Deeming Regulations have been released!!!!

[Oliver]

Please, and I mean this respectfully - can we give up on the notion of predicates? I'll go into it in detail when I have time, but there simply are none that will be helpful to the industry.

Put it this way - if you had a liquid on the market in 2006, you would have to prove that it had exactly the same constituents (including the flavoring compounds, likely at the molecular level) as the one you have on the market today.

There's no loopholes to be found here.

 

[Oliver]

Another thing worth pointing out.....

This is NOT a regulation. It's a strange hybrid of regulation and prohibition. The FDA simply does not have the resources to regulate the industry as it stands, but it can regulate the remnant that will be left after the shakeout.

 

[DC2]

I haven't read the whole 499 pages, only the summary. But I'm wondering if the FDA lays out all the standards that products would have to meet for the FDA to approve them? I mean, have they said juices will have to have <X diacetyl etc etc...Or will they just go "nah, this might be bad for people if they use it for a long time, and you can't prove it's not - FAIL"?

This is an overview of how it works...
Manufacturers

So smoking is down but vaping is up among kids. Does anyone have any research on use of nicotine vs flavor only vaping among youth?

There is most definitely such information floating around here.
If I knew where it was I would point you to it.


But if you started a new thread in the General vaping Discussion...
I'll bet someone could round it up for you in fairly short order...

The only way to reach them is through word of mouth and the media.

And the vendors.

So if all this is going to be Sent to Congress, and if they have any Power to effect changes to it, it would seem like it would be a Good Idea for Every Vaper/B&M Owner/Web Retailer to do a Massive Drive to get people to Contact there Federal Reps in mass.

I would imagine CASAA and SFATA will both come out with guidance.
I'm sure they are reviewing our options and how to proceed.

 

[r055co]

Take a long, deep breath. We are going to get through this. I don't believe for an instant that these regulations will stand as they are now written.

I'm sorry to say but you are wrong for one simple reason. Big Tobacco and Big Pharma are "Old Money". What this is in reality is they have long established money, government ties and well placed puppets in key positions. Look how Monsanto gets away with destroying small independent Farmers when Monsanto's GMO contaminates their crops and Monsanto brings and wins lawsuits against those very Farmers. That and how Monsanto products are fast tracked through the FDA.

It's Old Money, we really are screwed and I've pretty much knew this was coming. This doesn't mean roll over and give up, no we need to scream, yell and cause as many problems to them as possible. But at the same time establish and maintain a robust underground. That's really what needs to be done, maybe in the distant future some sanity will come to light, but I seriously wouldn't hold my breath.

 

[UnclePsyko]

Please, and I mean this respectfully - can we give up on the notion of predicates? I'll go into it in detail when I have time, but there simply are none that will be helpful to the industry.

Put it this way - if you had a liquid on the market in 2006, you would have to prove that it had exactly the same constituents (including the flavoring compounds, likely at the molecular level) as the one you have on the market today.

There's no loopholes to be found here.

Another thing worth pointing out.....

This is NOT a regulation. It's a strange hybrid of regulation and prohibition. The FDA simply does not have the resources to regulate the industry as it stands, but it can regulate the remnant that will be left after the shakeout.

OK, sure... but until you fill us in, what else do we have to discuss?

 

[sparkky1]

Nicotine
The chemical nicotine is an addictive component of cigarettes. The body develops a physical, as well as psychological, craving for nicotine. The patch helps satisfy this craving while the smoker is attempting to quit. Nicotine is well suited for transepidermal delivery because it is a liquid which is known to penetrate skin easily. In fact, there are documented cases of tobacco workers suffering from nicotine overdose as a result of handling raw tobacco leaves, a condition known as Green Tobacco Sickness. Depending on the type of patch, the amount of nicotine compound employed varies between 5% and 50%. The drug may be used in its pure form, or it may be linked with other chemicals entities such as hydrochloride, dihydrochloride, sulfate, tartrate, bitartarate, zinc chloride, and salicylate to form derivatives.


Read more: How nicotine patch is made - material, used, processing, components, product, Raw Materials
OR
PG/VG/ Flavoring

* ..........and is that not the best Double Speak ever written!!!!

Nicotine is ADDICTIVE........So use it to Become NOT ADDICTED
Nicotine is Nicotine

The Dose makes the Poison!!!

Now you are starting to understand, 2007 / tobacco control / cosmetic act
has nothing to do with vaping small dosage pure nicotine but yet makes you think that's what it's about
A very immoral way of misconstruing the truth for an industry take over / buy out, but the corporate owned media will help them out with the first part ............

 

[crxess]

I'm not sure what percentage of the global market the U.S. represents, but I'm hoping the overseas manufacturers are taking notice and are willing to take some action such as financially supporting/backing any litigation that arises in the future.
I find it hard to believe that the manufacturers would just sit by and let a large market get wiped out before their eyes.

Of course, I could be totally wrong... it wouldn't be the first time

I could be wrong...............but would venture to guess well over 50%

Another thing worth pointing out.....

This is NOT a regulation. It's a strange hybrid of regulation and prohibition. The FDA simply does not have the resources to regulate the industry as it stands, but it can regulate the remnant that will be left after the shakeout.

So sad and so accurate.

 

[buffaloguy]

[/QUOTE]

Please, and I mean this respectfully - can we give up on the notion of predicates? I'll go into it in detail when I have time, but there simply are none that will be helpful to the industry.

Put it this way - if you had a liquid on the market in 2006, you would have to prove that it had exactly the same constituents (including the flavoring compounds, likely at the molecular level) as the one you have on the market today.

There's no loopholes to be found here.

So then am I correct in assuming that in 90 days everything starts to dry up, including imports?

 

[r055co]

Please, and I mean this respectfully - can we give up on the notion of predicates? I'll go into it in detail when I have time, but there simply are none that will be helpful to the industry.

Put it this way - if you had a liquid on the market in 2006, you would have to prove that it had exactly the same constituents (including the flavoring compounds, likely at the molecular level) as the one you have on the market today.

There's no loopholes to be found here.

Only real route we actually have is being very vocal and inform every politician who supports this that you will be actively working to oust them from office.

Seriously, that's the only thing they really understand. Sadly though most will just whine and complain but really do nothing more.

 

[GunMonkeyINTL]

If we are going to pretend there is a political fight to be had, I do think Trump is our best bet. I'm all up for Democrats on this site seeing if Hillary would bend and go with what we all identify as the proper public health position with regards to eCigs. If anyone reading this truly thinks Hillary is a possibility, please move on this and let us know how it works out.

Me, I think there is between 0% and .00000001% chance that Hillary helps the pro-vaping cause. I'd love to shown that I'm mistaken and it's at least 20% chance that she's willing to help in the political fight.

I think due to the partisan divide, and Trump being presumptive nominee, that if the chances are 99% likely Hillary will support FDA, then theoretically, there's a 99% chance that Trump would support pro-vaping. Sure, that is very wishful thinking, but this is just me emphasizing the partisan divide that is very visible on pretty much all topics.

I do think there's a good 20% chance Trump would fight for pro-vaping cause because it is business related and because he goes against the grain with what Washington establishment seems to think is best way to proceed on matters.

If Trump today said he will fight for pro-vapers, I think he'd get at least 2 million more people in his camp. It could turn out to be a campaign lie, that's for sure, but all the stuff any of these politicians claim in campaigns fits into that category. It would just be awesome to see it come up and to have Trump and Hillary speak to it. Unless the partisan divide doesn't exist for this particular political item, I think one of them would appear to support pro-vaping, and the other would appear to stand opposed.

So, I think it would be sensible to have a CTA that floods Trump with lots of tweets about this being a significant concern for some voters (us) and see how he responds.

You get it. This is EXACTLY what I was saying.

The point stands, I think, regardless what candidate/party you support.

An issue of government overreach that has a large group of people ...... off is Trump's political currency. This is precisely the sort of thing that he crafts his sound-bites around.

We just need to make him aware of it. If we hand him a political stance he can take that he knows Hillary will oppose, taking the side of "big government" in the process, he'll jump all over it.

Sending him the petition says NOTHING about whether you support him or not. The politicians, all of them, use us all the time. This is our opportunity to use one of them.

Who is the resident CASAA tie around here? Someone associated with this board has to have ties there. Get them to send the petition to the Trump folks- don't modify it, keep the signatures we have, and send it to his campaign as-is.

Once we know they've seen the petition, we can start lighting up their email in-boxes and phone banks. They won't be able to miss how big this is to this fairly large group of voters.

 

[classwife]

Please, and I mean this respectfully - can we give up on the notion of predicates? I'll go into it in detail when I have time, but there simply are none that will be helpful to the industry.

Put it this way - if you had a liquid on the market in 2006, you would have to prove that it had exactly the same constituents (including the flavoring compounds, likely at the molecular level) as the one you have on the market today.

There's no loopholes to be found here.

Another thing worth pointing out.....

This is NOT a regulation. It's a strange hybrid of regulation and prohibition. The FDA simply does not have the resources to regulate the industry as it stands, but it can regulate the remnant that will be left after the shakeout.

 

[Bronze]

I agree, talking about pre-2007 gear/liquid as an escape to the regulations is a waste of time. It simply has no merit. And while scrounging for loopholes is interesting it wont save the vaping industry. Even if loopholes were found the FDA would just seal them off. We need to focus on those things that will make a large impact. One of those things is H.R. 2058. And I'm sure there will be more avenues opening up with the passage of time.

 

[sparkky1]

You get it. This is EXACTLY what I was saying.

The point stands, I think, regardless what candidate/party you support.

An issue of government overreach that has a large group of people ...... off is Trump's political currency. This is precisely the sort of thing that he crafts his sound-bites around.

We just need to make him aware of it. If we hand him a political stance he can take that he knows Hillary will oppose, taking the side of "big government" in the process, he'll jump all over it.

Sending him the petition says NOTHING about whether you support him or not. The politicians, all of them, use us all the time. This is our opportunity to use one of them.

Who is the resident CASAA tie around here? Someone associated with this board has to have ties there. Get them to send the petition to the Trump folks- don't modify it, keep the signatures we have, and send it to his campaign as-is.

Once we know they've seen the petition, we can start lighting up their email in-boxes and phone banks. They won't be able to miss how big this is to this fairly large group of voters.

Social media has become a weapon
Corey Lewandowski (@CLewandowski_) | Twitter Really that's not a bad idea, get out a few thousand tweets on his stance of the regs ?
You need our help we need your's ?

 

[AG51]

 

[Oliver]

So then am I correct in assuming that in 90 days everything starts to dry up, including imports?[/QUOTE]

Imports? You mean for personal use or for sale?

On the individual level, honestly, I don't know either way. One would hope that personal imports stay legal - but the postal services may simply refuse to carry the packages.

Imports for sale - this is an interesting one and we'll have to see what the FDA choose to do. Fundamentally, though, they're unlikely to pull stuff off the market unless they're certain that it wasn't on the market prior to the cut-off (August 8th). I mean, it's not out-with the realms of possibility that this does happen, but why would they bother?

After the cut-off, no new product may be introduced without prior authorisation from the FDA (PMTA, effectively). But all products on the market prior to that date have 2 years to file for authorisation.

 

[zoiDman]

So then am I correct in assuming that in 90 days everything starts to dry up, including imports?

This is Why I would think that the Congressional Review question would be so Important to Vaper's and Retailers.

Because I was Under the Impression that a Congressional Review had to happen before Any Rule Set could put in place.

So the 90 Day Clock couldn't start ticking Until after a Review was done. And a Congressional Review could take awhile if it proceeds the way Most things in Government Does.

 

[skoony]

A product must have "commercially marketed" in the United States to be eligible.
Not exactly sure what "commercially marketed" means though.

The FDA claim they've found 1 device that was commercially marketed in 2006. But they won't tell anyone what it is, and it doesn't really matter anyway.

Regarding what the FDA considers to be commercially marketed - my understanding is that they want to see multiple forms of evidence showing that a product was sold to US consumers in more than one state. This would include sales invoices, weighbills, purchase orders etc etc.

@SmokeyJoe first let me say I agree with your assessments 100%. I am just commenting
to maybe help clarify the issue.

My interpretation of the grandfather date is the product had to be physically in
the USA and available for purchase to an end user physically in the USA.
Even if this is technically inaccurate I will bet anyone this will be how the powers
that be interpret it. Additionally it is impossible for anything on the market today
to be substantially equivalent as everything today is substantially better. Even
cigalikes have improved since then. This maybe technically inaccurate also but,
again this will the interpretation an be and excuse to request scientific evidence
showing how and why the product is better,safer,etc..,etc.. .

Regards
mike

 

[Robino1]

Hopefully a lawsuit will effectively halt things in their tracks until it is decided.

 

[sparkky1]

So then am I correct in assuming that in 90 days everything starts to dry up, including imports?

Imports? You mean for personal use or for sale?

On the individual level, honestly, I don't know either way. One would hope that personal imports stay legal - but the postal services may simply refuse to carry the packages.

Imports for sale - this is an interesting one and we'll have to see what the FDA choose to do. Fundamentally, though, they're unlikely to pull stuff off the market unless they're certain that it wasn't on the market prior to the cut-off (August 8th). I mean, it's not out-with the realms of possibility that this does happen, but why would they bother?

After the cut-off, no new product may be introduced without prior authorisation from the FDA (PMTA, effectively). But all products on the market prior to that date have 2 years to file for authorisation.[/QUOTE]

For starters, it would have to be illegal contraband to be seized at any postal level, no one has made any laws to make anything illegal but on the state level that's a different story, if it's deemed a tobacco product of which permits should be issued

 

[Alexander Mundy]

They may have 2 years to file, but I have a suspicion they have an end run up their sleeve based on several things I read in the past. I don't have exact words or whom said them so if anyone remembers let me know where and whom. There were implications from FDA officials that an additional intent to file could be required to continue during the filing time and that a product could be removed if an intent wasn't filed. Maybe this was decided against, but I wouldn't put it above them to pull this out of a hat after the 90 days as a procedural thing that didn't have to be worded in the deeming.