FDA Submission Date Moved to 8/8/2022

[Kent C]

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.

Nice summary. Well said.

 

[stols001]

That's what I mean. It's impossible to tell, and I don't want to speculate, due to the fact that I don't want my speculations going anywhere they might not or should not.

As far as civil disobedience.... That's up to each individual member. IMO. I have practiced my share, now I'm older and do it more cautiously. But, I wouldn't hesitate to buy a new mod from anywhere, at this point in time.

Anna

 

[zoiDman]

Nice summary. Well said.

Thanks Kent.

 

[Rossum]

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?

For a product that is manufactured outside the USA, I'm reasonably sure it responsible party is the "importer of record". If a vape shop orders hardware directly from China, they are the responsible party. But if they order from a US distributor or warehouse, then the responsibility lies somewhere up the supply chain, with whomever imported it into the US to begin with.

Personally, if I were running a vape shop, I would not be ordering things directly from China unless I was darn sure (and had evidence to prove) that the exact goods I'm importing were available on the US market before 8/8/16.

 

[Bill Godshall]

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.

I basically agree.

But regarding enforcement, it could be much more difficult for FDA to monitor and enforce sales of e-liquid products (that weren't on the market by August 8, 2016) since tens of thousands (perhaps hundreds of thousands) of different e-liquid products have already been registered with FDA (and since the vapor products on the market on August 8, 2016 can still be registered with FDA).

Note that CTFK and other extremists have previously informed FDA of several different new cigarette sub brands that were introduced since 2007, but FDA has not yet ordered them to be removed from the market.

 

[Max-83]

I don't think the changes that the new FDA Commissioner announced can be seen as any kind of negative for vaping in the U.S. but I am confused by one aspect.

The FDA has said that one of the reasons for the change to the deadline for the pmta applications is to encourage innovation in non combustibles yet they still freeze the market at 8/2016.
How can the vape industry innovate in the U.S.?

 

[DC2]

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.

The California Lottery should have easily funded school reform.
If only that money had been used for what we were told it would be used for.

 

[stols001]

I want to know what CA spends its money on? They tax everything all the time and then go bankrupt? It's very confusing and I don't understand it at all. Who is actually gaining from all those taxes (I thought I was in another country , after we visited one time.)

I mean, it's fun, beautiful (except for parts of LA) they have tons of natural attractions for tourism, they hog much water to grow crops, I.do.not.understand. Also, the housing prices. (???)

Anna

 

[DC2]

I want to know what CA spends its money on?

I could easily answer that if this were the OUTSIDE! subforum.

 

[Kent C]

I could easily answer that if this were the OUTSIDE! subforum.

Only if it were a particular party statement....

 

[DC2]

Only if it were a particular party statement....

It most certainly would be.

 

[Rossum]

I could easily answer that if this were the OUTSIDE! subforum.

I was gonna say, "Let's start a 'California' thread there. But Anna is kinda new to ECF. I don't think it would be fair to bring her into that dark, shadowy place. Probably best if she never goes there.

 

[Myrany]

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 saw in a recent SUck My Mod Video on this new FDA announcement that the reason we are still seeing new gear is that before the cutoff date for new products many Chinese companys did the bare minimum they needed to do to get a ton of products listed as on the market before the date. Those same companys are slowly releasing them to the public now and those are the new mods, tanks etc we are seeing now.

 

[Fozzy71]

I saw in a recent SUck My Mod Video on this new FDA announcement that the reason we are still seeing new gear is that before the cutoff date for new products many Chinese companys did the bare minimum they needed to do to get a ton of products listed as on the market before the date. Those same companys are slowly releasing them to the public now and those are the new mods, tanks etc we are seeing now.

I didn't watch most/all of that SMM fda vlog but feel free to show me how anything released in 2017 from china was somehow on the market in July/Aug 2016........

 

[Myrany]

I didn't watch most/all of that SMM fda vlog but feel free to show me how anything released in 2017 from china was somehow on the market in July/Aug 2016........

Basically they did all the paperwork and shipped a few to the US before the 2016 date. THey established it way ahead of time. Then they just delayed releasing it to vendors. Or so SMM suggested. Do I think they all did this? No probably not but I do expect the BIG Chinese companys did. It just makes good business sense. All they have to do is show the paper trail.

 

[OldBatty]

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.

Thanks for the clarification! Suspected as much and this is why this is a (very nice) reprieve and not a true victory.

Now have 4 more years to stock up!

 

[Rossum]

The FDA has said that one of the reasons for the change to the deadline for the pmta applications is to encourage innovation in non combustibles yet they still freeze the market at 8/2016.
How can the vape industry innovate in the U.S.?

One might take this as a signal that the FDA does not intend to enforce the the "No new products" portion of the Deeming with any enthusiasm.

Then there's also the fact that most of the industry (and innovation) is now outside the US anyway.

 

[Fozzy71]

Basically they did all the paperwork and shipped a few to the US before the 2016 date. THey established it way ahead of time. Then they just delayed releasing it to vendors. Or so SMM suggested. Do I think they all did this? No probably not but I do expect the BIG Chinese companys did. It just makes good business sense. All they have to do is show the paper trail.

thanks for not showing me any proof..... i could give 2 ....s about the deeming regs or the 2007/2016 dates at this point.

 

[zoiDman]

Thanks for the clarification! Suspected as much and this is why this is a (very nice) reprieve and not a true victory.

Now have 4 more years to stock up!

I Think "Reprieve" is a Very Good word to describe what has happened. It is Also a Reprieve that spans into the Next Presidency.

And just like This President has placed his HHS Secretary/FDA Commissionaire into their respective positions, so can/will the Next. What we Need is a Permanent Congressional Solution.

 

[Myrany]

thanks for not showing me any proof..... i could give 2 ....s about the deeming regs or the 2007/2016 dates at this point.

Look I was clear about my source. It is the best logical explanation I have seen so far. There is no reason to be snarky because it does not meet your personal burden of proof.