naturally, be there.  

To help consumers, ConsumerLab.com has been periodically purchasing and testing red yeast rice supplements since 2008 and reporting the amounts of statin compounds they contain. It also reports the amounts of a contaminant, citrinin, which may be toxic to the kidneys. ConsumerLab.com has found an enormous range in the amounts of lovastatin compounds among products. In 2014, for example, it found these amounts to range as little as 0.05 mg to 25.1 mg per daily suggested serving — a 500-fold difference. This means some products are likely to be effective while others are not, and there is no way to tell from the labels alone. 

To find out how much lovastatin (and citrinin contaminant) ConsumerLab.com has found in red yeast rice supplements and which ones are, therefore, likely to be effective, see ConsumerLab.com's Red Yeast Rice Supplements Review >>

Also see answers to these related CL Answers



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To lower my cholesterol, I am taking a phytosterol supplement. Will taking other supplements, like red yeast rice or fish oil, help lower my cholesterol even further? >>

See other recent and popular questions >>
COMMENTS

Michael8409   January 31, 2016
People who take red yeast rice should be aware that they may be taking biologically active amounts of the statin drug lovastatin. There is some evidence that it can reduce the incidence of heart attacks. It may be prudent to become familiar with the side effects of this class of drugs which may include liver problems, muscle pain, memory loss, emotional disturbance, and in the case of severe allergy muscle disruption and kidney compromise. Just because it comes from a "health food" store, it is not necessarily safe or healthy. Contacting a physician is also one of the options for those with high cholesterol even if they decide that red yeast rice is somehow better than lovastatin prescription. If there is an existing history of heart disease (heart attack, angina, heart failure, etc.) or even a family history of heart disease, or if the person has liver problems, it is very unwise to proceed without physician evaluation.

Susana8407   January 31, 2016
I had to suspend Red Yeast Rice because cause me insommia. I took the pill at night. Is it possible ?

ConsumerLab.com   February 10, 2016
Hi Susana - Thank you for your question. We've now answered it here: https://www.consumerlab.com/answers/_/red_yeast_rice_insomnia/.

Also see the "Concerns and Cautions" section of the Red Yeast Rice Supplements Review: https://www.consumerlab.com/reviews/_/Red_Yeast_Rice/#cautions


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This CL Answer initially posted on 12/5/2015. Last updated 8/2/2017.
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