So is that what I was referring to above.....in that in the USA any Red Yeast Rice Supplement CANNOT have Monacolin K in it...unlike in the UK and EU where there is no such restrictions. The FDA are seriously supressive to you guys. Why would for example I go get a pharma statin that could impact my medical records and employment when there's a legal natural alternative....er nah! Although that doesn't apply to me personally I have seen great results on lipids using RYR with monacolin k.
I think that you may be misreading or misinterpreting what I wrote.
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.
^^^ that means that Red Yeast Rice containing the naturally occurring levels of monacolin-k by the traditional manner of production is fine and legal for sale as a dietary supplement.
It's saying that companies are not allowed to use raw materials that are extracted, enhanced, or otherwise manipulated to increase the level of monacolin-k above the levels that occur in the traditional manner of raw material production process.
It is also saying that companies are not allowed to add or spike their products with additional monacolin-k, and that if they do so, the product would no longer be considered a supplement and would be considered a drug.
Basically, they aren't making companies remove monacolin-k, they just aren't allowed them to add additional to what is already naturally occurring in it.
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.
^^^ this is a good thing and good for consumer protection because if companies are intentionally manipulating the monacolin-k content, then that may be dangerous to consumers because that it basically them walking in a store and thinking they're buying a natural supplement and actually winding up taking a drug, which they were probably trying to avoid taking if they were buying the supplement to start with.
Monacolin K is structurally similar/identical to the prescription medication, Lovastatin - and the average consumer has no idea of that.
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.
^^^ that is not specific to Red Yeast Rice. It's not legal to promote the sale of any supplement by marketing it as having a naturally existing level of a prescription drug content or to compare it to prescription drugs.
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Statins are serious prescription medications and can have a lot of negative side effects.
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.
Red Yeast Rice in general to me is not something I would recommend to people looking for a cholesterol support supplement.
To me, a cholesterol support supplement is something that a person takes to support healthy cholesterol levels and to help reduce cholesterol levels naturally - with the reasonable expectation of safety and having little to no side effects.
Red Yeast Rice to me is a supplement that would be introduced in an 'oh crap' situation where other things such as diet and exercise aren't working and their cholesterol is very problematic and they're reluctant to go on statins, so its kind of a last ditch attempt to avoid going on statins.
That was an important consideration for me when formulating the upcoming Cholesterol Support XT product - whether to use Red Yeast Rice in it or not - and it will not have it in there because I feel that Red Yeast Rice is not something that people should use unless they are really in a situation where they need to, and I wanted to formulate and offer a product to hopefully help a lot of people be able to avoid that situation to begin with. And then, the people that do need something additional can always buy it as a single ingredient product from a reputable company like NOW Foods and take it in addition to it.
I hope all of that makes sense.
