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Extension request for Sept. 9 PMTA deadline

JuicyLucy

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JuicyLucy

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It looks to me as if the petition has the wrong year for the 180 day extension - it should read March 2021, not March 2020, a date that has already occured

I emailed the attorney to point out the error in the year
 
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The Cromwell

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Looks messed up and we will go backwards if granted as written...

"for a limited set of small vapor product manufacturers" ??

This would be primarily for juice makers?
 
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JuicyLucy

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It seems that way, only got to page 18, lol

It does mention "tanks" and other vague terms though
 

JuicyLucy

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It talks about how open end systems are not proven to be appealing to children and so it is justifiable to allow open-end vape products to remain on the market - but doesn't exactly spell it out

It does ask that manufacturers with less that 50 employees or under $10 million in sales be allowed to keep selling for another 180 days before being required to submit a PMTA due to hardships brought on by Covid 19

It also claims the FDA has been less than forthcoming on promised guidelines
 

The Cromwell

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under 50 employees or under 10 million in sales?

Pretty much covers everyone?
 

The Cromwell

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One can hope but I do not see it flying.

Vaping has not won a single fight since the Deeming regs went into place.
I could be wrong though, maybe some vaping wins on some state or local level?
 

JuicyLucy

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under 50 employees or under 10 million in sales?

Pretty much covers everyone?

I highly doubt everyone - there are some pretty profitable vape outfits out there

Without reading the whole thing, it is unclear if they are referring to stores in that category, manufactures or those that are both

Don't know if I'll be able to read the whole thing or not - I do not enjoy that kind of reading and the mind starts wandering, lol
 

The Cromwell

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I highly doubt everyone - there are some pretty profitable vape outfits out there

Without reading the whole thing, it is unclear if they are referring to stores in that category, manufactures or those that are both

Don't know if I'll be able to read the whole thing or not - I do not enjoy that kind of reading and the mind starts wandering, lol
Only lawyers and accountants can handle or enjoy reading stuff like that.
Heck politicians do not even read their bills as a general rule just vote as they are told to on it.

another thought...
This would not impact any vape products that already have PMTA applications filed...
This would not impact BT vape interests as they have pretty much PMTA applications on file for their stuff..

I did a fast scan of the doc and agree with you assessment, incomplete though it may be at this point.
 
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The Cromwell

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yet another thought on this. the FDA cannot grant a PMTA extension without going thru the courts as they are under court order to start enforcing it on Sept 9.
 

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That's interesting on the open systems. One can only hope.
 
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The Cromwell

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That's interesting on the open systems. One can only hope.

So in a nutshell (I haven't kept up), what impact will this have on us come the 9th?
Depends on how agressively the FDA enforces deeming regs.
They have stated that first priority is protecting the children... yeah....

so Expect things like Puff bars and other convenience store sold vapes that do not have a filed and accepted PMTA application to be the first to go.

A cease and desist letter to credit card companies could cut them off from covering vape purchases..
Since they will be illegal in the US... Purchasing illegal things is already prohibited in the terms and conditions of the CC companies.

I do not figure it will be one big immediate door slam but how fast it all happens? I dunno.
 
Depends on how agressively the FDA enforces deeming regs.
They have stated that first priority is protecting the children... yeah....

so Expect things like Puff bars and other convenience store sold vapes that do not have a filed and accepted PMTA application to be the first to go.

A cease and desist letter to credit card companies could cut them off from covering vape purchases..
Since they will be illegal in the US... Purchasing illegal things is already prohibited in the terms and conditions of the CC companies.

I do not figure it will be one big immediate door slam but how fast it all happens? I dunno.


I agree totally. My thing is... why are online sellers refusing to ship accessories, like coils or tanks? I was under the impression that the ban is specifically for flavored E-Liquids. What am I missing?
 

JuicyLucy

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I agree totally. My thing is... why are online sellers refusing to ship accessories, like coils or tanks? I was under the impression that the ban is specifically for flavored E-Liquids. What am I missing?

Depends on where you live - many states have outlawed flavors on their own, and a handful of states have restricted online sales of vape stuff

The flavor ban is a separate issue from the Deeming Regs going into effect Sept 9

The Deeming Regs pretty much ban all vaping hardware and juice that does not have a PMTA on file

And of course, the FDA has rejected almost all vaping related PMTAs so far
 

The Cromwell

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I agree totally. My thing is... why are online sellers refusing to ship accessories, like coils or tanks? I was under the impression that the ban is specifically for flavored E-Liquids. What am I missing?

Not just flavored liquids in the US NO vape hardware or eliquids will be legal to be sold after September 9 without either having an Approved PMTA for each vape item. Tank, coil, mod, flavor /brand of juice, etc.

Any vape stuff with a filed and accepted PMTA application by Sept 9 can be sold for up to one year from filing date, or until rejected. of course can be sold if it passes PMTA process.

To date NO vape stuff has passed PMTA process and only a handful of accepted applications have been accepted. Maybe 20?

google Deeming Regulations, which went into effect on 8-8-2016 but enforcement has been delayed.
However due to a lawsuit the FDA was ordered by a US court to begin enforcing the Deeming regs starting last May, however the FDA filed for and got an extension from the court until Sept 9. The same court will have to grant any further extension. The FDA will have to petition the court for any extension.

One interesting thing is that US vape manufacturers can still sell their vape products outside of the US but not inside of the US.

also any vape product manufacturers will have to become a licensed tobacco product manufacturer. To sell PMTA approved vape stuff in the US.
This makes ALL house juice from vape shops illegal, unless they happen to meet the specifications and pay the fees, etc to become a tobacco product manufacturer. Even then they cannot sell any non PMTA approved stuff in the US.

The Deeming regs does not currently r planned to impact individual DIY juice manufacture.
However look for nicotine to soon be restricted for sale to licensed business and or taxed at a ridiculous amount in the future. One bill in congress would put around $5,000 tax on one liter of 100 mg/ml freebase nic. Another bill is cheaper at around $3,000 per liter.
 
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The Cromwell

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Also some Chinese companies quit selling vape stuff to US addresses many months ago. The ALI family of companies for one group.

The Deeming regulations also prohibits the importation of any non FDA approved vape stuff into the US.
 

The Cromwell

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And YES the Deeming Regs are a royal PITA and horribly wrong but it is what is happening here.

And why some of us have been prepping for most all vapoing stuff going away in the US for years now.
I have 20+ years worth of nic in the freezer.
Enough hardware with spare parts for over 20 years as well.
And have been 100% DIY and only rebuildables for several years now. No factory coils.
And since I am older than some dirt (in gutters) but younger than some lava rocks around Lucy's area, I am fixed for the rest of my life.
 
And YES the Deeming Regs are a royal PITA and horribly wrong but it is what is happening here.

And why some of us have been prepping for most all vapoing stuff going away in the US for years now.
I have 20+ years worth of nic in the freezer.
Enough hardware with spare parts for over 20 years as well.
And have been 100% DIY and only rebuildables for several years now. No factory coils.
And since I am older than some dirt (in gutters) but younger than some lava rocks around Lucy's area, I am fixed for the rest of my life.

What exactly could I stock up on now to continue vaping for a few years. A product list would be great.
 

The Cromwell

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What exactly could I stock up on now to continue vaping for a few years. A product list would be great.
Just general recommendations as vaping styles vary.
Rebuildable coil atomizers, no factory coils.
Replaceable battery mods, although if you only are looking for a couple of years then good built in battery mods would probably work for you.
Learn to DIY ejuice and order nicotine and flavorings to do so with. Although for now neither nic or flavorings are covered under the deeming regs/PMTA crap.

Or get non rebuildable atomizers but get enough coils for a couple of years.
Oh and get spare glass, etc for atomizers (if applicable) as accidents do happen.

Being in NY you may need to look into getting vape stuff shipped to someone you trust in another state. Then get it from them.
 

gsmit1

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Rebuildable coil atomizers, no factory coils.
I agree. 50 bucks could set somebody for life as far as coils (wire) and one thing we'll always be able to get is wire and wicking material. They are used so generally there's really no way for them to stop people from getting them and using them for vaping.
Replaceable battery mods, although if you only are looking for a couple of years then good built in battery mods would probably work for you.
Yes, if you're really only looking for a couple years. I suspect we'll be able to get batteries for a while, but I'm convinced they're coming after those too. All they have to do to massively cripple much of vaping is criminalize the possession or sale of round litium based batteries outside of their designed use in protected packs. For the zillions of external power devices out there, nothing else will matter. All done.
 

The Cromwell

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Yes, if you're really only looking for a couple years. I suspect we'll be able to get batteries for a while, but I'm convinced they're coming after those too.
Already happened. The major 18650 manufacturers do not authorize their sale for use in vaping.
But since flashlights and such use them they should still be available from non vaping sources.
Illumn.com, etc.

Now if they are promoted or labelled as for use in vaping then they become tobacco products and fall under the deeming regs.
Just like any wire (why lightning vapes changed their name), flavorings (why Bull City Vapor changed their name), etc The intended use part of the Deeming regs.

for example a vape supply selling Capella flavorings may have deeming regs issues but buying it from a non vaping related source would not be an issue since Capella does not promote or label it's products for use in vaping.
 

gsmit1

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With regard to batteries however, if the constitutional rule of law were still to matter (har DEE har har) ex post facto considerations might protect batteries already owned at the time of the enactment of the ridiculous law.
 
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gsmit1

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Already happened. The major 18650 manufacturers do not authorize their sale for use in vaping.
But since flashlights and such use them they should still be available from non vaping sources.
Illumn.com, etc.
Right, but that's not the same as the force pf law that would make it a crime to posses an item regardless of the wishes of the manufacturers. The manufacturers wanting sales to vapors stopped will certainly lend teeth and credibility to the politicians though.

"WHO ON EARTH COULD OPPOSE THIS!!! EVEN THE BATTERY COMPANIES THEMSELVES WANT IT!!

...is what they'll say.
 

The Cromwell

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With regard to batteries however, if the constitutional rule of law were still to matter (har DEE har har) ex post facto considerations ,ight protect batteries already owned at the time of the enactment of the the ridiculous law.
Ohh I do not think the FDA intends to go after any individually owned/possessed vape related product. They are just going after sales and purchases of vape related products after the enforcement date kicks in.
At least I have seen no indication of them pursuing individually owned products.

the deeming regs do not even prohibit the act of vaping (unless underage). And that I think is just for purchase/sales not for the act of vaping.
Now some states and localities may do that as usually they can have more restrictive laws than the feds but not less restrictive.
However I cannt really see the banning of the act of vaping happening unless they ban smoking.
Could well be wrong though as humans are pretty stupit as a general rule.
 
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gsmit1

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Ohh I do not think the FDA intends to go after any individually owned/possessed vape related product. They are just going after sales and purchases of vape related products after the enforcement date kicks in.
At least I have seen no indication of them pursuing individually owned products.
Oh I agree. That would cost them at least as much money as they'll make by killing vaping in the first place.

Batteries are a different story though. I can see huge screens in the house and senate committee hearings with phony bleeding heart babysitting bureaucrats pointing at bloody faces and burn injuries while weeping mothers testify about how their dead children were killed by these batteries and how can our parental guides in DC let these lethal weapons run free in society.

Boom. No more batteries useful for vaping and therefore no more external power devices once the existing batteries age out of use. People can have 200 great mods, but no way to power them.

Tell me one reason why they wouldn't do that? If I wanted what they want, I know I sure would.
 

MC5

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What exactly could I stock up on now to continue vaping for a few years. A product list would be great.
The first thing on your stock up list should be nicotine concentrate, 100mg/ml, one liter minimum for about $50. If you're in a state that doesn't allow it, have it shipped to a friend in another state that can tuck it in their freezer for now.

Everything else listed in previous posts is important but without the nicotine, almost useless.
 

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I, myself, with the collection of gear I have along with the DIY supplies (including 1L 99.9% pure nic, 1L 100mg nic, 24-120ml/100mg nic, 20-120ml/250mg nic)... I don't really have much to worry about when it comes to the PMTA or Deeming Regs or an all out ban on vaping. Even if, for some unknown reason all the circuit boards in my mods got fried, I have 78 Mech mods and probably enough wire to rewire the city of Dayton. And in the end, even if the quit selling batteries, I know how to disassemble a battery pack! I have a good battery analyzer that will give me all the information I need to safely integrate a "salvaged" battery into my vaping routine! (I take no chances, I use this analyzer on all my batteries before first use when using in mechanical mods)

HOWEVER...

I really feel bad for future of people looking for options to quit smoking! I wish I had the money and resources to offer information and a startup option for these people once it's all swept under the carpet in this country. The VU is an awesome site and has an awesome thing going with the Trading Post and Marketplace, but what good is it really going to do for those who are trying to quit and know absolutely nothing about vaping when they Google something and they follow a link only to get "error 404 page not found" because the site is now out of business due to PMTA, POLOTICS, AND BULLSHIT SCIENCE? They are going to give up!

QUESTION QUESTION QUESTION

How can we, as a community, promote VU, to future vapers if PMTA and other POLITICAL AGENDAS destroy the industry as we know it?

Sent from my LGL722DL using Tapatalk
 

The Cromwell

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Oh I agree. That would cost them at least as much money as they'll make by killing vaping in the first place.

Batteries are a different story though. I can see huge screens in the house and senate committee hearings with phony bleeding heart babysitting bureaucrats pointing at bloody faces and burn injuries while weeping mothers testify about how their dead children were killed by these batteries and how can our parental guides in DC let these lethal weapons run free in society.

Boom. No more batteries useful for vaping and therefore no more external power devices once the existing batteries age out of use. People can have 200 great mods, but no way to power them.

Tell me one reason why they wouldn't do that? If I wanted what they want, I know I sure would.
Some of us will just buy battery packs for drills and such and get the cells out of them.
or even laptop packs if one vapes at lower wattages like under ~40W. Just use the net to find out the amp rating of the cells and use them within their ratings.
 

The Cromwell

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How can we, as a community, promote VU, to future vapers if PMTA and other POLITICAL AGENDAS destroy the industry as we know it?

Not sure how well places like this will survive what is coming as they depend heavily on ad revenue.
We did however have places to gather on the net back before vaping became a money business for sites and likely still will.

I have noticed that several vape vendors I have browsed recently are selling masks and sanitizers and CBD stuff of course.

I do expect that vape stuff associated with now legal in some places substances will also be hit by the deeming regs. especially if the gear they sell can be used for regular vaping too.
I could however be totally wrong on this aspect as I have researched this angle very little.

I feel it is still important to have such places to gather and share knowledge and even hardware. I expect that person to person direct vape sales and trades will continue, esp if kept low key.

I do expect that a board named The Vape Trading Post or the like may have issues though.

US based vape reviewers will pretty much become extinct as they have become vape dependent business for the most part and what vape company will give you free stuff or money to advertise/promote products that cannot be sold in the US?
A few may still be around functioning like they were in the early days of vaping here.
 
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The Cromwell

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The first thing on your stock up list should be nicotine concentrate, 100mg/ml, one liter minimum for about $50. If you're in a state that doesn't allow it, have it shipped to a friend in another state that can tuck it in their freezer for now.

Everything else listed in previous posts is important but without the nicotine, almost useless.
I would respectfully disagree since the Sept 9 date does not apply to freebase nic at all. However yes i would get soon.
 

ProlineVaper

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Not sure how well places like this will survive what is coming as they depend heavily on ad revenue .

I know the forum is free to public right now, but some of us do donate. @VaporJoe and other admins, I believe, working on rewards for different levels of donating.

We can also look for other sponsors, maybe? The marketplace is also open to vendors who are open to private sales (and believe me there are some out there) who would probably be open to donations.

Just some thoughts bouncing around in this hollow dome on my shoulders...

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I would respectfully disagree since the Sept 9 date does not apply to freebase nic at all. However yes i would get soon.
Yeah, as far as accessibility for most, Sept 9 doesn't have to apply to nic because of the proposed taxes.
LNW is selling TFN 100mg @$320 pr liter but iirc synthetic nic would be taxed the same.
 

The Cromwell

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I know the forum is free to public right now, but some of us do donate. @VaporJoe and other admins, I believe, working on rewards for different levels of donating.

We can also look for other sponsors, maybe? The marketplace is also open to vendors who are open to private sales (and believe me there are some out there) who would probably be open to donations.

Just some thoughts bouncing around in this hollow dome on my shoulders...

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yep I am an annual donator here because I do support this board.

however if a board has become the main /sole source of income for someone vs a sideline I still think there will be difficulties as the Deeming regs become more enforced.

I look for sideline boards to be the ones that survive.

Do not get me wrong I seriously hope that all survive but do not expect that to happen.
 

The Cromwell

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Yeah, as far as accessibility for most, Sept 9 doesn't have to apply to nic because of the proposed taxes.
LNW is selling TFN 100mg @$320 pr liter but iirc synthetic nic would be taxed the same.
I expect that the taxes would be the same regardless and the same if freebase nic becomes only salable to licensed buyers and not individuals.
Which I kinda expect to happen in the not too distant future.
 

JuicyLucy

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Right, but that's not the same as the force pf law that would make it a crime to posses an item regardless of the wishes of the manufacturers. The manufacturers wanting sales to vapors stopped will certainly lend teeth and credibility to the politicians though.

"WHO ON EARTH COULD OPPOSE THIS!!! EVEN THE BATTERY COMPANIES THEMSELVES WANT IT!!

...is what they'll say.

A lot of flashlights, and other devises use individual cells, and also, they were on the market well before 2007 and are exempt

Manufacturers (Sony for example) long ago (years) disclaimed using their cells for vaping
 

Ms. Trixy

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As a woman who can never make up her mind, I'd better get the rest of everything I need this weekend. I wonder if anything in transit will banned from my mailbox. In any case, I'd better shop US vendors only. This is indeed sad. I hope the PMTA extension is granted.
 

The Cromwell

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As a woman who can never make up her mind, I'd better get the rest of everything I need this weekend. I wonder if anything in transit will banned from my mailbox. In any case, I'd better shop US vendors only. This is indeed sad. I hope the PMTA extension is granted.
I seriously doubt that anything in transit will be impacted.
That would require a far better organized government than we appear to have.
 

gsmit1

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A lot of flashlights, and other devises use individual cells, and also, they were on the market well before 2007 and are exempt

Manufacturers (Sony for example) long ago (years) disclaimed using their cells for vaping
I wasn't actually referring to PMTA. I meant as far as their future actions in their campaign to destroy vaping.
 

The Cromwell

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The latest from the FDA on the Sept 9 deadline. Current as of 8-25-2020


The United States District Court for the District of Maryland has granted FDA’s request for an extension of the premarket review submission deadline for certain tobacco products, which FDA requested due to the COVID-19 pandemic. Applications are now required to be filed by Sept. 9, 2020 for many e-cigarettes, cigars and other deemed tobacco products.

However, in accordance with the U.S. District Court for the District of Columbia ruling issued on Aug. 19, 2020, FDA will not enforce the premarket review requirement against manufacturers of premium cigars that do not submit premarket applications for these products by the Sept. 9, 2020 deadline.

FDA has compiled information and resources to assist with submission of premarket review applications.


wouldn't want Rush and the rich guys to not have their expensive cigars now would we?
That has actually been a cornerstone of the couple of bills that got submitted supposedly in support of vaping but went no where. Because the bills actually got contaminated with vaping stuff not just expensive cigars.
But none of them really did vaping much of any favors either.
 
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MC5

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I expect that the taxes would be the same regardless and the same if freebase nic becomes only salable to licensed buyers and not individuals.
Which I kinda expect to happen in the not too distant future.
That's the risk I had in mind for a new vaper, should it happen with little advance warning.
 

The Cromwell

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That's the risk I had in mind for a new vaper, should it happen with little advance warning.
The last time I looked at the tax bills the tax kicked in 180 days after passage of the bill I think.
But I have not reviewed the bills in months and one may have been dropped if I remember correctly.

the not selling nic to individual users. I have actually read nothing on this but suspect that it will happen at some point. Esp with the requirement of all 'tobacco' product manufacturers have to be licensed and certified under the Deeming regs.
.
 
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JuicyLucy

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And - sadly - this: VTA - FDA Says It Will NOT Extend September 9 2020 PTMA Deadline

The FDA says it will not extend the Sept. 9, 2020 deadline for to file a PMTA

It also says it will not allow a sell-off period so that retailers to sell off non-compliant items

It also says clearly that gear from or before 8.8.16 that does not have a PMTA on file is illegal

No vape gear released since that date that does not have a PMTA is also illegal

Read as much of the link as you can stomach - it is worth your while
 

The Cromwell

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Yep no vape gear not on US market prior to 8-8-2016 has never been legal to be sold in the US. that never got changed only the enforcement of it was delayed.
And that is probably 98% of stuff on retailers shelves are post 8-8-2016 products.

going to order? order now.
 
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The Cromwell

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From scanning the linked article it appears that the big hammer will not fall for 90 days or so.
Messed up PMTA applications have 90 days to straighten them out before they get rejected.
And the list of products allowed to be sold will probably not come out until after that.

But just procedural delays and such as per normal and with them allowing 90 days to fix an application due to covid restrictions and such.

I do not look for a big rush of applications between now and Sept 9 though...

And on juice there is too the must be a Tobacco Products Manufacturer thing... which also hits any US based vape products manufacturers.

Interesting to note...
the FDA has stated it's plans to continue monitoring of social media, web sites and publications And will issue warning letters when needed...
 
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JuicyLucy

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From scanning the linked article it appears that the big hammer will not fall for 90 days or so.
Messed up PMTA applications have 90 days to straighten them out before they get rejected.
And the list of products allowed to be sold will probably not come out until after that.

But just procedural delays and such as per normal and with them allowing 90 days to fix an application due to covid restrictions and such.

I do not look for a big rush of applications between now and Sept 9 though...

And on juice there is too the must be a Tobacco Products Manufacturer thing... which also hits any US based vape products manufacturers.

Interesting to note...
the FDA has stated it's plans to continue monitoring of social media, web sites and publications And will issue warning letters when needed...

yeah, that was disconcerting

I remember awhile back they came down on social media influencers - pathetic all the way

Gotta wonder what they think about us - they obviously don't listen
 
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The Cromwell

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yeah, that was disconcerting

I remember awhile back they came down on social media influencers - pathetic all the way

Gotta wonder what they think about us - they obviously don't listen
Well talking about vaping is not prohibited. Nor is sharing recipes for individual DIY.
I do not think they can stop real person to person sales.
The market place thing though might be viewed as some type of store front...

And of course they could go after the advertisers I suppose.
Coincidence that this came out on Friday and Joe made his announcement of Sept 1 when?

Of course no one should ever speak of someplace skirting FDA regs on vaping in the open any more here.
PM's only!!!!!!

However they may enjoy reading how much of low lifes we think FDA is :D

As far as I am concerned social media 'influencers' can all consume excrement and expire.

I do not view those giving honest reviews and the like or useful information as influencers.
 
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Smoky Blue

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Member For 5 Years
I wonder if anything in transit will banned from my mailbox. In any case, I'd better shop US vendors only. This is indeed sad.

I think we have time, as long as it is purchased before Sept 9th. maybe?
Does anyone know?
 

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