Statement from FDA regarding flavors, etc in vaping.

Discussion in 'Vaping Related But Doesn't Fit In a Category' started by The Cromwell, Mar 14, 2019 at 12:28 PM.

  1. The Cromwell

    The Cromwell The Frugal Vapist VU Donator Diamond Contributor Member For 3 Years

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  2. ajvapes

    ajvapes Bronze Contributor Member For 2 Years

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  3. lordmage

    lordmage Joined The Crusade - it's PG/VG, not VG/PG!!! Staff Member Senior Moderator VU Donator Gold Contributor Member For 4 Years ECF Refugee

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    Snips below but tons of prevent youth use of Ends and all that jazz.

    We won’t tolerate a whole generation of kids becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same unreviewed products, and we’ll continue to put the full scope of our regulatory tools against this mounting public health crisis.
    We cannot allow a generation of children to become addicted to nicotine through e-cigarettes. If the 2019 National Youth Tobacco Survey continues to show sharp increases in youth use of tobacco products, the FDA will consider additional measures to address this crisis. We’ll take all appropriate actions necessary to stop these rates from increasing.
    • We expect that some flavored e-cigarette products will no longer be sold at all.
    • We expect that other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access, while premarket authorization for these products is sought from the FDA by 2021.

    Specifically, today, with the strong support of the Secretary of Health and Human Services Alex M. Azar, and President Donald J. Trump, the FDA is proposing to end our current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products (other than tobacco-, mint-, and menthol-flavored). Previously, for all ENDS products on the market as of Aug. 8, 2016, the FDA had announced our intention not to enforce the premarket review requirements until August 2022, with the expectation that many such products would remain on the market. In addition, under this previous policy, we intended to continue deferring enforcement while an ENDS product’s application was pending review.

    Under the proposed policy announced today, we’re putting all manufacturers and retailers on notice: you may be subject to FDA enforcement for selling certain flavored ENDS products without authorization.

    We’re proposing to prioritize enforcement of flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that are offered for sale in ways that pose a greater risk for minors to access the products. For instance, we’ll consider whether the products are sold under circumstances, whether at retail or online, without heightened age verification.

    Today’s draft guidance states our expectation that manufacturers of all flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that remain on the market under circumstances to limit youth access and appeal also submit their premarket applications by Aug. 8, 2021. This is an important change in our expectations and enforcement priorities. For all flavored ENDS products, including any that continue to be offered for sale under circumstances involving heightened age verification, the FDA expects manufacturers to prepare and submit applications that demonstrate these products meet the public health standard by Aug. 8, 2021.

    In addition, we’re proposing to prioritize enforcement of unauthorized ENDS products that are targeted to minors or likely to promote use of ENDS by minors. Any efforts that entice minors to use tobacco products are of particular concern to the FDA. For example, the agency has already issued warning letters for products that resemble kid-friendly foods and drinks or that resemble other non-ENDS products that are often consumed by youth. Manufacturers and retailers are on notice that we’ll continue to be vigilant about efforts to make tobacco products that appeal to kids.

    At this time, we aren’t proposing to end our current compliance policy as it applies to tobacco-, mint-, and menthol-flavored ENDS products, except for those products that are targeted to minors or likely to promote use of ENDS by minors. This approach reflects a careful balancing of public health considerations.

    n 2017, when the agency extended certain compliance deadlines for newly deemed tobacco products, we recognized that, to promote higher quality applications, we could provide greater transparency about our recommendations and requirements through guidance and rulemaking. We had already published some resources to aid industry application submission. For instance, the FDA has published thePremarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) draft guidance; we’ve published the Tobacco Product Master File Guidance and a Small Entity Compliance Guide for Deeming; and we’ve conducted educational webinarsdescribing, among other things, the statutory requirements for premarket applications. We continue to develop proposed rulemaking regarding the requirements for premarket submissions. Manufacturers, however, need not wait to engage the agency. Our door is open, and we welcome discussions with ENDS products manufacturers about their preparation of premarket submissions.
     
  4. ajvapes

    ajvapes Bronze Contributor Member For 2 Years

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    Gottleib on CNBC this morning

     
  5. The Cromwell

    The Cromwell The Frugal Vapist VU Donator Diamond Contributor Member For 3 Years

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    Not sure, did a quick scanover some of it and it appears that they want to ban all flavorings except tobacco and menthol... At least for vape products attractive to youths.

    Sounds like the enforcement delay is off for all vape stuff they think endangers our youth.
    They Think...
     
  6. ajvapes

    ajvapes Bronze Contributor Member For 2 Years

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    "We expect that other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access, while premarket authorization for these products is sought from the FDA by 2021." I think that b&m's will be spared and on-line with age verification....Seems to be a turn around...
     
  7. The Cromwell

    The Cromwell The Frugal Vapist VU Donator Diamond Contributor Member For 3 Years

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    looks like for now unless they are caught selling underage.
    Look for a rise in checks on that.
     
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  8. Dan Hollis

    Dan Hollis New Member

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    The FDA will continue to lose all credibility with me as long as they refuse to add the potential banning of traditional cigarettes to their proposal. You can’t tell me you will consider banning e-cigarettes all together because they might lead kids to smoke cigarettes, but keep actual cigarettes legal. How does that logic make any sense to these people? They can’t possibly be that dense, so the only possible explanation is that they are in big tobacco’s back pocket.

    If I am understanding their stance correctly, this is equivalent to banning colorful razor blades because they might inspire kids to slit their wrists, but allowing a product (lets call it the “Marlboro Wrist Slitter Bracelet”) that if worn will slit your wrist for you to remain legal.

    F*ck off FDA.
     
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  9. 2WhiteWolves

    2WhiteWolves Platinum Contributor Member For 2 Years

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    Just follow the money...
    They want to create... NEW DRUGS!!!! (or did I hear it wrong towards the end???) BIG PHARMA

    Yes, Fuck off FDA!!!
     
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  10. AndriaD

    AndriaD Happy... almost-Spring! VU Donator Diamond Contributor Member For 4 Years ECF Refugee

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    This bullshit has tempted me back over to Twitter where I've been raising hell to Tobacco Control for about 2 days now. Gawd that place is addictive! but I can't just sit on my hands and do nothing, I'm damn well going to express my rage and outrage!

    Andria
     
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  11. NGAHaze

    NGAHaze Gold Contributor Member For 4 Years

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    'We cannot allow a generation of children to become addicted to nicotine through e-cigarettes"

    But hey, at least we still let you get addicted to caffeine through coffee and soft drinks! And as an added bonus, we are also allowing you to continue to consume vast quantities of fast food despite the well known health implications associated with them.

    Two out of three ain't bad ... or so the song goes.

    :facepalm:
     
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  12. JuicyLucy

    JuicyLucy My name is Lucy and I am a squonkaholic Staff Member Senior Moderator VU Donator Diamond Contributor Member For 2 Years VU Challenge Team ECF Refugee

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    Follow the money?

    The segment starts with how the news of his resignation affected the stock market....
     
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  13. 2WhiteWolves

    2WhiteWolves Platinum Contributor Member For 2 Years

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    Everything about this is about control and money..... Big Gov and Big Pharma. Most of what these people say is smoke and mirrors...snowballing everyone. They don't give one rats ass about the children nor the adults. Like NGAHaze said...
    Hell, they might as well get on the ban hammer with potatoes, tomatoes, and green peppers too, though, they might be lower in nicotine, it's still nicotine.
     
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  14. lordmage

    lordmage Joined The Crusade - it's PG/VG, not VG/PG!!! Staff Member Senior Moderator VU Donator Gold Contributor Member For 4 Years ECF Refugee

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    the key thing is the products that are allowed on the market at B&M must not even allow minors into the store
    "if flavored ENDS products are sold in locations where minors can enter at any time (e.g., the entire establishment or an area within the establishment); or, for online sales, if the products are sold without an appropriate limit on the quantity that a customer may purchase within a given period of time, and without independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records. We’re also specifically seeking comment on, among other things, whether there are new technologies that can help prevent youth access at retail locations and intend to consider the use of those tools when we finalize the guidance.

    "Under the proposed policy announced today, we’re putting all manufacturers and retailers on notice: you may be subject to FDA enforcement for selling certain flavored ENDS products without authorization. Today’s draft guidance states our expectation that manufacturers of all flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that remain on the market under circumstances to limit youth access and appeal also submit their premarket applications by Aug. 8, 2021

    In short Local Sales to adults will still require third party id checks but will be allowed for products that have Applied for the PMTA.

    In short all END's Manufacturers Must Apply for a PMTA by Aug 8 2021 and if they apply their products may be allowed to stay on the market if they are not marketed or seem to be marketed to minors under the legal smoking age.

    Sale of those products must not allow for a minor's to purchase or enter a local store and must limit the amount that may be purchased at any given time.

    Finally If they see Youth use higher in the 2019 study they may remove all pods off the market as stated in the video and inm a way " If the 2019 National Youth Tobacco Survey continues to show sharp increases in youth use of tobacco products, the FDA will consider additional measures to address this crisis. We’ll take all appropriate actions necessary to stop these rates from increasing.
     
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  15. lordmage

    lordmage Joined The Crusade - it's PG/VG, not VG/PG!!! Staff Member Senior Moderator VU Donator Gold Contributor Member For 4 Years ECF Refugee

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    to paraphrase the C-store Ban may become everywhere...
    Flavors may not look or even appear to appeal to kids in anyway.
    Flavors are anything besides the big three (mint,menthol,tobacco)
    Kids are under 18
    manufacturer's must do a PMTA on all products or have at least started a PMTA.
    Retailers Online or Local Have to have third party age verification and restrict access to the store to 18+

    Finally if the 2019 study does not find lower youth use they may enforce more regulations on the retailer or pull products completely
     
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  16. The Cromwell

    The Cromwell The Frugal Vapist VU Donator Diamond Contributor Member For 3 Years

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    And any vape product not on the market by the 2007? date not approved by the PMTA process will be banned from sales on 2022?
    Have any vape products applied for the PMTA process?


    And will the age be 18 or 21 where such states have legislated that as the minimum age to buy 'tobacco products'?
     
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  17. Dan Hollis

    Dan Hollis New Member

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    These kids are more likely to die from diabetes than vaping, but l doubt they’ll be banning McDonald’s Happy Meals anytime soon. The hypocrisy in our government is outstanding. This nonsense might have worked in the old days where citizens still respected their government enough to believe their bullsh*t, but the Wizard’s curtain got pulled back a while ago, and we are wise to the game now. Honestly, I would prefer it if they were just honest and said “you wanna keep vaping legal? Here is our price.” Maybe then we can all cut to the chase, start a “Go Fund Me”, and pay them off to leave us alone.
     
  18. NGAHaze

    NGAHaze Gold Contributor Member For 4 Years

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    Politicians being honest? What world do you live in? :D

    Plus, they will never sell a potential cash cow as evidenced by the fact that cigarettes are still on the market. Don't get me wrong, I think they should still be available for those who choose to use them. The harm they cause is well known but we should still have the right to choose even if it isn't necessarily good for us. Just don't feed me a line of BS about how you are implementing all these restrictions via 'sin' taxes as a means to discourage smoking. They don't give a shit about smokers other than how much money they can squeeze out of them before they die.

    They see another potential revenue windfall via ecigs so they manufacture some moral outrage to justify attacking them in the exact same manner they did cigarettes, totally ignoring the potential good they could conceivably bring about. Save the children my ass. What about the kids that are now just going to go ahead and smoke cigarettes once they put the stranglehold on vaping? Never mind adult smokers, they never mattered in the first place.

    :gaah:
     
  19. obijuan77

    obijuan77 Bronze Contributor

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    Yes, they must get addicted to traditional cigarettes like the rest of us did, right FDA?
     
  20. ajvapes

    ajvapes Bronze Contributor Member For 2 Years

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    Agreed. It seems to me they have extended the application process, have yet to define public heath standards and are looking to see vaping operate to the same standards as any age restricted business. Of course all things can change ....
     
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  21. Letitia9

    Letitia9 Therion/Nano Junkie VU Donator Gold Contributor Member For 1 Year VU Challenge Team

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    The only thing that won't change is kids finding a way to do what is forbidden.
     
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  22. The Cromwell

    The Cromwell The Frugal Vapist VU Donator Diamond Contributor Member For 3 Years

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    Truth.
     
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  23. BobsHere

    BobsHere Silver Contributor Member For 1 Year

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    Would someone please explain the deeming, application deal thing?
     
  24. The Cromwell

    The Cromwell The Frugal Vapist VU Donator Diamond Contributor Member For 3 Years

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    Ahh in a nutshell any product not on the US market befor I think it is February 2007 is subject to having FDA approval through a approval process. The process is for each item ie each flavor of a juice line, each model of mod, atty, etc. Change anything and it must be re-approved.
    The process requires testing data to show it is safe and is rumored to cost over $500,000 per application.
    With no guarantee of approval.
    Technically this approval is required before any vape product not sold here before 2007 can be sold in the USA without this approval process being completed. Products sold between 2007 and 2016 are applied to a delay in the permitting process and can be sold.
    The deadline got extended and products on the US market before 8-8-2016 are on probation so to speak.

    Also all products not on the market prior to 8-8-2016 are being sold in violation of the FDA deeming regs.
    No product not on the US market prior to 8-8-2016 is allowed to be sold without FIRST passing the permitting process.
    Enforcement has been delayed but that can change at any time.

    Violations of the Deeming regs can result in penalties up to $1,000,000.

    I think PMTA stands for Pre Market Tobacco Approval.
     
  25. BobsHere

    BobsHere Silver Contributor Member For 1 Year

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    Thank you. I have no idea how we will have vape products once this is enforced. None
     
  26. The Cromwell

    The Cromwell The Frugal Vapist VU Donator Diamond Contributor Member For 3 Years

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    Most all homemade or used since they even addressed importing them.
    Not absolutely sure if the importing ban thing was for resale or individual end users though.

    Of course things could change for the better in the next couple of years.
    Hope so but don't count on it.
    Actually them charging fees on vape stuff is the most promising hint that vape may not totally go away.
    But unless massive deregulation of the regulations most all of it will go away in a little over 2 years.
    It was technically supposed to go away in 2017 I think it was...
     
  27. AndriaD

    AndriaD Happy... almost-Spring! VU Donator Diamond Contributor Member For 4 Years ECF Refugee

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    They "deem" e-cigarettes to be "tobacco products." If you've ever read "The Emperor's New Clothes," you'll recognize the behavior.

    The FDA is buck nekkid and they know it, but that doesn't stop them from PRETENDING they have the power to do a damn thing except make vaping more difficult.

    Andria
     
  28. Dan Hollis

    Dan Hollis New Member

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    Stock up on vape gear while you can and slowly transition yourself to 0mg ejuices so you can DIY.
     
  29. The Cromwell

    The Cromwell The Frugal Vapist VU Donator Diamond Contributor Member For 3 Years

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    Nic will keep for years in a deep freeze in glass bottles.
     
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  30. AndriaD

    AndriaD Happy... almost-Spring! VU Donator Diamond Contributor Member For 4 Years ECF Refugee

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    Yeah, there's no need at all to vape 0mg just because you DIY -- buy the nicotine and mix your own eliquid, piece of cake.

    Think I've still got about 3.5 liters of 100mg/ml in the freezer.

    Andria
     
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