SallyAnne
02-19-2009, 01:32 PM
http://www.ironmagazine.com/blog/2009/fda-is-declaring-vitamin-b-6-a-drug/
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!
Foods that Contain Vitamin B-6 Naturally
Under the circumstances it is important to note that certain foods contain vitamin B-6 naturally. They are, in order of their content percentage of the recommended daily value of the vitamin:
Baked potato, flesh and skin, 1 medium: 0.7 mg ~ 35% DV
Banana, raw, 1 medium: 0.68 mg ~ 34% DV
Garbanzo beans, canned, 1/2 c: 0.57 mg ~ 30% DV
Chicken breast, meat only, cooked, 1/2 breast: 0.52 mg ~ 25% DV
Pork loin, lean only, cooked, 3 oz: 0.42 mg ~20% DV
Roast beef, eye of round, lean only, cooked, 3 oz: 0.32 mg ~ 15% DV
Trout, rainbow, cooked, 3 oz: 0.29 mg ~ 15% DV
Sunflower seeds, kernels, dry roasted, 1 oz: 0.23 mg ~ 10% DV
Avocado, raw, sliced, 1/2 cup: 0.2 mg ~ 10% DV
Salmon, Sockeye, cooked, 3 oz: 0.19 mg ~ 10% DV
Tuna, canned in water, drained solids, 3 oz: 0.18 mg ~ 10% DV
Peanut butter, smooth, 2 Tbs: 0.15 mg ~ 8% DV
More importantly, safe, simple Brewer’s Yeast contains relatively high levels of B-vitamins, including the pyridoxine form of B-6. Capsulated Brewer’s Yeast can be purchased in just about any health food store in the country, or is available through many online sources.
What to Do Now
Legally speaking, as of today, anyone wanting to purchase the pyridoxamine form of B-6, and probably soon the P5P form, will have to have a doctor’s prescription to do so. Of course, the ruling is brand new, and it is going to take some time for the FDA to implement it. Meanwhile, the pyridoxamine form of vitamin B-6 is still widely available in health food stores across the country. I suspect, however, not for long.
Today I went down to my local health food store and stocked up on a number of bottles of NOW Brand “B-50” vitamins, which contains the pyridoxamine form of B-6 along with all other B vitamins in 50 mg. per capsule dosages. I also picked up a number of bottles of the pure vitamin B6, in 100 mg. per capsule dosages. Since this vitamin is essential to cardiovascular health as well as mental health (and is also widely used to help heal carpal tunnel syndrome), it might be wise for you to do the same, particularly if the B vitamins are an integral part of your regular natural health regimen.
Another thing you can do is go to the web site of the American Association for Health Freedom and sign their petition to stop the FDA from turning any more vitamins into drugs.
You should also write and call your Congressmen and Senators immediately, and tell them you don’t want the FDA banning any more vitamins by turning them into “drugs.”
It is high time we all start expressing our outrage at this outlandish behavior by the FDA and other bureaucracies in regards to their disdain for nutritional supplements. We now have the EPA trying to re-classify colloidal silver as a “pesticide” so they can ban its sale in health food stores. And we have the FDA actually re-classifying common vitamins as drugs. And it is all at the behest of the major pharmaceutical companies.
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!
Foods that Contain Vitamin B-6 Naturally
Under the circumstances it is important to note that certain foods contain vitamin B-6 naturally. They are, in order of their content percentage of the recommended daily value of the vitamin:
Baked potato, flesh and skin, 1 medium: 0.7 mg ~ 35% DV
Banana, raw, 1 medium: 0.68 mg ~ 34% DV
Garbanzo beans, canned, 1/2 c: 0.57 mg ~ 30% DV
Chicken breast, meat only, cooked, 1/2 breast: 0.52 mg ~ 25% DV
Pork loin, lean only, cooked, 3 oz: 0.42 mg ~20% DV
Roast beef, eye of round, lean only, cooked, 3 oz: 0.32 mg ~ 15% DV
Trout, rainbow, cooked, 3 oz: 0.29 mg ~ 15% DV
Sunflower seeds, kernels, dry roasted, 1 oz: 0.23 mg ~ 10% DV
Avocado, raw, sliced, 1/2 cup: 0.2 mg ~ 10% DV
Salmon, Sockeye, cooked, 3 oz: 0.19 mg ~ 10% DV
Tuna, canned in water, drained solids, 3 oz: 0.18 mg ~ 10% DV
Peanut butter, smooth, 2 Tbs: 0.15 mg ~ 8% DV
More importantly, safe, simple Brewer’s Yeast contains relatively high levels of B-vitamins, including the pyridoxine form of B-6. Capsulated Brewer’s Yeast can be purchased in just about any health food store in the country, or is available through many online sources.
What to Do Now
Legally speaking, as of today, anyone wanting to purchase the pyridoxamine form of B-6, and probably soon the P5P form, will have to have a doctor’s prescription to do so. Of course, the ruling is brand new, and it is going to take some time for the FDA to implement it. Meanwhile, the pyridoxamine form of vitamin B-6 is still widely available in health food stores across the country. I suspect, however, not for long.
Today I went down to my local health food store and stocked up on a number of bottles of NOW Brand “B-50” vitamins, which contains the pyridoxamine form of B-6 along with all other B vitamins in 50 mg. per capsule dosages. I also picked up a number of bottles of the pure vitamin B6, in 100 mg. per capsule dosages. Since this vitamin is essential to cardiovascular health as well as mental health (and is also widely used to help heal carpal tunnel syndrome), it might be wise for you to do the same, particularly if the B vitamins are an integral part of your regular natural health regimen.
Another thing you can do is go to the web site of the American Association for Health Freedom and sign their petition to stop the FDA from turning any more vitamins into drugs.
You should also write and call your Congressmen and Senators immediately, and tell them you don’t want the FDA banning any more vitamins by turning them into “drugs.”
It is high time we all start expressing our outrage at this outlandish behavior by the FDA and other bureaucracies in regards to their disdain for nutritional supplements. We now have the EPA trying to re-classify colloidal silver as a “pesticide” so they can ban its sale in health food stores. And we have the FDA actually re-classifying common vitamins as drugs. And it is all at the behest of the major pharmaceutical companies.