FDA Says Cholestin Is A Drug, Not A Supplement

The US Food and Drug Administration is convinced that Cholestin, a redyeast product which is marketed in the USA as a dietary supplement for cholesterol-lowering, is in fact a drug and should be regulated accordingly. The agency made its position plain in a letter to the legal counsel for Pharmanex, the Californian company which sells the product.

The FDA states in its letter, dated September 30, that the issues involved with Cholestin "will affect both the dietary supplement and the pharmaceutical industries, as well as Pharmanex." Based on both the formulation and the labeling claims for the product, the FDA believes that Pharmanex intends to market, and is marketing, lovastatin (Merck & Co's cholesterol-lowering HMG-CoA reductase inhibitor Mevacor).

Pharmanex' counsel, legal firm Patton Boggs, sparked the FDA advisory letter by asking the agency to conclude its review of Cholestin, which started earlier this year, and confirm that Pharmanex may import red yeast for production and sale in the USA. The FDA detained a shipment of Chinese red yeast intended for use in Cholestin manufacture in mid-May, on the grounds that the substance appeared to be an "unapproved new drug."