Deeming Regulations have been released!!!!

[crxess]

I'm not 100% sure of this. So someone Correct me if I'm Wrong.

But I believe that the FDA Rule Set Only applies to Sales and Distribution Inside the USA.

Correct, with exception of possibly an appropriate label - Not for sale in the United States or its Territories.

 

[zoiDman]

They only have jurisdiction within the US. There are plenty of meds not approved for sale by the FDA in the US that are unavailable in other countries, with or without a prescription.

...

Drugs fall under a Completely Different Regulatory Framework than "tobacco Products".

But I still believe that a Company that is Solely an Exporter as Talyon mention is not subject to the FDA Deeming.

But Like I said, I could be Wrong.

 

[zoiDman]

Correct, with exception of possibly an appropriate label - Not for sale in the United States or its Territories.

And of course, any State/Local Regulations regarding Chemical Handling, Storage, Manufacturing, etc.

 

[SeniorBoy]

How much are the application fees?
We've been focusing on the PMTAs and I haven't heard much about application fees.

Not to worry. I made the same mistake even though I'm perfect! /lol

It's USER FEES and if you play in the FDA sandbox you WILL pay. Most everyone misses this point and that includes nearly all the experts ha! but you can't trump collective wisdom as in this thread. Period!

Start here

Dive down into the weeds with this Google search

 

[KODIAK (TM)]

So long as the reviewer is not selling or distributing the product, or receiving compensation to review the product from the seller, they can do and say whatever they like.

No, I meant if they run out of new products to review.

 

[Eskie]

No, I meant if they run out of new products to review.

Oh.

Then they will need to find a new pastime. Hopefully they have other hobbies and interests.

 

[KODIAK (TM)]

Oh.

Then they will need to find a new pastime. Hopefully they have other hobbies and interests.

Actually, a few of them make their living at this.

 

[Eskie]

Actually, a few of them make their living at this.

Well, if they owe you any money, I might try to collect it now. Just in case.

 

[crxess]

Actually, a few of them make their living at this.

Actually Few have ever made a living at much else and give working for a living little value

 

[Talyon]

Drugs fall under a Completely Different Regulatory Framework than "tobacco Products".

But I still believe that a Company that is Solely an Exporter as Talyon mention is not subject to the FDA Deeming.

But Like I said, I could be Wrong.

I dont believe your wrong, im sure your right.

So someone like Animal could stay in business, just not selling in the US but over seas.

Suicide bunny etc etc...

Which is why i assume the biggest eliquid maufacturers well survive, and of course HOPEfully be able to sell to the US once again some day, if the deeming get get defeated by some pretty smart lawyers.

 

[Talyon]

And of course, any State/Local Regulations regarding Chemical Handling, Storage, Manufacturing, etc.

I believe the company that PBusardo is using to make his eliquid line Moleculelabs, is compliant with all state and local laws already.

 

[Talyon]

No, I meant if they run out of new products to review.

Ill assume that the reviewers would just start to review eliquid again and all those subohm tanks they passed on because thers so many etc etc
Of course Grimm can always revert to Beer.

 

[crxess]

I believe the company that PBusardo is using to make his eliquid line Moleculelabs, is compliant with all state and local laws already.

Depends on Federal level compliance. Fed trumps State!

 

[Jingles]

I believe the company that PBusardo is using to make his eliquid line Moleculelabs, is compliant with all state and local laws already.

I watched Pbusardos reviews of Molecule Labs. Pretty impressive. I can't imagine our federal government shutting them down, but I guess anything is possible with the FDA! I think the FDA should watch that review (if they haven't already).

 

[Talyon]

Depends on Federal level compliance. Fed trumps State!

Agreed, and im pretty sure the owner is not putting in a few million on a whim, hes also been around for a bit, and probably currently meets all standards state fed etc.

 

[The Ocelot]

I was thinking more along the lines of:

OMG-Juice!
No Nicotine!
Not made from tobacco!
Not a tobacco product!

If you want the bull to charge, you have to wave the red flag around some.

OMG-Juice!
No Nicotine!
Not made from tobacco!
Not a tobacco product!
Lemur free!
Contains no cheese!

 

[crxess]

Agreed, and im pretty sure the owner is not putting in a few million on a whim, hes also been around for a bit, and probably currently meets all standards state fed etc.

Yet Johnson Creek, who just invested in another Updated Facility is Highly concerned

 

[classwife]

I don't see how manufacturing would be permitted here with the parameters we are looking at

 

[The Ocelot]

The biggest drawback is that in order to implement it, I expect I'd have to sign up as a "vendor" on ECF.

If the profits were sent to CASAA maybe Oliver would make an exception.

 

[LoriP1702]

I don't see how manufacturing would be permitted here with the parameters we are looking at[/QU

I don't see how. I think that's probably why ProVape said what they did.