The Facts: The Official Warning Letters went out – Picamilon Banned by FDA

November 30, 2015, the FDA sent five warning letters regarding picamilon.  They were published mid-December, and the companies are named below:

In addition, it was also reported that the FDA was going to label the compound Picamilon as “not a dietary ingredient”.  The difference between a “dietary ingredient” and a “non-dietary ingredient” is simply this: dietary supplements in the U.S. are regulated as food, sold directly to consumers, and cannot be marketed to treat disease.

The FDA call to action was reported as based on a finding in a new study led by Harvard Professor Dr. Pieter A. Cohen, and is now raising questions regarding ulterior political motives, media manipulation, and potential future attacks on safe ingredients.

The study analyzed 30 dietary supplements to determine the amount of picamilon contained in the product.  It is still not clear why the sole ingredient Picamilon was targeted in this study and we may never find out.  Based on the results, the various supplements contained anywhere between 2.7mg and 721 mg, while typical clinical doses range anywhere from 50-100mg.  Furthermore, Cohen, who is neither a lawyer nor a legal authority of any kind, also claimed that Picamilon has not been approved for use as an ingredient in dietary supplements, and thus should be banned.

Picamilon has given me a new lease on life. It took 6-8 weeks for me to feel the effects but now every day is a pleasure and I’m on top of the world.  Picamilon works well for both anxiety and depression.”  —M. McCarthy, Malibu, CA

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The Science: There is no public record of any single adverse event report with Picamilon

Picamilon is derived from two natural compounds: nicotinic acid (niacin) and gamma-aminobutyric acid (GABA). Why is Picamilon banned by the FDA?  The Facts, the Science and the Politics! 1 In effect, Picamilon, or nicotinoyl-GABA, is a nootropic compound with the neurotransmitter GABA bound to Vitamin B3 or Niacin.  So why take Picamilon, when it seems you can take GABA and Niacin separately to achieve identical results.

In reality, Picamilon is necessary because GABA supplements are incapable of traveling to the brain if ingested orally.  Picamilon’s importance is its mechanism of action, that is, it has the ability to cross the blood-brain barrier and then hydrolyzed into GABA and niacin.  The released GABA in turn would activate GABA receptors producing an anxiolytic response, that is, an anti-panic or anti-anxiety response.  The second released component, niacin, is a vasodilator, which refers to the widening of the blood vessels, meaning the resulting effect is to keep the body running normally.

“Picamilon is the best product I’ve ever used.  I have tried Paxil, Zoloft, SAMe, and Rhodiola.  SAMe worked well for awhile but then didn’t seem to work anymore.Rhodiola is good but nothing compares to Picamilon.” — V.D., Long Beach, CA

The Politics: What is behind the politicking over a non-issue ingredient?

nutrition-warThe choice of targeting Picamilon raises suspicion and alarm.  According to Jared Wheat, CEO of Hi-Tech Pharmaceuticals, “FDA has run amok, when it comes to Picamilon, their logic is extremely flawed.”  He continues, “FDA’s logic is that Picamilon is a drug although it is only comprised of niacin and GABA, two completely DSHEA (Dietary Supplement Health & Education Act of 1994) compliant products”.[the_ad id=”1196″]

In conclusion, Picamilon continues to be a safe ingredient which has shown to have positive action on the cerebral circulation, and also exhibits the properties of a tranquilizer with a stimulating component.  Unlike tranquilizer drugs, Picamilon does not induce muscle relaxation, drowsiness or lethargy.

“Picamilon helped my anxiety when none of the drugs the doctor prescribed worked for me.” — T.M.,Las Vegas, NV

REFERENCES:

  1. Matsuyama K, Yamashita C, Noda A, Goto S, Noda H, Ichimaru Y, Gomita Y (Oct 1984). “Evaluation of isonicotinoyl-gamma-aminobutyric acid (GABA) and nicotinoyl-GABA as pro-drugs of GABA”
  2. Kopelevich VM, Gunar VI (April 1999).”Some approaches to the directed search for new drugs based on nicotinic acid”. Pharmaceutical Chemistry Journal 33(4): 177–187.doi:10.1007/BF02509934
  3. Mirzoian RS, Gan’shina TS (1989). “[The new cerebrovascular preparation pikamilon]”.Farmakologiia i toksikologiia (in Russian) 52(1): 23–6.PMID2707413

See the Full Report from the FDA

See Also:

Is Picamilon Right For Your Anxiety?

Best Social Anxiety Medication

Ten Ways To Reduce Anxiety

 

Categories: BrainDepression

1 Comment

Sher · August 26, 2016 at 2:25 pm

The author of this article states “So why take Picamilon, when it seems you can take GABA and Niacin separately to achieve identical results.” In reading of this article I am left with the impression that it is the delivery method that allows the GABA and B3 to cross the blood-brain barrier in Picamilon. Is it possible to purchase GABA alone that crosses the blood-brain barrier? What about B3, can I purchase a type that will cross the blood-brain barrier alone? I have used Picamilon and love it. I never considered myself depressed just overwhelming tried. I always run out of energy. Been like that since I was 14 years old. Picamilon has helped tremendously. Sam-e helps for a few days using a low, low dose. I build up a intolerance to it very quick, I become irritable with major headache. The opposite is SSRI, for 1 to 2 days I feel blissfully relaxed and happy, then overwhelming tried with serious GH distress. For me Picamilon fits in the middle between Sam-e and SSRI. I have no side effects and use a low dose of 1, sometimes 2 caps a day.

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