FDA Says Red Yeast Supplements Illegally Contain Lovastatin

August 14, 2007 – 10:56 pm | posted in Cholesterol

FDA this week warned two companies to immediately stop promoting and selling red yeast products that contain the cholesterol-lowering drug lovastatin.

A warning letter was issued Tuesday to Sunburst Biorganics of Baldwin, New York, for the company’s Cholestrix red rice and yeast extract product. FDA issued a letter the next day to Swanson Health Products of Fargo, North Dakota, for the company’s Red Yeast Rice and Read Yeast Rice/Policosanol dietary supplements.

According to FDA, Swanson’s products, if taken as advertised on the company’s website, provide more than 5 mg of lovastatin daily, or half the lowest-recommended daily dose of FDA-approved formulations of the drug.

FDA stated that Sunburst’s product, Cholestrix, is advertised as containing “1.35% of naturally occurring lovastatin,” with two tablets daily providing 10 mg of the drug.

FDA contends that traditional red yeast contains, at the most, trace levels of lovastatin. The agency described the purported supplements as unapproved drugs that have been “enhanced” with lovastatin, which has been regulated as a drug since 1987.

Both warning letters also cited statements appearing on the two companies’ websites claiming that the red yeast products are intended for the diagnosis, cure, prevent, or treatment of diseases. Supplement makers and distributors are prohibited under the federal Food, Drug, and Cosmetic Act from making such claims for their products.

Both companies were given 15 working days to notify FDA of steps taken to respond to the agency’s warning letters or face possible consequences, including seizure of the products and criminal prosecution. FDA advised (PDF) consumers to avoid purchasing or using the three products.

A review of Swanson’s website this morning indicates the company is no longer advertising the red yeast products that prompted the warning letters.

But Sunburst this morning was still advertising Cholestrix capsules online. The website featured an image of the Cholestrix bottle with the label clearly stating that the product is “Standardized to Contain 1.35% Lovastatin.”

American Society of Health-System Pharmacists

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