Red Yeast Rice
FDA has stated that red yeast rice products containing more than trace amounts of monacolin K are unapproved drugs and cannot legally be sold as dietary supplements; the agency has issued warning letters to manufacturers. Adverse effects parallel those of lovastatin (myopathy, rhabdomyolysis, hepatotoxicity), and product potency is highly variable.
What it is
Rice fermented with Monascus purpureus yeast; produces monacolin K (chemically identical to the prescription statin lovastatin) and other compounds.
Traditional Chinese food coloring/flavoring; sold as a dietary supplement for cholesterol.
Why it's flagged
- functions as a statin (myopathy, rhabdomyolysis, liver injury)
- highly variable potency
- potential citrinin contamination
What regulators actually say
"FDA has stated that red yeast rice products that contain more than trace amounts of monacolin K are unapproved new drugs and cannot be sold legally as dietary supplements."
"EFSA Panel concluded that exposure to monacolin K from red yeast rice via food supplements could lead to estimated exposures within the therapeutic range of lovastatin and raises safety concerns."
Regulatory status
United States — FDA
Products with added or enhanced monacolin K are unapproved drugs; multiple warning letters issued.
European Union — EFSA
EU restricts monacolin K in supplements to <3 mg/day (Reg. 2022/860).
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