FDA: Red Yeast Rice and Lowering
Cholesterol. - Article By: Bruce Brightman
The ruling of the FDA on red yeast
rice that, a natural substance found in Red Yeast Rice (Cholestin) could not be
marketed as a cholesterol lowering agent is not correct, since Cholestin is a
natural substance. It turns out that this food source supplement contains a
naturally occurring component (monacolin K) that the FDA has already allowed to
go on the market as a patented drug called Mevacor (lovastatin).
The statin drugs do lower cholesterol, but the reason drug companies spend so
much money to market synthetic or modified substances is that they cannot
patent natural substances. When it was discovered that the statin-like molecule
in red-yeast-rice occurred naturally, FDA should have withdrawn the patent on
Mevacor. However, the rule of FDA on red yeast rice that it should be
withdrawn, is not correct since cholestin found in red yeast rice is a natural
substance and falls under the protection of the Dietary Supplement Health and
Education Act. Of course, the FDA can remove any substance that poses a health
risk from the market , natural or otherwise, but their actions on this product
clearly shows their bias against dietary supplements and their favorable
treatment of drugs.
The lead author of the article on Cholestin points out in a letter that dietary
supplements are not un-purified drugs, they are natural substances. Synthesis of
drugs by crystallization and purification of plant sources makes the resulting
medical treatment more expensive, more risky, and less accessible, and if
natural dietary supplements were available instead, public health would be more
affordable and safer. As is common with natural products, Cholestin contains a
variety of compounds related to monacolin K, all of which may have an effect on
cholesterol levels. It also appears to be quite safe.
Unfortunately, after a victory of the manufacturer over the FDA in District
Court, the Appeals Court ruled that the FDA could regulate Cholestin (this
court often sides with FDA). This threatens to deprive you of easy access to
this beneficial supplement for heart health. Stay tuned...
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have been evaluated by the FDA. These products are not intended to diagnose,
treat, cure or prevent any disease. As always, consult your physician before
taking any and all supplements. LifeSource Vitamins. Individual results may
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information contained throughout this website is based upon the opinion of the
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LifeSource Vitamins whose relentless research and studies have been ongoing on
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