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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 or multi-level marketing companies. 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) and citrinin by High Performance Liquid chromatography — mass spectroscopy (HPLC-MS).
  2. Disintegration of non-chewable, non-capsule and non-time released formulations utilizing USP (United States Pharmacopeia) <2040> methods.

Any product not passing a test was sent to another independent laboratory for repeat testing on 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 achieve a "Pass" in the testing, a product had:
  1. Meet label claims for monacolins K and KA.
  2. Have no detectable citrinin.
  3. If applicable to the product, meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, chewable and time-release products).
  4. Be in compliance with FDA labeling requirements.
* 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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