But first, a company would have to step up and submit it... which is doubtful, and unflavored nic would also be an issue... which just confirms the crisis that will occur in May and that it will just be BT's disposable garbage.
Who will win FDA approval on vape devices / liquids - post ban?
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Plus the "informal" market. The question is, just how far underground it will be?
I vaguely remember seeing something about the FDA stating that they reserved the right to decide how strictly they would pursue enforcement, based on an evaluation of the impact on the marketplace. Can't remember where I saw that, and I might be wrong.
I believe in the new process posted after the court settlement the FDA reserved the right to provide waivers on products whose PMTAs are not ready on the May cutoff on a case by case basis. So I guess if you ask them nicely with a pretty please they might leave you alone for an undetermined period. Great way to plan a long term business strategy.
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One of the better articles I've read about vaping and it's future. The article actually explains the options and the benefits of vaping pretty well.
From the National Review:
Vaping: Government Has No Business Wiping Out Industry That has Saved Lives | National Review
From the National Review:
Vaping: Government Has No Business Wiping Out Industry That has Saved Lives | National Review
BTW, speaking of the FDA...
FDA grants first-ever modified risk orders to eight smokeless tobacco products
FDA grants first-ever modified risk orders to eight smokeless tobacco products
Otherwise being about as Liberal as it gets, I don't generally find much in The National Review to agree with, but this could have been written by one of us.
I would say do that, but people also have to take a stand. I think the government IS protecting big tobacco and it's obvious why that is. There is no way to tax this industry as it currently exists and how on earth is the government going to reign in a bunch of DIYers who are perfectly content to fiddle-faddle in their own homes.
I don't see a conspiracy. The writing is on the wall. People are switching over to vape every single day and those numbers are going to continue to grow - and that is going to take a walloping bite out of tax revenue. This is not about whether vaping is or is not healthier, it is about money.
That's huge news. IIRC, those same General Snus products were also the very first ones to ever receive a PMTA, and there was considerable fanfare about it from the FDA, as in, "See, the PMTA process is viable!"
Now they're doing the same thing again:
What one might question though is: How come it took an additional four years after the PMTA was approved?
It is Huge News. And as I understand it, Gottlieb played a Large Role in making it happen.
But Now we have Turn a Page again. And I wonder what the Prevailing story will be as we Go Forward?
I have heard $1 Million per sku and, from what I've heard, the definition of an e-liquid is not clear. 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.
I guess a possible difference between $300K-$500K and $1 Million per sku could be the inclusion of things like Lawyer & and any other Legal fees (from beginning to end), paying employees, paying labs for e-liquid testing, new equipment that's now necessary for R&D or paying for outside R&D assistance, and anything else, other than FDA fees, added in for a Cost Sum Total.
This is why VTA (Vapor Technology Association) has recently sued FDA. They took it from highly unattainable to impossible, as the new "direction/guidance" has changed by removing some things that were required and added some new stuff, voiding many past submission efforts and the money spent on them. And this new one is even less clear than before, which is further complicated by the reduction in time (like 1+ year sooner now). The American Vaping Industry knows and accepts that Regulation is needed, but they ask for something more reasonable, and certainly more clearly defined. This is what VTA is fighting for.
And here's one for all of you to chew on, and answer if you know the real reason (not a supposition, please). If Vaping in general is a Tobacco product, as defined by FDA (even hardware and 0mg Juice have a Nicotine Warning label now), then why aren't we under the same Big Tobacco Umbrella of Protections that Cigarettes and other Tobacco products are?
This one above I'd like an answer for. The next ones I pretty much know already, but are here for your consideration...
If an E-Cig Hardware retail box, let's say for a Mod with no Tank, has a Nicotine Warning label on the outside, then why don't Nicoderm CQ patches and other NRTs have a one?
Why do we have a PMTA process as crazy as this when BT products do not?
If our PMTA approval process costs so much, takes so long, and is so hard to actually get an approval for (if at all), then why was Philip Morris' iQOS passed through so quickly?
Why don't Legal E-Cannabis products have to go through this same kind of PMTA? This is a "Vaping" product, is it not? The only difference is that the cannabis atomizer is designed for a cannabis oil/liquid, not a nicotine e-liquid like ours, with an absorption medium and heater element selected and made specifically for a cannabis oil/liquid, while our nicotine e-liquid atomizers go through a similar but different process which is a designing and manufacturing process for a nicotine e-liquid instead which uses Cotton and Kanthal or SS316L wires, or mesh now, but the cannabis product is still an Atomizer! According to both FDA and CDC, it is an "e-cigarette, or vaping, products" device. Even though e-liquid cannot be used in a cannabis atomizer, and vice versa!
I don't know about you, but a lot of stuff here is not adding up.
And even still, in CDC's latest "Outbreak of Lung Injury Associated with E-Cigarette Use, or Vaping" release, posted on October 17, it still says that Illicit THC Carriages are an "e-cigarette, or vaping, products" device, and it still says "Since the specific cause or causes of lung injury are not yet known" to justify saying that the use and/or purchase of any "e-cigarette, or vaping, products" is still not recommended at this time. They are still holding our legal "e-cigarette, or vaping, products" hostage!!!
I cannot help but believe that this is an intentional blurring of the line between our legal Vaping Industry products and an Illicit THC product, to classify both of them as just as dangerous, making most of the American public, and even some vapers, not to mention much of the World now, continue to believe, driven on by MSM (Mainstream Media) News fed by CDC misinformation, that e-cigs are just as dangerous as smoking cigarettes, if not more so.
Are you upset yet? As far as I'm concerned, this is a Criminal Action!
Plus the fact that CDC has been aware of, and studying, the illicit THC-caused lung injuries and deaths since March 31, as clearly shown in the graph from the weblink above. Check it out...
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
And they still insist, in a quote taken from the October 17 report weblink above, that "the specific cause or causes of lung injury are not yet known".
Really? It's either "How incompetent are you that you have not found anything definite to report yet, in nearly 7 months now?" or "Why are you Withholding Vital Information which the public needs to be made aware of?" and "Why do you still confuse and compound the issue by using the phrase 'e-cigarette, or vaping, products' in general when it's clearly a completely different kind of product and an illicit Cannabis (THC) Cartridge product, which has nothing to do with our 'e-cigarette, or vaping, products'?" Again, this is Criminal!!!
And...
If Juul is an "e-cigarette, or vaping, products" item (this "phrase" is used consistently by FDA and CDC), then why is Juul treated differently? A 50mg/ml Nicotine Salts "Mango" flavor is why the "Youth Vaping Epidemic" exists, because youth will chain-vape it 2-3 times to get a Lightheaded Buzz. Why nicotine salts? Because this Juul e-liquid has a very high 50mg/ml nicotine, but no (or practically no) Throat Hit: it is Smooth going down the throat, so the user gets no ill effects from vaping such a high nicotine concentration.
Youth choose Juul's "Mango" flavor because it is the least offensive of all the actually not-good-tasting Juul flavors. But our "e-cigarette, or vaping, products" 0mg, 3mg, and 6mg Flavors (which youth are not using) are being targeted Indiscriminately in the Flavor Bans, all because of Juul's "Mango" 50mg/ml nicotine salts that youth get as Buzz from. And some states are trying to impose, or are imposing, a complete e-cig Ban by adding the lung illnesses and deaths to the equation... among other possible reasons.
If Illicit Cannabis (THC) Cartridges are, admittedly by both FDA & CDC, what caused the majority of lung illnesses and deaths (if not all of them), then why are FDA and CDC compounding the THC illnesses and deaths with the Juul "Mango" flavor into one single issue to paint our "e-cigarette, or vaping, products" as the only issue? They are justifying this position by using the "margin of error" that was created (if not anticipated, but obviously allowed for) by kids, youth, and older folks who only mentioned using e-cigarettes, because "self-reporting" was all that CDC used in their studies since March 31, and this "self-reporting" was all that was required of the medical community.
If CDC really wanted to know what the cause(s) was(were), they would have taken blood samples from the people they saw for testing to find out, and they would have required this same blood testing from the medical community!!! But no, the only "evidence" CDC required of themselves and the Medical Community was what the individuals willingly reported: self-reported evidence.
There are numerous reasons why kids, youth, and even older folks might not report using THC, and especially not cheaper, illicit products obtained on the street. If THC products were not found on, or volunteered by, these people, and those people did not report ever using it, then CDC used these people to create a margin of users to be marked as only using our legal e-cigarettes and flavors to hold our legal "e-cigarette, or vaping, products" hostage, and make their misinformation and misdirection claims based on this by saying they are still studying the various other products found or volunteered.
The inclusion of 2 totally separate issues, 1.) a "Youth Vaping Epidemic" of a youth-abused Big Tobacco product which is made for Adults in a Juul "Mango" 50mg/ml nicotine salts and 2.) the illicit THC-related illnesses and deaths, wrapped up into one "e-cigarette, or vaping, products" issue by FDA and CDC, is what has created this Media Frenzy over our legal "e-cigarette, or vaping, products" Flavors and, in some cases, even our Hardware. But that will not have any effect on the Legal E-Cannabis Industry, nor have they been addressed about this (to my knowledge), nor will it have any effect on the Black Market THC products which caused the illnesses and deaths. However, if they ban our e-cig flavors, then and a new Black Market will show up quickly for that! Ban all e-cig Hardware and premade Juices, and Nothing will be regulated or made safely to any degree anymore, as the Black Market supplies this as well.
Yet, there has never been even one medical case reported, or any other kind of case that really existed, that was caused by any legal "e-cigarette, or vaping, products" in the 10+ years that they have been here in America, not counting Popcorn Lung, which did not exist as the name of the doctor behind it was something completely made up. Neither was Formaldehyde, which is only present in e-liquid vapor at 100 times less or more than that in a cigarette, so it went away, too.
And you had better know that if CDC had found anything that could even remotely be used against our legal "e-cigarette, or vaping, products", they would have blown it all out of proportion by now and they would have made sure that the "Fake Media", as President Trump calls it, would have been broadcasting it multiple times per day. But nothing has been found in all of these years, and nothing is likely to be found this time, and I think they know this, so they continue to demonize vaping as best they can by hammering it home every opportunity they get in using the catchall phrase "e-cigarette, or vaping, products" to confound and confuse the issue, as they continue to use this opportunity to destroy vaping while they can, or at least as much of it as they can while they milk it. As my bother would say, it's not paranoia when they really are after you. CDC has been demonizing e-cigs for 10+ years, so why would they stop now, when this Perfect Storm has allowed them such a great opportunity to do it again, and maybe even bring it to its conclusion this time?
If you have seen/read the FDA and CDC releases about the lung illnesses and deaths (if not, just click on the link above), you will see that they, and especially CDC, have REDEFINED what "e-cigarette, or vaping, products" really are (as defined by us years ago) to include the Illicit THC liquid products, and they continue to use our word "Vaping" to cover Every kind of liquid that can be heated and inhaled through the various means and processes needed, even though these other liquids, especially a cannabis oil/liquid, cannot be used in our Nicotine Atomizers. But this is what MSM News has taken and run with. This kind of misinformation has also been used by these "save the children" organizations to poison, or at least cloud, the minds of our Federal leadership through constant and persistent Lobbying. We should have been doing this all along!!! But now, you can thank CDC's continuous Demonizing for creating and continually feeding MSM with misinformation to generate and maintain this National Panic.
All of that said and I still have not mentioned the possible (if not likely) roll of the Big Tobacco Master Settlement Agreement (MSA) payments which are made to the states each December by Big Tobacco, which are based on the state's cigarette and tobacco sales through the year. If you did not know, the MSA basically guarantees that cigarettes will never be banned in the USA, also referred to as the "Philip Morris Protection Act", so that's why cries for a cigarette ban will never be approved here. But these payments have been diminishing, dwindling more and more annually due to increased e-cig use each year, and was practically wiped out in 2007 in some states, which was therefore why some states have attempt to Ban Flavors or Ban Everything E-Cig, but I won't go into it any further than this now... I just wanted you who knew about it to know that I am aware of it, too. There are many factors in play, but the 2 mentioned above are what caused President Trump to announce his Flavor Ban, which only fueled the fires of MSM's E-Cig Frenzy.
So to answer the OP's question of who will win, FDA approval or not, I will say that we have a force to be dealt with in Tony Abboud of VTA (Vapor Technology Association) and Greg Conley of AVA (American Vaping Association), plus the efforts of Vape Advocates like Brent Stafford of Regulator Watch through his YouTube Professional Newscaster coverage of E-Cig Regulation Issues here in America and in Canada (he makes some very interesting and enlightening USA-addressed videos!), Matt Culley "Matt From SMM" on YouTube who is @SuckMyMod on Twitter plus his leadership role in United Vapers Alliance, which can be found on their website and on Facebook, plus he is active elsewhere, and finally, the Amazing Team of Phil Busardo (PBusardo on YouTube) and Dimitris Agrafiotis the VapinGreek @VapinGreek on Twitter, both of whom have been long-time E-Cig Advocates. Dimitris has created, what I call, an E-Cig Informercial Campaign called "the Whole Truth" by teaming with Brent of Regulator Watch, which is talked about in this 2 hour RegWatch video, and they are trying to get the series aired on Cable TV channels in America (but they need support to get this done!), with some of these guys getting the word out through CASAA who is helping to coordinate some efforts for them. I know there are other good and worthy ones not mentioned here, but these are the ones I follow regularly…
Well, if they and any others cannot get this thing turned around, then I think that about the only ones left who could afford a shot at a PMTA approval would be Big Tobacco (who seems to be trying to Monopolize the market anyway), possibly Big Pharma, then NJOY, maybe Joyetech, SMOK, and a few other Big E-cig Manufacturers. But that may well depend on how long it takes to change public and political thinking, and especially MSM thinking and reporting.
But, to me, this is an "already defeated" way thinking! We are not there yet! All is not lost! Not even close! So let's all do our best to keep it from getting that bad!!! The Fight is On and we are making a difference. The Media is finally starting to notice and acknowledge us. United Vapers Alliance is mounting another Rally in D.C. on November 9 from Noon to 4, and MSM has already contacted Matt and said they will be covering it. Doctors and other professionals are starting to say "Hey, wait a minute. E-Cigs are much better than smoking. Let's back up and consider the facts." and their voices are being heard. Please keep calling, emailing, and/or sending your letters to the White House, your Senators, and Representatives, and your State Governor, your Mayor, Legislators, and public officials. Please stay active on Twitter and Retweet the people above and any others you know, trust, and follow.
Please do what to can to help these associations and individuals above with Donations or Memberships if you are a Manufacturer or Distributor, or you own a big enough Vape Shop to afford it. Individuals can join VTA as "Friend of VTA" to make a one-time (or maybe monthly) donation here, or go there to become a Member if you have a big enough Vape Shop or you are an Industry Leader, Distributor, or Manufacturer. I made a one-time donation of $100 as "Friend of VTA". Greg Conley of AVA is accepting Donations here.
The E-Cig Hardware and E-Liquid Manufacturers, Distributors, and Suppliers, both here and overseas, who have not joined the Fight by either making a Big Donation to VTA, AVA, CASAA, etc., or by Joining VTA with a monthly paid Membership, really need to Ante Up Bigtime and help us. All Vape Shop owners and/or managers should be in regular contact with their Suppliers, Distributors, and Manufacturers to urge them as often as necessary to Join VTA on the highest level they can afford, and contribute handsomely to AVA, plus CASAA, SFATA, and others, and support any other worthy causes you can recommend to them, including those individuals mentioned above. These guys are working tirelessly for us.
It may be considered late in the game to get stated (if you haven't already), but it's certainly not too late now! We may have missed some opportunities to be prepared for this before it happened, but it ain't over yet!!! Dimitris and Flavor Art have been trying to get some things organized for years. Come on ECF, let's get Amped Up about this and Get 'er Done!!!
Thanks for your time if you read this. I will monitor this thread and come back to answer any questions that this post may invoke. Over and out, for now, and I'll see ya next time. Vape on, stay strong, and know that we can do this!
"And here's one for all of you to chew on, and answer if you know the real reason (not a supposition, please). If Vaping in general is a Tobacco product, as defined by FDA (even hardware and 0mg Juice have a Nicotine Warning label now), then why aren't we under the same Big Tobacco Umbrella of Protections that Cigarettes and other Tobacco products are?"
@100%VG sorry to just pull that out,but excising from the quote would've been tough.
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.
@100%VG sorry to just pull that out,but excising from the quote would've been tough.
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.
Those are FDA approved smoking cessation products. They took the even more arduous drug pathway though the FDA.
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.
It took more that two years for the IQOS PMTA to be approved. I would hardly call that "quick".
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.
Absolutely correct, as is the rest of your post.
It's far from Liberal. Most rate it as a conservative mag, so much that it's been called the Bible of American Conservatism.
The difference is that the National Review is a respected and widely read publication with far reaching effect among the upper crust in political circles. NR is a friend right now. We need support from more magazines such as National Review, IMO.
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They make the point strongly in this notice that they found no indication that people under the age limit, or adult non-smokers, showed an inclination to use the SNUS products. That might change if vaping is banned. And they also mentioned that they would continue to monitor it.
If Juuls went away I suspect SNUS would be a good candidate for the next teenage fad. It would be even more stealthy than Juuls, not even a slight wisp of vapor. I don't know if you could get the buzz teens seem to like out of SNUS. Maybe if you sucked on several at once. Anyway, the FDA warned us that they will be on the alert for any signs of people having a good time.
I just hope they don't ban all phone numbers that end with 867-5309. You know, just to be sure they get the right one.
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.
I Don't really see SNUS catching on anymore with the Underage segment than it is Already. Which is Fractionally Small.
But this...
Vape Is Dead. Long Live Sprape?
... has ALL the Ingredients of a Teen Fad.
And I wonder How Long it will take an Enterprising High School Student to figure out that adding a few Drops of Lorann's Mango food flavoring make it Taste Better?
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