Government to Ban Vitamin D

[Racoon]

The FDA is out of control, and out of its mind..

 

You should already know this by now.. But heres the next step;

FDA Declares Form of Vitamin B6 a Drug, Effectively Banning Pyridoxamine from Dietary Supplements by Mike Adams the Health Ranger

 

FDA Declares Form of Vitamin B6 a Drug, Effectively Banning Pyridoxamine from Dietary Supplements

 

Natural News

February 14, 2009

 

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: Tyranny in the USA: The true history of FDA raids on healers, vitamin shops and supplement companies by Mike Adams the Health Ranger

 

Pyridoxamine occurs naturally in fish, chicken and other foods (Vitamin B6 - Wikipedia, the free encyclopedia), 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.

[Moontanman]

I guess they can do what they like, they banned THC and it's a naturally occurring molecule.

[Buffy]

Hey Rac, did you mis-title this thread? Or is Vitamin D also now a controlled substance?

 

Does this mean I can't go outside anymore without a prescription?

 

O conspiracy, shamest thou to show thy dangerous brow by night, when evils are most free? :)

Buffy

[Racoon]

Hey Rac, did you mis-title this thread? Or is Vitamin D also now a controlled substance?

 

Does this mean I can't go outside anymore without a prescription?

 

O conspiracy, shamest thou to show thy dangerous brow by night, wWhen evils are most free? :)

Buffy

 

:Bump2:

 

It gets blurry when you look between the lines.

[CraigD]

A preliminary point: The form of vitamin B6 found in most vitamin pills, pyridoxine, isn’t banned by the FDA or any US government agency. The ban described in Adams’s and other recent articles applies only to a less common form of the vitamin, pyridoxamine. Metabolically, there appears to be no significant difference in these two forms, as both do nothing until converted by the body to Pyridoxal phosphate. So people shouldn’t worry that their access to B6-containing supplements, such as typical “B-complex” vitamin pills, will be affected.

 

In his article, Mike Adams makes some interesting, accurate, and not widely known points. The main one, IMHO, is that the regulatory/legal concept of “adulterated with a drug” doesn’t mean what a reasonable person might assume. When I read this, my first impression is that it means “a drug added to”. However, the term as used by the FDA and other regulators, food supplement and drug industry professionals means “something subject to a particular regulation contains”. Hence, as Adams notes, a food supplement naturally containing a substance also contained in a product regulated as a drug can legally be deemed “adulterated”, even though the supplement is produced using natural food sources, not be adding the drug product.

 

This is because, since 10/15/1994, when the US congress passed a law known as DSHEA, food supplements have been subject to different regulations than foods or drugs. DSHEA is unique to the US – most other countries continue to regulate food supplements using the same rules as food. The law has a “grandfather clause” allowing supplements on the market in the US before 10/15/94 to continue to be sold.

 

DSHEA applies only to products labeled as dietary supplements – pills, tinctures, etc – not to the food ingredients from which they’re made, so Adams’s “it would be like” example of oranges and lemons being subject to such regulation is exaggerated. His example of red yeast rice, which is regulated in the US as a food supplement, is a bit more complicated, since red yeast rice isn’t a naturally occurring form of rice (or yeast), but a traditional food and medicine in which ordinary rice is artificially cultured with a specific mold. Red yeast rice is an interesting case of DSHEA arguably doing more harm than good, as some manufacturers have circumventing its ban by using different molds with less well-know properties, including apparently some in the penicillin family that can produce dangerous toxins.

 

What’s really going on with pyridoxamine is complicated, and best described, I think, as industrial warfare. The short version of the story, interpreted liberally by me (and with some guesswork to fill in gaps) is:

• In 1999, the drug company Biostratum filed patents and regulatory paperwork for a new pyridoxamine-based drug, Pyridorin, to treat diabetic kidney disease. To attract investors, they began touting the drug’s potential, with optimistic financial predictions that it could make the company (and, of course, its investors) $4 billion a year.
  
• Over the next few years, Biostratum spends about $100 million on clinical trials, FDA paperwork, and promoting Pyridorin and related drugs. It’s their big project – the company has only one other collection of tests and drugs in development, an unrelated cancer theraph (see BioStratum Strikes Deal To Develop Cancer Diagnostic Test :: WRAL.com), and nothing yet to market.
  
• Lots of companies hear about Biostratum’s project, study it, and discover that Pyridorin is basically just pyridoxamine. Though they can’t legally claim it’ll treat kidney problems, they can sell pyridoxamine as a dietary supplement, and let word of mouth do the rest. As a drug, Pyridorin is expected to sell for $1200/patient/year. Vitamin pills are way cheaper, and educated consumers can be expected to find this out and act on it.
  
• Biostratum’s investors learn the above. The promised $4 billion a year looks less and less realistic. Investors start backing out, and Biostratum finds itself short of cash just as, around 2005, they need it to complete clinical trials and regulatory paperwork. The investors – who, in a publically-owned company like Biostratum, basically control the company – fire 16 of 25 Biostratum employees, including its CEO, and start trying to figure out how to get at least some of their money back, and at best still make a profit.
  
• Biostratum petitioned the FDA to “remove” – that is, ban – food supplements containing pyridoxamine, arguing that there were none on the market prior to 10/15/94.
  
• CRN, a trade organization of dietary supplement companies, responds to the petition, basically contending “yes, pyridoxamine was on the market prior to 10/15/94, and we’ve got documents to prove it.”
  
• Biostratum responds “no, it wasn’t”
  

The rest seems to me a tale only a corporate lawyer can appreciate, with the FDA in the role of referee and judge. Their official list of filings from all parties is at Dockets: 2005P-0305: Remove Dietary Supplements that Contain the Drug Pyridoxamine. A 10/14/2005 business journal article on it is at Big problem for BioStratum - Triangle Business Journal:.

 

In my not-a-lawyer opinion, what’s going on here is a fight over money. On one side are a lot of presumably rich investors with a little, nearly bankrupt company (Biostratum) owning the intellectual property rights to claim that vitamin B6 can be used to treat diabetic kidney problems. On the other side are even more presumably rich investors and owners with lots of large and small dietary supplements companies organized as the CRN – in short, an amoral David and Goliath battle, with “big pharma” (in this case, not so big) in the role of David, and the “holistic/alternative/grass roots” dietary supplements industry in the role of Goliath, and the FDA in the role of onlookers. Writers like Adams are, IMHO, wittingly or unwittingly, in the role of Goliath supporters.

 

For those of us that are in neither group, the sound health advice in my not-a-clinician opinion is to eat a well-balanced diet including lots of raw foods, which will give you all the vitamin B6 you need.

 

If you’re a diabetic, consider taking a B-vitamin supplement, but don’t overdo, as B6 overdose affects include neuropathy, which is one of the worst chronic symptoms of diabetes. In short, if you start taking something, and your feet start hurting and/or your sense of balance goes to hell, stop taking it or cut back ‘til these nasty symptoms go away.

[SaxonViolence]

Just goes to show why there should be a strict separation between Business and The State.

 

Saxon Violence

[hardy5]

Vitamin D!

[jannamiltons]

The FDA wants to control the market so they can manipulate all medicines and supplement around the world. And the thing is, we cannot do anything about it.

[CraigD]

Just goes to show why there should be a strict separation between Business and The State.

In the sense that the US, and most other large nation’s governments, provide some sort of guarantee to individuals and corporations that they will provide a “redress of grievance” service, most commonly known as “courts”, I don’t think many businesses owner executives would agree with you, SV, that they should be strictly separated from the State. The alternative to governments providing a means of businesses, such as Biostratum and members of CRN, use government agencies, such as the USFDA, to settle their difference, such as whether pills containing pyridoxamine should be allowed to be sold as dietary supplements, or only as prescription medicines, would be either for Biostratum to offer no defense against companies that provided a much cheaper version of a substance useful in a medical therapy they developed, or for the competing companies to wage private war.

 

I think it’s better for governments to settle disputes between corporations and business people that they’ve failed to settle among themselves, than for people and corporations to resort to war.

 

On the other hand, I think Biostratum’s use of the FDA to block competitors making of products that existed before their drug, Pyridorin, that are as effective and much less expensive in a life-saving therapy, is wrong.

 

It’s possible to believe both that we’re better off with courts and government agencies to settle disputes, but also that courts and agencies could be better and fairer, and that the legal and regulatory principles and precedents on which they base their decisions should be replaced and/or better defined.

 

The FDA wants to control the market so they can manipulate all medicines and supplement around the world. And the thing is, we cannot do anything about it.

This sounds like a conspiracy theory, Janna, and as you’ve offered no supporting evidence, is unsupported. Do you have evidence supporting your accusation :QuestionM :Exclamati

[Lancewen]

It always comes back to following the money. I found the following article very illuminating on this issue.

 

http://www.npr.org/templates/story/story.php?storyId=14635216

 

Currently big Pharma pays the most in supporting the FDA, and until that changes their decisions will be suspect in my mind.