FDA: Red Yeast Rice and Lowering Cholesterol. - Article By: Bruce
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withdrawn the patent on Mevacor.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that it should be withdrawn, is not correct since cholestin found in red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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