Monacolin

EFSA Health claims policy, what if they were wrong?

In the last weeks, the EFSA Panel had to come against their own decision regarding an approved health claim, about the Red Yeast Rice and the Health claim approved for 10 mg intake per day.

On the 25th of June of 2018, a publication of the EFSA Journal reported that some cases of toxicity have been reported and the whole market of cholesterol reduction products is on hold until they present a new health claim policy…

The journal could be found on the following link.

Now, we are facing a big problem. Since 2011, when the claim was approved, around 40 millions of boxes have been sold in Europe, and only 55 adverse events have been reported.

Do we know if those adverse events were due to the lactone part of the Monacolin K, or is it the acid part?

In a publication of 2013 (Chen et al.,2013) it was reported that an intake of 5-6 mg of monacolin K was the equivalent to 20-40 mg of Lovastatin, a pharmaceutical drug… This means that 10 mg per day is similar to an intake of 40 to 67 mg of Lovastatin per day, taking into account the recommended dosage of Lovastatin is between 20 and 60 mg per day, it looks like that the Italian government, that was recommending only 3 mg day of Monacolin K was right, 15 years ago…

This new scientific opinion created a lot of uncertainty, but from the market point of view, this is not recent at all, as many companies were already working on something different, since 2015-2016, to avoid the current situation…

This is a simple example of how the market is far away from the regulatory authorities.

From Monteloeder, we could already propose you Metabolaid, our proposal for metabolic syndrome, including cholesterol reduction, as the European Union supported us with an H2020 financing of over 1 million €…

Back to the monacolin K concern, what happened in this case? Why authorities approved a health claim for an ingredient which looks like to be not safe? What will be the new dosage for monacolin K? Are they going to determine that only a certain form of monacolin K will be permitted? We have now around 12 months to wait until they take a decision…

Axel Salomon

Europe Sales Director