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 owering agent is not correct, since Cholestin is a natural substance.
It turns out that this food source supplement contains a naturally occuring 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 When it was discovered that the statin-like molecule in red-yeast-rice occurred naturally, FDA should have withdrawn the patent on Mevacor.
However, the rule of FDA on red yeast rice that it should be withdrawn, is not correct since cholestin found in red yeast rice is a natural substance and falls under the protection of the Dietary Supplement Health and Education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 unpurified drugsâ€“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.
In case you're looking to lower cholesterol naturally through the aid of natural supplements, click here.
This article with minor editions is by Dr. Michael Janson and can be found at Dr. Janson's website http://www.drjanson.com/news1200.htm#fda
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