Deeming Regulations have been released!!!!

[YoursTruli]

My best guess tells me, if the FDA cancels all PMTA's that were submitted AND bans vape products except for a few, the real fight is on.

The FDA will have then stepped on the toes of some heavy hitters like beard, Aspire, Triton, etc.

Bring on the court cases with firms that have deep pockets.

I'm almost salivating over the prospect.

...meanwhile back at the ranch... businesses will be destroyed, product availability slim to nonexistent and the general public view of vaping further deteriorated... IMHO the heavy hitters will concentrate on greener pastures where their market share and sales already far exceeds the U.S. ...not much to gain fighting the U.S. government for years on end

 

[440BB]

My concern with that rejection is whether this chain used the PMTA application format that was shared by many smaller applicants. If the language in those applications is the same in many others, they could justify many more rejections. These rejected application were almost certainly a repeated boilerplate format.

Perhaps someone more ambitious than myself will research this. It may be too late to matter at this late date though.

 

[Doffy]

That's exactly what I was thinking. 4.5 million applications, from what I understand, would cost literally trillions of dollars. IIRC, folks were saying 1 PMTA costs almost 1 million dollars. But assuming that was all BS and that one PMTA only costs $250K (only lol), 4.5 million PMTAs would cost $1.13 TRILLION. How does a local vape shop have that kind of liquid capital? No bank is going to give you a loan on such a gamble as a PMTA and good luck finding that many private investors. You'd have better odds at a positive ROI at the race track or a casino.

Not to mention, there is no possible way one company could have 4.5 million different SKUs. Even if they had 500 different house brand Eliquid flavors in 10 different strengths, that's only 5,000 SKUs.

I think that was estimate cost for one that would be suitable for approval.

 

[mikepetro]

My concern with that rejection is whether this chain used the PMTA application format that was shared by many smaller applicants. If the language in those applications is the same in many others, they could justify many more rejections. These rejected application were almost certainly a repeated boilerplate format.

Perhaps someone more ambitious than myself will research this. It may be too late to matter at this late date though.

Having done some 1099 work to help compile a PMTA for a well known TC board maker, I can say that the published requirements for the "Environmental Assessment" are fairly clear (as far as 3 letter agencies go).

The main things they are looking at is the "waste stream". Think packaging and end of life disposal. It was fairly simple to demonstrate "the benefit to public health" (the prevailing metric throughout the PMTA language) by comparing the waste stream of a given "open system" vape product to the waste stream of tobacco cigarettes, those ciggy butts are not bio-degradable, then you have the empty cigarette packs/cartons, etc..

The language to satisfy the requirement is pretty clear, and fairly simple in scope. If you dont give the "Environmental Assessment" its due diligence, they will reject the PMTA. I am told by insiders that the "Environmental Assessment" is the first part of the PMTA the Feds look at. They weed out a lot of applications that way. The logic being that if you didnt pay enough attention to detail to get that fairly simple requirement right, then you probably didnt do the due diligence to satisfy the more complicated portions of the PMTA.

I am not saying I agree with the Fed's PMTA requirements, but this particular one was pretty well defined, and frankly rather simple. I completed that section by myself, without much difficulty. It amounted to weighing the packaging/waste of the various products and showing that the vape product generated less waste. The PMTA was "accepted" BTW, not approved, but accepted for further review, which is the normal FDA workflow. It is still pending further review, but it has not been rejected.

BTW, the company in question now has this on their website.
NO products on this site are currently available in the United States
Sucks that this is the end result.

Yes, Sept 9th will be interesting.

 

[mikepetro]

That's exactly what I was thinking. 4.5 million applications, from what I understand, would cost literally trillions of dollars. IIRC, folks were saying 1 PMTA costs almost 1 million dollars. But assuming that was all BS and that one PMTA only costs $250K (only lol), 4.5 million PMTAs would cost $1.13 TRILLION. How does a local vape shop have that kind of liquid capital? No bank is going to give you a loan on such a gamble as a PMTA and good luck finding that many private investors. You'd have better odds at a positive ROI at the race track or a casino.

Not to mention, there is no possible way one company could have 4.5 million different SKUs. Even if they had 500 different house brand Eliquid flavors in 10 different strengths, that's only 5,000 SKUs.

I would "assume" that they "bundled" many products into a single submission.

"FDA has included an additional proposed form (Form FDA 4057b) in the docket that will assist industry and FDA in identifying the products that are the subject of a submission where an applicant groups multiple PMTAs into a single submission (referred to as a bundled submission or a grouped submission). FDA has previously stated that one approach to submitting PMTAs could be to group applications for products that are both from the same manufacturer or domestic importer and in the same product category and subcategory into a single submission. FDA discusses bundled submissions in the proposed rule (84 FR 50566 at 50578)"

 

[YoursTruli]

• Content current as of:
  05/20/2021
  

Update on FDA’s Application Review: PMTA List Posted, Metrics Updated

• Content current as of:
  08/09/2021
  

Deemed New Tobacco Product Applications Lists

• Tobacco Product Applications: Metrics & Reporting current as of:
  08/13/2021
  

 

[thanswr1]

Color me confused.

 

[Haylon357]

I have been away awhile. Went back to cigarettes on account of a very stressful situation. I have successfully put the cigarettes down again and decided to come back to the forums to check things out. It saddens and angers me to see this thread is still active.

Keeping tobacco products away from children should be the parents job. Not the governments. The government needs to know its role! The next thing I'm about to say may offend some of you. If it does, I'm sorry. Keep in mind, I'm a firm believer in one's freedom of choice. With that being said, the powers that be are concerned with the long term health risks of vaping. Yet another excuse to ban it. Where is that mentality with certain vaccines? It's okay to do one thing without thorough data and not alright to do another. See the hypocrisy?

Sent from my SM-N986U using Tapatalk

 

[englishmick]

Something really doesn't make sense here. 7M different products? On top of the 4.5M applications from that vape shop there's still another 2.4M applications. Scratched my head for a while and it just doesn't add up. Unless maybe the vape shop claimed 450,000 flavors each at 10 different nic levels. There has to be something I can't see behind those numbers.

 

[CMD-Ky]

I admire anyone who seeks intellectual consistency, it is kind of a unifying principle that brings a certain tranquility to the mind. The lack of intellectual consistency is one of the causes of the unending upheaval we experience.

...With that being said, the powers that be are concerned with the long term health risks of vaping. Yet another excuse to ban it. Where is that mentality with certain vaccines? It's okay to do one thing without thorough data and not alright to do another. See the hypocrisy?

Sent from my SM-N986U using Tapatalk

 

[Vapeon4Life]

The next thing I'm about to say may offend some of you. If it does, I'm sorry. Keep in mind, I'm a firm believer in one's freedom of choice. With that being said, the powers that be are concerned with the long term health risks of vaping. Yet another excuse to ban it. Where is that mentality with certain vaccines? It's okay to do one thing without thorough data and not alright to do another. See the hypocrisy?

"Phil Valentine, a Nashville-based conservative radio talk show host who had questioned whether it was necessary for all people to get Covid-19 vaccines, died on Saturday, his employer, WWTN Radio, announced on Twitter. Valentine was 61 years old.....

"Phil would like for his listeners to know that while he has never been an 'anti-vaxer' he regrets not being more vehemently 'Pro-Vaccine', and looks forward to being able to more vigorously advocate that position as soon as he is back on the air, which we all hope will be soon," his brother Mark Valentine wrote on July 22.

""He recognizes now that him not getting the vaccination has probably caused a bunch of other people not to get vaccinated," he said in the interview. "And that he regrets."

"See the hypocrisy?" - All I see is death, death, and more death with vaccines that have been around for what 75 years? - Often effective and with few side effects. Most of the people, which now include many children, who are dying of covid are un-vaccinated.

 

[classwife]

...back to Deeming Regulations please.

 

[MLEJ]

ZophieReviews posted a YouTube video a short while ago about her deleting all SMOK product reviews from her channel. Said SMOK wanted her to sign a contract stating that she would restrict her videos to viewers 21+ but that she couldn't do that because YouTube only has an 18+ restriction function.

It would seem that SMOK is concerned about getting tagged by the FDA as promoting vaping to minors -- aka 18-20 y/o adults -- and wants to cover it's corporate behind. i don't understand their concern given that all their products will be illegal to sell in the US in a few weeks regardless.

 

[CMD-Ky]

If they are smart enough to vote and volunteer for war, they ought to be considered smart enough to vape and buy a beer.

ZophieReviews posted a YouTube video a short while ago about her deleting all SMOK product reviews from her channel. Said SMOK wanted her to sign a contract stating that she would restrict her videos to viewers 21+ but that she couldn't do that because YouTube only has an 18+ restriction function.

It would seem that SMOK is concerned about getting tagged by the FDA as promoting vaping to minors -- aka 18-20 y/o adults -- and wants to cover it's corporate behind. i don't understand their concern given that all their products will be illegal to sell in the US in a few weeks regardless.

 

[YoursTruli]

Something really doesn't make sense here. 7M different products? On top of the 4.5M applications from that vape shop there's still another 2.4M applications. Scratched my head for a while and it just doesn't add up. Unless maybe the vape shop claimed 450,000 flavors each at 10 different nic levels. There has to be something I can't see behind those numbers.

I wouldn't be surprised if disposable ecigs are a big part of that number, I'm not sure most are aware of the vast number of brands flavors and nic levels actually involved or who is producing them. There are numerous small and large players.
A few of the key players operating in the global disposable e-cigarettes market
British American Tobacco
Global Tobacco, LLC
Imperial Brands
Japan Tobacco Inc.
Mistic E Cigs
NJOY
PHILIP MORRIS PRODUCTS S.A.
Philip Morris International Inc.
R.J. Reynolds Vapor Company
Reynolds American Inc.
Turning Point Brands
Vapelux Distribution Ltd

 

[newyork13]

I see that Carolina Extracts is still selling nic.
But, they have a disclaimer saying that "the intended purpose can no longer be for electronic cigarettes or the manufacturing of e-liquid".
I'm thinking that's for regulatory purposes and that the nic is fine for vaping.
Any thoughts anybody?

 

[UncLeJunkLe]

I see that Carolina Extracts is still selling nic.
But, they have a disclaimer saying that "the intended purpose can no longer be for electronic cigarettes or the manufacturing of e-liquid".
I'm thinking that's for regulatory purposes and that the nic is fine for vaping.
Any thoughts anybody?

Yes, it's the same nic as before. They used to have a disclaimer on their cart page that they were in the middle of a lawsuit (that I have no idea about other than that) and also stated that if anyone contacted them with questions about vaping/ecig, or even stating they were using their nic for vape/ecig, they would delete your account with them. IMHO, given the state of affairs, I agree with their approach and attitude. Use if for whatever you want to use it for and leave them out of it, they are merely selling nicotine. Apparently they must have a good enough non-vape customer base that they don't need to risk marketing themselves as a vape retailer & endanger their business.

 

[Bronze]

I see that Carolina Extracts is still selling nic.
But, they have a disclaimer saying that "the intended purpose can no longer be for electronic cigarettes or the manufacturing of e-liquid".
I'm thinking that's for regulatory purposes and that the nic is fine for vaping.
Any thoughts anybody?

I bought a bottle from them less than 2 years ago. Used it up. As you can see I’m still here for better or for worse.

 

[smacuser]

 

[newyork13]

I bought a bottle from them less than 2 years ago. Used it up. As you can see I’m still here for better or for worse.

LOL. I see you're still here. Which I'm glad about fyi.
Whether it's for better or worse, now that's something I can't see.
Certainly hope it's for the better.

So, if no one chimes in between now and who-knows, then I'll order a little bottle to top up my nic supply.