Judge rules against FDA

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Subj: [HEALTHE] Judge rules against FDA in Cholestin case

Date: 2/17/99 11:43:17 PM CST

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Judge rules against FDA in Cholestin challenge

Reuters News Service

WASHINGTON, February 17, 1999

A U.S. federal judge ruled against the Food and Drug Administration

(FDA) in the agency's struggle against a cholesterol-lowering supplement

on Wednesday, ordering it to reverse its ban on the product.

U.S. District Judge Dale Kimball in Salt Lake City, said the product,

Cholestin, is a natural food supplement and not, as the FDA says, a

drug.

Kimball reversed the FDA's ban on the product, which is made by

Pharmanex Inc. of Simi Valley, Calif., and which is based on a

traditional Chinese medicine known as hongqu.

The decision is a blow to the FDA, which has been seeking to more

closely regulate such supplements, which are widely sold in health food

stores.

A spokesman for the FDA had no immediate comment. " The agency is

reviewing (the decision) and we will evaluate where we go from here, " he

said.

Kimball ruled that Cholestin is not a drug and can be legally sold as a

dietary supplement under the Dietary Supplement Health and Education Act

of 1994 (DSHEA).

Cholestin is made from fermented rice and sold over-the-counter as a

dietary supplement to lower cholesterol.

Last year the FDA said Cholestin contains lovastatin -- the active

ingredient in Merck's prescription cholesterol drug Mevacor.

Pharmanex Inc., which is owned by Nu Skin Enterprises Inc., appealed the

FDA decision, arguing that mevinolin, one of several active ingredients

of Cholestin, is at most a cousin of lovastatin.

" We are pleased with the ruling which upholds Cholestin's status as a

dietary supplement, " Pharmanex president Bill McGlashan said in a

statement.

" This decision also reflects that good science, while contributing to

the health of Americans, does not transform a natural health supplement

into a drug. "

Earlier this month, doctor Heber and colleagues at the University

of California Los Angeles Center for Human Nutrition found that

Cholestin lowered levels of low density lipoprotein (LDL or 'bad'

cholesterol) by up to 15 percent among patients who took it for two

months.

Pharmanex, which has three facilities in China and one in Chile,

continued to sell Cholestin while it was appealing the FDA ban.

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Date: Wed, 17 Feb 1999 09:34:37 -0800

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Subject: [HEALTHE] Judge rules against FDA in Cholestin case

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