Doctor's Best, Inc. of San Clemente, California last Tuesday issued a voluntary recall of one lot of its Red Yeast Rice dietary supplement to the retail level. The company's press release, as posted on the website of the Food and Drug Administration (FDA), states that the product "has been found to contain undeclared lovastatin" which makes this product "an unapproved new drug" since lovastatin is "a previously approved drug indicated for the treatment of high cholesterol." The press release also noted that the company "has not received any reports of adverse events related to this recall."
Red yeast rice has been used for centuries as a food ingredient and traditional medicine. When manufactured by traditional processing it may contain trace amounts of compounds known as monacolins; one of these, monacolin K, has the same structure as the drug lovastatin.
FDA has long taken the position that red yeast rice in which the level of lovastatin is controlled may not be sold as a dietary supplement, since lovastatin was approved as a new drug prior to the marketing of any such red yeast rice products. On the other hand, FDA has also acknowledged that "food red yeast rice" is an allowable supplement ingredient.
The agency initiated removal from the market of the first prominent brand of a red yeast rice supplement, CholestinTM, in 1997 and has issued occasional warning letters to a few other companies in the meantime. In addition, in a December 2010 letter to dietary supplement manufacturers, FDA Commissioner Margaret Hamburg expressed concern regarding "significant public health problems posed by products that are marketed as dietary supplements but that contain the same active ingredients as FDA-approved drugs, analogs of the active ingredients in FDA-approved drugs, or other compounds ... that do not qualify as dietary ingredients [and that are] ... generally undeclared in the labeling" of these products." One of the "undeclared active ingredients" noted in this letter was "HMG-CoA reductase inhibitors (e.g., lovastatin)."
"While there was an earlier recall of red yeast rice raw material containing 0.4% lovastatin, this is the first time that FDA has pushed for a recall of a red yeast rice finished product due to the presence of lovastatin," commented Michael McGuffin, president of the American Herbal Products Association (AHPA). "This recall represents a significantly more assertive regulatory approach by FDA to finished product marketers."
In an attempt to clarify for AHPA members the regulatory status of red yeast rice as a dietary supplement ingredient, AHPA reissued today an updated document titled, "Background on the use of red yeast rice as an ingredient in dietary supplements."
AHPA Members log in to download the background paper below