Deeming Regulations have been released!!!!

[Bob Chill]

I heard it, too. Day 91. It was Zeller, but I think it was his answer to a question about a black market. After 90, no new products can enter the market without passing FDA approval, but the black market won't get going 'till way later, like about 2-3 years. He's been distorting and dodging so much, I think he's got himself confused.

The burden of proof is virtually impossible at this stage for new products. Age restrictions is most likely the core focus of day 90. I think we're all good with that. Online verification is old tech and face to face is even older.

I wish the FDA luck if they think they have any chance at effectively enforcing the new product part of day 90+. It would serve no real purpose and require way too much money and man power that in the end would prove to be a fruitless effort. What's the point if it will ALL be eradicated in 2 years. That's the real end goal.

Vendors should fully comply with age and advertising though. That will certainly be policed.

 

[Alexander Mundy]

I'm sorry if someone already posted this I didn't read every page but what is the FDA gona do about actual enforcement of this?Theres no way they have the manpower to send all kinds of people store to store seeing who is in compliance.Plus they have other duties so they cant put 100% of staff on vaping.This just doesn't seem thought out very well

Besides the feds, they will use the usual fed play book. Threaten to withhold $10 of federal monies if the state doesn't enforce it. Of course it ends up costing the state $12 but who's counting?

 

[salemgold]

I've read so much in the best two days, but I'm thinking this has to do with new products being introduced. Not sure though! By the way, it's nice to see you again.

You too, VG. Funny how the worst of times really seem to bring people together

 

[Katya]

Haven't seen a link from CASAA but the Appropriations goes to the full House next - so people can do as I have - contact their Representative to pass the Appropriations Bill; and contact the Senate Appropriations committee, who will get it next:

House Appropriations 4-19-16 - Cole Bishop HR2058

.. then the full Senate.

It's worth posting the 'taste your juice' blurb - although I'm not certain that HR 2058 is 'dead' yet but:

http://www.tasteyourjuice.com/wordpress/archives/12809

Page 3 "Where do we go from here?"

It says Cole "has endorsed the new approach" - his amendment on the Appropriations Bill.

I haven't seen that but there's this:
Cole Responds to FDA Expanding Regulatory Authority on Tobacco Products

MAKE SURE YOU SEND THIS MESSAGE!

CASAAA Response: You can edit and send your own ZESTY message. I sure did, and I hope their dictionary includes four letter words.

Sorry, I lost my post...

Let's try again. Why is CASAA pushing the original Cole bill, when Cole himself asks for support for the subsequent Cole/Bishop bill (House Appropriations) bill?

@JustJulie @Vocalek Anyone? Do we need a new CTA? ASAP?

And, has anyone seen Bill Godshall?

 

[phanner]

I just don't get some of you people. The war was declared today. Just today. And many of you are ready to capitulate without a battle. Everything that has been done before today has just been bluster, feather ruffling, posturing and chest thumping. You can't fight a proposed regulation in the courts, which is all the deeming has been until today. Today it is regulation and this is the first day of the actual war. Today is the day that the war machines are brought to bear on both side to determine the victor. Today is really the first day we can challenge the deeming in court. There is no reason to cede the war before the first real battle is fought.

To be clear, everything we have all done to date has just been to mitigate the rules of engagement because we all knew the war was coming. So OK, the negotiations we not favorable to us. We weren't good enough to achieve that. We tried but were outplayed. Yup. So now that that is out of the way, well... we fight.

Take a vape and calm down a bit and forget the efforts of the past 2 years. I know it sucks, but that was yesterday and we need to focus on the war that started today. Let's not revisit our failed efforts at "peaceful negotiation". That crap is done and it's time to get real and get smart. We do have a good chance of amending (although in my opinion not totally eliminating) the harmful results of this regulatory framework that has been enacted by the FDA through deceitful manipulation of media and science. We don't have to lay down and play dead. That could be an option, but it goes against every fiber of my being. Nope lets get smart and brutal if needed. And we have more powerful allies that many suspect. We do have friends in influential positions that can help in the war and give us a fighting chance. We don't have to do all of this alone with our pitifully small political presence. We need powerful allies with some of this, and this is the direction we should be looking I think.

But no matter what. Don't give up the fight before even the first battle.

 

[kbeam418]

The burden of proof is virtually impossible at this stage for new products. Age restrictions is most likely the core focus of day 90. I think we're all good with that. Online verification is old tech and face to face is even older.

I wish the FDA luck if they think they have any chance at effectively enforcing the new product part of day 90+. It would serve no real purpose and require way too much money and man power that in the end would prove to be a fruitless effort. What's the point if it will ALL be eradicated in 2 years. That's the real end goal.

Vendors should fully comply with age and advertising though. That will certainly be policed.

You my friend just described the drug war. The FDA has a blank check to enforce these rules and will!

 

[zoiDman]

I know for certain that in the past 48 hours I have seen something quoted from the FDA saying that they will be prepared to enforce on day 91. What part of this exactly will they be enforcing on day 91? Does anyone here know?

I have read so much but, that keeps coming back to me. Seems like there should not be anything to enforce until at least 2 years from now?

In your State, can you sell a "Tobacco Product" without any Requirements?

Such as a State License to sell Tobacco Products?
And or a Business License that list that you will Store/Sell Tobacco Products?
And or a Lease Agreement where Tobacco Products are not Excluded?
And or Bank Accounts/Accounting for Tobacco Taxes?

 

[Bob Chill]

Except that ignorance of the law is no defense usually.

And Zeller is wrong about the black market, because it's been gearing up for this for years.

T

The burden of proof is on the FDA though. There are tens of thousands of products on the market already. Why waste time, money, and resources trying to elimate a 2,001 watt mod when a 2,000 watt mod existed on day 89. Or trying to elimate blueberry, vanilla, and bacon flavored juice when blueberry, vanilla, and ham juice already exists.

 

[salemgold]

In your State, can you sell a "Tobacco Product" without any Requirements?

Such as a State License to sell Tobacco Products?
And or a Business License that list that you will Store/Sell Tobacco Products?
And or a Lease Agreement where Tobacco Products are not Excluded?
And or Bank Accounts/Accounting for Tobacco Taxes?

I have no clue but, point taken.

 

[Qew]

If a manufacturer plans to continue making and selling their product, will they have to start the application process in order to continue business during the 2 year period? -Or- Do they have until the end of the 2 years to start the application process? Does anyone have a clearer grasp on this than I do?

 

[Jazzman]

The law comes into effect in 90 days, then anything has 2 years to seek approval, but can still be sold in the interim.

I'm not sure about new stuff. What's to stop it?

T

I pretty sure @Myrany has it correct. Anything that makes it to market before Aug 8,2016 can stay on the market for the 2 year phase in period. Any item that was introduced to the market after Feb 15, 2007, but before Aug 8,2016 can no longer be sold until PMTA approval by the FDA after the 2 year phase in period. There can be no new items introduced after Aug 8,2016 without PMTA application and approval by the FDA. That means after Aug 8 you will see no new juice, mods, mechs, drip tips, atomizers, or other accessories to vaping without PMTA approval.

PMTA approval is , by best industry estimates, going to cost around 1.2 Million per application. Time frame for approval will likely be around 1 year under the best of circumstance, and much more likely to take longer.

So unless things change, you will see no new vaping products until at least Aug 2017. And Aug 2017 is optimistic. Even if some products achieve PMTA by then there will be very, very few.

 

[zoiDman]

... Mitch Zeller is a blind fool who is getting paid off.

...

Did Mr. Zeller have the Final say in what would be Included in the Deeming"?

I wonder what role Mrs. Hamburg/Mr. Califf (and of course Mrs. Burwell) played in all this?

 

[drysprocket]

Has anyone heard from the Chinese companies yet? That's the biggest piece that I can't figure out in all of this. They can technically carry on as usual making products...but then again, we're such a large part of their market.

Will we just see shiny new toys online and not be able to legally get them? Obviously workarounds, but just trying to imagine what this looks like.

 

[Alexander Mundy]

I'm a bit confused about the 90 day thing. I'm a modder and there is this pretty cool mod that I've been brainstorming for awhile and I REALLY would want to get it on the market. Does this mean I have to do it in 90 days to be safe?

What if I can't make too much in 90 days, but I made a very small batch and sold it to people on ECF. Would it count as "entering the market"?

Keep all receipts for both purchased material and invoices for sold goods and retain a good lawyer cause the government usually just bleeds people dry getting them to prove they are innocent.

 

[supertrunker]

i think that's what i said in the quoted post isn't it?

I pretty sure @Myrany has it correct. Anything that makes it to market before Aug 8,2016 can stay on the market for the 2 year phase in period. Any item that was introduced to the market after Feb 15, 2007, but before Aug 8,2016 can no longer be sold until PMTA approval by the FDA after the 2 year phase in period. There can be no new items introduced after Aug 8,2016 without PMTA application and approval by the FDA. That means after Aug 8 you will see no new juice, mods, mechs, drip tips, atomizers, or other accessories to vaping without PMTA approval.

PMTA approval is , by best industry estimates, going to cost around 1.2 Million per application. Time frame for approval will likely be around 1 year under the best of circumstance, and much more likely to take longer.

So unless things change, you will see no new vaping products until at least Aug 2017. And Aug 2017 is optimistic. Even if some products achieve PMTA by then there will be very, very few.

and you basically repeated what i said.


T

 

[nicnik]

Did Mr. Zeller have the Final say in what would be Included in the Deeming"?

I wonder what role Mrs. Hamburg/Mr. Califf (and of course Mrs. Burwell) played in all this?

And Obama. I really wish he had sided with us, considering his struggles to quit smoking, plus the fact that WE ARE RIGHT, and THEY ARE LYING.

 

[Bad Ninja]

In your State, can you sell a "Tobacco Product" without any Requirements?

Such as a State License to sell Tobacco Products?
And or a Business License that list that you will Store/Sell Tobacco Products?
And or a Lease Agreement where Tobacco Products are not Excluded?
And or Bank Accounts/Accounting for Tobacco Taxes?

Cigarettes, yes you need a tobacco lisc.

Pipes and gear? In Cali its the same business lisc as a gift shop. Nothing more.

 

[zoiDman]

I have no clue but, point taken.

So much Happens automatically when the products that you may be selling Statutorily become "Tobacco Products". And a seller will Now have to Comply with All City/County/State Requirements where applicable.

I know an Owner of a Vape Shop. And the building space he Leases is in a Strip Mall that is not Zoned to include the Sale of Tobacco Products.

His Lawyer has advised him that he will Probably be SOL at that Location when Deeming is Finalized.

 

[kbeam418]

Has anyone heard from the Chinese companies yet? That's the biggest piece that I can't figure out in all of this. They can technically carry on as usual making products...but then again, we're such a large part of their market.

Will we just see shiny new toys online and not be able to legally get them? Obviously workarounds, but just trying to imagine what this looks like.

Dimitris Agrafiotis would be the one who updates us on that. They'll get involved two years from now because there's not much they can do outside of they're country. They'll keep on trucking mod wise. Customs is a joke. You can get %99 liguid nicotine online which is illegal, so that won't be problem.

Disclaimer; I'm not suggesting that anybody should purchase nicotine in this strength. Just using it as an example.

 

[zoiDman]

Cigarettes, yes you need a tobacco lisc.

Pipes and gear? In Cali its the same business lisc as a gift shop. Nothing more.

The person I was Replying is Not a Resident of California. So She/Anyone should Check the Local Regulations.