Nutrivigilance: ANSES launches a consultation today for its opinion on food supplements containing red yeast rice

"Red yeast rice" is a red mould grown on rice. It is used in many food supplements claiming to "maintain a normal level of cholesterol". Consumers use these food supplements in addition to, or as a replacement for or alternative to cholesterol-lowering treatments. Red yeast rice in fact contains several compounds known as monacolins at levels which may vary greatly from one product to another. One of these substances, monacolin K, has the pharmacological characteristics of statins, meaning that it has the ability to inhibit an enzyme (HMG-CoA reductase) involved in the cholesterol synthesis pathway. Monacolin K is therefore marketed as a drug under the international nonproprietary name “lovastatin” in the United States, Canada, Germany, Austria, Spain, Portugal and Greece, but not in France. 

Since the creation of its nutrivigilance system in 2009, ANSES has received 25 well-documented reports of adverse reactions potentially associated with the consumption of food supplements containing “red yeast rice”. The 12 cases in which causality was “very likely” and “likely” include: 

• a majority of cases of muscle damage (myalgia that is often intense); 
• three cases of liver damage, independent of and associated with muscle damage. 

The nutrivigilance cases reported in France or in the other countries sharing their information with us are fully consistent with the clinical cases for lovastatin that are well-documented in the scientific literature. It therefore appears at the end of this assessment that, under current conditions the use of food supplements containing red yeast rice, and those containing monacolins in particular, can expose consumers - especially those particularly vulnerable due to genetic predispositions, pathologies or ongoing treatments, etc. - to a health risk. This health risk may be higher if their consumption is not accompanied by any medical advice or supervision. 

To regulate the market by preventing the development of any misleading advertisement about the benefits of certain food products, the European Commission requires that all health claims undergo a scientific assessment based on a dossier provided by the industrial applicant. In this regard, food supplements containing red yeast rice and a sufficient amount of monacolin K are entitled to make the claim “contributes to the maintenance of normal blood cholesterol levels”. In its Opinion of 26 May 2011 (PDF), ANSES had highlighted the difficulties that could arise from an assessment of the benefits of products without an assessment of the concomitant risks.

In order to collect as much data as possible to refine its assessment, ANSES has decided to submit this Opinion for consultation by the various stakeholders (consumer associations, manufacturers, etc.) and the authorities (international agencies, etc.) until 15 December 2013.  Given the free movement of goods within the territory of the European Union, this consultation will provide the authorities with the maximum scientific information from all the Member States in order to present this matter at EU level.

Contributions can be sent to the following address: consultation-LRR@anses.fr

Pending the publication of the Agency’s final Opinion and the decisions of the authorities, the Agency would like to reiterate the following:

• since high cholesterol is not a disease but a factor increasing the risk of developing cardiovascular disease, a suitable diet and regular physical exercise should be undertaken in order to lower cholesterol levels in primary prevention;
• it is preferable to seek advice from a doctor before taking food supplements containing red yeast rice, especially for individuals taking medical treatments;
• patients treated with statin-based cholesterol-lowering drugs and patients who had to stop taking these drugs due to adverse reactions (patients considered “statin-intolerant”) must refrain from consuming such food supplements;
• food supplements containing red yeast rice cannot be used as an alternative to cholesterol-lowering medication;
• the following vulnerable populations should not consume these food supplements:
  • women who are pregnant, breastfeeding or of childbearing age and not using contraception;
  • children and adolescents;
  • people over the age of 70;
  • people with predisposing conditions such as kidney failure, muscle disease or untreated hypothyroidism;
  • patients with progressive liver disease;
  • carriers of genetic polymorphisms that may increase plasma concentrations of statins;
  • people taking medication that may interfere with lipid or statin metabolism;
  • heavy consumers of grapefruit (juice or fruit) or alcohol.

It should also be emphasised that any adverse reactions following consumption of food supplements containing "red yeast rice" must be reported to a healthcare professional so that they can notify ANSES in the framework of the nutrivigilance plan.