FDA Zeller Actually Lets the Truth Slip Out - Let's Pay Attention

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Jan 19, 2014
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So it is 60 or so days left for the comment period (assuming no extension), another 6 months (and perhaps as much as a few years but......who knows) and then another 6 months to register.

Assuming the final ruling is similar to the present, in a few months over a year (worst case scenario) it is possible the vast majority of liquid (and hardware) will be off the market as I have to assume very few will actually bother to register.

If I am wrong in this Roger let me know.

No need to worry......... the black market will save us all.......

Yes, you're basically correct (including what I presume is your satirical final comment).

Once the comment period ends, the FDA has to send the final proposed rule (which may differ) to OMB for another look. If OMB signs off on it, then Congress gets a crack at it. But Congress doesn't hav eto do anything, it just gets to look it. Under the Congressinal Review Act, congress could theoretically stop it (subject to a potential veto). Not too much chance of it being stopped there.

The good news is that Bill G. thinks it might take up to two years for the FDA to send the final proposed rule to congress. I think congress has 30 days to act (? anybody know). Something like that anyway.

That's it, the rule's final then. And then - depending on what time of year it is - registrations have to occur no later than 6 months after that or thereabouts (p.116). I'm fairlly sure that registration includes the ingredients/manufacturering process declaration. Like you, I'm very concerned that many small manufacturers will not register. Some of these Chinese companies might just say "why bother?" and pull out of the US market.

The good news is that if the FDA doesn't get the final proposed rule submitted to congress by the time of the presidential changeover, then it's probably dead. So at some point, I suspect that CASAA will be asking us to put pressure on congresspeople to start peppering the FDA with letters, queries, etc. Anything to slow them down.

Under the current proposed rule, of course, any manufacturer who does register can keep the product on the market for two years after the rule becomes final. However FDA may change that 2-year window in the final version. Although it does mirror a very similar provision in the original tobacco act, and it may be that OMB forced them to put it in.

Hope that helps.
 

zoiDman

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Here's the thing...


BT is way behind the curve..

Of the Big 3, only Lorillard has anything serious going on, with $230 million in blu revenue in 2013 -- and keep in mind that last summer, blu rolled out a much cheaper kit at $35 to replace their $60-70 models.. Unit volume might increase, but at the expense of revenue, which has already stalled.. And blu's operational profits are razor thin (something like 2-3% margin), with tons more about to be thrown at marketing, as competition is still heating up..

They spent like $135 million on blu a couple years ago when it was a much smaller company.. Altria also recently spent like $110 million on Green Smoke.. And Reynolds American is launching their cigalike soon...

The Big 3 have spent a lot of time & money -- and what do they have to show for it? None of them even have an eGo type, let alone a real PV..

...

Why does BT need to have Anything more than a 2-Piece? If they are going to be the Only Ones who are Allowed to Sell e-Cigarettes and Pre-Filled Cartos.

Microsoft forged the Model a Long Time ago. You Don't have to be Innovative or make a Better Product if you can Find a way to Remove your Competitors from the Market who Do and Can.
 

Bobbilly

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BT may have gotten in behind the eight ball but they are catching up and are proactively setting themselves up with the proposed deeming. Look at the Vuse FAQs tamper-proof. Tobacco and menthol only. Even 21 or older to even view products. They know that smoking cessation is deadly to their combustibles. Oh and no online sales either
 

AndriaD

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It seems to me that one of the very best things we can possibly do to counter any or all of this doom, is keep enlisting new vapers all the time. Eventually there *will* come a point when smoking tobacco is just... obsolete, old-fashioned, just stupid in the eyes of whatever modern culture prevails at that time. When no one is buying tobacco, there will BE no "big tobacco."

Granted, this might take a while, maybe longer than some of us may have left, but typewriters were state of the art in 1900; by 1950 they were electric; by 1975 they were electronic mag-card spouting behemoths; by 2000, they were dinosaurs. When *better* means to do a thing become available, older, less-efficient means just die away.

Anybody still using a Walkman?

Andria
 

Gato del Jugo

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Why does BT need to have Anything more than a 2-Piece? If they are going to be the Only Ones who are Allowed to Sell e-Cigarettes and Pre-Filled Cartos.

Microsoft forged the Model a Long Time ago. You Don't have to be Innovative or make a Better Product if you can Find a way to Remove your Competitors from the Market who Do and Can.

As I mentioned, look at it this way...


I'm Altria.. You're Lorillard.. Roger is Reynolds American..

The FDA didn't change a thing, and the regs as proposed are now in effect.. The 2-year clock is ticking..


Are you going to trust Roger or me *not* to purchase ProVape, so neither of us could have a huge leg up (the ProVari) on you (stuck with your garbage cigalikes that nobody is going to buy)??
 

Oliver

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Ok, apologies, I'm coming rather late to this thread, and haven't yet had the opportunity to read through the replies.

On this specific quotation, notice the emphasis - "completely switch". It's important to note the language, because there is a strong Tobacco Control current of argument which says:

1. Dual use (i.e. cutting down) is not desirable, since it represents the perpetuation of smoking behavior (which otherwise would have disappeared?).

2. E-Cigarettes are only any good for dual use.

The MAJOR problem the US faces is that there is no credible population-level study which shows what is actually going on with smokers transitioning to vaping.

In the UK the Smoking Toolkit and a nationwide survey by ASH UK are demonstrating beyond argument that gateway concerns are not a concern; that a huge number of smokers have migrated fully to vaping; and that smoking prevalence is being reduced in all socio-economic groups. Similar data is coming out of France.

The CDC cannot be trusted to collect this data - so who might be? I believe that the best course of action is to try to persuade one or other of the alphabet soup to fund Robert West to run a US version of the Toolkit. It's not expensive - the UK version is funded by Cancer Research UK and costs about £125k ($170k approx) per year (it rolls out continuously to pick up trends quickly).


View attachment 336411

FDA Regulation ECigarettes | Video | C-SPAN.org

SEE: 38:30
"If we could get all of those people [who can't or wont quit smoking conventional cigarettes] to completely switch all of their cigarettes to the non-combustible products that would be good for public health."

SO... it seems that if there is a preponderance of evidence that people do in fact completely switch that the FDA should be our ally, by their own admission.

The next step would be to demonstrate what kinds of devices actually allow or enable people to completely switch, and that the 2007 date does not provide adequate attention to what actually works.

-----------

Just looking at things as we all start to maybe get our resources together for our official comments.
 

Bobbilly

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Come on, Lorillard..

For all you know, I may already be in talks with ProVape.. And I've got a huge financial war-chest at my disposal, willing to pay a very high price to lock in that e-cig market..


What are you going to do??

Tick tock, tick tock... :D

Why would I pick up a company that would have a hard time navigating the PMA and looks nothing like the other combustible line I have? Not to mention that line will be removed by government resources if I do nothing further helping me out. If there is no provari those customers will likely be dual users so I'm safe.

I'm also buddies with the other two players so there is enough to go around.
 

zoiDman

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As I mentioned, look at it this way...


I'm Altria.. You're Lorillard.. Roger is Reynolds American..

The FDA didn't change a thing, and the regs as proposed are now in effect.. The 2-year clock is ticking..


Are you going to trust Roger or me *not* to purchase ProVape, so neither of us could have a huge leg up (the ProVari) on you (stuck with your garbage cigalikes that nobody is going to buy)??

Great. I would have to be Lorillard Blu. LOL

Seriously though.

Are you making this Hypothetical Scenario in a Free Market? Or one where ALL e-Cigarettes need the Green Light from the FDA to be Sold?

In a Free Market, Of Course Not. Innovation, Functionality and Price are what makes people buy One e-Cigarette over Another.

But in a Market where the FDA calls the Shots, None of that Matters. Does the FDA want VV devices on the Market? Will they Allow them?

What about things like Sub-Ohm? Heck, there are Many Here on the ECF who Don't Believe in Sub-Ohm Vaping. How do you think the FDA will view it?

If there is Only going to be a Handful of People who can Sell FDA Approved Hardware, Making a Better e-Cigarette Isn't for the Market Consumers to decide. It will be for the FDA to Decide.
 

Gato del Jugo

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Why would I pick up a company that would have a hard time navigating the PMA and looks nothing like the other combustible line I have? Not to mention that line will be removed by government resources if I do nothing further helping me out. If there is no provari those customers will likely be dual users so I'm safe.

I'm also buddies with the other two players so there is enough to go around.

Bzzt! Too late.. I just put out a press release that I picked up ProVape for an undisclosed amount..

I may or may not be in talks with Innokin, as well.. And with that one, I don't even have to worry about moving manufacturing operations over to China!


Meanwhile, Roger is still stuck with his Vuse.. *snicker*


Anyway, don't worry about my wallet & ability to punch this thing through.. I'm sure I'll be able to afford the million $ per product application.. Already got my connections with the FDA, so they'll be able to fast-track that, no problem...
 
Jan 19, 2014
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[yes, exactly what I've tried to explain about dual use, cigAlikes, and the health effects test under the statute, to those who may be misapprehending Zeller's comment]

The MAJOR problem the US faces is that there is no credible population-level study which shows what is actually going on with smokers transitioning to vaping.

In the UK the Smoking Toolkit and a nationwide survey by ASH UK are demonstrating beyond argument that gateway concerns are not a concern; that a huge number of smokers have migrated fully to vaping; and that smoking prevalence is being reduced in all socio-economic groups. Similar data is coming out of France.

The CDC cannot be trusted to collect this data - so who might be? I believe that the best course of action is to try to persuade one or other of the alphabet soup to fund Robert West to run a US version of the Toolkit. It's not expensive - the UK version is funded by Cancer Research UK and costs about £125k ($170k approx) per year (it rolls out continuously to pick up trends quickly).

Are you saying that we could get this done for a lousy $200?
 

Gato del Jugo

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Great. I would have to be Lorillard Blu. LOL

Seriously though.

Are you making this Hypothetical Scenario in a Free Market? Or one where ALL e-Cigarettes need the Green Light from the FDA to be Sold?

In a Free Market, Of Course Not. Innovation, Functionality and Price are what makes people buy One e-Cigarette over Another.

But in a Market where the FDA calls the Shots, None of that Matters. Does the FDA want VV devices on the Market? Will they Allow them?

What about things like Sub-Ohm? Heck, there are Many Here on the ECF who Don't Believe in Sub-Ohm Vaping. How do you think the FDA will view it?

If there is Only going to be a Handful of People who can Sell FDA Approved Hardware, Making a Better e-Cigarette Isn't for the Market Consumers to decide. It will be for the FDA to Decide.

Well, it all depends on if one can successfully get the FDA to do your bidding..

Can they be "swayed" somehow? And what would sway them?
 

zoiDman

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Well, it all depends on if one can successfully get the FDA to do your bidding..

Can they be "swayed" somehow? And what would sway them?

Hard to Say... The FDA Doesn't sound all that Hip on e-Cigarettes in the 1st Place.

Not sure Why they would be all Excited to Approve "More Powerful" e-Cigarettes?
 

Bobbilly

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Anyway, don't worry about my wallet & ability to punch this thing through.. I'm sure I'll be able to afford the million $ per product application.. Already got my connections with the FDA, so they'll be able to fast-track that, no problem...Anyway, don't worry about my wallet & ability to punch this thing through.. I'm sure I'll be able to afford the million $ per product application.. Already got my connections with the FDA, so they'll be able to fast-track that, no problem...

You forgot that the stockholders hear that the provari works to reduce your combustible line. If they aren't smoking they might even quit the nicotine fix. That sounds like a gateway to abstinence no way. Let the regulators take care of them.
 

Gato del Jugo

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Hard to Say... The FDA Doesn't sound all that Hip on e-Cigarettes in the 1st Place.

Not sure Why they would be all Excited to Approve "More Powerful" e-Cigarettes?

Well, if I try & the FDA still doesn't want to play nicely, then I (Altria) am taking them to court..

See how hip they sound in front of a judge..


Wouldn't be the 1st time -- and you should check out my hordes of lawyers... :D
 

Gato del Jugo

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You forgot that the stockholders hear that the provari works to reduce your combustible line. If they aren't smoking they might even quit the nicotine fix. That sounds like a gateway to abstinence no way. Let the regulators take care of them.

Lorillard seems to be doing just fine with that..

Lorillard Management Discusses Q1 2014 Results - Earnings Call Transcript | Seeking Alpha


EDIT: Analysts Q&A on page 6...

http://seekingalpha.com/article/216...-2014-results-earnings-call-transcript?page=6
 
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