Pharmanex Wins Battle in Bid to Sell Cholestin

Pharmanex, an herbal supplement company owned by Nu Skin Enterprises, said it has won a court victory in its battle with U. S. regulators to sell its Cholestin as a cholesterol-lowering dietary supplement.

U. S. District Judge Dale Kimball has made final a preliminary order he issued in June allowing Simi Valley-based Pharmanex to continue importing the substances it needs to manufacture and sell Cholestin. The company went to court after the U. S. Food and Drug Administration declared in May that Cholestin was an unapproved drug instead of a dietary supplement and said it could not be sold in the United States without approval.

Kimball’s ruling rejects the FDA’s attempt to ban imports of the ground-up rice and yeast needed to manufacture Cholestin, Pharmanex said. It also designates Cholestin as a dietary supplement, part of a group of products that fall outside the FDA’s strictest regulations.

An FDA spokesman said the agency is reviewing the decision and deciding what to do next. A company spokeswoman said Pharmanex “wouldn’t be surprised” by an FDA appeal.

Pharmanex President William 8McGlashan said the court ruling is important because it could lessen the FDA’s authority to make similar decisions, which would discourage companies from doing research on dietary supplements.

Unlike drugs, dietary supplements do not need FDA approval before sale.