What do you think of FDAs attempts to remove cholesterol supplement Cholestin?

[Guest guest]

Today's Question

What do you think of the FDA's effort to remove the cholesterol-

lowering dietary supplement Cholestin (manufactured by Pharmanex)

from the market?

 

-- Gail Cohen

 

Today's Answer

(Published 12/18/1998)

 

I strongly support Pharmanex on this issue. And, so far, the company

appears to be ahead in its legal battle with the FDA.

 

In May, the FDA determined that Cholestin, a natural product with a

long history of traditional use as a nutraceutical in China, is not

a dietary supplement but a drug under the terms of the Dietary

Supplement Health and Education Act (DSHEA) of 1994.

 

In June, U.S. District Court Judge Dale Kimball in Utah granted

Pharmanex's motion for a preliminary injunction on the FDA's effort

to ban the company from importing Cholestin from China.

Furthermore, Judge Kimball took the position that Cholestin can be

considered a " dietary supplement " and not a drug within the meaning

of DSHEA.

The FDA's position is that Pharmanex may not sell Cholestin as a

dietary supplement since its primary ingredient, lovastatin, was

already an approved drug before Cholestin was brought to market.

 

Mevacor (lovastatin), produced by Merck, is one such approved drug

sold by prescription, but the reality is there are several natural

sources of statin drugs, notably from mushrooms and other fungi.

 

In fact, Cholestin and its active components come from a strain of

red yeast cultivated on rice that is used as a natural food

flavoring and coloring agent in Chinese cooking.

 

I believe that Cholestin is safer than its pharmaceutical

counterparts.

 

Pharmanex cites 17 clinical studies in China to support its claims

that Cholestin promotes healthy cholesterol levels.

Results of a double-blind, placebo-controlled study recently

completed at UCLA's School of Medicine are awaiting publication and

may tell us even more about Cholestin's usefulness.

 

Being cautious, Pharmanex says that Cholestin is intended for

healthy men and postmenopausal women whose cholesterol levels are

moderately elevated -- between 200 and 239 mg/dl -- and who are also

willing to undertake a regular exercise program and follow a healthy

low-fat diet.

 

Pharmanex further says that anyone whose cholesterol is 240 or

higher shouldn't be taking Cholestin without the knowledge and

supervision of a physician.

 

I have a feeling that the days when herbal remedies have to be

marketed under the euphemistic name of " dietary supplements " are

coming to an end, but it won't be until the FDA ceases its hostile

policy toward these products and develops a better method for

evaluating them.

 

I hope that the issue with Pharmanex can somehow catalyze that

change in FDA policy.

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