FDA TVECA post table of contents for Deeming Final Rule

[englishmick]

Yeah, but your dog doesn't bite you, right?

Yeah - you don't bite the hand that feeds you. And politicians have big appetites. I was a billionaire I would have one of my own and tell it to take care of vape for me.

 

[zoiDman]

...

If the FDA had Issued Regulations when they were Supposed to, then that would have Given Interested Parties 6 Months to submit an Application. And that sounds like about the right Amount of time.

BTW - I think that whenever the FDA Regulations are Issued/Finalized, that there will then be a 6 Month Period for Parties to File their Applications.

 

[Rossum]

Here is Section 905 of the FD&C Act.

http://www.fda.gov/tobaccoproducts/labeling/rulesregulationsguidance/ucm262072.htm

"2. Application to Certain Post-February 15, 2007, Products. A report under this subsection for a tobacco product that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after the date of enactment of the Family Smoking Prevention and tobacco Control Act shall be submitted to the Secretary not later than 21 months after such date of enactment.

Hey, there's that pesky "for introduction into interstate commerce" language again.

Reading the whole page at the link, it almost seems like someone who registers with the FDA and provides them with a list of the products (and ingredients labeling, etc) that they make, but only sells them locally, face-to-face (i.e. w/o a website, or one that rejects requests from out of state) would not have to file a PMTA.

Doing that would certainly make for an interesting test case.

 

[IanDVaypes]

Let;s be clear here - the regulatory action being pursued by the FDA has nothing to do with cloud chasers in public.

To understand the FDA in this, you have to have some understanding of the 20 year history of their trying to regulate nicotine. It certainly didn't start with vaping, and they were never going to leave vaping alone once it hit the scene.

Now, certainly there's a public issue with vaping, and inconsiderate vaping doesn't help. But seriously, the primary reason the public is troubled by vape is because of media scare stories. Had the messaging been consistently: "vape, basically safe" I doubt people would care anywhere near as much.

So, it's instructive to think about why the media is full of scare stories. There are two dynamics at play: 1. the media loves a good ol moral panic (great clickbait), so this is grist to their mill. 2. Tobacco Control people have been pushing the "vape is harmful" agenda, largely since the tobacco companies bought into the sector starting 2012.

Strategically, then, the tobacco industry have done well: buying into the industry "conferred their stigma" onto the category, and this stands to slow the disruption down. See the Senator video doing the rounds; he happily calls e-cig companies "Tobacco Companies", and does so untroubled because of 4 years of propaganda from Tobacco Control.

I agree with you. The media does this a lot. I've gotten an interview with a news guy while I was in the vape shop. I responded to all of his questions about "studies" with facts. I pointed out how the "studies" were biased and have many variables. I've also mentioned how innovative technology is making vaping much safer. The employees at the vape shop gave me a lot of props and free ejuice. They only cut out the important points that I made, which was practically the whole interview. I ended up looking like a fool who vapes on poison.

 

[MacTechVpr]

...The Real Fight should focus on challenging the "Deeming Authority" of the FDA not focused on writing Bills that only effectively reinforce it….

Only thing that ever made any sense MM. It's a "taking" of rights not in the federal gov's purview or authority to proscribe or prescribe beyond what is the classical definition of tobacco. Not that it couldn't be done by amendment. It's happened before and look where it got us. But this…the only smoke I see coming is from the regulatory gun pointed at our heads.

The efforts of our community I believe might have been and may still be far better spent in promoting a self-enforcing culture of utilization efficiency and safety. In the long fight, were this a legislative process. Then claims against vaping would be far more difficult and costly to entertain for the bureaucrats and plutocrats. There would be millions of us. And it's needed. There is now so great an over-reaching by our government that few really notice what happens to the little guy. The numbers matter. Our's is not a hobby or a pastime. It's serious business that we have no intention of allowing to be taken from our hands or relegated to others under the force of law. Any more than our natural right to self-defense. Because, in practical fact and effect, it is that.

Legitimacy would come when the benefits of vaping independence are as self-evident as the weather and not what they tell us. But we have to make it that. Demonstrate to government and all that we are the source of the solution and not what it deems to give or permit us.

But it would seem the time has passed for negotiation and reassuring attestations by all sides. The FDA's intentions have been made clear by their stunning indifference to vapers in handing us a soggy wad of toilet towel legalize immune to our concerns and interests. This after so many of our heartfelt good faith expressions of our expectations of fairness. It's time to take them on or yield to what amounts to an imminent threat of theft. Challenge their authority directly or submit.

Good luck all.

 

[MacTechVpr]

Hey, there's that pesky "for introduction into interstate commerce" language again.

Reading the whole page at the link, it almost seems like someone who registers with the FDA and provides them with a list of the products (and ingredients labeling, etc) that they make, but only sells them locally, face-to-face (i.e. w/o a website, or one that rejects requests from out of state) would not have to file a PMTA.

Doing that would certainly make for an interesting test case.

Yes there would result a black market. Never stopped federal raiders in the past. A list is always nice.

Good luck all.

 

[zoiDman]

Hey, there's that pesky "for introduction into interstate commerce" language again.

Reading the whole page at the link, it almost seems like someone who registers with the FDA and provides them with a list of the products (and ingredients labeling, etc) that they make, but only sells them locally, face-to-face (i.e. w/o a website, or one that rejects requests from out of state) would not have to file a PMTA.

Doing that would certainly make for an interesting test case.

Like I said, I'm not a Lawyer.

But as I understand it, once a something is Deemed a Tobacco Product, the something is going to have to go down One of a Couple Paths to be able to be Legally Sold. Either in the State where it is Made. Or in Another State. Or in Both. Or if it is Made Outside the USA and it is to be Imported into the USA.

If one wants to Apply for a SE Application, then Yeah, no PMTA would need to be Filed. If that Something doesn't go down any Path, then No-Ticky-No-Laundry. The Something would Not be Legal to Sell.

---

The whole Point of my Original Post was to say that I don't think Parties will have 21 Months to Submit a SE Application after the FDA Regulations are Finalized.

And it Wouldn't surprise if they had 180 Days to do so. No matter what the SE Cut-Off date is set to. But once Again, I'm not a Lawyer.

 

[Rossum]

Yes there would result a black market. Never stopped federal raiders in the past. A list is always nice.

Whilst there are legal questions, wouldn't it be a GREY market?

 

[Rossum]

Like I said, I'm not a Lawyer.

But as I understand it, once a something is Deemed a Tobacco Product, the something is going to have to go down One of a Couple Paths to be about to be Legally Sold. Either in the State where it is Made. Or in Another State. Or in Both. Or if it is Made Outside the USA and it is to be Imported into the USA.

If one wants to Apply for a SE Application, then Yeah, no PMTA would need to be Filed. If that Something doesn't go down any Path, then No-Ticky-No-Laundry. The Something would Not be Legal to Sell.

Well if you really want to take the pessimistic view, this section doesn't even mention sale, and could be construed to cover DIY done strictly for personal consumption:

Registration by Owners and Operators. On or before December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products shall register with the Secretary the name, places of business, and all such establishments of that person.

 

[zoiDman]

Well if you really want to take the pessimistic view, this section doesn't even mention sale, and could be construed to cover DIY done strictly for personal consumption:

DIY strictly for Personal Consumption is Great. In Fact, I have been doing it for over 4 Years.

But what makes it Possible is my Ability to Purchase, as an "End User", Unflavored Nicotine Base.

Every Single Thing that I have Read about Deeming is Not going to Effect my Ability to do DIY (for Personal Use) with the Nicotine Base that Already Have.

But Every Single Thing that I have read about Deeming Is going to Effect my ability to buy Nicotine Base.

 

[LaraC]

Something I haven't understood for a long time is if BT wants to own the vapor industry then why such crappy products from them?

My guess is that all along, the big tobacco companies have known what kind of e-cigarettes will be the only type to actually make it through the FDA's ridiculously onerous regulations, after the full stranglehold of FDA's proposed "deeming" takes effect.

The big tobacco companies have probably been consulting all along behind the scenes with the FDA to make sure their closed system proprietary cig-alikes will be the only ones allowed.

After "deeming" destroys all the independent e-cig and e-liquid manufacturers in this country, the big tobacco companies are in the driver's seat once again.

The big tobacco companies will be the only ones with the millions it takes to put an "electronic nicotine delivery system" on the market... after all the dust settles and practically every other e-cig or e-liquid manufacturer in this country is buried under the FDA's tons of dust.

Those dust particles kill.

 

[shatteredsoul76]

Im not good with law nor politics but couldnt several companies file lawsuits if these new rules are put into place, tying up the court system for possibly many years until its all figured out?

 

[Outcast]

Anyone this will drop buy the 1st of the year?


Sent from my iPhone using Tapatalk

 

[Outcast]

Lol was hoping to get a good stock pil come tax time


Sent from my iPhone using Tapatalk

 

[roxynoodle]

Im not good with law nor politics but couldnt several companies file lawsuits if these new rules are put into place, tying up the court system for possibly many years until its all figured out?

I hope so.

 

[squee]

To understand the FDA in this, you have to have some understanding of the 20 year history of their trying to regulate nicotine.

Almost 30 years now, kicking off with the Surgeon General's (C. Everett Koop) report in 1988 where he said that nicotine was just as addictive as h* and c*.

You still hear people saying that today - people including vapers and B&M owners. There was no actual evidence of this h*-like addictive quality (even mentioned in this article on the report, saying they had no additional studies or research to back up that claim https://library.cqpress.com/cqalmanac/document.php?id=cqal88-1141921 ) but the perception continues to this day.

Now, we do have countless studies showing that NOT to be the case, backed up by the FDA themselves, in their new guidelines for NRT marketing. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm345087.htm offers this statement: The changes that FDA is allowing to these labels reflect the fact that although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold OTC do not appear to have significant potential for abuse or dependence.

In other words, nicotine on it's own, outside of a combustible cigarette, with the MAOI's and other additives - isn't addictive. So why are we still perpetuating this myth? Why aren't we calling out the FDA and the guidelines that call for warning labels that say "nictotine is addictive". the FDA has already concluding that it isn't. Oh sure, "Potentially" addictive. Alcohol is "potentially" addictive because some people do become addicted. But most don't.

But until *we* stop repeating and perpetuating false information, why do we think anyone else will?

 

[shatteredsoul76]

I would love to hear what some of the larger juice/vape companies have to say and what they are currently doing with potential lawsuits. I havent seen any of them chime in one way or another. If everything pans out for the worst I guess they will be some major liquidation sales while they can still legally sell products,its sad really.

 

[MacTechVpr]

Whilst there are legal questions, wouldn't it be a GREY market?

It certainly is Ollie. Lookin' that way.

No doubt in many states there will be overlap from their own "regulations"…so purple? It that's what you meant, from a legal standpoint. Selective and creative use of law today makes me hardly recognize the place anymore. So I would hate to hazard what a rollout would look like.

 

[Kent C]

@Kent C , I finally had some time to read your post carefully. If I understand this correctly, the modified (how?) HR2058 is a rider but they haven't voted on it yet. Is that your understanding, too?

I just posted what someone posted on reddit. The way I read it is, that the Ag bill (I didn't look at it) had provisions that were 'similar' to HR 2058 that did the same thing - put the GF date to final rule. I don't think it was a 'rider' - just similar wording. Pretty sure HR 2058 is still in committee - not sure about the Ag bill...

 

[skoony]

@squee
The health results of an addiction were not being considered only the fact
that some thirty percent of"cigarette smokers" developed a dependency
to nicotine which is much higher than the things you mention. It was much
higher than the users of smokeless tobacco too.
Regard
Mi ke
I should have said 30% of cigarette smokers became dependent.