Picamilon removed

Just said a voluntary market withdrawal --- not recall.

Maybe the same "it's not derived from nature"

Although I thought it was basically GABA & niacin???
 
FDA is coming down hard on this whole "its not derived from nature" then its not compliant issue lately. Honestly I would expect to see many more "voluntary" (cough cough) recalls coming soon after friendly letters from the FDA etc.

Think: noopept, phenubut, basically all racetams, and much much more....unfortunately. How quickly this happens is just a guessing game at this point. So no need to panic just yet : )
 
kboxer7 said:
FDA is coming down hard on this whole "its not derived from nature" then its not compliant issue lately. Honestly I would expect to see many more "voluntary" (cough cough) recalls coming soon after friendly letters from the FDA etc.

Think: noopept, phenubut, basically all racetams, and much much more....unfortunately. How quickly this happens is just a guessing game at this point. So no need to panic just yet : )
Click to expand...

BREAKING NEWS!!!

Nootropic sales have suddenly skyrocketed over the last few hours. Analysts aren't sure what's causing the increase in demand.
 
kboxer7 said:
FDA is coming down hard on this whole "its not derived from nature" then its not compliant issue lately. Honestly I would expect to see many more "voluntary" (cough cough) recalls coming soon after friendly letters from the FDA etc.

Think: noopept, phenubut, basically all racetams, and much much more....unfortunately. How quickly this happens is just a guessing game at this point. So no need to panic just yet : )
Click to expand...

They don't actually mention natural vs. unnatural at all in this instance

Also, I'd strongly consider their FDA quoted source. "strategic communications and public engagement staff in the Office of Foods and Veterinary Medicine"

There's a reason that the quoted source isn't anybody from FDA DDSP, FDA OCI, or FDA CFSAN.

-Picamilon, and Phenibut for that matter are technically amino acids.
-Both were marketed in the United states before 1994 (You can find it for sale on multiple usenet boards pre-1994, archived on dozens of usenet archives)

That would be a potentially drawn out legal debacle for the FDA were they to face any industry pushback to go after an ingredient that isn't exactly lighting up the AERS at CFSAN.

--

I think the only worrying part about the outcome of Pieter Cohen's latest article is that yet again, the industry sucks at meeting label claims.

If proprietary blends didn't exist, and doses were clearly and accurately stated on all of the labels of products tested, there would be much less room to attack the industry.
 
from what it looks like, I havnt seen any info from the fda. Just a couple articles mentioning it it sold as a drug in russia and technically not found in nature. Its crap if you ask me.
 
De__eB said:
Theanine is a really underrated ingredient that I've always been frankly shocked isn't in more supplements.
Click to expand...

Completely agree. I've been loving it lately as part of my pre-bed stack. I've been sleeping much better since I started taking 200 mg with my magnesium.
 
kboxer7 said:
FDA is coming down hard on this whole "its not derived from nature" then its not compliant issue lately. Honestly I would expect to see many more "voluntary" (cough cough) recalls coming soon after friendly letters from the FDA etc.

Think: noopept, phenubut, basically all racetams, and much much more....unfortunately. How quickly this happens is just a guessing game at this point. So no need to panic just yet : )
Click to expand...

I see them coming down on others first before something like Picamilon
 
mw1 said:
I see them coming down on others first before something like Picamilon
Click to expand...

Except it seems they just did : (

Invalid Link Removed
 
hamdysayed said:
I mean the stuff is ok not sure what's the hype is about.
tried it n it was only ok.
Click to expand...

It's not about picamilon, it's about principle, and more importantly, legal precedent.

Maybe they picked picamilon because, well, who the hell is going to fight hard for that? No one. It's an easy win to set themselves up for takedowns of our more "valued" supps in the future.

#my2cents
 
kboxer7 said:
It's not about picamilon, it's about principle, and more importantly, legal precedent.

Maybe they picked picamilon because, well, who the hell is going to fight hard for that? No one. It's an easy win to set themselves up for takedowns of our more "valued" supps in the future.

#my2cents
Click to expand...
Never thought of it this way, u make sense man.
 
kboxer7 said:
It's not about picamilon, it's about principle, and more importantly, legal precedent.

Maybe they picked picamilon because, well, who the hell is going to fight hard for that? No one. It's an easy win to set themselves up for takedowns of our more "valued" supps in the future.

#my2cents
Click to expand...

Pretty much.

Based on some introductory paragraphs in the study it looks like picamilon won't be the only thing "attacked."

Dietary supplements in the United States (USA) are regulated as food, sold directly to consumers, and cannot be marketed to treat disease. Given this regulatory paradigm, it is surprising to find that hundreds of brands of dietary supplements are openly labelled as containing prescription drugs never approved by the US Food and Drug Administration (FDA). Vinpocetine and picamilon are two such drugs sold directly to consumers in dietary supplements.
Click to expand...



That is unless some settlement from Jared causes Cohen to take off the rifle scope. That's a lot of money man

I don't think he should be sued (for that much at least) but there is a hefty number of assertions in the study as to why it shouldn't be a dietary ingredient (not FDA approved, not naturally occurring): Invalid Link Removed

While GABA and nicotinic acid are both found in nature, to our knowledge, picamilon has only been produced synthetically and has no known natural source. Picamilon has been synthesized using several methods, often beginning with either nicotinic acid hydra- zide or nicotinic acid. The acid group in nicotinic acid is converted to an active ester and condensed with GABA or 2-pyrrolidinone to yield nicotinoyl-GABA (picamilon).
Click to expand...

FDA approval shouldn't be a requirement for the ability to sell as a supplement anyhow if that's what the abstract meant.

Edit: I misread the PP article. The lawsuit with big money involved is over something else
 
Looks like it's still around. Is anyone still using this? I just finish cycling off Phenibut and want a break for abit. This seems ideal to sub unless there's another strong GABAergic out there.
 
You must log in or register to reply here.
Back
Top