The FDA and hardware (questions)

[gpjoe]

OK, so still a bit unclear. Are we facing a total ban on mods, juice, attys, etc or just taxes to make up for the lost revenue on tobacco? What exactly is the endgame? Is all of this still up for speculation?

Regardless, much like the "few" 30-round AR-15 magazines that I have purchased (and expect to be grandfathered) in anticipation of a ban, I would probably be more comfortable having some spare vaping gear...and more critically important - some nic base.

 

[zoiDman]

It's commonly assumed that we'll have 2 years to stockpile post-deeming and pre-implementation of the registration/approval process. But that doesn't mean the FDA can't and won't go into rule-making mode on other aspects as soon as deeming is effective. ...

This is Something that I believe the vast majority of Vaper's are Not Considering.

 

[Douggro]

From the FDA synopsis of the proposed deeming regs:
"The term “covered tobacco products” is defined here as those products deemed to be subject to the Food, Drug, and Cosmetic Act under section 1100.2 of title 21 of the Code of Federal Regulations (CFR), other than a component or part that does not contain tobacco or nicotine."

And from the overview of the proposal:

"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 ecigarettes. The proposed rule also deems any future tobacco products that meet the statutory definition of "tobacco product" except accessories of such product to be subject to FDA’s authorities under chapter IX of the FD&C Act."

 

[Wow1420]

OK, so still a bit unclear. Are we facing a total ban on mods, juice, attys, etc or just taxes to make up for the lost revenue on tobacco? What exactly is the endgame? Is all of this still up for speculation?

Regardless, much like the "few" 30-round AR-15 magazines that I have purchased (and expect to be grandfathered) in anticipation of a ban, I would probably be more comfortable having some spare vaping gear...and more critically important - some nic base.

End game for the individual states, I'm sure, is taxes.

For the FDA, it's ensuring that their friends in BP re not hurt much by vaping. the exact route to that goal, we don't know yet. We'll know a lot more once we see the final deeming and if the 2007 grandfather date stands.

 

[Lessifer]

Yes they can regulate every single piece of hardware under the intended use doctrine.
That is what the deeming reg.'s intend to do. The question is how could they do it and
just as importantly will they try.
Theoretically under the intended use doctrine if the FDA notices a vendor selling a lot
of flashlights with 510 connections and discovered they were being used for vaping
devices they could flag the vendor. The vendor didn't advertise them as vaping products
but,customers are using them for that purpose. Advertised use v actual use. Its the
FDA's contention the vendor should know what the actual intended use is an therefore
is in violation. Whether or not the vendor is aware of the actual use is not relevant.
Again how they will go about doing this is anyone guess. I suggest if you can stock up
on some juice,extra batteries tanks and parts before the reg.'s are released. There will
be an almost 2 year period before they become final. If the reg.'s are really harsh 2
years is enough to do some major stockpiling. The price's may be higher but you'll
have enough time.

Regards
Mike

"intended use" gives them a lot of wiggle room. Whether or not it will stand up in court is another matter, as is whether or not they actually invoke it in the rule or enforcement of the rule.

This is Something that I believe the vast majority of Vaper's are Not Considering.

You're right, even if there is a two year period for PMTA applications to be filed, the FDA can start issuing guidances immediately to bring the new rule in line with the FSPTCA, like for flavors or advertisements, etc.

Something else that no one seems to ever mention:
If the rule passes and it looks like 99% of the juice makers will be put out of business, how much longer do you really expect the hardware makers to stay in the game?

 

[zoiDman]

"intended use" gives them a lot of wiggle room. Whether or not it will stand up in court is another matter, as is whether or not they actually invoke it in the rule or enforcement of the rule.

You're right, even if there is a two year period for PMTA applications to be filed, the FDA can start issuing guidances immediately to bring the new rule in line with the FSPTCA, like for flavors or advertisements, etc.

Something else that no one seems to ever mention:
If the rule passes and it looks like 99% of the juice makers will be put out of business, how much longer do you really expect the hardware makers to stay in the game?

IMO, the "Intended Use" provision is just a vehicle to Restrict Marketing and Advertising.

And Yes, the FDA does not have to wait 2 Years to Implement Many Restrictions once they have the Legal Authority to do so.

 

[Lessifer]

IMO, the "Intended Use" provision is just a vehicle to Restrict Marketing and Advertising.

And Yes, the FDA is not wait 2 Years to Implement Many Restrictions once they have the Legal Authority to do so.

There are so many restrictions that people don't realize apply to "tobacco products" as a whole. There are many things not mentioned in the deeming, because that is not the purpose of the deeming. The deeming is to define vapor products as tobacco products. Once that definition applies, the rest of the tobacco control policies can be applied with little or no fanfare. They're already in place, the agency just has to issue a guidance saying they apply to ALL tobacco products.

 

[AndriaD]

I see wording like, "tobacco delivery system related" as the danger. Cop catches you, cites you, you take it to court to argue, the judge agrees with the law. A mod or tank is just a little hard to argue for when the the cop says you were using it.

For the individual user, it will be a crock.

Umm... nobody is saying anything about making vaping illegal -- simply owning any piece of vaping equipment will not be a crime.

Andria

 

[zoiDman]

There are so many restrictions that people don't realize apply to "tobacco products" as a whole. There are many things not mentioned in the deeming, because that is not the purpose of the deeming. The deeming is to define vapor products as tobacco products. Once that definition applies, the rest of the tobacco control policies can be applied with little or no fanfare. They're already in place, the agency just has to issue a guidance saying they apply to ALL tobacco products.

Exactly.

I know the Owner of a B&M Vape Shop in a small strip mall. Last year, as a Preemptive move, he attempted to make a change to his City Business License to include the Storage/Sale of "Tobacco Products" at his location. It was Denied.

He is kinda SOL for that Location.

 

[Bunnykiller]

Jesus, whatever happened to innocent till proven guilty? I would be shocked to face charges for rolling papers in the absence of tobacco. I might even retain a lawyer just on principle.

and gawd forbid that you get caught with a lighter without a pack of ciggies... definately intent to do something not legally sanctioned... what else would you use a lighter for if its not for ciggies.. got to be up to something wrong

 

[Bunnykiller]

need to find a way to make synthetic nic.... not from tobacco plants that is just as cost effective as plant extraction process...
talk about confusion then

 

[Lessifer]

need to find a way to make synthetic nic.... not from tobacco plants that is just as cost effective as plant extraction process...
talk about confusion then

No confusion at all. Nicotine liquid is derived from tobacco, because nicotine comes from tobacco, so nicotine liquid is a tobacco product. Non-tobacco sourced nicotine liquid would be derived(the idea comes from) traditional nicotine liquid, which is a tobacco product, so any nicotine liquid is a tobacco product. This is what happens when you accept their definition.

No one, at least no one "important," is even fighting their definition any more.

 

[Bunnykiller]

No confusion at all. Nicotine liquid is derived from tobacco, because nicotine comes from tobacco, so nicotine liquid is a tobacco product. Non-tobacco sourced nicotine liquid would be derived(the idea comes from) traditional nicotine liquid, which is a tobacco product, so any nicotine liquid is a tobacco product. This is what happens when you accept their definition.

No one, at least no one "important," is even fighting their definition any more.

hmmm ok. then lets extract nic from eggplant and synthesize that then it would be from a non tobacco source

 

[MyMagicMist]

hmmm ok. then lets extract nic from eggplant and synthesize that then it would be from a non tobacco source

Why not tomatoes, beans, potatoes, beets, carrots, plain old grass? All of these contain trace amounts of nicotine.
Figure the extraction process would be nearly the same. Not sure it would be cost effective to rely on mono-cultured
nicotine, maybe better to extract from carrots & beets, potatoes & tomatoes and so on. Another thought occurs, not
sure what is done with soy bean hulls. May be able to extract from them if they're tossed as waste from livestock
fodder.

 

[Rossum]

Tobacco has 3-5% nic. All the other sources mentioned have orders of magnitude less. That means it would be necessary to process orders of magnitude more source material, using correspondingly more capital equipment and consumables, which would raise the cost of the finished product proportionately. Worse yet, the resulting nic wouldn't have the protection it has enjoyed under Sottera (because it isn't a tobacco product) and the FDA would simply ban it as an unapproved drug.

 

[ReigntheGamer]

As soon as it is extracted from something else they will change the definitions.

 

[skoony]

hmmm ok. then lets extract nic from eggplant and synthesize that then it would be from a non tobacco source

It's still derived from the predicate product tobacco as it takes the place of,simulates, mimics or
used instead of nicotine. As such it's a generational derivative.
See my post #13 in this thread.

Regards
Mike

 

[Rossum]

It's still derived from the predicate product tobacco as it takes the place of,simulates, mimics or
used instead of nicotine. As such it's a generational derivative.
See my post #13 in this thread.

Regards
Mike

Only if the FDA wants to classify it like that. If they don't, they won't. In that case, someone would have to spend years and a six (or more likely seven) figure sum on lawyers in an attempt to get the courts to make the FDA see things that way, a strategy that might counter productive since we'd rather not have our battery holders and evaporation chambers classified that way.

 

[AzPlumber]

Umm... nobody is saying anything about making vaping illegal -- simply owning any piece of vaping equipment will not be a crime.

Andria

Exactly.

All products (after the grandfather date) will need to go through the approval process. This will substantially increase costs and give manufactures/makers/mixers a massive incentive to cut corners.

 

[Rossum]

All products (after the grandfather date) will need to go through the approval process. This will substantially increase costs and give manufactures/makers/mixers a massive incentive to cut corners.

Most won't even apply for approval because their makers simply do not have the resources to file the required applications.