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FDA Declares Form of Vitamin B6 a Drug
Internal Administrator
Posted: Saturday, January 7, 2012 3:21 AM
Joined: 1/14/2015
Posts: 40463


Originally posted by: LouiseR

Wanted to alert those who use supplements to this latest event.

http://www.naturalnews.com/025606.html
Anonymous
Posted: Saturday, January 7, 2012 3:21 AM
Originally posted by: JAB

A very interesting legal situation.

First, please don't panic about availability of your favorite supplements. This is a relatively unusual situation, and I doubt very much that you'll see very many others like it. (See below.)

Second, if you're fond of vitamin B6, you can certainly still buy it.

Vitamin B6 was discovered in the 1930s during nutrition studies on rats. The vitamin was named pyridoxine to indicate its structural homology to pyridine. Later it was shown that vitamin B6 could exist in two other, slightly different, chemical forms, termed pyridoxal and pyridoxamine.

All three forms are converted in the body to pyridoxal 5-phosphate, which is the molecule that actually has the vitamin activity.

Until quite recently, the only form that was sold as a vitamin supplement was pyridoxine. Among other reasons, pyridoxine was the only one sold because it is far more stable than pyridoxamine.

And even today, most Vitamin B6 supplements contain pyridoxine, not pyridoxamine.

Pyridoxine is still readily available, and the FDA has no intention of trying to halt its sale. You will still be able to buy Vitamin B6.

Now, why would the nutrient supplement industry start selling something that is very unstable, when they've been happily selling the much more stable form for many years?

The answer is that when two molecules share a similar activity (such as a vitamin activity), that does not mean all of their biological activities are identical. Each one may have other, unknown, effects on the body.

A company, BioStratum, discovered that pyridoxamine dihydrochloride has potential use as a drug to slow or prevent the progression of diabetic nephropathy in patients with type 1 and type 2 diabetes. They filed an investigational new drug application (IND) with the FDA, and conducted clinical trials. The results of these studies were made public.

All of a sudden, nutrient supplement companies who never dreamed of selling pyridoxamine started offering it, and making claims for their product based on the discovery that BioStratum made, and the research that BioStratum conducted, and paid for, and published in accordance with accepted scientific practice.

BioStratum appealed to the FDA. In 2005, the FDA published a notification that they would be evaluating the company's claims. They gave the nutrient supplement companies four years to argue their case.

A compound is not considered to be a natural supplement simply because it can be found in some foods. It is only considered to be a natural supplement if (a) the health benefits of that compound are known and (b) methods for isolating and concentrating it have been developed and the compound has been sold as a natural supplement.

The natural supplement industry has not been able to show that anybody cared at all about pyridoxamine until BioStratum discovered its unique beneficial properties and published their findings.

After four years of debate, the FDA found that BioStratum had a good case. The nutrient supplement industry will have to go back to selling pyridoxine and only pyridoxine as Vitamin B6 -- just as they did for many, many years before BioStratum came along.

This is, actually, a benefit to all of us. Companies are not going to be willing to invest in research, especially in clinical trials (which are very expensive), if anyone else can just come along, decide they want to profit, and in essence steal that investment.

The FDA is making sure that the beneficial uses of natural compounds will be discovered, and new medicines developed based on those discoveries.
Anonymous
Posted: Saturday, January 7, 2012 3:21 AM
Originally posted by: JAB

The whole point of patents is to offer an incentive to invest time and effort and money into developing something new. If anyone could simply walk off with anything that is developed, no one would ever put money into the development in the first place.

Without BioStratum, there wouldn't be any discussion like this, and all of us who use natural supplements would be happily buying pyridoxine.

I rather imagine many of us have been, and didn't know the difference.

For that matter, I wonder how many of us actually do know the difference, and whether / when pyridoxamine would be preferable over pyridoxine.

And, of course, there's nothing to stop any of us from buying foods that contain pyridoxamine.

Every civilized country in the world recognizes the value that the patent process has to encourage the development of new technologies. For the most part, all countries work together to ensure the process is maintained, and intellectual property protected, for the good of all of us.

Also, we need to remember that patents have a limited lifetime. When the patent runs out, then anyone can exercise the patent.

The reason patents are set up this way is simple: any entity that developed new technology could protect it as a trade secret, instead of patenting. In fact, many companies opt for going the trade secret route, because a trade secret can be protected indefinitely.

So to encourage inventors to reveal their secrets -- publish them openly -- they are given a set period of time when their inventions are protected. But in return for that protection, the patent has a limited lifetime, and at the end of that time, anyone can use / sell the invention.
Anonymous
Posted: Saturday, January 7, 2012 3:21 AM
Originally posted by: hereannow

I agree with you on this issue. People can get it from their food.

Still have reservations about the effectiveness of synthetics in the body(side effects). Seems that they cause more trouble than they are worth. Wall Street seems to support my views.

I think Alternative Medicine is in an explosive growth phase and see many huge opportunities for investment. Even the Govment has a rapidly growing Dept. in this area. Drug Co.'s had their shot, they are letting people down. How long have they been looking for a cancer cure?

Right now they're looking in the wrong places, while science is leaping forward with new knowledge.
Anonymous
Posted: Saturday, January 7, 2012 3:21 AM
Originally posted by: hereannow

It would be really scary if they try to make some foods illegal??? They already are!!!
Anonymous
Posted: Saturday, January 7, 2012 3:21 AM
Originally posted by: john1943

[quote]http://www.naturalnews.com/025606.html[/quote]
Thanks for the tip. After reading that, I decided to order more nicotinamide, just in case it would be the next one on the FDA list.
Anonymous
Posted: Saturday, January 7, 2012 3:21 AM
Originally posted by: swarfmaker

Yes, expect it to get much worse. Most governments have adopted programs that will not work if people can opt out. Supplements provide a self-reliant option to government dependence, so I believe they will be targetted-- in the names of "purity" and "safety"-- especially if they are effective.

Another problem for governments is the consumption of resources by people no longer able to contribute more than they consume. Extending their lives by use of unregulated supplements will be most inconvenient.
Anonymous
Posted: Saturday, January 7, 2012 3:21 AM
Originally posted by: LouiseR

Yes, it is.

If the US stays on this path, and other nations don't go the same route, then I expect a "black market" in vitamins will eventually develop.

How strange will that be? Jailed for "illegal" vitamins...
Anonymous
Posted: Saturday, January 7, 2012 3:21 AM
Originally posted by: DebZ

WOW - this is scary....
Anonymous
Posted: Saturday, January 7, 2012 3:21 AM
Originally posted by: hereannow

You got it right it's a "patent grab". There goes another "naturally occuring" compound (fish & chicken) into the Drug Industry's coffins. I don't about you but I try to stay off of Drugs (synthetics), I got addicted to those when I young. Most drugs just treat symptoms, with huge amounts of potential side effects. All you have to do is look at Wall Street, to see nobody's buying those Drug stock's too many liabilities and lawsuits. Thank you for your response which shows your perspective.
 
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