FDA ORDERED TO LIFT BAN ON IMPORTS OF CHOLESTEROL-REDUCING SUBSTANCE

SALT LAKE CITY -- In a case that challenged the government's ability to
regulate natural remedies, a federal judge Tuesday ordered the Food and Drug
Administration to lift its ban on imports of a dietary supplement containing
a cholesterol-reducing drug.

The chemical lovastatin occurs naturally in ``red yeast'' rice powder from
China, and the company that markets the powder under the name Cholestin had
sought a preliminary injunction against the FDA.

The dispute was the first challenge to the FDA's powers under the 1994
Dietary Supplement Health and Education Act. The law provided for the
widespread sale of herbs, teas and capsules containing ingredients that are
not FDA-approved as safe and effective.

In a three-page order, U.S. District Judge Dale Kimball said Pharmanex, of
Simi Valley, would suffer irreparable injury if the FDA's ban remained in place.

He also found the company has ``raised substantial and serious questions
regarding the lawfulness of FDA's interpretation'' of the 1994 Dietary
Supplement Health and Education Act.

Moreover, Kimball defined Cholestin as a dietary supplement, not a new drug
that would be subject to FDA approval.

Pharmanex president Bill McGlashan said he was ``thrilled'' with the ruling,
which he said will prove ``very important'' to the dietary-supplement
industry. The possibility of an appeal remains open for the FDA.

Checked-by: Melodi Cornett