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) 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:
Some years back a North Carolina-based firm called Biostratum began research and testing on a pyridoxamine-based drug, which they called Pyridorin. It is 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 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 other 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 other forms 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.
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 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.
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) 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:
Some years back a North Carolina-based firm called Biostratum began research and testing on a pyridoxamine-based drug, which they called Pyridorin. It is 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 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 other 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 other forms 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.
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 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.
One 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.
The handwriting is on the wall. And frankly, it is up to "we the people" to put a stop to this egregious breach of our health freedoms.
-- S. Spencer Jones
FDA Declares Form of Vitamin B6 a Drug, Effectively Banning Pyridoxamine from Dietary Supplements
http://www.naturalnews.com/025606.html
Thursday, February 12, 2009 by: Mike Adams, the Health Ranger, NaturalNews Editor
(NaturalNews) The FDA has effectively banned a naturally-occurring form of vitamin B6 called pyridoxamine by declaring it to be a drug, reports the American Association for Health Freedom.
Responding to a petition filed by a drug company, the FDA declared pyridoxamine to be "a new drug."
Now, any nutritional supplements containing pyridoxamine will be considered adulterated and illegal by the FDA, which may raid vitamin companies and seize such products. See the history of FDA raids on vitamin companies here: http://www.naturalnews.com/021791.html
Pyridoxamine occurs naturally in fish, chicken and other foods (http://en.wikipedia.org/wiki/Vitamin_B6), putting the FDA in the strange position of banning a substance from dietary supplements even though it is already present in the food supply.
The FDA's war on Mother Nature
It's not the first time the FDA has declared a natural molecule to be a "drug" while attacking nutritional supplements that contain the same molecule. A similar story unfolded with red yeast rice and the lovastatin molecules it contains that lower high cholesterol. The drug companies engaged in biopiracy, ripping off the molecule from red yeast rice to make their now-famous "statin drugs."
Once the statin drugs were patented, Big Pharma and the FDA went after red yeast rice, claiming the supplement was "adulterated with pharmaceuticals." It wasn't really adulterated, of course. It just contained a natural statin-drug-like molecule that the drug companies copied and patented.
It would be like Big Pharma patenting vitamin C, then the FDA claiming that all oranges and lemons were adulterated with drugs because they naturally contain their own vitamin C.
This is the insanity of the FDA as it operates today. You can read more about the FDA on our channel webiste www.FDAreform.org which is updated every few days.
So will this ruling on pyridoxamine affect nutritional supplements? Yes, any supplements containing this form of vitamin B6 can now be declared "adulterated" by the FDA. Manufacturers of such supplements can be arrested and shut down for engaging in "illegal drug trafficking." Such is the nature of the FDA's agenda to criminalize nutritional supplement companies and limit consumers' access to Mother Nature's remedies.
The pyridoxamine "drug," by the way (which is just pyridoxamine), is designed to prevent the progression of diabetic nephrothapy (kidney disease). Most likely, the FDA will eventually approve the "drug" for that condition, even while claiming vitamin B6 supplements containing the very same chemical are useless and inert.
This is another classic oppression tactic of the FDA: Ban the herb, but promote the drug using the same chemicals. The same thing happened with ephedra, a Traditional Chinese Medicine herb known as ma huang. The FDA banned the herb, saying it was "dangerous at any dose," but pharmaceuticals containing the very same molecules (ephedrine) are still being sold over-the-counter as cold medicines, meaning they're available to any child without a prescription.
The bottom line is this: FDA approvals and bans have nothing to do with science and everything to do with protecting drug companies profits. If a drug company can make money selling a vitamin as a drug, the FDA will gladly ban the vitamin and protect the drug. If a drug company can rip off molecules from Mother Nature and patent them, the FDA will ban those same molecules found in nature.
All of this points to the urgent need to reform the FDA. A new petition demanding real FDA reform will be announced here on NaturalNews in the coming days.
Sources for this story include:
AAHF: http://aahf.nonprofitsoapbox.com/in...
NewsFood.com: http://www.newsfood.com/?location=E...
NaturalProductsInsider.com: http://www.naturalproductsinsider.c...Buzz up!5 votes
About the author: Mike Adams is a natural health researcher and author with a mission to teach personal and planetary health to the public He is a prolific writer and has published thousands of articles, interviews, reports and consumer guides, impacting the lives of millions of readers around the world who are experiencing phenomenal health benefits from reading his articles. Adams is an honest, independent journalist and accepts no money or commissions on the third-party products he writes about or the companies he promotes. In 2007, Adams launched EcoLEDs, a manufacturer of mercury-free, energy-efficient LED lighting products that save electricity and help prevent global warming. He's also a successful software entrepreneur, having founded a well known email marketing software company whose technology currently powers the NaturalNews email newsletters. Adams volunteers his time to serve as the executive director of the Consumer Wellness Center, a 501(c)3 non-profit organization, and pursues hobbies such as Pilates, Capoeira, nature macrophotography and organic gardening. Known on the 'net as 'the Health Ranger,' Adams shares his ethics, mission statements and personal health statistics at www.HealthRanger.org
-- S. Spencer Jones
FDA Declares Form of Vitamin B6 a Drug, Effectively Banning Pyridoxamine from Dietary Supplements
http://www.naturalnews.com/025606.html
Thursday, February 12, 2009 by: Mike Adams, the Health Ranger, NaturalNews Editor
(NaturalNews) The FDA has effectively banned a naturally-occurring form of vitamin B6 called pyridoxamine by declaring it to be a drug, reports the American Association for Health Freedom.
Responding to a petition filed by a drug company, the FDA declared pyridoxamine to be "a new drug."
Now, any nutritional supplements containing pyridoxamine will be considered adulterated and illegal by the FDA, which may raid vitamin companies and seize such products. See the history of FDA raids on vitamin companies here: http://www.naturalnews.com/021791.html
Pyridoxamine occurs naturally in fish, chicken and other foods (http://en.wikipedia.org/wiki/Vitamin_B6), putting the FDA in the strange position of banning a substance from dietary supplements even though it is already present in the food supply.
The FDA's war on Mother Nature
It's not the first time the FDA has declared a natural molecule to be a "drug" while attacking nutritional supplements that contain the same molecule. A similar story unfolded with red yeast rice and the lovastatin molecules it contains that lower high cholesterol. The drug companies engaged in biopiracy, ripping off the molecule from red yeast rice to make their now-famous "statin drugs."
Once the statin drugs were patented, Big Pharma and the FDA went after red yeast rice, claiming the supplement was "adulterated with pharmaceuticals." It wasn't really adulterated, of course. It just contained a natural statin-drug-like molecule that the drug companies copied and patented.
It would be like Big Pharma patenting vitamin C, then the FDA claiming that all oranges and lemons were adulterated with drugs because they naturally contain their own vitamin C.
This is the insanity of the FDA as it operates today. You can read more about the FDA on our channel webiste www.FDAreform.org which is updated every few days.
So will this ruling on pyridoxamine affect nutritional supplements? Yes, any supplements containing this form of vitamin B6 can now be declared "adulterated" by the FDA. Manufacturers of such supplements can be arrested and shut down for engaging in "illegal drug trafficking." Such is the nature of the FDA's agenda to criminalize nutritional supplement companies and limit consumers' access to Mother Nature's remedies.
The pyridoxamine "drug," by the way (which is just pyridoxamine), is designed to prevent the progression of diabetic nephrothapy (kidney disease). Most likely, the FDA will eventually approve the "drug" for that condition, even while claiming vitamin B6 supplements containing the very same chemical are useless and inert.
This is another classic oppression tactic of the FDA: Ban the herb, but promote the drug using the same chemicals. The same thing happened with ephedra, a Traditional Chinese Medicine herb known as ma huang. The FDA banned the herb, saying it was "dangerous at any dose," but pharmaceuticals containing the very same molecules (ephedrine) are still being sold over-the-counter as cold medicines, meaning they're available to any child without a prescription.
The bottom line is this: FDA approvals and bans have nothing to do with science and everything to do with protecting drug companies profits. If a drug company can make money selling a vitamin as a drug, the FDA will gladly ban the vitamin and protect the drug. If a drug company can rip off molecules from Mother Nature and patent them, the FDA will ban those same molecules found in nature.
All of this points to the urgent need to reform the FDA. A new petition demanding real FDA reform will be announced here on NaturalNews in the coming days.
Sources for this story include:
AAHF: http://aahf.nonprofitsoapbox.com/in...
NewsFood.com: http://www.newsfood.com/?location=E...
NaturalProductsInsider.com: http://www.naturalproductsinsider.c...Buzz up!5 votes
About the author: Mike Adams is a natural health researcher and author with a mission to teach personal and planetary health to the public He is a prolific writer and has published thousands of articles, interviews, reports and consumer guides, impacting the lives of millions of readers around the world who are experiencing phenomenal health benefits from reading his articles. Adams is an honest, independent journalist and accepts no money or commissions on the third-party products he writes about or the companies he promotes. In 2007, Adams launched EcoLEDs, a manufacturer of mercury-free, energy-efficient LED lighting products that save electricity and help prevent global warming. He's also a successful software entrepreneur, having founded a well known email marketing software company whose technology currently powers the NaturalNews email newsletters. Adams volunteers his time to serve as the executive director of the Consumer Wellness Center, a 501(c)3 non-profit organization, and pursues hobbies such as Pilates, Capoeira, nature macrophotography and organic gardening. Known on the 'net as 'the Health Ranger,' Adams shares his ethics, mission statements and personal health statistics at www.HealthRanger.org
Posts
Ok.
ReplyDeleteI went to the store to buy some B6 like you did, and only found the Pyridoxine form. There was no Pyridoxamine form on the shelves. Is this something I should seek out and buy stores of????
Johnnyjoe
Kansas City, MO
I'm pasting a copy of a e-mail I wrote to my U.S. Congressman and U.S. Senator,
ReplyDeleteDear Mr Rogers, Mr Levin
Why did the FDA declare Vitamin B-6 as a drug? When this gos into effect the only way all people will be able to get this important vitamin will be through a doctors prescription. Adding to the cost of a already ballooning health industry. When this gos into effect, a simple $3-$5 OTC vitamin will cost - $80 for doctors visit + a possible $15 - $100 for the vitamin = so a very good possibility of somewhere between $95 to $180 for a simple natural vitamin...
Amazing what GREED this country has succumbed to by way of large corporations favoring the peoples representives in this country... This is not the America I grew up in, that my forefathers fought for nor the America that I want my children to live in...
I will fight this action by the FDA any way I legally can - it's just wrong..
Thank You for your time...
Tom Kaminski
Thomas J Kaminski
Tax Consultant
810-231-1973 810-623-0875
This is just rehashed "old news" (4 years old to be exact) to scare monger you. The drug company does not even exist anymore as far as I can tell. (Their website is dead)
ReplyDeleteRead here for the "Real Story".
Keep in mind...all of these "natural health" websites are trying to sell you something...even if it is just in the form of website ads.
oops...the "missing link"
ReplyDeletehttp://triangle.bizjournals.com/triangle/stories/2005/10/17/story2.html
JohnnyJoe, there is no need to stock up on this form of B-6, unless perchance you are one of the people who have a specific medical need for it and have been successfully using it.
ReplyDeleteThe pyradoxine form is fine for just about everyone else.
Stevierayjon, what in the world are you talking about?
ReplyDeleteThis is not "old news." The only thing that is "old news" is the news article you linked to.
I reported on the latest developement in a long battle to stop the FDA from allowing drug companies to claim that vitamins they are studying are in reality "drugs."
The Council for Responsible Nutrition and other major health freedom organizations all agree that this latest ruling sets the precedent for just about any drug company to come along and claim some vitamin they want to patent is a "drug."
to stevierayjon:
ReplyDeleteEither you were trying to prove your "scare monger" point or you didn't research very hard to find the "Real Story."
I just googled Pyridorin™ and found on the very first hit:
"Pyridorin™ has demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy in two Phase 2 clinical trials, and it has been awarded Fast Track status by the FDA. Pyridorin™ is one of the leading drug candidates in advanced clinical trials for diabetic kidney disease."
http://www.nephrogenex.com -- a website copyrighted 2008.
"Rehashed Old News?" I don't think so!
The truth is, you simply failed to look under the company's new name: NephroGenex, re: http://www.nephrogenex.com/
Can someone who has done the research point me to the FDA's findings in which this B-6 "Drug" has been categorized an Rx Drug and not an OTC Drug? Aspirin is categorized as a "Drug" by the FDA, but I can buy it just like I would a supplement.
ReplyDeleteYou can check wikipedia.com and see for yourself that this form of b-6, pyradoxamine, is now classified as a pharmaceutical drug.
ReplyDeleteSee http://en.wikipedia.org/wiki/Pyridoxamine
Thanks Jones, for sharing the link.
ReplyDeleteWell, what's next? Will the FDA classify potato as a drug, given the amount of B6 it has naturally?
ReplyDeleteI recently came across your blog and have been reading along. I think I will leave my first comment. I don’t know what to say except that I have enjoyed reading. Nice blog. I will keep visiting this blog very often.
ReplyDeleteWe need a revolution. We must take our power back, we have more power than any goverment in the world.
ReplyDelete