Deeming Regulations have been released!!!!

[zoiDman]

At least the feds are finally making noises like they will be reasonable on PMTA for small businesses. Recent article, "Azar Promises Streamlined PMTA Approval for Small vape Businesses", sounds good. Now we just have to see if they follow through! Got the link from Paradigm vape News, Paradigm Vape News - Complete and current vape news, articles, videos, Call to Action for state advocacy, reviewers and more..

Azar Promises Streamlined PMTA Approval for Small Vape Businesses

 

[UncLeJunkLe]

He was the one pushing to ban "refillable e-cigs" back in Sept/Oct... so I agree, toss him in prison. lol

And he also has BT running through is veins, his wallet, his bank account and his resume...

Mitt Romney Made Millions off Cigarettes, Now He Wants to Kill its Competition

 

[Ceejay0875]

Throw him in prison. Don’t like him anyway.

Nah, just give him a $5000 tax on it.

 

[UncLeJunkLe]

Well, the fact that they've opened up a CBD section makes me wonder how confident they are that they'll have any so-called "tobacco product" approved.

Well, that does make me wonder, too. It's either a sign of not having faith in nic being a economically viable business in the future, or just another revenue stream/diversification. Heartlandvapes also has their own, separate CDB venture, Hempnetix.

 

[stols001]

While I am all for Mitt going to a dungeon, prison or whatever (I think he'd have a worse time in oh, say your run of the mill prison like Pima Co Jail)

I'm kind of confused what is wrong with chocolate milk? Specifically? I mean, I happen to think it can be gross, but he's just desperately trying to get the caffeine he needs that his religion will not allow. Lots of Mormons do it,. Can't we find his secret "extra" wife and lock him up for that?

Also, WHY? Are they worried about stains in the impeachement room? Can you only drink WATER in Congress? I would say that is punishment enough but like, they have all the aides hang out in there half the timem anyway...

I'm so confused.

Anna

 

[WorksForMe]

Azim Chowdhury posted this yesterday.

The Washington Legal Foundation (@WLF) has filed an amicus brief supporting our Fourth Circuit appeal of the PMTA deadline decision

.

 

[WorksForMe]

FYI, in case this hasn't been discussed here(my memory is not what it used to be).

Update: The Fourth Circuit denied stay request but granted motion to expedite PMTA deadline appeal; oral arguments will be on 3/18. Opening briefs filed by the vapor & cigar industry: https://tinyurl.com/u2o6d9q and FDA: https://tinyurl.com/wz3u3db. Public health response due in 30 days.

AFAIK, this the only lawsuit left.


.

 

[DavidOck]

And THIS was in the news today !
Mitt Romney violated Senate rules by drinking chocolate milk out of a bottle during the impeachment trial

"Romney has been known to enjoy chocolate milk. His wife, Ann Romney, revealed that the drink is his "guilty pleasure" in a 2012 interview, and the then-presidential candidate was photographed sipping chocolate milk on his campaign bus."

 

[stols001]

I wish I was rich enough to bribe effectively. Man, I mean it worked so well with the kid sometimes. IDK. Ooh, that reminds me I never checked the husband's lottery ticket. I don't think the winner has declared themselves yet.

I don't even know enough about the lottery about what and where to check, but it's more coffee time,, then the ticket.

Bathing soon even I cannot really handle being around me. Sick just doesn't smell good.

If I win, I will do some vape bribing. Most certainly. I also would continue working but more part time. Etc.
Anna

 

[stols001]

Also, I don't like it's the last, lonely lawsuit left, honestly. It's not good. We should have many many MORE. I would have filed one just now but I did check my lottery tickets and the husband has ZERO SKILL in choosing lottery numbers.

Well, it's probably not a skill exactly but he still sucks at tit.
Anna

 

[Taltos]

Yeah, that was posted here a week ago, but it only made me feel warm and fuzzy inside for about a minute. There is no information about what "Streamlined" means to them and the whole thing was too vague.

I agree, it is a horribly vague statement but they weren't even making noises like this until now. I doubt it will be pretty but if they even move noticeably in this direction, it would be a big help! Now we wait and see if it was just lip service. My suspicion is that they are going to let "smart" e juice PMTA's start to get through. By smart, I mean they more basic, moderate level nicotine juices. I suspect salt nics will have a rougher time.

Devices are a whole different story. That is the place where I'm concerned about what "Streamlined" means. I think that will be one of the other places where PMTA could still be very expensive and difficult.

Just guessing really. And some hoping as well!

 

[englishmick]

Devices are a whole different story. That is the place where I'm concerned about what "Streamlined" means. I think that will be one of the other places where PMTA could still be very expensive and difficult.

Just guessing really. And some hoping as well!

Supposedly the streamlined process is intended to make life easier for small American companies. That's not likely to include Geekvape or Aspire, etc.

 

[zoiDman]

I agree, it is a horribly vague statement but they weren't even making noises like this until now. I doubt it will be pretty but if they even move noticeably in this direction, it would be a big help! Now we wait and see if it was just lip service. My suspicion is that they are going to let "smart" e juice PMTA's start to get through. By smart, I mean they more basic, moderate level nicotine juices. I suspect salt nics will have a rougher time.

Devices are a whole different story. That is the place where I'm concerned about what "Streamlined" means. I think that will be one of the other places where PMTA could still be very expensive and difficult.

Just guessing really. And some hoping as well!

I'm just Not sure how one can Quantitatively describe in a PMTA the characteristics of their e-Liquid(s), and subjectively explain How/How Not these characteristics Will/Will Not effect things like Underage Use, when one Can't define How their e-Liquid(s) are going to be used?

 

[Taltos]

I'm just Not sure how one can Quantitatively describe in a PMTA the characteristics of their e-Liquid(s), and subjectively explain How/How Not these characteristics Will/Will Not effect things like Underage Use, when one Can't define How their e-Liquid(s) are going to be used?

My take on the latest guidance papers and statements like the article I posted is that the nit picky "holes" won't be used to kill applications for smaller juice manufacturers. Most of the latest guidance ask for specifics on "quantitative" information. They have a pretty well stated list for ejuice. I think the subjective holes that may have been used like the under age usage are going to be ignored as moot since the feds have made it illegal for anyone under 21 to buy. Much of the guidance is about showing your product is less harmful to the public health than existing (cigarettes) products. That is a WHOLE can of worms that we'll have to see what they will accept. Since we have been proving that for a while but too many don't want to listen or see.

It is still scary as hell but I know companies are submitting. We'll start to see results one way or the other in the next few months.

 

[stols001]

Zen/HOH needs to submit one. Making tons of his own products plus importing many would be interesting.
Anna

 

[BigPappa]

Zen/HOH needs to submit one. Making tons of his own products plus importing many would be interesting.
Anna

Odd are, due to a PMTA being required for each product, no one will have "tons" in the future... at least not in the US.

 

[Taltos]

Odd are, due to a PMTA being required for each product, no one will have "tons" in the future... at least not in the US.

I think some in the juice industry may surprise you. The estimate of $100k - $200k per SKU are horribly pessimistic estimates. If a manufacturer reads the lastest couple of guidances smartly, then there are some options for doing this for a lot less. It will still be expensive but not nearly what the common estimates have been lately. That is our own version of panic and pessimism.

 

[BigPappa]

I think some in the juice industry may surprise you. The estimate of $100k - $200k per SKU are horribly pessimistic estimates. If a manufacturer reads the lastest couple of guidances smartly, then there are some options for doing this for a lot less. It will still be expensive but not nearly what the common estimates have been lately. That is our own version of panic and pessimism.

You're a very optimistic person....

The FDA estimates PMTA's will cost about $117,000 to around $466,000. But that's the government making an estimate, we all know how they are when it comes to money and estimations. lol

Say it is just the average of those 2 numbers, that's $291,500 per flavor. If they want to sell 10 flavors, that's over 2.9 million dollars... and then of course they will want to sell each flavor in a variety of strengths. Where they can save money is when it comes to a PMTA for different mg, apparently there are options for that which will cost less than a house for each strength. Either way, there will be a lot less competition and variety in the near future.

 

[Bronze]

I think some in the juice industry may surprise you. The estimate of $100k - $200k per SKU are horribly pessimistic estimates. If a manufacturer reads the lastest couple of guidances smartly, then there are some options for doing this for a lot less. It will still be expensive but not nearly what the common estimates have been lately. That is our own version of panic and pessimism.

You're a very optimistic person....

The FDA estimates PMTA's will cost about $117,000 to around $466,000. But that's the government making an estimate, we all know how they are when it comes to money and estimations. lol

Say it is just the average of those 2 numbers, that's $291,500 per flavor. If they want to sell 10 flavors, that's over 2.9 million dollars... and then of course they will want to sell each flavor in a variety of strengths. Where they can save money is when it comes to a PMTA for different mg, apparently there are options for that which will cost less than a house for each strength. Either way, there will be a lot less competition and variety in the near future.

With no assurance the application will be approved. How many juice makers have that kind of money to gamble?

 

[BigPappa]

Aspire pretty much implied that they are going to do just one PMTA based on the tank that most people prefer... If a company like Aspire is limiting themselves to one PMTA, then what does that indicate small businesses will do? Aspire is worldwide, so they at least can continue to market their other products to other countries while only offering one product in the US.