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How Products were Selected:

Products tested represent those commonly sold and/or available nationally in the U.S. purchased products on the open market through retail stores, on-line retailers, and direct sales. Products were not accepted directly from manufacturers.

Testing Methods:

Red yeast supplements were tested in one or more independent laboratories for the following:
  1. Identification and quantification of monacolins K (lovastatin) and KA (the hydroxy acid form) by High Performance Liquid chromatography (HPLC) and HPLC tandem mass spectroscopy (HPLC-MS/MS).
  2. Identification and quantification of citrinin by HPLC-MS/MS.
Any product that did not pass (below) a test was sent to another independent laboratory to repeat testing for the criterion for which it did not pass. may modify or use other appropriate test methods if necessary to test special product formulations.

Identities of the products were not disclosed to laboratories performing the testing.

Passing Score:*

To be "Approved" by, a product must meet the following requirements :
  1. Meet label claims for monacolins K and KA. If no claims are made the amounts found will be reported. To be "Approved" a product also had to provide a total of at least 1.5 mg of monacolins K and KA per 600 mg of red yeast rice; a product with a lower but detectable amount may be listed as "Not Recommended."
  2. Have no detectable citrinin (<1ppm).
  3. Be in compliance with FDA labeling requirements.
A "Pass" was based on meeting the above criteria in either the first or second rounds of testing.

* Passing scores allow for specific margins of technical error associated with each analysis. reserves the right to disqualify a product at any time from passing its testing if it considers such product to display unacceptable variation in quality, present a safety risk, or provide misleading or inaccurate information in its labeling.

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