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Beware Dangerous Treatment for High Cholesterol

With all the media attention on high cholesterol and heart health, it’s not surprising that some companies are preying on consumers with “natural” treatments like “red yeast rice products” that may contain prescription drugs without obtaining authorization from the US FDA. The FDA is now warning consumers about these products sold on the Internet as dietary supplements for high cholesterol:

Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics.

These products were found to contain lovastatin, an anti-cholesterol drug, yet the manufacturers do not warn consumers about the potentially dangerous side effects of products containing this chemical the way that pharmaceutical companies are required by law to warn consumers. The FDA has sent warning letters to these companies to stop selling these products. Source: FDA

Updated: June 30, 2013 — 8:07 am

3 Comments

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  1. Hi There, Swanson Health Products has issued a statement regarding the FDA letter sent about their red yeast rice products:

    The FDA notified Swanson Health Products that we cannot sell our current red yeast rice formulations, and therefore we have pulled the products from sale. Lovastatin is a naturally occurring component of red yeast rice; however, the FDA has taken issue with the level of lovastatin that is in our products based on their testing. The products will be reformulated and returned to our shelves as soon as possible.

    For years Swanson Health Products has far exceeded the quality assurance standards set by the federal government for dietary supplements. Since 2001, we’ve participated in the GMP (Good Manufacturing Practices) program of the Natural Products Association, and we have consistently received their “A” rating for our compliance to it. Swanson Health Products is committed to complying with all laws and regulations pertaining to our products.

    Swanson Health Products is located in Fargo, ND, and has been a leading vitamin and health products company since 1969. Our customers are number one and to prove that, we offer powerful guarantees. All products are backed by a 100% Satisfaction, Money-Back Guarantee. If you are not satisfied with your purchase for any reason, simply return the unused portion for a full refund of the purchase price.

  2. Thanks for the additional information and clarification, Theresa. It’s always nice to get all sides of the story – the regulators’, manufacturer’s, and patients’ – to start.

    I’m assuming that during the reformulation process, the naturally occurring Lovastatin became concentrated, as opposed to the company adding this compound de novo.

    Jane Chin

  3. Right, and in the supplement industry there are several ways products can be tested and come out completely different. Either way, the issue is being resolved and we should hopefully have Red Yeast Rice available by October or November FDA approved!

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