FDA Why is there no hardware litigation?

[the_vape_nerd]

I understand by reading certain releases from CASAA that they are of the opinion that the juice we use is in fact a tobacco product and derived from the tobacco plant. And that very little can be done on that front to fight these deeming regulations. I would agree, juice is obviously regulatable under the TCA.

However, these proposed regs also attempt to deem the hardware, i.e., many non-tobacco derived products such as mods, atomizers, carts, etc also as tobacco products. Which they are clearly not.

To me there is a lot of noise that can and should be made over this.

Why are the hardware vendors or maybe CASAA itself not seeking court relief on this issue?

Why would we wait until hardware has already been deemed a tobacco product to fight it, instead of fighting it now before it is deemed? What benefit is there?

Surely someone, a group of vendors maybe or another interested group could file a petition for declaratory judgment pre-emptively with a federal court??

 

[Kent C]

I understand by reading certain releases from CASAA that they are of the opinion that the juice we use is in fact a tobacco product and derived from the tobacco plant. And that very little can be done on that front to fight these deeming regulations. I would agree, juice is obviously regulatable under the TCA.

However, these proposed regs also attempt to deem the hardware, i.e., many non-tobacco derived products such as mods, atomizers, carts, etc also as tobacco products. Which they are clearly not.

To me there is a lot of noise that can and should be made over this.

Why are the hardware vendors or maybe CASAA itself not seeking court relief on this issue?

Why would we wait until hardware has already been deemed a tobacco product to fight it, instead of fighting it now before it is deemed? What benefit is there?

Surely someone, a group of vendors maybe or another interested group could file a petition for declaratory judgment pre-emptively with a federal court??

Upon what would the litigation be based? Right now, the hardware is not against the law. And there are some who think that some components wouldn't be. Asking for an injunction against the proposed rule, might be perceived as acknowledging that they will be.

That said, there is probably some lawyer that might want to try it

 

[Kryyptyk]

Most manufacturers are playing wait-and-see. The comment period still has another month, and may be extended beyond that. After that there is still another 2 years before the rules take effect; plenty of time then for litigation. Things might change before it comes to that though. If all goes well, the hardware clause will go bye-bye.

 

[DC2]

You can't sue until you can prove harm.
And as of yet there is no tangible harm to anyone.

You almost have to wait until the proposed rules are final and in effect.

 

[the_vape_nerd]

Upon what would the litigation be based? Right now, the hardware is not against the law. And there are some who think that some components wouldn't be. Asking for an injunction against the proposed rule, might be perceived as acknowledging that they will be.

That said, there is probably some lawyer that might want to try it

The regs have in them, language which states that the hardware is also a tobacco product. Nothing is against the law yet. Even when deemed hardware and juice will still be legal. What it accomplishes though is judiciary oversight on the fda. It could limit their power from the start to regulate the hardware.

The 2009 decision more or less had a very strict standard in the it said "hey you MIGHT have some regulatory power under the TCA" but it stopped short of legally holding that the fda had such a power.

A suit could be brought that says in effect..."hey these products are not derived from tobacco, they are exempt and we'd like a judge to limit the fdas power in this regard".

 

[the_vape_nerd]

You can't sue until you can prove harm.
And as of yet there is no tangible harm to anyone.

You almost have to wait until the proposed rules are final and in effect.

harm is easily proven, we already have statements from a ton of vendors out there that say if you regulate this my business will suffer...beyond that i dont think you need a showing of harm in a case like this...the harm is simply the fda exceeding it regulatory power granted by congress

 

[DC2]

harm is easily proven, we already have statements from a ton of vendors out there that say if you regulate this my business will suffer...beyond that i dont think you need a showing of harm in a case like this...the harm is simply the fda exceeding it regulatory power granted by congress

No, you can't sue based on "if you regulate in this particular manner" my business will suffer.
Because there has been no determination of how they will actually regulate.

The only thing on the table now is a proposal.
Those proposed regulations could change dramatically before becoming final.

I'm no legal expert, although I am pretty certain this is how things work in the legal system.
I wouldn't mind at all being wrong, and look forward to any further discussion.

 

[DC2]

A suit could be brought that says in effect..."hey these products are not derived from tobacco, they are exempt and we'd like a judge to limit the fdas power in this regard".

Again, no. The FSPTCA was passed by Congress and signed by the President, and it is law.
And it says that a tobacco product is anything made of derived from tobacco.

Our nicotine is derived from tobacco, and it is going to be a tobacco product soon.
There is almost certainly no way of getting around that.

So that brings us to the hardware.

The definition of a tobacco product, as stated in the FSPTCA includes as a tobacco product...
Any part or component intended for use in a finished tobacco product

That is why rolling papers are currently regulated as a tobacco product.

 

[the_vape_nerd]

Again, no. The FSPTCA was passed by Congress and signed by the President, and it is law.
And it says that a tobacco product is anything made of derived from tobacco.

Our nicotine is derived from tobacco, and it is going to be a tobacco product soon.
There is almost certainly no way of getting around that.

So that brings us to the hardware.

The definition of a tobacco product, as stated in the FSPTCA includes as a tobacco product...
Any part or component intended for use in a finished tobacco product

That is why rolling papers are currently regulated as a tobacco product.

what do you say to the hardware vendor who says...im making these mods for people who intend to use them to vape zero nic eliquid?

are pipes currently regulated? if not, why not? they are intended to help people smoke tobacco arent they?

 

[the_vape_nerd]

No, you can't sue based on "if you regulate in this particular manner" my business will suffer.
Because there has been no determination of how they will actually regulate.

The only thing on the table now is a proposal.
Those proposed regulations could change dramatically before becoming final.

I'm no legal expert, although I am pretty certain this is how things work in the legal system.
I wouldn't mind at all being wrong, and look forward to any further discussion.

And one of the ways those "proposals could change dramatically" is via litigation itself or the threat of litigation....i just don't see why they are taking this wait and see approach...the time to keep these products "undeemed" for lack of a better term...is now...not after the fda acts...once they do a court will be reluctant to overturn the status quo

 

[Kent C]

what do you say to the hardware vendor who says...im making these mods for people who intend to use them to vape zero nic eliquid?

You say: "You don't know that."

 

[edyle]

If the definition of tobacco product is based on 'intent', then such legislation boils down to having an effect on advertising.
The burden of proof rests on proving intent.

 

[the_vape_nerd]

You say: "You don't know that."

the point is...and the same with a pipe maker or .... maker or what have you...is that the manufacturer can adverise it the way he wants

the point is that its not the manufacturer's business to run around figuring out what every possible use for the product is

some MAY try to vape out of a toaster....is the fda now going to try and regulate toasters under the tobacco control act? based on this possibility?

 

[edyle]

Quote Originally Posted by the_vape_nerd View Post
what do you say to the hardware vendor who says...im making these mods for people who intend to use them to vape zero nic eliquid?

You say: "You don't know that."

Who has burden of proof?

 

[Kent C]

Who has burden of proof?

The vendor. See the deeming doc, pg 6 and beyond. There is wording that may sound different to some here because of what we might consider 'accessories' - like batts, clearos, tips, etc., but the FDA is quite clear on what they consider accessories:

"FDA considers accessories to be those items that may be used in
the storage or personal possession of a proposed deemed product. Therefore, items such as
hookah tongs, bags, cases, charcoal burners and holders, as well as cigar foil cutters, humidors,
carriers, and lighters would be considered accessories and would not fall within the scope of this
proposed rule."

Tobacco products defined:

"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 [my note: see above], 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."

And although, as tombaker has pointed out many times ... the phrase 'intended use' is used and there is no way to determine with certainty, intent, so the next best way is by "use". And the majority 'use' is with a tobacco product - nicotine. The FDA isn't going to track down the no-nic users. It burden would be on the vendor to provide data that shows that his products were only being used by no-nic users and will always be. I don't see that happening.

 

[edyle]

The vendor. ...



And although, as tombaker has pointed out many times ... the phrase 'intended use' is used and there is no way to determine with certainty, intent, so the next best way is by "use". And the majority 'use' is with a tobacco product - nicotine. The FDA isn't going to track down the no-nic users. It burden would be on the vendor to provide data that shows that his products were only being used by no-nic users and will always be. I don't see that happening.

Again; I am making a point about "Burden of Proof".

The Vendor CANNOT have the burden of proof to prove that the intended use is for tobacco.

You are trying to say that the vendor has to prove a "not".

This is the point I am contesting.

If the regulatory body wishes to apply legislation to a product, based on the "intended use" of the product, then what this affects, as far as the vendor is concerned is how the vendor ADVERTISES the product.
The vendor does not have to prove to the FDA that the product's 'intended use' falls under the FDAs jurisdiction.
The vendor does not have to prove to the FDA that the product's 'intended use' falls outside the FDAs jurisdiction.
What happens is if the vendor clearly markets the product for the use covered by the FDAs jurisdiction, then the vendor have provided the evidence upon which the FDA can then act.

 

[pamdis]

I have heard Zeller make two interesting statements that show he feels the burden of proof is on the vendor:

"The FDA does not have to prove harm, the manufacturer has to prove no harm"

"If the nicotine in your product is not from tobacco, but from some other source, then you will need to prove it"

 

[Kent C]

Again; I am making a point about "Burden of Proof".

The Vendor CANNOT have the burden of proof to prove that the intended use is for tobacco.

You are trying to say that the vendor has to prove a "not".

This is the point I am contesting.

If the regulatory body wishes to apply legislation to a product, based on the "intended use" of the product, then what this affects, as far as the vendor is concerned is how the vendor ADVERTISES the product.
The vendor does not have to prove to the FDA that the product's 'intended use' falls under the FDAs jurisdiction.
The vendor does not have to prove to the FDA that the product's 'intended use' falls outside the FDAs jurisdiction.
What happens is if the vendor clearly markets the product for the use covered by the FDAs jurisdiction, then the vendor have provided the evidence upon which the FDA can then act.

I know what it means 'philosophically' ... but that isn't going to happen here. It's like the asset forfeiture that was discussed in another thread recently and the 'drug paraphernalia' as well.

And see pamdis' comment...

 

[edyle]

I know what it means 'philosophically' ... but that isn't going to happen here. It's like the asset forfeiture that was discussed in another thread recently and the 'drug paraphernalia' as well.

And see pamdis' comment...

pamdis comment, by the way, while relating to burden of proof, does not concern hardware, and does not concern 'intended use' of such hardware.

 

[Kent C]

pamdis comment, by the way, while relating to burden of proof, does not concern hardware, and does not concern 'intended use' of such hardware.

I disagree as I pointed out above what is considered a 'tobacco product'. There is another quote by Zeller but I can't find it right now, but it's posted somewhere here, that he would consider ecig components as 'tobacco products' regardless of use. Maybe someone else has the quote more at hand than I.