PMTAs - who is doing what?

[low_tar_neil]

I thought I'd start a thread on this so we can keep track of who is planning on submitting what in their PMTAs. (Unless there is another climb down from the FDA, always possible)

Some companies are being very vocal about it, others are keeping quiet, but from what I've been able to gather a lot of products are going to be submitted. The first ones are just off the top of my head I've seen in recent press releases etc.. so please add ones you know about (and link if possible).

Confirmed
Vuse
Blu
Juul (yawn)
Turning Point Brands (Brands including Solace)
Charlie's Chalk Dust
Cosmic Fog
Njoy
Black Note
Purilum (Bantam eliquid & others)
Smoore (Vaporesso)
Smok
Humble juice Co.
Avail Vapor
Savage Enterprises (Ripe Collection)
Nude Nicotine
Geekvape
Suorin

Rumors
Mad Vapes
Aspire

 

[r77r7r]

So, millions of American vapers are going to end up back on cig - likes like back in 09? Been thinking about snus instead for myself. Will there ever be mods and tanks again?

 

[Myrany]

So, millions of American vapers are going to end up back on cig - likes like back in 09? Been thinking about snus instead for myself. Will there ever be mods and tanks again?

I think from reading the PMTA guidelines awhile back anything with a 510 connection is dead. Some of the proprietary pod systems might be able to get through though. with the 510 the combinations of gear for testing just get impossible. a proprietary pod has limited combinations and becomes much more doable. In fact I suspect this is why we have seen such an uptick in pod systems (refillable and not) hitting the market since 2016.

 

[r77r7r]

I think from reading the PMTA guidelines awhile back anything with a 510 connection is dead. Some of the proprietary pod systems might be able to get through though. with the 510 the combinations of gear for testing just get impossible. a proprietary pod has limited combinations and becomes much more doable. In fact I suspect this is why we have seen such an uptick in pod systems (refillable and not) hitting the market since 2016.

Well, pods are good enough to get and keep people from cigarettes I think. That'd be great. Just hoping I can still get unflavored and flavor people can get something at least. Looking hopeful, ty.

 

[englishmick]

You can add the Nude Nicotine juice line to the list.

I haven't heard of any hardware being submitted, other than pods.

 

[bnrkwest]

Sad part is all these units submitted for PMTA are expensive for what they are and all internal batts. So glad I have stash of replaceable batt mods and RTA's. They maybe the dinosaurs of vape very soon.

 

[zoiDman]

I thought I'd start a thread on this so we can keep track of who is planning on submitting what in their PMTAs. (Unless there is another climb down from the FDA, always possible)

Some companies are being very vocal about it, others are keeping quiet, but from what I've been able to gather a lot of products are going to be submitted. The first ones are just off the top of my head I've seen in recent press releases etc.. so please add ones you know about (and link if possible).

Confirmed
Vuse
Blu
Juul (yawn)
Turning Point Brands (Brands including Solace)
Charlie's Chalk Dust
Cosmic Fog
Njoy
Black Note
Purilum (Bantam Eliquid & others)
Smoore (Vaporesso)
Smok
Humble Juice Co.
Avail Vapor
Savage Enterprises (Ripe Collection)
Nude Nicotine

Rumors
Mad Vapes

How many of these do You Think are serious Attempts at achieving a PMTA?

Verses trying to extend their Ability to sell past the FDA Dead Date as the Market exponentially contracts?

 

[low_tar_neil]

How many of these do You Think are serious Attempts at achieving a PMTA?

Verses trying to extend their Ability to sell past the FDA Dead Date as the Market exponentially contracts?

That's a very good question, and to some extent it's all going to depend on the FDA's mood for compromise on things, but it's not necessarily a case of how much you spend right? I mean, Juul have spent over $150 million and are still going, but they probably have a lower chance than most given their history.

Lots of these companies have teamed up with heavyweight Scientific / Regulatory businesses who do this for a living, so while it's up in the air, I do believe a lot are serious. I know at least one big company is planning on doing 50 liquids, which they will then have available for white-labelling, which could be a very good thing for B&M stores.

 

[BigPappa]

You can probably add Aspire to the rumor list... They had made a tweet a couple weeks ago asking people if they could vote for just one tank of theirs for a PMTA, which one would it be? That's a pretty strong indicator that they are going to move ahead with at least one.

 

[zoiDman]

That's a very good question, and to some extent it's all going to depend on the FDA's mood for compromise on things, but it's not necessarily a case of how much you spend right? I mean, Juul have spent over $150 million and are still going, but they probably have a lower chance than most given their history.

Lots of these companies have teamed up with heavyweight Scientific / Regulatory businesses who do this for a living, so while it's up in the air, I do believe a lot are serious. I know at least one big company is planning on doing 50 liquids, which they will then have available for white-labelling, which could be a very good thing for B&M stores.

Given that No One knows exactly what is Needed for a Successful PMTA, it is really All Uncharted territory.

My Guess is that a portion of PMTA applications (15 ~ 20% ?) will be Summarily Dismissed by the FDA due to the PMTA not being consider "Serious" enough. And just an Attempt to extend their ability to Sell while under review.

And a Significant Percentage will be Quickly Rejected because they Can Not comply as submitted. Some of these May receive an Extension but most probably won't. So these products will have to be Pulled.

This second Group is where the Crap Shoot comes in. Because if I spend 150K but can make say 300K in profits, that Isn't a Bad Business Model.

---

I just Question how Any stand-alone e-Liquid can receive a PMTA? Because so much seems to be Dependent on How the e-Liquid is going to be Used. And that Isn't Quantifiable.

The is Also the issue with "Adulteration". Something that I'm sure is Permanently Etched into the minds of those under Mitch Zeller in light of the entire "Vape Illness" saga.

 

[Myrany]

Vuse
Blu
Juul (yawn)
Njoy

I am pretty sure are serious. They have the backing I would think and probably the expertise.

Smok I think is big enough to pull it off on something. Most likely a pod system.

The rest I just don't know enough about to judge one way or the other.

 

[lorikay13]

Premarket Tobacco Product Marketing Orders

 

[Rossum]

I know at least one big company is planning on doing 50 liquids, which they will then have available for white-labelling, which could be a very good thing for B&M stores.

I thought the product labeling had to be defined/specified in the PMTA?

 

[bnrkwest]

I hope someone submits unflavored 50/50 VG/pg at say 36 mg nic or even lower. If that would pass, at least nic would be available unflavored. A lot can be done with that for diy.

 

[LoveVanilla]

Here's another one:
Pyxus Announces Agreement with Smoore on PMTA Projects

Pyxus identified Smoore as the clear ENDS supplier for PMTA submissions of Pyxus' affiliate brands, Bantam and Humble Juice Co."...The PMTA submissions are the next step in continuing to make our adult-use e-liquid products available for purchase and enjoyed by our consumers for years to come.

Under the new agreement, Bantam and Humble Juice Co. have paired certain Smoore ENDS devices—both an open tank device and a refillable cartridge-based device—with the brands' 84 e-liquid nicotine SKUs. The selected SKUs include many of Bantam and Humble's top-selling flavor profiles in various nicotine strengths and bottle sizes. These flavor profiles are manufactured by Purilum, LLC, a manufacturer of top-quality e-liquids, flavor concentrates and finished bottle products and a Pyxus joint venture.

Edit: New pr release though see the companies already listed by the OP

 

[Opinionated]

So according to Vaping 360 today the FDA has confirmed there has now been more than 30 submissions for FDA approval.

Of course, since the PMTA process applies to more than just the vaping industry, not all of those submissions will have been vaping related but it's a large enough number at least some of them will have been... so it's a positive sign anyway.

I was still thinking there was only 2 submissions (heat not burn and Vuse) earlier today, so I am happy to hear there have been more submissions, although we dont know exactly which ones.

It’s Official! PMTA Submission Deadline Will Move to Sept. 9th - Vaping360

 

[Doffy]

this was an email from about 2 months ago, from Mother's Milk, who produce WTA

Dear Dan,



From: Mothers Milk WTA

E-liquid Manufacture

Owner: Andrew Dyson

Phone Number: (408) 657-9262



This survey is for the purpose of submitting required documentation to the FDA when we submit our PMTA's in May of 2020. It is 12 questions and shouldn’t take more than a minute of your time.



Thank you in advance for participating.





Please Click link below



Mothers Milk WTA (MMWTA) Customer Survey



You have at some point been a MothersMilkWTA customer in the past. We are in the process of filing a PMTA (Pre-Market Tobacco Application)



We have never used our collected email list to advertise or for any other reason other than to communicate with you about your order. Please forgive us if you received this email in duplicate or have no interest in vaping products.



Our goal has always been to help folks get off and stay off the combustible cigarettes.

We really appreciate your time and participation by taking the survey.



Feel free to use the coupon code



“Survey20”



at www.MothersMilkWTA.com for 20% off.





Thank you

Andrew Dyson

(Owner)

 

[Coyote628]

Well, pods are good enough to get and keep people from cigarettes I think. That'd be great. Just hoping I can still get unflavored and flavor people can get something at least. Looking hopeful, ty.

If Humble Juice Co. stays in, they do have some decent flavors, but would probably have to lose the cute kitschy names they have for them and just label the flavor profiles. I vaped a few of theirs in the past and wasn't disappointed at all. The one thing I dont like is being stuck on one flavor. The ones I really like I can do for a month or two then I gotta have a change up. I'll probably go ahead and order another liter or 2 of nicotine while I can so I will be able to make the ones I like that probably won't be available later on. Just so I can still have variety.

 

[LoveVanilla]

Chicago alternative smokeless tobacco company raises nearly $10 million

The company said the new financing will enable it to assemble Premarket Tobacco Product Applications for its entire product portfolio, which the company intends to submit to the U.S. Food and Drug Administration's Center for Tobacco Products in the coming months.

The company explains how it worked to create the product without using tobacco and keeping the nicotine on its website.

 

[stols001]

Mother's Milk? To bad it's not Aroma. I didn't know they had repeat customers. Their WTA tastes (and has the effects of) dirt, although I kind of hope they get an approval so maybe other WTA will do so also.

I have not tasted their regular juices, to be fair to the company I guess but BLEUGH.
Anna