After reviewing information about Cholestin red yeast rice, which is marketed by Pharmanex Inc. of Simi Valley, a federal judge has temporarily overturned an FDA ruling that Cholestin is an unapproved drug.
Based on the ruling in the Federal District Court of Utah that Cholestin is a dietary supplement, Pharmanex can continue to import red yeast rice, a fermented yeast found on rice that is ground and used as a staple in Asia. The company sells the yeast under the brand name Cholestin.
In reviewing the request for a preliminary injunction against the Food and Drug Administration, the court noted that the safety of Cholestin is not at issue and continued availability of it is not a threat to the public interest.
"We are thrilled with the court's decision and believe it is a reflection of the weakness of the FDA's legal and factual position and the importance of the issues that are at stake in this case," said Bill McGlashan, president of Pharmanex.
The future of Cholestin came into question last September, when the FDA told Pharmanex that it considered Cholestin an unapproved drug rather than a dietary supplement, and that cholesterol information contained in the product's packaging constituted a drug claim.
The FDA based its claim on the fact that Cholestin naturally contains mevinolin, a substance the agency equates with lovastatin, the purified active compound in at least one prescription drug.
Pharmanex is a privately held manufacturer and marketer of natural dietary supplement products.