PMTAs - who is doing what?

[low_tar_neil]

Just because nobody has mentioned this in here, that I've seen, tobacco Free Nicotine is still not regulated by the FDA, I mean how that even works when they can regulate a battery I have no idea, but it isn't.

I know for a fact that there are at least 10 of the 'disposables' switching to this and a number of the regular juice guys too. Would expect it to become a big thing going forward.. for as long as they can get away with it.

 

[low_tar_neil]

That does appear to be what they're saying, but I'm not sure where they're getting their information. The Smok PMTA list I've seen doesn't include the kit on their site, and I haven't seen a list from vaporesso. If they're a store you buy from, you could email them and ask about it.

.

where does this SMOK list come from? I'm trying to confirm it with them, they're saying it's not final

 

[Katya]

Just because nobody has mentioned this in here, that I've seen, Tobacco Free Nicotine is still not regulated by the FDA, I mean how that even works when they can regulate a battery I have no idea, but it isn't.

I know for a fact that there are at least 10 of the 'disposables' switching to this and a number of the regular juice guys too. Would expect it to become a big thing going forward.. for as long as they can get away with it.

Right, however, they may change their mind if they so desire. The last sentence in their answer leaves a door wide open.

FDA ‘clarifies’ stance on synthetic nicotine as a tobacco product

“Q: The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?”
“A: The definition of "tobacco product" includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA's tobacco control authorities.
However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”

 

[Katya]

Since anything made before 8/16 is exempt, will there be a resurgence in old designs being manufactured for the niche market?

Nothing is exempt except products that were sold in the U .S. before the grandfather date of February 15, 2007. Everything after that date requires a PMTA.

 

[HigherStateD]

Right, however, they may change their mind if they so desire. The last sentence in their answer leaves a door wide open.

FDA ‘clarifies’ stance on synthetic nicotine as a tobacco product

“Q: The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?”
“A: The definition of "tobacco product" includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA's tobacco control authorities.
However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”

Well then, that clears that up...

 

[UncLeJunkLe]

Soooo.... Another ridiculous thought brought on by a ridiculous situation....
Since anything made before 8/16 is exempt, will there be a resurgence in old designs being manufactured for the niche market?

2/2007, not 8/2016.

 

[UncLeJunkLe]

Nothing is exempt except products that were sold in the U .S. before the grandfather date of February 15, 2007. Everything after that date requires a PMTA.

I thought anything after 8/2016 was forbidden from PMTA?

 

[Katya]

I thought anything after 8/2016 was forbidden from PMTA?

No, it's not. We've been back and forth on that subject in the deeming thread. My head is spinning. This is the latest post on the subject. Don't quote me.

A slight adjustment. The PMTA for a newer product doesn't have to have been approved as of 9/9, but rather accepted for review.

"... if a product SKU is not covered by a PMTA that has been accepted for review by the FDA, or if a manufacturer has simply failed to file any PMTA, those products cannot continue to be legally sold after September 9, 2020...."

From other info it sounds like the overall review cycle may take a decent amount of time before all accepted for review items have determinations made.

"...Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced..."

Somewhat contradictory (earlier) post:

No, no! The grandfather date of Feb 15, 2007 is very real and is something else completely. Anything prior to this date is exempt from the PMTA completely.

And anything marketed between Feb 15, 2007 through Aug 8, 2016 can still be sold legally and must file a PMTA by Sep 9, 2020. Anything marketed after Aug 8, 2016 can't be sold legally until a PMTA is filed and approved. Which basically means everything marketed after Aug 8, 2016 and sold in the country is illegal. Because nothing has been approved yet except iQOS and snus.

 

[UncLeJunkLe]

Right. I forgot.

 

[WorksForMe]

where does this SMOK list come from? I'm trying to confirm it with them, they're saying it's not final

That was posted on Reddit's PMTA Megathread. Now that line has been changed to the following:

"Smok (article here & Smok has asked that I remove the list and they will update when their list is finalized)"

.

 

[zoiDman]

Just because nobody has mentioned this in here, that I've seen, Tobacco Free Nicotine is still not regulated by the FDA, I mean how that even works when they can regulate a battery I have no idea, but it isn't.

I know for a fact that there are at least 10 of the 'disposables' switching to this and a number of the regular juice guys too. Would expect it to become a big thing going forward.. for as long as they can get away with it.

Up until Now, I think Tobacco Free Nicotine (TFN) has been more of a Curiosity rather than a Viable alternative. Due to it's cost.

Here is a Good Example: Bulk TFN Nicotine 100mg*

Of course, this may Change as we move Past Sept 9th.

 

[zoiDman]

Right, however, they may change their mind if they so desire. The last sentence in their answer leaves a door wide open.

FDA ‘clarifies’ stance on synthetic nicotine as a tobacco product

“Q: The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?”
“A: The definition of "tobacco product" includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA's tobacco control authorities.
However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”

This is what Lawyers like to call "Pointing at a Badge".

Where someone (like the FDA) Probably Doesn't have Authority over something. But wants to make it seem that they do.

Also, even though many Federal Courts like to rely on Judicial Deference when it comes to agencies like the FDA and their Infinite Wisdom, that Underlined part can be Problematic.

Because Courts are Supposed to be Bound by that "Equal Justice under the Law" thing that is Carved on the outside of their Courthouses. And the Concept that the FDA may decide to Remove one Product from the Market while leaving Others that are basically the same Doesn't sit well with Some Judges.

 

[440BB]

I've watched the shift in our enemies' marketing of the "problem" from the dangers of tobacco and ecigs to nicotine addiction over the last year or two.

Moving public opinion from anti tobacco => anti vaping => anti nicotine gives regulation and tighter restriction broader support.

Demonizing nicotine versus tobacco makes even synthetic nic a likely target IMO.

 

[Fidola13]

Here's How it Works. Or, at least, was supposed to Work Date-wise.

If your Tobacco Product was sold in a US Market On or Before Feb 15th 2007, it is Grandfathered. Nothing is Needed. Legal to Sell. Feb 15th 2007 is called the "Predicate Date".

If your Tobacco Product was sold in a US Market between Feb 16th 2007 and Aug. 8th 2016, then you were given 2 Years to Prepare/File a PMTA (or a SE or a MRT) for it. And you were Allowed to continue to Sell your Product while the FDA reviewed your application. This 2 Year "Grace Period" was extended by the former FDA Commissionaire. And then later rolled back in Court to what is now be Sept 9th 2020. Products sold between Feb 16th 2007 and Aug. 8th 2016 are referred to as "Existing Products".

If your Tobacco Product was Not Sold in a US Market On or Before Aug. 8th 2016, then it is considered to be a "New Product". And it Can Not Be Sold in a US Market UNTIL you receive a PMTA (or an SE or MRT) from the FDA.

---

Where there is much Confusion is the FDA did Not Enforce the requirement for "New Products" that were Released after Aug. 8th 2016. They took a "Look the Other Way" approach.

So Technically, most of what the Average Vaper uses Today wasn't even supposed to have been Legal to Sell. Since Most of what people use Today came into the Market after Aug. 8th, 2016.

But the Long and the Short of it is Now we are about done with the Grace Period. And on Sept 9th your are going to have to have a PMTA (or Se or MRT) on file with the FDA to keep selling your Tobacco Product.

And you can Keep selling your PMTA-ed (or SE-ed or MRT-ed) Product for up to 1 Year. Or until the FDA either Approves your Product (Yah!) or Denies it (then it must be Removed from the Market).

Thank you for this very simple explanation of what can be somewhat confusing. Well at least for me!

 

[zoiDman]

Thank you for this very simple explanation of what can be somewhat confusing. Well at least for me!

Hey No Problem Fidola.

My Dad used to say that... "If you know what is going on today, it is easier to plan for tomorrow."

 

[UncLeJunkLe]

I've watched the shift in our enemies' marketing of the "problem" from the dangers of tobacco and ecigs to nicotine addiction over the last year or two.

Moving public opinion from anti tobacco => anti vaping => anti nicotine gives regulation and tighter restriction broader support.

Demonizing nicotine versus tobacco makes even synthetic nic a likely target IMO.

I agree,

And I'm pretty sure someone on this thread or the deeming thread said (or I read somewhere else) that the deeming regs already addresses synthetic nic or nic derived from something other than tobacco. It's basically already deemed tobacco just like 0mg ejuice is deemed tobacco because the intent is to offer it to consumers as an alternative to smoking (or something like that). It's about the intent.

So if I start a new product called "invisible cigarettes" and that is what it literally is, an invisible, pretend cigarette (a box with nothing in it) then it's is a "tobacco products". lol

Not funny

I wonder where that leaves candy/gum cigarettes?

 

[HigherStateD]

So, there is still now word on if the nicotine tax is set to take effect on the 9th, barring an (unlikely) extension? Do we even know how much it will actually be? I'd imagine vendors would need at least some lead time to implement? Or am I being optimistic...

 

[UncLeJunkLe]

So, there is still now word on if the nicotine tax is set to take effect on the 9th, barring an (unlikely) extension? Do we even know how much it will actually be? I'd imagine vendors would need at least some lead time to implement? Or am I being optimistic...

The nicotine tax has nothing to do with the FDA and deeming regs. That's part of a bill that the Trump administration said it would veto if passed by the House . Of course talk is cheap and it is likely it will be lumped in with some other bill containing other proposed taxes and laws which the Trump administration will not veto. That tactic is used all the time.

ETA: If I remember correctly it comes to about $2,700.00 per liter. That's right, per liter.

 

[thanswr1]

I have a question to ponder: Assuming the FDA stops the sale of all non-PMTA products (unlikely), what happens to the products that were ordered and paid for before September 9th but have yet to be delivered?

Hmmm ............

 

[UncLeJunkLe]

I have a question to ponder: Assuming the FDA stops the sale of all non-PMTA products (unlikely), what happens to the products that were ordered and paid for before September 9th but have yet to be delivered?

Hmmm ............

They get delivered. If the sale was made before the 9th, it would be legal anyhow. There's no law against shipping it (yet, at least they don't enforce it), it's all about selling it (for now).

Besides, the FDA doesn't have the resources to stop shipments from being shipped or intercept domestic shipments mid-way.