FDA issues warning letters regarding DMHA and phenibut

[Aleksandar37]

Blog

From diet and sleep to recipes and coffee-making-tips, you'll find all the info you need to be your best self on the Bulletproof Blog.

blog.bulletproof.com

Here's a quick lesson in reading these articles critically. First off, it's a blog and not a peer-reviewed journal. This means they can literally say anything they want and nobody is there to check the validity of their statements. Peer-reviewed journals, like anything, are not 100% without fault or issues, but it's a better place to start.

Second, they use references sporadically to give the illusion that this is a researched article, but look carefully where they use the references for basic, benign statements, but then give no references for their bigger claims. It's like saying "the sky is blue (insert reference that indeed shows the sky is blue) and that sky can kill you!" Notice how I kept a reference off of the much more important detail.

Third, surprise! They are selling a product that is a direct alternative to the thing they are trying to scare you about. This is marketing, not science.

 

[rob112]

I don’t have a double blind study and decades of safety statistics, but it appears that educated people who are pro government come off as condescending assholes.

Edit: not Hit4Me. He does not come across as talking down to people using snarky remarks the whole time.

 

[HIT4ME]

I don’t have a double blind study and decades of safety statistics, but it appears that educated people who are pro government come off as condescending assholes.

Yeah. You got me.

 

[rob112]

Yeah. You got me.

Beat me to my edit. I don’t feel like you talk down to people as you make your point.

 

[ValiantThor08]

The Fda - How Independent Is The Fda? | Dangerous Prescription | FRONTLINE | PBS

www.pbs.org

 

[HIT4ME]

Same as kratom or CBD (prior to FDA approval) both are pain killers that helps when other options failed due to side effects or lack of accessible. It can be very hard for those in pain to get or even afford proper pain relief. Kratom, CBD, Phenibut gives people another option.

Baclofen is very similar to phenibut but lacks much of it's nootropic properties and it not studied in ADHD or other conditions like phenibut is. Phenibut is a known drug and it's been on the pharmacy market for decades I don't get how people see it as an rc or something.

Again, this is just not true. I know a lot of users want to believe that CBD, kratom, and marijuana are some wonder drug, but frankly, if it was really that useful - and the FDA is in the pocket of the pharma companies, do you really think they would have let it go? Nah, the drug companies have reams of private research and they recognize it as not being suitable for any medical purpose - else they would have lobbied to make sure it never got on the ballots for legalization.

CBD, marijuana and kratom have no safety studies, no proven benefits and only recently suggested benefits in seizure victims. As Aleksandar pointed out, it is moving through trials for this use. So you have that.

Beyond this, its use medicinally is way over blown and I will probably take a lot of heat for these statements because the mere suggestion that these drugs are not wonder drugs brings up such emotion in most users that anyone with a minimal amount of research will literally fear entering into a discussion with people.

minor correction

herbicide=weeds
pesticide=insects

Monsanto made gmo seeds roundup resistant so that farmers could spray fields with roundup without killing crops. some of the food you are eating has been sprayed with roundup. the question i have is if roundup sprayed on crops permeates the outer layer[skin] of crops?

It's not a minor correction, it's a BIG factor in the point I was making. They fault the FDA for approving something for a use OUTSIDE of human consumption. And then they use that to back up the argument that the FDA shouldn't be banning things FOR human consumption? The argument is so unrelated and illogical - So the FDA shouldn't ban the use of heroin because they approved glyophosphate?

So the FDA should ban banana's because of glyophosphate?

It's a worthless argument. It's apples and oranges (I kill me with my puns) and if you allow that, then it's in the FDA's favor (they shouldn't repeat the same mistakes by allowing stuff to slip by).

Spontaneous reporting to drug surveillance systems suggests one adverse reaction for every 5 million (UK) to 25 million (USA) 200 mg tablets sold, with one reported fatality for 0.6 to 23 billion tablets sold. During clinical and post-marketing studies, the frequency of adverse events was similar to that found with placebo or paracetamol. In a meta-analysis involving 46000 patients, the incidence of digestive events was 5 per cent, with 0.02 per cent upper GI bleeds. A prospective trial in 84000 children reported 0.007 per cent GI bleeds

Great post with some hard data. I learned a few things there. These stats above are kind of my point - spontaneous reporting to drug surveillance systems. This is a drug WITH the safety data behind it, and when self administered in large populations, we have these small percentages of people having issues. Yet, those small percentages turn into a large actual number of people being injured - and it is all because of self administration. The benefit (overall users who benefit) given the small percentages of people who are harmed is very small - but what would benefit look like if we were to start using phenibut on a scale of even 1/10th the use of acetominophen?

My guess is that at 1/10th the use we would easily see numbers similar to the harms of acetaminophen, based off the addiction stories on the internet. Will it be liver failure? No. Will it be life threatening? Probably only very rarely. But could it ruin the lives of 78,000 people a year to addiction? Sure. And what is phenibut being used for again?

It's like alcohol - really, what good is it? It doesn't serve a medical purpose. If it weren't for the fact it was socially accepted, people wouldn't use it. I don't drink for this reason, I don't see the risk of having problems being worth the small pleasure of drinking. I think the difference was that very early in life I just happened to realize that kids around me were drinking and none of them were picking up that first drink and going, "This is so great. I am going to be an alcoholic, but it's worth it!" No, they all thought, "I can handle my sh1t, it's only one drink."

And that's how we all start, and yeah we should make our decisions and live with it. I don't really believe in the FDA making things legal, but I'm more against bad information getting spread on the internet as fact, and then repeated, and then people can't assess the possible risk they are taken because they think it is harmless.

Beat me to my edit. I don’t feel like you talk down to people as you make your point.

lol, I can try harder?

Nah, I appreciate that man. I think I come across wrong with a lot of people on here, it's hard to communicate online and I try (most of the time) not to be a d1ck. The people on this board are great. I mean, I've had arguments with Aleksandar in other threads that are heated, and look at us now...we are on the same team almost. If you can't punch your friends once in a while, who can you punch? Honestly, I think there is some area where we can all agree. Even stimtron pointed out in his post that we have some common ground.

I think part of the issue here is that, from my perspective, I am not really for the FDA but I am VERY against the repeated -incorrect, one-sided, or whatever you want to call it - misinformation that we have online and in society that reduces perceived harms rather than educates.

Everything that does anything can have harms - even sugar destroys your health and we eat that every day. Safety is a bit of an illusion and we all have to make some decisions on that and what we are willing to live with. I have used phenibut and I like it. I can see why someone might think it would help with their anxiety, sleep issues, etc. But honestly, I'm not so sure that people with serious issues in these categories would benefit from it. It's NOT suitable for long term use, unless (maybe) it's being prescribed and monitored at low doses by an outside party. I mean, yeah, I'd be a lot less worried about a doctor prescribing my mom 250 mg a day and keeping that steady than handing her 100 grams of powder and saying, "Here you go, good luck."

And this highlights one problem - we lack A LOT of information. There is SO much out there. It makes my head spin. Pubmed may not be the best, 100% solid source of data, but I will tell you this, I have learned SO MUCH from following the trails. You read a study and the researchers talk about a concept you don't understand and you go to wikipedia, then to google scholar, then wherever and start learning those concepts and that leads to new concepts and next thing you know you've learned something that underlies things you had no idea about. And you start to realize that we are just scratching the surface here. Not me or you, but EVERYONE. The info just isn't there yet. We just don't have the information available. That's why we need more studies and so on. We expect doctors to know everything, and they know a lot, but they are on the edge of the abyss. The best doctors out there don't have the information/resources to do what they need at times. And then there are the worst doctors who we all have stories about.

In that light, I'm all for the FDA's guidance and sometimes that guidance has to be a strong law. It's not always right, it's often messed up.

As far as financial ties with the FDA, I think the best conspiracies have a small amount of truth to them. I mean, Howard Zinn points out the predecessor to the FDA wasn't even founded to protect consumers - it was created to help the export of beef after the beef companies made a bunch of European soldiers sick and no one would by American meat. The beef companies lobbied for a "watch dog" that would rebuild consumer confidence. And if you think of the FDA in that light, it does have an impact on your views. But that doesn't mean that they are all bad either.

 

[HIT4ME]

To kind of change gears here and maybe expose some common ground, I would like to know what @Aleksandar37 and the rest of you guys think about the FDA's ban of ephedrine in the early 2000's? This is something I always thought was a mistake, and I was probably on the "non-FDA" side of the group with that one. At the time I said, "People are going to start finding stimulants that aren't safe now." and here we are today, talking about DMHA. And the fact of the matter on that one was that, more studies were probably needed, but there WAS some statistical analysis and short term studies showing ephedrine could be used safely. There were loads of case reports where self administration in individuals trying to treat their own psychological issues were taking exceedingly high doses (hundreds of mg/day) and developed psychosis (an obvious concern), but returned to normal once it was stopped. There was also a report I had found of a woman who tried to commit suicide by swallowing an entire bottle of ephedrine pills and while she was admitted to the hospital, she was OK.

I also remember in the early 2000's we had GBL and tiratricol being used as supplements. GBL was known to cause seizures and even caused an NBA player to collapse on the court. Tiratricol was being studies by a pharmaceutical company. The FDA swooped in and shut down the company selling Tiratricol, and after the owner sent the owner sent the FDA his research and tried to discuss it with them and took the stance of "what is the danger, I don't want to sell something that is dangerous." - They said they just didn't like it and didn't give a reason. He believed the law allowed him to sell what he had, told them he was going to and the VERY NEXT DAY, they showed up at his warehouse and confiscated the product.

GBL remained on the market for years in the meantime.

Things like this do make me wonder what pressure from a pharma company can do.

But on the same hand, I also think the FDA can be in a tough spot. They approve glyophosphate and someone gets cancer, even if it wasn't through an approved use, and the public is up in arms, "Why did you allow this?" and then they ban something and, "They're taking our rights!?"

Look at caffeine powder - some kid takes a tablespoon of powder and dies. There's NO DENYING that is tragic. There is nothing in me that doesn't wish something could have changed that situation. But are we seriously going to ban caffeine powder? And if they don't act on it, what do people say about the FDA? "They only care about the pharma companies, not kid's lives."

 

[stimtron]

Again, this is just not true. I know a lot of users want to believe that CBD, kratom, and marijuana are some wonder drug, but frankly, if it was really that useful - and the FDA is in the pocket of the pharma companies, do you really think they would have let it go? Nah, the drug companies have reams of private research and they recognize it as not being suitable for any medical purpose - else they would have lobbied to make sure it never got on the ballots for legalization.

CBD, marijuana and kratom have no safety studies, no proven benefits and only recently suggested benefits in seizure victims. As Aleksandar pointed out, it is moving through trials for this use. So you have that.

Beyond this, its use medicinally is way over blown and I will probably take a lot of heat for these statements because the mere suggestion that these drugs are not wonder drugs brings up such emotion in most users that anyone with a minimal amount of research will literally fear entering into a discussion with people.

CBD was FDA approved as a prescription drug in kids last year under the name Epidiolex which guess what requires phase 1-3 studies which look at safety and effectiveness. Yet you're saying there's NO safety studies or proven benefits??? That's just blatantly false.

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm

Cannabis was also approved awhile ago as a extract spray for MS called Sativex in Europe but US studies in cancer pain did not hold up well. But it's well on it's way to FDA approval as a vape pellet by Tetra Pharm who already did Phase 1 safety studies.

https://www.practicalpainmanagement.com/treatments/pharmacological/fda-grants-orphan-drug-designation-cannabis-pellet

It's made it all the way to Phase 3 studies. Next step approval.

https://www.globenewswire.com/news-release/2019/04/09/1799525/0/en/Tetra-Bio-Pharma-Resumes-its-Phase-3-Clinical-Trial-Program.html

Plus it's been approved for medical use in several states which is unheard of historically but comes down to the fact you can't deny it has benefits. No other time in history has state governments legalized a treatment over the FDA because they disagreed with the DEA and FDA's take on it being schedule 1. But some people don't believe in anything unless a 3 letter group tells them to think.

Regarding kratom and safety studies in general. Such studies are only done by large companies usually seeking gov approval to treat health conditions. Kratom and natural products don't have strong patent protections and logically have less interest regardless of effectiveness because profits are more important typically. Kratom was never an approved drug in other countries like phenibut or most nootropics. Do I blame the herbs for lack of safety data or the system that promotes research on only the most profitable treatments? The latter.

Regardless with kratom it gives patients an option they don't have otherwise and if you've noticed thousands of people are taking it and it works for them. Who is anyone to deny them what helps their condition? Will the FDA take care of those patients when they take away the only treatment that works for them? Who bears the cost to society to have 1,00's of currently functioning people suddenly not have access to effective pain management both morally and financially. There's a reason the DEA held off on scheduling it people organized and fought back for the only thing that actually helped them because the FDA's system failed them.

 

[HIT4ME]

CBD was FDA approved as a prescription drug in kids last year under the name Epidiolex which guess what requires phase 1-3 studies which look at safety and effectiveness. Yet you're saying there's NO safety studies or proven benefits??? That's just blatantly false.

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm

Cannabis was also approved awhile ago as a extract spray for MS called Sativex in Europe but US studies in cancer pain did not hold up well. But it's well on it's way to FDA approval as a vape pellet by Tetra Pharm who already did Phase 1 safety studies.

https://www.practicalpainmanagement.com/treatments/pharmacological/fda-grants-orphan-drug-designation-cannabis-pellet

It's made it all the way to Phase 3 studies. Next step approval.

https://www.globenewswire.com/news-release/2019/04/09/1799525/0/en/Tetra-Bio-Pharma-Resumes-its-Phase-3-Clinical-Trial-Program.html

Plus it's been approved for medical use in several states which is unheard of historically but comes down to the fact you can't deny it has benefits. No other time in history has state governments legalized a treatment over the FDA because they disagreed with the DEA and FDA's take on it being schedule 1. But some people don't believe in anything unless a 3 letter group tells them to think.

Regarding kratom and safety studies in general. Such studies are only done by large companies usually seeking gov approval to treat health conditions. Kratom and natural products don't have strong patent protections and logically have less interest regardless of effectiveness because profits are more important typically. Kratom was never an approved drug in other countries like phenibut or most nootropics. Do I blame the herbs for lack of safety data or the system that promotes research on only the most profitable treatments? The latter.

Regardless with kratom it gives patients an option they don't have otherwise and if you've noticed thousands of people are taking it and it works for them. Who is anyone to deny them what helps their condition? Will the FDA take care of those patients when they take away the only treatment that works for them? Who bears the cost to society to have 1,00's of currently functioning people suddenly not have access to effective pain management both morally and financially. There's a reason the DEA held off on scheduling it people organized and fought back for the only thing that actually helped them because the FDA's system failed them.

Yeah, sorry - got a little carried away in some of the wording and probably went too far. Just kind of a reaction because I feel like people go too far thinking it is some amazing drug and that has yet to be shown. Just like people constantly say it has no side effects, which ignores a lot of research saying otherwise.

I am aware of the epilepsy thing, and it seems like a limited labelled use.

I Wasn't aware of the Sativex, interesting item.

One differentiating factor here - just because someone takes an ingredient and thinks it helps then does not mean it helps them. That is not solid evidence. Nobody here is looking to deprive people of whatever treatment they need, but you are a bit too far in accepting peopke need things without any evidence.

I will give you a personal instance of why this is bad. My grandmother has arthritis. Her doctor put her on opoids. I was unaware until escalation had already occured and she was suddenly on fentanyl.

I fought it hard, and my aunt and the doctor pushed back hard. They were concerned with my grandmother's pain and quality of life. They thought they were helping. The opioids were likely making her pain worse, and causing constipation, and infections, and confusion, etc. They were destroying her quality of life in the name of treating pain. And they were not helping the pain.

When I told my aunt the opioids were likely reducing her tolerance to pain she thought I was crazy, because they were pain killers. I must have been crazy.

Sometimes people think things help, and they don't realize they are worthless and doing more harm than good. People like us really want things to work...but they often deliver less than we hope and carry more risk than we admit.

If someone is in pain and wants to treat it themselves, great. But to start recommending things to others can take on another life ...and a lot of these things carry risks that are down played and benefits that are over presented.

 

[Aleksandar37]

I don’t have a double blind study and decades of safety statistics, but it appears that educated people who are pro government come off as condescending assholes.

Edit: not Hit4Me. He does not come across as talking down to people using snarky remarks the whole time.

I'll take it as a compliment that you view me stating facts as an attack. Education shouldn't be viewed as a bad thing, especially in a forum concerning supplements and training. And I'm not pro-government, but am pro-keeping people honest. I've never understood the supplement companies that want you to just buy their product and stop asking questions, but that's where the attacks on education come in handy.

Most impress me on this forum with their desire to learn, but then you get this facebook-level anti-vaxxer crap where people are so arrogant that they keep pushing lies, even after confronted with the truth. Maybe phenibut will help with your fragile little feelings.

 

[rob112]

Maybe phenibut will help with your fragile little feelings.

Exactly my point. You talk down to people constantly due to you being very smart. You can act like it isn’t true, but you do. You have a very belittling way of speaking. Once again it’s obvious you are very smart. You are just a dick about it.


Edit: a dick about it sometimes. I’m not saying every post.

 

[Aleksandar37]

To kind of change gears here and maybe expose some common ground, I would like to know what @Aleksandar37 and the rest of you guys think about the FDA's ban of ephedrine in the early 2000's? This is something I always thought was a mistake, and I was probably on the "non-FDA" side of the group with that one.

I'm indifferent on this ingredient. I don't think the safety data shows that it's safe, but if people want to risk cardiovascular and other issues to look a certain way, fine. I'm fine with making all drugs legal, so still not sure how that makes me pro-government lol.

This is a good example though of where the FDA and the supplement companies could have worked together, but the supplement companies didn't and they got what they deserved for lying. Do a search for any of this for more details, but the FDA wanted supplements with ephedra to show health risks on their labels. Some supplement companies got together and formed the Ephedra Education Council, a lobbying group, that chose to fight against data that made it look bad (e.g. trying to block this paper https://academic.oup.com/ajhp/article/57/10/963/5150899) rather than working on a compromise. Then you have metabolife and Michael Ellis who kept lying to the FDA about outcomes from ephedra studies.

So I'm not particularly for a ban on anything, but also think the whole story on this needs to be shown. Somebody at the FDA didn't just one day decide to go after ephedra.

 

[stimtron]

Yeah, sorry - got a little carried away in some of the wording and probably went too far. Just kind of a reaction because I feel like people go too far thinking it is some amazing drug and that has yet to be shown. Just like people constantly say it has no side effects, which ignores a lot of research saying otherwise.

I am aware of the epilepsy thing, and it seems like a limited labelled use.

I Wasn't aware of the Sativex, interesting item.

One differentiating factor here - just because someone takes an ingredient and thinks it helps then does not mean it helps them. That is not solid evidence. Nobody here is looking to deprive people of whatever treatment they need, but you are a bit too far in accepting peopke need things without any evidence.

I will give you a personal instance of why this is bad. My grandmother has arthritis. Her doctor put her on opoids. I was unaware until escalation had already occured and she was suddenly on fentanyl.

I fought it hard, and my aunt and the doctor pushed back hard. They were concerned with my grandmother's pain and quality of life. They thought they were helping. The opioids were likely making her pain worse, and causing constipation, and infections, and confusion, etc. They were destroying her quality of life in the name of treating pain. And they were not helping the pain.

When I told my aunt the opioids were likely reducing her tolerance to pain she thought I was crazy, because they were pain killers. I must have been crazy.

Sometimes people think things help, and they don't realize they are worthless and doing more harm than good. People like us really want things to work...but they often deliver less than we hope and carry more risk than we admit.

If someone is in pain and wants to treat it themselves, great. But to start recommending things to others can take on another life ...and a lot of these things carry risks that are down played and benefits that are over presented.

There's usually a range of side effects it comes not to the individual and their response. I've seen studies where a few people were cured of a terminal disease but most didn't so the treatment never got approved but for those who did it was a godsend. There's always a degree of uncertainty even with studies we just have to make the best decision we can with what we know.

CBD was approved for 2 rare conditions with more studies on the way for others. GW the drug company who sought approval did so in part because families were traveling to Denver on mass to get CBD to treat their conditions and obviously it looks bad to the FDA so it was an easy win for GW. Studies take a very long time and are only approved for 1 condition at a time which is abit ridiculous and why doctors write offlabel prescriptions because they know studies support other users but also because drugs work differently and in any given condition different factors play different roles.

I disagree that no one is capable of knowing what is helping or works for them especially for pain treatment. There's no way to independently determine how much pain someone is in or if a drug is working...except the one in pain! I think people are getting overtly focused on the FDA and not on how their body responses to something. Do you know if you'll like kissing a girl until you do it? Not always because you don't know if the chemistry is there not really much different with any given treatment. You have to try it to know. Not that it's conclusive but as conclusive as you'll get for now. If I had say a bad reaction to a food but research says it's safe do I continue to eat it or listen to my body and avoid it. Lots of examples of research is not everything but it is important if is is there.

Kratom was used for 100's of years without it being associated with deaths. Cannabis 1,000's even being used in TCM. We don't just dismiss this historial use entirely because we grew up in a different time where only paid studies tell us what may be effective.

Yes there are risks there are always risks with action or inaction. Weight them and make your choice. All we can do. Provided we have choices not entirely decided by one group or one way of thinking.

 

[Jiigzz]

I don’t have a double blind study and decades of safety statistics, but it appears that educated people who are pro government come off as condescending assholes.

Edit: not Hit4Me. He does not come across as talking down to people using snarky remarks the whole time.

This isn't being about pro government, it's about being pro evidence based information.

Those who are posting counter references haven't even read those references, or, if they had, haven't understood the premise of what is actually being said.

A lot of the posts are blog posts which, as Aleks already stated, should not form the basis for scientific enquiry as they are posted without scrunity and often themselves misinterpret data to skew a point.

If you can post solid data counter to what is being posted, then it would be considered and read. At this point, there are people in this thread who are using comparisons between decades of direct weedkiller use getting through the skin to a small amount being present on fruit and vegetables as though they are causing the same effect. It really is mind boggling. But not overly surprising given the state of evidence based minds in this lifetime.

 

[Jiigzz]

CBD was FDA approved as a prescription drug in kids last year under the name Epidiolex which guess what requires phase 1-3 studies which look at safety and effectiveness. Yet you're saying there's NO safety studies or proven benefits??? That's just blatantly false.

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm

Cannabis was also approved awhile ago as a extract spray for MS called Sativex in Europe but US studies in cancer pain did not hold up well. But it's well on it's way to FDA approval as a vape pellet by Tetra Pharm who already did Phase 1 safety studies.

https://www.practicalpainmanagement.com/treatments/pharmacological/fda-grants-orphan-drug-designation-cannabis-pellet

It's made it all the way to Phase 3 studies. Next step approval.

https://www.globenewswire.com/news-release/2019/04/09/1799525/0/en/Tetra-Bio-Pharma-Resumes-its-Phase-3-Clinical-Trial-Program.html

Plus it's been approved for medical use in several states which is unheard of historically but comes down to the fact you can't deny it has benefits. No other time in history has state governments legalized a treatment over the FDA because they disagreed with the DEA and FDA's take on it being schedule 1. But some people don't believe in anything unless a 3 letter group tells them to think.

Regarding kratom and safety studies in general. Such studies are only done by large companies usually seeking gov approval to treat health conditions. Kratom and natural products don't have strong patent protections and logically have less interest regardless of effectiveness because profits are more important typically. Kratom was never an approved drug in other countries like phenibut or most nootropics. Do I blame the herbs for lack of safety data or the system that promotes research on only the most profitable treatments? The latter.

Regardless with kratom it gives patients an option they don't have otherwise and if you've noticed thousands of people are taking it and it works for them. Who is anyone to deny them what helps their condition? Will the FDA take care of those patients when they take away the only treatment that works for them? Who bears the cost to society to have 1,00's of currently functioning people suddenly not have access to effective pain management both morally and financially. There's a reason the DEA held off on scheduling it people organized and fought back for the only thing that actually helped them because the FDA's system failed them.

That's not a safety study, that's an approval announcement.

 

[stimtron]

That's not a safety study, that's an approval announcement.

I posted that to confirm the FDA approved it. FDA requires 3 phases of studies. 1 a safety study. 2 a study on dosing. 3 and effectiveness study. Are you suggesting the FDA approved CBD...in seizure riddled kids without doing any safety research on it? Come on man. I wouldn't say the FDA is evil but they certainly make sure the basics of research are done any anything they approve.

 

[HIT4ME]

That's not a safety study, that's an approval announcement.

I think his point is that if it got FDA approval, based on what Aleks said, it had to likely go through safety trials.

 

[Jiigzz]

I posted that to confirm the FDA approved it. FDA requires 3 phases of studies. 1 a safety study. 2 a study on dosing. 3 and effectiveness study. Are you suggesting the FDA approved CBD...in seizure riddled kids without doing any safety research on it? LOFL man. Come on.

No I'm not, im simply saying you keep posting the wrong evidence to back your stance.

FDA Regulation of Cannabis and Cannabis-Derived Products: Q&A

Questions and answers about FDA regulation of cannabis and cannabis-derived products

www.fda.gov

I'm not even following the CBD point you are trying to make.

 

[Jiigzz]

I think his point is that if it got FDA approval, based on what Aleks said, it had to likely go through safety trials.

For certain medical conditions? I'm sure it is/ has but haven't looked into it.

So what's the issue for contention? That it isn't available to people outside it's prescribed use?

Ill have a read through the links myself

 

[stimtron]

No I'm not, im simply saying you keep posting the wrong evidence to back your stance.

FDA Regulation of Cannabis and Cannabis-Derived Products: Q&A

Questions and answers about FDA regulation of cannabis and cannabis-derived products

www.fda.gov

I'm not even following the CBD point you are trying to make.

I posted it so you can see it's FDA approved which by default means has safety studies on it but if you're more a literal person...

https://www.ncbi.nlm.nih.gov/pubmed/30374683
https://www.ncbi.nlm.nih.gov/pubmed/7413719
https://www.ncbi.nlm.nih.gov/pubmed/30390221

 

[HIT4ME]

For certain medical conditions? I'm sure it is/ has but haven't looked into it.

So what's the issue for contention? That it isn't available to people outside it's prescribed use?

Ill have a read through the links myself

I had over stated my stance on marijuana and he was showing that its constituents do have approved medical uses.

 

[Jiigzz]

I posted it so you can see it's FDA approved which by default means has safety studies on it but if you're more a literal person...

https://www.ncbi.nlm.nih.gov/pubmed/30374683
https://www.ncbi.nlm.nih.gov/pubmed/7413719
https://www.ncbi.nlm.nih.gov/pubmed/30390221

Thanks.

To be honest i dont even know why i injected myself in the cbd discussion because it's got nothing to do with the points i was making lol

 

[stimtron]

For certain medical conditions? I'm sure it is/ has but haven't looked into it.

So what's the issue for contention? That it isn't available to people outside it's prescribed use?

Ill have a read through the links myself

Yes. It's also had safety studies in healthy adults. All phase 1 studies typically look at healthy adults before they give it to those with health conditions.

HIT4ME was commenting there was no safety research at all. He just was not aware about the FDA's approval and safety studies.

When the US gov approved hemp they opened the door for CBD to be legal federally and most states have it legal. Hell Carl Jr's just had a burger special with CBD sauce to celebrate 420 day.

 

[Jiigzz]

I had over stated my stance on marijuana and he was showing that its constituents do have approved medical uses.

Ah, ok makes sense lol. I was skipping over the cbd stuff ITT.

 

[Jiigzz]

Yes. It's also had safety studies in healthy adults. All phase 1 studies typically look at healthy adults before they give it to those with health conditions.

[B]HIT4ME[/B] was commenting there was no safety research at all. He just was not aware that's all.

When the US gov approved hemp they opened the door for CBD to be legal federally and most states have it legal. Hell Carl Jr's just had a burger special with CBD sauce to celebrate 420 day.

Ahh, thanks for clearing that up

 

[Jiigzz]

What people are missing is that regulstory bodies come about because the public requires protection from the unknown.

Small supplement companies have been known to mix products in their own homes, with rudimentary safety procedures (if any at all) and without proper milling of ingredients.

You have companies blanatly deceive consumers by spiking products with anabolics, or ingredients with off label use.

People trust too much in others to be open and honest with them but the reality is they like money and reputation far more. They'd be willing to screw you over in the long term for the sake of a few dollars in the short term.

If you want to be a guinea pig, then you go buy the extracts yourself and mix your own concoction, but the second that product is opened up to the masses, expect to make sure it isnt going to kill anyone. You have a duty of care to everyone that ingests that product, you and you will be held accountable if you mess that up. Period.

People dont just weld together some aluminum plates, attach rocket propulsion and call it a spaceship and expect people to want to fly in it. It goes through rigorous testings all throughout its production cycle to minimise the cost to life.

And while a supplement isn't likely to cause a catastrophic loss to life, it can sure as hell cause a lot of very serious and painful effects. Looked at what happened to the people in Hawaii after something tainted USPlabs products.

The very fact you are open to that is a scary thought. It's like you fail to understand that something grown in nature could produce life threatening side effects.

There is always a lot of irony on these boards. We state that adults have the ability to do the research for themselves, then slam people for buying products based on how pretty the label is. Did you know the average adult in the US reads at an 8th grade level? A large proportion of adults still cannot read.

You think the average reader at an 8th grade level is going through a scientific journal?

 

[stimtron]

What people are missing is that regulstory bodies come about because the public requires protection from the unknown.

Small supplement companies have been known to mix products in their own homes, with rudimentary safety procedures (if any at all) and without proper milling of ingredients.

You have companies blanatly deceive consumers by spiking products with anabolics, or ingredients with off label use.

People trust too much in others to be open and honest with them but the reality is they like money and reputation far more. They'd be willing to screw you over in the long term for the sake of a few dollars in the short term.

If you want to be a guinea pig, then you go buy the extracts yourself and mix your own concoction, but the second that product is opened up to the masses, expect to make sure it isnt going to kill anyone. You have a duty of care to everyone that ingests that product, you and you will be held accountable if you mess that up. Period.

People dont just weld together some aluminum plates, attach rocket propulsion and call it a spaceship and expect people to want to fly in it. It goes through rigorous testings all throughout its production cycle to minimise the cost to life.

And while a supplement isn't likely to cause a catastrophic loss to life, it can sure as hell cause a lot of very serious and painful effects. Looked at what happened to the people in Hawaii after something tainted USPlabs products.

The very fact you are open to that is a scary thought. It's like you fail to understand that something grown in nature could produce life threatening side effects.

There is always a lot of irony on these boards. We state that adults have the ability to do the research for themselves, then slam people for buying products based on how pretty the label is. Did you know the average adult in the US reads at an 8th grade level? A large proportion of adults still cannot read.

You think the average reader at an 8th grade level is going through a scientific journal?

Protection to a degree sure but not where we lose our liberties. If people make claims without any type of backing I see an issue with that. Same with selling something that is very dangerous without warnings. There are always going to be some bad apples out there lacing sups with scripts and what have you. I'm fine with the FDA going after those guys but not at a cost of everything being so regulate there's no more innovation or products that actually do anything. I don't want to live in 1984.

Yes alot of people are ignorant and make bad, poor, unresearched decisions but they actually do this with their diet and life in other ways and suffer the fate of anyone who doesn't read. I don't see why others should suffer because of the actions of their lack of reading skills.

 

[Jiigzz]

Protection to a degree sure but not where we lose our liberties. If people make claims without any type of backing I see an issue with that. Same with selling something that is very dangerous without warnings. There are always going to be some bad apples out there lacing sups with scripts and what have you. I'm fine with the FDA going after those guys but not at a cost of everything being so regulate there's no more innovation or products that actually do anything. I don't want to live in 1984.

Yes alot of people are ignorant and make bad, poor, unresearched decisions but they actually do this with their diet and life in other ways and suffer the fate of anyone who doesn't read. I don't see why others should suffer because of the actions of their lack of reading skills.

Because a society has a duty of care to the lowest common denominator.

When you have blends of like 10-20 ingredients, is the expectation that people are going to research every single ingredient for every single safety test and then make an educated choice, or, does it make more sense if a regulatory body does that for you so that when you buy a compliant supplement you don't have to wonder if you'll make up in agony after your liver starts to shut down?

If i buy a car, i want to make sure it is constructed appropriately. What if joe bloggs decides to build a car and then starts to get mad when the automobile regulatory body tells him he cant mass reproduce it because it hasnt been put through testing? It's then found out that joe bloggs knows nothing about car manufacturing and put the spark plugs in the gas tank.

Regulations product you from cowboys. Most supplement companies don't have dedicated scientists/ RnD making products. They had enough money, had an interest in supplements and BOOM, now selling you products. That's it.

 

[Aleksandar37]

Regulations product you from cowboys. Most supplement companies don't have dedicated scientists/ RnD making products. They had enough money, had an interest in supplements and BOOM, now selling you products. That's it.

.

Exactly. And when it all goes south, scrap it, reinvent, and pop up again. Also, there are reps that just here for hopping from company to company as well and spitting out whatever marketing told them to say without understanding the basics behind it. When I started getting to know people back in the day and seeing behind the curtain, it was scary how the thinking behind some products wasn't based on anything. People were selling a mix of ingredients simply because some other company was doing the same thing. Thankfully there were companies that saw the benefit of bringing people with actual experience and knowledge on board, especially when going into areas beyond protein and creatine supplements.

 

[stimtron]

Because a society has a duty of care to the lowest common denominator.

When you have blends of like 10-20 ingredients, is the expectation that people are going to research every single ingredient for every single safety test and then make an educated choice, or, does it make more sense if a regulatory body does that for you so that when you buy a compliant supplement you don't have to wonder if you'll make up in agony after your liver starts to shut down?

If i buy a car, i want to make sure it is constructed appropriately. What if joe bloggs decides to build a car and then starts to get mad when the automobile regulatory body tells him he cant mass reproduce it because it hasnt been put through testing? It's then found out that joe bloggs knows nothing about car manufacturing and put the spark plugs in the gas tank.

Regulations product you from cowboys. Most supplement companies don't have dedicated scientists/ RnD making products. They had enough money, had an interest in supplements and BOOM, now selling you products. That's it.

It's on the consumer not the maker to determine if something is right for them. Personally I'm surprised people choose to put anything into their bodies without having some idea of what it is. Also what I want others may not it's not like companies are catering to everyone. Demand and supply. I personally want innovative products even with some health risk out there but if someone takes it and has a bad reaction maybe due them being on meds or overdoses that is on them for blindly taking something.

If Joe makes a lousy car he's not going to be in business long. Free market takes take of those situations

So you only want massive corps to offer supplements? or maybe just one company? That is a nightmare scenario. Alot of companies don't have a team of doctors to offer a sup no one else has or some formula they think will work. I go based on the ingredients and doses. Not the size of the company. As long as they have a quality product and there's some basis it may do something I would try it. Typically I'll know in a month if it's working. If it's not well I tried and found out that combo didn't work for me and try something else. I get a chance to try things and get an edge. Gotta love America for that.

 

[stimtron]

.

Exactly. And when it all goes south, scrap it, reinvent, and pop up again. Also, there are reps that just here for hopping from company to company as well and spitting out whatever marketing told them to say without understanding the basics behind it. When I started getting to know people back in the day and seeing behind the curtain, it was scary how the thinking behind some products wasn't based on anything. People were selling a mix of ingredients simply because some other company was doing the same thing. Thankfully there were companies that saw the benefit of bringing people with actual experience and knowledge on board, especially when going into areas beyond protein and creatine supplements.

Some sure and others not. Having freedom to offer products of course does not insure quality or effectiveness. How do we know which computer to buy, or which brand of shoes is going to last us, or what diet works best. Again comes down to trial and error. Supplementation isn't conclusive with all sups but neither is many drugs. Sure we could wait forever for studies to be done especially on combinations but it also may never happen. Alot of us aren't getting any younger I don't mind alittle risk with most sups out there. Honesty I'm not the biggest fan of sups with zero research but if you're tried everything where do you go next? Just give up? Sorry I at least can't do that and I've learned from t and e some products really do work and seem to have no sides. Will I cause an issue later on? I can't say 100%. I could have long term sides from something or benefit long term. It's abit of a gamble but so is doing nothing.

 

[Jiigzz]

It's on the consumer not the maker to determine if something is right for them. Personally I'm surprised people choose to put anything into their bodies without having some idea of what it is. Also what I want others may not it's not like companies are catering to everyone. Demand and supply. I personally want innovative products even with some health risk out there but if someone takes it and has a bad reaction maybe due them being on meds or overdoses that is on them for blindly taking something.

If Joe makes a lousy car he's not going to be in business long. Free market takes take of those situations

So you only want massive corps to offer supplements? or maybe just one company? That is a nightmare scenario. Alot of companies don't have a team of doctors to offer a sup no one else has or some formula they think will work. I go based on the ingredients and doses. Not the size of the company. As long as they have a quality product and there's some basis it may do something I would try it. Typically I'll know in a month if it's working. If it's not well I tried and found out that combo didn't work for me and try something else. I get a chance to try things and get an edge. Gotta love America for that.

Who said anything about company size?

It's on the person marketing and distributing the product to make that product safe. How the hell do you put that responsibility on the consumer? When you buy a supplement, are you walking it through the production line watching for contaminants? Are you testing it yourself for label adherence? Are you QAing the ingredients as they enter the facility and again after the product has reached full production? If not, how the heck can you put the onus of safety on the consumer???? It's not like labels haven't been falsified in the past.

I bet you are the kind of company that Driven Sports like to employ. You'd fit right in.

 

[rob112]

I bet you are the kind of company that Driven Sports like to employ. You'd fit right in.

There it is. Have to talk down to someone for their view.

 

[Jiigzz]

There it is. Have to talk down to someone for their view.

That depends on your view of driven sports. Maybe it's a compliment

 

[rob112]

That depends on your view of driven sports. Maybe it's a compliment

I am willing to be corrected if you meant something different, but i have the feeling you feel like the company is not a company of honesty and integrity which is where you think he would fit in.

Again I am always 100% open to new viewpoints if you mean that another way.

Edit: I want to be 100% clear I do not think DS is a company that is to be trusted.

 

[Jiigzz]

I am willing to be corrected if you meant something different, but i have the feeling you feel like the company is not a company of honesty and integrity which is where you think he would fit in.

Again I am always 100% open to new viewpoints if you mean that another way.

Edit: I want to be 100% clear I do not think DS is a company that is to be trusted.

It can be taken either way.

What i meant was that DS effectively made the consumer responsible for their decisions when choosing to purchase Craze, which is what he seems to want.

However, many customers ended up being shafted by them when they began popping drug tests and being questioned by employers. They thought the product would be safe to use because the assumption is that the producer of products takes consumer safety seriously, however this wasnt the case for them. And thats my argument.

So depending on how you see the protein spiking, the drug spiking, the failed QAs and other aspects will depend on whether it was a compliment or not.

In his case that seems to be the industry he wants to see more of.

It doesn't really matter, as the industry is what it is regardless of what side of the fence you are on

 

[rob112]

It can be taken either way.

What i meant was that DS effectively made the consumer responsible for their decisions when choosing to purchase Craze, which is what he seems to want.

However, many customers ended up being shafted by them when they began popping drug tests and being questioned by employers. They thought the product would be safe to use because the assumption is that the producer of products takes consumer safety seriously, however this wasnt the case for them. And thats my argument.

So depending on how you see the protein spiking, the drug spiking, the failed QAs and other aspects will depend on whether it was a compliment or not.

In his case that seems to be the industry he wants to see more of.

It doesn't really matter, as the industry is what it is regardless of what side of the fence you are on

I don’t want to speak for him but lying to the consumer is absolutely wrong. Attacking that part of the industry I am fine with. That is fraudulent.

My standpoint and what I thought he was saying is we just need to be honest. For example if you bought phenibut and the bottle just said “warning: no long term studies have been conducted”or something and people wanted to use it then who cares.

It might just be the dendrobium talking but I do think you and Alexsandar37 are very smart/valuable posters and I hold no actual ill will towards either of you.

 

[Jiigzz]

I don’t want to speak for him but lying to the consumer is absolutely wrong. Attacking that part of the industry I am fine with. That is fraudulent.

My standpoint and what I thought he was saying is we just need to be honest. For example if you bought phenibut and the bottle just said “warning: no long term studies have been conducted”or something and people wanted to use it then who cares.

It might just be the dendrobium talking but I do think you and Alexsandar37 are very smart/valuable posters and I hold no actual ill will towards either of you.

You make a valid point. And likewise, i dont either.

I guess I just have no trust in companies to do even the smallest due dilligence in trying to make safe products, so i feel more than a few would use a rule like that to pump out shady products.

We're always complaining of bunk, underdosed or spiked products yet we would trust them introducing new ingredients? I guess im cynical.

 

[Wobmarvel]

There is a difference between craze, where there are ingredients in it not listed on the label, and someone buying a bottle labelled phenibut that has phenibut in it and making a decision as to weather or not they want to take it based on the risks.

 

[rob112]

You make a valid point. And likewise, i dont either.

I guess I just have no trust in companies to do even the smallest due dilligence in trying to make safe products, so i feel more than a few would use a rule like that to pump out shady products.

We're always complaining of bunk, underdosed or spiked products yet we would trust them introducing new ingredients? I guess im cynical.

Well you do have plenty of reason to be cynical.

It would be nice to find a middle ground where people can take known risks while simultaneously minimizing unknown risks.

 

[stimtron]

Who said anything about company size?

It's on the person marketing and distributing the product to make that product safe. How the hell do you put that responsibility on the consumer? When you buy a supplement, are you walking it through the production line watching for contaminants? Are you testing it yourself for label adherence? Are you QAing the ingredients as they enter the facility and again after the product has reached full production? If not, how the heck can you put the onus of safety on the consumer???? It's not like labels haven't been falsified in the past.

I bet you are the kind of company that Driven Sports like to employ. You'd fit right in.

Who else can afford the millions in research and studies? Imagine all the claims companies make. If they had to do a study to determine how effective it is for each say weight loss, energy, depression, focus, improved insulin response, etc etc.

As far as I know the FDA currently regulates sup companies just like they do with food and drug companies. They don't inspect everyone all the time so some companies do come out with bad products from time to time. As a consumer how do I know if a brand of milk, aspirin batch, or BHB is pure? There's no official way to know at all. Some people go off of reputation alone others for lab tests. But it's not government required for them to prove anything to you or to them unless they get inspected. So yes it falls on us to make an educated decision to either trust them on what they say or whatever reports they provide or to do the testing ourselves be it by trying it or sending a bottle to a lab.

I think you expect more than what is both legally required from companies and offered by the majority. I make a good faith choice in buying meat or produce hoping it's not high in bacteria but it's on me to properly cook it or clean them to reduce my risk. Just like I see it on me to decide if a product seems safe enough for me to take. It should be my choice not the FDA's. Yes the FDA should review all companies and confirm there's no contaminants but they aren't doing their job. So that's really on them and of course those companies who make bad products.

 

[stimtron]

Well you do have plenty of reason to be cynical.

It would be nice to find a middle ground where people can take known risks while simultaneously minimizing unknown risks.

I think a rating system would be ideal based on what we know of any given chemical.

Safety data, known issues, possible risks based on it's mode of action, and limitations.

Any chemical either has studies in cells (outside the body to see how it affects cell structure so things like cancer, mito function, antioxidant etc) which just gives us an idea of it may do, animal studies which gives an idea of safety and effectiveness, and human studies which is gold standard but very expensive.

There's a ton of supplements with just animals studies which I think makes up half of the supplements out there. I don't see this as a bad thing offhand just that no ones invested into it more. It may or may not have the same effects in humans but it's available for me to try and see what if anything it does. I like this system since it gives me 1,000's of options for whatever health goal I have conventional medicine has nothing for.

Acetylcarnosine eye drops I've been using for years now as supplement and my vision is much clearer and sharper. It's not an fda approved drug but a supplement sold for aging eyes. They have done a handful of studies but given nothing to the FDA. Could the studies have been faked maybe? (although i think a few other researchers saw similar results) but I read the claims looked at the studies and decided it was worth a try. Am i risking my health? Yes but at a chance of a gain which in my case paid. I enhanced myself which I think is the goal of many here. To make ourselves better, stronger, faster, just better for as long as we can. It's why I'm here.

 

[thebigt]

.

Exactly. And when it all goes south, scrap it, reinvent, and pop up again. Also, there are reps that just here for hopping from company to company as well and spitting out whatever marketing told them to say without understanding the basics behind it. When I started getting to know people back in the day and seeing behind the curtain, it was scary how the thinking behind some products wasn't based on anything. People were selling a mix of ingredients simply because some other company was doing the same thing. Thankfully there were companies that saw the benefit of bringing people with actual experience and knowledge on board, especially when going into areas beyond protein and creatine supplements.

They test for that and have safety allowances as referenced above. 30ppm is considered the maximum reference range for glycosphate occurence, with most crops being well under that safe point.

The issue here is that people see that something could be dangerous at high occurences yet apply that to mean it is dangerous at any dose.

If i injected 4g of mercury and subsequently died, is the logical assumption that any level of mercury ingestion dangerous? No it isnt. The dose makes the poison.

not sure if law got passed requiring GMO's to be labeled-I know Monsanto was fighting this....I think the public should have the right to know rather a food product is GMO or not, don't you?

 

[Jiigzz]

not sure if law got passed requiring GMO's to be labeled-I know Monsanto was fighting this....I think the public should have the right to know rather a food product is GMO or not, don't you?

Sure.

I wonder if they were fighting it because the majority of the public have no idea what GMO actually means?

But still, people should be able to choose

 

[thebigt]

Sure.

I wonder if they were fighting it because the majority of the public have no idea what GMO actually means?

But still, people should be able to choose

probably, and what the majority do know they don't like, imo….with the kind of profits Monsanto stands to make I think they should invest in educating the masses, and if they don't make their case the public should be allowed to choose alternative. at any rate GMO's should be required to be labeled as such!!!

 

[Jiigzz]

probably, and what the majority do know they don't like, imo….with the kind of profits Monsanto stands to make I think they should invest in educating the masses, and if they don't make their case the public should be allowed to choose alternative. at any rate GMO's should be required to be labeled as such!!!

Yeah sure, im not sure what the argument against it is. Unless of course it means labelling things like Bananas, Breads (due to wheat modification) etc which would mean most food would have GMO labels lol

 

[thebigt]

Yeah sure, im not sure what the argument against it is. Unless of course it means labelling things like Bananas, Breads (due to wheat modification) etc which would mean most food would have GMO labels lol

exactly, if things were required to be labeled it would make organics even more appealing-people who normally wouldn't pay the additional cost might reconsider. would be great for smaller farms, imo.

 

[stimtron]

exactly, if things were required to be labeled it would make organics even more appealing-people who normally wouldn't pay the additional cost might reconsider. would be great for smaller farms, imo.

The only reason it's not labeled is the same for hormone treated milk, lobbyists hate labels and don't want to word anything that may discourage sales.

 

[Aleksandar37]

not sure if law got passed requiring GMO's to be labeled-I know Monsanto was fighting this....I think the public should have the right to know rather a food product is GMO or not, don't you?

The public (at least here in the US) tends to be lazy and not want to take a few minutes to read and learn something new. It's easier to stay ignorant and angry about things that aren't even true. I see people who I went to school with and barely made it through grade school science classes now not vaccinating their kids and afraid of GMOs because they did their "research" and selling essential oils online. I also see people on these boards who talk about buying organic, but then the same people have no issue buying "research chemicals." If this is me being condescending...good!

I'm all for transparency on new technologies of any sort, so definitely in favor of labels even though it's meaningless in regard to GMO food. Monsanto was also in favor of it... https://monsanto.com/company/commitments/safety/statements/gmo-food-labeling/

 

[Aleksandar37]

exactly, if things were required to be labeled it would make organics even more appealing-people who normally wouldn't pay the additional cost might reconsider. would be great for smaller farms, imo.

I see stuff labeled as organic, but my understanding is that there are a whole lot of loopholes in using that term. Seems like it started as a good idea, but now is a lot of marketing.