So, we will make those childish liquids ourselves with food grade flavors for making cakes and icecream ....
Who will win FDA approval on vape devices / liquids - post ban?
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So, we will make those childish liquids ourselves with food grade flavors for making cakes and icecream ....
You're right, it hasn't been made clear. There were some hints from the FDA that they would be flexible about different versions of the same thing. Like you would be able to use a list of ingredients that had been already cleared in a previous submission, and the new submission would only need to address specific effects of the different percentages. But I don't believe that was laid out in the PMTA requirements.
May not matter anyway because the basic PMTA submission for a single juice is so onerous that it would be beyond the financial resources of any current juice producers, with the possible exception of Juul and the other BT producers.
A while back I came across some burnt places under the ground about 2 feet below the surface. It was a road being built where the top couple of feet of a former farm field was cut off the reach the grade engineers designed to road to be after it was finished. On one side there was a series of blackened dirt showing on the vertical edges of the cut. It turned out to be an encampment of the Appomattox tribe supposedly some 1000 years ago. Apparently the blackened dirt had been cook fires.
In the soils were deposits of arrowheads, and other tools used by the folks back then. I kept the find to myself for a time but shared it with a fellow whose grandfather taught him about traditions back in the days before the Europeans made it to America. He was amazed at the treasure trove of information scattered about. At first nobody bit on trying to help us determine how profound the find was. But one day a local councilman who was a huge civil war buff struck up a conversation with the guy who I showed the site to.
The dirt had been cut away and the project was abandoned for about a year. It was going to be a subdivision built by two fellows who were the remainder of a family that used to farm tobacco on that tract of land. They built roads themselves and slowly added pipes and utilities to finish roads nearby and this was the last one scheduled to be built.
The civil war buff brought some archeologists to the site and a number of items found there ended up in the Smithsonian Institute. It seems some of the pottery found was carbon dated to times before the American Indian was supposed to have inhabited the east coast of America.
Anyway in the few artifacts I kept was a 3/4" long hunk of hollow clay the fellow I showed the site to told me was probably a piece of a clay pipe used during the Revolutionary War of America. He said back then in taverns hung a pipe folks paid to rent so to speak. He said folks who buy a pouch of tobacco and use the bars pipe to smoke it much like today we use their glass to drink cocktails. That folks bit the end off if they didn't want to "smoke" the previous users germs and that the small segment of hollow clay may have been the piece bit off the end of a clay pipe shared by some soldiers overlooking the Appomattox River into Pertersburg Va long after the "red man" no longer called that area residence.
Back then tobacco was like money, so it would be akin to rolling up some tobacco in a $5 bill these days. Only wealthy folks smoked "money" back then and I was told if that segement of hollow clay were from a pipe used by a soldier it would've likely been a high ranking officer. I used to gleefully think perhaps General Washington himself spit that piece of clay onto the ground only to be trash to him but treasure to me.
I asked the expert if the segment of hollow clay could have come from one of the Appomattox members to which he replied they smoked from wooden pipes.
I was fairly optimistic about our chances of getting through this without major damage before joining this thread, but with reading and absorbing all of the info provided here, now I'm wondering if we'll make it through at all. I'm not pessimistic about it, or at least I'm trying not to be, and I have not gotten the impression that most of you here really are either. The info has all been factual and well presented, except for my one pointed-out glitch. Of course, some are doubtful, but I have not seen the totally defeated pessimism I've seen elsewhere, or at least have not recognized it as such. But...
If anyone has something encouraging to say, I'd really appreciate hearing it now!
If anyone has suggestions for things to be done that will actually make a difference, or will work toward making a difference, I think this is what needs to be heard and concentrated on now. We have the facts we need, but what do we do with them now?
I mean, I will be OK for a good while. I can live perfectly fine without premade e-liquids because I DIY. Plus the fact that I cannot vape the majority of them anyway, because I am allergic to PG, so I DIY with PG-Free flavorings in alcohol and avoid PG completely. I have been in contact with my VG Nic and USP sources and my Flavoring sources, and they have been given permission to contact me by email or phone to tell me where they are if they either have to change online shop names because "vape", "vaping", "e-cig" or anything "telling" is in the name, or if they decide to go underground for sales. I have received some encouraging replies from some of them. One is already taking an action to be prepared. Wish she had given some details about it, so I could share them with others!
I bought about $550 worth of new vape gear in early August, well before this insanity got so out of hand. New Mods, RTAs, RBA coil heads for Subohm Tanks, and Rebuilding tools and supplies, either to replace many things that were stolen, or to replace one Mod that was dropped (first time I dropped and damaged anything since November 2012
), and I also bought a new single-21700 TC Mod and 2 Samsung 30T batteries for it, and 2 RTAs that were new while I was at it. Yeah, I got a lot of great hardware stuff!!!
My 18650, 20700, and 21700 Battery and Charger suppliers are Orbtronic and IMR Batteries, who also sell their products for flashlights and such, so at least they won't be as damaged as B&M Vape Shops and online stores will be.
So Yes, I will be OK for a good while, as will many of you. But what about those Mom and Pop B&M Vape Shops and their online presence if any, and all of those bigger online stores? And therefore, what about those of us, who are already prepared, when we need to replace something, need new rebuilding supplies, or want a new product which we could have easily found otherwise? What about those who rely on premade e-liquids? On premade coil heads? What about the percentage of those current vapers who will return to smoking, open system or not, without attractive flavors? What about the smokers who will no longer have access to safely-made Vaping Industry products to consider as a safer alternative? What about the Black Market that will surely appear and flourish if President Trump, FDA, CDC, "save the children" organizations and such, all have their way? What about the World's impression of America, due to such obvious corruption?
I guess this brings me back to my original post. But again, if anyone has something encouraging to say, or has a better idea of what could/should be done, then please tell us now! I know that I would appreciate hearing it, and likely most of us would, too.
If anyone has something encouraging to say, I'd really appreciate hearing it now!
If anyone has suggestions for things to be done that will actually make a difference, or will work toward making a difference, I think this is what needs to be heard and concentrated on now. We have the facts we need, but what do we do with them now?
I mean, I will be OK for a good while. I can live perfectly fine without premade e-liquids because I DIY. Plus the fact that I cannot vape the majority of them anyway, because I am allergic to PG, so I DIY with PG-Free flavorings in alcohol and avoid PG completely. I have been in contact with my VG Nic and USP sources and my Flavoring sources, and they have been given permission to contact me by email or phone to tell me where they are if they either have to change online shop names because "vape", "vaping", "e-cig" or anything "telling" is in the name, or if they decide to go underground for sales. I have received some encouraging replies from some of them. One is already taking an action to be prepared. Wish she had given some details about it, so I could share them with others!
I bought about $550 worth of new vape gear in early August, well before this insanity got so out of hand. New Mods, RTAs, RBA coil heads for Subohm Tanks, and Rebuilding tools and supplies, either to replace many things that were stolen, or to replace one Mod that was dropped (first time I dropped and damaged anything since November 2012
), and I also bought a new single-21700 TC Mod and 2 Samsung 30T batteries for it, and 2 RTAs that were new while I was at it. Yeah, I got a lot of great hardware stuff!!!My 18650, 20700, and 21700 Battery and Charger suppliers are Orbtronic and IMR Batteries, who also sell their products for flashlights and such, so at least they won't be as damaged as B&M Vape Shops and online stores will be.
So Yes, I will be OK for a good while, as will many of you. But what about those Mom and Pop B&M Vape Shops and their online presence if any, and all of those bigger online stores? And therefore, what about those of us, who are already prepared, when we need to replace something, need new rebuilding supplies, or want a new product which we could have easily found otherwise? What about those who rely on premade e-liquids? On premade coil heads? What about the percentage of those current vapers who will return to smoking, open system or not, without attractive flavors? What about the smokers who will no longer have access to safely-made Vaping Industry products to consider as a safer alternative? What about the Black Market that will surely appear and flourish if President Trump, FDA, CDC, "save the children" organizations and such, all have their way? What about the World's impression of America, due to such obvious corruption?
I guess this brings me back to my original post. But again, if anyone has something encouraging to say, or has a better idea of what could/should be done, then please tell us now! I know that I would appreciate hearing it, and likely most of us would, too.
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Prepare yourself to not be a victim. I have been telling people if you want to continue to vape you should have at least 1 mech mod and RDA and know how to use them. You need to know how to wind your own coils and DIY your own ejuice. A supply of nic base will also be a necessity. You can't stop the sheep from going to slaughter. All you can do is not be a sheep.I was fairly optimistic about our chances of getting through this without major damage before joining this thread, but with reading and absorbing all of the info provided here, now I'm wondering if we'll make it through at all. I'm not pessimistic about it, or at least I'm trying not to be, and I have not gotten the impression that most of you here really are either. The info has all been factual and well presented, except for my one pointed-out glitch. Of course, some are doubtful, but I have not seen the totally defeated pessimism I've seen elsewhere, or at least have not recognized it as such. But...
If anyone has something encouraging to say, I'd really appreciate hearing it now!
If anyone has suggestions for things to be done that will actually make a difference, or will work toward making a difference, I think this is what needs to be heard and concentrated on now. We have the facts we need, but what do we do with them now?
I mean, I will be OK for a good while. I can live perfectly fine without premade e-liquids because I DIY. Plus the fact that I cannot vape the majority of them anyway, because I am allergic to PG, so I DIY with PG-Free flavorings in alcohol and avoid PG completely. I have been in contact with my VG Nic and USP sources and my Flavoring sources, and they have been given permission to contact me by email or phone to tell me where they are if they either have to change online shop names because "vape", "vaping", "e-cig" or anything "telling" is in the name, or if they decide to go underground for sales. I have received some encouraging replies from some of them. One is already taking an action to be prepared. Wish she had given some details about it, so I could share them with others!
I bought about $550 worth of new vape gear in early August, well before this insanity got so out of hand. New Mods, RTAs, RBA coil heads for Subohm Tanks, and Rebuilding tools and supplies, either to replace many things that were stolen, or to replace one Mod that was dropped (first time I dropped and damaged anything since November 2012
My 18650, 20700, and 21700 Battery and Charger suppliers are Orbtronic and IMR Batteries, who also sell their products for flashlights and such, so at least they won't be as damaged as B&M Vape Shops and online stores will be.
So Yes, I will be OK for a good while, as will many of you. But what about those Mom and Pop B&M Vape Shops and their online presence if any, and all of those bigger online stores? And therefore, what about those of us, who are already prepared, when we need to replace something, need new rebuilding supplies, or want a new product which we could have easily found otherwise? What about those who rely on premade e-liquids? On premade coil heads? What about the percentage of those current vapers who will return to smoking, open system or not, without attractive flavors? What about the smokers who will no longer have access to safely-made Vaping Industry products to consider as a safer alternative? What about the Black Market that will surely appear and flourish if President Trump, FDA, CDC, "save the children" organizations and such, all have their way? What about the World's impression of America, due to such obvious corruption?
I guess this brings me back to my original post. But again, if anyone has something encouraging to say, or has a better idea of what could/should be done, then please tell us now! I know that I would appreciate hearing it, and likely most of us would, too.
In my view, this is modern-day, witch-burning, the sky is falling hysteria with a mob whipped into emotional and irrational frenzy either by the ill-informed or for purpose. Personally, I think it’s purposeful and we are seeing what several hundred million dollars spent on Washington lobbyists and New York media relations can buy. And yes, believe I have seen this handy work before.
Have you heard of the "Washington bubble"—it is real. However, this is a campaign directed to create (at least the appearance of) a "grass-root”, public uprising demanding immediate action of government. Who might have financed? Well, I only see one player standing to immediately and directly benefit. And they already spend more than anyone else on lobbying. Big pharma! Perhaps with a goal of pushing big tobacco out of the market and ring-fencing ecigs as medical devices?
Yes, we have a few rational players, but this is spin sustained at a very high-level. Will the rational players or spinners fold first? Can the spin be sustained? In my estimation, the outcome is highly unpredictable. Our situation seems one where we must hope and work for the best — but plan for the worst. GL
Have you heard of the "Washington bubble"—it is real. However, this is a campaign directed to create (at least the appearance of) a "grass-root”, public uprising demanding immediate action of government. Who might have financed? Well, I only see one player standing to immediately and directly benefit. And they already spend more than anyone else on lobbying. Big pharma! Perhaps with a goal of pushing big tobacco out of the market and ring-fencing ecigs as medical devices?
Yes, we have a few rational players, but this is spin sustained at a very high-level. Will the rational players or spinners fold first? Can the spin be sustained? In my estimation, the outcome is highly unpredictable. Our situation seems one where we must hope and work for the best — but plan for the worst. GL
Are you sure about that? My understanding is that there has been considerable consolidation in the juice industry and that there are some very large producers.
Silly question... but did you remember to stock up on a lifetime of nicotine? I did not see that in your post.I was fairly optimistic about our chances of getting through this without major damage before joining this thread, but with reading and absorbing all of the info provided here, now I'm wondering if we'll make it through at all. I'm not pessimistic about it, or at least I'm trying not to be, and I have not gotten the impression that most of you here really are either. The info has all been factual and well presented, except for my one pointed-out glitch. Of course, some are doubtful, but I have not seen the totally defeated pessimism I've seen elsewhere, or at least have not recognized it as such. But...
If anyone has something encouraging to say, I'd really appreciate hearing it now!
If anyone has suggestions for things to be done that will actually make a difference, or will work toward making a difference, I think this is what needs to be heard and concentrated on now. We have the facts we need, but what do we do with them now?
I mean, I will be OK for a good while. I can live perfectly fine without premade e-liquids because I DIY. Plus the fact that I cannot vape the majority of them anyway, because I am allergic to PG, so I DIY with PG-Free flavorings in alcohol and avoid PG completely. I have been in contact with my VG Nic and USP sources and my Flavoring sources, and they have been given permission to contact me by email or phone to tell me where they are if they either have to change online shop names because "vape", "vaping", "e-cig" or anything "telling" is in the name, or if they decide to go underground for sales. I have received some encouraging replies from some of them. One is already taking an action to be prepared. Wish she had given some details about it, so I could share them with others!
I bought about $550 worth of new vape gear in early August, well before this insanity got so out of hand. New Mods, RTAs, RBA coil heads for Subohm Tanks, and Rebuilding tools and supplies, either to replace many things that were stolen, or to replace one Mod that was dropped (first time I dropped and damaged anything since November 2012
My 18650, 20700, and 21700 Battery and Charger suppliers are Orbtronic and IMR Batteries, who also sell their products for flashlights and such, so at least they won't be as damaged as B&M Vape Shops and online stores will be.
So Yes, I will be OK for a good while, as will many of you. But what about those Mom and Pop B&M Vape Shops and their online presence if any, and all of those bigger online stores? And therefore, what about those of us, who are already prepared, when we need to replace something, need new rebuilding supplies, or want a new product which we could have easily found otherwise? What about those who rely on premade e-liquids? On premade coil heads? What about the percentage of those current vapers who will return to smoking, open system or not, without attractive flavors? What about the smokers who will no longer have access to safely-made Vaping Industry products to consider as a safer alternative? What about the Black Market that will surely appear and flourish if President Trump, FDA, CDC, "save the children" organizations and such, all have their way? What about the World's impression of America, due to such obvious corruption?
I guess this brings me back to my original post. But again, if anyone has something encouraging to say, or has a better idea of what could/should be done, then please tell us now! I know that I would appreciate hearing it, and likely most of us would, too.
Great question, maybe the only real question - not silly at all, in my opinion. If one has nicotine then the rest can be finessed.
Maybe so. Can't say I'm fully plugged into what's going on in the juice world. Still a bit of a gamble paying out a big bag of money to get a PMTA for juice when hardware and/or flavors could go away by the time it was approved.
Yep, it's definitely a gamble. But let's say you're one of the big juice "labs", one that has registered its product line with the FDA and invested in automation (i.e. bottle filling and labeling lines), and you're doing millions of dollars a year in B2b/wholesale sales. You're now too big to go underground. That leaves two choices: Pay the money required to prepare some PMTAs and submit them, or close your doors come next May. If you submit, you get to stay open at least for a time, while much of your competition is gone.
So are you of the Opinion that a "Bottled" e-Liquid can receive a PMTA?
I don't know. Let's assume it cannot and the FDA will eventually decline to issue any marketing orders for any bottled e-liquid. Then the question becomes: Can the manufacturer make more money during the extra time on the market that the applications bought him than the applications cost him?
I don't think the FDA can reject all such applications quickly. If they did, I think there would be a flurry of lawsuits. I don't know how they'd be phrased in legal terms but basically, "Hey, if you were going to just reject these out-of-hand, why didn't you tell us not to bother instead of having us spend all that money preparing these applications in good faith?"
So if credible applications are filed, I think the FDA has to at least give the appearance of considering/evaluating them for something like a year or more before rejecting them.
I just Don't Understand How a Bottled e-Liquid could be assessed using the listed Criteria below when there is No Assurance that a User will Use it the way a Tester Tested it?
(1) A summary of the nonclinical and clinical studies relevant to your PMTA, regardless of whether you consider these studies favorable or unfavorable to the application. It would be helpful to include the specific product or products that were studied and how those products have similar characteristics (similar materials, ingredients, design, composition, heating source, or other features) to the applicant’s product if used as a substitute or supplement for data for the product. It would also be helpful to include the study findings, such as whether the findings concern the product’s health risks compared to other tobacco products and whether the product presents less risk than other tobacco products. If no relevant health information is available, we recommend that you state so in this section;
(2) The relative health risks of the new tobacco product for both users and nonusers compared to other tobacco products on the market (e.g., other ENDS, combusted tobacco products such as cigarettes), including tobacco products within the same product category as it may be expected that consumers of current products within the same product category may switch to using a newly marketed product, and the health risks compared to never using tobacco products;
(3) The chemical and physical identity and quantitative levels of the emission of aerosols under the range of operating conditions (e.g., various temperature, voltage, wattage settings) and use patterns (e.g., intense and non-intense use conditions) within which consumers are likely to use the new tobacco product;
(4) The likelihood, based on the research information contained in your application, of current nonusers of tobacco products initiating or reinitiating tobacco use by using the new tobacco product;
(5) The likelihood, based on the research information contained in your application, that consumers will adopt the new tobacco product and then switch to other tobacco products that may present higher levels of risk, such as cigarettes;
(6) The likelihood, based on the research information contained in your application, of consumers using the new tobacco product in conjunction with other tobacco products;
(7) The likelihood, based on the research information contained in your application, of current tobacco product users switching to the product instead of ceasing tobacco product use or using an FDA-approved tobacco cessation product (because use of ENDS products includes inherent risk above quitting altogether or the use of an FDA-approved nicotine-replacement therapy (NRT));
(8) Assessment of abuse liability (i.e., the addictiveness, abuse, and misuse potential of the new product and the exposure to nicotine during product use);
(9) Assessment of user topography (how individual users consume the product, e.g., the number of puffs, puff duration, puff intensity, duration of use), the frequency with which consumers use the product, and the trends by which users consume the product over time; and
(10) A discussion demonstrating how the data and information contained in your PMTA establish that permitting the marketing of the new tobacco product would be APPH.
https://www.fda.gov/media/127853/download
Now if I was say BT or NJOY, and my specific e-Liquid was tied to my Specific e-Cigarette, and I was tying to get a PMTA for them as when they are Used/Sold together, then yeah, that makes Sense.
There is also this...
c. Principles of operation
Consumers may be able to alter an ENDS product’s effects by changing the product design, the way the product is used, or adding or subtracting other ingredients. Section 910(b)(1)(B) of the FD&C Act requires you to submit as part of your PMTA “a full statement of the . . . principle or principles of operation” of the new tobacco product. FDA interprets a full statement of principle or principles of operation to include a full narrative description of the way in which a consumer will use the new tobacco product, including a description of how a consumer operates the product, how the manufacturer reasonably believes a consumer could change the product characteristics, adjust the performance, or add or subtract ingredients. This description also should include examples of the other types of ENDS products with which your product can be used and also show the range of conditions under which the product may operate.
https://www.fda.gov/media/127853/download
... which I am Not Sure how a Bottled e-Liquid could be assessed in an the Multitudes of Open System atomizers paired with 510 interchangeable Mods?
To just have a Bottle of e-Liquid, and Not be able to Evaluate it with a Specific e-Cigarette, and to Not be able to make any Assurances that the e-Liquid will ONLY be used with that specific e-Cigarette, seems like a Non-Starter for FDA Market Order-wise.
Not trying to be the Big Black Fly in the Wedding Cake. But whenever I read Anything the FDA published with the word "e-Liquid" in it, I Always took it in the context of an e-Liquid being used in a Specific e-Cigarette(s).
(1) A summary of the nonclinical and clinical studies relevant to your PMTA, regardless of whether you consider these studies favorable or unfavorable to the application. It would be helpful to include the specific product or products that were studied and how those products have similar characteristics (similar materials, ingredients, design, composition, heating source, or other features) to the applicant’s product if used as a substitute or supplement for data for the product. It would also be helpful to include the study findings, such as whether the findings concern the product’s health risks compared to other tobacco products and whether the product presents less risk than other tobacco products. If no relevant health information is available, we recommend that you state so in this section;
(2) The relative health risks of the new tobacco product for both users and nonusers compared to other tobacco products on the market (e.g., other ENDS, combusted tobacco products such as cigarettes), including tobacco products within the same product category as it may be expected that consumers of current products within the same product category may switch to using a newly marketed product, and the health risks compared to never using tobacco products;
(3) The chemical and physical identity and quantitative levels of the emission of aerosols under the range of operating conditions (e.g., various temperature, voltage, wattage settings) and use patterns (e.g., intense and non-intense use conditions) within which consumers are likely to use the new tobacco product;
(4) The likelihood, based on the research information contained in your application, of current nonusers of tobacco products initiating or reinitiating tobacco use by using the new tobacco product;
(5) The likelihood, based on the research information contained in your application, that consumers will adopt the new tobacco product and then switch to other tobacco products that may present higher levels of risk, such as cigarettes;
(6) The likelihood, based on the research information contained in your application, of consumers using the new tobacco product in conjunction with other tobacco products;
(7) The likelihood, based on the research information contained in your application, of current tobacco product users switching to the product instead of ceasing tobacco product use or using an FDA-approved tobacco cessation product (because use of ENDS products includes inherent risk above quitting altogether or the use of an FDA-approved nicotine-replacement therapy (NRT));
(8) Assessment of abuse liability (i.e., the addictiveness, abuse, and misuse potential of the new product and the exposure to nicotine during product use);
(9) Assessment of user topography (how individual users consume the product, e.g., the number of puffs, puff duration, puff intensity, duration of use), the frequency with which consumers use the product, and the trends by which users consume the product over time; and
(10) A discussion demonstrating how the data and information contained in your PMTA establish that permitting the marketing of the new tobacco product would be APPH.
https://www.fda.gov/media/127853/download
Now if I was say BT or NJOY, and my specific e-Liquid was tied to my Specific e-Cigarette, and I was tying to get a PMTA for them as when they are Used/Sold together, then yeah, that makes Sense.
There is also this...
c. Principles of operation
Consumers may be able to alter an ENDS product’s effects by changing the product design, the way the product is used, or adding or subtracting other ingredients. Section 910(b)(1)(B) of the FD&C Act requires you to submit as part of your PMTA “a full statement of the . . . principle or principles of operation” of the new tobacco product. FDA interprets a full statement of principle or principles of operation to include a full narrative description of the way in which a consumer will use the new tobacco product, including a description of how a consumer operates the product, how the manufacturer reasonably believes a consumer could change the product characteristics, adjust the performance, or add or subtract ingredients. This description also should include examples of the other types of ENDS products with which your product can be used and also show the range of conditions under which the product may operate.
https://www.fda.gov/media/127853/download
... which I am Not Sure how a Bottled e-Liquid could be assessed in an the Multitudes of Open System atomizers paired with 510 interchangeable Mods?
To just have a Bottle of e-Liquid, and Not be able to Evaluate it with a Specific e-Cigarette, and to Not be able to make any Assurances that the e-Liquid will ONLY be used with that specific e-Cigarette, seems like a Non-Starter for FDA Market Order-wise.
Not trying to be the Big Black Fly in the Wedding Cake. But whenever I read Anything the FDA published with the word "e-Liquid" in it, I Always took it in the context of an e-Liquid being used in a Specific e-Cigarette(s).
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But... but... that's wack-a-doo conspiracy talk! Call the police! Call a doctor! Call a priest!Seriously though, you nailed it. It's cogent thinking like this, that puts me in the mood to watch The Aviator.
reading all of that, I agree. Just being in a bottle there is no way to predict how an end user might alter the product, and with open systems there are an exponential possible ways it could be vaporized. These rules read like an impossible labyrinth.
I understand where your'e coming from.
If I were a large e-liquid manufacturer, I suppose I would try to have my product tested for emissions in a wide range of devices and hope for the best.
If the FDA was being reasonable about this, they would either issue guidance as to what appropriate and acceptable test methodologies for an e-liquid are, or they would unequivocally say: "Don't bother, we're not going to approve any bottled liquid". The fact that they have done neither of these things may not be viewed favorably in the court system.
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I can see a time where sealed cartridges might be what the FDA prefers. Of course, the problem we are seeing with CBD oil stemmed from ill advised uses in vape devices. The public is largely unaware of the safe methods. Personally, I don't want oil in my vape for any reason.
Ran across this article recently. It's informative, but offers sketchy information about exactly how to use CBD oil safely.
Everything You Need To Know About CBD Oil - Vapor Works Online
Ran across this article recently. It's informative, but offers sketchy information about exactly how to use CBD oil safely.
Everything You Need To Know About CBD Oil - Vapor Works Online
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That kinda Sums Up things right there.
And about the Only way it would seem that a Bottled e-Liquid could comply with this FDA Guidance is it would have to be Tested/Studied using Every Type of Open System Atomizer, Coil Type, Wicking, Airflow, Volt/Watt setting(s) out there.
Hey maybe I'm wrong? And it would be Nice if I was. But I just Don't see the FDA going through All the Time and Effort to make the PMTA process so Difficult and Expensive to comply with, only to give Bottle e-Liquids some kind of pass.
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