Deeming Regulations have been released!!!!

[Rossum]

What the FDA needs to "investigate" is whether any of these products were on the market prior to 8/8/16. If so, it's legal to sell them. If not, well... I bet this "investigation" involves letters to these companies that demand they produce proof that their products were on the market prior to that date. After all, we do have a presumption of innocence in the USA...

An example of this would be juul. I believe they were sold Prior to 8-8-16.

Absolutely, they were. I have posts and pics from 2015 when I bought one to play with.

But Most, if not just About every juul-a-Like, wasn't.

I think that's likely correct, but again, I suspect the FDA is (rightfully) giving them all a chance produce documentation that this assumption is incorrect.

If I had to, I could use Only Pre 8-8-16 items. And I could get by.

I only use pre 8/8/16 products. I made a conscious decision around the time the regs were finalized to stop chasing a better vape. Instead, I have a nice collection of products that I will last "forever"; products that were good enough to get me off cigs and keep me that way for almost 5 years now.

But it is like Buying a Bigger Computer Monitor. Once you do, it is Very Hard (if Not Impossible) to go back to a Smaller one.

I know exactly what you mean. I hate having to use my laptop when I'm on the road. There is no substitute for big monitors and an IBM Model M keyboard.

 

[Rossum]

Yep, here it is, from @zoiDman 's link.

The letters issued today ask companies to provide information about the products in question, including evidence that the product is a deemed product that was on the market as of Aug. 8, 2016 and has not been modified since that date.
[...]
The agency has several tools to enforce the requirements of the FD&C Act and regulations, including pursuing administrative actions such as civil money penalty complaints (fines) or judicial actions such as seizures or injunctions.

 

[zoiDman]

What the FDA needs to "investigate" is whether any of these products were on the market prior to 8/8/16. If so, it's legal to sell them. If not, well... I bet this "investigation" involves letters to these companies that demand they produce proof that their products were on the market prior to that date. After all, we do have a presumption of innocence in the USA...

...

Yeah... I think that is Exactly what they are doing. And I Don't see it Boding well for Many OEM's/Retailers.

 

[Rossum]

Yeah... I think that is Exactly what they are doing. And I Don't see it Boding well for Many OEM's.

Well, I'm not sure what the ones who introduced new products after 8/8/16 were thinking. Now I'm not talking about the Chinese OEMs who have a world-wide market; I'm talking specifically about some of the US companies that are trying to compete with Juul here.

 

[zoiDman]

Well, I'm not sure what the ones who introduced new products after 8/8/16 were thinking. Now I'm not talking about the Chinese OEMs who have a world-wide market; I'm talking specifically about some of the US companies that are trying to compete with Juul here.

I'd say that Many/Most just looked at it and said if the FDA was going to take a "Look the Other Way" approach, then let's try and Make as much Money as Possible until we are told to Stop.

I mean, I don't see a Bunch of Fines coming down on them. Just Letters that say if you Don't Stop, then you will be Fined.

Like I said though, I worry more about Retailers than OEM's.

 

[englishmick]

I think it is more PR Damage Control on the part of the FDA.

The FDA has been getting a Black Eye by the Media and some select Members of Congress lately. And the 8-8-16 New Product date is Pretty Unambiguous.

The Political Winds have also Shifted. And there is a Very Real Possibility that the Appropriation Funding for next cycle will be determined by a Different Political Majority.

Interesting thought there. Maybe they will just clamp down on pods then declare victory in the War to Save the Children and move on. Truth is in government campaigns like this they know they can't really win, but the plausible appearance of victory is as valuable as actual victory.

 

[zoiDman]

Interesting thought there. Maybe they will just clamp down on pods then declare victory in the War to Save the Children and move on. Truth is in government campaigns like this they know they can't really win, but the plausible appearance of victory is as valuable as actual victory.

Perception is Reality was never Truer than in Government. And Everything in Government is Magnified by about a factor of 10 in run up to an Election.

Perhaps things will die down Slightly in January?

But my experience with e-Cigarettes has been that Once that Big FDA boulder starts rolling down the Hill, the Only Thing that will stop it is the Bottom.

BTW - When does the OEM's 60 Days to come up with a Solution or Else thing expire?

 

[englishmick]

Perception is Reality was never Truer than in Government. And Everything in Government is Magnified by about a factor of 10 in run up to an Election.

Perhaps things will die down Slightly in January?

But my experience with e-Cigarettes has been that Once that Big FDA boulder starts rolling down the Hill, the Only Thing that will stop it is the Bottom.

BTW - When does the OEM's 60 Days to come up with a Solution or Else thing expire?

I guess. Knew I could trust you to bring me down from that little sugar spike of optimism.

 

[Rossum]

Maybe they will just clamp down on pods then declare victory in the War to Save the Children and move on.

Let's assume these pod systems become hard to get or undesirable due to lack of flavors. How long do you think it will take "the children" to move on to bigger and better things?

 

[untar]

How long do you think it will take "the children" to move on to bigger and better things?

Just takes 1 kid, 1 camera and a bag of snickers...

 

[mikepetro]

 

[DPLongo22]

FDA Says Vape Liquid Contains Erectile Dysfunction Drug

Old news, this stuff has been around for at least 6 years.

Aw jeez, and here I've been calling my doctor every four hours for the past seven years.

Had I known...

 

[Katdarling]

Aw jeez, and here I've been calling my doctor every four hours for the past seven years.

Had I known...

 

[Hoggy]

Aw jeez, and here I've been calling my doctor every four hours for the past seven years.

Had I known...

No kidding, heh?

Talking about sucking the wick dry..

 

[ScottP]

If I had to, I could use Only Pre 8-8-16 items. And I could get by.

I could too. Especially considering the DNA 75C board was sold before that date and that is ALL I still use. Plus, I now have four HCigar VT 75D mods that use that board. Also all the DNA boards prior to the 75C are also grandfathered in and I >THINK< they also did some wizardry to get the 250C covered as well. All that combined with how they have been working with the FDA should mean that as a company they should be relatively OK. This means mods like the Jac mods, the HCigar mods, the LostVapes mods, and others that have been and still use these boards should be good as well. Same goes for the Yihi boards, and the mods that use them, that were out prior to this date.

This may kill the Gene boards and mods that use it though. It will also impact a LOT of Smok mods, Aspire mods, and other companies that are producing new boards for their mods. Which is really sad considering the improvements made in this time that probably make them actually safer.

The real question is how will this impact tanks and RDA's? I mean if you think about it they are all pretty much the same as what has been out since the beginning. I think they could all argue "Substantial Equivalence". I am not sure if this would fly or not, but really they are all a metal housing with a clamping system of some sort to hold coils, wick and liquid. There are really only two kinds of these. Those that allow consumer built coils and those that require factory built coils. Even if they consider RDA and RTA different, both types have been in use nearly since the beginning.

 

[DPLongo22]

I could use pre 8-8-13 items and still be happy.

Heck. '12, even!

 

[DPLongo22]

I could use pre 8-8-13 items and still be happy.

Heck. '12, even!

Maybe not atties. I'd have to think about that one...

 

[Rossum]

Maybe not atties. I'd have to think about that one...

When was the REOs RM2 released? Or the Cyclone?

 

[DPLongo22]

When was the REOs RM2 released? Or the Cyclone?

It looks like (approx.) mid '13 on the former, and early '13 on the latter (but don't make book on that).

Source (YouTube) is suspect (at best). Laaaaaaaazy, I (eye).

 

[puffon]

I could too. Especially considering the DNA 75C board was sold before that date and that is ALL I still use. Plus, I now have four HCigar VT 75D mods that use that board. Also all the DNA boards prior to the 75C are also grandfathered in and I >THINK< they also did some wizardry to get the 250C covered as well. All that combined with how they have been working with the FDA should mean that as a company they should be relatively OK. This means mods like the Jac mods, the HCigar mods, the LostVapes mods, and others that have been and still use these boards should be good as well. Same goes for the Yihi boards, and the mods that use them, that were out prior to this date.

This may kill the Gene boards and mods that use it though. It will also impact a LOT of Smok mods, Aspire mods, and other companies that are producing new boards for their mods. Which is really sad considering the improvements made in this time that probably make them actually safer.

The real question is how will this impact tanks and RDA's? I mean if you think about it they are all pretty much the same as what has been out since the beginning. I think they could all argue "Substantial Equivalence". I am not sure if this would fly or not, but really they are all a metal housing with a clamping system of some sort to hold coils, wick and liquid. There are really only two kinds of these. Those that allow consumer built coils and those that require factory built coils. Even if they consider RDA and RTA different, both types have been in use nearly since the beginning.

The only products really grandfathered in were products made before 2007.
Anything made 2007-2016 still needs an approved PMTA, which are due 2022.
Who knows if they will change that date...