FDA Submission Date Moved to 8/8/2022

[Robino1]

We still need to get something done by congress or we will always be at the mercy of whatever administration takes office.

As we have seen, it is very easy to change policy at the FDA level. We cannot just sit back and cruise thinking everything will be all right now.

Celebrate this minor victory then get back to work on the people that can make a more permanent change.

 

[Aus11]

Starts mumbling....
"Im soo excited, and I just cant hide it....."

 

[rwoodin]

No you you didn't. In my thread which you hijacked some time ago(president trump just saved vaping) you were emphatic that the deeming laws were unavoidable and already codified into law.

I was 100% correct. I graciously tried to inform ECF members that the deeming regs were not yet codified due to lack of legislative days in the federal register and were in fact invalidated by trumps second executive order.

The thanks I got is that my IP address gets banned from ECF because of your trolling in my thread. I encourage everyone who reads this to read thru my thread "President Trump just saved vaping" to see how right I was and incorrect you were.

Also, the FDA is directly investigating ECF. For further information regarding the progress and reasons for the investigation I require ECF to unblock my IP and an apology from those who derailed my thread . That is all.

Not sure about the backstory here. But I myself firmly believe this policy change would have never, ever, ever have happened under a Democratic administration. They would have walked vaping straight to the cliff and pushed it over. 5 Billion lives or more saved due to a policy change. Amazing what a few deplorables can accomplish when they put their heads and hearts together

 

[retired1]

Let's leave the partisan politics out of this please.

 

[mcclintock]

I still have to consider that vaping isn't fully "saved" yet, I think there's still a plan to regulate it strictly this could just be to have more time to "do it right" and not "ram it down our throats" but still not laissez-faire at all. The plan to manipulate nicotine in cigs would agree with this (although it also doesn't get along with the TCA as written).

Meanwhile, we're in limbo regarding significant progress in safety research or advice. The threat of making anything illegal needs to be taken out of the situation.

 

[stols001]

Not all 'good' but a rather new view from the new "FDA Commissioner Scott Gottlieb, M.D. "Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it's vital that we pursue this common ground."

THIS^

You know, I'm kind of loving Gottleib more and more as I read/watch more. Now of course we aren't going to know for certain the outcome until it arrives, but he seems to genuinely give a rats ... about stopping the next generation from smoking, and the "common ground" of harm reduction alternatives.

Like I've always said, I don't MIND paying a reasonable tax on vaping if part of it goes to harm reduction, not just the states, the States are going to freak out themselves now, seeing their tobacco tax go away, possibly, so we're nowhere near the end goal.

It's just nice to see an FDA member have some rationality about cigarettes versus harm reduction options. A reasonable look at the available data. The desire to create more never-smokers, (how I wish I had been included in this group), and a path to move forward, which seems reasonable (now). Obviously none of us can predict the future, but the statement above is such a rational one from the FDA I cannot help be pleased. (for now).

And yes, we need to keep going with our efforts. I actually DID email the FDA yesterday, LOL. Said not too much other than my own efforts with cigs and allowing vaping to continue being the right thing.

Anna

 

[Robino1]

I do not agree with any tax, above what the states charge for other goods.

No to any type of 'sin' tax. I have no problem with having the same taxes that are applied across the board. Extra? Oh Hell No!

 

[stols001]

I don't think we should have a sin tax on vaping... When I say reasonable, I wouldn't mind a 1% tax collected for harm reduction efforts, I truly wouldn't. Education for smokers to turn to vaping. To pay off BT bill? NO WAY.

Anna

 

[puffon]

I just hope any new FDA commissioner, who could replace the current one in 4 years, is not in the back pocket of BP, BT, or anti-politicians.

 

[Robino1]

I just hope any new FDA commissioner, who could replace the current one in 4 years, is not in the back pocket of BP, BT, or anti-politicians.

Or if Trump decides to fire him...

I keep saying to anyone that will listen, we need to keep pressure in congress to get vaping out of the grandfather date.

What the FDA is proposing now is not set in stone and can be changed at anyone's whim.

Nobody is listening ... just celebrations all over the place...

 

[Robino1]

I don't think we should have a sin tax on vaping... When I say reasonable, I wouldn't mind a 1% tax collected for harm reduction efforts, I truly wouldn't. Education for smokers to turn to vaping. To pay off BT bill? NO WAY.

Anna

Sorry, I don't even agree with that.

As soon as they get away with ANY extra tax, they will see it as a potential cash cow. Vulnerable to raises at whomevers whim.

Not acceptable.

 

[stols001]

Well, I agree that if any extra tax is placed, then the government gets SO excited... They couldn't keep their hands off the Social Security fund, honestly. So, I do see your point

Anna

 

[retired1]

Not only does ECF censor the word for that other stuff, it's a forbidden topic across the board.

Why we don't allow drug talk

 

[Beamslider]

I do not agree with any tax, above what the states charge for other goods.

No to any type of 'sin' tax. I have no problem with having the same taxes that are applied across the board. Extra? Oh Hell No!

The big problem here in CA is they put the sin taxes on the ballot and promise to spend the money on children health or other health uses. They also promise that it will cause thousands to stop smoking. It doesn't they are hooked on the smokes

People fall for it and approve the tax. The money disappears into the general fund.

Then a couple years later they come back for another round of raising the sin tax.

 

[Tonee N]

General Fund. Reminds me of the guy who invented global warming and the internet.

Ever wonder why the gov't spends $1500 for a hammer?

It always reminds me of the Robin Williams film Man of the Year.

They will tax vape and use the money to invest in companies that manufacture vape related products.

Sent from my SAMSUNG-SM-G891A using Tapatalk

 

[aviat0rK]

I usually read these threads and keep my mouth shut because someone else always brings up whatever I'm thinking. lol! BUT I have to add this and someone please let me know if I'm completely wrong.

This extension only applies to products that were already on the market before the deeming went into effect. The retroactive PMTA process we all dreaded. There is nothing here that changes any of the other parts that are already in effect particularly no new products as of 8/8/16 without first submitting a PMTA and having it approved.

With that said it hasn't stopped manufacturers (liquid or hardware) from releasing anything new. Every week we read about this or that new mod, liquid, tank, etc. I have what I believe to be a legitimate concern about this. The FDA could decide to start enforcing this today and start shutting manufactures and retailers down without question, damn the retroactive PMTA date if they can't prove these products were marketed prior to 8/8/16.

No, there are no indications they will start enforcing it but the fact is they CAN if they decide to. Am I misunderstanding this? Yes, my only other thread is in regard to this same thing months ago and I still see very little discussion going on about. The industry is still cranking along as if the deeming rule doesn't exist. On the other hand I go into vape shops and they're charging for samples using the deeming as a reason at the same time they're showing me the new Kanger 5-6 mod that was just released. It seems the industry is picking and choosing which parts of the rules to follow based on convenience and ignoring the long term effect this could have if the FDA decided to flip the enforcement switch. Even if they were only fined most would be fined out of business not being able to afford the fines any better than they could the PMTAs.

Just my thoughts and if I'm wrong, please tell me.

 

[Robino1]

I usually read these threads and keep my mouth shut because someone else always brings up whatever I'm thinking. lol! BUT I have to add this and someone please let me know if I'm completely wrong.

This extension only applies to products that were already on the market before the deeming went into effect. The retroactive PMTA process we all dreaded. There is nothing here that changes any of the other parts that are already in effect particularly no new products as of 8/8/16 without first submitting a PMTA and having it approved.

With that said it hasn't stopped manufacturers (liquid or hardware) from releasing anything new. Every week we read about this or that new mod, liquid, tank, etc. I have what I believe to be a legitimate concern about this. The FDA could decide to start enforcing this today and start shutting manufactures and retailers down without question, damn the retroactive PMTA date if they can't prove these products were marketed prior to 8/8/16.

No, there are no indications they will start enforcing it but the fact is they CAN if they decide to. Am I misunderstanding this? Yes, my only other thread is in regard to this same thing months ago and I still see very little discussion going on about. The industry is still cranking along as if the deeming rule doesn't exist. On the other hand I go into vape shops and they're charging for samples using the deeming as a reason at the same time they're showing me the new Kanger 5-6 mod that was just released. It seems the industry is picking and choosing which parts of the rules to follow based on convenience and ignoring the long term effect this could have if the FDA decided to flip the enforcement switch. Even if they were only fined most would be fined out of business not being able to afford the fines any better than they could the PMTAs.

Just my thoughts and if I'm wrong, please tell me.

I think the new stuff is stuff not able to be controlled by the FDA. In other words by foreign entities.

If it gets into the country.....

 

[stols001]

With hardware, I'm not sure where the responsibility lies? I mean... Is it with the manufacturer, or with the retailer(s) who are importing it and selling it? it's not really clear to me, I mean it's one thing if I were to import hardware (not a crime at this point) vs. buying it from a vape shop, either online or in person?

I'm leaving the whole thing alone. Vape shops should take a very close look at how easily the switch can flip, i.e. what happened to BT (which, I'm still not sure we know the whole story, there) and maybe think about "Wow, I want to start doing this correctly."

Then again, no clue what happens behind closed doors, either. Maybe some vendors have some... thing going to make sure they end up compliant. Vape staff won't talk about it.

OR, some shops will continue their practices, knowing that when the time comes, they may close their doors. IDK. But, I think it's a "more will be revealed" situation at this point, and I'm not certain I should even speculate, at this point. 4 years is a long time, and I guess we'll have to see what happens.

Anna

 

[Robino1]

And then are times when we should practice civil disobedience

Civil Disobedience (Thoreau) - Wikipedia

 

[zoiDman]

I usually read these threads and keep my mouth shut because someone else always brings up whatever I'm thinking. lol! BUT I have to add this and someone please let me know if I'm completely wrong.

This extension only applies to products that were already on the market before the deeming went into effect. The retroactive PMTA process we all dreaded. There is nothing here that changes any of the other parts that are already in effect particularly no new products as of 8/8/16 without first submitting a PMTA and having it approved.

With that said it hasn't stopped manufacturers (liquid or hardware) from releasing anything new. Every week we read about this or that new mod, liquid, tank, etc. I have what I believe to be a legitimate concern about this. The FDA could decide to start enforcing this today and start shutting manufactures and retailers down without question, damn the retroactive PMTA date if they can't prove these products were marketed prior to 8/8/16.

No, there are no indications they will start enforcing it but the fact is they CAN if they decide to. Am I misunderstanding this? Yes, my only other thread is in regard to this same thing months ago and I still see very little discussion going on about. The industry is still cranking along as if the deeming rule doesn't exist. On the other hand I go into vape shops and they're charging for samples using the deeming as a reason at the same time they're showing me the new Kanger 5-6 mod that was just released. It seems the industry is picking and choosing which parts of the rules to follow based on convenience and ignoring the long term effect this could have if the FDA decided to flip the enforcement switch. Even if they were only fined most would be fined out of business not being able to afford the fines any better than they could the PMTAs.

Just my thoughts and if I'm wrong, please tell me.

You are Basically Correct.

Tobacco Products before the Predicate Date are Grandfathered. No PMTA or SE or MRTP needed.

Tobacco Products sold between the Predicate Date and 8-8-16 can continue to be Sold but will require either a PMTA or a SE or a MRTP before 8-8-22.

Tobacco Products that were Not Sold before 8-8-16 Can Not be Sold until either a PMTA or a SE or a MRTP is approved by the FDA and a Market Order is Issued.

Where things start to get Fuzzy is what Tobacco Products the FDA chooses to Enforce.

An e-Liquid that contains Nicotine derived from Tobacco is (by the FDA and the Courts) a Tobacco Product. But 0mg may be considered a Tobacco Product by the FDA under "Intended Use".

Same with Hardware. A Disposable "Pen" is a Tobacco Product, or a Prefilled Cartridge, or a Kit that includes an e-Liquids that contain Nicotine. But what about an RTA or a RDA that is sold by itself? Once again, the FDA could apply "Intended Use" to it.

JMO. But now that the FDA has Judge Jackson's Ruling, I think the FDA is going to do Enforcement on Post 8-8-16 e-Liquids that contain Nicotine. Or any Post 8-8-16 products/kits that contain e-Liquids that contain Nicotine. And are going to Apply "Intended Use" on hardware selectively.

A Individual buying the Latest RTA from FT might not see it being Seized by Customs. But a US Retailer buying a Create Full of Post 8-8-16 products might. And US Retailers might start receiving FDA Letters warning them about Selling Post 8-8-16 products.

It's all Hard to Say?

Especially with the New FDA Commissionaire doing a Complete 180 from the previous FDA regarding e-Cigarettes and THR.