Red Yeast Rice - Clarifying Some Confusion:
There seems to be a lot of confusion as to the way that the FDA views Red Yeast Rice in the US.
The FDA does not have an issue with companies selling Red Yeast Rice in its natural form.
Their issue is with companies/raw material suppliers intentionally selling Red Yeast Rice products that are manipulated, enhanced, or extracted for monacolin k content &/or illegally adding Lovastatin (a prescription drug).
Monacolin K is structurally similar/identical to the medicine lovastatin.
Here are some things to help clarify some of the confusion:
- Red Yeast Rice can be legally marketed as a dietary supplement only when it is fermented in the traditional manner of production. Manufacturers and raw material suppliers cannot intentionally try to manipulate the extraction/production process to target or manipulate for the statin content.
- If a company standardizes its product or uses raw materials that are standardized/manipulated for monacolin content, then the FDA considers the product an unapproved drug. The reason for this is that monacolin is structurally identical to Lovastatin, which is a prescription statin drug.
- While it is legal for a company to sell a non-manipulated Red Yeast Rice supplement, it is NOT legal to sell the supplement if promoting it by promoting the monacolin or statin content.
Context:
The reason that a lot of people want to use Red Yeast Rice is to try to lower their cholesterol naturally in hopes to avoid having to go on a statin drug like Lovastatin to begin with; so companies intentionally manipulating for monacolin content or adding Lovastatin to their products is not only unsafe for unknowing consumers, but it defeats the purpose that most were using Red Yeast for to begin with. (Because if they wanted a prescription medication for cholesterol, they are easily obtainable from almost any general health practitioner).
I hope this information helps to clarify this issue to anyone interested.