I'm still attempting to engage Brown since he's been answering me. Its probably not doing any good, but so long as he's reading my emails, I will.
FDA TVECA post table of contents for Deeming Final Rule
- Thread starter Oliver
- Start date
- th_trl_thread_readers 0
- Status
I'm still attempting to engage Brown since he's been answering me. Its probably not doing any good, but so long as he's reading my emails, I will.
I would ask for the benefit of those listening if anyone can speak to where does the specific legal authority derives to regulate nicotine? Does it even exist? If not, then why are we even having this discussion? The battle is over the FDA's regulatory over-reach. But it does reveal a weakness as noted by the above post.
We can fight to overturn the onerous and coercive elements of the TCA rather than trying to fruitlessly work for bureaucratic accommodation from an agency incapable of compromise, for one; or, we can deprive them of the benefits they seek in the free marketplace. Put it out of their reach.
If the FDA is intent on neutralizing or destroying the entrepreneurial juice industry as it is which their actions certainly portend, there's not much we can do about it. We haven't the organization, money or political muscle to protect an entire industry. However, we can always make our own juice and the market opens up to an alternative juice industry that relies on a non-nicotine base product.
There is likely not the potential tax revenue stream in singling out the relatively small number of specialized nicotine makers to justify a week's worth of the FDA's budget to curtail it. What are we taking about here? In the millions of dollars? No, to make it even remotely profitable taxes would have to be assessed over a broad swath of non-nicotine products (or more likely limited alternatives and volume consumption) based on intended use. To attempt to channel all anticipated taxation through nicotine sales alone is untenable as it would result a ludicrously expensive end product.
Juice makers will have to decide whether they really want to be nicotine resellers or makers and structure themselves accordingly.
I'm sure this idea is not new. But perhaps now it is time for it to be considered seriously. The value of juice crafters is in their recipe formulations…not the nicotine content.
Yes I know this will be an uncomfortable notion to many. However, the longer we wait to commit to making a real fight of this, the more costly it will be. Perhaps even at the expense of vaping itself.
Deprive the FDA of its revenue generating potential. Cut them off at the knees.
If this were the structure today I'd doubt we'd be hearing much from the FDA or arguments about intended use. They'll never succeed to make resellers future crime card readers through legislation.
Again, they can certainly target a minuscule segment of the nicotine industry. True. But there's little return in that. Sorry if this makes some of you nervous. But don't be. It demonstrably affirms a governmental grant of monopoly to the very tobacco industry they've presumptuously worked so arduously to eradicate and the sanctioned pharma cartels soaking us despite the levels of recidivism.
I'm not suggesting this is the only approach (putting the FDA through wasteful tactical gyrations) but we've got to get serious about holding on to the vape. Convince them that we are determined to resist. If there are compromises to be made. We'll make them to be sure. But those that serve to limit government's intrusion into our lives. Their comfortable confidence that we will continue to serve in padding their revenue stream as ex smokers.
I will not be a victim. Let the choice to use nicotine remain an individual one not made at the retail flavor counter. And certainly not one which allows government to saddle us as tax chumps and addicts deserving of society's usurpation. Been there.
Good luck all.
We can fight to overturn the onerous and coercive elements of the TCA rather than trying to fruitlessly work for bureaucratic accommodation from an agency incapable of compromise, for one; or, we can deprive them of the benefits they seek in the free marketplace. Put it out of their reach.
If the FDA is intent on neutralizing or destroying the entrepreneurial juice industry as it is which their actions certainly portend, there's not much we can do about it. We haven't the organization, money or political muscle to protect an entire industry. However, we can always make our own juice and the market opens up to an alternative juice industry that relies on a non-nicotine base product.
There is likely not the potential tax revenue stream in singling out the relatively small number of specialized nicotine makers to justify a week's worth of the FDA's budget to curtail it. What are we taking about here? In the millions of dollars? No, to make it even remotely profitable taxes would have to be assessed over a broad swath of non-nicotine products (or more likely limited alternatives and volume consumption) based on intended use. To attempt to channel all anticipated taxation through nicotine sales alone is untenable as it would result a ludicrously expensive end product.
Juice makers will have to decide whether they really want to be nicotine resellers or makers and structure themselves accordingly.
I'm sure this idea is not new. But perhaps now it is time for it to be considered seriously. The value of juice crafters is in their recipe formulations…not the nicotine content.
Yes I know this will be an uncomfortable notion to many. However, the longer we wait to commit to making a real fight of this, the more costly it will be. Perhaps even at the expense of vaping itself.
Deprive the FDA of its revenue generating potential. Cut them off at the knees.
If this were the structure today I'd doubt we'd be hearing much from the FDA or arguments about intended use. They'll never succeed to make resellers future crime card readers through legislation.
Again, they can certainly target a minuscule segment of the nicotine industry. True. But there's little return in that. Sorry if this makes some of you nervous. But don't be. It demonstrably affirms a governmental grant of monopoly to the very tobacco industry they've presumptuously worked so arduously to eradicate and the sanctioned pharma cartels soaking us despite the levels of recidivism.
I'm not suggesting this is the only approach (putting the FDA through wasteful tactical gyrations) but we've got to get serious about holding on to the vape. Convince them that we are determined to resist. If there are compromises to be made. We'll make them to be sure. But those that serve to limit government's intrusion into our lives. Their comfortable confidence that we will continue to serve in padding their revenue stream as ex smokers.
I will not be a victim. Let the choice to use nicotine remain an individual one not made at the retail flavor counter. And certainly not one which allows government to saddle us as tax chumps and addicts deserving of society's usurpation. Been there.
Good luck all.
Last edited:
Hey, there's that pesky "for introduction into interstate commerce" language again.
Reading the whole page at the link, it almost seems like someone who registers with the FDA and provides them with a list of the products (and ingredients labeling, etc) that they make, but only sells them locally, face-to-face (i.e. w/o a website, or one that rejects requests from out of state) would not have to file a PMTA.
Doing that would certainly make for an interesting test case.
In looking for that post and re-reading this...that is interesting. So house made B&M juice not sold online would be exempt?
I think we are All Confused. Both by the Verbiage that we have seen. But Mainly from the Lack and Amount of Verbiage that has been available from the FDA.
The context of my post was Dealing with the "End User". If the TVECA PMTA Guidance is what the Final Version looks like, there was references to Exemptions to those who Supply Nicotine to Retailers who sell to End Users.
And this Makes Sense. Manufactures of Nicotine and or those who "Wholesale"/Distribute Nicotine to Retailers shouldn't come under the Same Regulations as those who Sell Nicotine to End Users.
I Don't see that Happening.
I can Grow Tobacco in my Backyard and then Roll my Own Cigars and or Make my Own Cigarettes. No Problems there. But then am I Exempt from Federal/State/Local Tobacco Laws if I want to sell them in my Store?
If it turns out to be the case, that sales model would certainly be the easiest for States to hit with taxes. Maybe the Feds are lobbing the ball up for the States to spike.
@Cam775 @MachTecVpr
Recalling what I remember from the original Deeming Proposal and most recently
Indiana's new regulations Nicotine was not specifically sited nor was PG/VG,Flavors
or, coloring. The way these regulations are being written they basically say anything
that is inhaled and mimics smoking a cigarette for all intents and purposes is a tobacco
product. This not only covers what is out there now but, any possible future developments
good or bad. If you smoked and or never smoked and do this instead of smoking and, it
looks like smoking,its a tobacco product. This catch all phraseology is how they are
going to justify regulating the hardware. A battery,wick,coil,and tank separately may
not be regulated separately.however when you put them all together and fill the tank
with anything you intend to vape they are a tobacco product as they mimic (are derived from)
the predicate product, a cigarette.
Regards
Mike
Recalling what I remember from the original Deeming Proposal and most recently
Indiana's new regulations Nicotine was not specifically sited nor was PG/VG,Flavors
or, coloring. The way these regulations are being written they basically say anything
that is inhaled and mimics smoking a cigarette for all intents and purposes is a tobacco
product. This not only covers what is out there now but, any possible future developments
good or bad. If you smoked and or never smoked and do this instead of smoking and, it
looks like smoking,its a tobacco product. This catch all phraseology is how they are
going to justify regulating the hardware. A battery,wick,coil,and tank separately may
not be regulated separately.however when you put them all together and fill the tank
with anything you intend to vape they are a tobacco product as they mimic (are derived from)
the predicate product, a cigarette.
Regards
Mike
Last edited:
Why do I think this would not withstand a proper court challenge? A nicotine-free vape has NOTHING from tobacco in it, and it's not a drug.
If I go out to my garden and grab some rose petals (or this time of year, some rose hips), throw them in in a pot of water, bring it to a boil on my stove-top, and inhale the resulting scented vapor, am I using a "tobacco product"? I don't think so!
@Cam775 @MachTecVpr
Recalling what I remember from the original Deeming Proposal and most recently
Indiana's new regulations Nicotine was not specifically sited nor was PG/VG,Flavors
or, coloring. The way these regulations are being written they basically say anything
that is inhaled and mimics smoking a cigarette for all intents and purposes is a tobacco
product. This not only covers what is out there now but, any possible future developments
good or bad. If you smoked and or never smoked and do this instead of smoking and, it
looks like smoking,its a tobacco product. This catch all phraseology is how they are
going to justify regulating the hardware. A battery,wick,coil,and tank separately may
not be regulated separately.however when you put them all together and fill the tank
with anything you intend to vape they are a tobacco product as they mimic (are derived from)
the predicate product, a cigarette.
Regards
Mike
Thx Mike. I kinda think that was my point. FDA presumes to "redefine" the permutations of use as tobacco. I personally don't think it's lawful even if legal for Congress to defer or allow such authority to be deferred. But it ain't no bakker if it ain't got that swing. Which blows the FDA outta tha water. So Congress either has to define nicotine and authority for its management or FDA has no authority at all if it's purchased with your vacuum cleaner. We're fighting magma. Let it flow to the sea.
Good luck.
I belong to no organized party. I am a Democrat. — Will Rogers
Last edited:
I am unaware of this concept having been over turned yet.
When the deeming regs were first released for public comment I came across
and interesting web page that to my regret forgot to book mark nor remember
the search term I used to find it that was quite informative. the basic premise
was the usage of the terms"dirivative of" and "derived from" in how the terms
are applied and what they mean in terms of their use in regulations and law.
'Derivative of' means a first generation product. Take the tobacco leaf. First
generation products would include cigarettes,cigars,chewing tobacco,pipe +
rolling tobacco and ,snuss.
'Derived from' means second generation product that need not have any of
the original product in them but,they mimic,copy,substitute for or,replace
the original product. Take gun powder. Derivative products would include
simple rockets + fireworks,the first bombs(hand grenades),rudimentary
fire arms, so on so forth until today. Today we have the H bomb. One can
argue that the 'bomb' is not a derivative of gun powder but,it certainly
is derived from the original predicate product,gun powder. Prior to
the 1960's when this distinction was first made derived from or derivative of
were pretty much interchangeable terms. they still are for most intents
and purposes. One exception is when these terms are used in regulatory
or law making at the Federal level. Unless otherwise specified they have
two distinct meanings. There has been discussions on and off since the early
70's about this distinction when it comes up. Most recently its usage has
mostly been confined to the on going battle of laboratory made illegal
things. It taint this and it taint that, So instead of requiring a new law
for each and every new illegal thing coming out of the labs they needed
a catch all law to keep ahead of clever chemist everywhere.
Regards
Mike
Thank you for not making me find it
I have to work tonight so I'm heading to bed and my eyes were starting to glaze over. Right now they are one in the same, where we buy our nic is where manf. buy theirs. I'm sure that will be top of the priority list to come to an end but now the verbage makes sense. I figured it would be grouped into the all encompassing verbage Skoony is talking about below but this makes it clear it will be one of the first things to go. No 2years for nic base. That's comparing apples to oranges. Grow in your backyard, no taxes and...see below
Taxes +a way to ID and make sure it's adults buying the products.
That was my understanding also, I was just hoping they'd deal with pre-made e-juice first. One can always hope!@Cam775 @MachTecVpr
Recalling what I remember from the original Deeming Proposal and most recently
Indiana's new regulations Nicotine was not specifically sited nor was PG/VG,Flavors
or, coloring. The way these regulations are being written they basically say anything
that is inhaled and mimics smoking a cigarette for all intents and purposes is a tobacco
product. This not only covers what is out there now but, any possible future developments
good or bad. If you smoked and or never smoked and do this instead of smoking and, it
looks like smoking,its a tobacco product. This catch all phraseology is how they are
going to justify regulating the hardware. A battery,wick,coil,and tank desperately may
not be regulated separately.however when you put them all together and fill the tank
with anything you intend to vape they are a tobacco product as they mimic (are derived from)
the predicate product, a cigarette.
Regards
Mike
Ok, Don't like that Analogy, Fair Enough. LOL
Say I make homemade Beer in my Local Shop. And do not engage in Interstate Commerce. I just make it and sell it to people who come into my shop. And I pay Any/All Taxes.
Am I Exempt from Liquor Laws? Just because it is Not Sold Online?
Good point. Some vestiges of Prohibition remain in our federal legal code. We shouldn't let it come to that.
Good luck all.
Good point. Some vestiges of Prohibition remain in our federal legal code. We shouldn't let it come to that.
Good luck all.
I don't really see it having Anything to do with Prohibition.
I see Modern Day Laws that govern how you can sell Liquor. And because you Don't Selling it Online, doesn't Release you from these Laws.
I'm having a Hard Time following the Chain of Thought that if a B&M doesn't sell On-Line, that they will somehow be Exempt from e-Cigarette Regulations?
Especially seeing that I Don't Think that e-Liquids will be Allowed to be Sold On-Line anyway.
FDA via Congress.
Regulation of tobacco by the U.S. Food and Drug Administration began in 2009 with the passage of the Family Smoking Prevention and Tobacco Control Act by the United States Congress.
https://en.wikipedia.org/wiki/Regulation_of_tobacco_by_the_U.S._Food_and_Drug_Administration
The EPA has regulatory control over nicotine and derivatives use in Agriculture (insect control) and hazardous waste disposal of nicotine in lozenges, patches, gum...
Federal jurisdiction of all alcohol production was assumed under the 18th Amendment. As I understand it, opportunistically inspired by this state laws quickly replaced it after repeal as revenue laws. So not so contemporaneous and something to watch for here in this effort.
The entire premise of FDA authority relays on a link between tobacco (not nicotine) and by application of proposed rules as noted earlier to what is considered "derived". Well derived I understand as the rules suggest may extend to anything that might be used to deliver it [tobacco). What's inferred is intended use. An outlandish and seriously harmful proposition. This is what would allow effectively the comprehensive control of the purely local activities of a B&M as virtually all of the component elements of vaping are delivered inter-state.
Should we accept the draconian premise of intended use there is little that government can't touch by even the most casual relationship I'm afraid. The expansion of intended use at the administrative level is a dangerous precedent and not only for this industry.
So rather than dwell on the Gordian Knot that the FDA would wind us in, let's not. We cut to the chase and let them know you can't have the money. That leaves it to them to play their hand and dare if they might outlaw nicotine (selectively) or call it a drug. We have a better chance I think in a proper legal legislative framework (as was intended constitutionally) than battling a behind closed doors committee who only uses our objections as the conceptual seedstock for a playbook of regulatory overwhelm.
So we're then to be content with what they allow us?
That's my belief. I feel for retailers and their passion for the boutique approach to marketing juices. Yet it's the very means by which we're being assailed. A shame for consumers in lost simplicity and utility. But rather that than a loss of right at a price they cynically set.
Really think isolation from nicotine is what retailers and producers must now seriously consider. Without the links to enable interstate jurisdiction we'll just have a great many local in-state nic makers. The states in turn may try to kill nic makers. Wouldn't put it past them. But not prudent. Likewise states can try but they'd risk killing them too with costs if they do. In the end, self-defeating, leaving dwindling tobacco revenues.
The fight here is for jurisdiction, taxes and representation. Did we really think this was about vaping?
Good luck all.
Last edited:
Federal jurisdiction of all alcohol production was assumed under the 18th Amendment. As I understand it.
The entire premise of FDA authority relays on a link between tobacco (not nicotine) and by application of proposed rules as noted earlier to what is considered "derived". Well derived I understand as the rules suggest may extend to anything that might be used to deliver it [tobacco). What's inferred is intended use. An outlandish and seriously harmful proposition. This is what would allow effectively the comprehensive control of the purely local activities of a B&M as virtually all of the component elements of vaping are delivered inter-state.
Should we accept the draconian premise of intended use there is little that government can't touch by even the most casual relationship I'm afraid. The expansion of intended use at the administrative level is a dangerous precedent and not only for this industry.
So rather than dwell on the Gordian Knot that the FDA would wind us in, let's not. We cut to the chase and let them know you can't have the money. That leaves it to them to play their hand and dare if they might outlaw nicotine (selectively) or call it a drug. We have a better chance I think in a proper legal legislative process (as was intended constitutionally) than battling a behind closed doors committee who only uses our objections as the conceptual seedstock for a playbook of regulatory overwhelm.
So we're then to be content with what they allow us?
That's my belief. I feel for retailers and their passion for the boutique approach to marketing juices. But it's the very means by which we're being assailed. A shame for consumers in lost simplicity and utility. But rather that than a loss of right at a price they cynically set.
Really think isolation from nicotine is what retailers and producers must now seriously consider. Without the links to enable interstate jurisdiction we'll just have a great many local in-state nic makers. The states in turn may try to kill nic makers. Wouldn't put it past them. But not prudent. Likewise states can try but they'd risk killing them too with costs if they do. In the end, self-defeating, leaving dwindling tobacco revenues.
The fight here is for jurisdiction, taxes and representation. Did we really think this was about vaping?
Good luck all.
We can Debate the Legal Authority of the FDA to Regulate e-Liquids that contain Nicotine. We did it in 2010. And in 2011. And 2012, 2013, 2014. And some are Still doing it Today.
I'm more in the Group that believes that the Train has Left the Station. And it Aint coming back. So I'll let someone else Carry that Torch.
And whereas the entire Intended Use concept is Troublesome, I don't think Anyone Actually knows to what Extent such a Concept might be Used outside of Marketing and Advertising.
- Status
Similar threads
- Locked
- Locked
- Locked
- Locked
