FDA TVECA post table of contents for Deeming Final Rule

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squee

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I did read today that the CDC estimates about 9 million vapers in the US, I just wish we could get at least half of them to participate.

Half? Hell, I'd settle for 1% - we didn't even get near that, with the public comments for the deeming. We got our asses kicked by cigar smokers :(
 

DC2

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"Finalizing this rule cannot wait until 2016."

What I find somewhat Comical about statement like this is "Why does it have to be Done by the End of 2015?". Seems like the Importance would be placed on Doing a review Right. Not on doing a review Fast.
It has to be done NOW because of the children.
 

DC2

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Right.
proxy.php


Whatcha gonna do...
I'm TRYING hard to give him a pass because he switched to a "more important" endeavor.
Only time will tell.
 

Katya

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I'm TRYING hard to give him a pass because he switched to a "more important" endeavor.
Only time will tell.

You're a bigger man... I wouldn't. Gotta keep them honest, IMHO.

But I did donate to a questionable video project myself once... :facepalm:

Now I'm more careful. CASAA, ECF, Dr. Farsalinos, etc.
 
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squee

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Speaking of the public comments from vapers on the deeming rule, or lack thereof, I haven't seen this posted yet (apologies if it has been)
http://www.regulations.gov/contentS...mber=1&disposition=attachment&contentType=pdf

The "Memorandum from FDA CTP regarding Summary of Write In Campaigns" is illuminating in several ways - not only for how overwhelming the comments were with regard to the cigar exemption but just how many were in support of the deeming for ecigs, wanting bans on flavors, etc..

If you want to get your blood pumping, check out this bit from the American College of Cardiology:

Further, the campaign proposes removing “lost pleasure” from the cost-benefit analysis, as tobacco users “…are either minors when they first [made] the decision or addicts, neither of whom by definition is able to make rational choices regarding their addictions.”
 

sofarsogood

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If you want to get your blood pumping, check out this bit from the American College of Cardiology:

Further, the campaign proposes removing “lost pleasure” from the cost-benefit analysis, as tobacco users “…are either minors when they first [made] the decision or addicts, neither of whom by definition is able to make rational choices regarding their addictions.”
I think they are talking about NFL football.

It's like, okay, I'm going to Mars. How much vape stuff should I take.
 

DC2

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If you want to get your blood pumping, check out this bit from the American College of Cardiology:

Further, the campaign proposes removing “lost pleasure” from the cost-benefit analysis, as tobacco users “…are either minors when they first [made] the decision or addicts, neither of whom by definition is able to make rational choices regarding their addictions.”
Yes indeed, we are all just addicts who derive no pleasure from the act of smoking.
I also derive no pleasure from reading a book, or laughing at a good joke.

And I definitely get no pleasure whatsoever from a good slice of pizza.
Or an nice cup of caffeine-laden coffee.

This kind of crap is the result of decades of anti-smoking brainwashing...
Rampant Antismoking Signifies Grave Danger

It would be funny, if it wasn't for the fact that most of the world has bought into these orchestrated lies.
 

Kent C

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‘Knock, Knock. It’s the FDA Calling’ Free Webinar Offered | VAPE Magazine

"The FDA’s final regulations will likely be out by the end of this year or in early 2016.

The webinar will be run by Azim Chowdhury, an attorney with D.C.-based Keller and Heckman, LLP and head of the firm’s e-cigarette practice. Chowdhury has represented many e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance.

“We have a pretty good idea what will be in the FDA’s final regs and how will it affect vape shops and e-liquid manufacturers,” Chowdhury said. “Basically, anyone who’s mixing e-liquids would be considered a manufacturer, and your e-liquids will be subject to FDA regulation and inspections.”

“Unless the FDA makes major changes from their deeming regs, e-liquid companies must submit their entire list of ingredients and obtain pre-market approval from the FDA,” he said. “If they don’t comply, the FDA could shut them down forever. And it could happen as early as next spring.”

The FDA has sent its final deeming regulations to the Office of Management and Budget (OMB). This is the final step in the FDA’s process to regulate the marketing and manufacturing of vapor products.

Chowdhury said that even vape shops could be shut down for selling e-liquids the FDA classifies as “adulterated.”"
 

MacTechVpr

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...Chowdhury said that even vape shops could be shut down for selling e-liquids the FDA classifies as “adulterated.”"

Were it so, effectively abolition without the amendment part and regard for process or jurisdiction. The federal mandate sure has come a long way since the onset of gun regulations in the '60's. Our only recourse I fear is massive and comprehensive non-conformance by both distribution and retail biz for the FDA's suppressive product approval imperatives. Resolve to resist or alternatively shut down in fear as compliance will be fiscally open-ended. The independent vape industry needs strong voices to make clear that their non-compliance will be certain and in practical terms unavoidable. We are not tobacco…but freedom from tobacco. Proscribed and we will be, must be, NO NIC, NO TOBACCO. There goes the revenue cash cow. This is the message the OMB should be getting right now from everyone. So first there must be the will or we'll witness the maceration of this industry. I'd be looking for position on support at the state level for protection of my intra-state mercantile interests and those of my customers.

Compel the FDA to attempt a ban of nicotine directly instead of this duplicitous slight of hand forcing the issue back into legislative process. We must not be so addicted to bottled juices and the albeit fashionable nicotine juice bar marketing model. If vape biz fails to allow itself the option to adapt in self-defense it loses. And so do we all.

As with all central planning, the real fallacy here, which they have yet to acknowledge, is to assume you can decimate an industry yet still reap revenue from it.

I'll reward the inevitable opposition with my patronage.

Good luck all.

:)
 
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Jingles

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I think we should be regulated more like the food industry. Should all bakeries make chocolate cake with the exact same ingredients? If one bakery produces a bad cake, should all be shut down? Both chocolate cake and nicotine go into my body and I don't think chocolate cake is exactly healthy. Even when there are ecoli and salmonella outbreaks, they don't take all like products off the market. The FDA is being totally ridiculous in regards to nicotine!
 

Kent C

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I think we should be regulated

That's a non-starter for me. We - the vape industry and customers - have self-regulated where we have increasing innovation and better and safer products by our own demand and companies have seen that and complied. We drive the 'regulation' from the bottom up and it works. No top-down regulation is needed. Our flavors ARE the food industry flavors which are regulated. No more is needed or wanted.
 

Jingles

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That's a non-starter for me. We - the vape industry and customers - have self-regulated where we have increasing innovation and better and safer products by our own demand and companies have seen that and complied. We drive the 'regulation' from the bottom up and it works. No top-down regulation is needed. Our flavors ARE the food industry flavors which are regulated. No more is needed or wanted.
I can't argue with anything you said there!
 

zoiDman

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That's a non-starter for me. We - the vape industry and customers - have self-regulated where we have increasing innovation and better and safer products by our own demand and companies have seen that and complied. We drive the 'regulation' from the bottom up and it works. No top-down regulation is needed. Our flavors ARE the food industry flavors which are regulated. No more is needed or wanted.

One thing that Confuses me when I hear the expression "Self-Regulation" is can Regulation Exist without Enforcement of said Regulations?

If so, who Enforces things when Something or Someone is in Non-Compliance in this Self-Regulated Market? And what are the Actual Regulations that we are Self-Regulating ourselves to in the First Place?
 
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