Deeming Regulations have been released!!!!

[Katya]

I always thought PMTA applications were required for "new tobacco products" that weren't on the US market by August 8, 2016.

No--if I understand you correctly.

PMTA applications are required for all ENDS that appeared on the market after February 2007. Since the first (?) FDA deadline for submitting PMTAs was August 8, 2016, everything that was on the market between February 2007 and August 8, 2016, needs a PMTA. That hasn't changed.

The deadlines for submitting PMTAs keep changing, but not the dates when products were being sold in U.S.

What happens to the new products introduced after the August 8, 2016, deadline hasn't been addressed, to the best of my knowledge.

The grandfather date hasn't changed either: "It's possible that an ENDS product exists that may have been on the market in the United States as of February 15, 2007 and could be used as a valid predicate. However, the burden of identifying a predicate falls to the applicant, so a manufacturer would have to prove such a product is grandfathered."

That's how I understand it, anyway. If I'm wrong, please let me know.

 

[JCinFLA]

That's how I understand it, anyway. If I'm wrong, please let me know.

Nope...you're definitely right. It was likely I just had a huge senior brain fart...or it was wishful thinking as far as the Aug. 2016 date.

 

[Katya]

or it was wishful thinking as far as the Aug. 2016 date.

Yeah, it would be nice if all pre-August 2016 ecigs were grandfathered in...

 

[UncLeJunkLe]

I can't have my peach vapes because it's a kid flavor

I hated peach and peach flavored foods when I was a kid.

As an adult, I love it.

 

[Rossum]

Since the first (?) FDA deadline for submitting PMTAs was August 8, 2016, everything that was on the market between February 2007 and August 8, 2016, needs a PMTA. That hasn't changed.

Allow me to wax pedantic and summarize the history of PMTA deadlines:

The Dooming Regulation became effective on August 8, 2016. Nothing new was supposed to come to market after that date without going through the PMTA process first, but that was never enforced with any vigor.

The deadline to submit PMTAs for products that were already on the market on or prior to August 8, 2016 was two years later, August 8, 2018.

When the current administration came into office and changed upper management at the FDA, the deadline was extended four years to August 8, 2022. Then due to all the angst surrounding teens vaping flavors, the deadline for "flavored" products (i.e. non-tobacco or menthol flavors) was pulled forward a year to 2021.

Last year there was a lawsuit by a bunch of ANTZ that claimed the FDA didn't follow proper rulemaking procedures when they punted the deadline. Technically, I believe they were correct in this assertion, and the court agreed, pulling it forward to May of 2020. Finally, it got punted a few more months due to the virus panic.

The only way an "ENDS" product could be exempt from the current PMTA deadline would be if it was on the market prior to the original grandfather date in February of 2007. Nothing currently on the market was, so everything currently on the market is subject to the current deadline.

 

[WorksForMe]

When the current administration came into office and changed upper management at the FDA, the deadline was extended four years to August 8, 2018.

My OCD couldn't let this pass. I think you meant 2022.

IIRC, if a manufacturer files a PMTA before 9/9/20 for a product that was on the market before 8/8/16, it can stay on the market for one year while the FDA reviews the PMTA. If the product wasn't on the market before 8/8/16, it can't be put on the market until after the FDA approves the PMTA.

After 9/9/20, it will be a lot easier for the FDA to enforce the PMTA requirements. Only products with a PMTA on file will be able to be sold. That won't be very many, compared to how many are are the market right now. The big question is how much enforcement will be done.

.

 

[Katya]

Allow me to wax pedantic

I wouldn't expect anything less from you, dear Rossum.

The sad bottom line doesn't change, alas! Nothing currently on the market has been approved by anybody yet and is subject to PMTA.

 

[Buster282]

The big question is how much enforcement will be done.

And will.the Feds interfere with or seize shipments from overseas?

 

[BillW50]

And will.the Feds interfere with or seize shipments from overseas?

They did in 2009. And during the big court case of 2009, vaping was classified as a tobacco product. But the other choice would have been worse. And that was it would become a Big Pharma product and they would have owned everything related to vaping.

 

[Rossum]

And will.the Feds interfere with or seize shipments from overseas?

Enforcement in general is the $6.4 billion question.

 

[Rossum]

. I think you meant 2022.

Yes I did. Fixed. Thank you.

 

[Bronze]

Allow me to wax pedantic and summarize the history of PMTA deadlines:

The Dooming Regulation became effective on August 8, 2016. Nothing new was supposed to come to market after that date without going through the PMTA process first, but that was never enforced with any vigor.

The deadline to submit PMTAs for products that were already on the market on or prior to August 8, 2016 was two years later, August 8, 2018.

When the current administration came into office and changed upper management at the FDA, the deadline was extended four years to August 8, 2022. Then due to all the angst surrounding teens vaping flavors, the deadline for "flavored" products (i.e. non-tobacco or menthol flavors) was pulled forward a year to 2021.

Last year there was a lawsuit by a bunch of ANTZ that claimed the FDA didn't follow proper rulemaking procedures when they punted the deadline. Technically, I believe they were correct in this assertion, and the court agreed, pulling it forward to May of 2020. Finally, it got punted a few more months due to the virus panic.

The only way an "ENDS" product could be exempt from the current PMTA deadline would be if it was on the market prior to the original grandfather date in February of 2007. Nothing currently on the market was, so everything currently on the market is subject to the current deadline.

This highlights the fact that had the original drafters of this law back in 2016 had their way, vaping would be nearing its 2nd anniversary of being effectively banned. We have been on borrowed time. Let's see what happens in a couple months when the latest drop dead date is upon us.

 

[Rossum]

This highlights the fact that had the original drafters of this law back in 2016 had their way,

More pedantry: The drafting of this regulation goes a good bit further back. The Dooming was formally proposed ("Notice of Proposed Rule Making" in the Federal Register) in the spring of 2014. That means the FDA bad been "drafting" it going back at least as far back as 2013.

It's all the legacy of a previous administration, and a law (the Tobacco Control Act, sometimes referred to as the Marlboro Protection Act) passed during a time when the same party controlled both chambers of Congress and the White House.

 

[Bronze]

More pedantry: The drafting of this regulation goes a good bit further back. The Dooming was formally proposed ("Notice of Proposed Rule Making" in the Federal Register) in the spring of 2014. That means the FDA bad been "drafting" it going back at least as far back as 2013.

It's all the legacy of a previous administration, and a law (the Tobacco Control Act, sometimes referred to as the Marlboro Protection Act) passed during a time when the same party controlled both chambers of Congress and the White House.

Their $2,500 healthcare rebate check took the sting out of it.

 

[hittman]

I don’t remember what year it was passed but the main affect the PACT act took shipping on snus from $5 to $40. It made it so it could only be shipped by UPS with adult signature required. I had to start ordering in bulk to offset the shipping cost. I hope the same thing doesn’t happen to vaping stuff.

 

[DaveP]

As has been said before, stock up on the ingredients and learn to DIY your own juice. It's the only way to ensure a supply of juice you like after Deeming. Buy a supply of 100mg Nic, freeze it, and calculate forward to ensure it will last. If you can cut your nic content to a lower level a liter can last several times longer. At 3mg strength vaping 8ml of juice a day, a liter of 100mg/ml nic will last me 11.4 years (last time I did the calculations).

Vaping Community e-liquid Calculator - Vapocalypse Calculator

 

[Bronze]

At 3mg strength vaping 8ml of juice a day, a liter of 100mg/ml nic will last me 9 years (last time I did the calculations).

Calculate it using the new math taught in our schools.

 

[DaveP]

Calculate it using the new math taught in our schools.

Vape juice calculator added to my post above.

 

[hittman]

I still use 12mg most of the time except if I’m doing a review on a high output mod/tank. The thing I’m struggling with adding to my calculations is the amount dumped when doing flavor or recipe testing. I should have plenty for my daily usage but might get one more liter to compensate for waste.

 

[DaveP]

I still use 12mg most of the time except if I’m doing a review on a high output mod/tank. The thing I’m struggling with adding to my calculations is the amount dumped when doing flavor or recipe testing. I should have plenty for my daily usage but might get one more liter to compensate for waste.

Never hurts to calculate with some overkill. Add 10% for waste. I bought another liter to increase my stock earlier this year. It's broken down into 100ml bottles in the freezer. My 4 liter stock fits into a box about 12"x8"x4".