I was under the impression that the FDA banned Red yeast rice supplements.
But I see it for sale all over the internet. While that doesn’t surprise me, it did surprise me that I was in Walmart today and they were selling the stuff. I checked it out and sure enough, it was the real thing. So what’s the Straight Dope on the legality of stores selling this?
They may be for sale all over the web, but that does not mean it is legal. Funny how, you didn’t go to the FDA to answer your own question:
In 1998 the Food & Drug Administration sought to regulate Cholestin, a red yeast rice product, containing lovastatin, as a drug, This product was marketed by Pharmanex, Inc., 203 Thomas Drive, Egg Harbor Twp., New Jersey 08234. The firm sued the Agency under the contention that the product, Cholestin, was a dietary supplement and was therefore not subject to regulation as a drug. Despite an initial ruling in favor of Pharmanex, the decision was remanded by the United States Court of Appeals and returned to the District Court in the District of Utah. In the dismissal of the suit on March 30, 2001, the U.S. District Court for the District of Utah, case number 2 :97CV262K, affirmed that red yeast rice products that contain lovastatin are subject to regulation as drugs within the meaning of section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act), and are not dietary supplements.
Moreover, they are also “new drugs” [section 201 § of the Act] because there is no evidence that these products are generally recognized as safe and effective for their intended uses. Since these products are “new drugs”, they may not be legally marketed in the United States without approved new drug applications [section 505(a) of the Act].
Source: http://www.fda.gov/foi/warning_letters/g1523d.htm
So, therefore Walmart is breaking Federal law by selling this stuff?
Who would have thought.
Indeed, that’s new ground for Wal-mart. They usually stick to violations of labor law and wage-and-hour regulations.