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Court orders FDA to set 10 month deadline for PMTA's

Discussion in 'FDA Regulations' started by squee, Jul 12, 2019.

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  1. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    [​IMG]

    ;)
     
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  2. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    Unless FDA files an appeal (as it should), it appears to me that Judge Grimm's order will result in:

    - a sharp increase of vapor product sales (especially open system vaporizers and 100/120ml bottles of e-liquid) as vapers stock up before FDA bans their sale (similar to 100 years ago just before alcohol prohibition took effect in the US),

    - several dozen PMTAs submitted to FDA by Altria/JUUL (for JUUL), BAT/Reynolds (for Vuse), Imperial/Fontem (for blu) by May 11, 2020 that FDA will actually evaluate (while FDA will immediately reject most/all other PMTAs due to "insufficient information"),

    - continued sales of most vapor products at most vape shops (and many convenience stores) for many months (perhaps a year or more) after May 11, 2020, as FDA doesn't have enough staff or budget to identify the million plus nicotine vapor products on the market, send letters to thousands of different manufacturers/importers notifying them of their newly banned products, and then visit and send letters
    to tens/hundreds of thousands of retailers notifying them of the many different banned vapor products on their shelves,

    - FDA will create/award a new multi billion $$$ nicotine vapor monopoly/cartel to one or several large tobacco companies in May 2021, which will sharply increase their stock value,

    - a new multi faceted $3B - $7B black/gray market for nicotine vapor products (after FDA sends out tens of thousands of letters notifying manufacturers and retailers of the banned products) will quickly emerge nationwide,

    - an increase in cigarette sales/consumption (as some vapers will switch back to cigarettes),

    - a decline in state vapor tax revenue (as nobody will pay taxes on banned vapor products),

    - news reports revealing that CDC/FDA misrepresented NYTS data for years to deceive the public about youth vaping in order to lobby for FDA regulations that banned/ban their sales to adults, and

    - hopefully, Donald Trump will be informed of these ramifications, and will order the FDA Commissioner to repeal the Deeming Rule because it was based upon false and misleading information, and was/is the worst federal regulation imposed by the Obama/Biden administration.

    Even if FDA appeals Judge Grimm's order, I suspect a similar scenario (cited above) will occur, but delayed by a year or more.
     
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  3. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    It's almost tempting to buy some Altria stock. It currently pays over 6% in dividends, and I sure can't get that in a savings account. ;)
     
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  4. zoiDman

    zoiDman My -0^10 = Nothing at All* ECF Veteran

    Supporting member
    Apr 16, 2010
    So-Cal
    Been There. Done That.
     
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  5. Jingles

    Jingles Ultra Member Verified Member ECF Veteran

    Supporting member
    Jul 18, 2011
    Ohio
    Someone point me in the direction of the Black Market when it's time to go there!
     
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  6. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    So you'd rather buy sketchy stuff at inflated prices later?

    The very fact that a market is "black" means that the vendor will be charging a substantial risk premium.
     
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  7. Horselady154

    Horselady154 Ultra Member Verified Member ECF Veteran

    Jan 15, 2013
    United States
    It isn't going to happen by osmosis. Is there a concise packet of information proving this that you are aware of, that we can each forward to our respective representatives and to President Trump too?
     
  8. Jingles

    Jingles Ultra Member Verified Member ECF Veteran

    Supporting member
    Jul 18, 2011
    Ohio
    I am hoping that some of my trusted juice vendors would go Black or just do private sales to their former customers.
     
  9. AvaOrchid

    AvaOrchid Super Member

    Sep 19, 2019
    USA
    It kills me that they keep basically saying we can't let kids use vaping to become addicted to nicotine because it might lead to cigarette smoking in the future and yet the focus is on the e-cigarettes and not what you're alluding to being the bigger problem the cigarettes themselves. Also if you're concerned that something may become a gateway the very last thing that you do is take that supposed Gateway out of the picture and leave the only option the saying you were allegedly afraid that Gateway was going to lead to. Basically if you don't want teens smoking cigarettes taking away vaping products it's not the best way to do it because then the only choice they're going to have is cigarettes so in that scenario the actual Gateway is the government regulation and overreach
     
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  10. P0P

    P0P Supplier Associate ECF Veteran

    Nov 23, 2011
    C'Ville Virginia
  11. zoiDman

    zoiDman My -0^10 = Nothing at All* ECF Veteran

    Supporting member
    Apr 16, 2010
    So-Cal
    • Like Like x 1
  12. Jman8

    Jman8 Vaping Master ECF Veteran

    Jan 15, 2013
    Wisconsin
    I see FDA items being challenged in court. I am wondering if anyone knows what happened with the "substantially equivalent" court challenge from a couple years ago? Reason I ask is cause I truly thought there was a challenge of some sort to the predicate date, of August 2007.

    And I honestly thought this memorandum was result of that ruling. Anyway, the "as of" statement is what I'm tripped up on. I literally had to google that. LOL. Or actually I googled: what does on the market as of Aug. 8, 2016, mean. Which actually lead to a variety of answers. One of those being what I think many understand it to be, and for sake of not having the argument here, I'm willing to go along with: "on or before that date."

    Yet, check this out. FDA says:

    *bolding emphasis mine

    FDA also says (in same document):

    Which essentially is where the legal challenge comes into play, no?

    And given the way the memorandum is worded, I don't see why a new tobacco product wouldn't be seen as "on market as of August 2016" rather than "on market as of February 2007."

    I think that opening line bears repeating:

    the FDA shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming Rule
     
  13. Jman8

    Jman8 Vaping Master ECF Veteran

    Jan 15, 2013
    Wisconsin
    So here's a link to the full court memorandum.

    Nowhere on that lengthy memo is February (2007) mentioned.

    It truly reads like this court has moved up the "new tobacco products" date from February 2007 to August 2016.

    I also (after checking the FDA site) strongly believe the FDA feels otherwise, but given the way the court ruling reads and the original FDA deeming reads, I'm quite surprised this isn't seen as possibly something else. Something beneficial to the industry, even while the whole ruling is fairly anti-industry.
     
  14. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    I believe the court worded it that way because anything that was not "on that market as of August 8, 2016" is already prohibited without PMTA approval.

    Now we all know that the FDA hasn't enforced the "no new products after 8/8/16 provision of the Deeming with a whole lot of vigor, but that doesn't seem to have been a major point of contention in this suit.
     
  15. Jman8

    Jman8 Vaping Master ECF Veteran

    Jan 15, 2013
    Wisconsin
    I'm not saying we ought to debate it, cause I don't see what that would amount to. But truly seems like it's worthy of legal challenge, given the wording and the FDA wording (I quoted before).

    The lawsuit this came from was group of people that are on opposite fence as us vs. FDA. That obviously wasn't going to work to our advantage. Yet, the way the ruling reads, it is technically to our advantage. Whether any of the many groups lined up for legal challenges see it that way, is another matter. Based on info I was seeing from 2016, it seems they don't.

    At this moment, it really does come down to the predicate date. Shame that slipped by us in terms of legal challenges.

    I honestly get the feeling that big players (on our side) want a black market. I realize that's contrary to common sense, but so far legal challenges outside of the NJoy one from a decade ago are not boding well for American vapers.
     
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