FDA sends a warning letter to MA sups over the opioid tianeptine in it's sups

[Standup]

but any supplement that makes non-compliant drug-like claims about diagnosing/treating/curing/etc. any diseases is a drug, and drugs are frowned upon more than adulterated supplements.

Just pointing out this is complete bs on the FDA's part. If supplements have studies supporting treating or preventing disease companies should be able to make honest health claims about it. The idea only the FDA "allows" health claims is more based on $$$ and politics than anything else. It's really disgusting since there are many conditions out there effectively treated with supplements but no one can tell you because the FDA won't let you. Unlike most drugs many supplements lost or never had a patent which is more a biggest factor in having allowed health claims than the research backing up said claims.

 

[muscleupcrohn]

Just pointing out this is complete bs on the FDA's part. If supplements have studies supporting treating or preventing disease companies should be able to make honest health claims about it. The idea only the FDA "allows" health claims is more based on $$$ and politics than anything else. It's really disgusting since there are many conditions out there effectively treated with supplements but no one can tell you because the FDA won't let you. Unlike most drugs many supplements lost or never had a patent which is more a biggest factor in having allowed health claims than the research backing up said claims.

I’m not saying it’s right or wrong, but it’s the current rules, and they were clearly broken lol. I’m a libertarian, you won’t see me personally saying to ban things very often.

 

[JoePaul39]

Man, I am in no way making any statements on the safety of the product AT ALL. I’ve made this abundantly clear. I’m just explaining to the guy that is insisting that the letter was sent to MA because people reported adverse effects from it to the FDA. I explained that it was the fact that they were making drug claims AND had an adulterated supplement that got them the letter. They were on the radar because of the many adverse effects reported in general from supplements containing tianeptine.

I 100% agree that it was the langue and claims that got them the letter. That’s all I’ve been trying to say the whole time man lol.

It is kind of interesting they left Mike alone over his MA Labs company that sells Sarms. There have been busts in the past on “research companies”.

 

[MedRat]

I understand where you're going with this argument, but it's not a valid one IMO.

L-Carnitine is considered a drug in other countries, doesn't mean we should treat it as one.

I'm not one sitting here and defending phenibut mind you. The FDA has declared it non-DSHEA, so in the eyes of the law its technically just as illegal as anything else to put in a dietary supplement. If the argument being made here "against" me is that "well phenibut is sold so this stuff should be able to as well", I'm disagreeing. I'm a HUGE proponent of a level playing field. If its deemed non-DSHEA, it shouldnt be in supplements until someone fights the FDA on it and forces a reclassification. Again, I dislike that we're bound to DSHEA, but the law is the law.

One thing phenibut does going for it however is many many years of human dosing showing that it can be relatively safe.

Now for something like flmodafinil, there is literally nothing out there showing safety. It's not a Rx drug anywhere I can find, but a full blown research chem. This means no human studies, no doctors anywhere writing Rx's for it...just people online consuming a random drug (yet again, I think people should be able to buy & consume whatever the hell they want). There have been 3 Phase I trials apparently on this compound, but to put it in an OTC product without REAL safety data, and given the current climate of FDA actions, man it just seems like a stupid idea to me. If you get away with it however, rock on I guess. I'm however SOLELY arguing the illegality.

I'm prescribed armodafinil due to experiencing extreme lethargy from the seizure medication I have to take daily. That at least has some safety data behind it.



Thank you sir, much appreciated



No, had nothing to do with that. I was given a great opportunity in the pharmaceutical industry and felt it would be my best career move, so I took it.

Armodofinils trade name is Neuvigil. It is a prescription medication for narcolepsy. Modafinil is the middle of the road prescription medication. Then you have the older and unclassified Adrafinil.

So here we have 2 drugs needing a prescription in America and one that doesnt. I felt the need to clarify the distinctions between these three substances.

 

[Standup]

I’m not saying it’s right or wrong, but it’s the current rules, and they were clearly broken lol. I’m a libertarian, you won’t see me personally saying to ban things very often.

Why not? I'm sure you have an opinion on it. The FDA is clearly broken (or bought) not much of a difference.

Bad laws are meant to be broken or changed. It's why many states literally broke the rules and approved cannabis as a medical treatment even though the FDA and DEA says otherwise. If states can do this to help improve the lives of it's citizens who are suffering I don't see an issue with any drug company the same.

What if I may ask would you advise to those in severe pain or with health conditions who can't get access to or don't respond to FDA approved treatments? I'm just curious.

 

[muscleupcrohn]

Why not? I'm sure you have an opinion on it. The FDA is clearly broken (or bought) not much of a difference.

Bad laws are meant to be broken or changed. It's why many states literally broke the rules and approved cannabis as a medical treatment even though the FDA and DEA says otherwise. If states can do this to help improve the lives of it's citizens who are suffering I don't see an issue with any drug company the same.

What if I may ask would you advise to those in severe pain or with health conditions who can't get access to or don't respond to FDA approved treatments? I'm just curious.

I’m not telling a consumer not to buy a non-compliant product, and they really can’t get in trouble for it anyway. I was talking about the topic of this thread, and why the letter was justified, as someone claimed people were claiming the product was somehow compliant.

And this product in particular wasn’t really meant for people with chronic severe pain; it was something to use a few times a week, more recreationally than anything; hell, its name was a portmanteau of VICodin and cocAINE.

I was trying to stay on topic ITT.

But a state has at least some legal recourse to try to disobey federal laws; a supplement company has no recourse with an ingredient that can never even possibly be an ingredient in a dietary supplement.

I think people should be able to use whatever they want, drugs included, but don’t confuse my (non-lawyer) analysis of the situation with my personal beliefs and ideology.

 

[VaughnTrue]

Just pointing out this is complete bs on the FDA's part. If supplements have studies supporting treating or preventing disease companies should be able to make honest health claims about it. The idea only the FDA "allows" health claims is more based on $$$ and politics than anything else. It's really disgusting since there are many conditions out there effectively treated with supplements but no one can tell you because the FDA won't let you. Unlike most drugs many supplements lost or never had a patent which is more a biggest factor in having allowed health claims than the research backing up said claims.

Supplements CAN give drug claims, when the same burden of proof is provided that drugs are mandated to have. It’s a category called “medical foods”. No, it’s not vitamin pizza or something like that, but are pills/powders that contain primarily vitamins/minerals/things we’d normally associate with supplements that have been rigorously studied and proven to provide drug like benefits.

Literally any supplement can make drug like claims...just have to prove it first. Something just about no supplement company wants to actually pay for because it costs more money for the studies than supp companies will gross in 25 years

 

[Standup]

Supplements CAN give drug claims, when the same burden of proof is provided that drugs are mandated to have. It’s a category called “medical foods”. No, it’s not vitamin pizza or something like that, but are pills/powders that contain primarily vitamins/minerals/things we’d normally associate with supplements that have been rigorously studied and proven to provide drug like benefits.

Literally any supplement can make drug like claims...just have to prove it first. Something just about no supplement company wants to actually pay for because it costs more money for the studies than supp companies will gross in 25 years

Yes and it costs far more than it should. Many supplements are already approved as drugs in other countries but the FDA does not take any research outside the US as valid or any research that is not done by the drug company trying to get approval which is pretty ridiculous.
.
Heh rigorously studied and proven how many FDA approved drugs get taken off the market after killing abunch of people or later on found to be ineffective. The FDA's approval process is an expensive joke and part of why drugs are so expensive to behind with. It does not help many FDA officials work switch jobs between drug companies and the FDA. People can't even afford insulin or epipen these days.

I think there should be degrees of approvals since it's obviously not a black or white issue. Insure companies are producing products without purity issues and let consumers decide based on the research if it's worth a shot. Have them sign a waiver understanding the risks. Otherwise all you're going to do is create a black market for drugs or people will resort to unsafe drugs aka people overdosing on K2 instead of cannabis, or worse people who really need treatments will never afford them or get the help them need. Who's hands are on those deaths? FDA, drug companies, and congress for not improving access to treatments.

Health should be treated more as a public issue not a for profit business. Hell some hospitals are starting their own drug companies for meds since they are being ripped off by the drugmakers.

 

[muscleupcrohn]

Health should be treated more as a public issue not a for profit business. Hell some hospitals are starting their own drug companies for meds since they are being ripped off by the drugmakers.

Technically the FDA’s regulations ARE the public (government) getting involved in the issue.

And before someone says that it’s the drug companies buying the government, that would mean the problem is corporatism, not capitalism. And the best solution to corrupt government probably isn’t more government IMO.

 

[Standup]

Technically the FDA’s regulations ARE the public (government) getting involved in the issue.

And before someone says that it’s the drug companies buying the government, that would mean the problem is corporatism, not capitalism. And the best solution to corrupt government probably isn’t more government IMO.

The government is run by businesses whose focus is making money not saving lives. The public themselves have little impact on gov regulations. Just because many vote for someone who is being funded by lobbyists does not mean they are going to do anything to actually benefit their constituents.

Capitalism and corporatism are interrelated. But it's more profitable to sell a pill than offer a cure and with the current regulations very difficult to get any drug approved without massive investments and political clout. I'm fine with there being a type of gov process but equally an alternative one with labels stating not fda approved with an independent body. I'm fine with less gov the line between regulation and making profits is too thin otherwise. Many laws and regulations while appearing good may exist entirely as ways to raise funds yet are promoting as helping keep you safe.

https://riderinstitute.org/pages/draco

Probably one of the most promising treatments to cure all viruses yet no one is funding it. Wonder why.

 

[De__eB]

https://riderinstitute.org/pages/draco

Probably one of the most promising treatments to cure all viruses yet no one is funding it. Wonder why.

Probably because there are already numerous other pipeline broad spectrum anti-virals in development, and there's nothing to indicate that DRACO is any more worth research dollars then the projects already underway.

Not everything is a conspiracy.

 

[muscleupcrohn]

Probably because there are already numerous other pipeline broad spectrum anti-virals in development, and there's nothing to indicate that DRACO is any more worth research dollars then the projects already underway.

Not everything is a conspiracy.

So much that last part. This is why I didn’t want to get involved in speculation or discussion of legislation and healthcare philosophy, as most people already have their minds entirely made up, so I figured I’d stick to the topic of the thread where we can deal in relevant facts instead of speculation and in issues where there’s no one right answer.

 

[Standup]

Probably because there are already numerous other pipeline broad spectrum anti-virals in development, and there's nothing to indicate that DRACO is any more worth research dollars then the projects already underway.

Not everything is a conspiracy.

Probably? Where? Why do you say nothing shows DRACO isn't effective or worth researching? What about their approach of published studies do you think is not suggestive it is a worthwide approach?

 

[muscleupcrohn]

Probably? Where? Why do you say nothing shows DRACO isn't effective or worth researching? What about their approach of published studies do you think is not suggestive it is a worthwide approach?

The burden of proof is on you to explain why you believe it should be funded more than it is, as you’re the one who originally brought it up, no?

 

[Standup]

The burden of proof is on you to explain why you believe it should be funded more than it is, as you’re the one who originally brought it up, no?

It's a novel approach and in animals studies was 100% effective and safe. There is no reason not to fund human studies. If you didn't know animal studies are the first step in getting a treatment FDA approved.

I think you read too much propaganda and not enough research.

 

[Standup]

So much that last part. This is why I didn’t want to get involved in speculation or discussion of legislation and healthcare philosophy, as most people already have their minds entirely made up, so I figured I’d stick to the topic of the thread where we can deal in relevant facts instead of speculation and in issues where there’s no one right answer.

So if you're not sure about something you avoid discussing it? Theories as well as fact are critical in expressing thoughts and relevant data to any subject. The FDA approval process factually has a long history of corruption. You can read and learn some cases examples here.

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

 

[muscleupcrohn]

So if you're not sure about something you avoid discussing it? Theories as well as fact are critical in expressing thoughts and relevant data to any subject. The FDA approval process factually has a long history of corruption. You can read and learn some cases examples here.

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

No, I try to stick to the topic of the thread if it is still being discussed. Switching to “should an ingredient be banned,” and “how should the FDA operate” weren’t the topic, so I wanted to be sure that the original questions were put to rest before switching topics. That is all.

When did I ever say I agreed with anything the FDA does? You act like me saying I’m making no comment means I’m defending them. I’m not beholden to addressing your related topics man.

 

[muscleupcrohn]

It's a novel approach and in animals studies was 100% effective and safe. There is no reason not to fund human studies. If you didn't know animal studies are the first step in getting a treatment FDA approved.

I think you read too much propaganda and not enough research.

Propaganda? I never said that the drug you brought up wasn’t promising, only that the burden of proof to show it warrants more research was on you, as you brought up the drug, not anyone else. I never claimed the drug wasn’t promising, only that it was on you to show it, since you made the claim. Two entirely different things; telling you to show proof (which I did) and claiming there is no proof (which I did not do).

 

[Aleksandar37]

It's a novel approach and in animals studies was 100% effective and safe. There is no reason not to fund human studies. If you didn't know animal studies are the first step in getting a treatment FDA approved.

I think you read too much propaganda and not enough research.

Yeah, Theranos had a novel concept too and look at how that turned out. I've seen drugs make it through pre-clinical, Phase I, and Phase II to simply not work. So if you're pushing one of an infinite number of biotech companies as the second coming based on in vitro and mice studies, then that's clearly propaganda and not research. If you read the FAQ from the link you posted, it says exactly why they haven't been picked up yet, but leaves out the part that this company is one of many that go this route. This is the way to make money in pharma now: start a small biotech, find something that looks promising, get bought out by a big pharma company, retire. Pharma companies have to gamble on who they buy since they'll be dumping in a lot of money and time over the next several years that they fund each phase of the clinical trials, and there is a huge pool of companies that they are picking from. Once they actually show promise, maybe they'll have a shot.

 

[Standup]

Yeah, Theranos had a novel concept too and look at how that turned out. I've seen drugs make it through pre-clinical, Phase I, and Phase II to simply not work. So if you're pushing one of an infinite number of biotech companies as the second coming based on in vitro and mice studies, then that's clearly propaganda and not research. If you read the FAQ from the link you posted, it says exactly why they haven't been picked up yet, but leaves out the part that this company is one of many that go this route. This is the way to make money in pharma now: start a small biotech, find something that looks promising, get bought out by a big pharma company, retire. Pharma companies have to gamble on who they buy since they'll be dumping in a lot of money and time over the next several years that they fund each phase of the clinical trials, and there is a huge pool of companies that they are picking from. Once they actually show promise, maybe they'll have a shot.

DRACO did actually do animal studies funded by the gov and they were very promising. However it could lead to a cure for all viruses. Obviously drug companies who make antivirals or those who have stock in those companies would not want to support this type of research. Can you imagine the loss of sales from every antiviral company and truly say this is not something that would ever happen? All businesses act to promote their own interest and will and have historically put pressure on those who want to do something different or better. If you look at Edison and Tesla's Edison spend alot of funds and smear campaigns against Telsa. No truly success business or monopoly would do nothing to both protect and serve their own self interests. Ask yourself if you were rich what lengths would you go to ensure your company has no competitors?

Just look at more recent examples like Uber.

https://www.autoblog.com/2014/01/26/gett-accuses-uber-unfair-tactics/

"Gett, another ride-sharing app, alleges that Uber employees in New York City ordered and canceled more than 100 of its cars over the course of several days last week, according to a report from CNN Money. That wasn't the real mischief, though. Gett includes a driver's cellphone number once the order has been submitted. Allegedly, the Uber employees called and attempted to recruit the rival drivers, offering money were they to switch sides."

And that's just one report who knows how much goes on behind the scenes?

 

[Aleksandar37]

DRACO did actually do animal studies funded by the gov and they were very promising. However it could lead to a cure for all viruses. Obviously drug companies who make antivirals or those who have stock in those companies would not want to support this type of research. Can you imagine the loss of sales from every antiviral company and truly say this is not something that would ever happen? All businesses act to promote their own interest and will and have historically put pressure on those who want to do something different or better. If you look at Edison and Tesla's Edison spend alot of funds and smear campaigns against Telsa. No truly success business or monopoly would do nothing to both protect and serve their own self interests. Ask yourself if you were rich what lengths would you go to ensure your company has no competitors?

Just look at more recent examples like Uber.

https://www.autoblog.com/2014/01/26/gett-accuses-uber-unfair-tactics/

"Gett, another ride-sharing app, alleges that Uber employees in New York City ordered and canceled more than 100 of its cars over the course of several days last week, according to a report from CNN Money. That wasn't the real mischief, though. Gett includes a driver's cellphone number once the order has been submitted. Allegedly, the Uber employees called and attempted to recruit the rival drivers, offering money were they to switch sides."

And that's just one report who knows how much goes on behind the scenes?

How the hell are you going to tell other people to focus on research when all you're doing is spreading conspiracy bull****? You didn't listen to a word I said and obviously don't know how research or these companies work. Yeah, they had an NIH grant and they showed an effect in a dish and in mice. So what? As I said, I've seen drugs show promise in pre-clinical, and then in human phase I and II trials, only to fail in phase III. But let me guess, somebody on youtube or reddit convinced you that there's a global conspiracy because some guy with an effect in a dish and mice is having trouble getting funding. Everybody is having trouble getting funding!

And why are you using Uber as an example to prove your point?!?! And Edison and Tesla?! Lay off the facebook ****ery and look into the actual research. If you think animal studies automatically equal efficacy and safety in human patients, you're going to be disappointed a lot. Using your own logic, why wouldn't a company pick DRACO up and make a huge profit off of it? What financial sense does it make to just let it sit?

 

[Standup]

How the hell are you going to tell other people to focus on research when all you're doing is spreading conspiracy bull****? You didn't listen to a word I said and obviously don't know how research or these companies work. Yeah, they had an NIH grant and they showed an effect in a dish and in mice. So what? As I said, I've seen drugs show promise in pre-clinical, and then in human phase I and II trials, only to fail in phase III. But let me guess, somebody on youtube or reddit convinced you that there's a global conspiracy because some guy with an effect in a dish and mice is having trouble getting funding. Everybody is having trouble getting funding!

And why are you using Uber as an example to prove your point?!?! And Edison and Tesla?! Lay off the facebook ****ery and look into the actual research. If you think animal studies automatically equal efficacy and safety in human patients, you're going to be disappointed a lot. Using your own logic, why wouldn't a company pick DRACO up and make a huge profit off of it? What financial sense does it make to just let it sit?

I cited references for my factual statements. I know exactly how research works and how some research doesn't happen because of stigmas or pressure to insure it does not happen.

It's not a conspiracy that companies use dirty tactics to insure they don't compete with them. That's just humanity you idiot.

If you don't understand my examples it shows your utter lack of intelligence. It shows companies have historically sabotaged other companies. If you don't think history can repeat it self then you are ****ing retarded. I never said animal studies equal human studies. Don't put words in my mouth or I'll put your foot or worse in yours.

Wow. How much profit is there in curing all viruses as oppose to taking a pill to manage everyday? Think man. But you don't seem capable of critical thinking. If I was a company who made antivirals I would do everything in my power to ensure that treatment never saw the light of day.

Another example the Einstein refrigerator was created as a far more effective and safer fridge but Electrolux bought up the patent and what did they do with the tech? They buried it. Why buy patents and never use them? So there's no competition. Still doesn't make sense to you then you're replying emotionally and not actually looking at the facts at hand. So take some Midol and chill out.

 

[Aleksandar37]

I cited references for my factual statements. I know exactly how research works and how some research doesn't happen because of stigmas or pressure to insure it does not happen.

It's not a conspiracy that companies use dirty tactics to insure they don't compete with them. That's just humanity you idiot.

If you don't understand my examples it shows your utter lack of intelligence. It shows companies have historically sabotaged other companies. If you don't think history can repeat it self then you are ****ing retarded. I never said animal studies equal human studies. Don't put words in my mouth or I'll put your foot or worse in yours.

Wow. How much profit is there in curing all viruses as oppose to taking a pill to manage everyday? Think man. But you don't seem capable of critical thinking. If I was a company who made antivirals I would do everything in my power to ensure that treatment never saw the light of day.

Another example the Einstein refrigerator was created as a far more effective and safer fridge but Electrolux bought up the patent and what did they do with the tech? They buried it. Why buy patents and never use them? So there's no competition. Still doesn't make sense to you then you're replying emotionally and not actually looking at the facts at hand. So take some Midol and chill out.

You cited completely irrelevant examples. A transportation company did something sketchy to another transportation company so all of pharma is evil? And now you're talking about refrigerators?! If you actually knew what you were talking about, you wouldn't be this excited over pre-clinical data. So now you have to lash out and cite some more examples you pulled off the internet without any actual real world experience.

 

[De__eB]

Probably? Where? Why do you say nothing shows DRACO isn't effective or worth researching? What about their approach of published studies do you think is not suggestive it is a worthwide approach?

I never said it wasn't effective.

There's a dozen other broad spectrum anti-virals under research.

Why would people fund his when they can fund their own?

What specific data indicates that DRACO is more promising than the other antivirals? One in vivo study and some in vitro data?

 

[Mike Arnold]

people act funny when money is involved.

I never said it was compliant.

 

[Mike Arnold]

oh I'm in full agreement there. I've always been and will always be a "it should be legal to sell" person. my laughter here was the argument(s) saying it wasn't illegal to sell (due to multiple ingredients).

Again, I never said it was compliant.

 

[Mike Arnold]

:box::You_Rock_Emoticon:

Thanks, brother.

 

[Mike Arnold]

It was inarguably not compliant lol. I don’t even see how that was up for debate. I always interpreted the view MA had as “I’ll sell this non-compliant supplement until I’m told to stop.” Maybe that was just how I interpreted it because that’s the only halfway logical explanation really. Of course the Tianeptine was much higher on the governing agency’s radar, and many other grey-market ingredients are also non-compliant but much less likely to result in getting a letter.

Exactly. Unlike what Vaugh is saying, I never once said it was compliant.

 

[Mike Arnold]

Just curious why not? Phenibut is a prescription medication in other countries just as modifinil is here in the US. And from an addictive standpoint one could argue that phenibut is the more addictive and dangerous of the two.

( also Vaughn not trying to get into any type of argument with you just curious about your thoughts on this?)

Correct. Phenibut is undoubtedly potetially more addictive and dangerous. Yet, tons of top supp companies sell it without issue. I, for one, am glad the FDA doesn't drop the hammer on every non-compliant compound (and belive me, they know about them). Otherwise, a TON of the industry's best-selling products would be gone. The FACT is that the FDA often cuts the industry a break and really only goes after something if they think it has the potential to cause real issues...and even then sometimes they leave it alone. They are not as hard on the industry as many think. In fact, a LOT of the time they are pretty cool about things. They drew a hard line on tianeptine in dietary supps, but they let many others slide. Look at synthetic DMHA, phenibut, Huperzine-A and a 1,000 others. All are non-compliant, yet the FDA doesn't come down on them because they aren't going to fighht battles that don't need to be fought. Only the bigger stuff generally draws their attention...and yes, sometimes they ban stuff that probably shouldn't be baned (ex. some of the stims, for instance), but most of the time, when they ban something, it is because the compound(s) are beyond grey and entering the black zone, such as designer steroids, etc.

Tons of benign, non-compliant supps are sold every single day, yet how many of the guys in this thread criticizing me for selling a non-compliant product currently use or at least have used non-compliant products? I would say most or even all. It's similar to the people that made milions off of Superdrol that now persecute other supp companies for selling SARMs. As far as I am concerned, if you ever used, sold, or benefitted in any way from the sale of a non-compliant product, you have absolutely ZERO right to criticize anyone's decision to sell a product on the grounds of "non-compliance".

 

[Mike Arnold]

No one was harmed? The FDA says otherwise. Take your beef up with them.



And rest assured, I've had plenty of beef with people putting out dangerous products.

But I can also assure you, it's nothing personal. I'll congratulate people on a good product, hassle them on underdosed crap, and harass them over things that are dangerous.



I've been around the block a while, and I'm already not particularly well-liked.



First off, if you yourself knew a product was illegal and that the FDA would pull it, then why would you sell it, lol.

Secondly I defer back to...

LOL. Bro, that comment was NOT specifically in regards to Vicaine, but tianeptine products in general. There was not a single adverse event report filed on Vicaine. If there were, it would have been mentioned by name, as Vicaine is a combination product containing 7 ingredients. All documented adverse reports can be pulled up and posted, so please, let's see the adverse report on Vicaine. They don't exist. Nice try.


Fortunately, the members here are bright enough to see through this slanderous crap.

 

[Mike Arnold]

error

 

[Mike Arnold]

So they had adverse events from Tianeptine products, and then sent warning letters to manufacturers of OTHER tianeptine products instead of the ones that generated the adverse events?

Now you're just acting dumb.

Plenty of sellers of tianeptine have ALREADY received letters--long before me. It was THEIR products that generated adverse event reports, not mine. Agaain, you either aren't as intelligent as you appear, or you are being disingenuous. I believe it is the latter.

 

[WesleyInman]

Speaking of Law and "Policies" .....

To those guys here, who don't sell supplements, you might be shocked at the stuff that goes on behind the scenes.

I had an Online Protein Only retail store. And my high-risk merchant account got shut down and of course they tried seizing/freezing the funds. The issue according to the bank is that Protein can now be considered a "quasi-pharmaceutical". And the Product description described that increased protein intake can lead to additional increases in Muscle Mass.

So I had to argue with some idiot on the phone for an hour, that protein powder is still a food, not a "quasi-pharmaceutical"....

Mind you these people work for banks and have ZERO clue what a supplement even is. This is alot of the reason companies do what they wish is because very often, the Gov't and it's entities, they do whatever they want. They break their own laws regularly. They make **** up as they go. They do whatever they want when they want. So alot of people say screw it....

Some of you may not believe this ,but I assure you behind the scenes, there is alot of crap going on.

I know for fact one of the top reasons Merchant Accounts are taken away and denied from Supplement Company owners, is that many of them rely on a specific company ( I won't name) This company is hired to determine if a companies products are "in compliance". The owner of this company is not only and Ex-FDA staff, but further he has worked in lobbying for Big-Pharma (conflict of interest you say? Absolutely) So anyways you have the "Match List" which is a legal way they ban and blacklist companies and brands...But this Company, they not only rely on that, but they also have their "off the grid" Match list that exists (but doesn't) So once you are on this list they will simply continually shut you down, and/or even make up lies to get your current bank/merchant account to shut you down. One of their most notorious tricks is that if you have a product that has been renamed. Say Angel Dust by Blackstone Labs. Even if you are sellling the new legal version, they will advise your Bank and that other company I am speaking of, that you are selling "ANGEL DUST" and they will even then lie and reference the old version send them the old labels with the banned compounds. And even if your new product description shows that you are not selling that version. They get to shut your account down. Sometimes they seize or refund your funds. Sometimes they hold a reserve upwards of 6-9 months.

Trust me, this happens regularly.

 

[De__eB]

Now you're just acting dumb.

Plenty of sellers of tianeptine have ALREADY received letters--long before me. It was THEIR products that generated adverse event reports, not mine. Agaain, you either aren't as intelligent as you appear, or you are being disingenuous. I believe it is the latter.

Which Tianeptine warning letters predate the two in November?

I don't see any in the FDAs published list or federal register, though I might have missed them.

There's also doesn't actually appear to be any published adverse events in CFSANs database at all for Vicaine, or any tianeptine product for that matter, at least not in Q1-3 of last year.

I get a feeling when they say adverse events they mean they're getting hospital reports, not actual submissions to CAERS or something.

--

I will say this, if your product didn't generate any adverse events, then I do apologize for suggesting it has. I've just never seen a situation come up where the FDA announced they were sending warning letters based on adverse events, and not been referring to the companies they're sending the letters to. You know what they say about assumptions.

--

My stance that marketing that kind of product for human consumption on the open market and not through not for human consumption research side of things remains. There's a gaping loophole we can all use to get our hands on non-compliant compounds, without creating negative PR for the supplement market and no good reason not to use it.

 

[meatneck71]

Although I am working on a "mood" supplement myself. R&D is a long process, and it probably won't be cheap when I bring it out. As the raws—at these dosages— are expensive. Also debating on making 100% DSHEA compliant or not. It should work while being complaint; however, it won't hit a few pathways that I think will really aid in this product being successful. Also depression is a complex thing, with sooooo many pathways involved.

. I was so impressed with this vicaine, I delve further into what was actually in this mix and started capping my own version following what was on the ingredients on the side of the bottle. I was surprised that I was actually able to find all of the ingredients online. It is rather expensive to make these as you need to buy in bulk raws to save money overall. I make a few batches here and there, and give them out to some family members who work out. Everything from the original formula is included.

 

[Outofbody]

I miss how easy it used to be to get capped or bulk tianeptine. Was the best thing for mood and productivity for me.

 

[meatneck71]

I miss how easy it used to be to get capped or bulk tianeptine.

Was the best thing for mood and productiviy for me.

There are plenty of companies that still sell it as research compounds.

 

[Outofbody]

There are plenty of companies that still sell it as research compounds.

I’ve found a bunch but they all want me to scan and send a copy of my passport before doing business. That’s super risky.

 

[stimtron]

Seems it's on track to be FDA approved as a prescription drug so can't have anyone buying it online.

https://www.biospace.com/article/releases/tonix-pharmaceuticals-announces-issuance-of-u-s-patent-for-crystalline-tianeptine-oxalate-salt-the-active-ingredient-of-tnx-601/

 

[MedRat]

This is complete bullshit. I've seen too much of this lately. Tianeptine is first banned, then repurposed. Drugs such as Dasatanib and rapamycin are heading that same direction. Rapamycin is an oral medication but, in New Zealand and Australia it's also available as a topical cream for advanced skin repair and rejuvenation. Yet the U.S. won't get it until at least 2022. On top of that the U.S. market will charge a fortune for it. This is absolutely repulsive and we don't need to take this horse crap. I for one say screw U.s. laws!!!!!

 

[MedRat]

This is complete bullshit. I've seen too much of this lately. Tianeptine is first banned, then repurposed. Drugs such as Dasatanib and rapamycin are heading that same direction. Rapamycin is an oral medication but, in New Zealand and Australia it's also available as a topical cream for advanced skin repair and rejuvenation. Yet the U.S. won't get it until at least 2022. On top of that the U.S. market will charge a fortune for it. This is absolutely repulsive and we don't need to take this horse crap. I for one say screw U.s. laws!!!!!

 

[Aleksandar37]

Seems it's on track to be FDA approved as a prescription drug so can't have anyone buying it online.

https://www.biospace.com/article/releases/tonix-pharmaceuticals-announces-issuance-of-u-s-patent-for-crystalline-tianeptine-oxalate-salt-the-active-ingredient-of-tnx-601/

That's not the only reason https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6072055/

The patent is for tianeptine oxalate and they're just now starting the Phase I trial. It's a long way off from approval, but they're the ones willing to put the money and time into it.

 

[Aleksandar37]

This is complete bullshit. I've seen too much of this lately. Tianeptine is first banned, then repurposed. Drugs such as Dasatanib and rapamycin are heading that same direction. Rapamycin is an oral medication but, in New Zealand and Australia it's also available as a topical cream for advanced skin repair and rejuvenation. Yet the U.S. won't get it until at least 2022. On top of that the U.S. market will charge a fortune for it. This is absolutely repulsive and we don't need to take this horse crap. I for one say screw U.s. laws!!!!!

What are you talking about? Dasatanib has been approved in the US since 2006 and Rapamycin like a decade before that!

 

[MedRat]

This is complete bullshit. I've seen too much of this lately. Tianeptine is first banned, then repurposed. Drugs such as Dasatanib and rapamycin are heading that same direction. Rapamycin is an oral medication but, in New Zealand and Australia it's also available as a topical cream for advanced skin repair and rejuvenation. Yet the U.S. won't get it until at least 2022. On top of that the U.S. market will charge a fortune for it. This is absolutely repulsive and we don't need to take this horse crap. I for one say screw U.s. laws!!!!!

What are you talking about? Dasatanib has been approved in the US since 2006 and Rapamycin like a decade before that!

For anti aging purposes. Dasatanib has been found to destroy senescent cells while Rapamycin pills make mTORC1 fluctuate when taken once every 5-7 days, reducing inflammation. Chronic systemic inflammation is one of the main reasons we age and die.

 

[Aleksandar37]

This is complete bullshit. I've seen too much of this lately. Tianeptine is first banned, then repurposed. Drugs such as Dasatanib and rapamycin are heading that same direction. Rapamycin is an oral medication but, in New Zealand and Australia it's also available as a topical cream for advanced skin repair and rejuvenation. Yet the U.S. won't get it until at least 2022. On top of that the U.S. market will charge a fortune for it. This is absolutely repulsive and we don't need to take this horse crap. I for one say screw U.s. laws!!!!!

For anti aging purposes. Dasatanib has been found to destroy senescent cells while Rapamycin pills make mTORC1 fluctuate when taken once every 5-7 days, reducing inflammation. Chronic systemic inflammation is one of the main reasons we age and die.

I'm aware of what they do, especially dasatanib in oncology. Your post makes it sound like these are readily available and the FDA is just now banning them. Sure, inflammation plays a role in aging, but it's not the only factor and it won't be an mTOR inhibitor cream that stops it.

 

[stimtron]

This is complete bullshit. I've seen too much of this lately. Tianeptine is first banned, then repurposed. Drugs such as Dasatanib and rapamycin are heading that same direction. Rapamycin is an oral medication but, in New Zealand and Australia it's also available as a topical cream for advanced skin repair and rejuvenation. Yet the U.S. won't get it until at least 2022. On top of that the U.S. market will charge a fortune for it. This is absolutely repulsive and we don't need to take this horse crap. I for one say screw U.s. laws!!!!!

Funny you mention this I ordered some of each awhile ago to try out. Dasa first to kill most of my zombie cells and rapa to keep the zombie cells at bay. Have you tried either?

Those in power really just don't want anyone buying rcs. Which supply and demand if people want it they will usually find a way.

 

[stimtron]

I'm aware of what they do, especially dasatanib in oncology. Your post makes it sound like these are readily available and the FDA is just now banning them. Sure, inflammation plays a role in aging, but it's not the only factor and it won't be an mTOR inhibitor cream that stops it.

A handful of companies sell both. Pricey as **** though. With you on skin aging there's alot going on.

 

[stimtron]

That's not the only reason https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6072055/

The patent is for tianeptine oxalate and they're just now starting the Phase I trial. It's a long way off from approval, but they're the ones willing to put the money and time into it.

FDA doesn't really care about people dying from their own choices. Moreso people having a choice other than what the FDA allows.

We'll see if they get breakthrough designation it could be sooner than later. But yeah they are continuing where Servier left off.

https://www.ncbi.nlm.nih.gov/pubmed/16329631

I'm not really impressed they took an old generic drug and slightly tweaked it to gain greater patent protections. Not the first time they did it and last time it failed epically for them.

https://www.reuters.com/article/us-tonix-study-idUSKCN11C1BU

Their stocks aren't looking so hot so we'll see how it all pans out.

https://www.nasdaq.com/market-activity/stocks/tnxp

It's already established as a very safe drug when used as indicated (you know unless you're a addict) even if it does gain approval the price won't be worth it for most over the rcs you can get right now. Or Stablon brand name from zxy online pharmacies.

 

[Aleksandar37]

I'm not really impressed they took an old generic drug and slightly tweaked it to gain greater patent protections. Not the first time they did it and last time it failed epically for them.

https://www.reuters.com/article/us-tonix-study-idUSKCN11C1BU

Their stocks aren't looking so hot so we'll see how it all pans out.

https://www.nasdaq.com/market-activity/stocks/tnxp

It's already established as a very safe drug when used as indicated (you know unless you're a addict) even if it does gain approval the price won't be worth it for most over the rcs you can get right now. Or Stablon brand name from zxy online pharmacies.

It's sort of become the norm now for smaller companies like this to take the risk by running the trials and then, if it looks promising, a larger company buys their company and they walk away with a nice pile of cash. Usually what happens though is they fail in one of their trials and the entire company goes away. The annoying thing is that a lot of these smaller companies don't know how to set up a proper trial, so even if they make it to approval, it's some weird indication with a bunch of restrictions. Looking at their pipeline, Tonix looks like they're trying a bunch of different angles and hoping one of them sticks.

And even if they get a breakthrough designation or some other label to fast-track approval, a lot of doctors won't use it. Some community docs might, but physicians at larger institutions want to see data backing up the drug, regardless of if there is approval or not. Most times there are other drugs in that space already or they'll use something else off label before using an approved drug that got rushed through trials.