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Red Yeast Rice: A Regulatory Quagmire for Clinicians

RYRIf you’re recommending Red Yeast Rice supplements to patients as a natural alternative for cutting CVD risk, you may be unwittingly guiding them to ineffective products, and simultaneously compromising your clinical credibility.

This is all thanks to a regulatory gray zone that permits companies to market Red Yeast Rice (RYR) products as dietary supplements so long as they do not contain levels of monacolin K—the main lipid-lowering component in RYR—in excess of what would naturally be found in traditional fermented foods.

Monacolin K is a byproduct of the fermentation of rice by Monascus purpureus, a reddish mold that can grow on rice, other types of grain, and some forms of tea (e.g. Pu’er). It is also naturally produced—in small amounts—by various types of mushrooms including Pleurotus ostreatus, better known to chefs as oyster mushrooms.

This compound is better known to physicians as Lovastatin, though the monacolin K in the prescription drug is derived from fermentation Aspergillus rather than Monascus.

Since monacolin K does arise naturally—at sub-clinical concentrations--in various food sources, the FDA permits companies to market these foods--and supplements derived from them--provided they do not contain pharmaceutical levels of the compound.

And that’s where the gray area begins.

There are no formal guidelines defining the “naturally-occurring” level of monacolin K in a traditional food or supplement product. From a practical point of view the FDA has considered products containing greater than 0.4% monocolin K to be either unapproved drugs—or adulterated products.

No Guidelines, No Dosing Info

Simply put, if a food or supplement contains levels of monocolin K higher than what would naturally result from traditional Asian fermentation processes, the FDA views it as an unapproved statin drug.

As a result, most companies selling RYR products in the US are simply side-stepping the issue by either not testing monacolin K levels in their products or not disclosing the information about monacolin K concentration on their labels.

Nutritionist and supplement industry expert Tom Guilliams, PhD, says regulators do not require disclosure of monacolin K on supplement products, and in fact, the way the law is written, companies have a very strong disincentive to post any such information.

Guilliams, who heads the Point Institute—an independent educational organization focused on natural therapeutics—and who serves as vice-president of regulatory affairs for Ortho Molecular Products—says the situation creates a potentially dangerous Catch-22 for practitioners and their patients.

If a RYR product does contain therapeutically active levels of monacolin K, and the precise concentrations are not disclosed on the labels, there is no way to accurately and safely control dosing.

If a product does not contain high levels of the compound, it will not likely work to lower LDL and modulate cardiovascular risk. This means that the patient has wasted money, and the practitioner has failed to fulfill the objective of mitigating risk and improving health.

Gambling in the Dark

Either way, both practitioner and patient are in the dark. Without meaningful disclosure of monocolin K content, it is not possible to know how much is too much, or even to guess at what might be a reasonable outcome from taking a RYR product.

Guilliams believes use of RYR is a very dicey gamble, one that too many clinicians are taking simply because they do not understand the regulatory situation.

In a recent White Paper on this subject, he recommends that clinicians discontinue dispensing or recommending RYR until all regulatory and quality control issues are sorted out, and there are no longer any gray areas.

He adds that while it seems reasonable to petition FDA to specify a clear permissible upper limit for monacolin K in each dose of RYR (perhaps 5 mg), the legal precedent this would set is likely to prevent such a ruling. In the past, the FDA has rejected several attempts to establish low-dose statins as OTC medications. The agency is unlikely to change its stance.

Guilliams stresses that there are many ways to reduce risk for chronic cardiovascular events. Reliance upon low-dose statin therapy via RYR supplements that do not disclose any information about concentration of active compounds is probably not the most intelligent or effective option.

To access Dr. Guilliams’ new White Paper exploring the Red Yeast Rice issue, visit http://www.pointinstitute.org/white-papers/

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