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Getbig Bodybuilding Boards => Nutrition, Products & Supplements Info => Topic started by: paulsed1 on February 14, 2009, 08:23:02 AM
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http://secretsofnaturalhealing.blogspot.com/2009/02/vitamin-b-6-declared-drug-by-fda-to-be.html (http://secretsofnaturalhealing.blogspot.com/2009/02/vitamin-b-6-declared-drug-by-fda-to-be.html)
Vitamin B-6 Declared a “Drug” by FDA; to be Banned from Vitamin Supplements
God help us, because the FDA has now opened the gateway for all vitamins to be declared “drugs” and removed from sale by the nutritional supplement industry.
What they have done is declared that pyridoxamine (one of the three primary forms of vitamin B-6 found in nature, and the most widely used form in multi-vitamin supplements) is in reality a “new drug,” thus clearing the way for it to be banned from sale as a nutritional supplement. (See the news article below this commentary for more details.)
Here’s what happened:
A North Carolina-based firm called Biostratum began manufacturing pyridoxamine-based drug called Pyridorin designed to prevent the progression of diabetic nephropathy (kidney disease). The company then petitioned the FDA to declare pyridoxamine a “new drug,” clearing the way for them to hold an iron-clad monopoly on its sale.
Today, the FDA agreed with Biostratum, and declared this most popular form of vitamin B-6 to indeed be a “new drug,” using the argument that its medical qualities had been under investigation for years before it was ever used as a nutritional supplement under the DSHEA, which ironically was enacted in 1994 in order to protect nutritional supplements from excessive FDA regulation.
Not to worry, said many observers in the nutritional supplement industry. After all, there are two other natural forms of vitamin B-6 that can still be used in multi-vitamin formulations. The problem is, another drug company has already petitioned the FDA to declare the second most popular form of B-6, pyridoxal 5'-phosphate, which is also called P5P, a “new drug,” apparently for the very same reason pyridoxamine has been declared a drug, i.e., it’s purely medical qualities have been investigated long before it was ever used as a nutritional supplement.
How much longer until the third most popular natural form of B-6 will be declared a “drug”? You can bet your boots the pharmaceutical companies are racing to get in on the FDA’s new fast-track for turning B-vitamins into drugs.
Will All Vitamins Eventually Be Declared Drugs?
Worst of all, the very same argument being used to declare vitamin B6 a “drug” can essentially be made for any vitamin. After all, every known vitamin on the face of the earth has been studied for their medicinal qualities even since the discovery of the existence of vitamins in food back in 1905, when a scientist named William Fletcher realized that foods contained special nutrients that actually prevented disease.
It is easy to see that the day is soon-coming in which all vitamins will be offered solely as “drugs,” by prescription only.
One of the most galling aspects of the whole thing is that the FDA flatly refuses to allow nutritional supplement manufacturers to even mention the incredible medicinal values of the vitamins, minerals and other supplements they sell. Indeed, the FDA routinely claims vitamin and mineral supplements are “useless” and “inert.” Yet when a drug company develops the same natural molecule as a “drug,” suddenly its medical benefits can be touted from the rooftops. The only problem is, the drug company is given a monopoly to produce the “drug,” and what was once a natural product available inexpensively in any health food store in America is now an expensive drug you have to get a prescription for.
Drug-Induced B-6 Deficiency a Growing Phenomena
Another serious issue regarding B-6 is that a growing number of medications actually deplete the body of this vital nutrient that is absolutely essential to life. The syndrome is called Drug Induced Pyridoxine Deficiency, and several drugs, including drugs for the treatment of tuberculosis, Parkinson’s Disease and for cancer are known to cause this syndrome, which essentially turns you into a mental vegetable by depleting your body of its needed stores of vitamin B-6.
In the past, people having to take these drugs could simply go down to their local health food store and pick up an inexpensive bottle of vitamin B-6 in order to prevent the depletion syndrome. But due to the new FDA ruling, people using these drugs will no longer be able to do so. Instead they will have to get a prescription from their doctor, and purchase the expensive “drug” form of the vitamin in order to resolve the devastating mental side effects of the first drug!
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So gathered from what I read, this is because a company claimed that they own it? For their drug that they made? Nice, and to show you how much political lobbying drug companies do in the wake of profits for their shareholders.
The Food and Drug Administration (FDA) has ruled that the vitamin B6 compound, pyridoxamine dihydrochloride, cannot be used in dietary supplements.
The decision, in response to a petition from a North Carolina-based firm called Biostratum, provoked the Washington DC-based Council for Responsible Nutrition (CRN) to issue a statement warning that a precedent could be established that could see the status of other ingredients challenged.
Biostratum and CRN have been debating the status of the ingredient via FDA petitions since at July, 2005. Biostratum is the manufacturer of a pyridoxamine-based drug called Pyridorin designed to prevent the progression of diabetic nephropathy (kidney disease).
The FDA verdict, delieved on January 12, reasoned that the ingredient was authorized for investigation as a new drug before it was ever marketed as a dietary supplement. Such situations forbid dietary supplement marketing, a fact CRN accepts, but the group said in a statement it was “disappointed” with the decision nonetheless.
Grandfathered?
There exists a grandfathering clause for ingredients that have been on the market for more than 15 years, but CRN said the way this list functioned “was not agreed upon”.
This 15-year period coincides with the enactment of the 1994 Dietary Supplements and Health Education Act (DSHEA), around which time much evidence was presented supporting ingredients such as pyridoxamine dihydrochloride.
“We are disappointed with FDA’s response to the recent citizen petition involving pyridoxamine that apparently views as inadequate the evidence presented by the industry, including CRN, of the previous marketing of pyridoxamine, even prior to the passage of DSHEA,” said CRN vice president of scientific and regulatory affairs, Andrew Shao PhD.
“FDA’s decision suggests that companies need to produce even more extensive evidence supporting an ingredient’s marketing as a dietary supplement, including catalog and business records from more than 15 years ago.”
Companies had to ensure that they could “substantiate that an ingredient has in fact previously been marketed as a dietary supplement.”
In a previous letter to the FDA, dated September 14, 2005, the CRN’s senior vice president of scientific and international affairs, John Hathcock, wrote that:
“Pyridoxamine is unequivocally a dietary ingredient because it is one of the three primary natural forms of vitamin B6, and it is one of the two predominant forms in animal products used as human foods.”
He noted pyridoxamine was on a CRN “gold list” of grandfathered ingredients that its marketing as a dietary ingredient was “entirely consistent with the long history of the science of this form of vitamin B6.”
At the time it said it would “gladly provide documentation of this fact”.
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This is just the tip of the iceberg. Look up Codex Legislation to get a peek at what's coming down the pike. :'(
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They are talking about pyridoxaMINE DIhydrochloride. Most supplements contain pyridoxine hydrocloride.