Deeming Regulations have been released!!!!

[crxess]

I'm probably wrong, but how I'm reading it is the 2007 predicate date is for products to try for "substantial equivalency (SE)" or "SE Exemption." A PMTA is required for products manufactured after the predicate date. Covered products currently on the market must go through the PMTA process to remain on the market. New products may not be sold without FDA approval, but they can be created and approval applied for.

 

[Bruce C]

This is a copy and paste from another person at FB.

Quick and dirty notes from the SFATA teleconference:
1) 0mg juice does not count as tobacco, and is basically therefor not affected by these new regs
2) because of #1, the ban on samples and testers will also not apply to 0mg juice. No more free juice giveaways or testers in store unless its 0mg, but 0mg is ok for the time being until the devices are regulated in 2 years
3) online selling of juice seems to be regulated less than face to face sales. This does not affect anyone who makes their own juice or hardware, as you are still held to the standard of a tobacco manufacturer. But for those who simply buy and resell, its ok. This point is unclear and will require more study of the regulations.
4) Clarification has been made that state laws that specifically say that ecigs are not tobacco are superseded by the new regulations. The Federal Government says its tobacco, so it doesn't matter what the states say.
5) clarification that if stores tell customers "you can add nicotine to this 0mg juice", that 0mg juice then becomes a tobacco accessory and falls under the FDA's regulatory power.
6) non tobacco extracted nicotine (such as eggplant nicotine or synthetic nicotine) will most likely not count as tobacco, but SFATA expects that the FDA would respond by saying that nicotine itself is a drug and close the loophole by regulating it as a drug delivery device.
7) SFATA will be releasing a "FDA regs for dummys" document next week, explaining all these shenanigans to those of us who are not lawyers or politicians. Even though the regs state that ecig juice and hardware is classified as tobacco, the states will all have to specifically tax and license retailers for ecig stuff. It is not included automatically.
9) out of country hardware manufacturers are still required to get FDA approval for ecig stuff. Generic items like batteries are exempt since they're not specifically made for ecig use.
10) If you are a straight retailer, who only buys product from other companies to resell, the only things the regs means to you is that you must ID everyone, and cannot alter products, and will most likely have to register as a tobacco retailer in your state. Also there will be no sampling. So you can't let the customer sample the juice before they buy it.
11) Building coils counts as altering a product, which makes it a new product, and since it's a tobacco accessory, building coils makes you a tobacco manufacturer.
12) 90 days starts the law, any products not for sale in the market will require a PMTA
13) No free samples
14) 2 years to file your PMTA, 1 year to get an approval, if no approval is received within the 12 months following you will have to remove your product from the market while you wait for FDA approval
15) Mandatory ID, Child Proof Caps, Warning Labels and Marketing Ban go into effect in 90 days
16) Litigation is HIGHLY unlikely to be successful and SFATA strongly suggests against it.
17) Software upgrades to mods would need a PMTA
18) Verbiage on how we talk about e-cigarettes have to change: no longer healthier, not smokeless, not a way to quit smoking, etc..

First off #18 can go straight to h...! If anyone thinks they can tell me what I can and cannot say or think, they will find themselves on the wrong end of a shotgun. That in itself is 1st amendment violation especially when there is evidence supporting it.

Second please help me out. What exactly is SFATA?

 

[The Ocelot]

A PMTA is required for products not marketed in the US by the predicate date (February 15, 2007). Manufatured by that date, isn't enough.

That's what I meant, thank you for articulating it better. I was thinking that manufactured and on the market would be the same in this context.

 

[sparkky1]

Here's something for everyone to ease their minds ..................

 

[Train2]

No I think that's an outdated guide, based on their hope to have had this deeming in place back then...
Companies have until August 2018 to file for equivalency.
What I don't get is
a) what is going to happen in 90 days
and
b) what about nicotine?
and
c) what exactly are they would they do if thousands of vape shops and hundreds of online vendors just sort of ignore them?

Oh hell, thats bad.... Really, really bad. If you havent filed for substancial equivalence by March 2011 you cannot even offer it for sale. Am I reading that right?

 

[snork]

Oh hell, thats bad.... Really, really bad. If you havent filed for substancial equivalence by March 2011 you cannot even offer it for sale. Am I reading that right?

The link is a quickie to a draft document which probably has been superceded.

 

[Train2]

 

[lynn508]

Personally I don't think they know enough about vaping to make a decision. The reason the regs are written as they are is to cover every possibility they can think of. If down the road they find one hair out of place you can be sure they will have covered it. Today common sense is unknown. They are trying to appease all those clamoring about the horrible vapors. Attorney gens in states are so worried about they send letters to Congress. The idiocy that abounds anymore is unbelievable. You can bet your ... there are sin taxes in there somewhere.

 

[salemgold]

First off #18 can go straight to h...! If anyone thinks they can tell me what I can and cannot say or think, they will find themselves on the wrong end of a shotgun. That in itself is 1st amendment violation especially when there is evidence supporting it.

Second please help me out. What exactly is SFATA?

Pretty sure that 18 is aimed at vendors and manufacturers not being able to make that claim. Still, that is forbidding them to speak the truth since they create vapor and not smoke. Seems to me that is against the right of free speech right there.

Smoke Free Alternative Trade Association ( close anyway)

See the first post in this thread. They were the first ones to announce that the regs would be announced on Thursday.

 

[The Ocelot]

Page 127 (Response to a comment about the potential of an illicit market.)

"FDA understands these concerns, but believes that this rule will not increase current illicit practices or create new illicit markets, because FDA is not banning any tobacco product with this deeming rule."

Mmmmk. Tobacco products aren't banned, but legal access is blocked by the requirement of unobtainable authorization.

 

[Sugar_and_Spice]

No I think that's an outdated guide, based on their hope to have had this deeming in place back then...
Companies have until August 2018 to file for equivalency.
What I don't get is
a) what is going to happen in 90 days
and
b) what about nicotine?
and
c) what exactly are they would they do if thousands of vape shops and hundreds of online vendors just sort of ignore them?

My guess is that c) a few good souls would be fined, jailed and made a public spectacle of, which could turn out to be a good thing in the long run....ie. brought to attention of media hype, go viral and put the FDA on display? Just brain storming....don't mind me.......

 

[buffaloguy]

The link is a quickie to a draft document which probably has been superceded.

Oh jeez... I almost threw my mod across the room in anger when I read that. Lets just hope thats not the current guidance. That would preempt even most variable voltage mods, forget vw or temp.

 

[snork]

Oh jeez... I almost threw my mod across the room in anger when I read that. Lets just hope thats not the current guidance. That would preempt even most variable voltage mods, forget vw or temp.

Sorry for the heart attack...but good luck!

 

[mcol]

My guess is that c) a few good souls would be fined, jailed and made a public spectacle of, which could turn out to be a good thing in the long run....ie. brought to attention of media hype, go viral and put the FDA on display? Just brain storming....don't mind me.......

I would demand a trial by a jury.
52 year old mother, jailed for trying to do the right thing
and quit cigarettes by vaping.
(Don't mind me either).

 

[Train2]

That is funny. They believe that? Really?
The BILLIONS of dollars currently spent on vaping is going to smoothly, over a two year period, shift nicely to the 3 brands of stick batteries with 4 flavors each that they're going to approve?

Vaping, 2018:
- new vapors will buy a cigalike, then start googling for "why does this suck?" and "where can a get a good one like I saw my friend vaping?"
- We'll tell them about FastTech
- China will close annually for a week-long party in May, celebrating "FDA Deeming Day".

Page 127 (Response to a comment about the potential of an illicit market.)

"FDA understands these concerns, but believes that this rule will not increase current illicit practices or create new illicit markets, because FDA is not banning any tobacco product with this deeming rule."

Mmmmk. Tobacco products aren't banned, but legal access is blocked by the requirement of unobtainable authorization.

 

[nicnik]

I posted this on another thread, forgetting it had been moved to the outside, so I'm pasting it here.

I doubt I'll vote Libertarian, but people who want to vote on the single issue of vaping, might consider supporting the Libertarian candidate when they decide which one to run. They're down to two contenders, I think.

The Libertarians will be on the ballot in many states, and have enough influence to at least possibly force the hands of the other two to take a stand. The Libertarians might take up the vaping cause with a true passion.

Many voters are looking for a 3rd party to support in the Presidential election, and this could be a good year for the Libertarians, and the vaping issue could help them as much as they could help get the word out about the corruption in the halls of Tobacco Control.

 

[Alexander Mundy]

They're down to two contenders, I think.

Pretty much.

 

[The Ocelot]

No I think that's an outdated guide, based on their hope to have had this deeming in place back then...
Companies have until August 2018 to file for equivalency.
What I don't get is
a) what is going to happen in 90 days
and
b) what about nicotine?
and
c) what exactly are they would they do if thousands of vape shops and hundreds of online vendors just sort of ignore them?

They could wind up on the OCI most wanted list. Criminal Investigations

This is guy's on it for freaking fish!

Office of Criminal Investigations (OCI) Most Wanted Fugitives

ETA:

Page 143:

"New products for which no application has been submitted by 24 months from the effective date of this rule will no longer be subject to this compliance policy and will be subject to enforcement."

 

[buffaloguy]

I posted this on another thread, forgetting it had been moved to the outside, so I'm pasting it here.

I doubt I'll vote Libertarian, but people who want to vote on the single issue of vaping, might consider supporting the Libertarian candidate when they decide which one to run. They're down to two contenders, I think.

The Libertarians will be on the ballot in many states, and have enough influence to at least possibly force the hands of the other two to take a stand. The Libertarians might take up the vaping cause with a true passion.

Many voters are looking for a 3rd party to support in the Presidential election, and this could be a good year for the Libertarians, and the vaping issue could help them as much as they could help get the word out about the corruption in the halls of Tobacco Control.

Unless you have public statements from said candidates that they do indeed support our cause I wouldnt personally back them on an "if" or "maybe".

 

[kbeam418]

No I think that's an outdated guide, based on their hope to have had this deeming in place back then...
Companies have until August 2018 to file for equivalency.
What I don't get is
a) what is going to happen in 90 days
and
b) what about nicotine?
and
c) what exactly are they would they do if thousands of vape shops and hundreds of online vendors just sort of ignore them?

A) Manufactures will be forced to insure there customers are 18, no more new products including firmware upgrades.
B) Nicotine will be regulated so no more nicotine.
C) Tons of fines and jail time. China will laugh at the FDA and Fasttech will sell thousands of mods called "flashlights." Hell China has been prepping for this, their nicotine is already marked as "vegetable glycerin" to trick customs.