Deeming Regulations have been released!!!!

[VNeil]

I'm mostly curious whether direct consumer nicotine sales will be targeted, and what kind of attempts they will make to "inspect" online purchasing - both in August and then also in 2018.

Not IF, but WHEN

 

[zoiDman]

I can think of one reason, it's the catch 22 of that one year. Remember it took YEARS for the FDA to sift through and START making decisions on all of the SE applications from 2009. If you think your PMTA has a chance of being approved, you'd better hope they have enough time to review it and make a decision before you're forced to pull your product from the market.

There is that Also.

But just my Opinion, I don't think Products that the FDA feels they Will approve will be forced off the market while the FDA completes the PMTA.

 

[VNeil]

There is that Also.

But just my Opinion, I don't think Products that the FDA feels they Will approve will be forced off the market while the FDA completes the PMTA.

Pardon me while I edit your opinion...

But just my Opinion, I don't think BT Products that the FDA feels they Will approve will be forced off the market while the FDA completes the PMTA

 

[KODIAK (TM)]

Seems imminently fair to me... never forget the chillren....

Don't forget the "young adults". FDA's been on this so long they're using that term because the "children" aged a bit. (That, and everyone's just tired of hearing about the lil' kiddies).

 

[Lessifer]

Let's break this down to some simple predictions....

1 - Pretty much nobody we buy from is going to submit a PMTA.
2 - The FDA will begin 8/9/16 looking for people violating rules in effect as of that time - specifically, they'll start going into vape shops, just like the go into cigarette stores. They'll send in a minor and try to buy juice. And check labels. And start the long slow process (warning letter, fine, fine, fine...big fine...).
3 - We'll have 2 years to either change the regs, or see all the juice and mod vendors go black market, because by 2018, the only people who'll be able to market their product officially will be a couple of the very biggest vendors (those who've applied) like NJoy, and Vuse and Blu...and that's IT.

I'm mostly curious whether direct consumer nicotine sales will be targeted, and what kind of attempts they will make to "inspect" online purchasing - both in August and then also in 2018.

Don't forget that these rules are just the foundation. The FDA will be issuing more guidance in the interest of public health, and who knows what that could be. Maybe it will be maximum nicotine content...

There is that Also.

But just my Opinion, I don't think Products that the FDA feels they Will approve will be forced off the market while the FDA completes the PMTA.

Yeah, I'm sure some(BT) already know that they'll get an extension, I do think some others might try to apply(with the intent of succeeding) and I'm not sure if it would be good for them to apply early or not.

 

[crxess]

What do you mean by this ? Why can't the vendors who have no plans to file a PMTA, stay in business until August 7, 2018,

Remember - August dates are Small Manufacturers - Calculated by Sales, not size
Feb, 8 dates for large intities

yeah, i know, i think i have it memorized !

August 8, 2018

Premarket Tobacco Applications Due
–
Full premarket tobacco applications must be filed for all products on market as of August 8, 2016.

Filing will allow your product to remain on the market until at least August 8, 2019.

PMTA is most likely route for ENDS product manufacturers

How do you relate this to 2017 Dates, which seem to indicate PMTA's Must be filed - Feb. 8th / Aug. 8th ?

Any such non-flavored or newly deemed tobacco-flavored product for which an application under one of the three marketing pathways has not been filed submitted within 24 months from the effective date of part 1100 of this final deeming rule will not benefit from this continued compliance policy

This looks like a Cloaked Removal of ALL Devices and immediate Removal of unflavored Nicotine as Non-Flavored Products.

 

[Lessifer]

Remember - August dates are Small Manufacturers - Calculated by Sales, not size
Feb, 8 dates for large intities



How do you relate this to 2017 Dates, which seem to indicate PMTA's Must be filed - Feb. 8th / Aug. 8th ?



This looks like a Clocked Removal of ALL Devices and immediate Removal of unflavored Nicotine as Non-Flavored Products.

The stuff required in 2017 like Ingredient Listing and Tobacco Health Documents are separate from PMTA. Still required though. I don't think we know yet what those will look like, that will be in a forthcoming guidance.

 

[crxess]

Two Facts Require Focus:
5/10/16 FDA Red Deeming Regulations into the Federal Register

(Specifically, we forecasted that 20 to 80 premarket tobacco applications would be submitted within the first 24 months and 10 to 20 annually thereafter.)

Our Mission - Stop Both

When What Will........HAPPEN.....down the Road(According to FDA) is irreverent in our mission, which Must be to Stop any of this or as much of this as possible from being allowed to happen.

Get Mad, Get Active, Get Satisfaction!!!

 

[Lessifer]

Two Facts Require Focus:
5/10/16 FDA Red Deeming Regulations into the Federal Register

(Specifically, we forecasted that 20 to 80 premarket tobacco applications would be submitted within the first 24 months and 10 to 20 annually thereafter.)

Our Mission - Stop Both

When What Will........HAPPEN.....down the Road(According to FDA) is irreverent in our mission, which Must be to Stop any of this or as much of this as possible from being allowed to happen.

Get Mad, Get Active, Get Satisfaction!!!

I think it's somewhat important to get all of this figured out. There's a lot of misinformation out there. Tons of vendors on FB have no idea what any of this means, or when what is due.

I was having an argument yesterday with a woman who was suggesting someone use the RCP report in their MRTP application. They knew that PMTA would cost too much, but thought that MRTP was at least worth a shot.

 

[Woofer]

What a great photo! ... and dog!! - black and tan fan here :- )

You may like this one - it was from 'my life' before ECF at DPreview's retouch forum. A member's dog had died and they didn't have a good take on one photo they liked - I don't have a "before", but there was not much 'separation' of the dog and the background - but this was 'after' and the person was quite appreciative of the effort....

Thank you very much Kent!

Nice work on the image you posted!
I'll shoot you a PM later if that is OK.

 

[crxess]

I think it's somewhat important to get all of this figured out. There's a lot of misinformation out there. Tons of vendors on FB have no idea what any of this means, or when what is due.

I was having an argument yesterday with a woman who was suggesting someone use the RCP report in their MRTP application. They knew that PMTA would cost too much, but thought that MRTP was at least worth a shot.

Completely agree, just do not want ANYONE forgetting the immediacy needed in taking action to prevent forthcoming actions.

 

[Lessifer]

Completely agree, just do not want ANYONE forgetting the immediacy needed in taking action to prevent forthcoming actions.

Some of us could write our reps until our hands fall off, it wouldn't make a difference because of who they are, so we find other ways to occupy our time

 

[HazyShades]

Then again, without any advertisers ECF will most likely go away?

ECF didn't have any advertisers to speak of when it began
LOL..maybe Oliver will just fire some admins and moderators..

 

[wiredlove]

I was having an argument yesterday with a woman who was suggesting someone use the RCP report in their MRTP application. They knew that PMTA would cost too much, but thought that MRTP was at least worth a shot.

That made my eyes glaze over and a) I work in IT and am used to initialisms and b) too many initialisms - I forgot c) and I've been following along with the class.

 

[DaveP]

Always gets me - 18 is old enough to join the service, get shot at - possible maimed or killed.
But you need to be 21 for buying cigs ...

Ah well, maybe it's meant to protect the medic from second hand smoke while patching up your sucking chest wound ...

That's another proof that government departments don't necessarily talk to each other when making the rules. Someone has to raise a ruckus to fix the issues. Hopefully, our collective voices will make that happen.

 

[Lessifer]

That made my eyes glaze over and a) I work in IT and am used to initialisms and b) too many initialisms - I forgot c) and I've been following along with the class.

Yeah yeah, you all know what I'm talking about

Point being, she was advising someone who was considering moving their liquid company from Taiwan to the US that they should try for the Modified Risk Tobacco Product application, and use the Royal College of Physicians report as evidence, but the cost of a Pre-Market Tobacco Application would be too prohibitive.

 

[Lessifer]

 

[crxess]

That's another proof that government departments don't necessarily talk to each other when making the rules. Someone has to raise a ruckus to fix the issues. Hopefully, our collective voices will make that happen.

There is also serious Evidence of inter-Agency Collusion on Deeming. To be Announced - Court filings in process.

 

[ZeroedIn]

I hope you're right - tried it about 3 1/2 years ago and it was a major fail - couldn't make anything I liked. Now I have to scramble to find/buy flavoring that I THINK I will like but not really knowing right away. I think there's a big learning curve to get it right

This might help...

E-Liquid Recipes

...enjoy. You're welcome.

 

[ZeroedIn]

BTW, ejuiceme up comes with a fairly large database
of pre formulated flavors, all you have to do is change the quantity
and the strength nicotine juice you want to make
eJuice Me Up - Best eJuice Calculator

...wondering if eJuice Me Up is a tobacco product... hhmmm...?