Deeming Regulations have been released!!!!

MacTechVpr

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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!

You're absolutely right. Without device compatibility there is no competition or innovation. The very premises of a controlled marketplace. Not capitalism, not representative government.

Good luck. :(
 

MacTechVpr

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Daily mailing sent to:
President President Barack Obama (D)
U.S. Senate
Sen. Mark Warner (D-VA) Sen. Tim Kaine (D-VA)
U.S. House of Representatives
Rep. Morgan Griffith (R-VA)

I am a 57 year old middle class constituent.

I was addicted to tobacco most of my life. I firmly believe that switching to ecigs has extended my life by years. Not only does scientific research show that it is 95% less harmful, but my own body (& my physician) tells me that it is less harmful.

Please see the scientific proof here:
https://www.rcplondon.ac.uk/file/3563/download?token=uV0R0Twz

Now, through regulation, the FDA is making it much easier to buy tobacco than to purchase an ecig that actually works. Tobacco is far more dangerous, this just doesnt make sense.

I urge you to support the
H.R.2058 - FDA Deeming Authority Clarification Act of 2015

Products that existed before the February 2007 "predicate date" simply did not work, where current generation products DO work. As a result I have been tobacco free for 3.5 years. Please allow me the legal means to stay off of tobacco!

I vote, and I will support politicians who support my right to "harm reduction".

Sincerely,
Mike Petro

Good job!

The downloadable .pdf is awesome mike. Everyone should bookmark this!

https://www.rcplondon.ac.uk/file/3563/download?token=uV0R0Twz

Another is the direct link to the report…

Nicotine without smoke: Tobacco harm reduction | RCP London

Good luck all. :)
 

Spazmelda

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Okay, I'm writing letters today. I've got a first draft, but I need the exact language I should use to refer to the two pieces of legislation that we are urging reps to support. What are they? Someone just please give me the wording for both. I know it's been posted before but indulge my laziness :)
 

Icemanxxxv

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I'm getting emails from online dealers blowing out products. And I'm taking advantage of it. By next week I'll have 5 iStic pico mods. 2 DAN200 2 DNA75 1 DNA40. 1 Aromamizer 3 Crowns 5 Lemo's and a .... load of retired rda. 2.5 liters of 100mg nic and planning to purchase more over the next few weeks.

Sent from my SM-G900T3 using Tapatalk
 

mikepetro

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Okay, I'm writing letters today. I've got a first draft, but I need the exact language I should use to refer to the two pieces of legislation that we are urging reps to support. What are they? Someone just please give me the wording for both. I know it's been posted before but indulge my laziness :)
One of them is

"I urge you to support the
H.R.2058 - FDA Deeming Authority Clarification Act of 2015"
 

Katya

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Okay, I'm writing letters today. I've got a first draft, but I need the exact language I should use to refer to the two pieces of legislation that we are urging reps to support. What are they? Someone just please give me the wording for both. I know it's been posted before but indulge my laziness :)

The Cole-Bishop amendment to the 2017 Agricultural Appropriations bill and the FDA Deeming Authority Clarification Act of 2015 (H.R. 2058).
 

Tucsonbroker

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Directly from the FDA website:

"If you operate a vape shop that mixes or prepares liquid nicotine or nicotine-containing e-liquids, or creates or modifies any type of ENDS, you are considered a manufacturer and must comply with all of the legal requirements for tobacco product manufacturers."

I'm not sure if anyone has caught this yet, but in order to become a "tobacco product manufacturer" a shop will have to submit an application to the BATF. They issue permits in about 65 days, are able to freely inspect your facility, and basically do whatever they want. The site says that it is free to apply. Also of note there appears to be special taxes required. https://www.ttb.gov/tobacco/manufacturer_products.shtml

So if mixing shops can apply and become approved to be tobacco product manufacturers they will be able to sell mixed juice that was already being produced prior to 8/10. At least for 2 years...
 
Last edited:

Spazmelda

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One of them is

"I urge you to support the
H.R.2058 - FDA Deeming Authority Clarification Act of 2015"

The Cole-Bishop amendment to the 2017 Agricultural Appropriations bill and the FDA Deeming Authority Clarification Act of 2015 (H.R. 2058).

Thank you both!!
 
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mikepetro

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Resent again today, and evry day until it needs updating, I just keep changing the "From" email address.

This link makes it easy, and automatically selects your own personal politicians.
Petition Your Legislator NOW to Support HR 2058! (Updated)



Daily mailing sent to:
President President Barack Obama (D)
U.S. Senate
Sen. Mark Warner (D-VA) Sen. Tim Kaine (D-VA)
U.S. House of Representatives
Rep. Morgan Griffith (R-VA)

I am a 57 year old middle class constituent.

I was addicted to tobacco most of my life. I firmly believe that switching to ecigs has extended my life by years. Not only does scientific research show that it is 95% less harmful, but my own body (& my physician) tells me that it is less harmful.

Please see the scientific proof here:
https://www.rcplondon.ac.uk/file/3563/download?token=uV0R0Twz

Now, through regulation, the FDA is making it much easier to buy tobacco than to purchase an ecig that actually works. Tobacco is far more dangerous, this just doesnt make sense.

I urge you to support the
H.R.2058 - FDA Deeming Authority Clarification Act of 2015

Products that existed before the February 2007 "predicate date" simply did not work, where current generation products DO work. As a result I have been tobacco free for 3.5 years. Please allow me the legal means to stay off of tobacco!

I vote, and I will support politicians who support my right to "harm reduction".

Sincerely,
Mike Petro
 

Robert Cromwell

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I'm not sure if anyone has caught this yet, but in order to become a "tobacco product manufacturer" a shop will have to submit an application to the BATF. They issue permits in about 65 days, are able to freely inspect your facility, and basically do whatever they want. It is not clear how much it costs to submit and get an an application approved. https://www.ttb.gov/tobacco/manufacturer_products.shtml

So if mixing shops can apply and become approved to be tobacco product manufacturers they will be able to sell mixed juice that was already being produced prior to 8/10. At least for 2 years...
They will actually need to become a Tobacco Manufacturer if they install hand wrapped coils or wicks. or sell coils they wrapped.
 

Tucsonbroker

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They will actually need to become a Tobacco Manufacturer if they install hand wrapped coils or wicks. or sell coils they wrapped.

Yes. So theoretically a shop that ONLY makes coils (wrapping wire into an electronic device), but doesn't add juice or even sell pre-made juice will still be a tobacco manufacturer. Mind boggling isn't it.
 

Robert Cromwell

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Yes. So theoretically a shop that ONLY makes coils (wrapping wire into an electronic device), but doesn't add juice or even sell pre-made juice will still be a tobacco manufacturer. Mind boggling isn't it.
Yep it boggles the mind. And as you pointed out even filling a tank for a customer..
And no free sampling of juice. Maybe a penny a puff charge will bypass that?
 

Tucsonbroker

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Yep it boggles the mind. And as you pointed out even filling a tank for a customer..
And no free sampling of juice. Maybe a penny a puff charge will bypass that?

I own several bars and the penny per drink work-around can be very effective for liquor laws. That said, sampling is the least of concerns for small mixing shops. They are now going to have to be under the thumb of the BATF, including background checks on owners and a whole new blizzard of paperwork. The BATF on a whim can come into any facility and inspect it. And all of that just for the ability to sell pre-existing recipes for another 2 years.
 

Blue73

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But two years?
Take me for instance. I have been vaping for over 2 years. In the past couple months, I started making my own coils. Yesterday, I ordered 1L of 100mg/ml nicotine concentrate and other supplies to DIY my juice. That is just the beginning. By 2018, my plan is to have everything I need to vape for the rest of my life, regardless of what stupid FDA regulations take effect.

Vaping saved my life. I am not giving it up because some government bureaucrat says it's bad for me.
 

Spazmelda

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Here is the letter I sent:


Dear [whoever],

I am writing today to express my dismay at the recently published FDA Deeming Regulations with regard to new tobacco products. These regulations, as written, are extreme regulatory overreach and will be damaging both to public health and to small businesses across the US. They will eliminate almost all (or possibly all) of the vapor products available in this country and contribute significantly to an unregulated black market. If any products do survive, they will most likely be unappealing and ineffective offerings from the major tobacco companies since they are the most likely to be able to afford the overzealous levels of testing required, and least likely to have incentive to produce anything better (they already have smokers). Because of this, I am urging you to support either H.R.2058 - FDA Deeming Authority Clarification Act of 2015 or the Cole-Bishop Amendment to the 2017 Agricultural Appropriations Bill. Either of these pieces of legislation would push forward the grandfather date for vapor products from 2007 (at which point there were essentially none on the market in the US) to 2016. Moving the grandfather date is not the most ideal solution, as innovation will be stifled and user choice will be limited, but would allow what products we have now to stay on the market for current users and contribute to the health of current smokers who might switch to vapor products in the future.

I am not associated with any vapor shop or vapor product manufacturing. I am simply a 25 year smoker, and 44 year old mother of 2, who has not had a combustible cigarette for over 5 years thanks to these products. Additionally, I do not protest this for myself. I have seen it coming for a long time and I will be able to continue using the products I have amassed for many years to come. I speak for the millions of smokers who deserve the chance to make an informed choice about their own health. I am not against sensible regulations such as reasonable testing and disclosure of ingredients, facility inspections, age restrictions, and health warnings. Look to the recently published report from The Royal College of Physicians (a prestigious health organization in the UK) Nicotine without smoke: Tobacco harm reduction. They correctly state that we don’t know everything we need to know about these products and that further testing should be done, but they acknowledge that these products are at least 95% safer than smoking combustible cigarettes and on that basis recommended that current smokers be ENCOURAGED to switch. Such sensible recommendations will not be possible if the FDAs Deeming Regulations are not challenged.

Thank you very much for taking the time to read my thoughts on this matter.

[my real name], Ph.D.
 

MacTechVpr

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Yes. So theoretically a shop that ONLY makes coils (wrapping wire into an electronic device), but doesn't add juice or even sell pre-made juice will still be a tobacco manufacturer. Mind boggling isn't it.

Right! ??? Preempts all state authority to determine what a business is. Who died and made FDA king?

Good luck all. :)
 

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