Why the FDA Won’t Let You Take This Powerful Vitamin for Alzheimer’s

Dr. Frank Shallenberger, MD

April 20, 2020



What if I told you there’s a vitamin that can help you avoid many of the complications of diabetes?

What if I also told you this same vitamin helps prevent and treat Alzheimer’s, heart disease, cataracts, and many other health problems?

Would you be interested? Of course you would.

Well, such a vitamin exists. It’s naturally occurring. It can work miracles. And the FDA won’t let you take it.

You read that right. At my age, I have no time for anger anymore. I just want to focus on doing what helps people. I especially don’t like to write about topics that will make you upset. But this one I just couldn’t let go. This one has me boiling.

With the help of the FDA, Big Pharma is now successfully taking your vitamins away. Are they doing it through legislation? No. They have tried that and it did not work because you protested. So now they have found a better way. One you can’t stop. They have now talked the FDA into making it impossible for you to buy certain natural vitamin forms unless you buy them from Big Pharma. And here’s the real clincher. Big Pharma may never make these vitamin forms available.

Here’s What Happened

Pyridoxamine is a form of vitamin B6. It is found in fish, chicken, and other foods. When you eat foods with B6, some of that B6 gets converted into pyridoxamine by intestinal enzymes. Pyridoxamine controls a reaction in the body called the Maillard reaction. And because of this it is able to decrease the formation of AGEs (“advanced glycation endproducts”). AGEs are molecules that occur within the body when a protein molecule combines with a sugar molecule.

Of course the higher your blood sugar is, the more AGEs you will make. That’s why AGEs are a particular problem with diabetes. In fact, they are associated with many of the complications from diabetes. These include neuropathy, kidney disease, and blindness. AGEs also play a role in other diseases including Alzheimer’s, heart disease, cataracts, muscle wasting, and stroke. That’s why pyridoxamine is such an important form of B6. It helps you avoid all of these health challenges.

So if you’re Big Pharma, why not work with your buddies in the FDA to call it a drug so that people can’t buy it over-the-counter like they used to be able to? Instead, now they will have to buy it from Big Pharma. Sounds ridiculous, but that is exactly what happened.

In 2009, the FDA ruled that the Big Pharma company BioStratum essentially owned pyridoxamine. It doesn’t belong to you and me anymore. If we want to buy some pyridoxamine, we will have to buy it from BioStratum. If that doesn’t get you boiling, I know what will. Because it gets even worse.

BioStratum’s goal in taking pyridoxamine off the market was to get FDA approval for the use of it as a drug. But it has been unable to do that. So you can’t even get it from BioStratum. So get this. You can’t buy this vitamin at the health store any more, and you can’t buy it from BioStratum. Since 2009, it has been off the market for no real reason at all. It may never become available again! What a great way for Big Pharma to take vitamins off the market without any legislative approval. Thanks for looking out for us, FDA. But of course this is just a onetime situation.

It Could Never Happen Again, Right? Wrong!

Not only has it happened again, but it involves another form of vitamin B6. This time it was the form called P5P (pyridoxal-5 phosphate). Before vitamin B6 can work any of its magic, your body has to convert it to P5P. The problem is that for genetic reasons, many people cannot make that conversion efficiently. So for them, it would be great to just take a supplement containing P5P instead of B6 itself. And that’s where Medicure Pharma, Inc. comes in.

Medicure wants sole use of P5P to market it as a drug. And so it has petitioned the FDA to ban health stores from selling it as a supplement. But just like with BioStratum, Medicure has no approval to sell P5P. However, that isn’t stopping them from asking the FDA to ban the sale of P5P until they do get approval. And if it takes 10 years to get the approval, or if like BioStratum they are unable to get the approval, that will just have to be too bad for anyone out there who really needs P5P. So what’s the logic behind this insanity? You won’t believe it.

According to Medicure, “Pharmaceutical companies developing new drugs must be protected from companies that may seek to market the ingredients in those drugs as dietary supplements. The marketing of such products has the potential to undermine the incentive for the development of new drugs because many people may choose to purchase the supplements rather than the drugs.”

But this is outrageous. P5P has been in humans and in the foods they eat since the beginning of life. It has also been available as a supplement for years. To say that P5P is competing with the drug industry is like saying that the sun is competing with the light bulb industry. But does Big Pharma really think in such ridiculous terms? I don’t think so. I do not believe they are that stupid. Instead, what I think Medicure is really saying is, “This is going to be really profitable. We’ll get the FDA to allow us to turn a vitamin into a drug. That way we can make it available only by prescription and mark up the price.” It’s happened before, with fish oil.

A few years ago, the FDA gave the go ahead to the pharmaceutical company Glaxo SmithKline to sell fish oil by prescription. The product is called Lovaza. Depending on what pharmacy you buy it from, Lovaza goes for about $2.30 to $2.50 per capsule. But if you were to buy the same thing from a health store, you would pay closer to 30-35 cents. As soon as the FDA approved fish oil for sale as a prescription, the price went up almost 10 times. This is exactly what you will see with any other nutritional substance that the FDA rules must be sold as a drug by prescription. So is there any good news at all to this story? Maybe.

The FDA has not yet responded to Medicure’s petition. And in the space of a few minutes you can send a message to the FDA to stop working for Big Pharma by calling vitamins drugs and banning them from sale in health stores. Tell them to start looking out for you instead. You can do that by going to this website: https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=334 and filling out the letter form. Your letter will automatically go directly to the FDA. Please do so today. The future of our supplements depends on us stopping every one of these actions.

Fortunately, you can still buy P5P supplements online. And the FDA has dragged its feet on this for years.

Hopefully, Medicure’s petition will just go away.


Alliance For Natural Health. http://www.anh-usa.org/vitamin-b6-p5p/.

Renter, Elizabeth. “FDA Looking to Ban B6 Supplements, Give Boost to Big Pharma,” Spartan of Truth, September 26, 2012 @ 10:09 http://www.activistpost.com/2012/09/fda-l

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