10th October 2002
I E – mailed the FDA stating
"I think it's utterly ridiculous that Red Yeast Rice is outlawed. The highly expensive statins (that you're making large amounts of money from) are life threatening and they're not nearly as affective as Red Yeast Rice. Bayer's drug Baycol caused over 100 deaths. Red Yeast Rice has been proven to be the safest, cheapest, and most affective way to lower cholesterol. What's wrong with having a safe, cheap, and affective way to lower cholesterol? Oh yeah, that's right, it causes you to loose a lot of money. In other countries people who use it live longer, healthier lives. Red Yeast Rice was sold in the U.S for over six years (and was proven by the people to be the most affective way to lower cholesterol, otherwise no one would have bought it) and not a single person reported any harm or injury from it. If you really want to outlaw something that's harmful to people (that has been proven to be harmful to people), why don't you outlaw cigarettes, cigars, alcohol, and other harmful substances. Oh yeah, that's right, because the government makes a fortune from these harmful substances. Yet marijuana is outlawed because the government can't regulate it (therefore the government doesn't make any money from it). I'm not saying that marijuana is a good thing for people to take, but I know for a fact that if the government can regulate it (and make money from it) they would legalize it in a split second. This proves that your number one concern isn't the well being of the people, but it's the well being of your money. I thought America is supposed to be for the people, by the people. Well I guess I was wrong."
Their response
"Thanks for writing. I understand you frustration, but please know the govt.
is not making money by prohibiting this product from the market."
My response
"Explain yourself.
Red Yeast Rice has been used in China for centuries for lowering cholesterol. It's probably the safest, most affective, and cheapest method of doing so. People who eat Red Yeast Rice generally live longer, healthier lives than people who don't. The UCLA School of Medicine conducted a study involving 83 people with high cholesterol levels. Within twelve weeks those who received Red Yeast Rice experienced a significant decrease in total cholesterol, LDL (bad) cholesterol, and triglycerides compared to those who received placebo. HDL (good) cholesterol wasn't affected in either group during the study. In 1999 two studies involving Red Yeast Rice were presented at the American Heart Association's 39th Annual conference. In the first study, 187 people with mild to moderate elevations in total cholesterol and LDL cholesterol revealed that treatment with red yeast rice reduced total cholesterol by more than 16%, LDL cholesterol by 21%, and triglycerides by 24%. HDL (good) cholesterol increased by 14%. In the second study, elderly people who received red yeast rice experienced significant reductions in total cholesterol and LDL cholesterol compared to those who were given placebo. Both studies were done over an eight-week period. In another 8-week trial with 446 people with high cholesterol levels, those who received red yeast rice experienced a significant drop in cholesterol levels compared to those who received placebo. Total cholesterol dropped by 22.7%, LDL by 31%, and triglycerides by 34%. HDL cholesterol increased by 20%. Red Yeast Rice has been sold in the U.S for over six years and there have been no reports of any harm or injury (from anyone). The very expensive statins now used in America are much more dangerous and less affective than Red Yeast Rice. Bayer's drug Baycol was removed from the market in August, 2001 because it caused over 100 deaths.
Give me one good reason why Red yeast Rice is outlawed."
Their response
"Below is the reason that you cannot market red yeast rice legally.
GC Litigation Summaries:
"Pharmanex v. Shalala (D. Utah) On March 30, 2001, the United States
District Court for the District of Utah (Judge Dale A. Kimball) denied
Pharmanex Inc.'s motion to Set Aside Administrative Decision, and granted
FDA's motion to Affirm Administrative Decision, in the Cholestin matter.
This matter involves a purported dietary supplement product that contains
lovastatin, the active ingredient present in the prescription drug Mevacor,
intended to reduce serum cholesterol levels. Last fall, the Tenth Circuit
Court of Appeals had ruled in favor of FDA on legal issues, but remanded the
matter back to the district court for resolution of certain factual issues.
In the latest ruling, the district court has affirmed the factual bases
supporting FDA's Administrative Decision that Pharmanex, in marketing
Cholestin, was marketing lovastatin, an article approved as a new drug that
was not before such approval, marketed as a food or dietary supplement. This
means that, under DSHEA, red yeast rice containing lovastatin is regulated
as a drug and not a dietary supplement.."
That means if the company Pharmanex could prove that their product
containing red yeast rice was marketed prior to the drug Lovostatin, then
they could continue to market.
mk11"
My response
"Why don't you just outlaw Cholestin? Why did you outlaw Red Yeast Rice. Red Yeast Rice has been around much longer than Mevacor. So basically what you're trying to tell me is that the medical system has the right to find an ingredient in any herb (or plant), create a drug that contains that ingredient (even though the herb / plant has been around much longer than the drug), outlaw the herb / plant, and sell the drug for as much money as they please? This isn't a democracy.
Here is the flaw in your reasoning for outlawing Red Yeast Rice.
The FDA says red yeast rice has not been approved through Stage 3 drug testing, therefore doctors cannot write prescriptions for it. If the ingredient in Red Yeast Rice is identical to lovastatin then it has already been approved through Stage 3. If it has not been approved, then that can only mean it is not identical, and thus the grounds for its ban are invalid."
------------------
Life is in the Blood
"I think it's utterly ridiculous that Red Yeast Rice is outlawed. The highly expensive statins (that you're making large amounts of money from) are life threatening and they're not nearly as affective as Red Yeast Rice. Bayer's drug Baycol caused over 100 deaths. Red Yeast Rice has been proven to be the safest, cheapest, and most affective way to lower cholesterol. What's wrong with having a safe, cheap, and affective way to lower cholesterol? Oh yeah, that's right, it causes you to loose a lot of money. In other countries people who use it live longer, healthier lives. Red Yeast Rice was sold in the U.S for over six years (and was proven by the people to be the most affective way to lower cholesterol, otherwise no one would have bought it) and not a single person reported any harm or injury from it. If you really want to outlaw something that's harmful to people (that has been proven to be harmful to people), why don't you outlaw cigarettes, cigars, alcohol, and other harmful substances. Oh yeah, that's right, because the government makes a fortune from these harmful substances. Yet marijuana is outlawed because the government can't regulate it (therefore the government doesn't make any money from it). I'm not saying that marijuana is a good thing for people to take, but I know for a fact that if the government can regulate it (and make money from it) they would legalize it in a split second. This proves that your number one concern isn't the well being of the people, but it's the well being of your money. I thought America is supposed to be for the people, by the people. Well I guess I was wrong."
Their response
"Thanks for writing. I understand you frustration, but please know the govt.
is not making money by prohibiting this product from the market."
My response
"Explain yourself.
Red Yeast Rice has been used in China for centuries for lowering cholesterol. It's probably the safest, most affective, and cheapest method of doing so. People who eat Red Yeast Rice generally live longer, healthier lives than people who don't. The UCLA School of Medicine conducted a study involving 83 people with high cholesterol levels. Within twelve weeks those who received Red Yeast Rice experienced a significant decrease in total cholesterol, LDL (bad) cholesterol, and triglycerides compared to those who received placebo. HDL (good) cholesterol wasn't affected in either group during the study. In 1999 two studies involving Red Yeast Rice were presented at the American Heart Association's 39th Annual conference. In the first study, 187 people with mild to moderate elevations in total cholesterol and LDL cholesterol revealed that treatment with red yeast rice reduced total cholesterol by more than 16%, LDL cholesterol by 21%, and triglycerides by 24%. HDL (good) cholesterol increased by 14%. In the second study, elderly people who received red yeast rice experienced significant reductions in total cholesterol and LDL cholesterol compared to those who were given placebo. Both studies were done over an eight-week period. In another 8-week trial with 446 people with high cholesterol levels, those who received red yeast rice experienced a significant drop in cholesterol levels compared to those who received placebo. Total cholesterol dropped by 22.7%, LDL by 31%, and triglycerides by 34%. HDL cholesterol increased by 20%. Red Yeast Rice has been sold in the U.S for over six years and there have been no reports of any harm or injury (from anyone). The very expensive statins now used in America are much more dangerous and less affective than Red Yeast Rice. Bayer's drug Baycol was removed from the market in August, 2001 because it caused over 100 deaths.
Give me one good reason why Red yeast Rice is outlawed."
Their response
"Below is the reason that you cannot market red yeast rice legally.
GC Litigation Summaries:
"Pharmanex v. Shalala (D. Utah) On March 30, 2001, the United States
District Court for the District of Utah (Judge Dale A. Kimball) denied
Pharmanex Inc.'s motion to Set Aside Administrative Decision, and granted
FDA's motion to Affirm Administrative Decision, in the Cholestin matter.
This matter involves a purported dietary supplement product that contains
lovastatin, the active ingredient present in the prescription drug Mevacor,
intended to reduce serum cholesterol levels. Last fall, the Tenth Circuit
Court of Appeals had ruled in favor of FDA on legal issues, but remanded the
matter back to the district court for resolution of certain factual issues.
In the latest ruling, the district court has affirmed the factual bases
supporting FDA's Administrative Decision that Pharmanex, in marketing
Cholestin, was marketing lovastatin, an article approved as a new drug that
was not before such approval, marketed as a food or dietary supplement. This
means that, under DSHEA, red yeast rice containing lovastatin is regulated
as a drug and not a dietary supplement.."
That means if the company Pharmanex could prove that their product
containing red yeast rice was marketed prior to the drug Lovostatin, then
they could continue to market.
mk11"
My response
"Why don't you just outlaw Cholestin? Why did you outlaw Red Yeast Rice. Red Yeast Rice has been around much longer than Mevacor. So basically what you're trying to tell me is that the medical system has the right to find an ingredient in any herb (or plant), create a drug that contains that ingredient (even though the herb / plant has been around much longer than the drug), outlaw the herb / plant, and sell the drug for as much money as they please? This isn't a democracy.
Here is the flaw in your reasoning for outlawing Red Yeast Rice.
The FDA says red yeast rice has not been approved through Stage 3 drug testing, therefore doctors cannot write prescriptions for it. If the ingredient in Red Yeast Rice is identical to lovastatin then it has already been approved through Stage 3. If it has not been approved, then that can only mean it is not identical, and thus the grounds for its ban are invalid."
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Life is in the Blood