Deeming Regulations have been released!!!!

The Ocelot

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BTW - Here is what Mr. Zeller said on the PBS Newshour (May 5th, 2016. A Date which will Live in Infamy) when asked about the Banning of Flavors...

HARI SREENIVASAN: If you know what attracts the young kids is the flavors, why not have something that addresses the flavors today?

MITCH ZELLER: We will be able to address the rule of flavors in each and every one of the applications that the companies submitted for marketing authorization, and they will have to answer our questions about what role are the flavors in your products playing in initiation by kids and initiation by anyone who’s never used the product? We’ll be able to handle that through the applications.

Skyrocketing teen use of e-cigarettes leads to new regulations

How would that be possible?
 

Lessifer

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Snus has been around for 200 years and its safety record and efficacy are not under dispute.
Tell that to Swedish Match and their MRTP application.

BTW - Here is what Mr. Zeller said on the PBS Newshour (May 5th, 2016. A Date which will Live in Infamy) when asked about the Banning of Flavors...

HARI SREENIVASAN: If you know what attracts the young kids is the flavors, why not have something that addresses the flavors today?

MITCH ZELLER: We will be able to address the rule of flavors in each and every one of the applications that the companies submitted for marketing authorization, and they will have to answer our questions about what role are the flavors in your products playing in initiation by kids and initiation by anyone who’s never used the product? We’ll be able to handle that through the applications.

Skyrocketing teen use of e-cigarettes leads to new regulations
Ding Ding! From his lips to Bob's ear. Even more than the flavors aspect, what we should take away from this statement is "Anything we don't like, we simply won't approve."

Congress gave FDA the authority. So that point is moot for now. But e-cigs should be treated like other tobacco products, which are recreational products for adult users, like cigarettes and cigars. Period. The FDA doesn't ask BT to prove that cigarettes are "healthy" or "harmless." Au contraire, the FDA knows perfectly well that they are not.

Parity. :D
Actually, they kind of do. The PMTA process for all tobacco products is remarkably similar. That's why there's only been one PMTA approved in the past 7 years. The difference is, none of the cigarettes currently on the market ever had to go through the PMTA process.
 

Lessifer

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Some one still has to make the juice for the carto's unless of course bulk juice makers who are not covered simply sell wholesale to BT who puts it in there complete tamper proof vaping system that happens to come with e-juice already in it. It will be disposable because rechargeable's will be banned
as being responsible for most of the real serious injuries and as long as the juice wasn't bottled and labeled for individual sale it's all good. OMG,what did I just do and or why isn't the FDA giving me job
offers?

Someone already mentioned discrimination. Lets not forget the current reason du jure,
profiling.
:thumb:
Mike
From my reading that's exactly how it will work. The e-liquid, as long as its not being sold directly to consumers, is treated as a raw material. It's only when it becomes a finished tobacco product that it needs to pass PMTA. A complete device, including a prefilled liquid, would be a finished tobacco product. A sealed bottle of e-liquid that is sold directly to consumers is a finished tobacco product.
 

The Ocelot

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I know, but if we do that, they win. They don't mind us puffing on PG/VG, as long as we keep byuing their useless NRT products.

Okay, what about using Snus while vaping 0mg nic?

Thanks FDA! The deeming regulations have now forced me to learn how to use Snus, something I never considered before.
 

Katya

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Okay, what about using Snus while vaping 0mg nic?

Thanks FDA! The deeming regulations have now forced me to learn how to use Snus, something I never considered before.

That's what I used to do when I first started vaping. But snus (and dissolvables) offer more than just nic--you'll be getting a cocktail of those lovely minor alkaloids, which you may not be willing to go back to. Something to consider.

But I think it's too early to worry about that. I haven't seen anything in the deeming specifically addressing nicotine sales. Time will tell.

Got a freezer? :D
 

Lessifer

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That's what I used to do when I first started vaping. But snus (and dissolvables) offer more than just nic--you'll be getting a cocktail of those lovely minor alkaloids, which you may not be willing to go back to. Something to consider.

But I think it's too early to worry about that. I haven't seen anything in the deeming specifically addressing nicotine sales. Time will tell.

Got a freezer? :D
Admittedly this is just speculation, most of what I say is, but anything containing nicotine that is being sold to consumers that is not exempt as being a drug or drug delivery device is considered a tobacco product. All tobacco products that were not marketed for sale prior to 2007 must be approved via PMTA. Bulk nic liquid, if being sold directly to consumers, will need to be approved via PMTA. Given the health and safety concerns associated with 100mg/ml nicotine liquid, I would be surprised if any are approved.
 

Sir Kadly

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    I'm saying that according to his site, he was selling to Johnson & Johnson before us, making him not solely a vapor product wholesaler/distributor, like say MFS or Nude Nicotine would be. Now that you mention it though, I do remember him being on here. Makes me curious if J&J were truly purchasing from him.
    Actually that isn't what it says. It says it is made in the same labs as J&J.
     

    MacTechVpr

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    IMO, every PMTA submitted by a juice company will be rejected ... unless the juice is packed in a non refillable, leak proof cartridge that works on a proprietary one piece single device (also part of the same submitted PMTA).

    there will be zero PMTAs approved for eLiquid manufacturers wanting to supply juice for refilling the devices we have today.

    We'll know it…when they see it. :( Good luck.
     
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    Katya

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    Admittedly this is just speculation, most of what I say is, but anything containing nicotine that is being sold to consumers that is not exempt as being a drug or drug delivery device is considered a tobacco product. All tobacco products that were not marketed for sale prior to 2007 must be approved via PMTA. Bulk nic liquid, if being sold directly to consumers, will need to be approved via PMTA. Given the health and safety concerns associated with 100mg/ml nicotine liquid, I would be surprised if any are approved.

    smiley26.gif
     

    Kent C

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    That won't keep them from seeing adult products being advertised on TV. Might need stronger protections, but leave a bit air to breathe.

    But air has more formaldehyde and 'carbon particles' than most cloud chasing mods. :laugh:
     

    The Ocelot

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    Posted May 9, 2016
    Georgia State University News

    http://news.gsu.edu/2016/05/09/e-ci..._medium=email&utm_campaign=ecigarettesrelease

    Most smokers who have tried electronic cigarettes have rejected them as less satisfying than regular cigarettes, reducing their potential to be a “disruptive technology” that could help a significant number of smokers to quit, according to a recent study by a team of researchers at the Tobacco Center of Regulatory Science (TCORS) at Georgia State University.

    E-cigarettes, also referred to as Electronic Nicotine Delivery Systems or ENDS, “need to improve as a satisfying alternative or the attractiveness and appeal of regular cigarette must be degraded to increase the potential of ENDS replacing regular cigarettes,” according to lead author Dr. Terry F. Pechacek, professor of Health Management and Policy.
     

    Katya

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    But air has more formaldehyde and 'carbon particles' than most cloud chasing mods. :laugh:

    Here in California, it's been scientifically documented, actually--see USC study. I could find a link, but my headache is getting worse by the minute...
     

    zoiDman

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    Yeah. All I've seen is speculation because "nic base isn't mentioned in the regs." The way I see it, since there is no specific exemption listed, that makes it just another "tobacco product."

    Does the FDA need to Specifically mention Nicotine Base?

    It's an Liquid that contain Nicotine derived from Tobacco. I think that in-and-of-itself would "Deem" it to be a Tobacco Product.

    Right?
     

    Lessifer

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    Does the FDA need to Specifically mention Nicotine Base?

    It's an Liquid that contain Nicotine derived from Tobacco. I think that in-and-of-itself would "Deem" it to be a Tobacco Product.

    Right?
    That's what I said. That's why I don't understand why people think DIY will be unaffected. That's why I asked if there is another viable "intended use" for nic base.
     

    Katya

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    But air has more formaldehyde and 'carbon particles' than most cloud chasing mods. :laugh:

    Here are all the data from the USC study, including Compounds, Outdoor air, e-Cigarette, and normal cigarette.http://www.rsc.org/suppdata/em/c4/c4em00415a/c4em00415a1.pdf

    For your convenience, listed below are the amounts of Cr, Ni, Pb, Zn and Al in outdoor air vs e-cigarette vapor:
    wink.gif


    Cr: 5.53 vs 4.22
    Ni: 5.57 vs 6.14 (+/-2.9)
    Pb: 13.28 vs 9.85
    Zn: 54.31 vs 56.08 (+/- 21 [sic])
    Al: 333.27 (±62.93) vs 161.43 (±71.35)

    So, vapor is actually healthier, per this study, than the air we breathe here in SoCal. :lol:

     

    Katya

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    That's what I said. That's why I don't understand why people think DIY will be unaffected. That's why I asked if there is another viable "intended use" for nic base.

    Natural, organic, environmentally friendly insecticide? My roses are always pestered by aphids. :)
     

    WillyZee

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    If these deeming regs succeed in banning open tank systems and stuff the Vaping Genie back in the bottle ... that is when I will actively start advertising how I can help people quit smoking with Vape products that were on the market pre-regulations.

    They say that we cannot advertise vaping as a smoking cessation product ... stay tuned.

    This is only a hint of what I have been planning for a long time ... I did not buy all the mods I have for my own personal backups.

    This stop smoking with vaping project/study, will produce real data with very high success rates.

    so far the success rate for the folks I've helped quit smoking is at 100%
     

    Lessifer

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    Natural, organic, environmentally friendly insecticide? My roses are always pestered by aphids. :)
    According to Ocelot a few pages back the patent on the last commercially marketed pesticide that used nicotine was not renewed and expired years ago.

    Also, was it pure USP nicotine suspended in PG/VG? Was it something we would actually want to use as a base?
     

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