14 replies to this topic

[john Egyptman]

Why arent nootropics (noopept) FDA approved in canada/USA?

[gamesguru]

Perhaps a dispute over safety or efficacy.  Those who make these decisions aren't much more well-informed than us, and they have to sometimes make provisional or tentative judgments (like with synthetic cannabinoids, generally good to clamp down on them), but then for example in 2005 Canada withdraws adderall for stroke risk, only to later concede there was no increased risk with adderall.  So in 10 years maybe tianeptine and phenibut are not OTC, but noopept is.

[john Egyptman]

thanks for that, does anyone else have any input?

[drg]

Fda approves drugs that treat illness unless nootropics are studied to treat a specific illness they will not be approved. Some nootropics are approved for alheimzers. Also the second part of the answer is the huge nutritional supplement market that makes a ton of money and lobbies against any sort of regulation by the fda. Tbh we are better off without the fda involvement otherwise we probably won't have access to half the compounds we have today, that are sold and tested by reputable companies. Also another factor is that noopept and most of the nootropic either noone has a patent for else no American company has a patent for. So without a patent there is little desire to do expensive clinical trials when money won't be made from it

[john Egyptman]

what would be more efficient: noopept or modafinil?

[metabrain]

Nootropics are not without side effects, many nootropics were created with a specific purpose and many of them failed for that specific purpose they are then shelved. Many people foolishly consider nootropics to be as harmless as vitamins when in fact they might be taking a drug designed for Alzheimer's or a blood disorder, take for example Piracetam,  people tout it's neuroprotection capability and the fact that it is well researched, sounds perfect right? Now consider that it is also a blood thinner and you can see why it is controlled in certain countries.

[john Egyptman]

Nootropics are not without side effects, many nootropics were created with a specific purpose and many of them failed for that specific purpose they are then shelved. Many people foolishly consider nootropics to be as harmless as vitamins when in fact they might be taking a drug designed for Alzheimer's or a blood disorder, take for example Piracetam,  people tout it's neuroprotection capability and the fact that it is well researched, sounds perfect right? Now consider that it is also a blood thinner and you can see why it is controlled in certain countries.

thank you for that. whats your perspective on noopept?

[metabrain]

 

Nootropics are not without side effects, many nootropics were created with a specific purpose and many of them failed for that specific purpose they are then shelved. Many people foolishly consider nootropics to be as harmless as vitamins when in fact they might be taking a drug designed for Alzheimer's or a blood disorder, take for example Piracetam,  people tout it's neuroprotection capability and the fact that it is well researched, sounds perfect right? Now consider that it is also a blood thinner and you can see why it is controlled in certain countries.

thank you for that. whats your perspective on noopept?

 

My perspective on all of the pharmacological nootropics is that you have no idea how they are altering your brain, at one point in history people use to smoke to treat anxiety and the opinion at the time was smoking was good for you now we look back at that opinion as crazy, we know what smoking does to your nicotine receptors, we know long term that it makes anxiety worse and causes cancer of the lungs, people will argue oh pharmacological nootropics are perfectly safe and many people based that on either short term studies or how they feel on a drug but I say show me the long term studies.

[john Egyptman]

 

 

Nootropics are not without side effects, many nootropics were created with a specific purpose and many of them failed for that specific purpose they are then shelved. Many people foolishly consider nootropics to be as harmless as vitamins when in fact they might be taking a drug designed for Alzheimer's or a blood disorder, take for example Piracetam,  people tout it's neuroprotection capability and the fact that it is well researched, sounds perfect right? Now consider that it is also a blood thinner and you can see why it is controlled in certain countries.

thank you for that. whats your perspective on noopept?

 

My perspective on all of the pharmacological nootropics is that you have no idea how they are altering your brain, at one point in history people use to smoke to treat anxiety and the opinion at the time was smoking was good for you now we look back at that opinion as crazy, we know what smoking does to your nicotine receptors, we know long term that it makes anxiety worse and causes cancer of the lungs, people will argue oh pharmacological nootropics are perfectly safe and many people based that on either short term studies or how they feel on a drug but I say show me the long term studies.

 

thank you for that. what do you think is most similiar drug to noopept that is FDA approved? (excluding adderall)?

[metabrain]

 

 

 

Nootropics are not without side effects, many nootropics were created with a specific purpose and many of them failed for that specific purpose they are then shelved. Many people foolishly consider nootropics to be as harmless as vitamins when in fact they might be taking a drug designed for Alzheimer's or a blood disorder, take for example Piracetam,  people tout it's neuroprotection capability and the fact that it is well researched, sounds perfect right? Now consider that it is also a blood thinner and you can see why it is controlled in certain countries.

thank you for that. whats your perspective on noopept?

 

My perspective on all of the pharmacological nootropics is that you have no idea how they are altering your brain, at one point in history people use to smoke to treat anxiety and the opinion at the time was smoking was good for you now we look back at that opinion as crazy, we know what smoking does to your nicotine receptors, we know long term that it makes anxiety worse and causes cancer of the lungs, people will argue oh pharmacological nootropics are perfectly safe and many people based that on either short term studies or how they feel on a drug but I say show me the long term studies.

 

thank you for that. what do you think is most similiar drug to noopept that is FDA approved? (excluding adderall)?

 

I don't know if there is one, Piracetam is a very close match but I don't think it is FDA approved, in my country it is a controlled drug. Nootropics are generally considered a grey area, I have used Piracetam before but never Noopept, if you are going to try it read up on the pros and cons but especially focus on the cons.

 

We studied the effect of a new nootropic dipeptide Noopept and reference nootropic preparation piracetam injected subcutaneously on days 8-20 of life on learning of alternative feeding response in a 6-arm-maze in male and female rats. Early postnatal administration of Noopept disturbed the dynamics of learning by parameters of declarative and procedural memory. Piracetam impaired learning by parameters of procedural, but not declarative memory (only in males). Both preparations decreased the ratio of successfully learned males (but not females). The observed effects were not associated with changes in locomotor activity.

→ source (external link)

 

[Brain Forza]

Hey guys, I can answer this pretty simply from the industry side. Noopept, the Racetams etc are not classified as dietary supplements. They are classified as drugs. To my knowledge, neither noopept and and of the racetams exist in nature. This automatically classifies them as a drug in most countries. Supplements in the USA and Canada, must exist in nature. Even though just about every single vitamin and amino acid are actually made "synthetically", they are still classified as dietary supplements because they are nature-identical replications. 

 

That is also why all those companies can sell them only online, it is techincally cheating in the supplement world, and usually the FDA does catch up and ban the product.

 

Nootropics are not in the grey area, just some of those compounds in the nootrpic class are. For instance, generally Rhodiola, Gingo, ALpha GPC, etc are also considered nootropics. But they are not drugs, so they are fine. Some are literally classified as controlled drugs, like Amphetamines etc. The grey area ones are the ones you find online, Racetams, etc.

 

The other issue is, even with our sourcing abilities, the quality of these materials that are available is very questionable (illegal nootropics - Racetims, noopept...). It is not a huge market, and the quality companies devote most of their time to producing the more profitable drugs for larger accounts. I used to take the standard Piracetam stack a while back, but stoped due to quality question. Much of the materials is not even made to food spec and sold anyways. Unfrtunately, it is hard to find good copanies overseas and many of these companies are just doing trade through Alibaba. So I don't feel safe going that route, and stick to supplements. My regime is actually pretty simple.

 

Hope that helps!

 

Greg L.

President and Founder

Brain Forza

brainforza.com

Edited by Brain Forza, 18 November 2016 - 10:27 PM.

[Serina]

Hey guys, I can answer this pretty simply from the industry side. Noopept, the Racetams etc are not classified as dietary supplements. They are classified as drugs. To my knowledge, neither noopept and and of the racetams exist in nature. This automatically classifies them as a drug in most countries. Supplements in the USA and Canada, must exist in nature. Even though just about every single vitamin and amino acid are actually made "synthetically", they are still classified as dietary supplements because they are nature-identical replications. 

 

That is also why all those companies can sell them only online, it is techincally cheating in the supplement world, and usually the FDA does catch up and ban the product.

 

Nootropics are not in the grey area, just some of those compounds in the nootrpic class are. For instance, generally Rhodiola, Gingo, ALpha GPC, etc are also considered nootropics. But they are not drugs, so they are fine. Some are literally classified as controlled drugs, like Amphetamines etc. The grey area ones are the ones you find online, Racetams, etc.

 

The other issue is, even with our sourcing abilities, the quality of these materials that are available is very questionable (illegal nootropics - Racetims, noopept...). It is not a huge market, and the quality companies devote most of their time to producing the more profitable drugs for larger accounts. I used to take the standard Piracetam stack a while back, but stoped due to quality question. Much of the materials is not even made to food spec and sold anyways. Unfrtunately, it is hard to find good copanies overseas and many of these companies are just doing trade through Alibaba. So I don't feel safe going that route, and stick to supplements. My regime is actually pretty simple.

 

Hope that helps!

 

Greg L.

President and Founder

Brain Forza

brainforza.com

 

Your information is quite a reference for me,thank you,man.
 

[gamesguru]

it's almost 2020.  but where is the progress?  where is the Skynet, the world peace, everything we read about in the books?  seems it's a long way off.

and meanwhile squirrels bury acorns in places they will never remember, well-paid scientists debate the classification of Pluto as a planet, and lonely girls struggle evermore with saying no to twinkies

[jack black]

 

it's almost 2020.  but where is the progress?  where is the Skynet, the world peace, everything we read about in the books?  seems it's a long way off.

and meanwhile squirrels bury acorns in places they will never remember, well-paid scientists debate the classification of Pluto as a planet, and lonely girls struggle evermore with saying no to twinkies

 

 

on the bright side, Trump is the prez of idiots and the Idiocracy movie became reality. Cheers!
 

[chipdouglas]

 

 

it's almost 2020.  but where is the progress?  where is the Skynet, the world peace, everything we read about in the books?  seems it's a long way off.

and meanwhile squirrels bury acorns in places they will never remember, well-paid scientists debate the classification of Pluto as a planet, and lonely girls struggle evermore with saying no to twinkies

 

 

on the bright side, Trump is the prez of idiots and the Idiocracy movie became reality. Cheers!
 

 

 

I've been linking people to the Idiocracy intro - I couldn't agree more with you that it's become a reality. Sadly, I'm not at all joking here :