Pharmanex of California can continue manufacturing the
cholesterol-reducing dietary supplement Cholestin until a
decision is made about whether the supplement is a drug, U.S.
District Judge Dale A. Kimball ruled Tuesday in Salt Lake
City.
The ruling bars the federal Food and Drug Administration
(FDA) from blocking imports of milled red yeast rice, the
substance that makes up Cholestin.
That frees up about 10 metric tons of the product just as
supplies were running out. The last shipment has been stored
in Mexico since the FDA imposed the import ban last summer.
The red yeast rice is imported from China, and the dietary
supplement is encapsulated in a plant in Farmington.
``The judge found that the case we represented showed that
the harm to the company was irreparable if the shipment wasn't
allowed in, that there was no safety issue,'' said Pharmanex
attorney Dan Kracov. ``The company has said all along that the
product they produce is a dietary supplement.''
The FDA never contended that Cholestin was not safe. It
contended that Cholestin was an unapproved drug masked as a
dietary supplement because its active ingredient,
``mevinolin,'' was identical biologically to lovastatin.
Lovastatin is the synthetically produced chemical in the
prescription medication Mevacor -- an approved drug prescribed
for patients with high levels of cholesterol.
FDA officials could not be reached Tuesday for comment on
whether they will appeal Kimball's decision to lift the import
ban. But the real issue of whether Cholestin will remain on
the market long term remains to be decided in the judge's
courtroom through a full trial.
During arguments before Kimball on Monday, Pharmanex
lawyers argued that the red yeast rice naturally contains
lovastatin as well as nine other components that naturally
inhibit the synthesis of cholesterol. Red yeast rice has been
used as a staple in Asian cuisine for years, they said.
But FDA officials said Pharmanex uses a mutant strain of
red yeast rice and manipulates it potency with temperature
controls to produce more powerful amounts of lovastatin than
naturally occur.
``I'm claiming the strain of yeast . . . is not a
traditional strain,'' said Jacquelin Eagle, counsel for the
Department of Health and Human Services, the umbrella
organization over the FDA. ``When one is able to concentrate,
alter or improve a product, that is fine, as long as they
don't do it to get a drug.''
Pharmanex attorney Alan L. Sullivan maintained that
temperature during fermentation of the rice is not closely
controlled, or even monitored. Additionally, he said, ``All
you can infer from [Pharmanex using] a single strain is that
we're trying to make a consistent product that is a beneficial
product.''
Pharmanex's suit against the FDA is the first test case of
the 1994 Dietary Supplement and Health Education Act, which
assured that such products would be available, and their
labels more detailed in their list of ingredients.
The act also prohibits the dietary-supplement industry from
using approved pharmaceutical components in its products
unless those components were sold as supplements or food
before the drug's approval. The industry also is restricted
from marketing products as cures, preventions or treatments of
disease.
© Copyright 1998, The Salt Lake Tribune
