After a public consultation and its own assessment, ANSES concluded the mostly muscle and liver health issues were, “likely to be linked to consumption of food supplements containing red yeast rice.”
“The Agency considers that use of this kind of food supplement containing monacolins may expose consumers to a health risk – especially individuals who are particularly susceptible due to genetic predispositions, pathologies, ongoing treatments, etc. ANSES therefore recommends seeking medical advice before taking these products.”
ANSES made special note of patients taking statin-based medications or those that had statin reactions as well as pregnant or breastfeeding women, children and adolescents, over-70s and, “those suffering from certain pathologies”. Monacolin K-red yeast rice has a near-identical chemical structure to popular statin drugs.
Red yeast rice-monacolin K are backed for cholesterol management under the EU nutrition and health claims regulation (NHCR) but are quizzically only approved for sale as food supplements at EU-approved levels (10 mg/day) in Italy’s liberal market. In most other markets they are only available under prescription or in reduced dose supplements.
See here for the European Food Safety Authority (EFSA) article 13.1 general function opinion on the matter which is written into EU law books.
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French consultancy Nutraveris, which has worked on building health claim dossiers for red yeast rice and monacolin K, said muscle pain (myalgia) was a potential consequence of statin consumption.
“It is therefore not surprising to observe some case of myalgia in red yeast rice consumers,” said Jérôme Le Bloc'h, PhD, from Nutraveris’ health claim and food safety department.
But Bloc'h said the ANSES opinion failed to account for typical usage and health condition of typical users.
“Have red yeast rice supplements been taken in association with other statins or cholesterol-lowering drugs? Were these subjects intolerant to statins? Clinical studies have reported similar rates of adverse events between red yeast rice and placebo, even if some cases of myopathies have been reported,” he observed.
“For the moment ANSES does not suggest banning red yeast rice in food supplements, but a reduction of the authorised monacolin K daily intake in France is not unlikely.”
The warning demonstrated the need for, “a real assessment of red yeast rice safety at the European level, and of a harmonisation of the legal status of red yeast rice among European countries, in order to protect consumers from products with large variability in their efficacy and their safety.”
ANSES acknowledged as much when it said, “the status of these products should be clarified on the EU level and that their marketing networks must be capable of ensuring compliance with these recommendations.”
The ANSES opinion is here.