Deeming Regulations have been released!!!!

[bobwho77]

For example, PMTAs for these
products should contain information on whether the product is likely to be used alone or together
with other legally marketed tobacco products (such as available delivery systems), as well as the
type and range of other products with which it is likely to be used...

In the case of ENDS hardware/apparatus components, FDA expects that it may be
difficult for manufacturers to make the showing necessary to meet the statutory standard, given the great extent of possible variations in combinations of hardware components, if all are
considered and sold separately. Thus, with respect to apparatus, FDA expects that manufacturers
will be most successful where authorization is sought for entire delivery systems, rather than
individual components. In the case of these complete delivery systems--systems for which the
application covers all potential parts, including customizable options as applicable, and where
labeling, instructions for use and/or other measures are used to help ensure use as intended--FDA
expects that the range of possible outcomes may be narrow enough for the manufacturer to
demonstrate, and for FDA to assess, public health impact...

FDA Deeming regulations
Pages 69-70.

Say goodbye to 510 connections.
The only way to get an open tank system approved (if anyone even bothers to try) will be if the system is completely proprietary, and nothing in it will work with any other systems.
The only way this works is with every product currently on the market pulled off of the shelves, and the manufacturers all designing new systems from the ground up.
Apple vs Android... PC vs Mac... VHS vs Betamax... Anybody?
These people are INSANE!

 

[markfm]

The live blogging by Jeff Stier of Zeller's TMA conference presentation is running: Deeming Live blog | vaping.com

 

[Train2]

It's written for BT.
Blu and the like.
They've always wanted a proprietary non-refillable cartridge device. That way you control the consumer, and keep them spending comparably to packs of cigs. And jack the margin on the consumable. They can give away the hardware... They want those former smokers to keep buying their "refills" - $5/day/addict just like before.

The hardware thing is bound to fail, as there's just no way they can enforce it. My little glass sculptures, wooden boxes, dimmer switches...they just can't call it all tobacco...or inspect millions of packages.

But they will end up, somehow, with a chokehold on Nicotine and will replace the cigarette cashflow.
And along the way, they will probably kill vape shops, and if things don't change quickly enough, they will also kill most U.S. mod and juice companies.

For example, PMTAs for these
products should contain information on whether the product is likely to be used alone or together
with other legally marketed tobacco products (such as available delivery systems), as well as the
type and range of other products with which it is likely to be used...

In the case of ENDS hardware/apparatus components, FDA expects that it may be
difficult for manufacturers to make the showing necessary to meet the statutory standard, given the great extent of possible variations in combinations of hardware components, if all are
considered and sold separately. Thus, with respect to apparatus, FDA expects that manufacturers
will be most successful where authorization is sought for entire delivery systems, rather than
individual components. In the case of these complete delivery systems--systems for which the
application covers all potential parts, including customizable options as applicable, and where
labeling, instructions for use and/or other measures are used to help ensure use as intended--FDA
expects that the range of possible outcomes may be narrow enough for the manufacturer to
demonstrate, and for FDA to assess, public health impact...

FDA Deeming regulations
Pages 69-70.

Say goodbye to 510 connections.
The only way to get an open tank system approved (if anyone even bothers to try) will be if the system is completely proprietary, and nothing in it will work with any other systems.
The only way this works is with every product currently on the market pulled off of the shelves, and the manufacturers all designing new systems from the ground up.
Apple vs Android... PC vs Mac... VHS vs Betamax... Anybody?
These people are INSANE!

 

[WhiteHighlights]

For example, PMTAs for these
products should contain information on whether the product is likely to be used alone or together
with other legally marketed tobacco products (such as available delivery systems), as well as the
type and range of other products with which it is likely to be used...

In the case of ENDS hardware/apparatus components, FDA expects that it may be
difficult for manufacturers to make the showing necessary to meet the statutory standard, given the great extent of possible variations in combinations of hardware components, if all are
considered and sold separately. Thus, with respect to apparatus, FDA expects that manufacturers
will be most successful where authorization is sought for entire delivery systems, rather than
individual components. In the case of these complete delivery systems--systems for which the
application covers all potential parts, including customizable options as applicable, and where
labeling, instructions for use and/or other measures are used to help ensure use as intended--FDA
expects that the range of possible outcomes may be narrow enough for the manufacturer to
demonstrate, and for FDA to assess, public health impact...

FDA Deeming regulations
Pages 69-70.

Say goodbye to 510 connections.
The only way to get an open tank system approved (if anyone even bothers to try) will be if the system is completely proprietary, and nothing in it will work with any other systems.
The only way this works is with every product currently on the market pulled off of the shelves, and the manufacturers all designing new systems from the ground up.
Apple vs Android... PC vs Mac... VHS vs Betamax... Anybody?
These people are INSANE!

Note the word "MAY" in the bolded line. Even a closed system isn't likely to make it through because the requirements are rigged - if you pass (a) closed system you will fail (b) public health impact which they've already ignored. I am so angry. Doing what I can while expecting the worst.

 

[Qew]

So, it turns out, resistance is not futile, it's vital.

 

[wiredlove]

Say goodbye to 510 connections.
The only way to get an open tank system approved (if anyone even bothers to try) will be if the system is completely proprietary, and nothing in it will work with any other systems.
The only way this works is with every product currently on the market pulled off of the shelves, and the manufacturers all designing new systems from the ground up.
Apple vs Android... PC vs Mac... VHS vs Betamax... Anybody?
These people are INSANE!

Regardless of whatever happens, we should also remember that information is free. As mentioned before in this thread, cable-tv (SMA) connectors make great connectors for all kinds of things - and 510 connectors are easy enough to replicate at home: M7 x 0.5

Beyond nicotine it's not going to be the basic hardware that's a problem - it could be software for more advanced hardware beyond VV, especially in the realms of TC, which is what should chap everyone's ...., since TC and the likes are making things safer for everyone involved and will be the things that likely won't get approved.

 

[Train2]

Interesting. CASAA just told me I should call the FDA with my questions.
I'm not sure the examples below are what I will ask, but maybe I will call them.
Every time I have a question!
Hello, FDA? Where are my glasses?
Hello? FDA? Can you make me a sandwich?


CASAA has been receiving a high volume of calls and emails from consumers and small businesses regarding how the FDA Deeming regulations will affect them. Fortunately, the FDA has set up a hotline to answer your questions.

Please take a moment today
To reach out to FDA at:
1.877.287.1373
(Operators are standing by to assist you with your FDA Deeming clarification needs.)

Some of the questions that CASAA has received that might be more appropriately answered by FDA include:

• Will I still be able to DIY at home or do I need to register as a tobacco manufacturer?
  
• I have an e-liquid line coming out next week. Will I be able to sell it?
  
• Will kanthal wire and cotton balls now be considered tobacco products?
  
• Will I have to pay to sample e-liquid even it it’s zero nicotine?
  
• Can I sell my device to a friend even if I’m not a shop owner?
  
• Can I give my old equipment to a friend who wants to stop smoking?
  
• Is my device a tobacco product even though I use it with zero nicotine?
  
• If I buy vegetable glycerine from a vape store, is it a tobacco product? If yes, what about if I buy it at a Walmart?
  
• And so on…

If you have ANY question, the responsible thing to do is ASK THE FDA! Even if you know an expert vaper, you should call the FDA to confirm their analysis of the deeming regulation

 

[bigdancehawk]

How can you tell if an adolescent is brain damaged?

Their behavior refects good judgment?

 

[bobwho77]

So, it turns out, resistance is not futile, it's vital.

OOOOHMMMM!

 

[sparkky1]

For example, PMTAs for these
products should contain information on whether the product is likely to be used alone or together
with other legally marketed tobacco products (such as available delivery systems), as well as the
type and range of other products with which it is likely to be used...

In the case of ENDS hardware/apparatus components, FDA expects that it may be
difficult for manufacturers to make the showing necessary to meet the statutory standard, given the great extent of possible variations in combinations of hardware components, if all are
considered and sold separately. Thus, with respect to apparatus, FDA expects that manufacturers
will be most successful where authorization is sought for entire delivery systems, rather than
individual components. In the case of these complete delivery systems--systems for which the
application covers all potential parts, including customizable options as applicable, and where
labeling, instructions for use and/or other measures are used to help ensure use as intended--FDA
expects that the range of possible outcomes may be narrow enough for the manufacturer to
demonstrate, and for FDA to assess, public health impact...

FDA Deeming regulations
Pages 69-70.

Say goodbye to 510 connections.
The only way to get an open tank system approved (if anyone even bothers to try) will be if the system is completely proprietary, and nothing in it will work with any other systems.
The only way this works is with every product currently on the market pulled off of the shelves, and the manufacturers all designing new systems from the ground up.
Apple vs Android... PC vs Mac... VHS vs Betamax... Anybody?
These people are INSANE!

Look at the post right above yours
We are not being banished by one corporation, we are being repressed by a trillion dollar "system" / cartel if you like, govt calls it new world order, allowing the methods ( special interests ) of everything against Article 1 Section 8 and the Bill of Rights and everything to do with the RICCO act
Insane ? they have pills for that one too ..........

 

[wiredlove]

This is the mentality we're dealing with:

"In an interview with Vox, Mitch Zeller conceded e-cigarettes are far less hazardous than tobacco cigarettes, but refused to endorse the 95 percent safety figure accepted by bodies such as Public Health England and the Royal College of Physicians.

<snip>

If I were a pack-a-day smoker who was unable or unwilling to quit, and I substituted my cigarettes for e-cigarettes, there’s no question I’d be significantly reducing my risk. But as a regulatory agency, we have to make decisions at the population level.”

[article here]

 

[ZeroedIn]

This guy is definitely anti-vaping

Mark Kirk (@SenatorKirk) | Twitter

 

[LoriP1702]

Nevermind.

 

[Qew]

What I take (reading between the lines) from Zeller's answers about flavors, they didn't specifically ban them in the deeming, they expect the PMTA process and the money required to get through that process, to get rid of them?

 

[bigdancehawk]

Senator Tim Kaine is another "blowoff" kind of guy.

I wrote him several weeks ago about the ammendment they were trying to pass that would prohibit Mods and ecigs on both carry-on and checked baggage. In other words you wouldnt be able to take it on the plane PERIOD.

Here is his blowoff response, judging by the non-stance of it, I can only assume my plea regarding the FDA will get a similar non-response:

Dear Mr. Petro:

Thank you for contacting me about S.Amdt.3547. I appreciate hearing from you.

With 66 public airports and 45 million annual travelers flying through Dulles and Reagan National alone, Virginia relies on a strong aviation system to move people and goods, provide jobs, and support economic activity. The Federal Aviation Administration (FAA) is tasked with managing both an air traffic control system comprising more than 60 million aircraft and the safety of some one billion passengers who travel throughout the nation each year. While the U.S. has one of the world's safest air traffic control systems, there is a general consensus that we need to make investments to upgrade this system's aging technology.

On April 19, 2016, the Senate passed a bipartisan bill to reauthorize the FAA's activities and financing through Fiscal Year 2017. The bill authorizes overdue investments in airport infrastructure and NextGen modernization and makes critical improvements to aviation safety, including strengthened security in areas like check-in and baggage claim. It also takes steps to provide for the responsible use of unmanned aircraft systems in concert with robust safeguards for safety and privacy. I was particularly pleased to work with my colleague Senator Mark Warner to keep all amendments out of the bill that would have authorized more perimeter rule-exempt slots at Reagan National. Such amendments would have increased overcrowding at Reagan National, exacerbated noise issues in nearby communities, and damaged the economic competitiveness of Dulles Airport. S.Amdt.3547 was not adopted as part of the final bill passed by the Senate.

This bill now moves to the House of Representatives. As the process moves forward, I will be sure to keep your thoughts on this measure in mind should it come up again in future versions of the FAA bill.

Again, thank you for contacting me.

Tim Kaine​

99.9% of the effort expended by ordinary citizens in writing these people is wasted. It takes campaign contributions and lobbyists. There is a reason why the suburbs surrounding Washington DC are among the wealthiest in the country.

 

[YoursTruli]

Do you happen to have a copy of this letter? And who are we supposed to contact at this point? Our Congress reps? Senators? Both?

I could use some help creating my own CTA. I want to do it right.

Thanks.

This is a good idea:

The purpose of this site is to make it easy for individuals and vape shops to get involved by pleading with their representatives to support HR2058 and the Cole-Bishop Amendment to the Agricultural Appropriations Bill.

The letter is subject to change if any new developments occur.

Currently, without the passage of either one of these bills, the entire Vaping Industry will be banned on August 8th 2018.

This One Letter Can Save Our Entire Industry

 

[markfm]

Zeller'ls presentation and Q&A responses had a lot of references to the use of Master Files. Great for BT/BP -- an upfront heavy (to mere mortals, chump change to them) cost of XX millions to qualify a totally proprietary, closed, device/liquid, followed by citing the Master File to greatly simplify their future HW/liquid tweaks.

Smaller shops, the overall eliquid ecosystem and hardware manufacturers, are left in the dust, since that stovepipe, vertically integrated, setup is something that only plays out for BT/BP.

 

[Qew]

Let's light up those phone lines!

 

[bobwho77]

Look at the post right above yours
We are not being banished by one corporation, we are being repressed by a trillion dollar "system" / cartel if you like, govt calls it new world order, allowing the methods ( special interests ) of everything against Article 1 Section 8 and the Bill of Rights and everything to do with the RICCO act
Insane ? they have a pills for that one too ..........

What we have is a government controlled by the very wealthy, and the largest and most profitable corporations, and run almost exclusively to protect their interests, and enact their agendas.
I know they have pills for insanity. (and they're FDA approved!) I felt much better, after I stopped taking them.

 

[ZeroedIn]

What we have is a government controlled by the very wealthy, and the largest and most profitable corporations, and run almost exclusively to protect their interests, a

AKA, fascism.