Innokin Zenith MTL tank--Phil Busardo

[gerrymi]

Zenith MTL tank...$19.10...
Innokin Zenith MTL Vape Tank Φ24mm Top filling 4ml Atomizer

Zenith Coil 5pcs...$4.52--$5.02...
Innokin Zenith Coil 5pcs 0.5ohm/0.8ohm/1.6ohm/1.2ohm Vape Tank

..

 

[Belushi]

Given the upcoming PMTA deadline... Will innokin Zenith coils be available after September 9th?

 

[Katya]

Given the upcoming PMTA deadline... Will Innokin Zenith coils be available after September 9th?

On paper, no. Everything post-2016 cannot be sold without a PMTA approval.

 

[Belushi]

I've been lazy on keeping up on the US e-cig politics.. This just hit me, picked up a big order of Juice given Vapewild is shutting down, they had no coils. Guess I'll be looking for a long term supplier. Have a few rebuildables laying around (including the Ares), guess I can go that direction, but... What are others in the US doing, China? Any chance Innokin submitted a PMTA application for the Zenith?

 

[Katya]

I've been lazy on keeping up on the US e-cig politics.. This just hit me, picked up a big order of Juice given Vapewild is shutting down, they had no coils. Guess I'll be looking for a long term supplier. Have a few rebuildables laying around (including the Ares), guess I can go that direction, but... What are others in the US doing, China? Any chance Innokin submitted a PMTA application for the Zenith?

Are you done stocking up?

Deeming Regulations have been released!!!!

 

[Zazie]

On paper, no. Everything post-2016 cannot be sold without a PMTA approval.

I thought that any products for which a manufacturer has started the PMTA process can remain on the market for a year.

 

[Katya]

I thought that any products for which a manufacturer has started the PMTA process can remain on the market for a year.

Nope. That is true only for pre-2016 gear. Everything post 2016 needs an approved PMTA in order to be sold in the US.

 

[Seiggy]

I thought it was everything post 2016 needed a PMTA being accepted by the FDA to remain on the market. Once approved by the FDA, it could remain being sold. If not approved it was to be removed from sale within like 180 days. Am I getting something confused ?

 

[Katya]

I thought it was everything post 2016 needed a PMTA being accepted by the FDA to remain on the market. Once approved by the FDA, it could remain being sold. If not approved it was to be removed from sale within like 180 days. Am I getting something confused ?

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.

 

[Seiggy]

Katya, Thanks for the clarification. I'm having a hard time keeping up with the before, during and after issues. I remembered the "filed" part but ignored the "approved" part.

 

[Katya]

Katya, Thanks for the clarification. I'm having a hard time keeping up with the before, during and after issues. I remembered the "filed" part but ignored the "approved" part.

Join the club.

 

[markfm]

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..."

 

[Seiggy]

Dang, its all about the wordage $#%@#$ Approved, submitted, reviewed, accepted. And the dreaded "Did Not PASS". Oh, yea....REJECTED

 

[Zazie]

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..."

Yes, this is what I thought. As long as a PMTA application has been filed for it, a product can be sold for a year. At least.

 

[markfm]

Luck of the draw on which ones get reviewed earlier, as they indicate they'll try to provide some balance between larger and smaller manufacturers.

 

[Katya]

Yes, this is what I thought. As long as a PMTA application has been filed for it, a product can be sold for a year. At least.

Not filed, but accepted for a review. Not the same thing, apparently.

And they may reject it within a week, if they want to. So I wouldn't count on "1 year at least."

This is so infuriating.

 

[Uncle]

It is my understanding that Innokin will be filling PMTA's . . . However to be sure, I think it is time to ask some one in the know like @Innokin_timmy or @Innokin_Joseph . . . Will Innokin be filling PMTA's? And continue to supply products to consumers in the USA ?



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[KonaNeil]

Coils should simply be electronic parts, likely resistors. As an electronics manufacturer in the states I bought millions of them over the years. I don't understand why they should be any different unless the vendors ship with packaging that shows people smiling and smoking.

 

[Katya]

Coils should simply be electronic parts, likely resistors. As an electronics manufacturer in the states I bought millions of them over the years. I don't understand why they should be any different unless the vendors ship with packaging that shows people smiling and smoking.

Or slap the mandatory "This product contains nicotine" even though is doesn't.

 

[Zazie]

Not filed, but accepted for a review. Not the same thing, apparently.

And they may reject it within a week, if they want to. So I wouldn't count on "1 year at least."

This is so infuriating.

It's going to be interesting to see how people react when the smoking rate starts going up.