FDA FDA's leaked guidance for PMTAs confirm deeming reg would ban >99.9% of nicotine vapor products

Status
Not open for further replies.

Endor

Super Member
ECF Veteran
Verified Member
Jan 31, 2012
687
2,074
Southern California
Adding this more for the historical record. This is a bit old-ish and needs to be taken with a grain of salt but I thought it would be worth a look see for those interested.

FDA Ruling On Cigars Frozen For Now –

In the comments section the blog's author claims they protect their sources, so who knows it could be something and it may also be nothing.
Thanks for sharing.

In some ways, it makes sense on several fronts. One, there appears to be no activity posted on Reginfo since mid-February, so it seems to be very stalled out right now. Two, the last two meetings posted on Reginfo were requested by US Senators; I don't know if this is normal, but it struck me as a bit curious. Three, if Obama is trying to open up the Cuba market, the last thing he needs is a whole lot of crazy regulations on cigars in the US hitting at the same time Cuban cigar imports are allowed.

If there is truth to this and we just happened to be a lucky bystander, I'll take it!
 

sofarsogood

Vaping Master
ECF Veteran
Oct 12, 2014
5,553
14,167
Thanks for sharing.

In some ways, it makes sense on several fronts. One, there appears to be no activity posted on Reginfo since mid-February, so it seems to be very stalled out right now. Two, the last two meetings posted on Reginfo were requested by US Senators; I don't know if this is normal, but it struck me as a bit curious. Three, if Obama is trying to open up the Cuba market, the last thing he needs is a whole lot of crazy regulations on cigars in the US hitting at the same time Cuban cigar imports are allowed.

If there is truth to this and we just happened to be a lucky bystander, I'll take it!
The headline would be "Cuban Dictator Saves Vaping in America"
 

Rossum

Eleutheromaniac
Supporting Member
ECF Veteran
Verified Member
Dec 14, 2013
16,081
105,222
SE PA
Correct me if I am wrong but, I saw nothing to indicate the vaping regs were put
on hold. " deeming regulations on cigars have been put to the side for now, say insiders, "
The article linked to only mentions cigars.
Regards
mike
It was kind of a package deal. IIRC the FDA had no authority to regulate cigars either, or anything except cigarettes, and they were trying to deem everything in sight, all in one fell swoop.
 

pennysmalls

Squonkmeister
ECF Veteran
Verified Member
Jul 26, 2013
3,138
8,472
51
Indiana
Correct me if I am wrong but, I saw nothing to indicate the vaping regs were put
on hold. " deeming regulations on cigars have been put to the side for now, say insiders, "
The article linked to only mentions cigars.
Regards
mike

See that's what I thought too but I don't see how the FDA could exempt cigars but still go after vaping so I thought just maybe, if this cigar thing is true, this will be our saving grace.
 

puffon

Vaping Master
ECF Veteran
Verified Member
  • Sep 18, 2014
    5,918
    15,748
    Florida

    zoiDman

    My -0^10 = Nothing at All*
    Supporting Member
    ECF Veteran
    Apr 16, 2010
    41,314
    1
    83,837
    So-Cal
    @schatz @pennysmalls @Rossum
    I hope you guys are right. I read the proposed Deeming Reg's and nothing
    in the proposal indicated to me it was a all or nothing deal.
    Regards
    Mike

    Man I would Love to read the Proposed Deeming Regulations.

    Do you have a Link to them?
     

    Robino1

    Resting in Peace
    ECF Veteran
    Sep 7, 2012
    27,447
    110,402
    Treasure Coast, Florida
    Man I would Love to read the Proposed Deeming Regulations.

    Do you have a Link to them?
    I don't think the actual ones are available. I do believe the only ones that are out there, are the ones that 'Could have been' or the 'worse case scenario'.
     

    zoiDman

    My -0^10 = Nothing at All*
    Supporting Member
    ECF Veteran
    Apr 16, 2010
    41,314
    1
    83,837
    So-Cal
    I don't think the actual ones are available. I do believe the only ones that are out there, are the ones that 'Could have been' or the 'worse case scenario'.

    Yeah... And what is Linked to in the 1st Post is only a Portion of what is going to be Implemented.
     

    Robino1

    Resting in Peace
    ECF Veteran
    Sep 7, 2012
    27,447
    110,402
    Treasure Coast, Florida
    Yeah... And what is Linked to in the 1st Post is only a Portion of what is going to be Implemented.
    We all have to wait and see what those playing with our lives are going to do. Waiting is a :censored:

    Hopefully it is giving us time to turn the tide. More is coming out that is positive news, compared to what we were seeing 2 years ago.
     

    zoiDman

    My -0^10 = Nothing at All*
    Supporting Member
    ECF Veteran
    Apr 16, 2010
    41,314
    1
    83,837
    So-Cal
    We all have to wait and see what those playing with our lives are going to do. Waiting is a :censored:

    Hopefully it is giving us time to turn the tide. More is coming out that is positive news, compared to what we were seeing 2 years ago.

    Yep... Heaven Forbid that the general public could get a Glimpse behind the Curtain. And Actually See what our government is going to do with a Product that effects 5 ~ 7% of the Population. And has the Potential to Save Hundreds of Thousands of Lives Every Year.

    "Meet the New Boss... Same as the Old Boss."
     

    Endor

    Super Member
    ECF Veteran
    Verified Member
    Jan 31, 2012
    687
    2,074
    Southern California
    @schatz @pennysmalls @Rossum
    I hope you guys are right. I read the proposed Deeming Reg's and nothing
    in the proposal indicated to me it was a all or nothing deal.

    Yes, I do to Skoony.

    The Intent document that was posted last year that opened the comment period did have an option to exclude "premium" cigars. I recall there was some open-ended definition as to what "premium" meant from a cost-per-cigar perspective. I also recall seeing a ton of comments to the FDA from the cigar community, probably outnumbering our comments by quite a bit.

    I think that many of us are assuming that the FDA has sent a final deeming rule to OIRA (which we don't have access too, even though it's supposed to be an "open" process...) and that OIRA will either a) accept them, or b) send them back to the FDA for revisions and resubmittal. I'm far from an expert, but I'm not sure if OIRA can accept it piecemeal, in other words, say that they accept the deeming for e-cigs but deny it for cigars; again, this supposedly "open" process seems to be all but open, so I'm not sure any of us really know.

    I read in the Califf Blog "premium" cigars may be exempt from the regs.
    Priorities – Teamwork to Achieve Common Goals | FDA Voice

    This is interesting. Obviously there is a pathway to eliminate premium cigars from the deeming as it stands today. Does Cuba only produce "premium" (which = expensive) cigars, I wonder? Or, would they also want to sell non-premium (less expensive) cigars in the US as well.... I don't know enough about the cigar market to have a clue.

    EDIT: There are, indeed two options in front of OIRA. From Reginfo.gov:

    "The proposed rule consists of two co-proposals, option 1 and option 2. The proposed option 1 deems all products meeting the statutory definition of "tobacco product" except accessories of a proposed deemed tobacco product to be subject to chapter IX of the FD&C Act. Option 1 also proposes additional provisions that would apply to proposed deemed products as well as to certain other tobacco products. Option 2 is the same as option 1 except that it exempts premium cigars."
     

    skoony

    Vaping Master
    ECF Veteran
    Jul 31, 2013
    5,692
    9,952
    68
    saint paul,mn,usa
    @Endor Thanks. That is what I was referring too. As I recall many people
    here read them and commented on them. Combined with the leaked PTMA
    it paints a pretty dim picture as to the possible outcome.
    I personally believe the deeming regs should be tossed completely and
    be left alone. We are not smoking. We are not exposed to anything pertaining
    to health risks that one can compare to the risks that are found in smoking.
    Yet another day has gone buy and the smoking gun that so many believe
    just has to be there because we don't know what it is yet,still hasn't appeared.

    Man I would Love to read the Proposed Deeming Regulations.

    Do you have a Link to them?
    https://www.gpo.gov/fdsys/pkg/FR-2014-04-25/pdf/2014-09491.pdf
    Regards
    Mike
     
    Status
    Not open for further replies.

    Users who are viewing this thread