Sometimes, trying to understand and discuss FDA proposed regulations is a lot like discussing theories about the island in Lost.
Every answer I give you will only lead to more questions
FDA Could the FDA really regulate E-Liquid??
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Sometimes, trying to understand and discuss FDA proposed regulations is a lot like discussing theories about the island in Lost.
Every answer I give you will only lead to more questions
But will they allow free flowing bottled juice? It's a big question. The biggest of them all. The possibility exists to make all juice come sealed in a device. Like a cigalike or cheap clearo. I don't like the bad press about "OMG THE KIDS! Their drinking the poison like cool aid!". If the FDA wants to play the card of bottled nic being too dangerous to allow they already have leverage. BT would hit a walkoff grand slam if that happened.
I have assumed from the beginning, that the regulations would absolutely make it illegal to come in contact with the juice.
So, if someone manufactured a flashlight with an interchangeable head that just "happened" to have a 510 connection then than would regulated?
Or a 510 adapter for an existing flashlight, in that case the connector would be. Hmm, 2 pieces of metal and some plastic.
Or a 510 adapter for an existing flashlight, in that case the connector would be. Hmm, 2 pieces of metal and some plastic.
The consensus seems to be that this will very likely be the indirectly-achieved end result for e-liquid that contains any ingredient derived from tobacco.
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1) The FDA is not proposing an explicit prohibition against e-liquid sales in containers other than sealed cartridges.
In sharp contrast to the clear, explicit, and unambiguous language used regarding access by minors, there's precious little in the PDF about e-liquid containers. Most of this has to do with the two references to poisonings from contact wiith e-liquid. These occur in the text with regards to poison control call center reports on p.54 and p.61.
On p.61, the FDA cites the CDC's comparison study in its weekly morbidity report which was published last month (4/4) with a companion press release in which CDC Dir. Tom Frieden crowed about the "skyrocketing" number of such calls. As many vapers know, the press release was quoted in myriad press reports, perhaps as many as a thousand (if we including syndications, etc.).
It may not be an exaggeration to say that virtually every news outlet in the US was careful to advise parents that American's emergency rooms were in imminent danger of filling up with small, helpless, innocent poisoned children who had fallen victim to the horrific perils of e-cigarettes, ruthlessly perpetrated on an unsuspecting public by the big tobacco companies.
Despite this apparent admonition from the CDC directed towards US parents about the need to head immediately for the safety of the hills with the little ones in tow, the PDF mentions poisonings only in one other place, and that's a brief reference to a 2010 parper which occurs on p.54.
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2) However there also seems to be a consensus that this scenario will be a result of the indirect effects of the proposed rule, should it become final. In other words, there will be no e-liquid sales to consumers in bottles or other containers other than sealed cartridges, nor will devices that can be filled with it be commerically available. (At least not for e-liquid that contains anything derived from tobacco.)
CASAA has said in its press release is that the rules will indirectly ban refillable devices - probably by regulating them as "components or parts" of "covered tobacco products." (All other credible sources have suggested the same thing.)
All credible observers also seem to agree tha the standards for getting any e-liquids approved for sale to consumers will be dauntingly high, so long as those e-liquids contain nicotine derived from tobacco. The situation with nicotine-free e-liquids that contain other ingredients derived from tobacco is murky at best, and it has been suggested by the FDA's former Chief Counsel that litigation may be required in order to legally sell them.
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The short answer is 'yes.'
http://www.e-cigarette-forum.com/fo...some-point-next-few-weeks-2.html#post13045370
P.S.: Congratulations for being the one thousandth poster on ECF to have asked a similar question. For your troubles, we have a special prize: a drip tip made out of the remanents of a Provari that was shoved down a garbage disposal by the FDA, in a 2009 test designed to evaluate the toxicity of APVs.
Well, there's another federal regulatory agency -- the BATFE -- under whose auspices similar questions have arisen. E.g. is a piece of metal that adapts 5/8-24 female threads to 3/4-16 male threads a "silencer"? The answer is: No, it's not. You can buy them all day long on eBay. However, the moment you screw it onto the muzzle of a gun and then screw an oil filter onto that, it is, and you're a felon. In fact, if you own a gun with a threaded barrel, such an adapter, and an oil filter, then you obviously must have "Constructive intent" and you're probably a felon.
Wait 'till the EPA deems your freezer stockpile a Toxic Chemical Repository....
Yep. There comes a time when otherwise honest and peaceable people decide that those who wish to control them have gone too far, and confiscating my private stockpile of formerly legal nicotine would easily qualify.
I Haven't seen Anything saying that Possession of Nicotine base is Somehow going to be Illegalized?
If you have, Please post a Link.
My comment was made in the context provided, which was clearly a hypothetical circumstance.
Of course a lot of intrusions into our lives were only hypothetical not that long ago.
You might consider dropping the 'consensus' and 'credible'. Those are just argument from authority fallacies. Doesn't work for Climate Change or ecigarettes, or anything major media attempts to push.
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The reason I asked is if you Limit the Amount of Something that a Person can Posses, you can Effectively Reduce His/Her Ability to Sell it.
Roger, I had this nice long (probably too-long) reply almost ready to go, yet somehow stupidly lost it, probably from having a couple ECF windows up & closed the wrong one, and also couldn't auto-restore it..
Anyway, not going to type it all up again, or even argue the other points.. But long story short, one of the things was that the FDA wants to go after hookah flavoring, which they specifically mentioned...
This is simply a flavored powder (like grape, cherry, mint, etc.) that one adds to the water at the bottom part of the hookah!
Well, guess what? The FDA wants to regulate it -- even though this flavoring product isn't derived from tobacco, and can also be used in conjunction with other non-tobacco combustible substances, as well...
As for the vitamin PV, if that's not already regulated via another part of the FDA, then they should probably be expecting that soon...
Can vape companies get around certain regulations with certain items, depending on how they do it? Possibly..
But keep in mind what I posted about in another thread concerning the Amish raw milk producer.. Basically the FDA busted him for selling it, so he then legally changed his business model where he sold "cow shares" and these new owners/shareholders were now technically receiving a dividend, of sorts (raw milk), since that was their legal right as owners.. The FDA couldn't do anything more at that point because of that, so instead they got a judge after him who forced him to shut it down, calling it "subterfuge"...
Could something like this also potentially happen to the future of vape products? Who knows, but it certainly wouldn't be the 1st time...
Anyway, not going to type it all up again, or even argue the other points.. But long story short, one of the things was that the FDA wants to go after hookah flavoring, which they specifically mentioned...
This is simply a flavored powder (like grape, cherry, mint, etc.) that one adds to the water at the bottom part of the hookah!
Well, guess what? The FDA wants to regulate it -- even though this flavoring product isn't derived from tobacco, and can also be used in conjunction with other non-tobacco combustible substances, as well...
As for the vitamin PV, if that's not already regulated via another part of the FDA, then they should probably be expecting that soon...
Can vape companies get around certain regulations with certain items, depending on how they do it? Possibly..
But keep in mind what I posted about in another thread concerning the Amish raw milk producer.. Basically the FDA busted him for selling it, so he then legally changed his business model where he sold "cow shares" and these new owners/shareholders were now technically receiving a dividend, of sorts (raw milk), since that was their legal right as owners.. The FDA couldn't do anything more at that point because of that, so instead they got a judge after him who forced him to shut it down, calling it "subterfuge"...
Could something like this also potentially happen to the future of vape products? Who knows, but it certainly wouldn't be the 1st time...
Perhaps I should've also mentioned that positions for which I cited authority had also been discussed at length on this forum, and were for all intents and purposes horses that had been beaten well past the point of death (at least in one case).
Hmm, I don't know how the FDA could be regulating the vitAcig under some non-tobacco-product rubric. It's not sold as a therapy. There's no drug involved. It's not a food or a drink. And it's not a cosmetic. Your guess is as good as mine there.
All I was saying is that even though we think of the vitAcig as an "electronic cigarette," and the FDA has said it will be regulating "electronic cigarettes" under the tobacoo act (FSPTCA), the vigAcig is not subject to that kind of regulation. Looks like you and I agree about that.
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Could a judge follow the example in the case of the Amish farmer selling "cow shares," for raw milk, and declare e-liquid which contains nothing derived from tobacco, and which is sold to be vaped by itself (i.e. not used in combination with anything that contains something derived from tobacco) as a "subterfuge?"
I don't know. Perhaps. Maybe a judge could declare it to be weapon of mass destruction. I'm not being flippant there, courts have make less plausible rulings.
All I was saying is that under the analysis provived thus far by the FDA, e-liquid can't be regulated under the FSPTCA, so long as this e-liquid contains nothing derived from tobacco and is intended to be vaped "as is" (i.e. not used in tandem with anything that contains anything derived from tobacco)
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The hookah flavoring case is interesting, because we can use it as a point of departure for looking at e-liquid (which contains nothing derived from tobacco) in two different ways.
E-liquid (which contains nothing derived from tobacco), which is sold as a flavor "base" and is intended to be mixed with high-concentration nic. base, is a lot more like hookah flavorings. It's combined with a tobacco product. If the hookah flavorings are "components or parts", so would the e-liquid flavor "base" (even if it contained nothing derived from tobacco).
So yes, maybe the FDA could regulate e-liquid "flavor base" as a component or part of a tobacco product.
E-liquid which is vapable by itself and which contains nothing derived from tobacco doesn't have that charcteristic. It is intended to be used with a component or part of a tobacco product. But it is not intended to be used with a tobacco product.
To be a "tobacco product," something has to be derived from tobacco or contain something derived from tobacco. None of the equipment we use is derived from tobacco, nor does it contain anything derived from tobacco.
So if the FDA is going to regulate e-liquid which is sold for vaping "as is," and which doesn't contain anything derived from tobacco, it will first have to find a way to associate the use of that e-liquid with something that is itself a tobacco prioduct, i.e. something that contains an ingredient or a part which is derived from tobacco.
Just because the hookah flavoring can be used with something that is not a tobacco product doesn't let it off the hook[ah] as it were. As long as it's sold to be used with a tobacco product, that's good enough. It's like saying that cigarette papers can be used to roll up herbs. (The cigarette papers issue is complicated, someone has been talking about Juicy Jay's in another thread.)
All I was saying is that even though we think of the vitAcig as an "electronic cigarette," and the FDA has said it will be regulating "electronic cigarettes" under the tobacoo act (FSPTCA), the vigAcig is not subject to that kind of regulation. Looks like you and I agree about that.
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Could a judge follow the example in the case of the Amish farmer selling "cow shares," for raw milk, and declare e-liquid which contains nothing derived from tobacco, and which is sold to be vaped by itself (i.e. not used in combination with anything that contains something derived from tobacco) as a "subterfuge?"
I don't know. Perhaps. Maybe a judge could declare it to be weapon of mass destruction. I'm not being flippant there, courts have make less plausible rulings.
All I was saying is that under the analysis provived thus far by the FDA, e-liquid can't be regulated under the FSPTCA, so long as this e-liquid contains nothing derived from tobacco and is intended to be vaped "as is" (i.e. not used in tandem with anything that contains anything derived from tobacco)
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The hookah flavoring case is interesting, because we can use it as a point of departure for looking at e-liquid (which contains nothing derived from tobacco) in two different ways.
E-liquid (which contains nothing derived from tobacco), which is sold as a flavor "base" and is intended to be mixed with high-concentration nic. base, is a lot more like hookah flavorings. It's combined with a tobacco product. If the hookah flavorings are "components or parts", so would the e-liquid flavor "base" (even if it contained nothing derived from tobacco).
So yes, maybe the FDA could regulate e-liquid "flavor base" as a component or part of a tobacco product.
E-liquid which is vapable by itself and which contains nothing derived from tobacco doesn't have that charcteristic. It is intended to be used with a component or part of a tobacco product. But it is not intended to be used with a tobacco product.
To be a "tobacco product," something has to be derived from tobacco or contain something derived from tobacco. None of the equipment we use is derived from tobacco, nor does it contain anything derived from tobacco.
So if the FDA is going to regulate e-liquid which is sold for vaping "as is," and which doesn't contain anything derived from tobacco, it will first have to find a way to associate the use of that e-liquid with something that is itself a tobacco prioduct, i.e. something that contains an ingredient or a part which is derived from tobacco.
Just because the hookah flavoring can be used with something that is not a tobacco product doesn't let it off the hook[ah] as it were. As long as it's sold to be used with a tobacco product, that's good enough. It's like saying that cigarette papers can be used to roll up herbs. (The cigarette papers issue is complicated, someone has been talking about Juicy Jay's in another thread.)
Roger, I had this nice long (probably too-long) reply almost ready to go, yet somehow stupidly lost it, probably from having a couple ECF windows up & closed the wrong one, and also couldn't auto-restore it..
Anyway, not going to type it all up again, or even argue the other points.. But long story short, one of the things was that the FDA wants to go after hookah flavoring, which they specifically mentioned...
This is simply a flavored powder (like grape, cherry, mint, etc.) that one adds to the water at the bottom part of the hookah!
Well, guess what? The FDA wants to regulate it -- even though this flavoring product isn't derived from tobacco, and can also be used in conjunction with other non-tobacco combustible substances, as well...
As for the vitamin PV, if that's not already regulated via another part of the FDA, then they should probably be expecting that soon...
Can vape companies get around certain regulations with certain items, depending on how they do it? Possibly..
But keep in mind what I posted about in another thread concerning the Amish raw milk producer.. Basically the FDA busted him for selling it, so he then legally changed his business model where he sold "cow shares" and these new owners/shareholders were now technically receiving a dividend, of sorts (raw milk), since that was their legal right as owners.. The FDA couldn't do anything more at that point because of that, so instead they got a judge after him who forced him to shut it down, calling it "subterfuge"...
Could something like this also potentially happen to the future of vape products? Who knows, but it certainly wouldn't be the 1st time...
Once the deeming regulations become final and the two-year window closes, anyone who has nic in their freezer will very likely not be able to transfer it to anyone else. Even now, you can't transfer tobacco cigarettes made with an injector machine to anyone else. (Well, I've let people bum from me before. Don't tell the FDA.)
If we look at the history of drug prohibition, this has occured before. Not just with alcohol. In the case of water-soluble nic., they would probably have to ban cigAlikes first. Which the FDA might be able to do under existing law, if the health data exists to demonstrate that cigAlikes encourage the use of tobacco cigarette smoking, as "dual use" technologies.
Prior or subsequent to that, BP could get approval to market advanced devices as cessation therapy. (After all, if they work for us, why wouldn't they work for others? This is precisely what the EU's TPD first envisioned.) And it's probably what clinicians abroad mean when they say that vaping has great cessation potential. They want BP to sell it, so they can prescribe it. They might not be aware of the difference between cigAlikes and what we use. But they get the general idea. And right now, US MDs aren't comfortable admitting that vaping could be useful. Otherwise they might lose their license, or the respect of their colleagues. (That's far worse than having lots of smokers die unnecessarily.)
While these two events may be 5-10 years down the road, I don't see them as impossible scenarios by any means.
Once digAikes are banned, and vaping is "medicalized," liquid nicotine becomes illegal to possess without a prescription.
A similar path has been followed before, with regards to a certain injectable opiate and other drugs. So if the same thing happened with water-soluble nicotine, I wouldn't be in the least bit surprised.
Maybe we should set up a pool here at ECF. 2020? 2025? Who knows.
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Has anyone given any thought to the future of eliquid and regulation, with regard to safety - after the report from Dr Farsalinos comes out? From what I gather, he's not just going to release his results to vapers - it's going to be a peer-reviewed published report. And it's going to say that 69% of liquid tested contains diacetyl or similar.
So when all the news headlines shout that ecigs give you 'popcorn lung', how can the FDA ignore that? Can they then regulate or ban that liquid under some other regulations other than the TCA? Will that give them the impetus to ban every other delivery method but sealed cartridges? And how many people will believe ecigs are healthier and switch to vaping after hearing that?
So when all the news headlines shout that ecigs give you 'popcorn lung', how can the FDA ignore that? Can they then regulate or ban that liquid under some other regulations other than the TCA? Will that give them the impetus to ban every other delivery method but sealed cartridges? And how many people will believe ecigs are healthier and switch to vaping after hearing that?
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