FDA TVECA post table of contents for Deeming Final Rule

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MacTechVpr

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I really feel like everything ive done, emails made, and calls sent hit a brick wall of money that theres no getting past. I've read articles about big pharma & tobacco's spending hundreds of millions on legal defense and their money really puts them above the law. Now they're going to monopolize the vape industry, and it hurts to sit and watch :(

No dishonor in that Nat. Price of being a member of the human race is engagement. Sometimes successful, often not.

“If you want to be a slave in life, then continue going around asking others to do for you. They will oblige, but you will find the price is your choices, your freedom, your life itself. They will do for you, and as a result you will be in bondage to them forever, having given your identity away for a paltry price. Then, and only then, you will be a nobody, a slave, because you yourself and nobody else made it so.”
― Terry Goodkind, The Pillars of Creation
 
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squee

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I really feel like everything ive done, emails made, and calls sent hit a brick wall of money that theres no getting past.
I may be wrong but I'm just not getting that sense. I'm not doubting the TOC that SJ linked to but I have serious doubts about the validity of those draft guidelines. Not that they aren't real but rather, they are old and outdated.

The comments from Zeller, the FDA recently and those of the former FDA employee lead me to think that may have been a starting place. Point A, if you will. And over time as more positive info has come in, as more actual science and research has been done - they have been changed, modified. I think that could also have been why the regs, which were due to be finalized in June, have only now been sent over to OMB.
 

Oliver

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I may be wrong but I'm just not getting that sense. I'm not doubting the TOC that SJ linked to but I have serious doubts about the validity of those draft guidelines. Not that they aren't real but rather, they are old and outdated.

The comments from Zeller, the FDA recently and those of the former FDA employee lead me to think that may have been a starting place. Point A, if you will. And over time as more positive info has come in, as more actual science and research has been done - they have been changed, modified. I think that could also have been why the regs, which were due to be finalized in June, have only now been sent over to OMB.

Maybe, but then I'm hearing from other sources that this is not good news. It's hard, at present, to know exactly what's likely to happen.

And you're quite right - the Draft Guidelines are a 2014 document. It's interesting because no-one seems to have seen it previously that I've spoken with, but it's clearly not a current text.
 

salemgold

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I may be wrong but I'm just not getting that sense. I'm not doubting the TOC that SJ linked to but I have serious doubts about the validity of those draft guidelines. Not that they aren't real but rather, they are old and outdated.

The comments from Zeller, the FDA recently and those of the former FDA employee lead me to think that may have been a starting place. Point A, if you will. And over time as more positive info has come in, as more actual science and research has been done - they have been changed, modified. I think that could also have been why the regs, which were due to be finalized in June, have only now been sent over to OMB.

Could be true but, then there is this
[EDIT] Despite previously having said they will post their leaked copy of the full deeming proposal online, TVECA are now saying they will not publish it.[/EDIT]

See here: http://tveca.com/tveca_docs/drp_redacted.pdf

Troublingly there's a new section on flavors, and intriguingly one on Vape Stores.

I'm hearing from my sources that this is worse than the original.

If they had actually taken any of the more recent positive info, research or science into account, I would think that it would indeed be better (not worse) than the original.
 

salemgold

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I could be wrong but, I really think that I read somewhere in this thread that they have no plans to make any additional comments until the regs are finalized. They are not going to release a copy of what was submitted to them.

Of course, I can't find that info now so I may be totally off base.
 

SeniorBoy

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Perhaps this post will help clarify some issues. I have always embraced the "same page" doctrine. When David is fighting Goliath, I will support our pro vaping allies, regardless of what they used to do or say. Even if some of their other views may not perfectly fit into what I would like to occur, if their pro vape actions are helpful in some manner or fashion, then I could care less what they used to do or say. I actually find it counter productive when well intentioned vapers publicly post about the history of our current friends. I also find it deplorable when a given "organization" throws another one under the bus publicly or one scientist argues with another publicly. Sure, have those disagreements but do it privately. For example, I had a serious disagreement with an organization on a given issue. Most of which was conducted via private email. In this case the totality of their actions helped the vaping movement and I have continued to support them in a aggressive and vigorous fashion.

My previous post indicated that I sent an email to TVECA | Tobacco Vapor Electronic Cigarette Association. I received an Email response which was followed with a phone conversation with Ray Story, CEO. Here is my summary of this phone call and my other observations.

They released two leaked documents. They initially indicated they would release the balance of the documents. Then they had a conversation with the FDA ("Mitch" is calling) about this issue which the FDA addresses on this page A Special Statement from CTP - October 31, 2015 They reached a negotiated agreement and TVECA will not release any further documents.

I was told that the two leaked documents which they released are "current". No more and no less. Please draw your own conclusions and the semantics of same.

As owner of Smoking Everywhere, Ray Story initiated the famous "SOTTERA" legal action against the FDA. The Intervenor-Plaintiff was SOTTERA, INC., d/b/a NJOY. A multi millon dollar cost to him and at the time a critical legal decision. Of course, I'm aware of the irony of this decision and my guess is that certain aspects of vaping will be regulated as either a "medical device" or a "tobacco product"

We discussed at length what I will call BT Money. He brought up the subject although it was on my own tick list. Yes, some of them are members and yes this means they paid money to join. I was granted paid membership status so I can read documents that you can't see. I've poked around quite a bit and so far I don't see anything that supports BT at the expense of vaping. Given the fact that TVECA is Global in nature, their certainly could be some issues that I'm not aware of in a given relationship with a regulatory authority in another country but I don't see anything pro BT with respect to the FDA. Your free to either take my word for this or ignore my thoughts. :)

Their latest Member Newsletter indicates that their lobbying efforts with respect to TVECA's support for H.R. 2058 are in full gear with interaction with politicians.

Ray Story is a passionate individual. Very aggressive and outspoken. Acutely aware of some of the "controversy" which surrounds him. Because he has been self employed and currently owns another vaping centric firm, he clearly understands "negotiations" at the table. Maintaining a channel of communications, even if you have serious disagreements with the other party but striving for common ground and making the best of the situation. A realistic private expectation when David is fighting Goliath.

Finally, Is TVECA a "perfect" Vaping advocate. NO. Neither are YOU, ME, or anyone else engaged in this fight. By this I really mean my own "same page" doctrine, you take the pluses and the minuses and live with the inherent imperfection and move forward trying to save our industry. I'm happy we have TVECA on our side.
 

skoony

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Perhaps this post will help clarify some issues. I have always embraced the "same page" doctrine. When David is fighting Goliath, I will support our pro vaping allies, regardless of what they used to do or say. Even if some of their other views may not perfectly fit into what I would like to occur, if their pro vape actions are helpful in some manner or fashion, then I could care less what they used to do or say. I actually find it counter productive when well intentioned vapers publicly post about the history of our current friends. I also find it deplorable when a given "organization" throws another one under the bus publicly or one scientist argues with another publicly. Sure, have those disagreements but do it privately. For example, I had a serious disagreement with an organization on a given issue. Most of which was conducted via private email. In this case the totality of their actions helped the vaping movement and I have continued to support them in a aggressive and vigorous fashion.

My previous post indicated that I sent an email to TVECA | Tobacco Vapor Electronic Cigarette Association. I received an Email response which was followed with a phone conversation with Ray Story, CEO. Here is my summary of this phone call and my other observations.

They released two leaked documents. They initially indicated they would release the balance of the documents. Then they had a conversation with the FDA ("Mitch" is calling) about this issue which the FDA addresses on this page A Special Statement from CTP - October 31, 2015 They reached a negotiated agreement and TVECA will not release any further documents.

I was told that the two leaked documents which they released are "current". No more and no less. Please draw your own conclusions and the semantics of same.

As owner of Smoking Everywhere, Ray Story initiated the famous "SOTTERA" legal action against the FDA. The Intervenor-Plaintiff was SOTTERA, INC., d/b/a NJOY. A multi millon dollar cost to him and at the time a critical legal decision. Of course, I'm aware of the irony of this decision and my guess is that certain aspects of vaping will be regulated as either a "medical device" or a "tobacco product"

We discussed at length what I will call BT Money. He brought up the subject although it was on my own tick list. Yes, some of them are members and yes this means they paid money to join. I was granted paid membership status so I can read documents that you can't see. I've poked around quite a bit and so far I don't see anything that supports BT at the expense of vaping. Given the fact that TVECA is Global in nature, their certainly could be some issues that I'm not aware of in a given relationship with a regulatory authority in another country but I don't see anything pro BT with respect to the FDA. Your free to either take my word for this or ignore my thoughts. :)

Their latest Member Newsletter indicates that their lobbying efforts with respect to TVECA's support for H.R. 2058 are in full gear with interaction with politicians.

Ray Story is a passionate individual. Very aggressive and outspoken. Acutely aware of some of the "controversy" which surrounds him. Because he has been self employed and currently owns another vaping centric firm, he clearly understands "negotiations" at the table. Maintaining a channel of communications, even if you have serious disagreements with the other party but striving for common ground and making the best of the situation. A realistic private expectation when David is fighting Goliath.

Finally, Is TVECA a "perfect" Vaping advocate. NO. Neither are YOU, ME, or anyone else engaged in this fight. By this I really mean my own "same page" doctrine, you take the pluses and the minuses and live with the inherent imperfection and move forward trying to save our industry. I'm happy we have TVECA on our side.
Thanks for the response. I completely agree to your sentiments on us all working together as best we can.
At this point in time negotiating a more equitable regularity agreement may be the best chance to get
anything remotely reasonable.
I appreciate the fact that so many fine individuals and organisations are working very hard on my behalf.
This however does not negate the feeling I have as an end user that some how once again I will be getting
the short end of the stick. Its not like anyone is throwing me under the bus. I get to ride the bus but, all
the seats are already taken.
:(
Regards
Mike
 
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zoiDman

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Perhaps this post will help clarify some issues. I have always embraced the "same page" doctrine. When David is fighting Goliath, I will support our pro vaping allies, regardless of what they used to do or say. Even if some of their other views may not perfectly fit into what I would like to occur, if their pro vape actions are helpful in some manner or fashion, then I could care less what they used to do or say. I actually find it counter productive when well intentioned vapers publicly post about the history of our current friends. I also find it deplorable when a given "organization" throws another one under the bus publicly or one scientist argues with another publicly. Sure, have those disagreements but do it privately. For example, I had a serious disagreement with an organization on a given issue. Most of which was conducted via private email. In this case the totality of their actions helped the vaping movement and I have continued to support them in a aggressive and vigorous fashion.

My previous post indicated that I sent an email to TVECA | Tobacco Vapor Electronic Cigarette Association. I received an Email response which was followed with a phone conversation with Ray Story, CEO. Here is my summary of this phone call and my other observations.

They released two leaked documents. They initially indicated they would release the balance of the documents. Then they had a conversation with the FDA ("Mitch" is calling) about this issue which the FDA addresses on this page A Special Statement from CTP - October 31, 2015 They reached a negotiated agreement and TVECA will not release any further documents.

I was told that the two leaked documents which they released are "current". No more and no less. Please draw your own conclusions and the semantics of same.

As owner of Smoking Everywhere, Ray Story initiated the famous "SOTTERA" legal action against the FDA. The Intervenor-Plaintiff was SOTTERA, INC., d/b/a NJOY. A multi millon dollar cost to him and at the time a critical legal decision. Of course, I'm aware of the irony of this decision and my guess is that certain aspects of vaping will be regulated as either a "medical device" or a "tobacco product"

We discussed at length what I will call BT Money. He brought up the subject although it was on my own tick list. Yes, some of them are members and yes this means they paid money to join. I was granted paid membership status so I can read documents that you can't see. I've poked around quite a bit and so far I don't see anything that supports BT at the expense of vaping. Given the fact that TVECA is Global in nature, their certainly could be some issues that I'm not aware of in a given relationship with a regulatory authority in another country but I don't see anything pro BT with respect to the FDA. Your free to either take my word for this or ignore my thoughts. :)

Their latest Member Newsletter indicates that their lobbying efforts with respect to TVECA's support for H.R. 2058 are in full gear with interaction with politicians.

Ray Story is a passionate individual. Very aggressive and outspoken. Acutely aware of some of the "controversy" which surrounds him. Because he has been self employed and currently owns another vaping centric firm, he clearly understands "negotiations" at the table. Maintaining a channel of communications, even if you have serious disagreements with the other party but striving for common ground and making the best of the situation. A realistic private expectation when David is fighting Goliath.

Finally, Is TVECA a "perfect" Vaping advocate. NO. Neither are YOU, ME, or anyone else engaged in this fight. By this I really mean my own "same page" doctrine, you take the pluses and the minuses and live with the inherent imperfection and move forward trying to save our industry. I'm happy we have TVECA on our side.

Thank you for the post SeniorBoy. And the legwork that went into it.

I think one thing that causes Confusion with some Members is that they forget that TVECA is Trade Organization. Not a Consumer Advocacy Organization.

This is not to say that the Views, Methods and Goals of both can not be Aligned. But if there are Choices to me made in the Direction that TVECA is going to move in, the Direction is Always Based on what Benefits TVECA's members.
 

DC2

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BTW - Here is some Interesting reading that was sent to
me regarding a Recent FDA Action.

http://publichealthlawcenter.org/si...urces/tclc-fda-tobacco-products-apps-2015.pdf
Regarding the PreMarket Tobacco Application (PMTA) path...
1) the product does not appropriately protect public health, considering the product’s impact on initiation and cessation

Regarding the Substantial Equivalence (SE) path...
This process is intended to be used for products that have the same characteristics as products marketed as of February 15, 2007, or that have different characteristics that do not raise different questions of public health.


For anyone who doesn't understand the meaning and impact of the following wording...
--considering the product’s impact on initiation and cessation
--or that have different characteristics that do not raise different questions of public health.


I offer you this thread so you can see with your own eyes how they can be used to crush the vaping industry...
FDA issues Brief Summary of “Not Substantially Equivalent” Determinations

[sarcasm]
Maybe some of the people who claim nothing will change might want to chime in here.
They seem to think they know a lot more than the rest of us.
[/sarcasm]
 

Katya

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[...]When the FDA issues an NSE order, the tobacco product in inventory, including at a retail location, becomes adulterated and misbranded. As a result, it is illegal to sell or distribute the product in interstate commerce, or sell or distribute the product received from interstate commerce. Doing so may result in the FDA initiating enforcement action, including seizure, without further notice.

Recognizing that retailers may have limited options for disposing of products in their current inventories, the FDA does not intend to take enforcement action for 30 days on previously purchased products that a retailer has in its inventory. [...]

Failure to obey federal tobacco product laws may result in the FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. [...]

:facepalm:

Does anyone know if those rules also apply to purchasing "illegal" or FDA not approved e-cigarettes from other countries for personal use, not resale? Like Fasttech, Heaven's Gifts etc.? 2010 PACT Act very specifically does not include e-cigarettes.
 

DC2

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Does anyone know if those rules also apply to purchasing "illegal" or FDA not approved e-cigarettes from other countries for personal use, not resale?
My understanding is that the PACT Act would have to be modified by Congress to include e-cigarettes.
I am almost positive that this is the truth.
:)
 

Katya

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My understanding is that the PACT Act would have to be modified by Congress to include e-cigarettes.
I am almost positive that this is the truth.
:)

IOW, let's destroy some more American businesses and help Chinese economy?

Am I reading this correctly? Are they really going to do this? :shock:
 

zoiDman

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My understanding is that the PACT Act would have to be modified by Congress to include e-cigarettes.
I am almost positive that this is the truth.
:)

I believe you are Correct DC.


‘‘(2) CIGARETTE.—

‘‘(A) IN GENERAL.—The term ‘cigarette’—

‘‘(i) has the meaning given that term in section

2341 of title 18, United States Code; and

‘‘(ii) includes roll-your-own tobacco (as defined in

section 5702 of the Internal Revenue Code of 1986).

‘‘(B) EXCEPTION.—The term ‘cigarette’ does not include

a cigar (as defined in section 5702 of the Internal Revenue

Code of 1986).

http://www.gpo.gov/fdsys/pkg/PLAW-111publ154/pdf/PLAW-111publ154.pdf


Title 18 Section 2341...

U.S.C. Title 18 - CRIMES AND CRIMINAL PROCEDURE
 
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Katya

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Ray Story is a passionate individual. Very aggressive and outspoken. Acutely aware of some of the "controversy" which surrounds him.

Like I said before, I have nothing against TVECA and I'm sure that they are more with us (vapers) than against us. But I also remember Smoking Everywhere kits being sold in malls around here for 200 bucks for 2 cigalike batteries, a charger and a few cartos (no returns, no money back, no customer support to speak of). I almost bought a kit. But luckily I didn't--I went home instead and googled e-cigarettes. I found GreenSmoke for half the price of SE and 30-day money back guarantee--no questions asked. So I ordered a kit from them. Searching for more information about GreenSmoke, I found ECF and learned that I can get 2 kr808 batteries, a 5-pack of cartomizers and a charger from V4L for 30 bucks shipped. And a helpful forum and plenty of information, tips, and consumer support from Steve and fellow V4L users.

Memory is a funny thing.

And thank you very much for your efforts to get some more information about TVECA and their current position and activities.
 

Mikedin

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Thank You | We the People: Your Voice in Our Government

Go on the link above also to sign a petition to rework the deeming regulations

Go to the tab that says open petitions
Go down to the one regarding re-working the deeming regulations to keep vaping equipment available

Sign up to make your signature active it takes just minutes , 80,000 signatures are required! Only 18000 have been done!
 

zoiDman

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For those interested.....Dimitri will be discussing the FDA/OMB topics further on his Smoke Free Radio show tonight at 9pm. Guests will be Bill Godshall and FDA/Ecig Attorney Azim Chowdhury
vapersplace.com/vplive
Should be really good discussion!

Thank you for Posting this 2coils.
 
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