The govt has just announced that henceforth 2+2 shall equal 5. Some confusion is understandable but in time you will learn to love Big Brother FDA and your calculators will be adjusted accordingly on their next firmware release.
Deeming Regulations have been released!!!!
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Don't really know what you mean by that, but if it's that the FDA isn't open to consumer questions, that's not true. If you mean they're not open to having our guys at their seminars - well, that simply seems to be the case :- ) They can't make speeches at the podium like Glantz, but even then, they can submit questions and comments.
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
Then, skoony, my baking tin is a cake? Roaster a turkey? 2 by 4 a house?
Yeah, I've taken the mental exercise down both paths, and I've come to the same conclusion, it doesn't matter. They will try to regulate it if they can, and if they regulate it as tobacco or drug, it will not end well for us. Loopholes and workarounds will not save vaping.
Ah... the fog lifts. Henceforth tomatoes and potatoes will also require labels declaring them made from tobacco. It is all so clear now...
Accidental leftover from a delete Quote. This message box likes to hold removed information.
Edited for correction
Please ignore
Agree, but ... I think the link between the catch phrase and their definition of 'tobacco product' in their response to eggplant nic, is there. In the other thread, I make a suggestion that people do a search on "nicotine" in the doc. All the stuff about teen brains, addiction, dual users, net population, etc., etc., should give a clear indication of where they might come down on nicotine of any source. :- )
@Kent C This stuff even confuses me.
derivative.
Read more at Derivative dictionary definition | derivative defined
As one can see these words can be used interchangeably. The key to understanding
what is meant is when they use the phrase 'made or derived from'. They certainly
do not mean,'made or made from' or,'derived or derived from'. If the term made
has a definite connotation the term derived has to have a different connotation.
When the proposed deeming regs were released I stumbled on a web page that
explained the interchangeability of the terms derived from as opposed to a derivative of
and the context they are used in. They can mean the same thing or describe relationships.
One could say a ICBM is derived from a bottle rocket. contextually one could go even
further and say a ICBM is derived from gun powder. They do both go bang.
Regards
Mike
derivative.
- derived
- using or taken from other sources; not original
- of derivation
Read more at Derivative dictionary definition | derivative defined
As one can see these words can be used interchangeably. The key to understanding
what is meant is when they use the phrase 'made or derived from'. They certainly
do not mean,'made or made from' or,'derived or derived from'. If the term made
has a definite connotation the term derived has to have a different connotation.
When the proposed deeming regs were released I stumbled on a web page that
explained the interchangeability of the terms derived from as opposed to a derivative of
and the context they are used in. They can mean the same thing or describe relationships.
One could say a ICBM is derived from a bottle rocket. contextually one could go even
further and say a ICBM is derived from gun powder. They do both go bang.
Regards
Mike
As I said, in the end, I'm not sure it really matters. All the round and round speculation is like going to a strip club, everyone just ends up frustrated. If the FDA remains in control of vaping, with anything resembling the final regulations, all of this will be moot as the likelihood of anything being approved that isn't a closed system is nil.
Not until a government agency has deemed them to be.Then, skoony, my baking tin is a cake? Roaster a turkey? 2 by 4 a house?
Regards
Mike
The problem there and actually to our advantage is All Nicotine Research supporting addiction is related to Long term Whole Tobacco use and over 95% Cigarette Smoking.
That was like CDC attempting to imply Diacetyl, while ignoring all other surrounding compounds/chemicals in workers developing Popcorn Lung. They left it at being a Possible cause rather than in combination with........
Politics and Science do not do well together. In the end, we pay for their shortcomings.
Again, derived, made from etc. etc. doesn't matter - what matters is 'for human consumption' (at least at the retail level) and how they define 'tobacco products' - as any component "intended or reasonably expected to be used with or for the human consumption".
The problem there and actually to our advantage is All Nicotine Research supporting addiction is related to Long term Whole Tobacco use and over 95% Cigarette Smoking.
That was like CDC attempting to imply Diacetyl, while ignoring all other surrounding compounds/chemicals in workers developing Popcorn Lung. They left it at being a Possible cause rather than in combination with........
Politics and Science do not do well together. In the end, we pay for their shortcomings.
Totally agree. There were 'mitigating' factors in the Popcorn lung suit - mainly lawyers. lol. The Pierce studies show this well.
Call it a "tobacco product" and hand it over to BT, or call it a "drug" and hand it over to BP. Either way the FDA intends to regulate it.
All of these lawsuits over terminology and hardware etc wont make a bit of difference if they put a choke-hold on nic (regardless of source) solution in a bottle.
All of these lawsuits over terminology and hardware etc wont make a bit of difference if they put a choke-hold on nic (regardless of source) solution in a bottle.
Have any of the lawsuits called out the circular definition of tobacco product>tobacco product component>tobacco product?
My interpretation of the regs is that if you can hold it in your hand and inhale smoke or vapor from it, it's a tobacco product. It will be regulated and taxed accordingly regardless of product source or contents. My hope is that some of the lawsuits can at least have this definition refined to a realistic level.
Wow, even though this thread is slowing down a little, I still cannot keep up with it.
In any event, we should all be clear in our understanding of the FSPTCA. Congress did NOT give the FDA the authority to regulate ENDS devices. Congress gave the authority to the FDA to regulate tobacco products, which, at the time, were defined as cigarettes, cigars and little cigars/cigarillos, and smokeless tobacco such as chewing tobacco, dip and SNUS. That's it - not vaping products, because at the time, vaping products were in their infancy.
The FDA is attempting to take it upon themselves to do so with the deeming regulation. This is the main reason we're all pi**ed.
The "broad interpretation" comment is throughout the khlaw/Coalition suit, and they mention the 'flexibility' that was written into the TC Act itself, and attempt to show how such definitions are not flexible at all. For example.
43. Under the Deeming Rule, FDA has taken a broad interpretation as to what items
are covered under the definition of “tobacco product.” As to ENDS products, these would not
only include e-liquids containing nicotine and other ingredients (like flavors), but also products
that do not contain tobacco or are not derived from tobacco, including tanks and tank systems,
coils, cartomizers, digital display/lights, software, and even batteries. 81 Fed. Reg. at 29,016.
And although this is aimed at the grandfather clause, it would certainly apply to definitions as well:
72. Under the Administrative Procedure Act (“APA”), a court may hold unlawful and
set aside agency action found to be “arbitrary, capricious, an abuse of discretion, or otherwise not
in accordance with the law . . . [or] in excess of statutory jurisdiction, authority, or limitations, or
short of statutory right.” 5 U.S.C. § 706.
It gets into the definitions here:
COUNT SIX
Violation of Administrative Procedure Act Definition of “Tobacco Product” and Application to ENDS
Pg 32.
116. FDA intends to regulate these products despite the fact that they do not contain
tobacco, are not derived from tobacco, and are not components or parts of an actual tobacco
product. The Agency offers no rationale based on the definition of “tobacco product” or the
legislative history indicating that such definition can be stretched so far as to capture these types of ENDS products (e.g., merely because they are used to consume a tobacco product).
https://brvliquids.com/wp-content/uploads/2016/06/R2B-Complaint.pdf
However, most of that suit is attacking the PMTA process - how it is by the FDA's own assessment - impossible to comply, and how it would put, as Bill says, 99.9% of the industry out of business.
See also my:
Another lawsuit filed! E-Vaping Coalition of America
Nicopure suit: again more on PMTA but there's this:
34. The Deeming Rule violates those provisions because, inter alia, its definition of “tobacco product” and attendant proposed reach of its provisions is unambiguously foreclosed by, and is an unreasonable construction of, the text of the Act.
https://tveca.com/frontpagenews/NicoPure-suit.pdf
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Again, just me speculating, but the problem I see with that is, the whole Component of a Tobacco Product makes it a regulated tobacco product even though it contains no tobacco isn't new. It was in the original FSPTCA, and it's why RYO tubes and filters are regulated by the FDA.
I don't know if anyone challenged that before, but it's been in play for 7 years now.
I know, bad wording. It should have said tobacco. I am totally aware of what is going on, and if you had been reading this thread you would know that. Sorry for the confusion.
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