Link to webcast of Dec. 17 FDA Public Hearing on NRT & Innovative Products

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orson

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One really annoying moment during the hearing was a presentation from a law professor from the University of Maryland. She came off like a rabid prohibitionist, and even accused R.J. Reynolds of having ulterior motives for getting into the NRT business.

Kathleen Dachille, she speeks right after Bill Godshall at the end of the second segment.

Second segment: https://collaboration.fda.gov/p95861884/
 

Drewsworld

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For those that watched, are watching, or show interest in this hearing , I wanted to ad a couple facts...
There were several CASAA board members as well as one or two CASAA members presenting yesterday. The FDA announced late in the game that they were only allowing one person from each "Agency or Org" so everyone that spoke didn't necessarily announce themselves a "CASAA" representatives...In order of Appearence...
Gregory Conley, Director, Medford, NJ, gconley@casaa.org First Speaker 8:30 in on this link https://collaboration.fda.gov/p98191651/
Dr. Carl V. Phillips, Science Director, cphillips@casaa.org 23:50 in on this link https://collaboration.fda.gov/p98191651/
Elaine Keller, President, Springfield, VA, ekeller@casaa.org 1:00 in on this link https://collaboration.fda.gov/p98191651/
Bill Godshaw Smokefree Pennsylvania (CASAA Advisor) 1:11 in on this link https://collaboration.fda.gov/p95861884/

There are a couple other CASAA members that spoke as well and I would like to personally thank all those that took the time at this busy time of year to prepare themselves and travel to DC to protect all our rights as vapers.

Standing Ovation Smiley here....
 
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FloridaNoob

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I have a question, why are the devices, as in our PV's considered a tobacco product, when some people actually use them w/o nicotene in them at all. Technically it is only the liquid that can actually contain the nicotene. It goes to having a regular pipe. If I use that pipe for tobacco I am fine, but if I use that pipe for *other* combustibles I am breaking the law. It is how you use it. If I use my PV with 0mg nicotene how can the FDA try and regulate something that they have already regulated as being safe, the PG/VG content?

I also can't see why they are trying to regulate nicotene are we going to have to get FDA approval on drinking coffee and soda next for the caffine content? Why isn't nicotene regulated as a supliment like caffine is in energy drinks?
 

kristin

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I have a question, why are the devices, as in our PV's considered a tobacco product, when some people actually use them w/o nicotene in them at all. Technically it is only the liquid that can actually contain the nicotene. It goes to having a regular pipe. If I use that pipe for tobacco I am fine, but if I use that pipe for *other* combustibles I am breaking the law. It is how you use it. If I use my PV with 0mg nicotene how can the FDA try and regulate something that they have already regulated as being safe, the PG/VG content?

I also can't see why they are trying to regulate nicotene are we going to have to get FDA approval on drinking coffee and soda next for the caffine content? Why isn't nicotene regulated as a supliment like caffine is in energy drinks?

E-cigarettes which contain no nicotine likely wouldn't be regulated as a tobacco product, but the FDA may require some sort of "proof" from companies that claim not to have nicotine in their cartridges/refill bottles, because a few tests of products labeled as 0 mg were found to actually have nicotine in them. E-cigarettes that claim to be smoking cessation products would likely have to submit to the FDA for approval as such regardless of nicotine content, because they would be presenting the product as a "treatment" for smoking addiction and the FDA requires such claims to be tested and proven "safe and effective" before they can be marketed as such.

Nicotine, because it is "addictive," extremely toxic and used as both a pesticide and drug treatment, has been regulated for years. This is nothing new. The FDA got control over regulating the tobacco industry in 2009 with the passing of the FPSTCA. So, the FDA basically has control of all forms of nicotine now.
 
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Bodach

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s§sZAN;8078790 said:
All the ingredients in the juice has already been approved by the FDA, so what's the problem? I just don't get it!
From what I understand, it's the long term effects of inhaling these components for long periods of time at once. Kind of like how carrots are safe, but if you started mainlining carrot juice, it would raise some eyebrows. Extreme example to clarify the point, but in the end, it comes down to big tobacco lobbying, in my opinion.
 

Gummy Bare

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I sure would hate to have to resort to black market smuggled ecig products and juice from the countrys that didn't ban them if it went down like that. That and unsafe home made flashlight mods and janky ... atimizors make from hardware stores and random radio shack parts.

Thanks to everyone fighting and sticking up for the rest of us that are uninformed, missinformed, and just pron to getting upset as the only responce. goverment organizations have a language all their own, it takes people on our side that can speak the same language.... I'm not one of them. But I'm glad for the people that are.
 

Lina

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And then I ask... hmmm what are the long term effects of smoking and just why are cigarettes legal?

From what I understand, it's the long term effects of inhaling these components for long periods of time at once. Kind of like how carrots are safe, but if you started mainlining carrot juice, it would raise some eyebrows. Extreme example to clarify the point, but in the end, it comes down to big tobacco lobbying, in my opinion.
 

Poeia

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The FDA campus was really, really pushing the fact that HHS properties are "tobacco-free." There were, however, no upper lip checkers during the meeting, so shockingly the enforcement seemed to be rather lax on the smokeless side.

A-UxGe5CAAE-SZJ.jpg
I'm really hung up on this sign. If the point is that all products containing nicotine extracted from a tobacco plant are prohibited at HHS, surely the patch, gum and lozenges should be taboo as well. After all, Glaxo isn't boiling tomatos to make Nicorette.

Thanks for the links. Working my way through slowly. Interesting stuff.
 

TennDave

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Skinny Pete, apparently, they take public input until mid-January and then they (FDA) will submit their "findings" to the government and at which time the FDA can recommend to extend the NRT time periods (if they choose- as this is what the 1 day "hearing" was all about)- currently NRT's are approved for a 120 days time period. We are talking about patches, gums and lozenges that are approved by the FDA. Of course, anyone over 18 can buy them at Walgreen and use them for as long as they want. The info collected by the FDA may also impact their course (in the future) regarding "deeming regulations" for unregulated tobacco products which they have said they plan to come out with. At leas this is my understanding of what can happen next. So, what do we do? We give public input and there are links in posts above supplied by Elaine and other CASAA members where you can give your opinion, insights, personal stories, research info, etc.
 
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