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

[kisaj]

Funny how many of us were arguing with MA about this product and it all just comes out now.

 

[muscleupcrohn]

I'm trying to find the thread but having a hard time. I fought back and forth for quite a while, and even went in DEEP with screen shots from the label and direct law quotes etc.


What amazes me is what else MA labs is still selling despite getting this letter:

https://masupps.com/product/gw/ - non compliant, illegal dietary supplement.

https://masupps.com/product/somatozine/ - non compliant, illegal dietary supplement

I always thought everyone knew/admitted it wasn’t compliant, and that they’d sell until they were caught and told not to? It was bold to actually sell it with directions and as a dietary supplement instead of a “RC not for human consumption,” but I never thought they claimed it was compliant. Sort of a “we’ll do this until we can’t” sort of deal. Maybe I’m wrong?

 

[VaughnTrue]

I always thought everyone knew/admitted it wasn’t compliant, and that they’d sell until they were caught and told not to? It was bold to actually sell it with directions and as a dietary supplement instead of a “RC not for human consumption,” but I never thought they claimed it was compliant. Sort of a “we’ll do this until we can’t” sort of deal. Maybe I’m wrong?

the thread in question was the owner and me going at it. He was the most vocal about why it wasn't illegal. I believe he deleted the thread from what I recall.

 

[muscleupcrohn]

the thread in question was the owner and me going at it. He was the most vocal about why it wasn't illegal. I believe he deleted the thread from what I recall.

I don’t remember that. I do remember I went back and forth about my concerns with him being as clear as possible about the addictive potential of the ingredient, but I don’t recall anyone claiming it was a compliant dietary supplement. Maybe I missed it? But I think Mike is smarter than thinking it was somehow compliant. Hell, even Noopept isn’t technically compliant, and I don’t think you’ll see many people arguing that it is, yet it’s so low on the radar of the governing agencies and is well tolerated that many companies use it anyway, if that makes any sense.

 

[VaughnTrue]

I don’t remember that. I do remember I went back and forth about my concerns with him being as clear as possible about the addictive potential of the ingredient, but I don’t recall anyone claiming it was a compliant dietary supplement. Maybe I missed it? But I think Mike is smarter than thinking it was somehow compliant. Hell, even Noopept isn’t technically compliant, and I don’t think you’ll see many people arguing that it is, yet it’s so low on the radar of the governing agencies and is well tolerated that many companies use it anyway, if that makes any sense.

people act funny when money is involved.

 

[carguy123]

Im slightly confused regarding all this backlash against this product, unless people are fighting saying it is compliant. Which it never obviously was.

But if we are just talking about using "grey area" ingredients then this can be applied to most brands on this site. Noopept, phenibut, DMAA,DMHA, Amp Citrate all fall into this spectrum if you want to argue details

 

[VaughnTrue]

Im slightly confused regarding all this backlash against this product, unless people are fighting saying it is compliant. Which it never obviously was.

But if we are just talking about using "grey area" ingredients then this can be applied to most brands on this site. Noopept, phenibut, DMAA,DMHA, Amp Citrate all fall into this spectrum if you want to argue details

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).

 

[Standup]

just seeing this now.


LOL is all I can say.


I was on here stating how Vicaine was CLEARLY an illegal dietary supplement and tons of people and the company themselves were telling me I was wrong.


hahahahaha

I think it's important to note illegal according to FDA guidelines not DEA. Any number of violations can be considered illegal with usually result in a warning letter but that does not in any way mean the product is unsafe or can't be safely used anymore than anything you can buy otc and overdose on or happen to have a bad reaction.

If you ever look at how many times pharmaceutical companies have had violations and were fined (many more than once) yet they go on because they have the funds, lobbyists, and connections to ensure they do.

The FDA declared vinpocetine not a supplement and thus illegal yet it's still in a ton of sports products. No real safety issues there just politics influenced decisions.

 

[Ricky10]

I think you will be quite happy when it is released. I am workimng on two...actually three...novelty, feel-good products; all with drastically differnet effects.

:box::You_Rock_Emoticon:

 

[VaughnTrue]

I think it's important to note illegal according to FDA guidelines not DEA. Any number of violations can be considered illegal with usually result in a warning letter but that does not in any way mean the product is unsafe or can't be safely used anymore than anything you can buy otc and overdose on or happen to have a bad reaction.

If you ever look at how many times pharmaceutical companies have had violations and were fined (many more than once) yet they go on because they have the funds, lobbyists, and connections to ensure they do.

The FDA declared vinpocetine not a supplement and thus illegal yet it's still in a ton of sports products. No real safety issues there just politics influenced decisions.

we're not just talking about one random ingredient however in this supplements ingredient panel.

Yes, the specifically mentioned Tianeptine, but what about Flmodafinil? Its a drug.

What about Sunifram? Its a drug.

 

[muscleupcrohn]

we're not just talking about one random ingredient however in this supplements ingredient panel.

Yes, the specifically mentioned Tianeptine, but what about Flmodafinil? Its a drug.

What about Sunifram? Its a drug.

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.

 

[JoePaul39]

Subbed.

 

[Standup]

we're not just talking about one random ingredient however in this supplements ingredient panel.

Yes, the specifically mentioned Tianeptine, but what about Flmodafinil? Its a drug.

What about Sunifram? Its a drug.

Labels. Many supplements are prescription drugs in other countries. Just because their considered drugs by some doesn't mean they can't be safely used. The term drug in this context is whether or not a drug company paid to get it approved somewhere. Fish oil ethers is also a prescription drug in the US yet it's basically fish oil.

The ingredients are unnatural yes but most people don't care about that they just care if it works and is reasonably safe. MA's products get the job done for those intelligent enough to see the advantage in what they can do.

I could care less if it's "compliant" but I also don't give a flying **** if the FDA approves everything I take and do.

People are numb, dying, and in need of something to help improve their lives. MA stepped up and made something novel. Takes guts and smart to put together something especially when many disagree with you on whatever grounds they chose to stand on.

Now if there were dozens of people ending up in the hospital then I'd be concerned. But moreso what health issues they had and their dosing than anything else.

How we treat and chose to address our health issues is ultimately up to each person to decide and no one else. I rather not live in a world where it's decided what I can or can't eat or take (I'm fine with some reasonable regulations like signing a wavier when buying chems and showing I'm aware of the risks). 1984 much?

Their doses were not excessive high and nothing in the formulas was inherently counter reactive. If this had I don't know 100 mg of tianeptine and 200 mg of some mod alt sure that's risky but MA did it right and accomplished what they were aiming for. Sadly the FDA does not want people to treat themselves even when they fail to help. Not too different from kratom. Some people in severe pain have no legal option for relief. Everyone taking kratom as a sub had no or little other options. Sure it's illegal in alot of states and may be banned federally. Doesn't mean it should not be available for those who benefit from it especially if nothing else works.

Another analogy is CBD which is also not compliant and an FDA approved drug (formly an IND) but families knew it could help their kids with seizures when all else failed and guess what those parents who either went to Denver or illegally ordered hemp/cannabis oil ending up saving their kids lives. Compliant or not results matter.

 

[rtmilburn]

we're not just talking about one random ingredient however in this supplements ingredient panel.

Yes, the specifically mentioned Tianeptine, but what about Flmodafinil? Its a drug.

What about Sunifram? Its a drug.

Ya but hi-tech sells a sleep aid loaded with a non compliant drug. Phenibut is a WAY stonger drug than any meantioned here, and way higher addiction potential. Yet hi-tech uses ridiculously high doses of it. Let's all calm are tits

 

[VaughnTrue]

Ya but hi-tech sells a sleep aid loaded with a non compliant drug. Phenibut is a WAY stonger drug than any meantioned here, and way higher addiction potential. Yet hi-tech uses ridiculously high doses of it. Let's all calm are tits

what hi-tech does or doesn't do has nothing to do with me at this point. I have absolutely zero connection to them at this point.

do i think phenibut should be a legal supplement? yes. is it dshea compliant? according to the FDA nope, and it should be pulled.

as for the difference between selling phenibut and selling a modafinil analogue, you can't be serious with comparing those two, can you?

 

[rtmilburn]

what hi-tech does or doesn't do has nothing to do with me at this point. I have absolutely zero connection to them at this point.

do i think phenibut should be a legal supplement? yes. is it dshea compliant? according to the FDA nope, and it should be pulled.

as for the difference between selling phenibut and selling a modafinil analogue, you can't be serious with comparing those two, can you?

Wait when did you split ties with hi-tech?

 

[VaughnTrue]

Wait when did you split ties with hi-tech?

this past summer. i'm no longer employed in the dietary supplement industry.

 

[Godstrength]

what hi-tech does or doesn't do has nothing to do with me at this point. I have absolutely zero connection to them at this point.

do i think phenibut should be a legal supplement? yes. is it dshea compliant? according to the FDA nope, and it should be pulled.

as for the difference between selling phenibut and selling a modafinil analogue, you can't be serious with comparing those two, can you?

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?)

 

[rtmilburn]

this past summer. i'm no longer employed in the dietary supplement industry.

Well I didn't know that. It's been a long run for you, and you have always been excellent. Wish you the best with for next career avenue.

 

[Outofbody]

Wow I've been a tianeptine fan for years, speak about it all the time, and I'm just finding out about this now? Where've I been lol

 

[JoePaul39]

this past summer. i'm no longer employed in the dietary supplement industry.

Just curious, was any of your decision to leave Hi Tech due to all the legal trouble Hi Tech has had with current FDA lawsuits over DMAA and the owner Jarret Wheat facing criminal charges? I cant imagine they are in a good financial status due to all of that. I know they sold off Gaspari Nutriton.

 

[De__eB]

...except for the fact it wasn't dangerous. Np one was ever harmed, so stop slandering me and my company or I will seek assistance from the adminstrator. I don't think he would take too kindly to lies being posted about sponsors, especially lies of such a serious nature.

Half the pre-workout supps you probably chug on a dialy basis are technically more "dangerous" tham Vicaine ever was, as many of them are loaded to the hilt with powerful stims that increase both BP and heart rate. They can easily exacerbate a cardiovascular health condition leading to heart attack and/or stroke.

Perhaps you should go tell those 1,000+ companies how dangerous their proucts are. It would have been better advice.

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

These actions follow reports to the FDA of serious adverse events associated with the use of products containing tianeptine.

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.

Keep going...and soon, no one will like you. If you care that much about DSHEA complaince, go work for the FDA. I can tell you this, the FDA employees I've spoken with are a LOT more lax than you...and don't generally care about involving themselves in the business of others unless they are told to. Basically, they are decent people...and they sure don't spend time pulling FDA reports from cases that are already over. You seem to be awully interested in a product that isn't even sold anymore.

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

What you predicted would happen? EVERYONE knew it would eventually happen, myself included.

People were harmed? Who? No one was hurt.

You are acting like you predicted the winning lottery number. "Predicting" something that is guaranteed to eventually happen (sooner rather than later) doesn't take too much smarts....and as for your "people were hurt" comment, I don't have a clue where that came from.

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...

These actions follow reports to the FDA of serious adverse events associated with the use of products containing tianeptine.

 

[muscleupcrohn]

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...

That seems to indicate that there have been adverse effects reported from PRODUCTS containing tianeptine, a non-compliant ingredient, in general, not specifically this product.

Ask anyone, I’ve butted heads HARD with MA when this product was first announced, but don’t be disingenuous to try to prove a point.

 

[muscleupcrohn]

And plenty of people will do illegal/non-compliant things if they know all they’ll get is a letter or a slap on the wrist, as the potential benefits for them in terms of profit or brand-recognition or building can be worth far more. I’m not saying I support it or don’t support it, but it’s the nature of this sort of thing.

 

[De__eB]

That seems to indicate that there have been adverse effects reported from PRODUCTS containing tianeptine, a non-compliant ingredient, in general, not specifically this product.

Ask anyone, I’ve butted heads HARD with MA when this product was first announced, but don’t be disingenuous to try to prove a point.

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?

 

[De__eB]

And plenty of people will do illegal/non-compliant things if they know all they’ll get is a letter or a slap on the wrist, as the potential benefits for them in terms of profit or brand-recognition or building can be worth far more. I’m not saying I support it or don’t support it, but it’s the nature of this sort of thing.

The other nature of this sort of thing, is that you don't get to complain about criticism of your illegal products.

 

[muscleupcrohn]

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?

Yeah. That’s very likely. Most places selling it sell it as a research chemical, not for human consumption, with no directions, but he sold it as a supplement with directions. Not to mention that, according to the letter, he made claims about the product that also aren’t allowed, and you can see why he’d get a letter as soon as tianeptine landed on the FDA’s radar. I’m sure the other products that were associated with adverse effects got letters too.

 

[muscleupcrohn]

The other nature of this sort of thing, is that you don't get to complain about criticism of your illegal products.

That is true, so long as the criticism is accurate, which I think you may not be entirely in your last post, but I guess you two were going at it before then lol.

 

[Standup]

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?)

Phenibut is at least more natural than mod. It really is just a modified vitamin. Not much different than acetyl-l-carnitine to regular carnitine. At lower doses it's addiction risk appears very low if you look at the actual clinical studies in teens no serious issues were ever reported and they used up to 1,000 mg or so a day. Most people I see buying powder are taking 2-4 grams or more are just setting themselves up for addiction.

 

[muscleupcrohn]

You think the only company to be told to stop selling caffeine powder after the kid OD’d on it was the company he bought it from? If other companies kept selling it, you bet they’d get letters too.

 

[muscleupcrohn]

Phenibut is at least more natural than mod. It really is just a modified vitamin. Not much different than acetyl-l-carnitine to regular carnitine. At lower doses it's addiction risk appears very low if you look at the actual clinical studies in teens no serious issues were ever reported and they used up to 1,000 mg or so a day. Most people I see buying powder are taking 2-4 grams or more are just setting themselves up for addiction.

If something even has the potential to be seriously abused, even if it’s at higher doses than it’s normally and effectively used at, it’ll likely be at least regulated eventually.

 

[muscleupcrohn]

Pretty much every article and analyses of the letter (which was sent to two companies) says that there have been reported adverse effects from tianeptine use, and some even link to outside reports of these effects, but none mentioned any company’s product in particular.

 

[De__eB]

Yeah. That’s very likely. Most places selling it sell it as a research chemical, not for human consumption, with no directions, but he sold it as a supplement with directions. Not to mention that, according to the letter, he made claims about the product that also aren’t allowed, and you can see why he’d get a letter as soon as tianeptine landed on the FDA’s radar. I’m sure the other products that were associated with adverse effects got letters too.

Only two companies got warning letters.

 

[muscleupcrohn]

Only two companies got warning letters.

Read my other posts, and some articles about the letters. The actual letter to the company makes no note of adverse effects associated with the product. There have been a substantial amount of reported adverse effects from people using supplements (and likely RCs) containing tianeptine recently, so the FDA decided to start by going after companies who explicitly sold it as a dietary supplement, and it’s also part of a new trend that the FDA will have going forward with non-compliant supplements they say. Most companies only sold it as a RC. Selling it as a supplement with directions and non-compliant claims made it a much easier and more prominent target than a liquid RC that says not for human consumption and has no directions on it.

 

[muscleupcrohn]

The fact they solid them as supplements and made claims that only drugs can make was what got them the letters:
https://www.nutraingredients-usa.com/Article/2018/11/21/FDA-issues-warning-letters-on-tianeptine-supplements-making-opioid-related-claims

That said, don’t be surprised if they go for other companies that sell it as a supplement without making drug claims next, or even if they go after RCs eventually.

 

[Standup]

Yeah. That’s very likely. Most places selling it sell it as a research chemical, not for human consumption, with no directions, but he sold it as a supplement with directions. Not to mention that, according to the letter, he made claims about the product that also aren’t allowed, and you can see why he’d get a letter as soon as tianeptine landed on the FDA’s radar. I’m sure the other products that were associated with adverse effects got letters too.

To quote Dave Chappelle he kept it real. He didn't hide or dose the pills he openly stated what's in it for people to research and see if they wanted it. For those with severe pain or treatment resistant depression their product is a godsend.

 

[muscleupcrohn]

To quote Dave Chappelle he kept it real. He didn't hide or dose the pills he openly stated what's in it for people to research and see if they wanted it. For those with severe pain or treatment resistant depression their product is a godsend.

But it was clearly non-compliant. Obviously with the tianeptine, and also according to the FDA, in the claims it made. I’m not going to argue about it’s utility or benefits for people, as that’s an entirely different philosophical discussion.

 

[De__eB]

You think the only company to be told to stop selling caffeine powder after the kid OD’d on it was the company he bought it from? If other companies kept selling it, you bet they’d get letters too.

I think that the one he OD'd on got a letter.

Just like it's hard to imagine that the FDA had an adverse event for a specific product, and then warned two other random companies and not the companies whose products were generating adverse events.

 

[muscleupcrohn]

I think that the one he OD'd on got a letter.

Just like it's hard to imagine that the FDA had an adverse event for a specific product, and then warned two other random companies and not the companies whose products were generating adverse events.

I told you why those two companies were singled out man... they marketed and labeled it as a supplement, unlike most companies, and made drug-like claims about it, unlike most companies. They were the easiest targets here. There are a myriad of articles with various citations and sources about the letters that explain very clearly that them making non-compliant drug-like claims with non-compliant products made them targets. Making drug-like claims is perhaps the biggest no-no in the industry, and will get you a letter even if you have a product that is otherwise entirely compliant.

 

[muscleupcrohn]

From the FDA’s write-up, basically supplements containing tianeptine are adulterated supplements, but anything that claims to diagnose/treat/cure/etc. any disease is a drug. And selling drugs as supplements is frowned upon more harshly than selling adulterated supplements.

The tianeptine made it an adulterated supplement, the claims made it a drug.

I don’t get what’s so hard to understand about this.

 

[Standup]

But it was clearly non-compliant. Obviously with the tianeptine, and also according to the FDA, in the claims it made. I’m not going to argue about it’s utility or benefits for people, as that’s an entirely different philosophical discussion.

Not in accordance with what the FDA considers compliant currently no. No one is arguing otherwise. That said a quick look of all of pulled otc and prescription drugs the FDA did approved or is considered compliant it isn't a solid barometer for what is safe or effective.

 

[muscleupcrohn]

Not in accordance with what the FDA considers compliant currently no. No one is arguing otherwise. That said a quick look of all of pulled otc and prescription drugs the FDA did approved or is considered compliant it isn't a solid barometer for what is safe or effective.

Dude, I just explicitly said, and have been saying throughout this entire thread, that I’m not discussing safety or efficacy, I’m discussing legality and compliance. The product clearly was not compliant, so the letter was legally justified. That is all I’ve said. Quoting me to say things that are irrelevant to what I’m saying is just that; irrelevant.

Also, it never would have been compliant. They just caught wind or it now. Tianeptine was never a compliment ingredient, and the claims the product made were non-compliant claims according to the FDA. Neither of thee rules are new, it’s just the attention on tianeptine in particular that is, and that got these supplements on the FDA’s radar.

 

[MedRat]

Im pissed about the attention Tiameptine is going to get from the government now. It was just an old french antidepressant that also worked somewhat on the opiod receptors. People who abused opiods didn't feel anything from tianeptine. I didnt want this unscheduled medication to become part of the opiod witch hunt. We already have had to nearly bash the DEA in the face over Kratom.

 

[VaughnTrue]

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?)

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.

Well I didn't know that. It's been a long run for you, and you have always been excellent. Wish you the best with for next career avenue.

Thank you sir, much appreciated

Just curious, was any of your decision to leave Hi Tech due to all the legal trouble Hi Tech has had with current FDA lawsuits over DMAA and the owner Jarret Wheat facing criminal charges? I cant imagine they are in a good financial status due to all of that. I know they sold off Gaspari Nutriton.

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.

 

[muscleupcrohn]

I think people are missing the distinction that the FDA seemed to be making that any supplement that contains a non-compliant ingredient is an adulterated supplement, 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.

 

[VaughnTrue]

I think people are missing the distinction that the FDA seemed to be making that any supplement that contains a non-compliant ingredient is an adulterated supplement, 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.

yes and no.

the product in question would fall into both categories. It was an adulterated supplement in that it contained (multiple) non-compliant ingredients, AND that it made drug-like claims.

 

[muscleupcrohn]

yes and no.

the product in question would fall into both categories. It was an adulterated supplement in that it contained (multiple) non-compliant ingredients, AND that it made drug-like claims.

Yes, I’m saying that people (person?) is asking/claiming why only two companies got letters, and I’m saying that it’s pretty clearly because they were essentially selling their supplements as drugs, not “just” adulterated supplements. He’s claiming that the letter was sent to MA because people reported adverse effects with that specific product, but that does not seem to be the case, and that is never stated anywhere, and a different reason is clearly given as to why MA got the letter.

 

[VaughnTrue]

Yes, I’m saying that people (person?) is asking/claiming why only two companies got letters, and I’m saying that it’s pretty clearly because they were essentially selling their supplements as drugs, not “just” adulterated supplements. He’s claiming that the letter was sent to MA because people reported adverse effects with that specific product, but that does not seem to be the case, and that is never stated anywhere, and a different reason is clearly given as to why MA got the letter.

gauging a product or its safety on side effect reports is not a good decision IMO. There are an insane amount of AERs (adverse event reports) submitted each year for vitamin c products. People can placebo themselves into anything, good or bad.

considering the size of the company (not large), I'm going to assume that the reason they were singled out is that they used opiate themed language which is a hot button topic right now everywhere due to the shambles that the pharma industry is in and all the heat being placed on opiate manufactures.

 

[muscleupcrohn]

gauging a product or its safety on side effect reports is not a good decision IMO. There are an insane amount of AERs (adverse event reports) submitted each year for vitamin c products. People can placebo themselves into anything, good or bad.

considering the size of the company (not large), I'm going to assume that the reason they were singled out is that they used opiate themed language which is a hot button topic right now everywhere due to the shambles that the pharma industry is in and all the heat being placed on opiate manufactures.

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.

 

[VaughnTrue]

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.

and I was never disagreeing with you, just commenting on your post