FDA issues warning letters regarding DMHA and phenibut

[stimtron]

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.

Both are based on natural compounds I'm simply referring to the light modification between the 2 making no other comparison.

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.

No one said it does.

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

People will kill themselves any number of ways. Do we ban all otc drugs, toys, foods, no. Yes some people have no other option than to self administer. It's their only chance for life and to function because doctors don't help them or there is no prescription option for their condition. Would you have these people suffer and die needlessly?

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.

According some some sources Acetaminophen overdose sends as many as 78,000 Americans to the emergency room annually, results in 33,000 hospitalizations, and an estimated 458 deaths a year. Sounds like all that experience and research is really paying off.

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

Phenibut was approved in several countries since the 60's it has over 300 publications. Not sure why you think it's somehow an unknown.

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.

Tolerance occurs with coffee do you want to ban that?

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.

If you don't know how your body is being affected by something you shouldn't take it. Likewise if you're overdosing it to get high.

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

If you abuse them I would be surprised if some tolerance didn't occur.

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.

If you have an addictive personality you will find whatever you can and abuse it. Doesn't matter what it is. I feel no sympathy for people overdosing on anything. Let them kill themselves.

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.

There's some common sense involved. Everyone is responsible for their own actions. If you take things without knowing what you're taking or how safe it is well that's on you.

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.

None of the studies showed any rapid tolerance but yes tolerance over time can happen especially with overdosing. We are talking about something studied in babies as young as 1 years old safely and yes many adults aren't much more intelligent than kids when it comes to decisions about their health but that is their choice. Just like it's their choice to buy alcohol and either a. drink responsibly or b. don't. There's no warning labels in bars and many people don't care. It comes down to choice. Eating fast food over a lifetime will give you all kinds of health problems and may kill you but just because it does it over a longer period of time means we don't treat it as seriously as some nootropics with potential issues when abused. Damage is damage. Be it short or long term. But again adults should have the right to decide for themselves and as always smarter people will avoid doing stupid things while idiots die. I think they call that evolution.

 

[stimtron]

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.

Both are based on natural compounds I'm simply referring to the light modification between the 2 making no other comparison.

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.

No one said it does.

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

People will kill themselves any number of ways. Do we ban all otc drugs, toys, foods, no. Yes some people have no other option than to self administer. It's their only chance for life and to function because doctors don't help them or there is no prescription option for their condition. Would you have these people suffer and die needlessly?

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.

According some some sources Acetaminophen overdose sends as many as 78,000 Americans to the emergency room annually, results in 33,000 hospitalizations, and an estimated 458 deaths a year. Sounds like all that experience and research is really paying off.

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

Phenibut was approved in several countries since the 60's it has over 300 publications. Not sure why you think it's somehow an unknown.

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.

Tolerance occurs with coffee do you want to ban that?

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.

If you don't know how your body is being affected by something you shouldn't take it. Likewise if you're overdosing it to get high.

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

If you abuse them I would be surprised if some tolerance didn't occur.

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.

If you have an addictive personality you will find whatever you can and abuse it. Doesn't matter what it is. I feel no sympathy for people overdosing on anything. Let them kill themselves.

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.

There's some common sense involved. Everyone is responsible for their own actions. If you take things without knowing what you're taking or how safe it is well that's on you.

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.

None of the studies showed any rapid tolerance but yes tolerance over time can happen especially with overdosing. We are talking about something studied in babies as young as 1 years old safely and yes many adults aren't much more intelligent than kids when it comes to decisions about their health but that is their choice. Just like it's their choice to buy alcohol and either a. drink responsibly or b. don't. There's no warning labels in bars and many people don't care. It comes down to choice. Eating fast food over a lifetime will give you all kinds of health problems and may kill you but just because it does it over a longer period of time means we don't treat it as seriously as some nootropics with potential issues when abused. Damage is damage. Be it short or long term. But again adults should have the right to decide for themselves and as always smarter people will avoid doing stupid things while idiots die. I think they call that evolution.

 

[AndroRage]

How does this impact Eria Jarensis??

Is there any impact??

 

[AndroRage]

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)

How does this impact Eria? (Genuine question)

Are the two even comparable though in potency (Eria & Dynamine)?

Serious question, I’m guessing Dynamine may be needed at a higher dosage?

 

[Anabaholic]

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.

I often wonder why no one seems to question that every news story is negative. I take a lot of supplements and I can't even tell you how many times I've had people tell me, "but don't you know that's completely unregulated?" Which is simply untrue.

 

[rob112]

I am not for anything that makes non-violent people that respect private properties a criminal.

Edit: I realize the context of this makes no sense. I’m just stating this due to the overriding debate in the thread.

 

[Aleksandar37]

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

This is quite simple. There has not been a safety study done on phenibut in humans. Until there is a safety study done, you can only guess at the safety. Everything you're citing as "evidence" isn't actually data showing safety. I'm glad the ADHD kids didn't show dependence at therapeutic levels at 2 months, but was there a follow-up study to check on them long-term and what happens in an adult taking normal doses at 4 months or a year? You can't infer that from short efficacy studies.

ADHD kids or kids in general are not representative of the normal population and the original purpose of the drug was to treat psychiatric issues. ONLY 300 studies since 1964?! If it had potential there would be over 300 published studies easily over a 5 year period. There were 2 studies in 1964, then 1 in 1975, and then again nothing until 1980. Also, most of those studies are in animal models and most of the studies have never been translated into English, so unless you read Russian, you're just seeing that something was done, but are guessing at the results. Looking at the titles, all I see are efficacy studies or it's a paper that simply mentions phenibut, but that isn't the focus of the study.

And we're not supposed to trust the FDA, but you want to use Soviet era experiments on cosmonauts as evidence of safety! Really? You're going to need to check your source on that again, but safety isn't the reason it's used by the Russians. It stems from the Apollo-Soyuz mission when it was used when they ran out of options, but has since taken on legend status since the story has been embellished over the years.

 

[stimtron]

How does this impact Eria Jarensis??

Is there any impact??

It doesn't yet but EJ is also an FDA approved food additive so they can't ban entirely.

 

[stimtron]

[QUOTE="stimtron, post: 6211888, member: 283083"
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.

I often wonder why no one seems to question that every news story is negative. I take a lot of supplements and I can't even tell you how many times I've had people tell me, "but don't you know that's completely unregulated?" Which is simply untrue.
[/QUOTE]

People don't do any research or have any actual understanding. They go off fb or tv for "news".

 

[thebigt]

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

I bet vodka was #1?

 

[N2ofusion]

Again, curious to see what happens to the products. And what replacements are out there besides Eria & Dynamine

 

[Jiigzz]

I am not for anything that makes non-violent people that respect private properties a criminal.

Edit: I realize the context of this makes no sense. I’m just stating this due to the overriding debate in the thread.

A lot of crimes are non violent and do not impact private property. Drunken disorder, smoking meth in public, emotion abuse etc etc etc.

 

[rob112]

A lot of crimes are non violent and do not impact private property. Drunken disorder, smoking meth in public, emotion abuse etc etc etc.

But just because I don’t like something doesn’t mean I need the government to jail someone over it. I don’t like people who act smug in forums. That doesn’t mean I need the government to bail me out and take away their freedom.


Maybe you could twist my arm on the one that is attached the word abuse as in abusing another human depending on the circumstance.

 

[_Endure_]

Can someone give me the 10k foot view. Is the issue here that they aren't fully disclosing the label that they have these ingredients or is the FDA just trying to strong arm the ingredients themselves just like they are trying with 1,3 though it isn't illegal or a controlled substance?

 

[Aleksandar37]

Can someone give me the 10k foot view. Is the issue here that they aren't fully disclosing the label that they have these ingredients or is the FDA just trying to strong arm the ingredients themselves just like they are trying with 1,3 though it isn't illegal or a controlled substance?

I believe all of the companies involved disclosed what their ingredients are, but the FDA has a list of dietary ingredients that meet this definition: "The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. "And this "Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as “reduces pain” or “treats heart disease.” Claims like these can only legitimately be made for drugs, not dietary supplements."

More info here: https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/default.htm

I believe ingredients used before the act passed in 1994 are grandfathered in as well.

The FDA is making the claim that these two ingredients are not dietary ingredients, so the companies need to remove them or file a new dietary ingredient application, which would require safety studies.

 

[The Solution]

The Food and Drug Administration has launched a tool to help inform consumers about potentially dangerous and seemingly unlawful ingredients that can be found in some dietary supplements. The administration has given the tool the lengthy title of “Dietary Supplement Ingredient Advisory List”.

The new system from the FDA is essentially a page that lists ingredients it has preliminarily assessed and says may not be lawful dietary ingredients. **At the moment it has just four ingredients on it with 1,4 DMAA, higenamine, andarine, and hordenine, although the FDA says more may be added or even removed.**

FDA introduces a tool to alert the public about unlawful ingredients - Stack3d

The FDA has released a tool to promptly alert the public about potentially dangerous and seemingly unlawful dietary ingredients.

www.stack3d.com

 

[HIT4ME]

@stimtron

Both are based on natural compounds I'm simply referring to the light modification between the 2 making no other comparison. - Then what is the point of the comparison though? Arsenic is a natural substance as well, would that be OK in your supplements?

No one said it does. - Again, what's the point then? What are you trying to claim by bringing ALCAR into it?

People will kill themselves any number of ways. Do we ban all otc drugs, toys, foods, no. Yes some people have no other option than to self administer. It's their only chance for life and to function because doctors don't help them or there is no prescription option for their condition. Would you have these people suffer and die needlessly? -First off, you are saying that some people's only chance for life and function has anything to do with Phenibut and DMHA? Who has EVER died because they did NOT recieve a dose of Phenibut? Seriously? For real?

Second, yes, we do ban a lot of things that are determined to be dangerous. Right and wrong. Life, unfortunately, doesn't have a lot of clear cut, easy answers. I don't agree with government oversight. As a matter of fact, I'm pretty darned conservative and believe individual rights should be held above government rights when possible. And with my beliefs come some incongruities that I have to accept. I don't view the FDA as a protection agency - it has A LOT of flaws. It makes a lot of mistakes. I can think of a lot of things it got wrong. Look at ephedrine. That drug had safety data behind it, and they pulled it - which is what the DMHA debate we are now having stems from. And as someone else said, if DMHA gets banned, they will just come up with something else. It's a tough call, but I don't see much redemption for phenibut and DMHA in this, even though I like the effects of phenibut, do see a narrow margin for it to be used effectively and won't call it crack. But even with that, if you're going to deny its addiction potential, you are just being foolish - and I mean that with all due respect. We are all foolish at times, I know I can't see what I can't see.

Third, careful what "condition" you claim these compounds treat, because in that very argument lies a big part of the legal reasoning to pull these ingredients from the market, if there is anything they actually treat. I mean, you can say anxiety for phenibut but...how good is it for long term anxiety when you take it for 2 days and you are already experiencing escalation?

Toys, foods, etc. all have regulations. And if someone were in a position of life and death - there are two things. One - I don't care what the law says if it comes down to saving my life. If I have to shoot someone to live, I am going to shoot someone. If I have to locate a scheduled substance and inject it into myself and risk jail to avoid death...the law isn't going to do much to deter me. At the same time, I don't want to be injecting false hope either.

According some some sources Acetaminophen overdose sends as many as 78,000 Americans to the emergency room annually, results in 33,000 hospitalizations, and an estimated 458 deaths a year. Sounds like all that experience and research is really paying off.

Umm, wasn't that part of my point? Even with all that safety research and warnings, etc. - when people SELF ADMINISTER this is what happens. And that's with something studies and tested in both lab and real life clinical situations. At least there is some proof of a benefit, some safety margin we can calculate, etc. You want to take something lacking all that experience and research, with a known escalation issue and stand behind it? I just don't get that.

Phenibut was approved in several countries since the 60's it has over 300 publications. Not sure why you think it's somehow an unknown.

Maybe I am wrong. Show me some human safety studies. We can discuss that, it is possible that I'm wrong. Likely even

Tolerance occurs with coffee do you want to ban that?

Tolerance occurs in a lot of things. So, let's use your analogy and follow the logic. Answer this for me - do you think people should be using phenibut like caffeine? What would happen if phenibut were added into 1-2 drinks a day (at effective doses), and people started taking phenibut Monster drinks on top of that, etc.?

You know it wouldn't be good. Phenibut creates tolerance and yields escalation in days. If I take in 200 mg of caffeine (relatively high dose) a day for a week, I will still notice pretty much the same effects after a week. If I take 200 mg of phenibut (relatively small dose) for a week, I will notice that I need more pretty quickly to get the same effects. Even using Google you can find cases of people needing hits of phenibut almost hourly and taking up to 20 grams a day because they couldn't function without it, and the withdrawl was debilitating.

And again, I'm not all out guns blazing saying we should be banning things. Just that people are too quick to say things like phenibut or DMHA are safe and the FDA is evil. Those beliefs are extreme for this situation, IMO. Sure, if someone wants to use something like phenibut - they should have the ability to do it. I am not for illegality per se, but I'm also not for people on the internet putting people at risk by acting like something is completely "safe".

If you don't know how your body is being affected by something you shouldn't take it. Likewise if you're overdosing it to get high.

First, you could say this about everyone who ever took a drug and wound up in the emergency room. How do you know how your body is going to be affected by something if you've never taken it?

Second, look up at what you wrote above about Acetominophen; which gets to the point - self administration requires a margin of safety. Even with something that has a pretty wide margin of safety, like acetominophen, a lot of people get screwed. It's easy to say they shouldn't be taking it, but that's like saying, "If you're going to become an alcoholic you shouldn't start drinking." Well, who starts drinking and goes, "Yeah, I'm gonna be an alcoholic, let's do this!" Nobody. We don't know until the hammer hits us.

If you abuse them I would be surprised if some tolerance didn't occur.

Do you know anyone who hasn't been able to function at work because of their use of tylenol, caffeine, or cough syrup? Some tolerance will occur, but it will be relatively little. How many people do you know that have a bottle of cough syrup habit per day habit?

If you have an addictive personality you will find whatever you can and abuse it. Doesn't matter what it is. I feel no sympathy for people overdosing on anything. Let them kill themselves.

That is a pretty harsh stance, but with some tempering we would be in agreement. People should be allowed to do what they want, as long as they live with the consequences. But some people, as you say, have issues and addictive personalities that set them up for issues when they do exactly the same thing you and I can get away with. It doesn't make us smart, just lucky.

I have a doctor friend who worked in a low income area for a long time. He told me the other day how hard it was dealing with people coming in with medical issues that he knew were due to underlying problems he really couldn't help with. Like, "Here's a prescription for nalaxone to help with your alcoholism." And then he knew she was poor and heading home to her abusive husband. Sometimes people just can't do any better.

Anyway - I wanted to respond because you took the time as well. I appreciate the thought provoking convo, even if you are wrong (kidding with you). It's good to be able to have different views, sometimes it takes you down an unexpected path.

Also, I'm still figuring out this new forum format. It's a pain, but growth comes from pain, haha.

 

[_Endure_]

I believe all of the companies involved disclosed what their ingredients are, but the FDA has a list of dietary ingredients that meet this definition: "The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. "And this "Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as “reduces pain” or “treats heart disease.” Claims like these can only legitimately be made for drugs, not dietary supplements."

More info here: https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/default.htm

I believe ingredients used before the act passed in 1994 are grandfathered in as well.

The FDA is making the claim that these two ingredients are not dietary ingredients, so the companies need to remove them or file a new dietary ingredient application, which would require safety studies.

So basically they need to stop "marketing" them and making health "claims"? Just put the product out and/or notate no intended usage claim... not intended to treat... etc.

 

[Jiigzz]

Can someone give me the 10k foot view. Is the issue here that they aren't fully disclosing the label that they have these ingredients or is the FDA just trying to strong arm the ingredients themselves just like they are trying with 1,3 though it isn't illegal or a controlled substance?

The argument for 1,3 is that it isnt a dietary substance. Same as a lot of newer compounds.

If a new drug is created, it would not be legal to sell as a supplement even if its specific nomenclature was not explicity listed as controlled

 

[Jiigzz]

So basically they need to stop "marketing" them and making health "claims"? Just put the product out and/or notate no intended usage claim... not intended to treat... etc.

They need to be DSHEA compliant or have an NDI filed.

 

[Jiigzz]

But just because I don’t like something doesn’t mean I need the government to jail someone over it. I don’t like people who act smug in forums. That doesn’t mean I need the government to bail me out and take away their freedom.


Maybe you could twist my arm on the one that is attached the word abuse as in abusing another human depending on the circumstance.

A lot of things are illegal because they are huge contributors in driving violent crime. Smothing meth is a non violent act that has high rates of burglarys, car theft and family violence statistics associated with it.

High associative risk of commiting violent crime is enough for me to want it controlled. Have i been a victim of any of those acts personally? Just twice in my life, but i know of people who are continually assaulted by people on meth because they have a strong connection to them.

 

[Jiigzz]

The argument that the FDA also bans things over smoking or alcohol is so fallacious.

Smoking and alcohol has been legal for a long long time. So much so that there are large lobby groups hell bent on protecting those rights. The government also tried to ban liquor and prohibition started. People still see that as a victory over the government.

The difference is is that many things sold as supplements were never supplements. They were never legal under DSHEA.

See the difference there?

 

[Aleksandar37]

So basically they need to stop "marketing" them and making health "claims"? Just put the product out and/or notate no intended usage claim... not intended to treat... etc.

No, the marketing and making claims is what got the FDA's attention. That might be another issue, but these letters are the fact that you can't use non-dietary ingredients in a dietary supplement. If anything in the ingredient list isn't what the FDA has defined as dietary, then it's adulterated and not within compliance.

 

[rob112]

A lot of things are illegal because they are huge contributors in driving violent crime. Smothing meth is a non violent act that has high rates of burglarys, car theft and family violence statistics associated with it.

High associative risk of commiting violent crime is enough for me to want it controlled. Have i been a victim of any of those acts personally? Just twice in my life, but i know of people who are continually assaulted by people on meth because they have a strong connection to them.

So if someone steals or hurts people due to the substance then they should go to jail. But making drugs illegal has been a horrible fail.

We can’t keep drugs out of prison. How many freedoms would you be willing to give up in order for the government to be successful in doing so?

You can have the opinion all of them. I have a live and let live mentality. I don’t tell people how to live their lives and I don’t want them telling me how to live mine.

 

[Jiigzz]

So if someone steals or hurts people due to the substance then they should go to jail. But making drugs illegal has been a horrible fail.

We can’t keep drugs out of prison. How many freedoms would you be willing to give up in order for the government to be successful in doing so?

You can have the opinion all of them. I have a live and let live mentality. I don’t tell people how to live their lives and I don’t want them telling me how to live mine.

Ive worked in emergency response too long to know how much of an impact drugs have in the wider picture of emergency response.

Allowing a drug like meth to be illegal opens up the door to only having a response driven emergency response and not a proactive response to wider drug harm.

Just because you dont see it, doesnt mean the harm doesnt exist.

What you are effectively saying is that, only when people are hurt in a crime directly then the offender should be held accountable. Youd rather pick up the pieces than prevent the harm before it happens, and that to me is actually classed as a failure of the government to protect the vulnerable.

We would never see eye to eye in this topic, but id encourage you actively reach out to victims of drug related harm and see just how much of an impact drug fueled crime destroys their lives. Alcohol is legal, and that already destroys enough lives. We shouldnt be openly encouraging the legalisation of other drugs.

But anyway.

 

[rob112]

A lot of things are illegal because they are huge contributors in driving violent crime. Smothing meth is a non violent act that has high rates of burglarys, car theft and family violence statistics associated with it.

High associative risk of commiting violent crime is enough for me to want it controlled. Have i been a victim of any of those acts personally? Just twice in my life, but i know of people who are continually assaulted by people on meth because they have a strong connection to them.

Much of the crime is due to it being black market. I whole heartily disagree with prohibition. It doesn’t work. It has never worked. If we want to keep freedoms for good people it never will work.

Our government can not keep drugs out of prison.

If someone does drugs and then steals, or hurts other people then I’m with you on prosecution.

 

[Jiigzz]

Much of the crime is due to it being black market. I whole heartily disagree with prohibition. It doesn’t work. It has never worked. If we want to keep freedoms for good people it never will work.

Our government can not keep drugs out of prison.

If someone does drugs and then steals, or hurts other people then I’m with you on prosecution.

Some of the crime is related to it being black market. A large portion of the crime is due to it being highly addictive and highly mind altering.

Im all for crime prevention, not just prosecution. Prevention is a far more effective tool than picking up the pieces. A partner of someone who is drinking and on meth who has just had their head kicked in in is much harder to deal with than removing them from the situation before the harm occurs.

Like i said, why not reach out to people who are victims, i assure you your mindset will change if you attitude is only to pick up the pieces rather than prevent it from being broken.

If your premise for something being legalised because it cannot be stopped anyway, why not nake all crime legalised? A lot of burglarys are never solved, should we just legalise those?

 

[Old Witch]

No, the marketing and making claims is what got the FDA's attention. That might be another issue, but these letters are the fact that you can't use non-dietary ingredients in a dietary supplement. If anything in the ingredient list isn't what the FDA has defined as dietary, then it's adulterated and not within compliance.

I just wish they would turn a blind eye in certain instances or actually decide there’s a safe way to use these substances, define them as a third category between dietary and pharmaceutical, and give us the ability to have actual legal fitness drugs. With the appropriate restrictions.

But that’s crazy talk. I know.

 

[John Smeton]

This is old school witch hunt thinking. Just like Richard aka "tricky dick" Nixon made cannabis illegal and came out with the horror stories or it making people insane, in this day and age its legal in some states, and approved for medical prescription in others for seizures, killing cancer cells. and cbd is legal , at least where I live head shops sell it on every corner. This type of thinking is gone in todays society for the most part, except for those die hard witch hunters who are ignorant and will believe anything. Theyre easily influenced and dont know how to think for themselves. Theyre the ones the stuff should be illegal for because they spout off misinformation and go on crusading and punishing those they can that don't align with their beliefs. They're hypocrites. People generally hate being around them and are very unpleasant to be around, and have very little friends of quality or higher value. Its a certain type.

My point is there is plenty of over the counter products which are intended to be used responsibly. The Fda , in many cases, treat people like they're uneducated children of about two years old. If people abuse phenibut or dmha thats because they are ignorant enough and these people should not be allowed to use it. Its the case of the bad apple can spoil the whole barrel of apples. The solution is to take the bad apple out before it spoils the rest, not throw out the other remaining good apples.

 

[Aleksandar37]

I just wish they would turn a blind eye in certain instances or actually decide there’s a safe way to use these substances, define them as a third category between dietary and pharmaceutical, and give us the ability to have actual legal fitness drugs. With the appropriate restrictions.

But that’s crazy talk. I know.

If it's not based on actual data then what you're suggesting is just as bad as what you're all accusing the FDA of doing. Supplement companies could work with the FDA, but most would rather take the easy way, partially because people are lazy and partially because it's an expensive and complicated process. However, that makes it harder for the companies that are willing to play within the rules. Anytime one of my clients wants to give a half hour or hour talk on their drug at a medical conference, I spend about 3-4k just on printing and shipping at FedEx for the binders that I submit to the FDA. People go on and on about lobbyists for pharma companies and expect things to just happen for the supplement industry without anybody getting off their ass. If people would put as much energy into writing their elected officials as they do making up conspiracy theories on here, you might be surprised at what comes of it.

 

[rob112]

Some of the crime is related to it being black market. A large portion of the crime is due to it being highly addictive and highly mind altering.

Im all for crime prevention, not just prosecution. Prevention is a far more effective tool than picking up the pieces. A partner of someone who is drinking and on meth who has just had their head kicked in in is much harder to deal with than removing them from the situation before the harm occurs.

Like i said, why not reach out to people who are victims, i assure you your mindset will change if you attitude is only to pick up the pieces rather than prevent it from being broken.

If your premise for something being legalised because it cannot be stopped anyway, why not nake all crime legalised? A lot of burglarys are never solved, should we just legalise those?

I live in an area heavily affected by the opioid epidemic. People that were once close to me have died. I do not live in a paradise that knows no troubles. I am 100% for prevention. Most of the violent crimes seem to be the black market regulating itself which is why I wish it didn’t exist. Tons of thievery to bystanders which I am 100% for prosecuting.

Also that is not my only premise. I did a lot of research on the drug war for a project in college. We have spent trillions, dealers have made trillions, tons of violent crime, non violent people in jail, etc. There are many reasons I am against the drug war.

 

[stimtron]

Same ones who thought any of us wanted red light cameras.

Because if you're driving at 3 am and there's no cars around what justifiable reason is there not to just go through it? Because an unintelligent timer with no awareness of road conditions tells you to? Skynet in it's early stages.

 

[HIT4ME]

This is old school witch hunt thinking. Just like Richard aka "tricky dick" Nixon made cannabis illegal and came out with the horror stories or it making people insane, in this day and age its legal in some states, and approved for medical prescription in others for seizures, killing cancer cells. and cbd is legal , at least where I live head shops sell it on every corner. This type of thinking is gone in todays society for the most part, except for those die hard witch hunters who are ignorant and will believe anything. Theyre easily influenced and dont know how to think for themselves. Theyre the ones the stuff should be illegal for because they spout off misinformation and go on crusading and punishing those they can that don't align with their beliefs. They're hypocrites. People generally hate being around them and are very unpleasant to be around, and have very little friends of quality or higher value. Its a certain type.

My point is there is plenty of over the counter products which are intended to be used responsibly. The Fda , in many cases, treat people like they're uneducated children of about two years old. If people abuse phenibut or dmha thats because they are ignorant enough and these people should not be allowed to use it. Its the case of the bad apple can spoil the whole barrel of apples. The solution is to take the bad apple out before it spoils the rest, not throw out the other remaining good apples.

So you're saying there isn't a correlation between schizophrenia and marijuana use and that people who believe there is are just foolish? Because the guy at your corner drug store said so? And if you hold a certain belief then you must be a certain "type" of person who is unpleasant to be around, has few friends and low value? Interesting.

Also liked "If people abuse phenibut or dmha thats because they are ignorant enough and these people should not be allowed to use it." - which is EXACTLY what the FDA is saying. Congrats, you agree with the FDA.

 

[rob112]

Also liked "If people abuse phenibut or dmha thats because they are ignorant enough and these people should not be allowed to use it." - which is EXACTLY what the FDA is saying. Congrats, you agree with the FDA.

You are misunderstanding his point when you take this out of context. He is saying that because someone can abuse Tylenol that does not mean people who do not abuse Tylenol should be stopped from using Tylenol. Now just insert Dmha or phenibut for Tylenol.

 

[Wobmarvel]

This thread is turned up to eleven!!

 

[HIT4ME]

You are misunderstanding his point when you take this out of context. He is saying that because someone can abuse Tylenol that does not mean people who do not abuse Tylenol should be stopped from using Tylenol. Now just insert Dmha or phenibut for Tylenol.

I am not missing the point, I get it. We have to either ban everything, or ban nothing and the argument in this thread of the people on the side of phenibut/DHMA is basically that because caffeine and tylenol are legal, phenibut should be too. I mean, I can understand the cigarettes/alcohol are legal so what is the point of laws arguement - but once you move past an all or nothing argument, comparing tylenol and caffeine to phenibut and dmha is pretty far fetched.

Fine, let's hold phenibut and dmha to the same safety standards of tylenol and caffeine. Tylenol has a lot of research and actual safety data behind it. We can point to studies, case reports and real world results showing it has a measurable positive effect, and a measurable danger and we can make a judgement based on the risk/reward. The risk, despite the large numbers of hospital visits, are small. Plenty of people abuse tylenol, and only a small fraction of these people ever have issues. They don't become addicted, they probably stop the abuse without ever realizing they were misusing it, and they never end up in the hospital. Same for caffeine.

On the flip side, only a VERY SMALL percentage of the population currently uses phenibut. Despite this, there are plenty of reports from personal experience showing significant addiction potential and harms - and what exactly are we using it for? It's a supplement, not a treatment for anything. If it is to be used as a treatment, it will need to be proven (show me the studies), and then it becomes medicine and not a supplement since it was not part of the food supply. Just think of the addicts and issues we would have if every person using APAP were to start taking phenibut. Maybe we would have no issues, which I significantly doubt because even people making the counter argument, as above, are stating that there is a portion of the population that is "too stupid" to be using it. This stance, BTW, is counter to the very underlying free thinking people are claiming to have. You can't say that people should be free to make their own decisions, and then say that the population in question (in this case I guarantee more than 80% of the population as a whole) is too stupid to handle it. That basically makes the FDA's argument for them.

Again, my stance is not directly in opposition to you and I am not "for the FDA control of drugs" - I am just stating that I can see where they are coming from on this, and that people have this mind set that things are safe and the FDA is taking them when they shouldn't - then they come on here and spew the same misinformation (phenibut or DMHA has 300 studies and is safe and so on) that the FDA is trying to combat.

And the FDA is not without fault on this. They have made some mistakes too - the current opioid epidemic being a prime example. We allowed pharmaceutical companies to make claims that were not backed by science, just because they seemed like we could believe them. For instance, opioids have insufficient evidence supporting their use for chronic pain. The science actually points to the possibility that long term use may INDUCE pain. But that doesn't make sense that a pain killer would induce pain, so let's just keep using them the way we always have. The science was slighted, and look where it got us.

Now, the anti-fda crowd uses that as a defense to do the same thing on the other side of the fence. The FDA didn't handle Oxycodone correctly, so they shouldn't handle phenibut correctly. But if you take away the bias, you realize that we should learn from the oxy issue and not repeat it with other chemicals we know little about.

And I'm not saying we should be making everything illegal, but we also shouldn't be basing our defense on emotion and poor science either. Great, you love phenibut. Educate yourself, be careful. But don't tell others it doesn't have risks or downplay those risks because you've decided they were acceptable to you.

If it came out that a supplement company used an ingredient in a product that you used that they never researched, or maybe even KNEW was dangerous, and they decided your health was worth the risk because it was outweighed by their desire to make money, I bet you'd be up in arms.

Purdue did it and a lot of us ARE up in arms about it. If it's wrong, it should be wrong regardless of who you are or what industry you are in, not just for a certain group.

We should be focused on true education and not spreading what we WANT to believe. It creates a line that you are either for the FDA or you are for the internet crowd. There IS something in between, but once you've chosen your side you are locked in.

I always feel a little bad on the forum because I feel like it is a difficult medium to communicate complex ideas in. Things can come across as being much more aggressive than intended. If you're sitting in a room having debate and you've established rapport, you can be a little snarky and it may even be funny.

 

[ValiantThor08]

I get your stance @HIT4ME there are legal substances that are not, or will not be banned because of existing safety studies. I see the logic in the FDA scheduling something. What I don't like is their resistance to having safety studies performed on some of these substances that we like.

 

[ValiantThor08]

So if the FDA is even unwilling to even allow safety studies on certain products, is sucks for consumers because a group of people have the decision making power to make something illegal forever, and turning people into criminals because they won't even have safety studies.

 

[HIT4ME]

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 missed this. Sorry about your experience brother. You are correct. I do believe that if someone has a legitimate health issue they are trying to treat and they have a belief that something can help, they should be allowed to do whatever they feel is necessary, on their own behalf, to survive. This goes beyond what is factually right or wrong.

People will do all kinds of things that are "wrong" in their lives. But it should be their call. Just like if someone is going to kill you and you have a gun, you should be able to defend yourself with all means necessary.

On the same hand I think it is sad how much bad info is on the net that may give people false hope, cause undue danger, or prevent proper treatment.

And the FDA dropped the ball big time with the opioid thing. So many people should have done better - the pharma companies, the FDA, the hospitals, the doctors.

 

[HIT4ME]

I get your stance @HIT4ME there are legal substances that are not, or will not be banned because of existing safety studies. I see the logic in the FDA scheduling something. What I don't like is their resistance to having safety studies performed on some of these substances that we like.

Well, I can agree with this as well. I would say that safety studies have to be well designed and properly planned - or else you could be putting the people in the study at undue risk as well (never a good look).

Having said that, I'm all for more studies. Have you seen any evidence that the FDA has prevented studies? I am unaware but would love to see it...it would have an impact on things for certain. They shouldn't be actively preventing the acquisition of knowledge.

My understanding/guess at this point is that these studies are incredibly costly and require an immense amount of funding. I mean, look at what Aleksander said he spends just on mailing stuff to the FDA in some instances. Getting even $500,000 for a safety study is tough, and what will one study prove? Just that we need repeated results at best. It can be tough to get that cash unless you have some upside for the investors, and potential benefit/potential risk definitely play a huge factor in that.

For instance, Phenibut may be the best sleep aid ever. But are you going to spend $500,000 of your money to find out that it works, but 75% of the people who used it in the study lost their jobs because they became addicted (exaggerating for the point here)? It's kind of a big risk.

 

[ValiantThor08]

Well, I can agree with this as well. I would say that safety studies have to be well designed and properly planned - or else you could be putting the people in the study at undue risk as well (never a good look).

Having said that, I'm all for more studies. Have you seen any evidence that the FDA has prevented studies? I am unaware but would love to see it...it would have an impact on things for certain. They shouldn't be actively preventing the acquisition of knowledge.

My understanding/guess at this point is that these studies are incredibly costly and require an immense amount of funding. I mean, look at what Aleksander said he spends just on mailing stuff to the FDA in some instances. Getting even $500,000 for a safety study is tough, and what will one study prove? Just that we need repeated results at best. It can be tough to get that cash unless you have some upside for the investors, and potential benefit/potential risk definitely play a huge factor in that.

For instance, Phenibut may be the best sleep aid ever. But are you going to spend $500,000 of your money to find out that it works, but 75% of the people who used it in the study lost their jobs because they became addicted (exaggerating for the point here)? It's kind of a big risk.

Reason studies have waivers, and everyone should have informed consent. And I'm just assuming that they have no interest in safety studies. I don't see them having a interest in really helping out the supplement industry get a nice exotic stimulant.

 

[rob112]

@HIT4ME I see how you took that phrase and I took that phrase was different. If he truly means that if your educational standard determines your freedom to use a supplement or OTC drug I disagree with him also. I believe people have the right to make mistakes. Now if someone is truly incapable then maybe a guardian should make the call.

I have a lot of other thoughts on what you have said, but I don’t have the time at the moment to articulate them all.

I would say as a basic rule of thumb from my perspective most people want what’s best for people. I believe it’s the how we get there that most of us disagree on. Some of us believe the checks and balances should be government driven, others like myself believe issues can be better fixed with strong communities with high standards for one another. Maybe many believe partially both I don’t know.

I appreciate a well thought out response, and I agree with the last paragraph.

 

[HIT4ME]

Reason studies have waivers, and everyone should have informed consent. And I'm just assuming that they have no interest in safety studies. I don't see them having a interest in really helping out the supplement industry get a nice exotic stimulant.

I don't want them to have any interest in helping anyone though , right?

I mean, if they funded a study for opioids, that would be kind of sketchy...

They are geared toward being tried and true, not exotic. They shouldn't be looking to solve problems, merely avoid them.

Stimulants as a category tend to bring health consequences with them as well. In our eyes on this board, those consequences are manageable and acceptable. To someone who is clueless, it is russian roullette. I mean, the FDA is looking at news stories about kids taking too much caffeine powder and dying.

If you were in their shoes and 95 out of 100 people were at your door with pitchforks asking what you are doing to protect the kids, and 5 people were like, "Really? He took 200 times the recommended dose and didn't even know to use a scale?" - which direction would you go?

And this is why we need signs. haha.

 

[HIT4ME]

issues can be better fixed with strong communities with high standards for one another.

I really like this statement.

Not to go way off topic, but I don't use facebook. I feel that society has adopted a lot of bad habits and individuals have been manipulated and have become isolated.

A few months ago, when my dad had a stroke, I was fortunate to have some people who really stepped up to help out. I would say thank you and a couple times they would say, "What are friends for?"

And I secretly thought to myself, "Likes?"

 

[Aleksandar37]

Reason studies have waivers, and everyone should have informed consent. And I'm just assuming that they have no interest in safety studies. I don't see them having a interest in really helping out the supplement industry get a nice exotic stimulant.

Are you under the impression that the FDA goes around initiating or performing safety studies? That's not at all how this works. If you want something approved as a drug or a new dietary ingredient, you need to fund and perform the studies and then use that evidence to apply for approval. The FDA provides guidance documents on all of this, but they're never the ones doing it.

 

[Aleksandar37]

Well, I can agree with this as well. I would say that safety studies have to be well designed and properly planned - or else you could be putting the people in the study at undue risk as well (never a good look).

Having said that, I'm all for more studies. Have you seen any evidence that the FDA has prevented studies? I am unaware but would love to see it...it would have an impact on things for certain. They shouldn't be actively preventing the acquisition of knowledge.

My understanding/guess at this point is that these studies are incredibly costly and require an immense amount of funding. I mean, look at what Aleksander said he spends just on mailing stuff to the FDA in some instances. Getting even $500,000 for a safety study is tough, and what will one study prove? Just that we need repeated results at best. It can be tough to get that cash unless you have some upside for the investors, and potential benefit/potential risk definitely play a huge factor in that.

For instance, Phenibut may be the best sleep aid ever. But are you going to spend $500,000 of your money to find out that it works, but 75% of the people who used it in the study lost their jobs because they became addicted (exaggerating for the point here)? It's kind of a big risk.

Very well said, but you'll probably spend $500,000 on the attorneys alone lol. Research is expensive and sometimes goes nowhere. Trying to get FDA approval is also expensive and sometimes goes nowhere. I see pharma and biotech companies go out of business all the time because of failed studies.

 

[Aleksandar37]

So if the FDA is even unwilling to even allow safety studies on certain products, is sucks for consumers because a group of people have the decision making power to make something illegal forever, and turning people into criminals because they won't even have safety studies.

When did the FDA not allow a safety study? I haven't heard of this, especially in regards to the ingredients listed in this thread.

 

[justhere4comm]

I've never used Phenibut but I want to try it now. I love kava kava and other herbals. My favorite sleep aid has been probably discontinued. Sedation by Vein Nutrition. @VeinNutrition

 

[ValiantThor08]

When did the FDA not allow a safety study? I haven't heard of this, especially in regards to the ingredients listed in this thread.

Thanks for educating me on the process.

 

[ValiantThor08]

I've never used Phenibut but I want to try it now. I love kava kava and other herbals. My favorite sleep aid has been probably discontinued. Sedation by Vein Nutrition. @VeinNutrition

Just use 2 to 3 times week max for sleep.