Who will win FDA approval on vape devices / liquids - post ban?

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BigPappa

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Can you imaging having to pay $1 Million (or whatever) for each nicotine concentration of a single juice flavor which is offered in 0mg, 3mg, and 6mg? That's $3 Million for one juice flavor, or 3 times whatever the cost is.
You forgot about all of the many higher nicotine levels.. I do 18mg, some people do 24mg, etc.... (I used to do 36). Also the different concentration combinations of PG/VG and 100% of either. They can't possibly require one for each of those possible scenarios, could they? Maybe just a smaller "add on" for each minor variation? (most of the information would be identical).
 
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zoiDman

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... Maybe just a smaller "add on" for each minor variation? (most of the information would be identical).

You can use what is called "Bridged Data".

But seeing that the Amount of PMTA's that the FDA has issued can be Counted on 2 Fingers, and that the FDA gives No Clear Guidance as to How Bridged Data is supposed to work (let alone How a PMTA is supposed to work), No One Really Knows how much Documentation Overlap can be avoided?
 

zoiDman

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The other issue for juice manufacturers is do you go through the whole process when there is no assurance whatsoever that refillable products will even be approved. Not much point of it’s all closed systems.

How can a Bottled e-Liquid be PMTA-ed if you Can't define How it is going to be used?
 

zoiDman

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This is a federal agency. Do you really expect any of this to be logical?

It is actually Very Logical.

What Most people Don't Understand/Consider is that the Entire PMTA process was Never designed as a way for Tobacco Products to Enter the Market Place.

It was Designed to Prevent Tobacco Products from Entering the Market Place. So it is Doing precisely what it was Intended to do.
 

LoveVanilla

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Started to post elsewhere but perhaps more relevant here:

A month ago, I might have guessed 70% odds on full prohibition. Now with pockets of sanity emerging in the FDA, maybe 55%. But one should never underestimate potential for very real harm to life and health by our current predatory capitalism (i.e. lives do not matter, only profit). Look no further than our current opioid crisis, insulin prices, or Wall Street's crime spree, etc. for examples. No one is prosecuted--much less sent to prison.

While I hope not, my best prognostication is vaping may soon look quite different. Options will be highly constrained. Available devices likely be limited to closed system (they maximize profits). And costs will rise to near parity with cigarettes. The legal market in the U.S. will gradually close and be sealed with only big pharma and big tobacco remaining. Barring a peace treaty, there will be an eventual shakeout and ascension by big pharm in the US with the demise of big tobacco due their tainted past and weaker D.C. lobby.

Also, consider that if vaping costs can/will approach cigarettes, it will not matter much to corporate interests if they have to constraint/limit the "market" (i.e. our access) in order to establish dominance.

Stock up!
 

100%VG

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@100%VG sorry to just pull that out, but excising from the quote would've been tough.
Hello Eskie,

There's a very easy way to select and quote only what you are interested in. Click and hold the left mouse button at one end of what you're interested in and drag the cursor to the other end of it, which will Highlight everything you want quoted. A dark grey +Quote | Reply popup balloon will appear below it on the far right end. Click Reply and it will be quoted...

upload_2019-10-23_9-2-18.png

The answer is we do. If we were on the market in 2007, just like every cigarette brand out there, we would be grandfathered in and not subject to this. But we weren't so we are subject to it. So is BT, which is why they have not been able to release a new brand since 2007, as it would require FDA approval via a PMTA, and we know that will never be granted. So same umbrella, we just came late to the party.
Thanks, but now I'm confused. Seems like there are tons of new and cheaper somewhat no-name cigarette brands. Some mimic brands like Marlboro Light and Winston, plus other Menthol brands, including some that are just what they are; a new cheaper pack of cigarettes, but with what seems like even more additives. They cost a good bit less than brands like Marlboro Light and Winston. IIRC, this started with Dorel. If you are telling me that all of those brands have been out since before that 2007 thing, then OK, but it seems like new ones are still popping up here and there.
Those [Nicoderm CQ patches and other NRTs] are FDA approved smoking cessation products. They took the even more arduous drug pathway though the FDA.
So then what I'm hearing from this is that, this means they are not associated with Tobacco Products, being Pharma products, and therefore need no Nicotine Warning label. Right?
New BT products must go through exactly the same process, unless they have a grandfathered "predicate" product to which they are "substantially equivalent", in which case an SE application must still be filed, which details the exact changes from the predicate product. Unfortunately, it looks like there are no grandfathered vape products available to use as predicates. The FDA claims there is one, but won't divulge what it is.
Something made here in 2007? In that case, it must be something much like the original e-cig design by Hon Lik in China, created some time in 2003. According to Google, e-cigarettes, invented by Hon Lik, were introduced to the American market in 2007, so since his was not developed here, unless he also Patented it here, it must be some kind of early change(s) made to his design. Sound about right? If so, something like that would be useless to nearly everyone. I could not stop smoking with a cig-a-like!!!
It took more that two years for the IQOS PMTA to be approved. I would hardly call that "quick".
Some of the questions I asked came from side comments made in Live YouTube videos by Matt Culley. He did not comment on most of them, but I wrote them down and remembered them. But Philip Morris and Altria are moving forward with it here now. I guess that's where the confusion came from. Thanks!
Because those are cannabis products, not tobacco products. Cannabis is still an illegal, Schedule 1 drug at the federal level. The Tobacco Control Act requires the FDA to regulate tobacco products. Nothing in federal law gives the FDA the power to regulate any cannabis product.
I already knew this, but thanks. :)

I see that I've been quoted elsewhere, so I'm going looking for them now. :thumb:
 
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Rossum

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I Don't really see SNUS catching on anymore than it is Already. Which is Fractionally Small.
As the only tobacco product that's now able to claim (advertise?) that it's safer than smoking, I think Swedish Match may just have a winner on its hands.

I looked at their US website yesterday. You gotta register with 'em before they let you see much of anything. It seems they only offer five varieties in the US. I guess that's all they could afford to file PMTA/MRTP applications for?

But this...
Vape Is Dead. Long Live Sprape?
... has ALL the Ingredients of a Teen Fad.
Maybe. But if it's made by GlaxoSmithKline, you know it's gonna be stupid expensive.
 

zoiDman

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As the only tobacco product that's now able to claim (advertise?) that it's safer than smoking, I think Swedish Match may just have a winner on its hands.

...

Just for Clarity, I should have posted this...

"I Don't really see SNUS catching on anymore with the Underage segment than it is Already. Which is Fractionally Small."

... so as Not to confuse the Adult Market with the Underage/Youth Market.
 
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100%VG

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I am certainly no fan of how the CDC has acted in this particular situation, as I've posted elsewhere.

However, just because they now have data on cases back to March 31 does not mean they were aware of it and studying then --- it just means they are doing their jobs and working with the medical community in backtracking admissions/records for clinically relevant cases to attempt to determine timing, location(s), and spread of the outbreak.
OK, maybe not at first. I'll grant you that much, but again, if CDC had really wanted to know what the cause(s) of the lung illnesses and deaths was(were), they would have been taking and examining blood samples all along, or at least once they started finding out about dead people, and they would have then required this same blood testing of the medical community, since they did not at first, or least should have once they learned about Deaths! But they did not do this themselves at any point and they did not require it of the medical community at any point. If they were really doing their job(s), they would be doing the job as thoroughly as possible, and doing it to the furthest extent possible, that is, if they really wanted to know! But they did not and they have not.

As their posted information provided stands, CDC has not looked deep enough or, apparently, even cared to. How much accuracy in information could actually be expected to be attained from kids, youth, or even older folks from only relying on self-reported use? Accurate information is attained from scientific studies, like blood testing, not simply word of mouth. Add to this the fact of how misleading it is to keep saying "e-cigarette, or vaping, products" while continuously telling people not to use or even buy those "e-cigarette, or vaping, products", especially those containing THC. Then in the next lines, saying Not to use or even buy "e-cigarette, or vaping, products" which contain e-liquid nicotine.

What is it about this that you cannot see? What is it about this that you cannot agree with?In it's totality, not one simple case of a statement made about "since March 31"?

If you cannot see this, or don't agree with this, then there is nothing left to say or talk about with you. Sorry, but that's all you'll get from me. I'm moving on now.
 

jandrew

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What is it about this that you cannot see? What is it about this that you cannot agree with?In it's totality, not one simple case of a statement made about "since March 31"?

If you cannot see this, or don't agree with this, then there is nothing left to say or talk about with you. Sorry, but that's all you'll get from me. I'm moving on now.
I wasn't commenting on your entire post --- and, as I said, I've been critical of the CDC elsewhere on this forum. I was only pointing out and attempting to shed light on one piece of misinformation you were claiming in your post --- misinformation serves no one, whether it comes from the CDC, the media, or from you. Move on or don't, that's up to you.
 

100%VG

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You forgot about all of the many higher nicotine levels.. I do 18mg, some people do 24mg, etc.... (I used to do 36). Also the different concentration combinations of PG/VG and 100% of either. They can't possibly require one for each of those possible scenarios, could they? Maybe just a smaller "add on" for each minor variation? (most of the information would be identical).
It seems that they can and might! I have no idea how FDA might handle "minor variations", etc., and while most of it may be the same, it seems that anything at all different about one from the next, for the same juice flavor, actually could be considered as being different products, requiring more PMTAs (or processes) to cover all of them. While it would be great if a small variance was considered in a lesser process, FDA has not made it clear how differences will be handled. At least not from what I've heard. However, I am no expert here!

While I did not mention nicotine concentrations like those you did, this was mostly because they are not available in most vape shops anymore. I also did not delve into the different concentration combinations of PG/VG and 100% of either, as these are personal preferences for individuals to decide on. I mentioned 0mg, 3mg, and 6mg as 3 common choices for one single vape juice flavor, only as an example of something that could be seen as 3 different products! However, I have seen the same thing said by others in this thread... that every iteration of one juice flavor, like various nicotine concentrations, things like added sweeteners that aren't in the first one, anything at all different that could be done to one flavor, which to anyone in their right mind might consider a single juice flavor, FDA could consider all of them as a different product, so it's not just me saying it. The PMTA Guidelines (or whatever) are not clear. There are others here that know much more about this than I do, and hopefully they will answer you in more specific detail that I can, if it's any more clear to them.

I doubt that helps much, but it's all I have.
 

100%VG

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I wasn't commenting on your entire post --- and, as I said, I've been critical of the CDC elsewhere on this forum. I was only pointing out and attempting to shed light on one piece of misinformation you were claiming in your post --- misinformation serves no one, whether it comes from the CDC, the media, or from you. Move on or don't, that's up to you.
The fact remains that CDC includes the first date, in this chart, as March 31, so I did as well. How can this be considered false information? It's on CDC's chart and CDC said so themselves. All I did was point out the fact that CDC has been aware of the issue since March 31, and if they did not start studying it then, they should have. That's what they are supposed to do to protect us, is it not? Especially since they have been studying and researching it since then, or at least soon after, yet to this day, nearly 7 months later, they continue to say that the cause or causes have not been determined. Sorry if you have an issue with me, but I have an issue with them. You said you do, too, so what's the problem?
 

jandrew

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The fact remains that CDC includes the first date, in this chart, as March 31, so I did as well. How can this be considered false information? It's on CDC's chart and CDC said so themselves. All I did was point out the fact that CDC has been aware of the issue since March 31, and if they did not start studying it then, they should have....

Like I said, they now have data going back to March 31 --- that doesn't mean they were aware of anything at that time. They have been getting back-data from hospitals/clinicians reviewing earlier admissions/case histories --- working back in time is part and parcel of epidemiological work. I once published a paper using data from epigenetic dental traits of ancient Egyptians ... if I knew so much 3,000 years ago, why did I wait so long to tell anyone?
 

100%VG

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Like I said, they now have data going back to March 31 --- that doesn't mean they were aware of anything at that time. They have been getting back-data from hospitals/clinicians reviewing earlier admissions/case histories --- working back in time is part and parcel of epidemiological work. I once published a paper using data from epigenetic dental traits of ancient Egyptians ... if I knew so much 3,000 years ago, why did I wait so long to tell anyone?
6iYqWiJ.gif
OK, I'll bite. Why did you wait so long?
PmDZjbQ.gif


In all actuality, you did not know this 3,000 years ago!

But, OK, I gotcha now. Sorry I got upset. Guess I took it personally.

The Title of that graph says "Dates of symptom onset and hospital admission for patients with lung injury associated with e-cigarette use, or vaping — United States, March 31–October 12, 2019".

It does not say "Dates we actually had lung injury patients seen here at CDC".

But it still pizzas me off about the consistent use of the phrase "e-cigarette, or vaping, products", and their use of the word Vaping to include every kind of liquid that can be heated and inhaled, but especially when They use it in relating Bootleg THC Cartridge usage! So does their redefining what an e-cigarette really is. This makes their position too easy to justify to anyone Stupid enough and/or Ignorant enough to believe it! After all, we are talking about a national flock of sheep who blindly accept and believe everything they see and hear on the News, both on TV and radio, and the Internet, and whatever else.

Dang! There are so many sources of disinformation, purporting to tell the truth. Plus the fact that they openly, flagrantly (guess I have to say) "seem to be" concealing critical information while confusing and compounding the issue with info taken from 2 completely separate issues. And you have to admit that they should have done blood tests on anyone they saw and they should have required blood testing of the medical community.

What they should be doing is telling the truth!!! But they are too busy destroying the "e-cigarette, or vaping, products" Industry.
 

ScottP

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Seems like there are tons of new and cheaper somewhat no-name cigarette brands. Some mimic brands like Marlboro Light and Winston, plus other Menthol brands, including some that are just what they are; a new cheaper pack of cigarettes, but with what seems like even more additives. They cost a good bit less than brands like Marlboro Light and Winston. IIRC, this started with Dorel. If you are telling me that all of those brands have been out since before that 2007 thing, then OK, but it seems like new ones are still popping up here and there.

I don't know all brands of cigarettes but Dorel was introduced by R.J. Reynolds in 1969. Another discount brand, Pall Mall was created in 1899 by the Black Butler company. The brand has changed hands several times but has been another R.J. Reynolds brand since 2004. If you can think of any other discount brands we can look into them but I can't think of any brands that are actually "new".
 

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Back when cigarettes were less than a buck a pack none were really seen as discount brands. Back then it was more about the gimmick that made one better than the other. The unique filter of True for example or ulta low tar and nicotine of Now. One day prices reached a point where some brands became premium priced and others were discount priced. First "discount brand" I remember was called Buck. They gave away all kinds of swag too. Every young adult I knew back then had a Buck hat or t-shirt.

Marlboro and Merit had promos to give away swag in trade for bar code coupons. Merit stuff was expensive to obtain but was premium items like Seiko watches or real nice leather jackets with their logo on them, where Marlboro was giving away mostly outdoor gear for modern day "Marlboro Man" types.

My parents used Pall Mall brand while one neighbor was stuck on filterless Lucky Strikes or Camels long before the Joe Camel promotion. Winston tried "pure tobacco" as a gimmick. Most of the brands I knew as a kid are long gone.

Anyway, I agree with what some say here in that this could result in cigarette-esque costs to the public. Not because of high prices of the products themselves but because of the fees and taxes applied.

Cigarettes without the added taxes and fees are actually pretty cheap. But $2 here, 36 cents there have quadrupled what is paid at the check out counter. I envision the government doing the same with vaping products. But I also envision scenes in future movies where "G Men" are shown busting up kegs of illicit e-juice like during the alcohol prohibition days, or even today in some cases.

There'll probably come a day when ECF threads will discuss those brands we used to know and love. Some we already do. But as the market shakes out after the regulations do their part to create winners and losers, there'll likely be a lot more brands we were fond of before then.
 
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DarrenMG

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We had a nearby tobacco store that sold cured tobacco by the bag. $25-$30. They also had a rollie (sp?) machine. Wait a few minutes and it would churn out a carton. New laws, and so they had to shut-down and re-open as a vape shop. I guess the government didn't want sales of tobacco without the taxes doubling the price and more?

They were actually pretty good, no additives. Just what you'd get if using a pipe and grew it yourself.

People have been using tobacco long before what is going on today.
 
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