Sunday, August 3, 2008

The ConsumerLab Red Yeast Rice Product Review - FDA Enforcement Policy

If you take red yeast rice products, for cholesterol-lowering, then you need to read this post, "ConsumerLab Red Yeast Rice Product Review Creates Potential Safety and Regulatory Problems." It appears that ConsumerLab; Hyman, Phelps & McNamara, P.C.; and the FDA converge to make this a compelling read. As stated in a posted Hyman etal memo, " Red Yeast Rice Product Review Is in Conflict with the Law and FDA Enforcement Policy, Creating Safety Issues for Consumers and Regulatory Issues for 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 monacolins that FDA has determined to be unsafe."

I'm perpetually perplexed that these kind of situations continue to exist. There are FDA regulations, and companies are expected to comply with them. I care, because when the regs aren't followed, I as a consumer, might inadvertently pay the adverse consequence.

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