FDA delivers Final Deeming Rule to OIRA

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zoiDman

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Leaked FDA industry guidance to ecig manufacturers. If this is for real, we're doomed. Read the part that says even zero-nicotine eliquid would be classified as "tobacco"

That would be on Line [HASHTAG]#214[/HASHTAG].

BTW - Check out Page 7, Lines 253 ~ 271.
 
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xtwosm0kesx

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Leaked FDA industry guidance to ecig manufacturers. If this is for real, we're doomed. Read the part that says even zero-nicotine eliquid would be classified as "tobacco"


Not that this is a surprise but reading through that, specifically the Summary of Research section, basically EVERYTHING is gone, it'll even crush the BT ciga-likes, at some point even the big boys will lose interest in jumping though hoops for a semi-limited market.

Its actually scary how well they've buttoned up everything, i mean, my god, an atomizer would have to be tested for aerosol particle size throughout its ENTIRE operating/draw range.

Detailed descriptions of how a mods software 'increases/decreases the risk profile'. Seriously?

A mod/tank combo looks like it would need about 50-75 'studies' before it is even able to be brought to market.

I knew it would be bad but if this goes through as is, it truly is the end of vaping, and those who see that as fear-mongering are just plain ignorant.
 

navigator2011

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Not that this is a surprise but reading through that, specifically the Summary of Research section, basically EVERYTHING is gone, it'll even crush the BT ciga-likes, at some point even the big boys will lose interest in jumping though hoops for a semi-limited market.

Its actually scary how well they've buttoned up everything, i mean, my god, an atomizer would have to be tested for aerosol particle size throughout its ENTIRE operating/draw range.

Detailed descriptions of how a mods software 'increases/decreases the risk profile'. Seriously?

A mod/tank combo looks like it would need about 50-75 'studies' before it is even able to be brought to market.

I knew it would be bad but if this goes through as is, it truly is the end of vaping, and those who see that as fear-mongering are just plain ignorant.

I sure hope this is not the "legacy" the president is looking to be known for--"the president that destroyed the vaping industry and kept millions of smokers in the dark."
 

Jman8

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I knew it would be bad but if this goes through as is, it truly is the end of vaping, and those who see that as fear-mongering are just plain ignorant.

It is worse than I anticipated. As it includes eLiquid, and if a de facto ban is a result, then the 99.5% is (way way way) conservative of a number, given there are way way way more flavors than all other product types combined.

At same time, the genie is out of the bottle. The legal market will take the hit, and that assumes zero law suits and no political fight over it. But to think an underground market / DIY won't flourish is (as you said) just plain ignorant.
 

skoony

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Leaked FDA industry guidance to ecig manufacturers. If this is for real, we're doomed. Read the part that says even zero-nicotine eliquid would be classified as "tobacco"

I have believed this to be the case since the first deeming proposal was issued.
Then there was Indiana and Arkansas. It looks like they have e-cigarettes wrapped
up tighter than fish parts in news paper.
Regards
Mike
 

Roadtrip635

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I sent the emails a few days ago and received the typical generic automated response....
I did get one response from one of my senators that at least mentioned the specific issue.




Dear Mr. xxxxxxxxxx:

Thank you for contacting me regarding the Food and Drug Administration (FDA). I appreciate having the benefit of your comments on this important issue.

As you may know, on April 24, 2014, the FDA issued a proposed rule that would extend new regulatory authority to e-cigarettes and various other tobacco products, including cigars, pipe tobacco, and nicotine gels. Under the proposed rule, these products would be subject to controls such as registration and product listing requirements, prohibition on providing free samples, and restrictions on marketing products prior to FDA review. Moreover, the proposed regulations would use February 15, 2007, as the grandfather date for newly deemed products, as established under the Tobacco Control Act. The public comment period for this rule closed July 9, 2014, and a final rule was expected to be issued by June 2015.

On April 28, 2015, the FDA Deeming Authority Clarification Act of 2015 (H.R. 2058) was in introduced in the House of Representatives. This legislation would change the grandfather date for newly deemed tobacco products from February 15, 2007, to the date on which the FDA’s regulations are finalized. H.R. 2058 has been referred to the House Committee on Energy and Commerce for further consideration. Although no similar legislation has been introduced in the Senate, you may be certain that I will keep your views in mind should relevant legislation be considered during the 114th Congress.

I appreciate having the opportunity to represent Texas in the United States Senate. Thank you for taking the time to contact me.


Sincerely,

JOHN CORNYN
United States Senator

517 Hart Senate Office Building
Washington, DC 20510

Tel: (202) 224-2934
Fax: (202) 228-2856
http://www.cornyn.senate.gov

Please sign up for my monthly newsletter at http://www.cornyn.senate.gov/newsletter.
 

AndriaD

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It is worse than I anticipated. As it includes eLiquid, and if a de facto ban is a result, then the 99.5% is (way way way) conservative of a number, given there are way way way more flavors than all other product types combined.

At same time, the genie is out of the bottle. The legal market will take the hit, and that assumes zero law suits and no political fight over it. But to think an underground market / DIY won't flourish is (as you said) just plain ignorant.

I agree! There are a LOT of us with a nice freezer stash of nicotine, and if members of our family or friends want to give it a try, we'll help them. And there may even be those perfectly willing to "bootleg" that stashed nicotine for outrageous prices -- anyone who thinks that WON'T happen needs to study 1920's history a lot more closely.

As long as there are any of us out here vaping visibly, vaping is NOT dead, it's just being oppressed -- the oppressed have a way of making comebacks.

Andria
 

Racehorse

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I would like to know where the "leaked" document came from. Mr. DmA posted it I think and noted "if this is for real......."

Yet,

It is interesting to me that nobody has even asked. o_O

It is interesting to me that nobody has even set out to determine the veracity of this leaked document. Or where it came from.

Interesting because on this forum, we members will argue down a mean cornered bear over the slightest thing........yet, nobody even QUESTIONED where this document came from, first appeared, etc.

To me, that is sort of a shame.

yet it's intellectual dishonesty to post a photo of a blown up ecig because everyone WILL say it was photoshopped, etc.

Just sayin' *usually* there is some notion to verify things that are posted......verify the contents as well as verify where it came from.

There must've been 100+ responses to a popular vendor has test results posted on ejuice.....ripping it apart.

Yet.....total silence on this document. Hmmmm............nobody EVEN ASKED.
 
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AndriaD

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I would like to know where the "leaked" document came from. Mr. DmA.

It is interesting to me that nobody has even asked. o_O

It is interesting to me that nobody has even set out to determine the veracity of this leaked document.

Interesting because on this forum, we members will argue down a mean cornered bear over the slightest thing........yet, nobody even QUESTIONED where this document came from, first appeared, etc.

To me, that is sort of a shame.

What I think is a shame is this assumption that the white house is just going to rubber-stamp whatever nonsense the FDA dishes up. If that was true, then why bother submitting it at all? Because it's the law? Hell, those idjits MAKE the law, I'm sure they could do away with it if they felt so inclined; they've been whittling away at our constitutional rights for a couple centuries now, it would be no biggie.

I just want to know how much more of the Constitution has to be trampled before we finally rise up and tell them WE'RE MAD AS HELL AND NOT GOING TO TAKE IT ANYMORE!

Andria
 

YoursTruli

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What I think is a shame is this assumption that the white house is just going to rubber-stamp whatever nonsense the FDA dishes up. If that was true, then why bother submitting it at all? Because it's the law? Hell, those idjits MAKE the law, I'm sure they could do away with it if they felt so inclined; they've been whittling away at our constitutional rights for a couple centuries now, it would be no biggie.

I just want to know how much more of the Constitution has to be trampled before we finally rise up and tell them WE'RE MAD AS HELL AND NOT GOING TO TAKE IT ANYMORE!

Andria

I think this is something the pro-vape advocates in the front lines have been asking for years now because let's face it only a small minority have become directly involved in this fight and many of them not until it jumped up and bit them in their own back yard and/or threatened their pocketbook.... rather amazing given how long this has been going on (at all levels of government) the shock and horror just now being expressed in the final hours.
 

DrMA

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I would like to know where the "leaked" document came from. Mr. DmA posted it I think and noted "if this is for real......."

Yet,

It is interesting to me that nobody has even asked. o_O

It is interesting to me that nobody has even set out to determine the veracity of this leaked document. Or where it came from.

Interesting because on this forum, we members will argue down a mean cornered bear over the slightest thing........yet, nobody even QUESTIONED where this document came from, first appeared, etc.

To me, that is sort of a shame.

yet it's intellectual dishonesty to post a photo of a blown up ecig because everyone WILL say it was photoshopped, etc.

Just sayin' *usually* there is some notion to verify things that are posted......verify the contents as well as verify where it came from.

There must've been 100+ responses to a popular vendor has test results posted on ejuice.....ripping it apart.

Yet.....total silence on this document. Hmmmm............nobody EVEN ASKED.

TVECA is the source.
http://tveca.com/tveca_docs/industry_guide_draft_tveca.pdf
 

Katya

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Yet.....total silence on this document. Hmmmm............nobody EVEN ASKED.

Total silence???? Nobody asked????

The information came from TVECA (the Tobacco Vapor Electronic Cigarette Association):

http://www.tveca.com/

You may like or dislike TVECA, they have done some questionable things in the past, but the leak is from them undoubtedly. SmokeyJoe, the founder of this forum, started a thread about the leak, and I don't know anybody here who would question Smokey Joe's sources, credentials or his judgement. :)

https://www.e-cigarette-forum.com/f...le-of-contents-for-deeming-final-rule.709637/
 

skoony

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It is interesting to me that nobody has even set out to determine the veracity of this leaked document. Or where it came from.
Ditto DrMA's post.
Smokey Joe had said in a post here somewhere his sources were confident
of its originality or something similar to that.
Regards
Mike
 

Kent C

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SJ on the post in Regulation:

"I should mention this here...

There's some very odd smoke and mirrors coming out of TVECA. I'm not sure what they're up to, but they've "released" an FDA industry guidance document which, on closer examination, is an old document from 2014.

I've had calls from several people doubting the veracity of the Table of Contents, but on the whole I'm satisfied it's genuine. Tveca are also saying now that they'll release the whole document 100 pages at a time - who knows, perhaps they will - I'll keep this thread current if they do.

Regardless, now is the time for vapers to cause a stink. The deeming is on the desk of OMB, and I've spoken to someone who has seen the whole thing, and who says unequivocally that it's "worse than the previous proposal"."
 
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