February 7, 2000
WASHINGTON--The Food and Drug Administration (FDA) is in court over a red yeas that contains mevinolin, a component found in nature and chemically similar to Lovastatin, an FDA-approved drug proven to lower cholesterol levels.
The FDA believes the red yeast needs to be marketed as a drug, and not as a dietary supplement. Products containing red yeast, many of which are on the shelves already, may now need the FDA's approval.
In early 1999, a Utah court upheld red yeast as a dietary supplement. In July of the same year, the FDA filed an appeal with the U.S. Court of Appeals. The agency believed that the lower court had erroneously defined a drug as a combination of active and inactive components, and should have based the definition solely on one active ingredient.
While the issue is still being debated in the courts, manufacturers are allowed to use .40 percent of the red yeast in their products. Anything above .40 percent is considered a drug. Even though products with this red yeast have the same cholesterol-lowering effects as Lovastatin, some manufacturers say they will find something else if the product is no longer economically viable.
If the courts rule that the red yeast is not a drug, the FDA may stop importing the supplement into the U.S.
Because this issue is on appeal, the FDA was not able to comment for this article.
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