Red Yeast Rice
monacolin K, Monascus purpureus (hong qu)
Sold freely in European Union and unregulated in United States. Same substance, same evidence, different decisions.
A rice fermented with Monascus purpureus (hong qu), long used in China and Chinese traditional medicine, that naturally produces monacolin K, a compound chemically identical to the statin drug lovastatin.
Red yeast rice is where "natural" and "drug" become the same molecule. Its active compound, monacolin K in lactone form, is chemically identical to the prescription statin lovastatin, so treating it purely as a food effectively puts a statin on the shelf without a prescription. The EU capped how much monacolin K a supplement may contain and later voted to remove it altogether; the US treats products carrying more than trace lovastatin as unapproved drugs, though shelf enforcement has been uneven and actual monacolin K content varies widely between products.
Where it stands, jurisdiction by jurisdiction
European Union
Restricted, restrictedDecided on: Precaution, Evidence
Commission Regulation (EU) 2022/860, in force 22 June 2022, prohibits food supplements delivering 3 mg or more per day of monacolins from red yeast rice and requires warning labelling on products below that level. The trigger is that monacolin K in lactone form is chemically identical to lovastatin, an authorised statin medicine, so higher-strength products are pushed out of the supplement market. The measure followed the EFSA safety opinion of 25 June 2018. In May 2026 the Member States' Standing Committee voted to approve a further step toward a full ban of monacolin K in food supplements.
United States
Unregulated, unregulated, sold anywayDecided on: Contested
FDA treats red yeast rice products containing more than trace amounts of lovastatin (monacolin K) as unapproved new drugs, not lawful dietary supplements, since lovastatin was approved as the drug Mevacor in 1987 and was not marketed as a supplement before then. This position was upheld in the 1998 Cholestin litigation involving Pharmanex, and FDA has since issued warning letters and used Import Alert 54-16 to detain lovastatin-containing imports. In practice products remain widely sold and their monacolin K content varies considerably, so enforcement has been uneven.
Regulatory positions change, sometimes quickly. Check the date on a source before relying on it.