Question 1

Does your product contain any significant amount of monacolin k; the compound identical to lovastatin, a hmg-coa inhibitor, or is it the u.s. version?

Accepted Answer

Red yeast rice contains 14 naturally occurring compounds called monacolins, one of which is monacolin K.  Monacolins naturally inhibit the synthesis of cholesterol in the liver, with the resulting positive effect being that cholesterol levels in the blood are correspondingly reduced.  The FDA has approved a number of statin drugs that achieve this very same purpose; i.e., these drugs can lower cholesterol levels in the blood.  For example, the FDA-approved synthetic lovastatin drugs (brand names such as Altocor, Altoprev, and Mevacor), come from various sources of synthesized monacolins. The naturally-occurring monacolin content in red yeast rice has the same therapeutic effect that the lovastatin drugs do - it lowers cholesterol in the blood.  But as a dietary supplement product, the naturally-occurring monacolin content in red yeast rice cannot be increased (fortified) in the product by the manufacturer, nor can manufactured lots of red yeast rice be made to contain the same amount of monacolin (standardized).  If Thorne Research's Choleast label claimed either of those two things - that the red yeast rice ingredient was either fortified or standardized with respect to its overall monacolin content or its monacolin K content - then the FDA would designate Choleast to be a misbranded drug and issue a Warning Letter demanding that it stop being sold. On the other hand, Thorne Research is also obligated to comply with the FDA's Good Manufacturing Practice (GMP) regulations that are found at 21 C.F.R. Part 111 and that have been imposed on dietary supplement manufacturers since June 2009.  In order to comply with the FDA's GMP regulations, which have the force of federal law, Thorne Research must measure every raw material used as an ingredient in its products in order to be in compliance with the GMP regulatory requirement that a manufacturer must determine every dietary ingredient's identity, purity, strength, and composition.  Therefore, Thorne Research does measure the amount of naturally-occurring monacolin content in its red yeast rice raw ingredient, but only for the purpose of determining that the raw material meets their ingredient specification for monacolin content - but not for the purpose of determining that the raw material has been either fortified or standardized.  Based on Thorne Research's specification for naturally occurring monacolin content in red yeast rice - which specification has an upper limit and a lower limit - Thorne Research knows that it will receive a raw material whose monacolin content will deliver the desired therapeutic effect of promoting a reduced level of cholesterol in the blood.  Thorne Research would reject a raw material whose monacolin content was either too low or too high.  The variability in red yeast rice's total monacolin content is a natural phenomenon that is attributable to seasonal variations in the planting and harvesting of the rice and that variability will always exist, which is why their ingredient specification has an upper limit and a lower limit. Thorne Research does not divulge the exact monacolin content in Choleast because they do not want to risk that that information might inadvertently be conveyed to the FDA, who then might mistakenly conclude that the monacolin content in their product is a result of the product being either fortified or standardized.  Generally speaking, however, the daily suggested use of Choleast will contain approximately one-tenth of the amount of naturally occurring monacolin content (1 mg) as the synthetic monacolin content in the lowest recommended daily dose of an FDA-approved lovastatin drug (10 mg).

Question 2

Is citrinin used in the fermentation process?  Also is the the extract or the powder?

Accepted Answer

No, citrinin is not used in the fermentation process. The product is also tested for citrinin and there is none in the product. Could you please clarify the second part of your question?

Question 3

Is this Choleast the same as the 120 vegetarian capsules?

Accepted Answer

I do not know what's in the vegetarian capsules. Here's all the ingredients listed on this bottle:  Red Yeast Rice (Monascus purpureus) 2.4g, Coenzyme Q10 60mg, Other Ingredients Hypromellose (derived from cellulose), Leucine, contains ingredients derived from soy (rice).  Instructions are 2-4 capsules per day. I took 1 capsule per day which greatly improved my cholesterol lab work numbers. But after about 9 months I experienced tingling and numbness in my fingers and had to stop taking these capsules. The tingling and numbness resolved within 1 month after I stopped taking this med. Hope this helps!

Question 4

What is the expriation date, I want to buy two?

Accepted Answer

The expiration date on mine is 12/2014.

Additives	Red Yeast Rice
Allergen Information	Soy Free
Weight	0.4 Pounds
Units	120 Count
Brand	THORNE
Format	Capsule
Age Range Description	Adult

THORNE Red Yeast Rice + CoQ10 - Maintain Healthy Cholesterol Levels and Supports Cardiovascular Health - Gluten-Free, Dairy-Free - 120 Capsules

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