FDA issues warning letters regarding DMHA and phenibut

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The US Food and Drug Administration has issued a whole bunch of warning letters this month regarding misbranded and adultered dietary supplements. Letters have been sent out by the administration to over ten different companies including the likes of Hi-Tech Pharmaceuticals and eFlow Nutrition.

The reason behind most of the brands receiving the warnings is that they have a product or products containing 2-aminoisoheptane better known as DMHA. While the majority of the letters are related to DMHA, there are a few for supplements using beta-phenyl-gamma-aminobutyric acid also known as phenibut.

The other brands that have been sent warning letters outside of Hi-Tech and eFlow are NeuroScience, Evol Nutrition, Atomixx, Forbidden Labz, Total Body Nutrition, Down To Earth Solutions, Line One, Iron Brother Supplements, and Metabolic Nutrition regarding Synedrex and E.S.P. Extreme.

 
Aleksandar37

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DMHA barely has any scientific evidence backing it up as safe and phenibut has been shown to cause dependence and benzo-like withdrawal symptoms. Labeling either of those as dietary was asking for trouble and here it is. But somehow the FDA is evil for basing their decision on science and not on what random people on the internet said was alright to use.
 
WesleyInman

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Really gonna protect the FDA @Aleksandar37 ?? The same Agency that approves meds that kill tens of thousands annually but we can’t be adult enough to understand the risks of dmha and phenibut.

Those of you who need the govt to think for you so be it. The rest of us don’t need or want them interfering in our daily lives.

Most of the time they are busy either getting lobbied or chasing down ghosts. Also falsifying studies, documents, etc. Anything you ingest has risks. Too much water can kill you. Maybe the FDA should ban water too?
 
Aleksandar37

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Really gonna protect the FDA @Aleksandar37 ?? The same Agency that approves meds that kill tens of thousands annually but we can’t be adult enough to understand the risks of dmha and phenibut.

Those of you who need the govt to think for you so be it. The rest of us don’t need or want them interfering in our daily lives.

Most of the time they are busy either getting lobbied or chasing down ghosts. Also falsifying studies, documents, etc. Anything you ingest has risks. Too much water can kill you. Maybe the FDA should ban water too?
It's my old friend straw man. I'm speaking to this specific instance. And if being an "adult" means not basing medical decisions on science, then adult away. You can't understand the risks if the studies haven't even been done.

Your logic isn't actually logic. It's not about banning things, it's about making sure they're safe and there is a government agency concerned with making water safe.
 

stimtron

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DMHA barely has any scientific evidence backing it up as safe and phenibut has been shown to cause dependence and benzo-like withdrawal symptoms. Labeling either of those as dietary was asking for trouble and here it is. But somehow the FDA is evil for basing their decision on science and not on what random people on the internet said was alright to use.
True with DMHA but I disagree with you on phenibut which is no different than acetyllcarnitine is to carnitine it's just a better form of GABA and while some people massively overdose on it causing such problems it's been studied at lower doses safely in teenagers for months with no serious side effects. Please don't take people who abuse a product in the same light as the research showing it can be safely and effectively used.
 
Wobmarvel

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I had issues with phenibut, anesthetized has about 2 grams per serve and if I used it a few times in a row I would then suffer crazy insomnia without it but I still stand by it as my number one sleep supplement. I use bsl growth now which is melatonin based among other things meaning I'll only use anesthetized maybe twice a week and then often only at half a serve.

The FDA are not protecting us. Phenibut can not be bought OTC in the UK but can be prescribed. As usual it's all about money.

The answer should be to put warnings on the labels stating that it can become addictive etc. Then it should be up to us to decide if we use it.

I mean it's funny that they haven't taken cigarettes away from us. Nicotine is an addictive drug but no, the government make way too much tax money from them so let's just stamp the packets with warnings and let the public decide if they want to take the risk.
 
Aleksandar37

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True with DMHA but I disagree with you on phenibut which is no different than acetyllcarnitine is to carnitine it's just a better form of GABA and while some people massively overdose on it causing such problems it's been studied at lower doses safely in teenagers for months with no serious side effects. Please don't take people who abuse a product in the same light as the research showing it can be safely and effectively used.
Got a link to the study you're referencing?
 
cheftepesh1

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Should I put a label on cereal, frozen TV Dinners, 2L's of soda, and ice cream that it can become addictive?
Maybe this is why america is obese.....

Hmm....
I have to agree with this. There is basic intelligence when it comes to certain things. People can become addicted to anything if it is their personality. On certain things people have to make a choice and know what they are ingesting.
 
Aleksandar37

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Even ignoring the fact that these are not normal kids, these are all efficacy studies. Safety isn't determined after 2 months and there are case reports of phenibut dependence which leads to people continually increasing doses, especially when threads like this pop up and people claim it's completely safe because the FDA is "evil."

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5952553/

https://www.ncbi.nlm.nih.gov/pubmed/28614159

Some people don't even require increased doses:

http://europepmc.org/abstract/MED/20841974

Just to be clear, I'm not saying phenibut is overall dangerous or safe. I'm saying the studies have not yet been done.
 
HIT4ME

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Really gonna protect the FDA @Aleksandar37 ?? The same Agency that approves meds that kill tens of thousands annually but we can’t be adult enough to understand the risks of dmha and phenibut.

Those of you who need the govt to think for you so be it. The rest of us don’t need or want them interfering in our daily lives.

Most of the time they are busy either getting lobbied or chasing down ghosts. Also falsifying studies, documents, etc. Anything you ingest has risks. Too much water can kill you. Maybe the FDA should ban water too?
Too much water can kill you, sure. But you would be REALLY hard pressed to imgest enough water to kill you. I do get a kick when people say that particular thing. Unless you have an underlying medical condition, you will never fuark up and drink too much water by accident. Most people will feel nauseous and stop drinking well before they have any serious issue. Then, they will start throwing up if they continue trying to drink water. Then, if they can overcome that they will pass out and no longer be able to ingest more. So...good luck.

But on your side I get where you are coming from. The FDA isn't perfect. And a lot of us don't want to have someone protecting us, especially someone who doesn't do a great job protecting us but impacts our rights. My perspective has always been that if alcohol and cigarettes are legal, then how can we justify making any drug illegal? What drug has had more impact on society and cost us more than alcohol?

But I am also pretty cold. If you want to OD on a drug and you show up in the ER, sorry, you are on your own...unless you have enough to pay for private care on your own.
 
HIT4ME

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True with DMHA but I disagree with you on phenibut which is no different than acetyllcarnitine is to carnitine it's just a better form of GABA and while some people massively overdose on it causing such problems it's been studied at lower doses safely in teenagers for months with no serious side effects. Please don't take people who abuse a product in the same light as the research showing it can be safely and effectively used.
Comparing ALCAR to Phenibut is way oversimplifying things. Phenibut is its own unique chemical, just like ALCAR is its own unique chemical. They share some characteristics of their parent compounds and some benefits. Phenibut is well known to have addiction potential and escalation issues. It isn't like Carnitine has effects but doesn't cross the BBB and ALCAR crosses the BBB but also has a bunch of negative sides that create issues as well.
 
justhere4comm

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That's adorable. Now tell us why again the Earth is flat.
Please don't equate me with 'flat earthers' or 'anti-vaccine' nutwads. I could also surmise the Universe is flat and the earth is a 3 dimensional projection, or a number of other scenarios that are far more thoughtful. How about a simulation? That's another thread so, let's talk FDA. We can have fun with reality another time.

Risky Drugs: Why The FDA Cannot Be Trusted


Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns


FDA staff calls for end to corruption, wrongdoing

The FDA approves of drugs to help one quit smoking yet they approve of cigarettes being legal? When the cure for cigarettes may well be worse than cigarettes? (i.e., Chantix)

Whitewashing a black box warning: The Chantix story that didn’t get told

Cancer treatment

The horrible slow death my parents endured because of the cancer treatments approved by the FDA Yet, they were not able to utilize the benefits of Canabis to help with the side effects. Thank you FDA. Instead of more opiates causing all sorts of unpleasantries in their lives, the simple act of eating and then having more side effects. Not wanting to eat because you are constipated due to the opioids is a nightmare. You don't want to take the pain medication and you wither away because you won't eat. Just thinking about my mother crying at having to go to the washroom every other 2 hours and try... it was a living hell. It was the opioids. Not the cancer.

I watched my father reduced to a skeleton of a man because of cancer and the inability to take his own care in his hands as an adult. I would be risking prison to help him with a plant. I had to carry him to the car and transport him to the VA for his final days. I have photos so I won't forget that image.

It's late.
I'm tired.
I'm sorry I wrote anything.
 
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LiveToLift

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DMHA barely has any scientific evidence backing it up as safe and phenibut has been shown to cause dependence and benzo-like withdrawal symptoms. Labeling either of those as dietary was asking for trouble and here it is. But somehow the FDA is evil for basing their decision on science and not on what random people on the internet said was alright to use.
Not what folks will like to hear but good points and interesting input for sure.
 
Aleksandar37

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Please don't equate me with 'flat earthers' or 'anti-vaccine' nutwads. I could also surmise the Universe is flat and the earth is a 3 dimensional projection, or a number of other scenarios that are far more thoughtful. How about a simulation? That's another thread so, let's talk FDA. We can have fun with reality another time.

Risky Drugs: Why The FDA Cannot Be Trusted


Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns


FDA staff calls for end to corruption, wrongdoing

The FDA approves of drugs to help one quit smoking yet they approve of cigarettes being legal? When the cure for cigarettes may well be worse than cigarettes? (i.e., Chantix)

Whitewashing a black box warning: The Chantix story that didn’t get told

Cancer treatment

The horrible slow death my parents endured because of the cancer treatments approved by the FDA Yet, they were not able to utilize the benefits of Canabis to help with the side effects. Thank you FDA. Instead of more opiates causing all sorts of unpleasantries in their lives, the simple act of eating and then having more side effects. Not wanting to eat because you are constipated due to the opioids is a nightmare. You don't want to take the pain medication and you wither away because you won't eat. Just thinking about my mother crying at having to go to the washroom every other 2 hours and try... it was a living hell. It was the opioids. Not the cancer.

I watched my father reduced to a skeleton of a man because of cancer and the inability to take his own care in his hands as an adult. I would be risking prison to help him with a plant. I had to carry him to the car and transport him to the VA for his final days. I have photos so I won't forget that image.

It's late.
I'm tired.
I'm sorry I wrote anything.
You and many others in this thread are basing their opinions on emotion and not medical facts. This thread began with a simple story about the FDA telling multiple companies that they can't label two non-dietary ingredients as dietary, that's it!. But nobody ever reads the actual story and everybody pulls out the torches at the mention of the FDA.

Yes, some people within the FDA and pharma have done some illegal and immoral things, but that isn't the norm. Should that mean everything the FDA does is now "evil" because we can easily tear apart the pot industry with little effort if we use the same rationale. Cannabis and components of it show a lot of potential in helping cancer patients, but you also have people online claiming that it kills cancer cells and the FDA is supposedly hiding that. Dishonesty and making claims based off of hype does damage to the researchers trying to get the proper studies done to get these things into the hands of patients and physicians.

I am truly sorry about your parents and that you had to go through that. I've lost count of how many people I've personally lost to cancer and I deal professionally with oncology docs and patients on a daily basis. It's nearly impossible to not be emotional about the subject, but when you go through it, you want anything to help whether it's backed by data or not. That leads down a dangerous path though and I'd argue is exactly what got us into the current opioid epidemic.
 

chedapalooza

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This is why I decided not to use it in Inērtia and opted for dynamine + Eria J (which is likely up next but but yet being cracked down on like dmha)
 

chedapalooza

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Please don't equate me with 'flat earthers' or 'anti-vaccine' nutwads. I could also surmise the Universe is flat and the earth is a 3 dimensional projection, or a number of other scenarios that are far more thoughtful. How about a simulation? That's another thread so, let's talk FDA. We can have fun with reality another time.

Risky Drugs: Why The FDA Cannot Be Trusted


Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns


FDA staff calls for end to corruption, wrongdoing

The FDA approves of drugs to help one quit smoking yet they approve of cigarettes being legal? When the cure for cigarettes may well be worse than cigarettes? (i.e., Chantix)

Whitewashing a black box warning: The Chantix story that didn’t get told

Cancer treatment

The horrible slow death my parents endured because of the cancer treatments approved by the FDA Yet, they were not able to utilize the benefits of Canabis to help with the side effects. Thank you FDA. Instead of more opiates causing all sorts of unpleasantries in their lives, the simple act of eating and then having more side effects. Not wanting to eat because you are constipated due to the opioids is a nightmare. You don't want to take the pain medication and you wither away because you won't eat. Just thinking about my mother crying at having to go to the washroom every other 2 hours and try... it was a living hell. It was the opioids. Not the cancer.

I watched my father reduced to a skeleton of a man because of cancer and the inability to take his own care in his hands as an adult. I would be risking prison to help him with a plant. I had to carry him to the car and transport him to the VA for his final days. I have photos so I won't forget that image.

It's late.
I'm tired.
I'm sorry I wrote anything.
I’m sorry to hear about what you went through with your parents. I’ve not personally been affected like you have but I fully share your sentiments and hope eventually something will change so the agency that is supposed to keep us safe does so without lining their pockets as a prerequisite
 
Jiigzz

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Really gonna protect the FDA @Aleksandar37 ?? The same Agency that approves meds that kill tens of thousands annually but we can’t be adult enough to understand the risks of dmha and phenibut.

Those of you who need the govt to think for you so be it. The rest of us don’t need or want them interfering in our daily lives.

Most of the time they are busy either getting lobbied or chasing down ghosts. Also falsifying studies, documents, etc. Anything you ingest has risks. Too much water can kill you. Maybe the FDA should ban water too?
Lol at this argument.

If you hate the government so much, why do you drive on their roads and live in their cities?

That sounds like your argument - rather than discussing the issues of phenibut, you someone twist the argument and liken it to water abuse. If you need an exacerbated argument to make a point, then you have no point at all.
 
Jiigzz

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Please don't equate me with 'flat earthers' or 'anti-vaccine' nutwads. I could also surmise the Universe is flat and the earth is a 3 dimensional projection, or a number of other scenarios that are far more thoughtful. How about a simulation? That's another thread so, let's talk FDA. We can have fun with reality another time.

Risky Drugs: Why The FDA Cannot Be Trusted


Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns


FDA staff calls for end to corruption, wrongdoing

The FDA approves of drugs to help one quit smoking yet they approve of cigarettes being legal? When the cure for cigarettes may well be worse than cigarettes? (i.e., Chantix)

Whitewashing a black box warning: The Chantix story that didn’t get told

Cancer treatment

The horrible slow death my parents endured because of the cancer treatments approved by the FDA Yet, they were not able to utilize the benefits of Canabis to help with the side effects. Thank you FDA. Instead of more opiates causing all sorts of unpleasantries in their lives, the simple act of eating and then having more side effects. Not wanting to eat because you are constipated due to the opioids is a nightmare. You don't want to take the pain medication and you wither away because you won't eat. Just thinking about my mother crying at having to go to the washroom every other 2 hours and try... it was a living hell. It was the opioids. Not the cancer.

I watched my father reduced to a skeleton of a man because of cancer and the inability to take his own care in his hands as an adult. I would be risking prison to help him with a plant. I had to carry him to the car and transport him to the VA for his final days. I have photos so I won't forget that image.

It's late.
I'm tired.
I'm sorry I wrote anything.
That's some story man, damn.

I am curious though, is marijuana under the jurisdiction of the FDA to make legal for medicinal purposes in the US or do states have to pass their own laws legalising it before the FDA can regulate it?

The system in the US is very different to what im used to and i cbf googling while on my break lol
 

chedapalooza

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That's some story man, damn.

I am curious though, is marijuana under the jurisdiction of the FDA to make legal for medicinal purposes in the US or do states have to pass their own laws legalising it before the FDA can regulate it?

The system in the US is very different to what im used to and i cbf googling while on my break lol
It’s currently a state issue. My state has legalized it for medicinal use, as have many others. A small % of states have made it legal for recreational sale and use. Unfortunately there are now rumbles that large pharma and the infamous Monsanto are making moves to corner the market with mass produced genetically modified marijuana.
 

chedapalooza

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That's some story man, damn.

I am curious though, is marijuana under the jurisdiction of the FDA to make legal for medicinal purposes in the US or do states have to pass their own laws legalising it before the FDA can regulate it?

The system in the US is very different to what im used to and i cbf googling while on my break lol
It’s currently a state issue. My state has legalized it for medicinal use, as have many others. A small % of states have made it legal for recreational sale and use. Unfortunately there are now rumbles that large pharma and the infamous Monsanto are making moves to corner the market with mass produced genetically modified marijuana.
 
Aleksandar37

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It’s currently a state issue. My state has legalized it for medicinal use, as have many others. A small % of states have made it legal for recreational sale and use. Unfortunately there are now rumbles that large pharma and the infamous Monsanto are making moves to corner the market with mass produced genetically modified marijuana.
I don't know about other companies, but Monsanto isn't working on gmo marijuana, although that has been an internet claim for a while that's been debunked. Honestly, there isn't a need for gmo marijuana due to selective breeding over the years. It wouldn't make financial sense to produce it. Pharma would be looking at components of it, but not marijuana as a whole.
 

stimtron

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Even ignoring the fact that these are not normal kids, these are all efficacy studies. Safety isn't determined after 2 months and there are case reports of phenibut dependence which leads to people continually increasing doses, especially when threads like this pop up and people claim it's completely safe because the FDA is "evil."

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5952553/

https://www.ncbi.nlm.nih.gov/pubmed/28614159

Some people don't even require increased doses:

http://europepmc.org/abstract/MED/20841974

Just to be clear, I'm not saying phenibut is overall dangerous or safe. I'm saying the studies have not yet been done.
Not normal kids? You think because they have some health issues they are immune to side effects or addiction? They even gave it to kids with acid reflux. http://childshealth.zaslavsky.com.ua/article/view/101405 My point of those studies was it has been studied in kids and teens and is gov approved for treating those and other conditions in Russia at those doses . If you look at the full studies they of course look at and mention safety and side effects which they found no serious issues at those doses. Check out sci hub for the full study. Why would you think any study would ignore serious side effects in 7 year old kids and continue to do more studies in kids? Makes no sense. If it was so dangerous why give to to kids as young as 1-3 years old? https://www.ejpn-journal.com/article/S1090-3798(08)70676-7/abstract

You're coming at this solely from a viewpoint of reading about reports of people who have bought phenibut powder or caps usually in the US and taken FAR more than was ever studied to be safe and effective aka people overdosing on it (the same issues with tianeptine). Where I actually looked at the studies where it was approved and used at much lower doses and in all of these studies there were few to no side effects certainly none serious.

Phenibut studies started in 1964 and has over 300 studies done in Russia. You can't find even one study in Russia at the recommended doses showing any serious problems for a reason. It is considered so safe they gave it to astronaut to use in space instead of benzos so they could focus on doing their job. One key aspects of why is they take lower doses and take it at the same time every day. Not downing 2-10 grams anytime they feel stressed or want to get high.

Just last year it became one of the best selling drugs in Russia. https://www.ptcommunity.com/wire/olainfarm-groups-turnover-first-quarter-exceeds-30-million-euros-noofen-becomes-sales-leader
 
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stimtron

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Comparing ALCAR to Phenibut is way oversimplifying things. Phenibut is its own unique chemical, just like ALCAR is its own unique chemical. They share some characteristics of their parent compounds and some benefits. Phenibut is well known to have addiction potential and escalation issues. It isn't like Carnitine has effects but doesn't cross the BBB and ALCAR crosses the BBB but also has a bunch of negative sides that create issues as well.
I'm solely comparing the fact that both like carnitine is to alc phenylgaba is a modified form of a natural brain chemical and clinically speaking phenibut is not known to cause addiction why? because it's dosed much lower and is taken at the same time daily. If you actually look at the clinical studies there's no serious issues reported due to any side effects including addiction. It's addicts who are overdosing on it that is the problem. It's normally used at 250-500 mg at once upwards depending on the condition. Where addicts are taking 3-10 grams. Yet you're blaming phenibut for these side effects not those oding on it? That's like saying benadryl or cough syrup is dangerous solely because some people overdose on it. No it's not dangerous at studied doses. Idiots overdosing is dangerous.
 
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stimtron

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The FDA is evil.
The FDA is basically a business and they exist to enforce regulations as a way to make money justified by the bad apples they take down. If anyone of you take the time to read FDA history it's full of controversies ranging from FDA officials pre or post work history to be the very drug companies they regulate, to denying drug approvals not based on science, to alot of scary actions. Just read a handful here and tell me all of their actions were justifiable.

https://en.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration
 
Wobmarvel

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Should I put a label on cereal, frozen TV Dinners, 2L's of soda, and ice cream that it can become addictive?
Maybe this is why america is obese.....

Hmm....
That depends, how much money does the American government make from obese people paying medical bills. Quite a bit I imagine. Let's not mess with junk food just now.

Most junky snack foods in the UK state "this can be enjoyed as part of a balanced healthy diet".
 
ValiantThor08

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Phenibut is addictive, tolerance and habit forming. That said, caffeine powder in the hands of a kid is more dangerous as OD will result in probable death due to mis-dosing. A lot of things can be legally bought on the internet that are not scheduled that could harm an idiot or someone without self control.

The FDA has to appear as though they are protecting lives, and they have a vested interest through the pharmaceutical industry. When the FDA bans something, do they intend to perform studies on what they ban? I don't think so because they do not have a vested interest in what they ban, nor do the pharmaceutical industry; no real substancial financial gain. BPC 157 is a great example. A compound that should be extensively studied, and provided wholesale to various types of patients, but the compound cannot be patented, and cannot make a substantial financial gain. Unfortunately, a lot of what is going on is political, and financially motivated.
 

N2ofusion

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So what’s next? Will this make DMHA hard to find? Or will it be ignored like some prior warning letters on say methylsynephrine? Hi Tech got a letter directly which is concerning from a product availability standpoint
 
ValiantThor08

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So what’s next? Will this make DMHA hard to find? Or will it be ignored like some prior warning letters on say methylsynephrine? Hi Tech got a letter directly which is concerning from a product availability standpoint
Most companies with dmha products will probably start reformulating their supplements. If they do not schedule dmha, it will probably be sold on research sites.
 

stimtron

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So what’s next? Will this make DMHA hard to find? Or will it be ignored like some prior warning letters on say methylsynephrine? Hi Tech got a letter directly which is concerning from a product availability standpoint
I'm sure alot of companies will remove it but there will probably always be someone making it even if it's sold as an rc.
 

Danksta710

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Wouldn't this just encourage the industry to push out more stim analogs? Seems like a whack-a-mole game the FDA will never win.

Could get some interesting new pre's outta this tho...
 
ValiantThor08

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Wouldn't this just encourage the industry to push out more stim analogs? Seems like a whack-a-mole game the FDA will never win.

Could get some interesting new pre's outta this tho...
Eventually they will stop playing the game and take control of the supplement industry entirely. That is their end game.
 

stimtron

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Probably but they tend to be less safe and not as well researched.
Eventually they will stop playing the game and take control of the supplement industry entirely. That is their end game.
They have been pushing to do so for years. Nearly every media report is only on negative studies so most people think it's all placebo or dangerous. Which is ironic since so many otc and prescription drugs kill, injure, or are recalled but no one questions the flawed FDA approval process. Personally capitalism and healthcare is a fucked up combination.
 
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ValiantThor08

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Probably but they tend to be less safe and not as well researched.


They have been pushing to do so for years. Nearly every media report is only on negative studies so most people think it's all placebo or dangerous. Which is ironic since so many otc and prescription drugs kill, injury, or are recalled but no one questions the flawed FDA approval process. Personally capitalism and healthcare is a fucked up combination.
Government intervention is not capitalism though. A free market would allow dmha and dmaa to be sold, anyone being able to sell it. This is what happens when healthcare is both attempting to be free market, and government regulated at the same time. It sucks in every way.
 

stimtron

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Government intervention is not capitalism though. A free market would allow dmha and dmaa to be sold, anyone being able to sell it. This is what happens when healthcare is both attempting to be free market, and government regulated at the same time. It sucks in every way.
The gov is run by businessmen for the FDA many work for the very drug companies they regulate. They do this in part to step aside the courts since the FDA and fine or penalize companies much like a judge would. But even states are starting to challenge companies like Purdue since there's countless deaths due to them yet nothing is done.

Ironic since tobacco, nicotine, and alcohol is legal despite it kills and sickens millions yet still on the market. Is the FDA protecting people from those drugs? No. Yet they go after sups and rcs. Hypocrisy abound. We don't see anyone writing about the epidemic or crisis from those drugs. Why? it's very profitable to regulate and creates new patients or clients for healthcare companies.
 

stimtron

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That's some story man, damn.

I am curious though, is marijuana under the jurisdiction of the FDA to make legal for medicinal purposes in the US or do states have to pass their own laws legalising it before the FDA can regulate it?

The system in the US is very different to what im used to and i cbf googling while on my break lol
The FDA is the federal regulator for all drugs so if a company did studies and sought approval they would make it country wide legal but any state with laws on cannabis would have to change before it could be sold in pharmacies. Similar to CBD gw drug reps went to many states before the FDA approved it so it could be sold in state where it was in a legal gray area.

All state cannabis providers submit to state regulators the FDA is not at all involved.
 
HIT4ME

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I'm solely comparing the fact that both like carnitine is to alc phenylgaba is a modified form of a natural brain chemical and clinically speaking phenibut is not know to cause addiction why? because it's dosed much lower and is taken at the same time daily. If you actually look at the clinical studies there's no serious issues reported due to any side effects including addiction. It's addicts who are overdosing on it that is the problem. It's normally used at 250-500 mg at once upwards depending on the condition. Where addicts are taking 3-10 grams. Yet you're blaming phenibut for these side effects not those oding on it? That's like saying benadryl or cough syrup is dangerous solely because some people overdose on it. No it's not dangerous at studied doses. Idiots overdosing is dangerous.
I am not for the FDA making things illegal per se, but posts like this really lend a lot of creedance to their efforts since it displays the exact issues they are trying to protect against.

You confound things that are not even related by saying ALCAR and Phenibut are at all analogous. You could make a similar argument about ANY chemicals if you tried hard enough. Something like, "The FDA is banning this, but it is just made up of atoms and so isn't water! And we need water! They are trying to take away what we need!"

The fact that you understand a particular chemical trickery used to improve upon the parent molecule is great, but it doesn't mean anything beyond that.

Just because one modified neurochemical has particular effects and safety profile does not mean that another neurochemical modified in a similar way has the same effects or safety profile.

You are also taking a study with controlled dosing and then extrapolating that into the wild where people will be self administering.

Perhaps a better analogy on your side of the argument would have been Tylenol - since this gets used in hospitals and studies quite often with very few incidents under controlled administration, yet it sends more people to the hospital when self administered than almost any drug. So why is tylenol not controlled?

Except, again, this overlooks a number of factors. Tylenol for one, has plenty of experience and research demonstrating particular benefits and a definite safety profile. Notice I didn't say safe - safe is kind of a moving target. We know how to set limits on tylenol to reduce issues, what issues it creates, how to treat them, etc.

Phenibut and DMHA simply lack the research that has yielded this knowledge. We don't have a definitive safety profile for these drugs.

But equally as important, at least for phenibut, is that we know it quickly builds tolerance. This is seen in studies and in the real world.

And tolerance can be good with controlled dosing where the effects we are looking for aren't something we need to conciously notice.

But with self administration in a group of people who want acute effects, that is a recipe for disaster.

And Tylenol, cough syrup, benedryl, etc. - none of these examples have tolerance and escalation issues like phenibut.

I am not arguing that phenibut is dangerous per se, and yeah it CAN be used responsibly - but you can say the same for most opioids as well. The fact is, even a moderate amount of research into people's real world experiences will show that it has tremendoud abuse potential and people who have gone through withdrawals from it will tell you it was horrible.

Add to this the fact that a number of the products with phenibut in them are proprietary formulas with limited dosing info and it becomes even more difficult to figure out if what you are doing is reasonable.

Don't get me wrong, I have used phenibut and liked it. I don't want it taken away. I am sure others can use it responsibly as well. I also know the general population will run into big problems with it. I mean, look at your post and the lack of any recognition that the mere fact it induces rapid tolerance is bad juju...and you are probably more educated than 90% of the people that walk into a store and buy this stuff.
 
WesleyInman

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Lol at this argument.

If you hate the government so much, why do you drive on their roads and live in their cities?

That sounds like your argument - rather than discussing the issues of phenibut, you someone twist the argument and liken it to water abuse. If you need an exacerbated argument to make a point, then you have no point at all.
How do you infer I hate the Gov't just because I don't agree with the FDA banning our suppz? That's a pretty huge stretch to be honest. And I never even said I hate the FDA, I just don't agree with alot of what they do, though the "intent" of the Agency is understood. The fact they abuse their power, and also politically the FDA is abused, I do dislike very much.

I am not comparing water to phenibut by the way, rather I am equating that being an adult, requires us to make decisions and take risks, some of which are higher then others. I can drink 2 gallons of water in one sitting and potentially die. Meanwhile I would never do that. LIkewise I would never take a bottle of Phenibut and chug it either. Could I overdose on a small amount of phenibut, unlikely. Does it have more risk then water, sure.

It is one thing to control something to keep people safe, and another to "ban" and "criminalize" it IMO.
 

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