Deeming Regulations have been released!!!!

[Lessifer]

water = alcohol component

Alcohol is often consumed in red plastic cups, therefore red plastic cups are alcohol components. Water can be drunk from a red plastic cup, water is also often added to alcohol in the form of ice, therefore water is an alcohol component. Not to mention, water is a key ingredient in most alcohol products.

 

[skoony]

water = alcohol component

Alcohol is often consumed in red plastic cups, therefore red plastic cups are alcohol components. Water can be drunk from a red plastic cup, water is also often added to alcohol in the form of ice, therefore water is an alcohol component. Not to mention, water is a key ingredient in most alcohol products.

This begs the question how are batteries,tanks,wicks altering the vapor? It's not vapor until after its vaporized. Aside from the percentage of nicotine, it is what it is. The only thing left to
alter the vapor is the air around us. Is the air now a tobacco product?

How can one regulate glorified aroma therapy?

Mike

 

[Smoke_too_much]

and those nasty coke mixers.

I've finally figured out why they call them "deeming" regulations, it's because we all deem them stupid.

This is the part that makes me laugh;

Chantix

• behavior changes
• irregular heartbeats
• feelings of panic
• thoughts of killing oneself

Bupropion

• hyperventilation
• irregular heartbeats
• buzzing or ringing in the ears
• false beliefs that cannot be changed by facts
• seeing, hearing, or feeling things that are not there
• attacking others

Zyban

• Actions that are out of control
• anger
• assaulting others
• attacking others
• being aggressive
• being impulsive

And they are worried about vaping, seems to be bass ackwards to me.

 

[Sugar_and_Spice]

I think Nicopure missed a good argument. FDA says tanks are tobacco products because they're intended for use with liquid containing nicotine and that's mostly what they're used for. Therefore, all nicotine free liquids are subject to regulation as components or parts because they're going to be put in a tobacco product.

Don't you think both parties left this out because
1. This suit has not ever mentioned the 'hardware' of intended use
2. Doesn't the outcome of this lawsuit pave the way on the hardware issue. ie. If the zero nic is not tobacco then products used to vape it cannot be considered as a tobacco product.
Just food for thought.

 

[bigdancehawk]

Don't you think both parties left this out because
1. This suit has not ever mentioned the 'hardware' of intended use
2. Doesn't the outcome of this lawsuit pave the way on the hardware issue. ie. If the zero nic is not tobacco then products used to vape it cannot be considered as a tobacco product.
Just food for thought.

1. The Nicopure lawsuit was consolidated with one brought by the Right to Be Smoke Free Coalition, which I believe consists of about a dozen groups representing various segments of the industry. But their brief must not have make much of an impression on me because I can't remember what, if anything, it said about hardware.
2. Seems plausible.

 

[zoiDman]

Don't you think both parties left this out because
1. This suit has not ever mentioned the 'hardware' of intended use
2. Doesn't the outcome of this lawsuit pave the way on the hardware issue. ie. If the zero nic is not tobacco then products used to vape it cannot be considered as a tobacco product.
Just food for thought.

Whereas e-Liquids were (and should) be the Primary concern, I was Baffled and Dismayed to not see really Much (Anything?) Hardware Related.

 

[Eskie]

Whereas e-Liquids were (and should) be the Primary concern, I was Baffled and Dismayed to not see really Much (Anything?) Hardware Related.

Well the plaintiff, Nicopure, is a liquid manufacturer, so I'm not sure of their standing regarding "hardware". Their retail arm, Halo, does sell rebranded hardware, but they don't manufacture it. Then there's the issue of without juice, who needs a mod? (ignoring DIY for both juice and even hardware)

 

[Sugar_and_Spice]

Whereas e-Liquids were (and should) be the Primary concern, I was Baffled and Dismayed to not see really Much (Anything?) Hardware Related.

I think I was at first also. But I can see this working in our favor if Nicopure wins the suit. It brings everything into question at that point, doesn't it. If Nicopure doesn't win, then I am afraid we won't have much of a leg to stand on. jmho and of course I pray I am wrong.

edit to add
What if all ejuice sold commercially was zero nic? What is done after the consumer has paid for and receives it remains to be seen, but the FDA has no skin in the game at that point....

 

[zoiDman]

Well the plaintiff, Nicopure, is a liquid manufacturer, so I'm not sure of their standing regarding "hardware". Their retail arm, Halo, does sell rebranded hardware, but they don't manufacture it. Then there's the issue of without juice, who needs a mod? (ignoring DIY for both juice and even hardware)

I would think that Anyone who is seeking Profits by selling e-Liquids would be Very Interested in how the FDA Regulates e-Cigarette Hardware.

 

[zoiDman]

I think I was at first also. But I can see this working in our favor if Nicopure wins the suit. It brings everything into question at that point, doesn't it. If Nicopure doesn't win, then I am afraid we won't have much of a leg to stand on. jmho and of course I pray I am wrong.

edit to add
What if all ejuice sold commercially was zero nic? What is done after the consumer has paid for and receives it remains to be seen, but the FDA has no skin in the game at that point....

Hard to say.

I see e-Liquids that contain Nicotine derived from Tobacco, 0mg e-Liquids, and Hardware as Separate Concepts.

And where there may be a Legal Overlap with regards to "Intended Use", it would seem that Each would have to be Fought on its own Basis.

But then again, I'm not a Lawyer who specializes in Federal Regulation Litigation.

 

[Kent C]

But their brief must not have make much of an impression on me because I can't remember what, if anything, it said about hardware.

Nicopure, while focusing on eliquid since that is what they sell, each count listed includes 'vaping devices and eliquids'.
http://www.fdalawblog.net/Nicopure Complaint.pdf

In the Right 2B smoke free lawsuit there is much discussion of hardware (42.,43, 113 and others - basically search "components" :- )... leading up to the counts but also within the counts:

http://www.khlaw.com/Files/27053_FDA_Deeming_Rule_Complaint.pdf

COUNT SIX


Violation of Administrative Procedure Act

Definition of "Tobacco Product" and Application to ENDS

....


112. Under the TCA, the term "tobacco product" is defined to mean, in part, "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product." 21 U.S.C. § 321(rr).

113. In the Deeming Rule, FDA defines "component or part" as "any software or assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product." 21 U.S.C. § 1100.3. Components and parts are subject to regulation under the Deeming Rule. 81 Fed. Reg. at 28,975.

...
115. FDA considers a broad range of ENDS products to be regulated as "tobacco products" or "components or parts." These include software used to operate devices, batteries, atomizers, cartomizers, digital display/lights, tanks, and glass e-liquid containers. See, e.g., 81

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).


117. Accordingly, FDA’s application of the TCA’s definition of "tobacco product" to certain ENDS is unreasonable and unlawful under the APA. Thus, the regulation of such products should be enjoined in its entirety.

 

[Sugar_and_Spice]

Hard to say.

I see e-Liquids that contain Nicotine derived from Tobacco, 0mg e-Liquids, and Hardware as Separate Concepts.

And where there may be a Legal Overlap with regards to "Intended Use", it would seem that Each would have to be Fought on its own Basis.

But then again, I'm not a Lawyer who specializes in Federal Regulation Litigation.

Yes, I see these as separate also. Its the 'intended use' that gives me nightmares. I still say one cannot assume anything. When you buy a bottle of alcohol ones assumes you will drink it, some will drink it straight but most will often dilute it with something. ie. Rum and coke a cola, etc. Note that the coke a cola and the glassware are not regulated or assumed that they will even be used. With ejuice, it can stand on its own per the consumers preference just like the alcohol.

Will the vendors sell both the zero nic ejuice and the nic to go with as a separate component? Who knows. But it would certainly put the whole vaping industry back in the game without all this unneeded deeming bs.

I am aware that the above will most likely never happen. But it should.

 

[seminolewind]

Don't you think both parties left this out because
1. This suit has not ever mentioned the 'hardware' of intended use
2. Doesn't the outcome of this lawsuit pave the way on the hardware issue. ie. If the zero nic is not tobacco then products used to vape it cannot be considered as a tobacco product.
Just food for thought.

Just because regulations are deemed doesn't mean they will work.
Anyone who claims that vaping will be a pathway to kid's smoking has no proof.
Anyone who claims smoking is better than vaping has no proof
Anyone who claims vaping contains antifreeze or toxic chemicals has no proof.
Anyone who claims that vaping is not predominantly used for smoking cessation has no proof
Anyone who claims that e-liquid is a tobacco product is not telling the truth.
I think the only thing that the FDA should be checking is that the mg.nicotine is actually accurate to keep people safe. And that e-juice makers or sellers should be inspected to prove that they know what they are doing, and have the correct facilities to manufacture e-liquid. Not "Joe" making juice in their basement with no proof they know what they are doing or providing a quality check . There are many of these that should not be practicing "basement" factories.

 

[seminolewind]

I think they did mention hardware because the hardware cannot be anything created or invented after 2007.

 

[bigdancehawk]

Nicopure, while focusing on eliquid since that is what they sell, each count listed includes 'vaping devices and eliquids'.
http://www.fdalawblog.net/Nicopure Complaint.pdf

In the Right 2B smoke free lawsuit there is much discussion of hardware (42.,43, 113 and others - basically search "components" :- )... leading up to the counts but also within the counts:

http://www.khlaw.com/Files/27053_FDA_Deeming_Rule_Complaint.pdf

COUNT SIX


Violation of Administrative Procedure Act

Definition of "Tobacco Product" and Application to ENDS

....


112. Under the TCA, the term "tobacco product" is defined to mean, in part, "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product." 21 U.S.C. § 321(rr).

113. In the Deeming Rule, FDA defines "component or part" as "any software or assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product." 21 U.S.C. § 1100.3. Components and parts are subject to regulation under the Deeming Rule. 81 Fed. Reg. at 28,975.

...
115. FDA considers a broad range of ENDS products to be regulated as "tobacco products" or "components or parts." These include software used to operate devices, batteries, atomizers, cartomizers, digital display/lights, tanks, and glass e-liquid containers. See, e.g., 81

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).


117. Accordingly, FDA’s application of the TCA’s definition of "tobacco product" to certain ENDS is unreasonable and unlawful under the APA. Thus, the regulation of such products should be enjoined in its entirety.

It's in the complaints, but the plaintiffs didn't seem to attach any importance to it because it's not addressed in the briefs. I don't see the judge adjudicating an issue that hasn't been briefed, do you?

 

[bigdancehawk]

Yes, I see these as separate also. Its the 'intended use' that gives me nightmares. I still say one cannot assume anything. When you buy a bottle of alcohol ones assumes you will drink it, some will drink it straight but most will often dilute it with something. ie. Rum and coke a cola, etc. Note that the coke a cola and the glassware are not regulated or assumed that they will even be used. With ejuice, it can stand on its own per the consumers preference just like the alcohol.

Will the vendors sell both the zero nic ejuice and the nic to go with as a separate component? Who knows. But it would certainly put the whole vaping industry back in the game without all this unneeded deeming bs.

I am aware that the above will most likely never happen. But it should.

Different but related question: If this lawsuit and the few others like it fail, do you think the FDA will approve any bottled e-liquid?

 

[Sugar_and_Spice]

Different but related question: If this lawsuit and the few others like it fail, do you think the FDA will approve any bottled e-liquid?

Probably not. They will probably only approve the closed systems and those little pod things or prefilled cartomizers.

 

[zoiDman]

Yes, I see these as separate also. Its the 'intended use' that gives me nightmares. ...

"Intend Use" should Scare you. It Should Scare the Hell Out of You.

Because it Opens a Door where Regulatory Agencies can take a Congressionally Granted Authority and Subvert it to about Anything they want.

It also Provides a Vehicle for Discriminatory Enforcement. And allows an Agency to Pick and Choose who is Allowed and who is Not Allowed to participate in a Market.

 

[Eskie]

"Intend Use" should Scare you. It Should Scare the Hell Out of You.

Because it Opens a Door where Regulatory Agencies can take a Congressionally Granted Authority and Subvert it to about Anything they want.

It also Provides a Vehicle for Discriminatory Enforcement. And allows an Agency to Pick and Choose who is Allowed and who is Not Allowed to participate in a Market.

While I do agree with you, this is hardly the first time regulatory agencies will have, and in fact do, subvert their authority in all sorts of ways. And discretionary enforcement is hardly new.

Just because regulations are deemed doesn't mean they will work.
Anyone who claims that vaping will be a pathway to kid's smoking has no proof.
Anyone who claims vaping is better than smoking has no proof.
Anyone who claims vaping contains antifreeze or toxic chemicals has no proof.
Anyone who claims that vaping is not predominantly used for smoking cessation has no proof
Anyone who claims that e-liquid is a tobacco product is not telling the truth.
I think the only thing that the FDA should be checking is that the mg.nicotine is actually accurate to keep people safe. And that e-juice makers or sellers should be inspected to prove that they know what they are doing, and have the correct facilities to manufacture e-liquid. Not "Joe" making juice in their basement with no proof they know what they are doing or providing a quality check . There are many of these that should not be practicing "basement" factories.

I agree with you across the board. If this were about rational regulation, assuring basic safety and quality control was applied to these products, most of us would have no issue at all.

OK, I do disagree with you on "Anyone who claims vaping is better than smoking has no proof."
Maybe "Anyone who claims vaping is worse for you than smoking has no proof"?

 

[Sugar_and_Spice]

OK, I do disagree with you on "Anyone who claims vaping is better than smoking has no proof."
Maybe "Anyone who claims vaping is worse for you than smoking has no proof"?

Exactly. Try telling a vaper who has vaped any length of time that they have no 'proof'. All one has to do is look at their health before and after ecigs. The proof can be found in dr's office around the country, if one cares to look. While this is not proof that ecigs are responsible, it definitely shows that stopping smoking can improve ones health. That is the beauty of ecigs. It allows us to keep the things we do want and none of the things we don't. Even if it is found that ecigs is in some way harmful, you have to agree that the reduction in harm is well worth any effort you put in it.