From: Paul Schaefer, ENN
Published August 13, 2007 04:29 PM

FDA Warns Consumers Over Doctored Red Yeast Rice

Minneapolis - The US Food and Drug Administration is warning consumers that a specific brand of Red Yeast Rice supplement contains an "added" pharmaceutical ingredient used in prescription medicines. The supplement according to the FDA in a news release today, is sold under the name "Swanson Vitamins", based in Fargo N.D.. The FDA says a lab analysis confirmed the presence of the drug "Mevacor". The supplement-maker, who sells online, faces possible criminal charges.


The FDA informed Lee Swanson, the president of Swanson Health Products, Inc. that his firm's products "Red Yeast Rice and Red Yeast Rice/Policosanol Complex on your website, www.swansonvitamins.com" are suspect. The FDA told Swanson in a letter that "You promote Red Yeast Rice and Red Yeast Rice/Policosanol Complex as dietary supplements. A laboratory analysis conducted by the Food and Drug Administration (FDA) determined that your Red Yeast Rice and Red Yeast Rice/Policosanol Complex products contain significant levels of lovastatin. Lovastatin is the active pharmaceutical ingredient in Mevacor and its generic counterparts, which are FDA-approved drugs used to treat patients with primary hypercholesterolemia. If consumed as directed, your products would provide more than 5 mg lovastatin per day, which is approximately half of the lowest recommended daily dose of lovastatin in Mevacor and its generic counterparts."


Traditional red yeast rice does not contain more than trace amounts of lovastatin, if any. The FDA said that because Swanson's Red Yeast Rice and Red Yeast Rice/Policosanol Complex contain red yeast rice with "enhanced or added lovastatin "and bear claims about lipid control and other cardiovascular benefits supplied by this ingredient, they cannot be marketed as dietary supplements.


The FDA told Swanson their agency "approved Mevacor as a new drug on August 31, 1987; neither lovastatin as a single ingredient, nor any red yeast rice product manufactured and promoted for lovastatin content, was marketed as a dietary supplement or as a food before that date. Therefore, lovastatin's approval as a new drug preceded its marketing as a food or dietary supplement, and your lovastatin-enhanced Red Yeast Rice and Red Yeast Rice/Policosanol Complex are excluded from the dietary supplement definition."


The FDA took issue with the company's website, which touted the supplements' ability to prevent, treat, or cure disease conditions or to affect the structure or function of the body. Statements on the website included, the following assertions.


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Ӣ "An all-natural supplement that helps maintain healthy lipid levels"


Ӣ"constituents in red yeast rice help promote a healthy lipid balance in the bloodstream."


Red Yeast Rice/Policosanol Complex


Ӣ "Policosanol decreases cholesterol levels"


Ӣ "Policosanol moderately decreased total cholesterol levels and raised levels of apolipoprotein Al (APO Al), a component of high-density lipoprotein (HDL) cholesterol . . ."


Ӣ "Total plasma cholesterol dropped from 7.37 to 6.99 mmol/L . . ."


Ӣ can help keep your blood lipid levels within a healthy range . . ."


Ӣ"safe and effective ways to promote healthy serum lipid levels for everyday heart-health maintenance."


Ӣ"[P]olicosanol has earned widespread acclaim in the scientific community for its lipid-balancing capabilities."


The FDA says Swanson/s Red Yeast Rice and Red Yeast Rice/Policosanol Complex products are being sold as new drugs, because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The FDA continued, "a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of Red Yeast Rice and Red Yeast Rice/Policosanol Complex without approved applications violates these provisions of the Act."


For more information: http://www.fda.gov/foi/warning_letters/s6455c.htm


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