The Pulse of Natural Health Newsletter

Stay informed about what is hot in Washington and the states about natural health

FDA Attacks Brain Health Supplements

16

We think this is to pave the way for a new blockbuster drug. Action Alert!

In October we told you about a potential new blockbuster drug for Alzheimer’s from drug giant Eli Lilly. Solanezumab is in the third and final phase of FDA drug trials, and if approved, could bring in at least $7.6 billion in sales by 2024 and probably much more. Other drug companies also have “big” Alzheimer’s drugs in the works.

Now the FDA has sent warning letters to five supplement companies targeting the supplement picamilon, which may help with Alzheimer’s, anxiety, and general brain health. It is a combination of natural ingredients niacin (vitamin B3) and GABA, a substance our body makes from the amino acid glutamine. This particular combination crosses the blood–brain barrier more effectively than GABA alone. The FDA, however, claims that picamilon does not meet the statutory definition of a dietary supplement because it is neither a vitamin, nor (in its combined form) a completely organic substance, nor a minor component of foods. The agency says that although picamilon can be synthesized from niacin, it is a different chemical entity, and is therefore “adulterated.”

According to the Dietary Supplement Label Database, forty-eight supplements currently list picamilon as an ingredient on the label. There is no public record of a single adverse event report with picamilon. It has also been widely used by doctors in Europe for decades, although it may be an approved drug there. It will never be an approved drug in the US, because it is natural and therefore cannot be patented. Not being patentable, no company will pay billions for FDA approval.

Fortunately there are other natural ways to get GABA to the brain, but we are reluctant even to mention them, lest the FDA go after them too.

One observer noted that “almost all vitamins and minerals are bound to some salt or compound for stability of the molecule, and usually for better bioavailability”—meaning that the same logic could be used to target any number of supplements on the market.

The FDA’s attack on picamilon appears to be an attempt to give Big Pharma an unobstructed playing field for their Alzheimer’s drug. Picamilon is the perfect ingredient to attack if you want to rewrite DSHEA (the law governing supplements) without actually rewriting it—simply because picamilon has very small sales and is too “small potatoes” for anyone to mount a major protest. But banning it sets a massive legal precedent that could affect countless other supplements. It could have devastating ramifications for the supplement industry.

Action Alert! Write to the FDA and tell them that picamilon is not a synthetic drug at all, and needs to stay on supplement store shelves! Please send your message immediately.

Take-Action

 

Other articles in this week’s Pulse of Natural Health:

FDA, Allied Monopolists, and Allied Media Continue War on Medical Testing Innovation

New Study: GMO Crop Contamination Spreading

Share.
  • I.M. Pistoff

    They’ll die miserable deaths, though not soon enough.

  • Richard Smith

    The bastards want every last penny any way they can get it without any real concern for people’s health. Such is life in the fascist country we live in. Pass the aspartame…

  • Robert Morrow

    Just how much Payola from the Pharmaceuticals is going to grease the palms of scum bag Politicians and Bureaucrats? The FDA approves high price, high profit drugs that kill over 100,000 citizen each year as these scum are in the pocket of the Pharmaceuticals. Yet you will never hear anything about it. I know, as time and time again I have brought this to the attention of my scum bag politicians that stare like zombies and more worried about the payola then they are about the people.

    • DL

      Yep. The drug that killed those people recently in the clinical trial in France was a drug made from cannabis. They took a naturally occurring medicinal herb and tried to adulterate it into something big pharma could make a billion on. They don’t want us to have access to anything natural that works. No money it for them.

  • bob

    Writing the FDA is futile and is the wrong Argument. The FDA does not have the Constitutional authority to ban any substance, period. If you are denied access to Picamilon, you have standing to sue.

  • bob

    I see this site is censoring my
    legitimate posts, can’t let the people be informed about the truth.

    • Pamela Ann Arky

      Are you a shill? You sound like one.

  • Sir David Haddon

    THE FDA IS SO CORRUPT AND OUR AMERICAN GOVERNMENT HAS HIRED X EMPLOYEE’S OF MONSANTO,,,, DOES THAT TELL YOU HOW CORRUPT THEY ARE? NOTHING WILL EVER GET DONE WITH ANYTHING NATURAL WHEN YOU HAVE A CORRUPT GOVERNMENT TAKING CORRUPT MONEY FROM BIG BUSINESS, 2015 MONSANTO SPENT 6.5 BILLION DOLLARS IN SPECIAL INTEREST CASH TO KEEP PEOPLE IN THE DARK ABOUT GMO SEED FOOD AND THE POISON PESTICIDES THEY SPRAY ON OUR CROPS TILL THE DAY THEY ARE HARVESTED… HOW MANY COUNTRIES HAVE A BAN ON GMO, AND THE ROUNDUP CANCER CAUSING PESTICIDE THAT IS WIDELY USED IN AMERICA,,, THEY CAUSE EVERY KNOWN CANCER AND EVERY KNOWN PLAGUE OF THE 21st. CENTURY ONLY TO MAKE MORE MONEY FOR BIG PHARMA TO SELL HUNDRED$ OF BILLION$ OF DOLLAR$ IN DRUG$… OUR POLITICAL SYSTEM IS MORE CORRUPT THAN RUSSIA,,,,,,,,,,

  • Tactical111

    Do your own research, eat healthy and organic as much as possible and DON’T buy poison Pharma concoctions. Starve the Beast. Coconut oil cures Alzheimer’s as shown by Dr. Mary Newport who gave it to her husband. She’s on Youtube if you want to find it.

  • Thank you for linking to our article. We agree with the sentiment that the FDA should have no legal authority to do what they did (especially with a seemingly DSHEA-compliant compound!), but their choice of attacking picamilon was smart: nobody cares about it enough to spend the resources to fight it. They set up a nice slippery slope, but nobody cares about it. Question is, what’s next, and will anybody fight that one either?

  • rickart

    Merck sued mother nature and thereby won its patent on a (one) Statin. Made billions on bogus cholesterol drugs, now many years later we know lipitor etc, cause more harm than good. Sounds un-real but true. Now they want folics, or even just ONE , like you said – it becomes a precedent

    …regardless natural or not – they want it all.

  • wa3zgt

    The FDA will now target and ban other similar supplements, like SAM-e, that are safe and effective — MORE safe & effective than R/X Drugs — for psychiatric and medical conditions.

    UNLESS a supplement is really hurting people, they should not ban it.

    The FDA should NOT ban supplements just so Big Pharma can get even bigger !

    IF this is an open, democratic and “free market”, why not let ALL types of medicine compete ?

  • justified

    yep!

  • Excuses, excuses, excuses. They will blame us for breathing if they thought a new breathing machine would help us breath better…and then charge us sky high for using it. While there are many pills and other things out there that can really help, how about the many that can’t [ just look at the TV ads ] ? Money, money, money is in their eyes more than caring about people. Greed and power can become and for many have become their God. Foods, herbs, spices, etc, came from God to help us stay healthy, not boiled down natural things that are turned into pills and other medications. God has allowed there to be doctors and medicines because we as a nation have ruined the natural and organic ways of farming, producing the products that God has given us…and why, because of greed. Organic is the way to go, but men of greed don’t want that, no they want to use us as Guinea pigs by putting out things like GMO and other chemicals that we ingest every day. Make us sick and we will have to go to a doctor and most likely have to pay big bucks to get well. I am grateful that there are still some doctors that I know are still around helping those that truly need it and are not just out to get rich or famous, but just plain care for others…more than for themselves. These are the people that God smiles upon and loves so much and I know will have a place in his kingdom. The others that don’t change I’m afraid will end up in a bad situation that is mentioned in Revelations and Daniel…and they will beg for help and there will be none. And since I know we’re in the end times, this thing that’s coming is only around the corner.

  • Ben William

    The FDA is yet another one of those lessons of big centralized government. When the FDA was unwrapped from it’s pretty box the sales pitch was… “It’s here to protect you” Years later, there is no pretension that the FDA was created to ‘protect’ large corporations from us and their competitors.

  • wermfood

    The further down the rabbit hole you go, you find that that all of this has a very simple and satisfying explanation. There is a cartel of petro-chemical industrialists who together control big pharma and big Agra pretty much on a global scale,- this done through the evolution of codex ailimentarius. This cartel is engineering a depopulation of the planet. No big deal unless you yourself don’t want to die of nutritional deficiencies or poisoning. A toxic and nutritionally deficient food supply is critical to their goal. We can help them achieve their goal by encouraging government officials to go along to get along.