ConsumerLab Red Yeast Rice Product Review Creates Potential Safety and Regulatory Problems

August 3, 2008

On July 1, 2008,, LLC published a product review titled “Red Yeast Rice Supplements.”  Hyman, Phelps & McNamara, P.C. sent an 8-page letter to ConsumerLab on July 17 to inform the company that, as confirmed in FDA warning letters, the product review created potential safety issues for consumers as well as regulatory issues for the dietary supplement industry. 

The ConsumerLab product review of red yeast rice supplements makes incorrect statements about the law and FDA enforcement policy, and creates general confusion about the marketing of red yeast rice products.  Most important, the review encourages consumers to purchase dietary supplements with high levels of lovastatin, the active ingredient in the prescription drug Mevacor™, that FDA has determined to be unsafe.  In addition, FDA has repeatedly warned industry that the marketing of products with levels of lovastatin represented as “high” or “moderate” in the ConsumerLab review is illegal. 

Although ConsumerLab has updated its product review, ConsumerLab has not corrected the safety and regulatory issues addressed in FDA’s warning letters and this firm’s July 17 letter.  In a telephone call with counsel to ConsumerLab on July 30, this firm was informed that ConsumerLab did not intend to make further changes to the red yeast rice product review.  For this reason, we are posting a memorandum based on the firm’s letter to ConsumerLab as a warning to industry and consumers that the ConsumerLab review is in conflict with FDA’s view of the law.

By A. Wes Siegner