Deeming Regulations have been released!!!!

[SeniorBoy]

Good morning Girls and Boys

Generally speaking /cough many but not all of us believe that "NIC" extracted from tobacco leaf will be regulated by the FDA under the Final Rule and or subsequent "enforcement discretion" of same. I like to call this the "Choke Point" /lol

An old topic landed in my email box this AM.

"TFN™ Nicotine is the purist, cleanest nicotine available not derived from tobacco leaf, stem, or waste dust."

Source: Next Generation Labs

My email was sent by VapeRev who is currently selling an entire line of TFN™ Nicotine ejuice at: TFN Tobacco Free Nicotine liquids - Vaperev Shop

A very good and old ECF thread on this issue at 100% Tobacco Free Nicotine??? Marketing Ploy or Truth?

EDIT: Another great ECF thread at Synthetic Nicotine - Is there really such a thing?

My thoughts: I like and have purchased from VapeRev. I remain extremely skeptical of the claim. I'm not a chemist, attorney, or accountant. The following questions are roaming around in my gray matter:

Is this a ploy to capitalize on the Final Rule consternation?

How the heck can the cost of a 30ML bottle be about the same as normal extracted NIC when my understanding is that cost to synthesize is way more exspensive? 6x the last time a looked?

Where is the independent lab reports and why is their no company/department/university name on the posted lab reports?

Isn't this a "ploy" to present the appearance that a PMTA will not be required?

Waving to my best friend Mitch, aka desk killer, what if anything will the FDA due?

Does this "claim" move this product into another FDA regulated category like say "drugs"?

Is this "claim" no more or less than an attempt to convince vapers that this TFN™ Nicotine ejuice is going to taste better and or be "safer" to vape? Think "organic" on either side of the issue?

I have other questions and thoughts but I need to take my meds! I'm confident that YOU can run with the ball.

 

[Kent C]

Isn't this a "ploy" to present the appearance that a PMTA will not be required?

You might check this post and the follow-ups on that thread:

WV Politician takes on FDA

It's not that the FDA hadn't heard about it:

(Comment 164) Some comments sought clarification as to FDA's authority over e-liquids
that do not contain nicotine or other chemicals derived from tobacco plants and those e-liquids
that contain nicotine derived from a nontobacco source (e.g., eggplants or tomatoes). Others
claimed that FDA does not have regulatory authority over e-cigarettes that are refillable and do
not contain nicotine, but does have authority over e-liquids if the liquid contains nicotine. Yet,
some said that e-liquids used in e-cigarettes should have an entirely new classification, because
use of the words "tobacco product" in marketing materials would cause undue confusion for
consumers.

pg257
(Response) As stated in section 201(rr) of the FD&C Act, the definition of "tobacco
product" includes any product made or derived from tobacco, including any component, part, or
accessory of a tobacco product. An e-liquid made or derived from tobacco meets this definition
and, therefore, is subject to FDA's chapter IX authorities. E-liquids that do not contain nicotine
or other substances derived from tobacco may still be components or parts and, therefore, subject
to FDA's tobacco control authorities, if they are an assembly of materials intended or reasonably
expected to be used with or for the human consumption of a tobacco product and do not meet the
definition of accessory.

 

[snork]

Good morning Girls and Boys

Generally speaking /cough many but not all of us believe that "NIC" extracted from tobacco leaf will be regulated by the FDA under the Final Rule and or subsequent "enforcement discretion" of same. I like to call this the "Choke Point" /lol

An old topic landed in my email box this AM.

"TFN™ Nicotine is the purist, cleanest nicotine available not derived from tobacco leaf, stem, or waste dust."

Source: Next Generation Labs

My email was sent by VapeRev who is currently selling an entire line of TFN™ Nicotine ejuice at: TFN Tobacco Free Nicotine liquids - Vaperev Shop

A very good and old ECF thread on this issue at 100% Tobacco Free Nicotine??? Marketing Ploy or Truth?

EDIT: Another great ECF thread at Synthetic Nicotine - Is there really such a thing?

My thoughts: I like and have purchased from VapeRev. I remain extremely skeptical of the claim. I'm not a chemist, attorney, or accountant. The following questions are roaming around in my gray matter:

Is this a ploy to capitalize on the Final Rule consternation?

How the heck can the cost of a 30ML bottle be about the same as normal extracted NIC when my understanding is that cost to synthesize is way more exspensive? 6x the last time a looked?

Where is the independent lab reports and why is their no company/department/university name on the posted lab reports?

Isn't this a "ploy" to present the appearance that a PMTA will not be required?

Waving to my best friend Mitch, aka desk killer, what if anything will the FDA due?

Does this "claim" move this product into another FDA regulated category like say "drugs"?

Is this "claim" no more or less than an attempt to convince vapers that this TFN™ Nicotine ejuice is going to taste better and or be "safer" to vape? Think "organic" on either side of the issue?

I have other questions and thoughts but I need to take my meds! I'm confident that YOU can run with the ball.

How about just letting them try to sell their product and see what happens instead of making it into some kind of Five Pawns diacetyl-conspiracy type freak out?
Since they specifically exclude the "impurities" which I actually seek, it's a non-issue for me.

 

[Wing]

E-liquids that do not contain nicotine
or other substances derived from tobacco may still be components or parts and, therefore, subject
to FDA's tobacco control authorities, if they are an assembly of materials intended or reasonably
expected to be used with or for the human consumption of a tobacco product and do not meet the
definition of accessory.

(not a lawyer)
By their own response, I would say that Nic not derived from tobacco should be OK.
Eliquid with non-tobacco Nic would not be intended or reasonably expected to be used with tobacco Nic as it already contains the desired chemical.

 

[skoony]

An e-liquid made or derived from tobacco meets this definition
and, therefore, is subject to FDA's chapter IX authorities.

@Kent C this is how I interpret this.
This is the part I have been trying to explain for a long time.
Consider the term "made or derived from". At first glance this seems
redundant. It is made from or it is derived from. So lets break this
down as the FDA is understanding this.

It is made from tobacco whole or in part.
This means anything made from the actual tobacco or taken from the
actual tobacco.

Is derived from in whole or in part.
This means anything made from the actual tobacco or used to take
the place,mimic,substitute for,etc.,etc., for the actual tobacco or any part
of the actual tobacco. Otherwise they would have used the term derivative of.

When referencing this to e-cigarette products substitute finished tobacco
product " a Cigarette" with juice,batteries,coils wicks and tanks,etc. .
Once all of these things are assembled and vapable the are derived from
a tobacco product > a cigarette and are as such a tobacco product the same
as the filters and paper in a cigarette are under the regulatory authority
of the FDA.

Regards
Mike

 

[Kent C]

(not a lawyer)
By their own response, I would say that Nic not derived from tobacco should be OK.
Eliquid with non-tobacco Nic would not be intended or reasonably expected to be used with tobacco Nic as it already contains the desired chemical.

If you go to the link posted - I say that it 'isn't clear' but.... the catch all phrase - "intended or reasonably expected to be used with or for the human consumption" will be operative, imo.

 

[Wing]

Is derived from in whole or in part.
This means anything made from the actual tobacco or used to take
the place,mimic,substitute for,etc.,etc., for the actual tobacco or any part
of the actual tobacco. Otherwise they would have used the term derivative of.

That is not the standard definition of "derive".

 

[Wing]

If you go to the link posted - I say that it 'isn't clear' but.... the catch all phrase - "intended or reasonably expected to be used with or for the human consumption" will be operative, imo.

I don't see the distinction your trying to make.
If the liquid already contains non-tobacco Nic, there is zero reason or intention that tobacco Nic would/should be added to it as well.

 

[Kent C]

this is how I interpret this.

Mike, it's basically what you said in the other thread.... we disagree on this. Their definition of "Component part" is where they get around this. None of the "component parts", (other than nic eliquid) even no nic eliquid, are 'made or derived from tobacco', but they are still "tobacco products", and hence covered by the deeming. :- )

It will be something that almost all the lawsuits will take up - BECAUSE the FDA considers them so.

 

[Kent C]

I don't see the distinction your trying to make.
If the liquid already contains non-tobacco Nic, there is zero reason or intention that tobacco Nic would/should be added to it as well.

If it's intended for human consumption - which is what the non-tobacco Nic is for, then it's a "component part" just like all the other non-tobacco parts are - wire, software, drip tips - all covered by the deeming. The only things that aren't covered are "accessories" (as defined by the FDA) cases, mod stands, etc. But if you really think that is all wrong, contact the FDA and ask them directly. They're open for questions.

 

[Wing]

If it's intended for human consumption ...

"human consumption of a tobacco product"

You're leaving out a very important part of that sentence...

 

[Kent C]

"human consumption of a tobacco product"

You're leaving out a very important part of that sentence...

I thought everyone knew but perhaps not - maybe not even Lessifer!.... anyway. whatever - look up how the FDA defines "tobacco product" Even non-nic eliquids have to have the label that it's a tobacco product. "This product is made from tobacco" I'm done here.

 

[Wing]

I thought everyone knew but perhaps not - maybe not even Lessifer!.... anyway. whatever - look up how the FDA defines "tobacco product" Even non-nic eliquids have to have the label that it's a tobacco product. I'm done here.

Because one could reasonable assume that tobacco-Nic could be added to it.
If it already contains the desired chemical, one would not reasonable assume that tobacco-Nic would be added to it.

 

[skoony]

That is not the standard definition of "derive".

Mike, it's basically what you said in the other thread.... we disagree on this. Their definition of "Component part" is where they get around this. None of the "component parts", (other than nic eliquid) even no nic eliquid, are 'made or derived from tobacco', but they are still "tobacco products", and hence covered by the deeming. :- )

It will be something that almost all the lawsuits will take up - BECAUSE the FDA considers them so.

If one looks up the terms derivative and derived it can be said the could be used
interchangeably.
The closest definition I could come up with was this.

1.1(derive something from) Base a concept on a logical extension or modification of (another concept):
derive: definition of derive in Oxford dictionary (American English) (US)

To get a better understanding of what I am basing this on consider these synonyms.

• I found great synonyms for "derived" on the new Thesaurus.com!

regards
Mike

 

[Lessifer]

I thought everyone knew but perhaps not - maybe not even Lessifer!.... anyway. whatever - look up how the FDA defines "tobacco product" Even non-nic eliquids have to have the label that it's a tobacco product. "This product is made from tobacco" I'm done here.

I agree with Wing's interpretation, components are tobacco products because they can be used with tobacco products and the Covered Tobacco Product is the nicotine. I believe even Zeller said that CTP wouldn't have jurisdiction over non-tobacco derived nicotine. I do, however, believe that they'll pursue the drug route with non-tobacco nicotine.

As for "This product is made from tobacco" on the label, there was one interpretation, I think by the ECIGAttorney guy, that said everyone was confusing that part. Eliquids would have to be certified as not containing nic, and if the company doesn't want to certify, it would have to include that label. Not meant for components. That would be because of the "examples" the FDA found of 0nic labeled products that actually included trace amounts of nic, probably from cross contamination.

 

[Lessifer]

I agree with Wing's interpretation, components are tobacco products because they can be used with tobacco products and the Covered Tobacco Product is the nicotine. I believe even Zeller said that CTP wouldn't have jurisdiction over non-tobacco derived nicotine. I do, however, believe that they'll pursue the drug route with non-tobacco nicotine.

As for "This product is made from tobacco" on the label, there was one interpretation, I think by the ECIGAttorney guy, that said everyone was confusing that part. Eliquids would have to be certified as not containing nic, and if the company doesn't want to certify, it would have to include that label. Not meant for components. That would be because of the "examples" the FDA found of 0nic labeled products that actually included trace amounts of nic, probably from cross contamination.

Or, it could have been that the warning "This Product is Made From Tobacco" is for new tobacco products, that are actually made from tobacco, but DO NOT contain nicotine. Which is what this suggests to me:

Nicotine Warning Statement
The product packages and advertisements of all newly-regulated covered tobacco products must bear the following warning statement:


“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”



If the tobacco product manufacturer submits a self-certification statement to FDA that the newly-regulated tobacco product does not contain nicotine (and that the manufacturer has data to support such assertion), then an alternate statement must be used on product packages and advertisements:


“This product is made from tobacco.”


You can find more information about nicotine warning statements in Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act.

 

[skoony]

I agree with Wing's interpretation, components are tobacco products because they can be used with tobacco products and the Covered Tobacco Product is the nicotine.

I am leaning toward they are necessary to be used with. As single inert components
they appear to be non-tobacco. Put them all in the same room it's reasonable to assume
something may be going on here. Put them all together and you have a ENDS.
You can not vape (as we know it) without all the parts being in a whole.
You can not smoke a cigarette without a piece of paper at the bare minimum.
Cigarette ='s at least two separate components.
e-cigarette ='s 6 or more components depending on how far you want break it down.
Ergo cigarette ='s ENDS.

Regards
Mike

 

[Alexander Mundy]

A couple of bullet points from an interview with Ron Tully, with Next Generation Labs:

"Synthetic nicotine used to sell for $125,000 for a kilo(2.2 lbs). It is less today, but still more expensive than cultivated products.Now $5,000 a liter, about $.19 per bottle."

"14 brands currently use TFN."

"The FDA’s view on TFN: they still have jurisdiction."

"This product is NOT derived from tobacco, which will be a conversation with the FDA. Tully advises staying away from any mixing with tobacco."

"Congress or the Court may be the final decision when the FDA is called to task."

*broke the link below with hxxp instead of http or else it showed here as a audio media file instead of a link to the webpage I got the bullet points from*

hxxp://vapenewsradio.podbean.com/e/introducing-tobacco-free-nicotine-guest-ron-tully

$5,000 a liter......wow. In bulk, tobacco extracted nic is less than $200 a liter. If synthetic was to become the future of vaping....cue up the black market for tobacco extracted nic.

 

[Kent C]

I believe even Zeller said that CTP wouldn't have jurisdiction over non-tobacco derived nicotine. I do, however, believe that they'll pursue the drug route with non-tobacco nicotine.

Yeah, Zeller said that likely before he found out about the possibility - which was slight at the time - see also Carl Phillips - "don't waste your time' piece about it. And SAFTA is where the 'drug route' started.

But... :- ) the deeming says otherwise, not in the clearest way, I agree, but in response to the comment about eggplant nic - they put forward the "component" argument And when they say "for human consumption of a tobacco product" you have to follow that up with their definition of a "tobacco product" which includes all "components". This is the point I thought you, at least, would understand.

Again, it IS a fertile area for lawsuits, and it encourages ideas of workarounds, but as Carl P. said "Whether an e-cigarette is a tobacco product or medical device or whatever for purposes of regulations depends on none of these things. It depends merely on what the regulators (or those who authorize them) decide, and they are not going to care about what vapers decide, even if it is unanimous, any more than the authorities would care if ......users universally declared that their drug of choice is salad."

 

[crxess]

I agree with Wing's interpretation, components are tobacco products because they can be used with tobacco products and the Covered Tobacco Product is the nicotine.

A message in a bottle could be written on Cigarette paper. Does that make it illegal to send?
If Should of could of it would of. The more we add to the meaning of a specific word, the less meaning it has.
IF............covers the most to least likely
If Nicotine is Tobacco we can Control and Tax it.
If Nicotine is a Pharmaceutical we can receive kickbacks.
If Frogs had wings............

@DC2 is an Example of Non-intent - His E-liquid and Gear are Not intended for consumption of Nicotine. Well, until retirement anyway


Intent< the action of doing something someone who is not you objects to.