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The FDA Deeming Can Not, and Does Not Regulate Vaping Hardware. Detailed Explanation.

tombaker

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Summary: All APV hardware that is not prefilled is outside of the scope of the FDA and it can not be regulated, under all current laws at the disposal of the FDA. This means a Protank sold by itself, this means every Battery (MOD or VW, or VV, all of them), this means replacement coils packs, every RBA. All APV hardware as sold in the market commonly sold in the market today, is outside of the FDA regulations and control.

For those who were concerned, but then thought there is no way the FDA could regulate APV hardware, because there was just way to many ways around it, they have better things to do, its crazy if they try that….you are right. Does this mean because all hardware is out of scope, that the FDA deeming is meaningless, NO. But lets focus attention and energy on what is real.

Boiled down to the Regulatory Core, E-Liquid equals E-Cigarettes. That means all of vaping, disposables, Cart and Recharge, EGO threading, Clearomizers, and MOD type drippers, and RBA.

E-Liquid being the Tobacco Product should not be controversial, it is 1:1 with Tobacco, being the constant to Cigarettes and Cigars, Tobacco Pipes, Chew, and the rest.

E-Liquid is the common denominator for EVERYTHING. Ignoring the subjectives of works better, tastes better…a disposable has the same E-Liquid in it, as the E-Liquid dripped in a RBA, filled into a EGO threaded Tank System, and refilled into 510 or 808 blank Cartomizer. It is ALWAYS the Same E-Liquid. Always means ALWAYS, if its E-Liquid its Vaping.

E-Liquid (with Nic) is all that counts. You have it, you can vape, you don’t have it you don’t vape. If for some whacked reason anyone wants to debate this, start a your own thread, I can promise to let you win over there, I won’t show up. The FDA has regulatory authority over E-Liquid and stuff packaged with E-Liquid.

There is lots of confusion between Product vs Usage, that is for another thread.

It’s a given that FDA can regulate E-Liquid .

It also is no surprise to anyone, the FDA states they can regulate a Finished Product, which CONTAINS E-Liquid. That means they can regulate the disposables in the single packs at the convenience stores.

Simularly Blu, Apolloecigs, Haloecigs, sell the exact same thing as a disposable in a rechargeable battery, and prefilled cartomizer. Everybody agrees these are all in scope of FDA.

So what is the FDA talking about when they say Component or Part used or expected to be used in a Finished Tobacco Product. They mean the Prefilled Cart.

1. We know this because they says so in their example in the Deeming itself

2. The cart is prefilled with EGOs sold inside the finished product, as a kit.

3. They are talking about E-Liquid that is put inside of the finished tobacco part.

4. The are saying if it does not have a Tobacco in it, that is NOT a Tobacco Product, and further, they only have regulatory power of Tobacco. The FDA says this.

The FDA states it can regulate Components or Parts of intended or expected to be used as part of a Finished Tobacco Product. So must mean that my Provari, the precious, they are coming for my Precious. The Precious is sold on the same site, site that sells E-Liquids, hey they are going to figure it out. Nope. The FDA is not going after the hardware, it would make zero sense. They already are using misfit regulations to work E-Cigs, its hard enough already, they are not going to fight to regulate a Tobacco Pipe, Otherwise known as a Clearomizer.

Of course it makes sense that the FDA won’t try to go after APV hardware, buttttttt that does not mean they are going to do it, look at when they tried to ___X_in back in 20xx__ you think they won’t do it again!!!!!

Well yes, because they got beat back hard by NJOY cigs, who’s lawyer’s single handedly beat back the FDA, and in the appeal. NJOY crushed the FDA in court, and the effects still hurt. The FDA is not going to go after things where they will lose so dang easily with a judge. The FDA is not going to go after hardware because it can be worked around easily.

For examply, my usage of an Ego Twist and an iClear16, is a vape pure water, it’s a nice personal humidifier. I think that is pretty much a decision proof usage of a legal product.

But enough of what makes sense. Lets look at what the FDA actually says.

1. FDA is proposing to deem those products meeting the definition of "tobacco product" in section 201(rr) of the FD&C Act, except the accessories of proposed deemed tobacco products to be subject to chapter IX of the FD&C Act.

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.

So right there we can understand that a battery and a coil, are a “lighter” Fine you think that is not enough, the FDA would want to go to court on it….Fine NEXT

1. 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.

AH HA, there it its. The FDA said intended. It could mean anything. This is why Johnny is hording drip tips, they are coming after our drip tips. The courts will rule the FDA is right to go after drip tips, and my Precious.

Some heads just exploded, how dare I. How dare I say that the FDA is clearly talking about E-Liquid, that E-Liquid is Vape. How dare I suggest they are talking about things or kits that containt E-Liquid.

I dare because I read the next sentence.

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.

The FDA gives an exact and specific example. The component in question is the pre-filled cartomizer. Its not an E-Cig, it can not fire by itself. The coil inside the Cart, is a coil, but so is a windproof lighter. If they said E-Cig, some may be confused that a Cart is not an E-Cig, but will be part of the regulations. So to clarify, to explain what on earth they are meaning, when talking about E-Cigarettes, they tell you. THEY MEAN A CART, filled with E-Liquid, which makes it a Tobacco Product.

But my Precious, why should I think my Provari is safe. The FDA can regulate Tobacco Products. The Precious contains no nicotine. Without Nicotine its not a Tobacco Product.

Nevertheless, all tobacco products containing nicotine are addictive, and FDA is not currently aware of any tobacco products that do not contain nicotine.

And there are other things where the FDA is twice shy because of what NJOY did in the courts, by themselves, on their own dime. For example.

FDA does not at this time intend to enforce the requirements of 910 and 905(j) for components of regulated tobacco products that are sold or distributed solely for further manufacturing into finished tobacco products.

It could be a huge wasted effort to go after Kanger being a supplier to V2. But it also shows they understand they can not win a fight with Joe who buys 100 and builds them, but only builds them and sells them to vape water, or Zero-Nic.

FDA’s Zeller explains it again. “If its intended or expected to be used in a Finished Product, that meets the definition of a Tobacco Product, then it a covered Tobacco Product subject to the Agency’s regulatory reach.

A Provari is never a finshed TOBACCO product. Nor is every empty Tank or Clearomizer, or RBA. They got no nicotine, and they are being sold as finished products without Nicotine. Without Nicotine you are not Tobacco. Without Tobacco you are not inside of the FDA. Zeller is asking them to read it, then to make comments if there is any confusion. Have not seen a good comment yet on this specific item….but lets continue.

Just what in the heck is a Finished Product: From Cornell Law

Finished product means a product which has been completely manufactured, packaged, and labeled.

Is a Provari a finished product. YES
Does it contain Nicotine NO
Is it a Tobacco Product NO

Will a Provari be included with Nicotine as a Kit, as in 1 Provari, and 1 bottle of juice inside the same package? NO. If it does, then yah it just like a prefilled Cart. Is some idiot about to do that, actually I don’t even think an idiot would.

What about a Protank. Same.

What about a CE4, that comes in a starter kit, that includes the E-Liquid and EGO. YES, its got the E-Liquid, E-Liquid = FDA

What about a kit that has a Protank and a Provari, packaged together. No E-Liquid.

Look at what Zeller said.

Generically,
APV hardware, is not ever expected to be used inside of a FINISHED TOBACCO PRODUCT, because it is never kitted that way. A PRODUCT is a definition. It does not just mean a device. The FDA is not regulating E-Cigs as Devices. It has to be a Tobacco Product to be with the FDA. All APV hardware is used for applications which do not contain Nicotine. All those applications are outside of the FDA reach.


Boil it all down, ALL HARDWARE without containing E-Liquid (with Nic) is outside of the FDA.
 

Myk

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Rolling papers and cigarette tubes are regulated as tobacco products yet contain no tobacco. Their regulation is based on intended use.

When I read the proposal I got the idea that FDA has no real clue what ecigs are outside of cigalikes. Going by their proposal the 100' spool of kanthal from Vape Supply is a tobacco product. The same spool from electrical supply is not. Flavoring from TFA gets regulated, flavoring from LorAnn does not.

Pretending the parts of an APV are not going to be regulated serves no purpose except to create complacency and get people to not mention those issues with the proposal in their comments.

Possible outcomes:
If the intention is to regulate them and no comments are made against that they will regulate them.
If the intention is not to regulate them and comments are made against regulating them nothing changes.
If the intention is to regulate them and comments are made against regulating they may listen and not regulate.

Given those possible outcomes I question why you are trying to create the feeling that everything is safe so people won't raise issue with the possibilities of the proposal.
 

tombaker

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1. Rolling papers etc, are burned and inhaled into the lungs. That is why the FDA is concerned about them.

2. A pipe holds the tobacco (or whatever) and its not inhaled, this is why they are not regulated, and won't be.

3. Your theory that a spool of Kanthal is a Tobacoo product is wrong, because it does not contain nicotine. And a host of other reasons.

4. Tell what would be the criteria for review by the FDA if they were to consider Kanthal as Tobacco Product. Right, it makes zero sense, when you try to go past the first step.

5. Flavorings for food are part of a large class that has been evaluated as safe for human consumption. If they were going to go the next step and review the same for inhalation (if not already done in the MSDS), I would not be opposed.

6. I am not pretending about anything, if you read the OP. I think you should comment, I think you should comment with whatever you feel. The FDA can not regulate items which do not contain Nicotine. A Clearomizer, can be used for many different things, and the FDA can not regulate it because they THINK it could be used for something. Have you been to any smoke shop? A battery with a standardized connection can be used for any number of things. The facts of the matter do not serve your wild theory of complacency, why would they. You should comment, and tell everyone to do so, don’t wait, you can comment as often as you like. Do it.

7. I wish you would have read the OP.

8. There is no legal means to regulate a pipe, or a clearomizer. The FDA is going to be regulating E-Liquid, and what contains E-Liquid. Read it again. Let it sink in.

9. I can not buy into your premise that if people know what is real and what is not, that they won’t act in their own freedom. Question me all you want, the way you do is laughable because you think everyone is a sheeple and follows along. I think my fellow vapers are not so naïve, and if they read and dismiss me, they do so. Your entire argument is that you think others are not as bright as you, so you worry they will do something you don’t approve of.

Point out anywhere where you think I am wrong on the facts in the OP.
Until then, comment to the FDA, do it any way you want.

People making APV hardware will be fine, so will Sony and their 18650s. That does not mean there is nothing to do. Most of anyone selling Hardware is selling E-Liquid.

And E-Liquid is definitely in play. And that means if you are selling products that contain E-Liquid as part of the finished product.
 

kelli

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isn't there a possibility they could just change the FDA regulations tho? the old "change the laws to fit the crime" thing.
 
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tombaker

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isn't there a possibility they could just change the FDA regulations tho? the old "change the laws to fit the crime" thing.
Yes the Congress can create new laws. But remember that the FDA is still bound by the laws they have. That is why Sottera pushed back and won huge against the FDA. Ralph Tyler, the then Chief Council of the FDA went and appealed, and the appeals court beat back the FDA in with very strong language. The next court would have been the Supreme Court, and the FDA gave up at that point.

The FDA is using the 2009 Tobacco Act. That act can not ban Tobacco, specifically saying that. The 2009 Act has a premise where they want to approve new Tobacco Products that are NOT more harmful than existing. That is the only punch the act has. Its a problem for E-Cigs because there were no comparable product at the time, for companies to use now as "predicate products".

This 2009 Act is a very weak law, and for the last 4 years, they have done nothing with it for E-Cigs. Because its going to be hard. They are still several years away from having any control of anything on E-Cigs.

Companies will have to do product approvals of E-Liquid in Cigalikes and refillables. Without E-Liquid its not part of the 2009 Act.

Smoke shops sell all sorts of equipment, and the FDA has no control of it. They won't with Tanks, and Tube Batteries, or VW devices. This does not remove the problem for E-Liquid. Which remains the real barrier. No E-Liquid means no Vape.
 

Myk

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You obviously have no clue about pipe smoking. Peterson Pipes are known for being tough to break in because they get the stain in the bowl. It is burned and put into your body. The wood is charred and put into your body.

Why do you never answer? Why are you trying to make people complacent when that complacency will allow the things to be regulated?

The FDA has clearly said they consider the whole ecig to be a tobacco product. It doesn't have to make sense.
 

lordmage

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here is your flaw from your OP
"The FDA states it can regulate Components or Parts of intended or expected to be used as part of a Finished Tobacco Product"

we agree the E-liquid is what is vaped and thereby makes adding that to any device ,tank,carto,rda or otherwise a complete and finished 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.

Now from the deeming it's self

FDA considers accessories of proposed deemed products to be those items that are not included as part of a finished tobacco product or intended or expected to be used by consumers in the consumption of a tobacco product

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 e-cigarettes. 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. For example, FDA envisions that there could be tobacco products developed in the future that provide nicotine delivery (e.g., via dermal or buccal absorption), similar to currently marketed medicinal nicotine products, but which are not marketed for therapeutic purposes. Such products would be “tobacco products” and subject to FDA's chapter IX authorities should the deeming rule be finalized.

in addition, FDA realizes that there are distinctions in the hazards presented by various nicotine-delivering products. Some have advanced views that certain new tobacco products that are noncombustible (such as e-cigarettes) may be less hazardous than combustible products given the carcinogens in smoke and the dangers of secondhand smoke from combustible products. Accordingly, FDA is seeking comment in this proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products. We welcome comment on how to implement the provisions in the FD&C Act with respect to e-cigarettes. We also welcome any health and behavioral data about the effects of using e-cigarettes.

once a tobacco product is deemed, FDA may put in place “restrictions on the sale and distribution of a tobacco product,” including age-related access restrictions and advertising and promotion restrictions, if FDA determines the restrictions are appropriate for the protection of the public health. The proposed rule has two purposes: (1) To deem products that meet the definition of “tobacco product” under the law except accessories of a proposed deemed tobacco product and subject them to the tobacco control authorities in the FD&C Act and (2) to apply specific provisions that are appropriate for the protection of the public health to deemed tobacco products. To satisfy these purposes, FDA is proposing two options (Option 1 and Option 2), which would provide two alternatives for the scope of the deeming provisions and, consequently, the application of the additional specific provisions.

Back to me

so the key here is how they define a finished tobacco product, and how are APV and related parts fit in.
the data they have at the moment is way out dated and they want more data on what a E-cig is and what not.
which is what the deeming seeks. yes they mention Carts but also include future items
 
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tombaker

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You obviously have no clue about pipe smoking. Peterson Pipes are known for being tough to break in because they get the stain in the bowl. It is burned and put into your body. The wood is charred and put into your body.

Why do you never answer? Why are you trying to make people complacent when that complacency will allow the things to be regulated?

The FDA has clearly said they consider the whole ecig to be a tobacco product. It doesn't have to make sense.
The Deeming Regulations do not effect Tobacco Pipes any differently than they stand now. If you want to show me where the FDA regulates Tobacco Pipes now, or where in the Deeming they do so, yes, I would be surprised. (Something that is not under-18)

I am suggesting that people comment, and comment often. I am not suggesting they have some things in their comments or other thing not. You fears of complacency are yours. You may also like to say just exactly what the testing and approval protocol would be for a Clearomizer?
 

tombaker

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here is your flaw from your OP
"The FDA states it can regulate Components or Parts of intended or expected to be used as part of a Finished Tobacco Product"

we agree the E-liquid is what is vaped and thereby makes adding that to any device ,tank,carto,rda or otherwise a complete and finished 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.

Now from the deeming it's self

FDA considers accessories of proposed deemed products to be those items that are not included as part of a finished tobacco product or intended or expected to be used by consumers in the consumption of a tobacco product

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 e-cigarettes. 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. For example, FDA envisions that there could be tobacco products developed in the future that provide nicotine delivery (e.g., via dermal or buccal absorption), similar to currently marketed medicinal nicotine products, but which are not marketed for therapeutic purposes. Such products would be “tobacco products” and subject to FDA's chapter IX authorities should the deeming rule be finalized.

in addition, FDA realizes that there are distinctions in the hazards presented by various nicotine-delivering products. Some have advanced views that certain new tobacco products that are noncombustible (such as e-cigarettes) may be less hazardous than combustible products given the carcinogens in smoke and the dangers of secondhand smoke from combustible products. Accordingly, FDA is seeking comment in this proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products. We welcome comment on how to implement the provisions in the FD&C Act with respect to e-cigarettes. We also welcome any health and behavioral data about the effects of using e-cigarettes.

once a tobacco product is deemed, FDA may put in place “restrictions on the sale and distribution of a tobacco product,” including age-related access restrictions and advertising and promotion restrictions, if FDA determines the restrictions are appropriate for the protection of the public health. The proposed rule has two purposes: (1) To deem products that meet the definition of “tobacco product” under the law except accessories of a proposed deemed tobacco product and subject them to the tobacco control authorities in the FD&C Act and (2) to apply specific provisions that are appropriate for the protection of the public health to deemed tobacco products. To satisfy these purposes, FDA is proposing two options (Option 1 and Option 2), which would provide two alternatives for the scope of the deeming provisions and, consequently, the application of the additional specific provisions.

Back to me

so the key here is how they define a finished tobacco product, and how are APV and related parts fit in.
the data they have at the moment is way out dated and they want more data on what a E-cig is and what not.
which is what the deeming seeks. yes they mention Carts but also include future items

Finished product means a product which has been completely manufactured, packaged, and labeled.

Is a Provari a finished product. YES
Does it contain Nicotine NO
Is it a Tobacco Product NO

A Provari is not designed to be used with a Tobacco Product. The FDA clearly says they are not aware of any products without Nicotine that are Tobacco Products.

A Provari is simply designed to give a regulated DC power source through a 510 connection. Thats all. It has multiple usages including LED bulbs to make it a Flashlight via the 510. The 510 does give access to a host of atomizers, and tanks.

A tank, can be used to vape any number of substances, Zero-Nic, raw water, anything. Its has no single specified intent. Kanger describes its products with specifications, and that is about it. I have seen no sites talking about Nicotine extraction capabilities.

Pipes, are not regulated by the FDA, they don't need testing, and there are no plans for this. Perhaps I consider a Mega-Aero Tank as artwork, I want to put it on my shelf and admire it. Free speech, its a lovely expression of design. Can they stop artwork?

Lets go worse case, how would the regulation guide or effect a Clearomizer. Test the kanthal? That is about the closest you can do.....I believe that Kanthal will have a MSDS, and the work is done. How would the FDA determine the safety of a Provari?

They can not, they won't, they aren't. APV hardware is out of scope of the FDA
 
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Myk

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The FDA doesn't presently regulate pipes or pipe tobacco. That is one thing the proposal is about. By what they say they may include pipes which means each and every pipe is unique. Do you see any mention of excluding unique pipes like excluding unique expensive cigars?

"distributed for consumer use OR further manufacturing"
Stop ignoring stuff you don't want others to know about.
A mod is sold so the consumer can further manufacture the ecig by screwing an atty on top.
 

tombaker

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The FDA doesn't presently regulate pipes or pipe tobacco. That is one thing the proposal is about. By what they say they may include pipes which means each and every pipe is unique. Do you see any mention of excluding unique pipes like excluding unique expensive cigars?

"distributed for consumer use OR further manufacturing"
Stop ignoring stuff you don't want others to know about.
A mod is sold so the consumer can further manufacture the ecig by screwing an atty on top.
Look Myk, how about you grow up, you can read, and please at least read the OP. I am not ignoring stuff, that relates to E-Cigs. As you say, and hopefully understand. The FDA does not regulate Pipes. The Deeming proposal does not either. And if they tried they would have a real hard time, because the Pipe is not part of the inhalation that goes into the lungs.

You have a hard time grasping that FDA is having a hard time with doing anything with little cigarette sized cigars, actual Cigarettes, and E-Cigs. For you think they are going to spend any resources on regulating Tobacco pipes is infantile reasoning. If that was the case, every Smoke shop would have to take their products out of their stores.

Look at you quote in bold above.......you just ignore what the OP says. "FDA does not at this time intend to enforce the requirements of 910 and 905(j) for components of regulated tobacco products that are sold or distributed solely for further manufacturing into finished tobacco products." They won't even regulate the Kanger parts that V2 uses in their Kits. Again notice the finished Products clarification in the actual FDA language.

Kanger is selling parts that can be used for any number of things, many of which are not Tobacco Products, and will never be, under the law. The FDA tried to regulate the hardware, they lost. The effects of the Sottera case remain.
 

Myk

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You keep on ignoring that the FDA doesn't regulate pipes YET and that is part of what this proposal does.

Convenient that's what you always do. Ignore what you don't want to hear and keep on repeating what suits you to be the worst for ecigs.

I have listened to every conference and haven't heard them say they don't plan on doing what you say. I do recall them hinting very strongly that even 0mg liquid would be covered. I do recall them clearly stating that even mods with no nicotine would be covered. All because their intended use was for an ecig.
And it really doesn't matter what they say. What matters is what the proposal says.
I know the last conference was pretty much them saying, "Gee, we don't know...." the whole time.
 

tombaker

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You keep on ignoring that the FDA doesn't regulate pipes YET and that is part of what this proposal does.

Convenient that's what you always do. Ignore what you don't want to hear and keep on repeating what suits you to be the worst for ecigs.

I have listened to every conference and haven't heard them say they don't plan on doing what you say. I do recall them hinting very strongly that even 0mg liquid would be covered. I do recall them clearly stating that even mods with no nicotine would be covered. All because their intended use was for an ecig.
And it really doesn't matter what they say. What matters is what the proposal says.
I know the last conference was pretty much them saying, "Gee, we don't know...." the whole time.
1. The FDA does not regulate tobacco pipes, and they are not proposing to do so. For reasons I have explained above, its simply not an effiecent use of their time, and they would not win if they tried. But go ahead, what is the language you think make it so obvious they will be regulating pipes that can be used for all sorts of legal items, not related to Tobacco.
2. You have listened to WHICH "every conference" by the FDA. Links would help, with the time stamps.
3. You recall them hinting......okay.....what did they say?
4. You recall them saying MODs with no Nicotine would be covered.....1. I am sure they never said MOD, 2. What did they say. Go ahead and present it. I am not conveniently ignoring what you are saying, I am asking you to go on, do tell.
5. There has been no discussion of the intended usage as an E-Cig, on the Federal level, which is the FDA. There have been some local cities defining Vape as Smoke. That is an entirely different discussion, I started the thread specific to the FDA.
6. Yes it does matter what the proposal says, this is why I have quoted it above, and why others have as well. I know you are fixated on the "intended" word, but you are ignoring over and over the rest of the sentence. They are talking about Tobacco Products, they are talking finished Tobacco Products, or cartridges sold independently of a full kit, but they still contain E-Liquid.
 

lordmage

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Finished product means a product which has been completely manufactured, packaged, and labeled.
yes the key phrase is Expected to be used in a Finished product and how are device's will be classified. The nic Is technically a drug, but due to the old court case they can only regulate it as tobacco. using that tobacco requires a device of some kind. the question is whether or not the FDA will deem flavored liquid without nic a tobacco product.

the key point i point out and you missed or ignored was The current FDA knowledge is outdated and the deeming seeks more updated and newer information.

what i will add is the deeming will reduce what can be made and marketed as an E-cigarette either thur application or thru a Equivalent ie "cig-alike" those two things will force new devices to either be a cigalike or apply for FDA market approval.

to quote the FDA

Which means a lot of currently available items and newer items may not be on the market

"According to the Food, Drug & Cosmetic Act, a new tobacco product is any product that was not commercially marketed in the United States as of February 15, 2007. This includes tobacco products that were modified and marketed after February 15, 2007. (see Section 910(a)(1)."

New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product meets the following criteria:

  1. It was commercially marketed after February 15, 2007 but before March 22, 2011; and
  2. A Substantial Equivalence Report was submitted by March 22, 2011,
then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product.

What is a substantially equivalent tobacco product?

A substantially equivalent tobacco product has been found by FDA to either have the same characteristics as a predicate tobacco product, or has different characteristics, but does not raise different questions of public health. If the new product raises different questions of public health, the product is not substantially equivalent.

What is a predicate tobacco product?

  1. A predicate tobacco product is one that was commercially marketed (other than in a test market) as of February 15, 2007, or
  2. A product previously found to be substantially equivalent by the FDA and in compliance with the requirements of the FD&C Act.


How does substantial equivalence work?

For FDA to determine that a new tobacco product is substantially equivalent to a predicate product, you must submit a Substantial Equivalence Report.

FDA reviews these reports to determine if the new tobacco product is substantially equivalent and is in compliance with the requirements of the law. If both of these criteria are met, FDA will issue a written order permitting the product to be legally marketed in the United States.

You cannot legally market a new tobacco product if you receive an FDA order stating that the product is not substantially equivalent.



Could I ever sell my new tobacco product without receiving an order from FDA?

To answer this question, determine the following:

  • Was your new tobacco product first commercially marketed between February 15, 2007, and March 22, 2011; and
  • Did you submit a Substantial Equivalence Report to FDA by March 22, 2011?
Yes: If you answered “yes” to both questions, you may market your tobacco product, unless FDA issues an order that your product is not substantially equivalent. If FDA makes this determination, your product must be withdrawn from the market.

No: If you answered “no” to either question, then your new tobacco product may not be marketed without an order from FDA based on either a Substantial Equivalence Report or a Premarket Tobacco Application. There is one other option: You may request an exemption from demonstrating substantial equivalence under 21 CFR 1107.1 and Section 905(j)(3).

Draft Guidance
FDA has published Draft Guidance for Industry about substantial equivalence and the public may provide comments on the document. When this guidance is finalized, it will represent FDA’s current thinking on this topic.


 

tombaker

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yes the key phrase is Expected to be used in a Finished product and how are device's will be classified. The nic Is technically a drug, but due to the old court case they can only regulate it as tobacco. using that tobacco requires a device of some kind. the question is whether or not the FDA will deem flavored liquid without nic a tobacco product.

the key point i point out and you missed or ignored was The current FDA knowledge is outdated and the deeming seeks more updated and newer information.

what i will add is the deeming will reduce what can be made and marketed as an E-cigarette either thur application or thru a Equivalent ie "cig-alike" those two things will force new devices to either be a cigalike or apply for FDA market approval.

to quote the FDA

Which means a lot of currently available items and newer items may not be on the market

"According to the Food, Drug & Cosmetic Act, a new tobacco product is any product that was not commercially marketed in the United States as of February 15, 2007. This includes tobacco products that were modified and marketed after February 15, 2007. (see Section 910(a)(1)."

New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product meets the following criteria:




    • It was commercially marketed after February 15, 2007 but before March 22, 2011; and
    • A Substantial Equivalence Report was submitted by March 22, 2011,
then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product.

What is a substantially equivalent tobacco product?

A substantially equivalent tobacco product has been found by FDA to either have the same characteristics as a predicate tobacco product, or has different characteristics, but does not raise different questions of public health. If the new product raises different questions of public health, the product is not substantially equivalent.

What is a predicate tobacco product?




    • A predicate tobacco product is one that was commercially marketed (other than in a test market) as of February 15, 2007, or
    • A product previously found to be substantially equivalent by the FDA and in compliance with the requirements of the FD&C Act.

How does substantial equivalence work?

For FDA to determine that a new tobacco product is substantially equivalent to a predicate product, you must submit a Substantial Equivalence Report.

FDA reviews these reports to determine if the new tobacco product is substantially equivalent and is in compliance with the requirements of the law. If both of these criteria are met, FDA will issue a written order permitting the product to be legally marketed in the United States.

You cannot legally market a new tobacco product if you receive an FDA order stating that the product is not substantially equivalent.



Could I ever sell my new tobacco product without receiving an order from FDA?

To answer this question, determine the following:




    • Was your new tobacco product first commercially marketed between February 15, 2007, and March 22, 2011; and
    • Did you submit a Substantial Equivalence Report to FDA by March 22, 2011?
Yes: If you answered “yes” to both questions, you may market your tobacco product, unless FDA issues an order that your product is not substantially equivalent. If FDA makes this determination, your product must be withdrawn from the market.

No: If you answered “no” to either question, then your new tobacco product may not be marketed without an order from FDA based on either a Substantial Equivalence Report or a Premarket Tobacco Application. There is one other option: You may request an exemption from demonstrating substantial equivalence under 21 CFR 1107.1 and Section 905(j)(3).

Draft Guidance
FDA has published Draft Guidance for Industry about substantial equivalence and the public may provide comments on the document. When this guidance is finalized, it will represent FDA’s current thinking on this topic.


I comprehend all of that. And while the Ruyan E-Cig was out near the same time in 2007, many/most think that it will still not be able to be used as Predicate Product. So all E-Cig everything will need to go through some form of approval, most likely all will need to go through Pre-Market approval, or be equivilant to a market approved E-Cig that has gone through the new approval process. Those are finished Tobacco Products.

The old court case you refer to did not actually say the FDA could appropriately use the Tobacco Control Act of 2009, they suggested that because E-Cigs were not medical devices, they would have to try regulating it under a different Law, citing the TCA of 2009. There can still be legal challenges that Nicotine is a drug, or a molecule, that is not Tobacco. Whether or not that challenge will come in, is unknown. Or whether or not its even worth the effort to try. But no court has said the 2009 Act is valid for nicotine, its just the FDA is running with it, after they lost on the Sottera appeals.

You are acting as if because a bolt is used in a finished product, it can be regulated as the finished product. A battery is a bolt in this example. Some people think that Efest 18650s are going to be regulated.

Intended to be used in a finished product, is the prefilled Cartomizers. That is the example they used.

  • A Provari is an entirely finished product. How can the FDA regulate that? Please explain. What would be the testing criteria. What would be the paperwork burden. What FDA warnings. I think after they tell people not to eat the Provari, that will be pretty much it.
  • Same thing for a Protank or any atomizer. How would the FDA regulate it? Please explain.

The Deeming already addresses the old citations that you list. What the Deeming says is that after the Final Rule is published (some think that is 1.5 years away from today) the items to be regulated by the rule, will have 24 months to file the paperwork for approvals. ALL that time 3.5+ years they will be able to legally sell the products in the USA. Then after that, the FDA has said, that they will have to dispostion the applications before they remove products. There are 3500 tobacco products that have been being sold for last 3 years on the market, that are still waiting to hear from the FDA. Put all those reasonable cases together and its 6.5 years of products being sold. Take it down to the conservative level and its 3.5.

Last on your concern about flavorings. The current law says that Flavorings apply only and specifically to Analog Cigarettes. They ask for comments on this, but they simple can not get around the text of the law. They will need an new law to stamp out flavorings. You will hear legal challenges if they try, with words like, "what the intent of Congress was when they passed the law"

We can talk about all the Deeming stuff unrelated to Hardware on a different thread.
For this thread. It remains.
APV hardware like Provari, AeroTanks, RBA, Tube Mods, are all OUTSIDE of the scope of the FDA, they can not ban them, they can not regulate them, they remain Not a Medical Device.
I am not saying there are not other issues, I am saying that these items, when sold as finished products, without Nicotine in them, are not controlled by the FDA.

Listen to the Conference call on the OP, the FDA explains it to the Caller, the caller remains confused, Zeller explains it again, saying you have to read it. Each time he is repeating FINISHED TOBACCO PRODUCT. It needs to be a Tobacco Product. A Provari has not Tobacco. NONE. And it gets used for all sorts of things without any Nicotine. The FDA is just not going to fight this fight, that will never win.
 

Myk

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1. We can hope that is not what they want to do. But that is exactly what the proposal says they can do. Not only that but it's what the law says they have to do (you also need to read the law).
"(1)The term tobacco product means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)." https://www.govtrack.us/congress/bills/111/hr1256/text

2. "Every" is pretty clearly defined. I missed a few minutes of the latest one but what I caught was them not knowing anything so that one was worthless. You're asking me to provide a quote of them not saying something???
OK, here... "____________________________________________________", didn't say Mitch Zeller, time stamp _______

3. I don't have the transcripts. That would've been the first conference post proposal that you posted above. Conley's question and Zeller's answer. That one answer says it all.

4. You're right, they didn't say, "mod". See above

5. See above

6. Zeller was pretty clear that the products don't need to actually contain nicotine. Yes it's circular logic, that an ecig is a tobacco product because it's intended to be used with nicotine, nicotine is a tobacco product, therefore anything used in an ecig qualifies as a tobacco product.
It's also circular log that non-tobacco nicotine isn't a tobacco product yet a product that doesn't contain nicotine is if it's intended to be used with a tobacco product, which turns that non-tobacco nicotine into a tobacco product if it's for an ecig.

What I don't get about you is Zeller says it and then says they want input on those issues with ecigs. You seem to want to ignore that those issues exist when even Zeller says they do.
I've said it ever since I read the proposal, they seem to be completely clueless about what modern ecigs are. They seem to think everything is a disposable cig-a-like. You seem to take that as meaning their proposal only applies to cig-a-likes, the problem is laws don't work like that. The law saying every part means every part and that means every separate part intended for an ecig needs approval whether or not it is sold with nicotine.
That is exactly why people need to comment with that in mind, to keep it from going that far, to get them to not include batteries, tubes, wick and wire or atty's as something that needs approval (although it would be good if they would have GMP guidelines for those things).

Could they decide not to include those things? I think so. I think the odds of them not including those are much better if we bring those issues up.

The FDA doesn't care about fighting what they can't win. They use tax payer money not their own. They plan on fighting stuff they can't win.

Just because they say something doesn't mean that is what actually is. They also claim there won't be a ban on internet sales. Just like technically there's not a ban on internet sales of cigarettes, yet to actually do internet sales of cigarettes is such a hassle and cost prohibitive nobody does it.
 

tombaker

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Myk says:
1. We can hope that is not what they want to do. But that is exactly what the proposal says they can do. Not only that but it's what the law says they have to do (you also need to read the law).
"(1)The term tobacco product means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)." https://www.govtrack.us/congress/bills/111/hr1256/text
Yes that is what the law says, the Deeming Clarifies how the FDA is considering things as it applies to E-Cigarettes, most of the OP it talking about the Deeming. I don't stand on this only, but what you see above is a clear exception to raw materials used in components etc. A RBA is stainless steel, or other metal, and some silicone O-Rings. Its nothing but raw materials, which are exempted. A battery is nothing but raw materials, and its not in anyway a tobacco product. More raw materials, wire, circuit boards, metal springs, Make a Provari. Its all raw materials, and its all not containing Tobacco, and its applications are well beyond anything with Tobacco. An AeroTank adds in Pyrex. APV hardware without Nicotine is outside the domain of the law.

2. "Every" is pretty clearly defined. I missed a few minutes of the latest one but what I caught was them not knowing anything so that one was worthless. You're asking me to provide a quote of them not saying something???
OK, here... "____________________________________________________", didn't say Mitch Zeller, time stamp _______​
You said you listened and found things, such as them saying MODs would clearly be included. I asked where and what. Your answer is you now don't know. You can go back to what you said----->" I do recall them clearly stating that even mods with no nicotine would be covered. All because their intended use was for an ecig."<-------Myk, YOU said that. I asked you to show this clarity you heard. Not able?

3. I don't have the transcripts. That would've been the first conference post proposal that you posted above. Conley's question and Zeller's answer. That one answer says it all.​
I think you did not listen to it, what is the clarity you are talking about. Or just skip it. You skipped it.

4. You're right, they didn't say, "mod". See above​
You had said: " I do recall them clearly stating that even mods with no nicotine would be covered." Now its not that, when asked for what they did say, you don't know it now, and can not show it.

5. See above

6. Zeller was pretty clear that the products don't need to actually contain nicotine. Yes it's circular logic, that an ecig is a tobacco product because it's intended to be used with nicotine, nicotine is a tobacco product, therefore anything used in an ecig qualifies as a tobacco product.
It's also circular log that non-tobacco nicotine isn't a tobacco product yet a product that doesn't contain nicotine is if it's intended to be used with a tobacco product, which turns that non-tobacco nicotine into a tobacco product if it's for an ecig.​
Yup, you are using circular logic, based off reading things the wrong way. Zeller in the link I provided said, that Nicotine, not derived from Tobacco is not under the scope of the law. Lots of threads talking about Eggplant after he said that. You fears skew you reading of things. I am not going to keep responding to your fears.

What I don't get about you is Zeller says it and then says they want input on those issues with ecigs. You seem to want to ignore that those issues exist when even Zeller says they do.​
Zeller wants input for things that are outside of the law, that would need a new law, so he can tell Congress if they want to do X, they have to pass a new law. I am talking about what the current law can do. If some comes up with a law that will ban a Copper RBA, you will hear about it when its proposed. I can only deal with the current law, as it applies to APV hardware.

I've said it ever since I read the proposal, they seem to be completely clueless about what modern ecigs are. They seem to think everything is a disposable cig-a-like. You seem to take that as meaning their proposal only applies to cig-a-likes, the problem is laws don't work like that. The law saying every part means every part and that means every separate part intended for an ecig needs approval whether or not it is sold with nicotine.​
You know that FDA can regulate hardware, when its a medical devices, otherwise no. UNLESS it contains nicotine, as SOLD, in a Finished Product. You have an infant smoking a cigar mentality, that EVERY means EVERY, so that means, the Stainless Steel Drip tip is gonna need FDA approval. That is the level. And a Stainless drip tip is nothing but Raw material. See the law.

That is exactly why people need to comment with that in mind, to keep it from going that far, to get them to not include batteries, tubes, wick and wire or atty's as something that needs approval (although it would be good if they would have GMP guidelines for those things).​
Comment, Comment often, Comment on everything you want, Go to www.freetovape.org to do it, go to www.regulations.gov to do it, wait for CASAA at the end of this week to tell you what they want said......you can comment as often as you want....do it.....do it on hardware.

Could they decide not to include those things? I think so. I think the odds of them not including those are much better if we bring those issues up.​
You CYA your self up. I guess when they can not regulate a 18650 you will have provided for that now.

The FDA doesn't care about fighting what they can't win. They use tax payer money not their own. They plan on fighting stuff they can't win.​
After the last legal failure, and failure on appeal. The FDA has spent the last 4 years doing nothing, so you are wrong, they just don't want to be stuck with temporary injunctions, and lose cases.

Just because they say something doesn't mean that is what actually is. They also claim there won't be a ban on internet sales. Just like technically there's not a ban on internet sales of cigarettes, yet to actually do internet sales of cigarettes is such a hassle and cost prohibitive nobody does it.​
This is just stupid, again. The FDA does not regulate Internet Sales today. There has never been a huge market of Internet Sales of Tobacco, it never was a big thing. Some Indian Tribes do it. What happened is that States getting taxes from Cigarettes, moved in to make Internet sales just as taxed as local sales......so guess what, people buy locally.

Things in laws and contracts are tossed out by the courts all the time, the rest of the law remains, you want to think the FDA can control battery sales, or stainless steel objects, its fantasy, a stoner's paranoia type. The FDA will regulate E-Liquid, this is the concern, and it should be, because without E-Liquid there is no vaping. And equally important is what Cities can do, they can ban the sales of Alcohol inside of a city and county, and all that is able to be done with E-Cigs regardless of the FDA.
 

VapingHippie

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So if they go after the ejuice, them it would pay to get into making the ejuice. You can buy the ingredients by themselves as food products, except the nicotine base. But who is to say that the nicotine base is going to be used for vaping? Nicotine is also used in veterinary to put down cats and dogs. Also it is used in agriculture as a natural pesticide.
Just another way of looking at things.
Yes it is still regulated by the FDA, but it's access to the consumer is a bit more relaxed, especially if bought under the natural pesticide angle. Also they would not be too concerned if it is mixed in a VG based liquid.

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kelli

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So if they go after the ejuice, them it would pay to get into making the ejuice. You can buy the ingredients by themselves as food products, except the nicotine base. But who is to say that the nicotine base is going to be used for vaping? Nicotine is also used in veterinary to put down cats and dogs. Also it is used in agriculture as a natural pesticide.
Just another way of looking at things.
Yes it is still regulated by the FDA, but it's access to the consumer is a bit more relaxed, especially if bought under the natural pesticide angle. Also they would not be too concerned if it is mixed in a VGA based liquid.

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^which is exactly why i am stockpiling 100 mg nic juice in my freezer. i buy 100 ml every other month or so. the other stuff will always be available no matter what.
 

VapingHippie

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^which is exactly why i am stockpiling 100 mg nic juice in my freezer. i buy 100 ml every other month or so. the other stuff will always be available no matter what.
Even so, who is to say what that nicotine base is going to be used for?
There are many applications that it is used for other than vaping and smoking. Although regulated, those regulations are more relaxed.

Wizard labs, here I come.

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Artisan Vaping

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While I would hope that you are correct, Tom, about the regulation of hardware, I have my doubts.

My main concern is that one of the research programs the FDA is funding is "Looking at facebook posts to see how users MODify e-cigs to increase their nicotine output"

Why would the FDA be spending money on this unless they have their sights set on regulating hardware???
 

Smoky Blue

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because we put a hurting on the big tobacco and big pharma mafia and they are coming for their death money..:oops:
 

Smoky Blue

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that was the "start" not the cause.. they want their money and they will try their damnest to get it..
when you are used to getting funds from one source, and they dry up.. in order to keep going, you look for another revenue. ..
you can only rob Peter to pay Paul so many time tho.. :D
 

lordmage

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there is one thing with internet sales and tobacco products that we all have to remember and that is the PACT act which bans the shipping of Tobacco products.

On March 31, 2010, President Obama signed into law the Prevent All Cigarette Trafficking Act of 2009 (PACT Act). The law goes into effect on June 29, 2010.

Which has stopped all importing of Cigarettes and Tobacco products some might slip by but not much.

E-cigs defined as a tobacco product which this deeming does seek among others all they then need to do is Amend the PACT act to included tobacco products and no more fasttech.

Yes the FDA does need congress to write and pass a Law for them to be able to enforce. This Deeming is the first step in that process. in addition to each state Setting there own. in my case it is already in the clean indoor air act.

Step one seek information and comments
step two redefine and rewrite a new deeming if needed which of course would get them further comments and information if done
step three congress Lawmaking if so needed to fill the gaps.
 
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Artisan Vaping

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there is one thing with internet sales and tobacco products that we all have to remember and that is the PACT act which bans the shipping of Tobacco products.

On March 31, 2010, President Obama signed into law the Prevent All Cigarette Trafficking Act of 2009 (PACT Act). The law goes into effect on June 29, 2010.

Which has stopped all importing of Cigarettes and Tobacco products some might slip by but not much.

E-cigs defined as a tobacco product which this deeming does seek among others all they then need to do is Amend the PACT act to included tobacco products and no more fasttech.

Yes the FDA does need congress to write and pass a Law for them to be able to enforce. This Deeming is the first step in that process. in addition to each state Setting there own. in my case it is already in the clean indoor air act.

Step one seek information and comments
step two redefine and rewrite a new deeming if needed which of course would get them further comments and information if done
step three congress Lawmaking if so needed to fill the gaps.


That is a very interesting point, I was not aware of the PACT act.

And really what I meant by invoking the MSA is that the surest way to get a politician to work against you is to take money out of their budget, which E-cigs do on several levels.
 

Smoky Blue

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there is one thing with internet sales and tobacco products that we all have to remember and that is the PACT act which bans the shipping of Tobacco products.

On March 31, 2010, President Obama signed into law the Prevent All Cigarette Trafficking Act of 2009 (PACT Act). The law goes into effect on June 29, 2010.

Which has stopped all importing of Cigarettes and Tobacco products some might slip by but not much.

E-cigs defined as a tobacco product which this deeming does seek among others all they then need to do is Amend the PACT act to included tobacco products and no more fasttech.

Yes the FDA does need congress to write and pass a Law for them to be able to enforce. This Deeming is the first step in that process. in addition to each state Setting there own. in my case it is already in the clean indoor air act.

Step one seek information and comments
step two redefine and rewrite a new deeming if needed which of course would get them further comments and information if done
step three congress Lawmaking if so needed to fill the gaps.


Lordmage.. what do you think they will do next? - curious..:(
 

lordmage

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Lordmage.. what do you think they will do next? - curious..:(
i would surmise that the deeming will not be changed and simply put thur and a latter new deeming will come out to add ,flavors and zero nic since the current one hints at it. once they parse the huge amount of data they will receive they may even classify the hardware differently especially if the new deeming goes after flavors then it can be said that all parts are expected to be used in a finished product

the question being is how they decided the PACT will play with Tobacco products
 

Smoky Blue

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i would surmise that the deeming will not be changed and simply put thur and a latter new deeming will come out to add ,flavors and zero nic since the current one hints at it. once they parse the huge amount of data they will receive they may even classify the hardware differently especially if the new deeming goes after flavors then it can be said that all parts are expected to be used in a finished product

the question being is how they decided the PACT will play with Tobacco products

On the zero nic, what do you think might happen? seeing that it has zero tobacco/nicotine usage..
 

lordmage

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On the zero nic, what do you think might happen? seeing that it has zero tobacco/nicotine usage..
if they go after flavored liquid, outside of menthol and tobacco's that could affect Zero nic in some way. but merely going for flavored liquid would allow them to expect all parts of hardware to be part of a finished product. only time will tell what they choose to do.
 

Myk

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Myk says:
1. We can hope that is not what they want to do. But that is exactly what the proposal says they can do. Not only that but it's what the law says they have to do (you also need to read the law).
"(1)The term tobacco product means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)." https://www.govtrack.us/congress/bills/111/hr1256/text
Yes that is what the law says, the Deeming Clarifies how the FDA is considering things as it applies to E-Cigarettes, most of the OP it talking about the Deeming. I don't stand on this only, but what you see above is a clear exception to raw materials used in components etc. A RBA is stainless steel, or other metal, and some silicone O-Rings. Its nothing but raw materials, which are exempted. A battery is nothing but raw materials, and its not in anyway a tobacco product. More raw materials, wire, circuit boards, metal springs, Make a Provari. Its all raw materials, and its all not containing Tobacco, and its applications are well beyond anything with Tobacco. An AeroTank adds in Pyrex. APV hardware without Nicotine is outside the domain of the law.


You can't talk about the proposal without looking at the law. Perhaps that is why you don't understand what is going on.
Raw materials aren't a finished RDA. Raw materials is the steel to make the RDA.
They don't consider rice to be a tobacco product because rice is used to make rolling papers.
But once that rice is made into rolling papers it becomes a tobacco product.

No, you asked me to quote someone NOT saying something.
"I have listened to every conference and haven't heard them say they don't plan on doing what you say."
To which you wanted me to quote them not saying something.
Cheap debate tactic to claim someone said they didn't know and fudging with the quote when it's you who doesn't know.

I think you don't listen to the reply to Conley. Or you did and for some reason you don't want others to know what was said.

I explained their circular logic. Again you don't want to hear it because replying to that faulty logic of the FDA might actually be a good thing for ecigs while ignoring it would be very bad.
So again I ask, what is the harm is commenting to the FDA about what the ramifications of their proposal might be?
If they don't want to do those things such comments may get them to change the wording. If they do want to do those things such comments might change their mind. Saying nothing about them makes it a sure thing they will go ahead with those things that would destroy ecigs.

Do you really believe the FDA would allow non-tobacco nicotine to slide? That was a disingenuous statement. He knows it would still be a tobacco product because of the relationship to other tobacco products, he knows vegetables don't contain enough nicotine for such a thing to be possible, or if someone came up with a synthetic it would be regulated as a drug.

You said you aren't talking about the law, you're talking about the proposal. Actually Zeller is pretending they can't change the law. Zeller can ban a copper RBA without a law. Let's go with lead instead, he doesn't need Congress to pass a law to make a GMP that says no lead can be used in contact with liquid.

Containing nicotine has nothing to do with "medical device". That comes down to the claims made about the product.

You know I'm right in all of this and that's why you try to divert attention to my avatar.

Actually there was a big market for internet sales of tobacco. To address that law you would have to look at PACT. https://www.govtrack.us/congress/bills/111/s1147/text
"Smokeless tobacco

The term smokeless tobacco means any finely cut, ground, powdered, or leaf tobacco, or other product containing tobacco, that is intended to be placed in the oral or nasal cavity or otherwise consumed without being combusted."

You're right, the FDA won't ban internet sales. In fact Congress hasn't banned internet sales. It's just going to cost you a ton in shipping and be a huge hassle for everyone involved so that nobody will sell ecigs or liquid over the internet. Deliveries to stores will be handled by the local tobacco distributor (I'm guessing this is the reason for Johnson Creek teaming up with the rolling paper company, so they will have a distribution network in place).
I can no longer buy nasal snuff from the place I used to get it from because of PACT.
 

tombaker

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snipped a bunch of garbage about me knowing I am wrong, that I have some sort of nefarious plan of caused by reading the Law.
1. I am going to disregard all you trash talking based in logical fallacies.
2. In a Copper RDA its entirely raw material. Your theory if it was made out of lead, it would be a problem, is worthless.
2. I am not talking about what is burnt up and inhaled, as your Rolling papers example is. I am talking only about hardware.
3. I have told you to comment, and I have gone on VaperPlace multiple times to ask people to comment, and I have told you multiple times here also. Comment, comment on hardware if you like. I am talking about what the FDA can do, NOT what you should do.
4. I question the wisdom of any person such as yourself, that would take a baby, put a lit cigar in their mouth, and gets off on it thinking its funny, and shares the image with everyone when the post. Its fodder to the anti-E-cig groups. You won't change opinion of this, so get over it. I am not telling you what to do here.
5. You said "I have listened to every conference and haven't heard them say they don't plan on doing what you say." So what is the point of saying that? I point out to your are being meaningless, and pretending to have something to say. So just tell me what the point of your statement is, instead of the protestations. Good to know you have been listening to every conference.....how about some links for all those.
6. I am talking about the Law, and what the Deeming and explanation of what the law will do with regard to APV hardware. Nicotine, and the rest of it, are for a different thread. Go ahead and start that thread.
7. You said "Zeller can ban a copper RBA without a law." Just how is that? Idiot.
8. You said "You're right, the FDA won't ban internet sales." Yah and so what, it has nothing to do with hardware, I said it explaining to you that the FDA has certain abilities under the law, and when it comes to APV hardware, they say and its clear they can not control them under the law.
9. If Congress makes new laws, that is different. Right now the FDA has this law, and it was a law created without E-Cigarettes in mind, when written, and its a law that can not ban forms of Tobacco, or ban Nicotine. It says that. It also can not ban flavorings in E-Cigarettes. The FDA knows that the courts will reverse any attempt at this.
10. You are a fear based twit who is regurgitating the standard dribble and thinking that because you don't hear something that means they could. Look at the law, and if you want to have a discussion on it. Cite what you got. And stop asking my permission for you and others to comment, Do it already. Hey maybe create a thread of suggested comments, or wait for CASAA to tell you what to do. Maybe they will have some sort of amazing helpful stuff, I certainly hope they do.
11. The FDA can not regulate APV hardware, without E-Liquid being sold in it, or as a complete kit. The FDA can regulate E-Liquid up until a successful court challenge to the Nicotine being defined as Tobacco is ruled upon.
12. I am sure when the FDA gets your comment to not regulate an copper RBA with some silicon 0-rings, as a tobacco product it will have all the worth of your insightful comments in this thread. Next you will be telling us that they are coming to take a protanks glass tube off the market.
 
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tombaker

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i would surmise that the deeming will not be changed and simply put thur and a latter new deeming will come out to add ,flavors and zero nic since the current one hints at it. once they parse the huge amount of data they will receive they may even classify the hardware differently especially if the new deeming goes after flavors then it can be said that all parts are expected to be used in a finished product

the question being is how they decided the PACT will play with Tobacco products
I don't know how you get there. Deeming just puts E-Cigs into the law itself, they are Deemed as a Tobacco Product, whereas previously they have not been. Even that first step can be challenged in the courts. After the Deeming, they don't deem again. The can then regulate under the law. You are talking about regulations under the law, that the law does not allow. Sure Glantz etc wants them to ban flavorings, but they need a different law. To get this law to ban flavorings as written, it won't hold up in court. The FDA knows this, and they are not attempting it. And NJOY who won in the Sottera case, weeks after the Deeming rules....announced their flavors, timing wise, it suggests they know they are in the clear.
 

Roger Schaeffer

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Its been my gut feeling from the beginning without a new law passed by Congress The FDA cannot regulate stand alone [no nicotine] hardware. I do not believe it is within there pervue. I have just today submitted my comment to the FDA.Told my story. Advocated for flavors,restriction to minors and safety caps. A mech is a flashlight tube. am atomizer can be used to vape straight PG. A battery is a battery. This hardware regulation would be a lawyers wet dream IMO
 

lordmage

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maybe i choose the wrong wording there, i was tired when writing it.

in short this deeming will make E-cigs with Nic a tobacco product & Parts expected to be used in a Finished product. even if the end User is the one to Assemble it. the key words for that are "distributed for consumer use OR further manufacturing"

How they determine What form and shape a finished product takes is simple. "Any device designed to Vaporize Liquid containing Nic"

Then all it will take is an amendment to the PACT to include Tobacco products or a new law to stop all importing of Nic liquids "except as part of the manufacturing of a finished product."

Then in order to receive the Nic Liquid in any form you would have to be licensed and registered as a manufacturing plant, or distributer like they treat Traditional Cigarettes.

as far as flavorings they can do a marketing restriction to all E-liquid and only allow traditional and menthol Flavorings to be marketed since those are the flavors the real deal has.
 

Roger Schaeffer

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The lawyers will say it was designed to use non nic liquid. FDA knows they will have one hell of a legal fight on hardware.
 

lordmage

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The lawyers will say it was designed to use non nic liquid. FDA knows they will have one hell of a legal fight on hardware.
that works until they go after flavors as a whole , let alone we forget the "other uses" for are hardware
 

Artisan Vaping

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I personally believe the FDA can and will regulate any part of the E-cig industry that it wants to, including non-nic and hardware. Whether
they do or not depends on the balance between the ANTZ + BP + BT pressure on the one side, and the possibility of legal hassles from the E-cig industry on the other. I absolutely do think they would regulate and/or ban everything if they could. E-cigs are products born of the grass roots with no particular lobbying interests so they have no champion (other than the people and the thousands of small businesses that make and sell them, but no politician gives a fuck about that).

Tom Baker, don't fool yourself into thinking that non-nic juice and hardware will never fall under FDA jurisdictoin. That is a fool's paradise, IMHO. They can regulated them, although if they will depends on the fight facing them.

A lot of groups with a lot of money at stake hate E-cigs. This is never going to go away, it is only going to get worse once the bonds from the MSA start defaulting. These groups can put a lot of pressure on the industry with tons of little state/regional laws, however the big ban hammer would have to come down from the FDA, so they are not going to let go of that.
 

tombaker

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a. How they determine What form and shape a finished product takes is simple. "Any device designed to Vaporize Liquid containing Nic"

b. as far as flavorings they can do a marketing restriction to all E-liquid and only allow traditional and menthol Flavorings to be marketed since those are the flavors the real deal has.

a. The language is not finished product, its finished Tobacco product. If it has no Nicotine from Tobacco, its not a tobacco product. A Provari, is not designed to do anything with Nicotine. Its designed to give a constant current, and be variable to volts. A RBA can be used with all sorts of things, like no nicotine, or even plain water. They are not designed for nicotine, and I have never even heard of anyone saying gosh, my Protank really extracts that nicotine well.

The FDA says: "Nevertheless, all tobacco products containing nicotine are addictive, and FDA is not currently aware of any tobacco products that do not contain nicotine." in the Deeming. The FDA knows what Tobacco Products are, and they say clearly they need Nicotine. APV hardware has multiple applications, and is not designed for Nicotine in all cases.

b. The FDA can not just go an restrict flavors in E-Cigarettes, and they know it. Your statement is entirely wrong. The FDA says they can not, and then asks for comments, the only purpose for the comments, is essentially to give those back to Congress for them to write a new law. They have to have a new law to ban flavors. To do this they would have to change the legal definition of what a Cigarette is, which is different from a Cigar's definition.

From the FDA in Deeming:
The prohibition against characterizing flavors established in the Tobacco Control Act applies to cigarettes only.

FDA requests comments on the characteristics or other factors it should consider in determining whether a particular tobacco product is a "cigarette" as defined in section 900(3) of the FD&C Act

So what is that definition:

(1) The term “cigarette” means—

(A) any roll of tobacco wrapped in paper or in any substance not containing tobacco, and

(B) any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in subparagraph (A).
There is no magic comment that will ever enable them to define an E-Cig as an Analog.​
 

lordmage

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ah and who says that they will not do as you just said. once the deeming is final and E-cigs are a Tobacco product. then a lot of stuff is already in place

yes the FDA requires a law to enforce i am simply going to the extreme the whole give them an inch they take a mile approach.
who is to say how those laws are amended or created to further reduce or control the Market.

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) became law on June 22, 2009. It gives the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health.

mind you a market restriction is exactly that. as i said before.
to quote an old thread at the other place spoken by yvilla on 4-20-2010

snip " I am not stating that TPTB could not amend the PACT Act in the future to cover ecigs/eliquid, if and when ecigs/eliquid do get legally defined as "tobacco products", and if and when TPTB get taxation statutes passed that would cover ecigs/eliquid, but all of that is still years away. "

we are at the "tobacco products" stage.

we all know they wanted to ban all E-cigs back in '07 that failed but who is to say they would not go the route alluded to by "yvilla" it might take some more time but it could happen. plus we have the state laws to fight and contend with in the mean time.

remember in all my replies i state all it takes is an amendment to Current Tobacco Regulation to cover E-cig as an "other" Tobacco Product
 

Myk

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ROFLMAO, logical fallacies from the king.
And then the king calls me an idiot because he's too stupid to understand simple language.
You're not worth reading any more.

Maybe you should try actually reading the laws. Or maybe not since it seems your intent is to do as much harm as possible to vaping and convince people nothing bad will happen.

Deeming ecigs as a tobacco product makes them instantly illegal to ship by USPS and a pain to ship by other means. That is how PACT and FSPTC is written, ecigs and their equipment are a non-combusted tobacco product once deemed.
https://www.usps.com/ship/domestic-tobacco-restrictions.htm

I just hope nobody is dumb enough to listen to you.
 

tombaker

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ROFLMAO, logical fallacies from the king.
And then the king calls me an idiot because he's too stupid to understand simple language.
You're not worth reading any more.

Maybe you should try actually reading the laws. Or maybe not since it seems your intent is to do as much harm as possible to vaping and convince people nothing bad will happen.

Deeming ecigs as a tobacco product makes them instantly illegal to ship by USPS and a pain to ship by other means. That is how PACT and FSPTC is written, ecigs and their equipment are a non-combusted tobacco product once deemed.
https://www.usps.com/ship/domestic-tobacco-restrictions.htm

I just hope nobody is dumb enough to listen to you.
This is why this forum is better than ECF, when I ask your, to back up you claims, you spew out a bunch dribble. Normally you would run off and hide under a skirt, and ask her to ban me. When I read you post on CASAA whining about how you want to protect the children, from ideas, you were oh so surprised when I called you out on it. Then par for the course, you got the Moderators on CASSA to protect you, and got the thread closed. Poor whittle BAAAAABY.

When I called you and idiot because you think that Zeller can ban an all copper RBA, without any law. Do you defend it? Well do you? Nope, you run and hide. On the one thing, that one thing, you don't even try. Show it, explain it, or run away, and say you simply can not support your statements. So bad, you don't even try. Carl Philips is the same way, when pressed, he just scampers away, does not even try to respond.
Did you see what Philips wrote out as the individual responses to the questions posed by the FDA on E-Cigs???????????

On all the items I list here, YOU GOT NOTHING TO SAY http://vapingunderground.com/thread...ardware-detailed-explanation.3743/#post-40917 Nothing....just stupid silence. Because you can not back your shit up. Did you read the OP, how much quoting from the actual law do I need to post for you. Whining I did not read it, when I actually posted it.

Run Coward Run away. Can not back it up, run away. Hide, complain, do everything you can to not admit you don't know squat. AWWW you fear that others may not read what I have written. How many times do I have to tell you to go comment, comment as many times as you want, and do it. Just do it, and tell everyone you know to comment as well. Heck tell them what they already wrote out, that they can not ban Hardware.

  • IS ANYONE BESIDES YOURSELF, CASAA, SFATA, VISTA, AVA, anyone saying the FDA is going to ban or regulate a Provari, or a Protank, or a battery? Link it up, show it. Show me any official communication saying that. Can you do it? Then DO IT.

NOW TO YOUR LASTEST WRONG CLAIM.

You say : "Deeming ecigs as a tobacco product makes them instantly illegal to ship by USPS" because of https://www.usps.com/ship/domestic-tobacco-restrictions.htm

Did you read the first line? Did you READ THE FIRST LINE?
With few exceptions, cigarettes and smokeless tobacco shipments cannot be mailed.

1. Cigarettes are a legal definition, which I already posted on this thread.
2. Smokeless Tobacco is a legal definition.
3. Vaping and all of E-Cigs, are NOT either Cigarettes or Smokeless Tobacco, as defined under law.

Wonder why nobody else besides yourself has made this asinine claim, because if pure BS.

Coward, or admit your wrong, and a lack of reply says it all. And you still can not address all the stuff in the previous posts. Can you?
 

Myk

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No need for me to defend it. It's all there. The need is for you to shoot it down. Instead you decided to name call which says you can't shoot it down. You know what the laws say. The only question left is why you try to put on an air of complacency knowing that has the potential to be as bad as what many say it will be. And I think most people have the correct answer to that in mind.
 

tombaker

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No need for me to defend it. It's all there. The need is for you to shoot it down. Instead you decided to name call which says you can't shoot it down. You know what the laws say. The only question left is why you try to put on an air of complacency knowing that has the potential to be as bad as what many say it will be. And I think most people have the correct answer to that in mind.
1. There are plenty of things to address in the Deeming, it all about E-Liquid, not the hardware. Vape is vape regardless of how its created, which device. The FDA can not regulate the devices. If you are concerned about it, comment about it. Do it.
2. You just made a new assertion that the Deeming will enable another law which will end all internet sales. I showed with one sentence you are wrong. You immediately walked away from you false claim. You know its a false claim, and you again are a coward for not defending it, or why not just saying OOPS I was wrong.
3. IS ANYONE BESIDES YOURSELF, CASAA, SFATA, VISTA, AVA, anyone saying the FDA is going to ban or regulate a Provari, or a Protank, or a battery? Link it up, show it. Show me any official communication saying that.
4. All of these items http://vapingunderground.com/thread...ardware-detailed-explanation.3743/#post-40917 you just run away from. If you could you would, you just run away.
5. "Most people think" sure they do, goto 3.

Sorry if you understood that I am calling you a coward.....I am identifying you as one, as a simply a definition of your actions, I don't know or care who you are. When put tot he test after making your claims, you refuse to back any of it up, you won't take the test, instead you won't even come back to post. When I see that I think...........
 

VapingHippie

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Personally I think tombaker is correct on this issue after reading the. CASAA website.
Just let it go, your making what started out as an informative thread look like a big dick contest.

Sent from the scariest place on earth, my mind.
..
using Tapatalk 2
 

tombaker

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Everyone should comment, Comment at Will, Open fire

Using all the numbers below, subtracting out the estimated Negative comments, it appears that pro Vapers have made less than 2,500 comments so far to the FDA .Multiple comments that are the same are collected and grouped as one. On Regulations.gov you can see some that are done that way already.

Right now the Cigar folks are dominating the FDA commenting. There are 50,091 comments that are accepted and searchable right now. (3400 on Date extensions rejected) Of the 50,091:
  1. 750 comments include the word “vaping”
  2. 386 include “vape” 72 “vaper” 146 “vapers” 505 “vapor”
  3. 1,565 use “e-cigarette” 994 use “e-cigarettes”
  4. 183 “ecig” 212 “ecigs” 395 “e-cig” 528 “e-cigs” 49 “ecigarette” 80 “ecigarettes”
  5. 9 “THR” , 520 “harm”, 34 “CASAA”
  6. 2,041 “quit” “quitting”
  7. To estimate E-Cig stuff, which are Against them…570 use “ENDS” So about ¼ of the comments about E-Cigs are against their usage.
This leaves in excess of 90% of the comments, and its clear where they are.

44,587 of the 50,091 (89%) use the word “Cigars” or “Cigar” None of these are going to be from Vapers.

No need to look at what they are doing…..its down to the wire.
 

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