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FDA 3/13/19 Press Announcement

Discussion in 'FDA Regulations' started by RichardV, Mar 13, 2019.

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  1. RichardV

    RichardV Vaping Master Verified Member ECF Veteran

  2. zoiDman

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

    Supporting member
    Apr 16, 2010
    So-Cal
    May lead to Flavor Bans?

    This is the Procedural Mechanism to Ban Flavors.
     
    • Agree Agree x 4
  3. Opinionated

    Opinionated ECF Guru Verified Member ECF Veteran

    Supporting member
    Aug 19, 2015
    My Mountain
    Yep.. glad I mix because this has the intention to absolutely go after flavored e-liquids..

    Of the 7 adults I know in person who vape, only one prefers menthol to other flavors, and we are all over 30..

    This is stupid.. just stupid.
     
    • Agree Agree x 3
  4. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    Looks like they're bumping up the PMTA deadline from 8/8/2022 to 8/8/2021 for "flavored" products.
     
    • Agree Agree x 4
  5. MrsAngelD

    MrsAngelD Senior Member Verified Member ECF Veteran

    Aug 5, 2010
    A, A
    Ok so a couple of questions, does this apply to online vendors? Also what exactly are the repercussions of this? Basically I'm asking if someone can Explain it like I'm five...lol. I'm a bit confused about what this means.
     
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    • Optimistic Optimistic x 1
  6. Opinionated

    Opinionated ECF Guru Verified Member ECF Veteran

    Supporting member
    Aug 19, 2015
    My Mountain
    For manufacturers of flavored eliquids, or flavored eliquid products, the deadline for applicants been moved up by one year.

    After 8/8/2021 it will officially be illegal to sell flavored eliquid without a PMTA application on file, and the FDA plans on going after those manufacturers and sellers first, those who are trying to sell without an application filed.
     
    • Like Like x 2
    • Agree Agree x 1
  7. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    And in the meanwhile, it sounds like they're going to try to enforce age verification for on-line vendors of flavored vape products.

    Now age verification was supposed to have been "the law" for all "tobacco products" since 8/8/16, and quite a few vape vendors did implement it in some form in late 2016 (remember "BlueCheck"?), but it was very unpopular and many seem to have dropped it again, at least in part because there was effectively no enforcement against those who didn't implement it.
     
    • Like Like x 3
  8. Jumpin' In...

    Jumpin' In... Ultra Member ECF Veteran

    Sep 11, 2013
    Maui, Hawaii
    I don’t understand why there isn’t more chatter about this. I thought that YouTube would be exploding about this by now.

    Or maybe I’ve just had my head in the sand and most people are mentally prepared and are thinking “No big deal - we’re just losing 1/3 of the time we expected to have left.”

    Doesn’t this mean that the vast majority of commercially available, flavored eliquids will disappear after August 2021? Didn’t the FDA estimate the cost of filing a PMTA as being upwards of $300K per eliquid?

    Guess I’ll have to get into DIY a year or so earlier than planned. :unsure:
     
    • Like Like x 2
  9. bombastinator

    bombastinator ECF Guru Verified Member ECF Veteran

    Sep 12, 2010
    MN USA
    First thing I read in the first document:

    “This guidance document is being distributed for comment purposes only.
    Comments regarding this draft guidance may be submitted within 30 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Electronic comments may be submitted to Regulations.gov. Alternatively, submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
    For questions regarding this draft guidance, contact the Center for Tobacco Products at (Tel) 1- 877-CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m. – 4 p.m. ET.”

    Time to get the phone tree up and the letterbombs flying.


    Regarding text copy/paste instead of linking:
    Heh. Gov’t documents have no DMCA protections. The American people own them by definition
     
    • Agree Agree x 1
  10. bombastinator

    bombastinator ECF Guru Verified Member ECF Veteran

    Sep 12, 2010
    MN USA
    welcome to the magic of the news cycle. More important things are happening like that white supremicist wiping out an entire mosque in New Zealand. Plus it’s saturday.
     
    • Agree Agree x 2
  11. zoiDman

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

    Supporting member
    Apr 16, 2010
    So-Cal
    Yeah... And most Hardware will disappear the Following Year. And these, IMO, are Best Case scenarios.

    I also think that the Next and or the Acting FDA Commissionaire will Not take such a Look the Other Way approach to New Hardware that is being introduced after 8-8-16.

    I think the Vast Majority of people are Pretty Much disconnected with what is going on. Because for them, nothing really Changes from Day to Day.

    And Most Retailers don't see it in their best interest to Let their Customers know what is going on. Because about the Last thing a Retailer wants is for someone to switch to DIY. e-Liquids are where the Profits are.

    BTW - Not sure if you have ever Seen this thread? But if you Haven't, it will kinda Blow Your Mind.

    Heads Up - News - Updates Thread

    Because there is Stuff going on in Every State in the USA.
     
    • Agree Agree x 2
    • Optimistic Optimistic x 1
  12. bombastinator

    bombastinator ECF Guru Verified Member ECF Veteran

    Sep 12, 2010
    MN USA
    Iirc the by far most probable next acting FDA head is known, but when last I looked here almost nothing was known about her. Has this changed?
    part of that I think is that the “save the children” thing managed to quell discussion by dividing the nation into decided groups: those who believed them and those who didn’t.
    Those that believed them are generally non smokers who don’t really care if a bunch of other people die if it keeps their kid a little safer. Things are going their way, they think. (They’re really really not but that’s another thought)
    The other group, those that didn’t were given more reason to view the whole thing as blizzard of BS and stop paying attention. I happen to go to a philosophy discussion club, one member of which is (for a highly democratic state) a not insignificant republican official. I tried to tell him exactly what was missing from Chuck Shumer’s concepts on vaping from a DFL perspective and exactly how to make him look like a fool. To Democrats. He didn’t care. Not because making Chuck Shumer look like a ..... wasn’t handy, it was. The problem was he genuinely thought the whole vaping thing was a ridiculous distraction.
    ah a Marxist then. Wasn’t it Marx that said “when the time comes to hang the capitalists one of them will happily sell us the rope”? Or something similar anyway. I’m not a follower of Marx myself. Marx always struck me as being a lot better at pointing out problems than finding solutions. (Sorry, that was a barb I couldn’t help but plant)
     
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  13. zoiDman

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

    Supporting member
    Apr 16, 2010
    So-Cal
    Google is you Friend. Try "acting fda commissioner".

    ---

    Marxist?

    I won't even ask how far out of Left Field that one came out of?

    LOL
     
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    • Agree Agree x 1
  14. bombastinator

    bombastinator ECF Guru Verified Member ECF Veteran

    Sep 12, 2010
    MN USA
    That’s what made it so funny. It’s literally a Marxist statement.
     
  15. zoiDman

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

    Supporting member
    Apr 16, 2010
    So-Cal
    :lol:
     
    • Like Like x 1
  16. stols001

    stols001 Mistress of the Dark Nicotinic Arts Verified Member ECF Veteran

    Supporting member
    May 30, 2017
    Simple terms a four year old can understand....

    You know that stuff that comes out of your butt? This means the government is going to like, put some stuff INTO that hole and trust me, you will not enjoy it.

    Then, they will send you a bill, come lock up all your toys and if you protest too much, you might wind up in prison/dead.

    Etc

    Anna
     
    • Funny Funny x 1
  17. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    It sounds like nothing really disruptive is going to happen until after the election. Why piss off millions of vapers/voters until after you win a second term.

    What important action is going to happen sooner than 2 1/2 years?
     
    • Optimistic Optimistic x 1
  18. Rossum

    Rossum Surly Curmudgeon Verified Member ECF Veteran

    Supporting member
    Dec 14, 2013
    NE FL
    Nothing disruptive to most of us, but are we really representative of the vaping market anymore? The folks who tried a Juul they bought at a c-store and quit with it don't generally hang out here. I know I've read at least one report here of someone's relative (niece, I think) who fits the latter category and she's royally pissed that she can't get her favored mango Juul pods at such stores anymore.
     
    • Agree Agree x 3
  19. Opinionated

    Opinionated ECF Guru Verified Member ECF Veteran

    Supporting member
    Aug 19, 2015
    My Mountain
    This is what I was trying to express in the deeming thread before everyone got judgy and offended at my wording or equivocations..

    But we (former smokers who found a way away from smoking through vaping) are addicts, and our little stashes of nicotine isn't something everyone has.

    Heck most people who love us won't listen to us when we tell them they might need to purchase some nicotine, let alone the common vaper who has no contact with someone who knows what's going on.

    There will be millions back to smoking, and they probably won't even care that much because they will be told vaping was dangerous for them and had to be pulled from the market and they will trust that because they are used to trusting the government.

    I mean, they let cigarettes stay on the market so if they deem something too dangerous to be sold then it must be truly dangerous right?

    People will just smoke again and die again, and no one will care but us, and we just end up looking like conspiracy theory nutjobs.

    And whether anyone on this forum believes it or not, vaping for a few months or even a couple years does not always provide enough distance from a cigarette for most people to successfully put down vaping without ever returning to smoking cigarettes.
     
    • Agree Agree x 4
    • Optimistic Optimistic x 1
  20. sofarsogood

    sofarsogood Vaping Master ECF Veteran

    Oct 12, 2014
    Back in the day I quit smoking the old fashioned way and relapsed 10 years later. I've heard of that with others. It can't happen to me again because vaping is an entirely superior experience. (Did I forget to mention that it's also free for practicacl purposes?)

    In my neighborhood there are Wild Bill tobacco shops. Won't the entire Juul product line continue to be available there?

    I'm reading references to "flavored products". By that are they saying that the 2021 deadline will only apply to liquids and hardware with liquid built in, like Juul? Another thing I wonder about, the FDA wants eliquids to be in locations where children can't enter or in a separate area of a location where children can't enter. In my neighborhood virtually all gas stations have glass walls between the customer and cashier areas. The cigarettes are always behind the cashiers, out of reach. Doesn't that meet the standard?

    As far as I can tell Juul pods aren't in gas stations because of an action by Juul, not a new rule from the FDA. FDA progress is so glacial I wonder if they wish congress would clarify their authority before they start real enforcement. I read an article to the effect that the interim FDA comissioner says he knows Gottlieb's approach and supports it. Gottlieb says he is happy with his replacement. Summing up, are the FDA and Trump administration more on our side than it appears sometimes?

    The most puzzling thing to me is the apathy of most vapers, who won't speak out or stockpile, considering how easy and inexpensive they are.
     
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