Note: This Victory for Pharmanex couldn't have come at a better time, and
we can use it against the FDA's proposed rule to impose arbitrary limits on
structure-function claims! I am drafting a new form letter in light of this
victory and will post it tomorrow. Although Pharmanex won in court, we
can't let down our guard! We must continue flooding the FDA with letters
protesting their proposed rule to severely limit structure function claims.
They were hoping to get a test case to use against us here, and they
failed, but they won't give up unless we READ THEM THE RIOT ACT!
 

FOR IMMEDIATE RELEASE

Contact: Brandi Griffin
  Ketchum Public Relations
  (310) 444-1341
  brandi.griffin@ketchum.com
 

PHARMANEX WINS FIGHT TO IMPORT PRODUCT
WHILE COURTS DECIDE CASE ON CHOLESTIN™
--Consumers Retain Access to Safe, Low-Cost Healthcare Alternatives--
 

SIMI VALLEY, Calif., June 16, 1998 -- After reviewing scientific, legal and
medical information about Cholestin™ red yeast rice manufactured by
Pharmanex, Inc., the Federal District Court of Utah decided that Cholestin
is preliminarily declared a dietary supplement and not a drug.  Pharmanex
can import sufficient Cholestin red yeast rice to satisfy the market demand.

In reviewing the case for preliminary injunction, the court determined the
safety of Cholestin is not at issue and that continued availability of
Cholestin is not adverse 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, Inc.  "Natural dietary supplements such as
Cholestin™ play an important role in maintaining and promoting good health
in a cost-effective manner and Congress passed DSHEA to ensure access to
these products."

The future of this very popular, beneficial and relatively inexpensive
supplement came into question September 30, 1997, when the FDA told
Pharmanex 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 initial claims on
the fact that Cholestin™ naturally contains mevinolin, a substance the
agency equates with lovastatin, the purified active compound in Merck's
prescription drug Mevacor™.
-more-

This decision allows continued consumer access to Cholestin™ -- a natural
dietary supplement composed of red yeast rice – to promote and maintain
healthy cholesterol levels.

Cholestin™ is intended for use as part of an overall cholesterol
maintenance program that includes regular exercise and a diet low in
saturated fat.  Nothing in Cholestin's™ labeling or promotional material
suggests the product treats, prevents or cures any disease.

Founded in 1995, Pharmanex, Inc. is a privately held manufacturer and
marketer of natural dietary supplement products.  Based in Simi Valley,
California, Pharmanex engages in extensive research and development and
employs strict quality controls to assure the safety and efficacy of its
line of natural products and strives to broaden acceptance of natural
healthcare products in mainstream America.  Pharmanex' product line
includes BioGinkgo™, Cholestin™, CordyMax™, Tegreen™, EstroCare™ and Bio
St. John's™.

# # #
 
 
 
 

******************************************
Donations Needed- Need Help to Keep Helper On
International Advocates for Health Freedom
John C. Hammell, Legislative Advocate
2411 Monroe St. Hollywood, FL 33020 USA
800-333-2553, 954-929-2905, FAX 954-929-0507,
jham@iahf.com    http://www.iahf.com
HERBS ARE _NOT_ DRUGS! HELP PASS HR 2868
THE CONSUMER HEALTH FREE SPEECH ACT!!!