email I got from the FDA

[HaploVoss]

Assuming that you trust the word, experience, chemical knowledge and anecdotal accounts of members here...why is the FDA making the same or similar discoveries...not valid?
-K

Sorry for the cross-post there... I do not think it is a matter of validity, it is more a matter of investigative responsibility.

Why did they not go through the same rigorous processes that they usually do with other products? Why did they not pose inquirys to the companys at the time and request further samples, rather than sit on results and then make a public announcement later? Why did they not give the products in question the same standards of submission and re-submission as others?

I think that is what is bothering people here for the most part, not whether or not their initial reports have a valid statement to what they found or not. Just how they went about it and how they are comparing it to similar situations and product variations in the past.

 

[MrKai]

Pardon me as I am coming in on the middle of this, but I don't understand your point...

*snip*

I am not trying to be rude - I am just trying to understand your question and what answer you are trying to get here.

Take care,
- Hap

Part of the problem, or, if you will, "problem" the FDA stated it had was with labeling inconsistencies as well as how the products were being marketed: carts claiming to have "No Nicotine" and having some, carts claiming to have "0mg" but not specifying how much under 1% they had, carts labeled as having a certain amount of nicotine and being found not to outside of acceptable standards, carts having chemical components present but not listed...the standard stuff.

A previous poster made a case that this was a problem and posed the "well how DO we know and trust what is in these things" question and it kind of devolved into a to-and-fro, so I attempted to inject a bit of rational thought into the conversation, which of course in an issue such as this, garnered some...passionate...response

*Part* of the FDA's non-sensationalist problem, and no one rational, certainly not me doubts the fact that there was a little "battle in the court of public opinion" going on here, was just that: labeling inconsistencies in a product who's active ingredient is a drug under their jurisdiction.

Just using anecdotal evidence gathered on these forums, I cannot see the reasoning behind dismissing this because the FDA said so, or why anyone engaging in thoughtful and honest debate on the topic of how Mom and Pop shops popping up everyday online are not very possibly growing the risk of people just becoming exposed to eCigs buying something "cheap" that has too much nicotine in it to be safe or who knows what else.

I hope that clarifies it somewhat for you

BTW...what's a HaploVoss?

-K

 

[crashtestjeep]

I agree- after testing 2 brands, non-american brands, im sure....they have concluded ALL e-cig products are unsafe...The nitrosamines(sp?) they speak of, funny enough are the same "carcinogens" found in bacon and any meat burned a little on the grill (the black burnt parts we all love). Im not sure about anyone else, but Id much rather poison myself with a little e-juice than dying of a FDA approved BACON OVERDOSE!!!!!!!!

With that said, and the knowledge we all have here that juice made in the US is mostly PG/VG/Nic and flavoring, I think were pretty safe.

The only thing Im wondering is, why more companies dont submit thier product to the FDA for testing... Looks to me like they must submit it, they wont come to the supplier first. All our US suppliers should submit----and get this ordeal taken care of.....

Moreover-Id like to know Im only inhaling a few chemicals, rather than 4,300 ones I know for a fact are killing me slowly....

Id love to know what the FDA says when they cant find a thing wrong w/good ol' AMERICAN BUILT PV'S/JUICE......... Guess we'd finally win our case, huh?!?!??

Looks like they have already made up their mind and are just going through a formality of pointing out any problem they can find to support their case.

 

[MrKai]

Sorry for the cross-post there... I do not think it is a matter of validity, it is more a matter of investigative responsibility.

This seems like a fair enough concern.

Why did they not go through the same rigorous processes that they usually do with other products? Why did they not pose inquirys to the companys at the time and request further samples, rather than sit on results and then make a public announcement later? Why did they not give the products in question the same standards of submission and re-submission as others?

I think that is what is bothering people here for the most part, not whether or not their initial reports have a valid statement to what they found or not. Just how they went about it and how they are comparing it to similar situations and product variations in the past.

If you want my honest opinion, I believe it is because we aren't talking about a vitamin or something. We are talking about nicotine, that, if not handled properly etc. is deadly *now* as opposed to *deadly down the line* like cigarettes.

I realize the more...skeptical...amongst us cannot or will not accept this simple, rational explanation because of confirmation bais, and I am fine with that, as long as that bias doesn't cloud the "Big Picture" as directly relevant to us at the consumer level.

I do believe it is far, far more likely than not that my explanation is more plausible than Secret Back-room Dealings With Big Pharma and Big Tobacco.

Believe it or not, I also believe that in a Court of Law, a judge, if presented evidence about this study would actually make FDA go back and do their job; find a bit more evidence than this than a one-off case (tho they will carry weight...they are the FDA) and get back to us; people are obviously at this point not dropping over dead from *this*...and a smart legal team would be making this *crystal clear*.

The FDA will likely try to flex, and depending on the judge and the evidence presented questioning the legality of their action and their basis, tell them to come back with a bit more teeth if they really believe it is a problem.

OF COURSE the IDIOTS at SmokingEverywhere have thrown gum into the works with their damned smoking cessation claims...but of course, like many other things, judges can and do inform the FDA what they can and cannot do.

PV's without nicotine are not Medical Devices, now are they? Simply settle, agree to cut out the nicotine and watch the marketing and that is that.

In the end, it really boils down to how much NJOY and SE have set aside for good legal representation.

-K

 

[HaploVoss]

BTW...what's a HaploVoss?
-K

Haplo was a character from a favorite novel series of mine. Voss was another character and I just used them both for a first / last name alias for a long time now online

I see your point, and it is a valid concern, but where I and I think many other people on here are concerned is that the FDA did not follow the same procedures as they do in most others. If there is a problem with labeling, especially in such small 'macro' quantaties as these, they usually contact the suppliers and inform them of results, after a set period do another test, and see if it meets standards... they don't rush to the public with - you have to admit - dramatized statements of their findings.

Before you deny my statement of dramatized - do remember that the companies that were found to be on par and were found to have no problems were never mentioned in the release, and that the chemicals found were made out to 'sound' much more harmful than they really are.

So I think this is where the animosity is coming from that basically it was in fact a slanted test. Although the tests may have been conducted properly, and the results truthful - the products being tested were not treated in a fair manner by any stretch.

EDIT: Just saw your last post, forum juggling here... I see the point with nicotene juice - and a simple solution might be just to cut out the nicotine and then let the juice itself become the point of concern, however you will just start over.

Going on that route, I think you would have to convert over to something along the lines of the 'alternative foods' like I was talking about earlier in some fashion - which again - they would need to retest. It is a difficult situation, but even looking a nicotine juice as a *poison* compared to *burned nicotine* - it is somewhat irrelevant because looking at it this way you can leave out a can of smokeless tobacco and a child or animal get sick from that just as easy using that argument... so... the circle continues eh?

Take care,
- Hap

 

[MrKai]

With that said, and the knowledge we all have here that juice made in the US is mostly PG/VG/Nic and flavoring, I think were pretty safe.

My turn for sarcasm and biting wit:

Of course, crashtestjeep* we all know that all 'Merkin companies great and small are above board and make products with the best intentions and customer health, safety and happiness in mind

All jokes aside, we know this now. As this gains momentum/competition grows, without *some kind* of oversight, industry based (ECA), consumer based (CASAA) or otherwise, don't believe this can or will continue...the draw of a buck, and a quick one at that, is mighty enticing...especially when you can get in on the ground floor with a buch of addicts legally for relatively minimal startup cost.

The only thing Im wondering is, why more companies dont submit thier product to the FDA for testing... Looks to me like they must submit it, they wont come to the supplier first. All our US suppliers should submit----and get this ordeal taken care of.....

Moreover-Id like to know Im only inhaling a few chemicals, rather than 4,300 ones I know for a fact are killing me slowly....

Id love to know what the FDA says when they cant find a thing wrong w/good ol' AMERICAN BUILT PV'S/JUICE......... Guess we'd finally win our case, huh?!?!??

Honestly? Because it is an expensive, expensive, long process. One of the big complaints against the FDA is that they are cutting it short, letting things slip thru that are later proven to be harmful

-K

*I'd love to know the story behind this, heheh. CrashTestJeep?

 

[MrKai]

Haplo was a character from a favorite novel series of mine. Voss was another character and I just used them both for a first / last name alias for a long time now online

...novels?

I see your point, and it is a valid concern, but where I and I think many other people on here are concerned is that the FDA did not follow the same procedures as they do in most others. If there is a problem with labeling, especially in such small 'macro' quantaties as these, they usually contact the suppliers and inform them of results, after a set period do another test, and see if it meets standards...

Have these other cases concerned known addictive drugs that are poisonous and can cause death in doses under 100mg?

This is not rhetorical or baiting; it is a sincere question because I do not know.

they don't rush to the public with - you have to admit - dramatized statements of their findings.

Oh I don't disagree at all that there was some "Public Awareness Theater" going on

Before you deny my statement of dramatized - do remember that the companies that were found to be on par and were found to have no problems were never mentioned in the release, and that the chemicals found were made out to 'sound' much more harmful than they really are.

So I think this is where the animosity is coming from that basically it was in fact a slanted test. Although the tests may have been conducted properly, and the results truthful - the products being tested were not treated in a fair manner by any stretch.

Take care,
- Hap

I do believe my previous question has some relevance here as well; have they ever consistently let companies relabel something as potentially deadly as nicotine for a second go? Especially if it was OTC/Retail?

I know people are focusing on the what they said about DEG thing ("Public Awareness Theater") but if a company who's business is to make nicotine carts and makes them by the boatload, presumably mechanically, can't get it right...

-K

 

[MrKai]

EDIT: Just saw your last post, forum juggling here... I see the point with nicotene juice - and a simple solution might be just to cut out the nicotine and then let the juice itself become the point of concern, however you will just start over.

Right. Just sell flavored vapor. Oxgen bars do

Heh. Oxgen bars.

Going on that route, I think you would have to convert over to something along the lines of the 'alternative foods' like I was talking about earlier in some fashion - which again - they would need to retest.

Without nicotine I think the whole thing takes a totally different turn.

It is a difficult situation, but even looking a nicotine juice as a *poison* compared to *burned nicotine* - it is somewhat irrelevant because looking at it this way you can leave out a can of smokeless tobacco and a child or animal get sick from that just as easy using that argument... so... the circle continues eh?

Take care,
- Hap

Except for one thing: smokeless tobacco is regulated/monitored and just became more so

-K

 

[HaploVoss]

Except for one thing: smokeless tobacco is regulated/monitored and just became more so
-K

Well... that's exactly my point. It is regulated and monitored... and just fine. And it also goes back to your question about retesting - Tobacco companies were told 'Nope sorry try again' - 'Ok here's the new samples' - 'Nope sorry try again' - 'Ok how bout this?' - 'Ok that will work, now we can put this on the shelves and the warnings and labeling information we agree with'.

Rather than... Gathering product on their own without directly requesting the product (from some of the companies that is), doing a limited test, then declaring failure without continued discussion.

That was what I was trying to get across, just not great with words.

I gotta hit it - thanks for good debate - I will check thread tomorrow.

Take care,
- Hap

 

[MrKai]

Well... that's exactly my point. It is regulated and monitored... and just fine. And it also goes back to your question about retesting - Tobacco companies were told 'Nope sorry try again' - 'Ok here's the new samples' - 'Nope sorry try again' - 'Ok how bout this?' - 'Ok that will work, now we can put this on the shelves and the warnings and labeling information we agree with'.

Rather than... Gathering product on their own without directly requesting the product (from some of the companies that is), doing a limited test, then declaring failure without continued discussion.

That was what I was trying to get across, just not great with words.

I gotta hit it - thanks for good debate - I will check thread tomorrow.

Take care,
- Hap

Due to the idiot claims of SA, the FDA doesn't have to go thru this; SA has made claims that eCigs are smoking cessation devices in some marketing.

eCigs have been around for awhile and the wrong people went for the Cash Grab, causing this mess.

For PV's to stay around, they need to be re-marketed and sold without nicotine, like say lobeline if they want to add any kind of "ine" at all and play the "head shop" game.

Trying to fight this fight the way it is being fought now is very, very risky.

-K

 

[Thulium]

I'll stick my neck out for a moment and suggest that a company market a personal vaporizer that doesn't especially look like a cigarette and does not include nicotine but instead has various cartridge options with caffeine or vitamins and market it to dance club kids--instead of a light at the end that looks like a burning cherry, perhaps it is a blacklight or multicolored blinky LEDs. It could be sold as a toy without age restrictions--the age restrictions come if you want to use it with nicotine cartridges that have warning labels and you show proper identification to buy tobacco products

In this way, only Nicotine cartridges would be legally considered a "tobacco product". The vaporizers themselves would be under the same regulations as room vaporizers--legal for anybody to buy and useful without any recreational or therapeutic additives that may have specific age restrictions or require a prescription.

 

[MrKai]

...won't come to that sort of stupid song and dance.

 

[mjkerz]

Just wondering, any idea what the FDA's stance on the Nicotrol Inhaler by Pfizer is? It's not the same, and it's a nebulizer, rather than a vaporiser.

Seems though, when big pharma lobbies, they get what they want. Who knows what's in their product, though? Could be nicotine, could be arsenic, nobody really knows. I would love to see the FDA's response.

 

[oldtechno]

Well, after reading some of this...I don't see what the FDA's hold up is. I thought they knew about these E-cigs years ago--maybe they just mentioned it recently?

Of course, nobody but oldtechno ever claimed oldtechno was quick.

Despite all the information I've read on this thread...I still don't get it.
1. They want the suppliers to send them samples? Why not go out and buy their own? Do they think the suppliers will send them an off the shelf sample as opposed to making double/triple sure it is perfect?
2. Drug delivering device? Take a steel thimble, pour some smoke juice into it (or Campbells Chicken Noodle soup into it, and stick a 'cool' soldering iron into it--inhale deeply.

Are these guys kidding me?

I can see their concern though, '...we got a couple of samples...they were not consistant with what the suppliers listed as their chemical content...'. So they requested 'more' samples? They should have canvased the market and bought samples from each--that day. Surely some of them at the FDA use E-cigs----'they' have samples.

So all in all, I'm of a mind to believe--behind the scenes they have already gotten all the samples they need and want. They have already done all the test possible. They already know if it is safe or not. They've already had a year or more to 'look' into it.

When we had that lead paint scare from China...how long did it take them to test the products? How long before they reacted?

On the other hand, like some of you, I 'do' worry about these things sometimes...I 'do' want them to be totally safe. I just don't understand why the FDA doesn't stepforward and simply say '...using this...that...the other...and this, that, other--are safe to vape at between 200degrees and 300 degrees using this percent mix. SURELY the market suppliers would jump on it and ultimatly squeeze out anybody who 'didn't' mix their smoke juice correctly.

And we would support them.

 

[Thulium]

...won't come to that sort of stupid song and dance.

It wouldn't bother me, personally. I'd love if PVs became popular and common enough that people wouldn't presume you are using nicotine or whatever just because you are vaping. You might just be playing with the vapor, you might be taking your vitamins or prescription, you might be looking for a caffeine boost, or you might be using it to curb your craving for a cigarette.

Just like every individual has different reasons for smoking, every individual may have different reasons for vaping and I don't presume that my reason is better than yours--we both should have the right to choose the smoking alternative that is most effective for each of us.

Even if you're someone who only smokes socially or rarely, you're still better off vaping. ...oh and to people who think this will cause people who are underage to develop a nicotine addiction? Although nicotine is addictive on its own, studies have shown that nicotine without other MAOIs from tobacco is not especially habit forming. For the same reason that nicotine gum and lozenges are candy flavored but nobody's really worried that they are being used by children as a gateway to smoking, vaping should be considered no less safe.

Really, the one major roadblock we have is always going to be nicotine laced e-juice. Highly concentrated nicotine is dangerous, and so its likely that unless you fly under the FDA's jurisdiction by using tobacco proper...obtaining nicotine is gonna get tricky.

 

[MrKai]

Well, after reading some of this...I don't see what the FDA's hold up is. I thought they knew about these E-cigs years ago--maybe they just mentioned it recently?

Contrary to what some people believe, the FDA cannot just "decide" they can ban or restrict something. They have to have lawful jurisdiction.

So basically, until some idiot says or does something that puts them under their jurisdiction, you can sell anything you want as long as you don't claim it does anything or someone makes a credible complaint about said product.

A perfect example of how to do this correctly would be "herbal" pills for "male enhancement". A claim such as this is very vague; it doesn't define "male enhancement" and doesn't claim to treat, cure or diagnose anything.

So, up until recently, no one selling eCigs with a brain in their head sold or marketed them for Smoking Cessation. After Winter CES this year tho, the product got wider recognition and chinese factories started pumping them out. Someone could start an "eCig company" in as little as 60 days, complete with their own "brand" for probably less than 10K USD at this point.

With increased competition and a desired quicker RoI, it was inevitable that *someone* would make claims about the products that were untrue to get bigger/faster market penetration, but as the industry itself had no standards body, trade association, etc in place to separate, distance sanction or anything else...it was like a mini-boom market.

I mean, think about it. For less than a car, you too could start a legal business selling an addictive drug! It is the American Dream

Smoking Anywhere crossed the line in their retail establishments, not only with their sales tactics and poor customer service (causing ire, pissing off customers...who complained) but additionally with their marking claims. Smoking Anywhere is known to market eCigs as a Smoking Cessation device/methodology/program.

Uh-oh.

So yeah, oldtechno, if you want to, right now, bottle water with a twist of lime and some cloves and maltose, call it "Tek-Formula2/O" and say it "focuses energy in a refreshing new way!" and label the contents according to FDA regulations and standards, you are free to sell it to anyone that buys it.

In the case of Tek-F2/O as a food/"dietary supplement".

When you decide to try to jump your market penetration and claim that it can "reduce cancer risk" then you are the FDA's b*tch...especially if you forget to mention that you cannot prove it

-K

 

[Angela]

MrKai:

No comments on your take on things, but I have read a few of your posts where you appear to be mistaken about the copany you are referring to. "Smoking Everywhere" and "Smoking Anywhere" are 2 different companies. SE are the ones embroiled in the court case with the FDA

 

[dragonpuff]

Contrary to what some people believe, the FDA cannot just "decide" they can ban or restrict something. They have to have lawful jurisdiction.

So basically, until some idiot says or does something that puts them under their jurisdiction, you can sell anything you want as long as you don't claim it does anything or someone makes a credible complaint about said product.

A perfect example of how to do this correctly would be "herbal" pills for "male enhancement". A claim such as this is very vague; it doesn't define "male enhancement" and doesn't claim to treat, cure or diagnose anything.

So, up until recently, no one selling eCigs with a brain in their head sold or marketed them for Smoking Cessation. After Winter CES this year tho, the product got wider recognition and chinese factories started pumping them out. Someone could start an "eCig company" in as little as 60 days, complete with their own "brand" for probably less than 10K USD at this point.

With increased competition and a desired quicker RoI, it was inevitable that *someone* would make claims about the products that were untrue to get bigger/faster market penetration, but as the industry itself had no standards body, trade association, etc in place to separate, distance sanction or anything else...it was like a mini-boom market.

I mean, think about it. For less than a car, you too could start a legal business selling an addictive drug! It is the American Dream

Smoking Anywhere crossed the line in their retail establishments, not only with their sales tactics and poor customer service (causing ire, pissing off customers...who complained) but additionally with their marking claims. Smoking Anywhere is known to market eCigs as a Smoking Cessation device/methodology/program.

Uh-oh.

So yeah, oldtechno, if you want to, right now, bottle water with a twist of lime and some cloves and maltose, call it "Tek-Formula2/O" and say it "focuses energy in a refreshing new way!" and label the contents according to FDA regulations and standards, you are free to sell it to anyone that buys it.

In the case of Tek-F2/O as a food/"dietary supplement".

When you decide to try to jump your market penetration and claim that it can "reduce cancer risk" then you are the FDA's b*tch...especially if you forget to mention that you cannot prove it

-K

MrKai, some clarification please. If the FDA has no jurisdiction over a product until some idiot makes unproven health claims, then how does that give them jurisdiction over the whole rest of the market that DOESN'T make health claims? Wouldn't they, in such a case, only have authority to ban products that make such claims, i.e. just ban smoking everywhere, those ...... buffoons, and any other companies who make claims while leaving those businesses who rightfully kept their mouths shut alone?

 

[MrKai]

MrKai:

No comments on your take on things, but I have read a few of your posts where you appear to be mistaken about the copany you are referring to. "Smoking Everywhere" and "Smoking Anywhere" are 2 different companies. SE are the ones embroiled in the court case with the FDA

And see? This too, sigh, is a problem

But indeed, the culprit in question is Smoking Everywhere.
Thanks,

-K

 

[MrKai]

MrKai, some clarification please. If the FDA has no jurisdiction over a product until some idiot makes unproven health claims, then how does that give them jurisdiction over the whole rest of the market that DOESN'T make health claims? Wouldn't they, in such a case, only have authority to ban products that make such claims, i.e. just ban smoking everywhere, those ...... buffoons, and any other companies who make claims while leaving those businesses who rightfully kept their mouths shut alone?

..specific and general. The FDA could if they wished certainly make the case that these are all pretty much OEM'd and for want if a better phrase "tainted at the source".

This probably wouldn't fly though if pressed, tho. Who knows?

And again, my apologies to Smoking *Anywhere*...both for substituting you all for Smoking *Everywhere* and the unfortunate fact that you share a very similar name with these junk-peddling troublemakers

-K