PMTAs - who is doing what?

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Myrany

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Was surprised to see an email this morning from EightVape pushing Glas brand e-liquid with flavors like "Fizzy Lemonade," "Strawberry Gummy," and "Sugar Cookie." One would think that submitting PMTA applications for items like that is a guaranteed waste of money & effort. ???
They could be betting they can make more than the cost of the PMTA before being rejected.
 

Koolkiz

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Was surprised to see an email this morning from EightVape pushing Glas brand e-liquid with flavors like "Fizzy Lemonade," "Strawberry Gummy," and "Sugar Cookie." One would think that submitting PMTA applications for items like that is a guaranteed waste of money & effort. ???
A casual look at the vape Pmta site and glass is on there.
You don't need to be a coder
 

zoiDman

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Was surprised to see an email this morning from EightVape pushing Glas brand e-liquid with flavors like "Fizzy Lemonade," "Strawberry Gummy," and "Sugar Cookie." One would think that submitting PMTA applications for items like that is a guaranteed waste of money & effort. ???

Are we sure that those Line-Items were part of the PMTA's that Glas submitted?
 
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Rossum

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Yeah... There must be a Lot of them.

But Maybe because I'm Jaded and Cynical, and as an e-Cigarette user having been Kicked at every Bend in the Road, I Firmly believe that "Premium Cigars" are going to get a Pass by the FDA.

And all those PMTA's for "Premium" Cigars" will somehow get Converted into a "Streamlined" SE just for the Higher End Cigar Market. Probably just some eForm to Fill Out.

FDA Plans to Defer PMTA Enforcement for Some Cigars; Not Vapes - Vaping360

https://www.tobaccolawblog.com/wp-c...8/Dkt-214-Memorandum-Opinion-and-Order-c2.pdf
I don't disagree that "premium" cigars may get something of a pass. And TBH, I don't have a problem with that. Personally, I've never cared for cigars, but my sense is that "premium" cigars don't cause much in the way of public health issues, nor do the have much appeal with the kiddies.

Of course if they do get the kind of "pass" that you're describing, that doesn't change the fact that they are "deemed products" and probably account for a plethora of SKUs.
 

zoiDman

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I don't disagree that "premium" cigars may get something of a pass. And TBH, I don't have a problem with that. Personally, I've never cared for cigars, but my sense is that "premium" cigars don't cause much in the way of public health issues, nor do the have much appeal with the kiddies.

Of course if they do get the kind of "pass" that you're describing, that doesn't change the fact that they are "deemed products" and probably account for a plethora of SKUs.

I think the Part that Feels like a Bone in the Throat for me is that the FDA is in all Likelihood going to Apply the FSPTCA and the Deeming Rule set differently for certain sectors of the "Tobacco Market".

Easy and Affordably for some. Horrendous and Unaffordable for Others. And I have a Good Idea where We will Fall into the FDA's Shades of Grey.

I've got Nothing against "Premium Cigars". But it does seem a Tad Disingenuous to make a Big Deal over e-Cigarettes and not over some Form of Combustible Tobacco.

That is, If the Goal of the FDA is actually about Public Health for the Entire Public.
 
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zoiDman

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I think I posted this Here before? But if Not, here it is.

---

Here is a Site that is putting together a Database of who has and has not submitted a PMTA.

You don't need to be a coder

Still Very Little Information as to Actual Line Items. But I would say that is by Design for Many OEM's and Retailers.
 

Juice Chris

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I think I posted this Here before? But if Not, here it is.

---

Here is a Site that is putting together a Database of who has and has not submitted a PMTA.

You don't need to be a coder

Still Very Little Information as to Actual Line Items. But I would say that is by Design for Many OEM's and Retailers.
LOL you beat me to the post by a few minutes, I was just preparing to paste this site as well. Nice layout they built out there.
 

Rossum

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UncLeJunkLe

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    Uwell claims to have submitted PMTAs. From their site:

    'UWELL has been preparing the PMTA for quite some time and we have submitted PMTAs to the FDA, and will submit more and more PMTAs for more products in the future. Our Popular Products: [list of popular products here]"

    Again, just a list of popular products but not clear if those products are their PMTA products. I guess these manufacturers like to keep this a secret :confused:
     

    UncLeJunkLe

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    Heartlandvapes just sent out an email stating that they submitted PMTAs for many of their house eliquid flavors.

    But I think MAYBE they are steering people in the wrong direction with false information.

    1) they are saying "we are legal" bu tin fact they are only legal until they get rejected.

    2) They are claiming that you (as an eliquid brand owner) can offer "legal" eliquid because all they have to do is slap your brand label on their eliquid and BOOM, you are legal. However, if I am not mistaken, since the new label/brand is technically another SKU, doesn't that mean a new PMTA has to be filed for that SKU?

    This is what the email shows...

    Did you not submit PMTA'S?

    We got You covered!
    We registered hundreds of E-liquid skus.
    We can put your logo on our legal products. Call us today for details.
    Affordable pricing, low MOQ'S.

     

    cats5365

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    Heartlandvapes just sent out an email stating that they submitted PMTAs for many of their house eliquid flavors.

    But I think MAYBE they are steering people in the wrong direction with false information.

    1) they are saying "we are legal" bu tin fact they are only legal until they get rejected.

    2) They are claiming that you (as an eliquid brand owner) can offer "legal" eliquid because all they have to do is slap your brand label on their eliquid and BOOM, you are legal. However, if I am not mistaken, since the new label/brand is technically another SKU, doesn't that mean a new PMTA has to be filed for that SKU?

    This is what the email shows...

    Did you not submit PMTA'S?

    We got You covered!
    We registered hundreds of E-liquid skus.
    We can put your logo on our legal products. Call us today for details.
    Affordable pricing, low MOQ'S.

    I think they are half-right. If the bulk manufacturer gets his PMTA approved, the relabeler would be allowed to file his own PMTA as a substantial equivalent to the bulk product. The relabeler would still need a blessing for his label and packaging and anything else that would be changed from the original bulk product. He won't get a free ride to get out of the PMTA process.
     

    zoiDman

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    I think they are half-right. If the bulk manufacturer gets his PMTA approved, the relabeler would be allowed to file his own PMTA as a substantial equivalent to the bulk product. The relabeler would still need a blessing for his label and packaging and anything else that would be changed from the original bulk product. He won't get a free ride to get out of the PMTA process.

    I might be Wrong on this.

    BAIUI... If a Product has an Accepted PMTA currently under review for a "Tobacco Product", a 2nd Party such as a Retailer can Re-Brand/Repackage the Line Item and the 2nd Party would just have to submit a PMTA for the Branding/Packaging. And the rest of the PMTA the would be in the form of "Bridge Date" to the Original PMTA from say Heartland Vapes.

    This is, of course, as long as the Line Item was Not Changed in ANY Way with regards to the Original PMTA.

    This would be a Very Short Road for a 2nd Party to take. And a Much More Affordable way for someone to Selling a PMTA-ed Product using their Brand Name.

    Depending on the Agreement you could reach with say someone like Heartland Vapes.

    I Don't think a SE Application can be Filed on a Non-PMTA Approved "Tobacco Product". Unless it is a "Grandfathered" product of course.
     

    zoiDman

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    This is what the email shows...

    Did you not submit PMTA'S?

    We got You covered!
    We registered hundreds of E-liquid skus.
    We can put your logo on our legal products. Call us today for details.
    Affordable pricing, low MOQ'S.

    I saw that Also.

    It it Did Raise an Eyebrow when I read it.
     

    UncLeJunkLe

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    BTW - I Noticed that Heartland Vapes has pulled Almost all of it's Finished Flavored e-Liquids.

    Really? I bought from them for many years, but only peppermint and sometimes HY4 and orange cream so I never paid much attention to their other flavors. But they seem to have about as many as I can tell.
     

    zoiDman

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    Really? I bought from them for many years, but only peppermint and sometimes HY4 and orange cream so I never paid much attention to their other flavors. But they seem to have about as many as I can tell.

    I pulled down e-Liquids under their "Bottled e-Liquid" section and there wasn't much left.

    Double D's - None
    eDrops - None
    Firehouse - 3 Items (All OOS)
    Liberty E-Liquids - None
    Straight Outta Cereal - 1 Item
    Suicide Sauces - 1 Item (OOS)
    Texas Tea - 18 Items (All OOS)
    the7 - 7 Items (All OOS)

    ETA: I should have been More Clear in my Original Post. Just about all the Non Heartland Vapes Finished e-Liquid seem to be Gone.


     

    UncLeJunkLe

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    I pulled down e-Liquids under their "Bottled e-Liquid" section and there wasn't much left.

    Double D's - None
    eDrops - None
    Firehouse - 3 Items (All OOS)
    Liberty E-Liquids - None
    Straight Outta Cereal - 1 Item
    Suicide Sauces - 1 Item (OOS)
    Texas Tea - 18 Items (All OOS)
    the7 - 7 Items (All OOS)

    Oh right. I always forget they have those other brands.
     
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