FDA Could the FDA really regulate E-Liquid??

[Bob Chill]

Thankfully, decent NETs can be done by just about anyone with simple tools like a crock pot and some filters. I plan of getting into that within the next couple months.

Again, it comes back to the nic. Can we still buy bottled unflavored or not. That question is going to burn inside me until there is a clear answer.

If the government enters my house and tries to take my nic, I'll likely be on the front page news shortly after.

 

[Gato del Jugo]

I posted this video in the other thread just now..


According to Zeller's response during the 4-24-14 FDA teleconference, it appears the FDA is aiming to define zero-nic liquid as a component or part of a tobacco product, which would fall under regulation...


Starting at the 14:00 mark..

FDA Deeming Teleconference 4/24/2014 - YouTube

 

[Roger_Lafayette]

Would you mind if we discussed this in just one thread

Here's what I said to you in the other thread, where you posted this. Or can we start a new thread.

It's very confusing to have to have the exact same conversation in two distinct threads

Here's what I said to you in that other thread ... please pick one of the two, or start a new one ;-)

http://www.e-cigarette-forum.com/fo...-fda-proposal-vp-live-radio.html#post13101055

I posted this video in the other thread just now..


According to Zeller's response during the 4-24-14 FDA teleconference, it appears the FDA is aiming to define zero-nic liquid as a component or part of a tobacco product, which would fall under regulation...


Starting at the 14:00 mark..

FDA Deeming Teleconference 4/24/2014 - YouTube

 

[Roger_Lafayette]

Bottled unflavored nic - or any e-luiquid w/ nic will be regulated as a tobacco cigarette - so long as the nicotine is derived from tobacco.

I think virtually everyone agrees on that.

Thankfully, decent NETs can be done by just about anyone with simple tools like a crock pot and some filters. I plan of getting into that within the next couple months.

Again, it comes back to the nic. Can we still buy bottled unflavored or not. That question is going to burn inside me until there is a clear answer.

If the government enters my house and tries to take my nic, I'll likely be on the front page news shortly after.

 

[Roger_Lafayette]

Well, not exactly IMO. The language on p.6 and p.7 of the PDF is saying the same thing that Zeller was saying in the teleconference that you cited in another post.

Equipment - which of course is not itself a tobacco product - can be regulated as a tobacco product because it is a "component or part' of a [finished] tobacco product (i.e. a PV with nic. juice derived from tobacco, is the "finished" tobacco product).

Just because e-liquid which doesn't happen to be derived from tobacco can be used with equipment (which itself may be a component or part of a covered tobacco product), doesn't make the e-liquid which is not derived from tobacco into a component or part of a tobacco product.

Do you see what I'm saying? They can regulate tobacco products. They can regulate things which are not tobacco products, but that doesn't make those things tnto tobacco products themselves. An APV is not a tobacco product, it's a "component or part."

E-liquid which is not derived from tobacco cannot be regulated merely because it can be used with a "component or part of a tobacco product."

Again, the "component or part of a tobacco product" is not itself a tobacco product.

The "chain" (as it were) can only have one link. Either you have something derived from tobacco (a tobacco product) - whether or not it contains nicotine - or you have a component or part of a tobacco product.

But they can't regulate a component or part (which is not itself a tobacco product) of a component or part (which is not itself a tobacco product) of a tobacco product.

Makes sense?

Crazy, isn't it??

Roger, thanks for your transcript..

For those interested, that discussion starts at the 1:18:27 mark of the replay...


Anyway, I believe what they're getting at is the FDA wants to consider zero-nic e-liquid as a component or part of a tobacco product, as discussed on pages 6 & 7 of the PDF, for example...

http://www.ofr.gov/OFRUpload/OFRData/2014-09491_PI.pdf

 

[Stosh]

....Again, the "component or part of a tobacco product" is not itself a tobacco product.

The "chain" (as it were) can only have one link. Either you have something derived from tobacco (a tobacco product) - whether or not it contains nicotine - or you have a component or part of a tobacco product.

But they can't regulate a component or part (which is not itself a tobacco product) of a component or part (which is not itself a tobacco product) of a tobacco product.

Makes sense?

Crazy, isn't it??

Make sense, I can't even tell what it's supposed to mean....
And from everything I've read, it would seem the FDA is setting itself as the arbitrator of what the words mean.
At least the FDA is apprehensive of the high costs it could suffer fighting this out in court for 2 or 3 years, for each carto, coil, tank or liquid. They would make everyting simple to avoid court costs...

We will fight them on the websites.
We will fight them in the B&Ms
We will fight them in the state legislatures
We will fight them in congress
We will fight them in the halls of buracuracy
We will fight them in the courts
Let them say this was their finest hour.
This is not the beginning of the end, this is the end of the beginning.

(yeah I stole it...)

 

[zoiDman]

...

We will fight them on the websites.
We will fight them in the B&Ms
We will fight them in the state legislatures
We will fight them in congress
We will fight them in the halls of buracuracy
We will fight them in the courts
Let them say this was their finest hour.
This is not the beginning of the end, this is the end of the beginning.

(yeah I stole it...)

Somewhere Winston Churchill is Smiling.

 

[aikanae1]

And the FDA has been tweeting that regulations aren't a ban on ecigs.
This is the problem with the FDA. No one can tell if / when they are telling the truth.
It's better to retrain your brain to think like them and stay one jump ahead.
I think most people agree that our health and welfare are not within their top priorities.
Watching them parse their words carefully is a good sign because it means they've gotten the idea that there could be a sheet storm if they just said what they wanted. But they are still in messaging mode - change the message, not the policy. It's going to take a lot to change the policy (regulations) which is about the last thing they want to do. For anyone thinking "this is just a draft". They don't change drafts much.

Gato, thanks for pointing this out!

Despite what you may have heard on VP Live about what the former FDA Chief Counsel said, zero-nic. e-liquid is safe, as long as it is NOT derived from tobacco.

It's taken me well over an hour to delve into this and get an idea of what happened. (This is a perfect example of how rumors start.)

We need to be extremely careful about exactly what's involved!

Headline: The confusion here in the VP Live report is almost certainly between zero-nicotine products that are derived from tobacco VERSUS zero-nicotine products that are NOT derived from tobacco.

So under the act, it has to be a "tobacco product" or a "component or part or accessory" of a tobacco product. In the latter case (equipment) it could be "intended or anticipated for use" with a tobacco product. The act says ABSOLUTELY NOTHING about nicotine. (It's the ALA, the ACA, the CFTFK and our opponents who are saying nicotine = tobacco. But that's not what Congress did when it passed the FSPTCA.)

Take a look at these page numbers in the FDA's PDF, and you'll see that they're also very careful to precisely indicate that they are talking about zero nicotine products that are derived from tobacco:

pp.79-80

pp.93-94

p.139

p.181-2

p.232

***

Now that we understand that, the mystery of how all this confusion arose isn't hard to figure out.

BTW I used this direct link for my download: Central Park Vaping Civil Disobedience Protest - Dimitris Cisco and Kevin on fighting the FDA by VP Live on SoundCloud - Hear the world

Now, we're trying to figure out not just what the former FDA Chief Counsel actally said, in response to Dimitri's query, but also what the lawyer actually meant. And that's where it gets tricky. In fact, we don't even know what the fmr. Chief Counsel said. We only know what Dimitri said, when summarizing the conversation. (Ever wonder why courts don't generally allow hearsay? This is a great example ...)

I suggest everyone read this transcript over very carefully, and ask themselves whether my theory makes sense.

I think the attorney thought that Dimitri was asking about zero nicotine products that are derived from tobacco, and Dimitri thought he was asking about what we all think of as zero-nicotine e-liquid - i.e. something that is almost certainly NOT derived from tobacco.

I've bolded the parts that I think are critical to my interpretation of how this confusion came about. Italics, are my interpretation of the emphasis in the original, based two listenings of the entire colloqy, starting at 1:18:27, at 50% speed:

Dimitri [moderator]: So the last last thing that I want to bring up because a lot of people have been talking about the zero-nicotine thing, and when the attorney [referring to the former FDA Chief counsel] was up again I took the microphone and I asked this question ... ah ... because he gave a clear definition of what the FDA considers to be tobacco, ummm, including the device, right? The device that actually vaporizes the [indistinguishable] ... nicotine to the user. So-o, after the entire presentation I asked him, there's a lot of confusion about zero nicotine products 'cuz based on the regulations themselves, they say that even zero nicotine products has to be applied for and treated as tobacco, which makes absolutely no sense to you and me, and of course a lot of vapers who are out there. And, [he?] said, the attorney said, that, that would require litigation as well, so don't think, don't-don't sit back and say [that] you're a vendor and 'I'm just going to sell zero-nicotine flavoring product. You won't be allowed. It's going to take a legal challenge for you, to prove that not only the e-liquid but the device that you're using 'cuz they're including device in this wording ... the device that you're using in the e-liquid delivering a non-tobacco product [sic] so, I just wanted to put that out there for the people who are [indistinguishable due to interruption].

Participant A [Russ?]: So, that just - what you just said Dimitri - kinda illustrates how difficult it is to know what to do in any direction in all this, because I've been sitting here and my understanding is that the way everything was written, at least the proposal, was that it had to have nicotine in order to come under this in some way, if this was a zero-nicotine product or the device was somehow designed not to be used with nicotine, you could clearly state that, then it's exempt from all this, and now you just shattered all that.

Dimitri: I can bring you up the page, I can bring you up the page ... ah ... I'll do some research ...

Participant B: It includes everything, it doesn't have to have nicotine in it --

Participant A [Russ?]: Shows what I know --

Participant B: It's ridiculous, it's almost as like, ah, you know, [indistinguishable] cigarette lighters ...

[later]

Dimitri: The issue was raised up, and the attorney said the same thing, it's gonna take a legal challenge to be able to overturn that if it is included inside the reg--the final--again these are the proposed, make sure everybody knows that it's not the final, but it appears the way it is now, don't think that you're gonna sell zero nicotine and uh and, and -- be able to get away ... there's ah, another study that's going to be released here in the next couple of days about batteries venting and other issues ... [rest is irrelevent].

***

It turns out that what "Participant A" (Russ?) says in his first response to Dimitri is correct. But Dimitri got confused because Dimitri thought he was asking the attorney about 0% nicotine products that are not derived from tobacco, but the attorney thought Dimitri was making reference to the FDA's own statements in their PDF, which refer to zero-nicotine products that ARE derived from tobacco. (As per the page #s I listed earlier.)

***

This is why we need to be very careful

P.S.: If anyone knows anyone on the VP Live team, can you please send them link to this post? If I send them an e-mail, they probably won't pay any attention. We have enough trouble with all the other misunderstandings here about these proposed reg.s We don't need any more. Here's the link:
http://www.e-cigarette-forum.com/fo...-really-regulate-e-liquid-2.html#post13099825

 

[patkin]

..^ Thinking like them is this: All cloud blowing must stop. That's it plain and simple. They don't care what's in the clouds they want them to stop. They will twist, contort, manipulate meanings, spin, redefine, ... whatever... to that end. When reading what they say, keep that in mind and their meanings and intent becomes clear. Its not about nic nor tobacco, that's just what they're using to obtain control and succeed with prohibition... of vaping.... not nic/tobacco. Oh, forgot to add... they know its going to take a long time to accomplish and in the meantime expect high revenues from vaping and dual use smokers and smokers... but they're not going to let vaping take hold like smoking did.

 

[zoiDman]

And the FDA has been tweeting that regulations aren't a ban on ecigs.
This is the problem with the FDA. No one can tell if / when they are telling the truth.
...

I really Don't Think the FDA has any plans to Completely Ban e-Cigarettes.

Because that would Eliminate the Ability of States and the Fed to Tax them. That, and BT wouldn't have Moved into the e-Cigarette Market and spent the Money they did if there was even a Remote Possibility that e-Cigarettes, in some form, weren't going to be Sold in the Future.

Banning Bottled e-liquids? Now that is a Different Story.

I worry about the FDA doing something Drastic with Bottled e-Liquids Immediately After the Public Comment Period is Over.

 

[wv2win]

And the FDA has been tweeting that regulations aren't a ban on ecigs.
This is the problem with the FDA. No one can tell if / when they are telling the truth.............................

Their version of the truth is, that as long as a company (BT) pays the millions necessary to get their ineffective cig-a-likes approved, then they can claim they are not banning ecigs. When they build the wall so high that only a giant can jump over it, they can wink/nod and state they didn't ban vaping. Really no different than what they did in 2009 when they stated that they found TSNA's in two of the 18 cartridges they tested. They just neglected to inform the public that it was an acceptable level also found in approved NRT products. Lying through omission. Just sick when you consider we pay for this.

 

[aikanae1]

If they completely ban ecigs, then many would go back to smoking. Same with the states. It's win-win for them. No loose either way. BT products are in and they are crap. I'm in a hurry or I'd post links for you. The more I look into this that is exactly what they intend to do. No 0mg eliquids? They can pass a regulation 1 day after the final version is published and zip. It's gone too. Don't count your eliquids before there vaped.

 

[Roger_Lafayette]

[...]
I worry about the FDA doing something Drastic with Bottled e-Liquids Immediately After the Public Comment Period is Over.

They'd have to invoke one of the exceptions to the Admin. Procedure Act under step 3: http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

What they could do is to eliminate or substantiallly reduce the 2-year "no-enforcement" window, and claim that they were doing so based on the comments (from the ANTZ orgs, of course).

If they could (somehow) turn out the final proposed rule in a month, and jam it through OMB in week or two, and then cut the "window" down to six months, we could be looking at enforcement by (say) March '15.

Given the glacial pace with which they and other Fed'l agencies move, I'm not sure how likely that is. And I don't know why OMB rejected their original proposal - now that they have a new Dir., it's not clear what OMB would say about the change I described.

But based on that PDF above, it doesn't look as if they'd be violating the APA if they followed the mandated procedure. After all, a proposed rule is just that. It's not a promise.

 

[zoiDman]

If they completely ban ecigs, then many would go back to smoking. Same with the states. It's win-win for them. No loose either way. BT products are in and they are crap. I'm in a hurry or I'd post links for you. The more I look into this that is exactly what they intend to do. No 0mg eliquids? They can pass a regulation 1 day after the final version is published and zip. It's gone too. Don't count your eliquids before there vaped.

Yeah... Some Would. But I also think a Huge Black Market would Also Crop Up. Because Many people, like myself are NEVER going back to Analogs.

Also think of it this way. e-Cigarette/e-Liquid Taxation has a Big Thing going for it over Analog Taxation. And that is the People who are Paying the Tax aren't Dying as Fast as those who use Analogs.

So e-Cigarette User can pay Taxes Much Longer than Analog Users. And that is Appealing to Anyone in Government.

 

[zoiDman]

...

Given the glacial pace with which they and other Fed'l agencies move, I'm not sure how likely that is. And I don't know why OMB rejected their original proposal - now that they have a new Dir., it's not clear what OMB would say about the change I described.

But based on that PDF above, it doesn't look as if they'd be violating the APA if they followed the mandated procedure. After all, a proposed rule is just that. It's not a promise.

I'm just Not Exactly sure what they Can and Can't do.

And My Theory is if I'm going to have a Couple of Liters of 100mg Nicotine Base in my Freezer Sooner or Later. I might as well Do it Now.

Verses doing it Later.

 

[Gato del Jugo]

Roger, I agree: This discussion over 2 threads was getting silly.. Reason that occurred is because I posted the video in the other 1st, then came to this thread & saw the same thing.. We'll stay here for this zero-nic thing...


From page 7 of the PDF..

"Products that meet the statutory definition of "tobacco products" can include currently marketed products such as certain dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco. Components and parts of tobacco products, but not their related accessories, would also be included in the scope of this proposed rule. Components and parts are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes."


- The FDA is defining an e-cig as a tobacco product.. What makes an e-cig, an e-cig? If one were to remove any part(s) of this e-cig, at what point, if any, would it cease to be an e-cig?

- They also want to regulate the components and parts of a tobacco product.. What is a component or part? At one point in the video, as well as implied in the above, Zeller states that it does not mean it has to contain tobacco or nicotine..

- Does zero-nic liquid fall under the accessory category? Because in the FDA's eyes, there can only be a tobacco product, a part/component, or an accessory, when it comes to an e-cig..


The bottom line is, and I've stated this before, this proposal is very vague, undefined & open to public interpretation.. And it's my sense that this was done intentionally.. They were extremely careful on how they worded this, or more aptly, how they didn't word this.. which I'm sure is part of the reason why it took so long to come out..

Even in the teleconference, Zeller's answers to Greg's questions were pretty vague, undefined & open to public interpretation..

A person should ask themselves: Why is this?


And why didn't Zeller or the FDA mention anything specifically about the other half of the non-cigalike e-cig industry, instead choosing to mention only "e-cigs" & "cartridges"? Are they truly not aware of all the other stuff, as Dimitris relayed from the SFATA conference? The FDA really has no idea about the thousands of other non-cigalike products? All the PVs, all the juice, all the toppers? Surely the FDA has internet access & could conduct a simple search & find all sorts of info & photos of this $1 billion part of this industry, no?

One would think it would be a little important to look into prior to writing a 240-page proposal to regulate this industry..

Or maybe they did -- and chose not to discuss it for some reason? So why would they play dumb?


Anyway, for those who think the FDA isn't already after flavored e-liquid, regardless if it contains nic or not, read this part again (bold mine)...

"Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes."

 

[Stosh]

....The bottom line is, and I've stated this before, this proposal is very vague, undefined & open to public interpretation.. And it's my sense that this was done intentionally.. They were extremely careful on how they worded this, or more aptly, how they didn't word this.. which I'm sure is part of the reason why it took so long to come out..

Even in the teleconference, Zeller's answers to Greg's questions were pretty vague, undefined & open to public interpretation..

A person should ask themselves: Why is this?....

"Because the words mean what I say they mean, nothing more and nothing less"....

 

[aikanae1]

A little context. I think some of this is due to a posting earlier that caught a few off guard. W. Australia raid a company making a popular 0mg eliquid - and they lost their case. A person might think "well that's over there and we're over here" but countries are mirroring each other on this ecig stuff. The tobacco companies are usually the same too.

 

[edyle]

E-liquid is juice with nicotine, not everyone vapes with nicotine in their juice, I for one, on occasion. The way I see it, many businesses will change the way they make e-liquids. Business will start mixing e-liquid flavors without nicotine, possibly selling the nicotine separately. The FDA could not possibly regulate flavorings that do not contain nicotine. The consumer will buy nicotine at a strength they wish and mix it themselves, vape users will all become DIY mixers. Of course some large businesses will make e-liquid with nicotine, that will be FDA regulated. But I see many making it without.
This will also spawn rebranding and new terminology for e-liquids, no longer calling it e-juice or e-liquid, but something different. E-liquid right now, that does not contain nicotine is basically the same as MiO Liquid Water Enhancer, MiO is nothing more than PG and artificial flavoring / sweeteners. Hell you could vape it if you wanted to.

To, me there are way too many loop holes.

Heck!! Thanks alot! Didn't know that.
That could come in handy for some DIY.

 

[Roger_Lafayette]

Yes, let's please do it in one thread. I was going nuts there, esp. because ECF was coming through very slowly this afternoon.

-The FDA is defining an e-cig as a tobacco product.. What makes an e-cig, an e-cig? If one were to remove any part(s) of this e-cig, at what point, if any, would it cease to be an e-cig?

This is where I think you may be going wrong. You are are assuming that the FDA intends to regulate ALL "electronic cigarettes." This is not so.

The fact that the PDF refers to "e-cigarettes" is a shorthand. The legal language in the proposal is very specific about the types of products that are regulated.

Once again, please take a look at the vigAcig: VitaCig – Vitamin Electronic Cigarette

(I'm not promoting it, mind you. But it might save us some back-and-forth here in discussions.)

1) There's no e-liquid in the vitAcig which is derived from tobacco, or which contains anything derived from tobacco. (Trust me, there isn't.)

2) There are no parts on the vitAcig (like a battery or a carto) that can be used with a tobacco product - the whole thing is proprietary, right?

This is an example of something that we would all call an "e-cig" but which is designed from the ground up to be completely free from FDA regulation as a tobacco product.

It does not contain any tobacco products, and it does not contain any "components or parts" that can be used with a "covered tobacco product."

***

If a vendor sells an RDA, a Provari, and 0% e-liquid (assume this e-liquid contains nothing derived from tobacco) as part of a "kit," the combination is not a "covered tobacco product."

What's the difference between the vitAcig and the kit that contain an RDA, a Provari, and 0% e-liquid (assume this e-liquid has nothing in it derived from tobacco)?

The RDA and the Provari are both "components or parts of tobacco products" because they are "components or parts intended or anticipated for use with a covered tobacco products" (because you can use them with e-liquid that contains nic. derived from tobacco, and that really is the "intended or anticipated" use - as Zeller says in that teleconference).

However you can't use the vitAcig or the vitAcig batteries/sealed cartOs/etc. as part of a covered tobacco product. (Not without tearing them apart, etc. And it's not "anticipated" that the purchaser of a vitAcig will put it into a vice, cut it apart, and sotter it back together after putting nic. juice in the cartridge

***

- They also want to regulate the components and parts of a tobacco product.. What is a component or part? At one point in the video, as well as implied in the above, Zeller states that it does not mean it has to contain tobacco or nicotine..

Correct. But the 0% e-liquid (assume this e-liquid contains nothing derived from tobacco) is not part of a tobacco product, because it can be only be used in a setup which is not itself a tobacco product, right?

Let's take that e-liquid, drip it into a kayfun, and put the kayfun on a provari. Is that setup a "tobacco product?" No.

Is the kayfun and the provari a "component or part of a covered tobacco product?" Yes! Because they are "anticipated or intended for use" as a component or part of a covered tobacco product (as Zeller says at 14:00 in the teleconference that you cited).

But the provari and the kayfun are not themselves tobacco products.

Again, just because something can be regulated as a tobacco product doesn't not mean that it is a tobacco product.

In the case of vaping, I've argued (and CASAA seems to agree) that "components or parts" include: drip tips, cartridges, cartomizers, atomizers, RDAs, RTAs (gennys), tanks, clearos (vivis are clearos) tankomizers, EGO and other special-purpose batteries, APVs and mechs. I might have left something off that list, but you get the idea.

***

[from pp.6-7] "Products that meet the statutory definition of "tobacco products" can include currently marketed products such as certain dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco. Components and parts of tobacco products, but not their related accessories, would also be included in the scope of this proposed rule. Components and parts are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes."

So let's go through every word.

"Products that meet the statutory definition of "tobacco products" can include currently marketed products such as certain dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco."

That first sentence is intended to be helpful, but it is not legal language. For example, a "gel" that contains nothing derived from tobacco will not be regulated. (They are not intending to regulate hair gel, right?)

That's why we shouldn't assume that all "e-cigs" are regulated (again, back to the vitAcig: VitaCig – Vitamin Electronic Cigarette

***

[continuing from PDF, pp.6-7] "Components and parts of tobacco products, but not their related accessories, would also be included in the scope of this proposed rule. Components and parts are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product."

Is 0% e-liquid (assume this e-liquid contains nothing derived from tobacco) a "component or part of a finished tobacco product?"

Only if we assume that ALL e-cigs are "finished tobacco products."

But as the vitAcig example shows, there are some things out there that we would call "electronic cigarettes" which are not "finished tobacco products."

Just like there are some "gels" which are not going to be regulated ... hair gel, for example

***

[continuing from PDF, pp.6-7] "Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes."

You bolded the word "flavorings" here, right?

Well, we have to be careful about flavorings for what?

Is the "kit" that we have with a provari, a kayfun, and 0% e-liquid (assume this e-liquid contains nothing derived from tobacco) a "deemed tobacco product?"

Well, yes, after all ... it's an e-cigarette, right?

<bzzzt!> NO!! Got ya Just kiddin

Just because we call it an "e-cig" doesn't mean it's regulated as a "covered tobacco product. Isn't the vitAcig an "e-cig?"

Could they regulate some kind of "flavor base" sold which is intended to be mixed with high-concentration nic, to create e-liquid? Yes, that probably would be a "component or part."

But that's not the same as 0% e-liquid (assume this e-liquid contains nothing derived from tobacco), and which is intended to be vaped "as is."

If you DIY, you know that nic. changes the flavor. And flavor concentrate is NOT 0% e-liquid. (You don't vape the flavor concentrate by itself, right?)

Do they intend to treat all water-soluble flavorings as "components or parts" of "covered tobacco products" ? Probably not, based on practicality. THey aren't going to be regulating 186xx batteries and rubber O-rings as "componenets or parts" of "covered tobacco products' either. They could. But they're not crazy.

What if a vendor sold 0% e-liquid (assume this e-liquid contains nothing derived from tobacco) that could be vaped by itself, but also included extra flavoring so the purchaser could mix it with high-concentration nicotine base?

That probably wouldn't fly, because the flavoring was "anticipated or intended for use with a covered tobacco product." (As in the part of the teleconference you cited at 14:00).

***

And why didn't Zeller or the FDA mention anything specifically about the other half of the non-cigalike e-cig industry, instead choosing to mention only "e-cigs" & "cartridges"? Are they truly not aware of all the other stuff, as Dimitris relayed from the SFATA conference? The FDA really has no idea about the thousands of other non-cigalike products? All the PVs, all the juice, all the toppers? Surely the FDA has internet access & could conduct a simple search & find all sorts of info & photos of this $1 billion part of this industry, no?

I have no clue what the FDA knows. Although I was surprised by some of the parts in that section on pp.6-7 that apply to hookah use. They seem to have a pretty good grasp of that, so far as I can tell.

They seem to be doing a pretty good job of dividing and confusing the vaping community, don't they? We have a lot of disinformation and ambiguity floating around.

Is that bad? Not for the FDA.

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The bottom line is, and I've stated this before, this proposal is very vague, undefined & open to public interpretation.. And it's my sense that this was done intentionally.. They were extremely careful on how they worded this, or more aptly, how they didn't word this.. which I'm sure is part of the reason why it took so long to come out..

It is, but remember that the statute - not the PDF - determines the outer limits of their authority.

They can't say "Well, we're regulating gels," and then start regulating hair gel.

Can I promise you that they won't go completely insane and try to treat 186xx batteries, rubber O-rings, and kanthal wire as "components or parts" of "covered tobacco products?"

Well, no. I can't guarantee that. But it's unlikely.