PMTAs - who is doing what?

Status
Not open for further replies.

rosesense

15years and counting
Supporting Member
ECF Veteran
Verified Member
Contest Winner!
  • Jan 1, 2010
    17,697
    52,264
    TN
    Apparently there are quite a few companies that have either already filed PMTAs or plan to before 9/9. I'm not sure if I'm allowed to do this, but some people on Reddit are compiling a list.

    .
    I am surprised at the number going for it. Kudos to them. Not much about hardware though, I hope innokin and the others do make it through.
     

    markfm

    Aussie Pup Wrangler
    ECF Veteran
    Verified Member
    Jul 9, 2010
    15,268
    45,866
    Beautiful Baldwinsville (CNY)
    Um I somehow thing US customs knows FT has a "discreet" packaging option also.

    No way am I buying from China until reports start trickling in from October.

    I mean, if you get a "we intercepted your package" and we sent it back letter, and you are out some money that's annoying and bad, but worth consideration if you really NEED something.

    If you get a hefty fine and or whatever else, no thank you. I don't think the FDA has made that clear. I could be wrong IDK.

    Anna
    There's no hefty fine for me as a buyer.

    PMTA is about what a vendor can sell, not about what I can use.

    It's analogous to eliquids where I live in central NY. I can own eliquids, I can make eliquids (not for sale). My ability to buy commercial eliquids, however, has pretty much gone up in smoke (d'oh [emoji16]) Vendors won't sell me eliquids because they bear financial liability, real fines.

    (I did get one last order of a commercial liquid I had wanted to try in early July, slipped through the cracks before all the suppliers got their warnings and updated order processing. Glad I did, since I came up with a pretty decent DIY clone that I like.)
     

    MacTechVpr

    Vaping Master
    ECF Veteran
    Verified Member
    Aug 24, 2013
    5,725
    14,411
    Hollywood (Beach), FL
    Unless I've missed something, or misread analysis by others, where would the legal basis be for the FDA to order interception and destruction of a private purchase from overseas? There is no ban on the purchase of vape products but a requirement for US manufacturers and resellers to register with the FDA. I would call interference with private individual contracts of good to be a significant over-reach.

    Good luck. :)
     

    Territoo

    Diva
    Supporting Member
    ECF Veteran
    Verified Member
  • Jul 17, 2009
    7,696
    37,949
    Texas
    Unless I've missed something, or misread analysis by others, where would the legal basis be for the FDA to order interception and destruction of a private purchase from overseas? There is no ban on the purchase of vape products but a requirement for US manufacturers and resellers to register with the FDA. I would call interference with private individual contracts of good to be a significant over-reach.

    Good luck. :)

    The ban includes importation as well. Besides when does the government have to be logical in when comes to over-reach.:evil:
     

    MacTechVpr

    Vaping Master
    ECF Veteran
    Verified Member
    Aug 24, 2013
    5,725
    14,411
    Hollywood (Beach), FL
    The ban includes importation as well. Besides when does the government have to be logical in when comes to over-reach.:evil:

    There should be a distinction I believe between importation for resale and personal consumption. Further I understand the courts have proscribed an outright ban of vape products. Again, if I've missed something in the last 8 years please forgive.

    If an article or commodity is forbidden, where is the basis to do anything beyond collecting the self-prescribed "taxes" associated with FDA rules? Where does the TCA or any other law grant the FDA police authority? Tobacco is not a scheduled drug to warrant such confiscatory measures.

    If we have a reason to fear such as individuals at this point, we've travelled quite far.

    Good luck. :)
     
    Last edited:

    UncLeJunkLe

    ECF Guru
    ECF Veteran
    Verified Member
    Nov 29, 2010
    10,626
    2
    28,682
    ¯\_(ツ)_/¯
    Unless I've missed something, or misread analysis by others, where would the legal basis be for the FDA to order interception and destruction of a private purchase from overseas? There is no ban on the purchase of vape products but a requirement for US manufacturers and resellers to register with the FDA. I would call interference with private individual contracts of good to be a significant over-reach.

    Good luck. :)

    I can't remember the exact year but it I think was 2010 or 2011.
    US customs was confiscating vape shipments. I only knew about it because ECFers were reporting about it. I personally did not buy vape from outside the USA back then.

    I don't know who gave orders to do it.
    I don't know what the reason was.
    I don't know why it stopped.
     

    Territoo

    Diva
    Supporting Member
    ECF Veteran
    Verified Member
  • Jul 17, 2009
    7,696
    37,949
    Texas
    I can't remember the exact year but it I think was 2010 or 2011.
    US customs was confiscating vape shipments. I only knew about it because ECFers were reporting about it. I personally did not buy vape from outside the USA back then.

    I don't know who gave orders to do it.
    I don't know what the reason was.
    I don't know why it stopped.

    I recall that too.
     

    Katya

    ECF Guru
    Supporting Member
    ECF Veteran
    Verified Member
    Feb 23, 2010
    34,804
    120,147
    SoCal
    I can't remember the exact year but it I think was 2010 or 2011.
    US customs was confiscating vape shipments. I only knew about it because ECFers were reporting about it. I personally did not buy vape from outside the USA back then.

    I don't know who gave orders to do it.
    I don't know what the reason was.
    I don't know why it stopped.

    First salvo, 2009:

    FDA wants to extinguish electronic cigarettes

    "Concerned that e-cigarette products do not contain health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes, the agency has begun looking into how the products are being marketed. Besides finding traces of the toxic antifreeze component diethylene glycol, the FDA's Division of Pharmaceutical Analysis also discovered carcinogens such as nitrosamines in the samples it tested."

    "Put on the defensive by the FDA's seizure of e-cigarette shipments at U.S. borders, makers of these products have challenged in federal district court the agency's jurisdiction over this situation. In a May court filing, e-cigarette makers Sunrise, Fla.–based Smoking Everywhere, Inc., and Sottera, Inc., in Scottsdale, Ariz., (makers of the NJOY brand) sought a preliminary injunction against the FDA's seizures. The agency earlier this month responded with a document stating the confiscations should be allowed to continue because the e-cigarettes meet the definition of both a drug and device under the Federal Food, Drug, and Cosmetic Act Family Smoking Prevention and Tobacco Control Act signed into law last month."
     
    Last edited:

    MacTechVpr

    Vaping Master
    ECF Veteran
    Verified Member
    Aug 24, 2013
    5,725
    14,411
    Hollywood (Beach), FL
    Where we stood…

    HIGH COURT HOLDS F.D.A. CAN'T IMPOSE RULES ON TOBACCO

    Then came the ambiguous TCA in 2009 and broad deference to the FDA which left "tobacco" undefined as regards vaping. But nowhere do I see or find a police or confiscatory power granted the FDA.

    I was not involved at the subsequent period of shipment seizures but seem to recall some court action/s stemmed it.

    However, the track of discussion is how any of this relates to the possibility of confiscation involving individual purchases of vaping products. I am curious if anyone recalls any addition to deeming rules or case law that might allow the FDA such an assumption of authority. Don't want to broaden this too much.

    Good luck. :)

    p.s. A Historical Timeline of Electronic Cigarettes
     
    Last edited:
    • Like
    Reactions: stols001

    zoiDman

    My -0^10 = Nothing at All*
    Supporting Member
    ECF Veteran
    Apr 16, 2010
    41,619
    1
    84,742
    So-Cal
    Unless I've missed something, or misread analysis by others, where would the legal basis be for the FDA to order interception and destruction of a private purchase from overseas? There is no ban on the purchase of vape products but a requirement for US manufacturers and resellers to register with the FDA. I would call interference with private individual contracts of good to be a significant over-reach.

    Good luck. :)

    Put the Shoe on the Other Foot.

    After Sept 9th, will it be Legal for a Foreign Seller to Sell a Non PMTAed "Tobacco Product" to a US Buyer?
     
    Last edited:
    • Like
    Reactions: MacTechVpr

    thanswr1

    Super Member
    ECF Veteran
  • Jan 16, 2017
    341
    1,308
    70
    Put the Shoe on the Other Foot.

    After Sept 9th, will it be Legal for a Foreign Seller to Sell a Non PMTAed "Tobacco Product" to a US Buyer?

    What I'm wondering is if it will be legal for Fasttech to keep selling me filters. Apparently, for umpteenth years, that's all they've been selling to me. ;)
     

    MacTechVpr

    Vaping Master
    ECF Veteran
    Verified Member
    Aug 24, 2013
    5,725
    14,411
    Hollywood (Beach), FL
    Put the Shoe on the Other Foot.

    After Sept 9th, will it be Legal for a Foreign Seller to Sell Non PMTAed "Tobacco Product" to a US Buyer?

    PMTA's are a requirement imposed upon US makers and sellers of record, are they not? Why would such fall on any other foot? FDA has no jurisdiction on production of other nations, i.e. unless Congress makes it so (protectionism). I see no ban on Chinese products in law or spec to which consumers should conform.

    Hell, we don't even know what an approved product looks like by definition. That's the bogus irony of all this. It's all tobacco…so just pay us 'tilll we figure it out. The whole framework smacks of ex post facto law — we'll know it when we see it. There's no canvas wide enough given this preposterous [and precarious] excuse for legislation and regulation.

    If there is a legitimate concern about the PMTA requirement (deeming) serving as the basis for personal property confiscation, I'm def curious what that might be.

    Good luck. :)
     
    Last edited:
    • Like
    Reactions: DavidOck

    zoiDman

    My -0^10 = Nothing at All*
    Supporting Member
    ECF Veteran
    Apr 16, 2010
    41,619
    1
    84,742
    So-Cal
    PMTA's are a requirement imposed upon US makers and seller of record, are they not? Why would such fall on any other foot? FDA has no jurisdiction on production of other nations, i.e. unless Congress makes it so (protectionism). I see no ban on Chinese products in law or spec to which they should conform.

    Hell, we don't even know what an approved product looks like by definition. That's the bogus irony of all this. It's all tobacco…so just pay us 'tilll we figure it out. The whole framework smacks of ex post facto law — we'll know it when we see it. There's no canvas wide enough given this preposterous excuse for legislation and regulation.

    If there is a legitimate concern about the PMTA requirement (deeming) serving as the basis for personal property confiscation, I'm def curious what that might be.

    Good luck. :)

    Not say'n the FDA has any Authority over a Foreign Companies production. Or what or how they Sell to Other Nation's Companies or Citizens.

    My Question was Does the FDA have any Power with regards to a Foreign Company Selling an Non PMTAed Tobacco Products to an Individual in US?

    Especially given that...
    The Sale Originated Inside the USA
    And that the US Funds were used to Fulfill the Sale
    And if a US Company/CC/Bank was used to Facilitate the Sale
    And Finally, a US Entity would be Needed to Deliver the Goods
     
    Last edited:
    • Agree
    Reactions: Territoo

    MacTechVpr

    Vaping Master
    ECF Veteran
    Verified Member
    Aug 24, 2013
    5,725
    14,411
    Hollywood (Beach), FL
    No say'n the FDA has any Authority over a Foreign Companies production. Or what or how they Sell to Other Nation's Companies or Citizens.

    My Question was Does the FDA have any Power with regards to a Foreign Company Selling an Non PMTAed Tobacco Products to an Individual in US?

    Especially given that...
    The Sale Originated Inside the USA
    And that the US Funds were used to Fulfill the Sale
    And if a US Company/CC/Bank was used to Facilitate the Sale
    And Finally, a US Entity would be Needed to Deliver the Goods

    I don't know. Have laws been written across the US code targeting e-cigs at every level?

    Does FDA have authority and jurisdiction over fiduciary transactions? Am I a subject of the FDA because I conduct such contracts internationally, independent and removed of their defined regulated merchants and makers? Does FDA have auth and juris over interstate carrier transport? Direct authority (without warrant) to command law enforcement seizure (at any level) of personal property? That is precisely what I'm asking. They might, I'd wager if nicotine were a scheduled drug and tobacco specifically deemed to be nicotine. But the courts so far have found otherwise I think having ruled FDA could regulate it as a "drug" if they so choose. They haven't, to my knowledge.

    Anything a maker imports or incorporates into an end product for a direct market sale, or the sale of such by their ultimate reseller/s qualifies as subject to regulation to my understanding.

    So that's what I'm asking expressly: From where does the authority and jurisdiction derive for the FDA to intercede in consumer direct orders abroad? Has there been an import ban?

    Do we need to fear this?

    Good luck. :)
     
    • Like
    Reactions: Rossum

    zoiDman

    My -0^10 = Nothing at All*
    Supporting Member
    ECF Veteran
    Apr 16, 2010
    41,619
    1
    84,742
    So-Cal
    I don't know. Have laws been written across the US code targeting e-cigs at every level?

    Does FDA have authority and jurisdiction over fiduciary transactions? Am I a subject of the FDA because I conduct such contracts internationally, independent and removed of their defined regulated merchants and makers? Does FDA have auth and juris over interstate carrier transport? Direct authority (without warrant) to command law enforcement seizure (at any level) of personal property? That is precisely what I'm asking. They might, I'd wager if nicotine were a scheduled drug and tobacco specifically deemed to be nicotine. But the courts so far have found otherwise I think having ruled FDA could regulate it as a "drug" if they so choose. They haven't, to my knowledge.

    Anything a maker imports or incorporates into an end product for a direct market sale, or the sale of such by their ultimate reseller/s qualifies as subject to regulation to my understanding.

    So that's what I'm asking expressly: From where does the authority and jurisdiction derive for the FDA to intercede in consumer direct orders abroad? Has there been an import ban?

    Do we need to fear this?

    Good luck. :)

    As to Jurisdiction or Authority over an Individual with No Intent to Re-Sell, I don't think there is much Debate. e-Cigarettes are Not Illegal to Own or to Use at the Federal Level.

    But to have a Sale, you need Both a Buyer and a Seller. And it is as to the Seller where all the Debate has been. Honestly, I Don't know the Answer Either.

    The FSTCA gave the FDA broad authority over the "Sale" of "Tobacco Products". And Many Believe that the FDA's Authority is Implied as soon as a "Tobacco Product" arrives on US Soil.

    Some argue that the Justice Department would be the Ones who would need to Perform any Actions.

    A Few say that No One have Authority over "Imported" Non PMTAed "Tobacco Products".

    The Whole thing sounds like Something that a Bunch of Lawyers can get Rich over Arguing whatever side one chooses.
     
    • Agree
    Reactions: DavidOck

    zoiDman

    My -0^10 = Nothing at All*
    Supporting Member
    ECF Veteran
    Apr 16, 2010
    41,619
    1
    84,742
    So-Cal
    I don't know. Have laws been written across the US code targeting e-cigs at every level?

    Does FDA have authority and jurisdiction over fiduciary transactions? Am I a subject of the FDA because I conduct such contracts internationally, independent and removed of their defined regulated merchants and makers? Does FDA have auth and juris over interstate carrier transport? Direct authority (without warrant) to command law enforcement seizure (at any level) of personal property? That is precisely what I'm asking. They might, I'd wager if nicotine were a scheduled drug and tobacco specifically deemed to be nicotine. But the courts so far have found otherwise I think having ruled FDA could regulate it as a "drug" if they so choose. They haven't, to my knowledge.

    Anything a maker imports or incorporates into an end product for a direct market sale, or the sale of such by their ultimate reseller/s qualifies as subject to regulation to my understanding.

    So that's what I'm asking expressly: From where does the authority and jurisdiction derive for the FDA to intercede in consumer direct orders abroad? Has there been an import ban?

    Do we need to fear this?

    Good luck. :)

    BTW - Way Back in the day, when the FDA instructed US Customs to Intercept e-Cigarettes, Judge Leon said the FDA couldn't do this because they Lacked Legal Authority because we Argued that e-Cigarettes were Not Drug Deliver Devices. That we used them for the Recreational Use of Tobacco. And He Agreed.

    But he said that if e-Cigarettes were "Deemed" as to be "Tobacco Product", then the FDA Would have the Authority over them.

    It was the 1st Time I heard the word "Deeming". And I Cringed when I heard it knowing the Road we would have to Go Down.
     
    Last edited:

    MacTechVpr

    Vaping Master
    ECF Veteran
    Verified Member
    Aug 24, 2013
    5,725
    14,411
    Hollywood (Beach), FL
    BTW - Way Back in the day, when the FDA instructed US Customs to Intercept e-Cigarettes, Judge Leon said the FDA couldn't do this because they Lacked Legal Authority because we Argued that e-Cigarettes were Not Drug Deliver Devises. That we used them for the Recreational Use of Tobacco. A He Agreed.

    But he said that if e-Cigarettes were "Deemed" as to be "Tobacco Product", then the FDA Would have the Authority over them.

    It was the 1st Time I heard the word "Deeming". And I Cringed when I heard it knowing the Road we would have to Go Down.

    I saw that as I looked by thru my bookmarks and CASAA's timeline. Remember I cringed too when I saw that cavalier position. Including the more recent deference by SCOTUS as to FDA interpreting its own rules (well except if the SCOTUS takes exception seeing its own authority). Talk about convoluted ball of wax. WTF has the law gone off to? There's such a rotten stench of indifference to public will such as I've never seen.

    We have travelled too far…they are gods in their own minds.

    Also don't misconstrue please. I've slowed down in recent years and don't have the stamina to follow as closely as I have in past. I appreciate very much the efforts you and others make to dissect as much of the developments as you have. Enjoy reading everyone's take on these issues. Truly regret how things have gone but Oliver was right on point with many of his projections. It was one of the things that prompted me to join and be a part of the solution if possible.

    Best of luck Z, and all. We'll vape on here. :)

    p.s. Still would like to know everyone's read on any FDA presumption of auth to seize.
     

    zoiDman

    My -0^10 = Nothing at All*
    Supporting Member
    ECF Veteran
    Apr 16, 2010
    41,619
    1
    84,742
    So-Cal
    I saw that as I looked by thru my bookmarks and CASAA's timeline. Remember I cringed too when I saw that cavalier position. Including the more recent deference by SCOTUS as to FDA interpreting its own rules (well except if the SCOTUS takes exception seeing its own authority). Talk about convoluted ball of wax. ... has the law gone off to? There's such a rotten stench of indifference to public will such as I've never seen.

    We have travelled too far…they are gods in their own minds.

    Also don't misconstrue please. I've slowed down in recent years and don't have the stamina to follow as closely as I have in past. I appreciate very much the efforts you and others make to dissect as much of the developments as you have. Enjoy reading everyone's take on these issues. Truly regret how things have gone but Oliver was right on point with many of his projections. It was one of the things that prompted me to join and be a part of the solution if possible.

    Best of luck Z, and all. We'll vape on here. :)

    p.s. Still would like to know everyone's read on any FDA presumption of auth to seize.

    It's been a Long Road Traveled. With Many Twists and Turns. And I guess I Always Knew that we would Eventually get to the End.

    It just Seems Surreal that we are Finally Here.

    And that Something that has the Potential to Reduce So Much Harm is going to be Ground Down Under the Wheel by those Entrusted to Ensure Public Health.
     
    Last edited:
    Status
    Not open for further replies.

    Users who are viewing this thread