FDA Economic Impact Analysis

[pamdis]

Is the 300K based on Roughly 5,000 Hours of Studies? If one study is down on Brand "X" 510 Atomizer, does another 5,000 Hours of Evaluation need to be done on Brand Y's 510 Atomizer?

Yes, the 300K is based on 5000 hours of application work.

Yes, I believe brand X and Y would both have to spend their own 5,000 hours. For a couple reasons:

I think SE only applies to pre-2007 products. So if X gets approved, Y can't use them as SE. Y has to do their own 5000 hours.

Even if SE will be allowed for post-2007 approved products, assuming X gets approved, does anyone think it will happen before the 2 year grace period is over? If not, then Brand Y would be SOL if they haven't already invested their 5000 hours because they were waiting to piggyback X.

And does anyone really think brand X will share their information and application for any other brand to copy?

 

[Kent C]

I read this as they figure they will have between 20 and 80 applications. Really?? That's all? They really have no clue about the current market. Probably looked at the big cigalike companies, figured they would each put in a couple, and done.

So take the lower dollars and divide by 20, or the bigger dollars and divide by 80. You get around $334,000 per application.

Well that's the table in the FDA doc. What variables they're looking at, I don't know. They may have a baseline on general applications needed by all, then a number of individual applications that apply to certain products... but that's just a guess.

According to the one note above in my #81 post:

²² A single online retailer, myvaporstore.com, claims to sell over 1,000 unique products <http://www.myvaporstore.com/aboutus.asp>. FDA analysts counted over 150 unique products among just the top 5 brands.

.... indicates that their 'analysts' have looked around at some vendors. myvaporstore has a larger stock than many, so that would be at the high end - higher than the "high bound" number, so I'm guessing, the low, medium and high bound number of products are an average of the vendors that they already checked out.... and perhaps some mom & pop shops as well. Who knows?

And it could be.... but this would have to mean analysts actually know as much about the products as we do here .... but it could be that they take Kanger clearomizers and even though there is the T3S, T3D, evod, evod2, evod glass, mini T3S, Aerotank - all have the basic configuration of base, bottom coil, tank, mouthpiece to where one application would be sufficient for all. However, perhaps the T2 because it is a top coil wouldn't fit. Or that any other manufacturers - Vision, joyetech, etc. would have to be separate from any Kanger applications.

BTW, my 'inside guy' in China, doesn't think the Chinese manufacturers will get involved with the US FDA. Although he does think they would feel the effects from their US markets, but they have other markets.

And despite the fact that if they were US companies, we might think that those corporations would have the ability to pay for the applications - and they would, but in China, such companies are under a communistic government where 'taxing the rich' isn't even a consideration because and much of the profits go into the government directly and not to the companies that make the products.

Of course the Chinese Gov't could say, 'Hey no regulations on ecigarettes or we don't loan you any more money' I don't think that will happen.

 

[pamdis]

Ah - maybe they figure each vendor would need between 20 and 80 applications each? That makes sense too. I was thinking they were only expecting between 20 and 80 in total from everyone. Could be either one, but the per application figure is still the same.

Who do we lobby in China to make that threat?

 

[Kent C]

Just a Quick Question:

How "Significantly" has an Atomizer changed since the 1st Atomizer you used?

Seems that the Concept of the Coil and the Wick Hasn't changed Much.

Because there is Another Pathway then the Costly Application Process you have described to FDA Approval.

First, "I" haven't 'described' anything - I'm posting what is written in the docs. I broke down some definitions but the rest is theirs. And while it is their intention to gather info and comments, regarding their proposal and those may or may not affect what actually happnens, what they have layed out, is how they're thinking about it and is likely a format for everything that has come before them in the past. IOW, they know their regulation business well.

Coils haven't changed that much but if you're thinking that the 'other pathway' is to assume there's a predicate for any components of ecigarettes, I think you're mistaken. That said, they did say 'IF there are no predicates...' but they've also assumed there are none. And it isn't like IF there's another product out there that is similar - it would have to be for atomizing nicotine and have been before them already and have passed their requirements. IOW, an electric lighter isn't going to be a 'pathway'. Just for example.

 

[Kent C]

Ah - maybe they figure each vendor would need between 20 and 80 applications each? That makes sense too. I was thinking they were only expecting between 20 and 80 in total from everyone. Could be either one, but the per application figure is still the same.

Who do we lobby in China to make that threat?

Well, like I said, Kanger and Joyetech likely don't have the resources or the 'ok' from their government to do anything, so you'd have to go to the Chinese gov't directly. That would be Xi Jinping, President and General Secretary of the Communist Party of China.

 

[zoiDman]

First, "I" haven't 'described' anything - I'm posting what is written in the docs. I broke down some definitions but the rest is theirs. And while it is their intention to gather info and comments, regarding their proposal and those may or may not affect what actually happnens, what they have layed out, is how they're thinking about it and is likely a format for everything that has come before them in the past. IOW, they know their regulation business well.

Coils haven't changed that much but if you're thinking that the 'other pathway' is to assume there's a predicate for any components of ecigarettes, I think you're mistaken. That said, they did say 'IF there are no predicates...' but they've also assumed there are none. And it isn't like IF there's another product out there that is similar - it would have to be for atomizing nicotine and have been before them already and have passed their requirements. IOW, an electric lighter isn't going to be a 'pathway'. Just for example.

Just say's that Someone with Lawyers I Hope is pouring over this Document...

http://www.fda.gov/downloads/TobaccoProducts/ResourcesforYou/ForIndustry/UCM252235.pdf

... and has a Small Army of Para-Legals doing research on "Substantial Equivalence Exemptions".

Because if they Aren't, we are in for some Dark Days.

 

[Vicky]

I think the first legal challenge should be that the 'Proposal' open for public comment is not a proposal at all as it asks more questions than it answers. So we should answer (in an orchestrated manner!) and then get a real proposal with real economic impact figures. I do not think they have a good handle on how many jobs will be lost and we should provide that to them.

 

[Jman8]

I think SE only applies to pre-2007 products. So if X gets approved, Y can't use them as SE. Y has to do their own 5000 hours.

My first response to this is it doesn't make any sense. Not "you" don't make any sense, but that anyone espousing this (namely FDA) is being utterly ridiculous. Like if X made a pencil, it would take FDA 2000 hours to review and approve/reject that, and if Y came along later and made very similar pencil, it would take FDA 2000 hours to review and approve/reject that. I can see first one ever taking maybe, like if I stretch really hard, 1000 hours. Everyone after that, in same category, ought to be 50 hours or tax payers literally deserve full transparency on the process. Make a reality show. Public might enjoy watching it. Seeing how some (so called) scientists twiddle their thumbs and perform meaningless tasks for the 48th time. "Honey, is this a rerun?" "No, but this is the one where they get the newbie from UCSF who is actually an ANTZ in disguise."

My second response, which I am being serious about, is that respondents then deserve 5000 work hours to review the proposal. Ya know, given the itemized parameters, enumerated inquiries and outlined gobblety-geek that will lead FDA to justify 5000 hours for review process for a drip tip. 40 hours a week, for 2.5 years... that ought be sufficient timing to provide adequate, and reasonable response. Heck, 24 hours a day for 75 days adds up to 1/3rd that.

And does anyone really think brand X will share their information and application for any other brand to copy?

I would think it would be a matter of public record. In fact, I believe main proposal asks question about whether the data collected will serve a useful purpose to the public. And if this isn't the case (of it being matter of public record), then I'd think industry ought to be able to put 2+2 together and realize if your business is only one accepted, well wonderful for you in short term, but horrible for you when political winds start a blowin.'

 

[Kent C]

Just say's that Someone with Lawyers I Hope is pouring over this Document...

http://www.fda.gov/downloads/TobaccoProducts/ResourcesforYou/ForIndustry/UCM252235.pdf

... and has a Small Army of Para-Legals doing research on "Substantial Equivalence Exemptions".

Because if they Aren't, we are in for some Dark Days.

I see many of the links for 'ecigarette timeline' say 'late 2006' is when ecigs were first introduced in the US by mall kiosks and online. Maybe SE is a play.... for cigalikes.

 

[Kent C]

I think the first legal challenge should be that the 'Proposal' open for public comment is not a proposal at all as it asks more questions than it answers. So we should answer (in an orchestrated manner!) and then get a real proposal with real economic impact figures. I do not think they have a good handle on how many jobs will be lost and we should provide that to them.

Frankly, I don't think 'job loss' is any concern to them at all. But you're right, we should tell them anyway.

I posted this regarding 'consumers'....

"And if you think they have the consumer in mind in their regulations:

"We acknowledge that product exit reduces product variety and the range of choices available to consumers, but we do not estimate the value of this loss of consumer choice." "

Their stated purpose is 'health'. Their real purpose is control.

 

[zoiDman]

I see many of the links for 'ecigarette timeline' say 'late 2006' is when ecigs were first introduced in the US by mall kiosks and online. Maybe SE is a play.... for cigalikes.

Hey Man...

I'm telling you. We are coming to the Point of the Sword here.

It's time someone with some Big Time Non-BT Lawyers step up and finds something. Anything.

BTW - In the Wake of the FDA's Announcement, it kinda makes all those threads about Vaping Inside Chiles seem Trivial.

LOL

 

[MD_Boater]

I realize this.

Hopefully science isn't corrupt, as some believe.

We have evidence that it is. Look at "climate change". Political economic assassination disguised as science.

 

[MD_Boater]

Science Isn't Corrupt.

It is the Bottom Feeding Shills who push their Agenda's thru the Use of Something that they make look like Science that is Corrupt.

You are correct. Climate change all over again. This time, it is vaping that they "believe" is bad.

 

[wv2win]

Going by my post just above, which explains what the UPC represent - components - there would be a need for a 'application' (form to fill out by vendors) for each of their products or UPC's (component products not assembled into a kit). So FDA gives a range - what they call a 'bound' - from low - 20 applications needed, to high 80 applications needed and estimate the cost on the low end to be @$6.6 million dollars and at the high end at @$26.6 million.

I read that the same way you did and just could not believe that they would expect a small or medium sized company to outlay millions of dollars just to sell vaping equipment. It is just so absurd and actually down right evil. Stalin is looking up from below and laughing.

 

[wv2win]

Hey Man...

I'm telling you. We are coming to the Point of the Sword here.

It's time someone with some Big Time Non-BT Lawyers step up and finds something. Anything.

BTW - In the Wake of the FDA's Announcement, it kinda makes all those threads about Vaping Inside Chiles seem Trivial.

LOL

Since the only group actually representing vaping consumers is CASAA and a large percentage of ECF vapers are not willing to even join for free, much less donate, the likelihood that consumer interests will be legally represented, looks quite dim. There are ECF members who do not want others to even know that CASAA exists. Not a good sign at this critical time.

Fortunately there are those on ECF who advocate that all vapers join CASAA.

 

[aikanae1]

I think that's been part of it..

Let the industry grow just enough (they probably waited a little too long for that, since it happened so unexpectedly quick), and let the big players position themselves first..

Then the FDA can throw the 1st pitch of the game...

Exactly.

...And so I think we are ahead of the industry, certainly the bulk of the industry, in preparation for what we'll always would be expecting to have CGMPs on, on these product. So I think from a practical standpoint there, it's -- I find that to be good news because we're prepared. And that should give us competitive advantage....

It's from Lorillard's management talking about the deeming regulations the day it was published. That was fast and it appears they've already been working on compliance ... I haven't read anything saying GMP's were required (good manufacturing practices).

I'm sure someone will tell me I'm reading too much into this. All I know is that I NEVER want to touch another BT product again. I find it insulting that I may not be given that choice. If I could give up nicotine, I would have by now.

Cut the "progressive" "liberal" crap please. It's not true outside of the FAUX bubble. Seriously, there is more in common than in differences. After all, Obamacare was Romneycare first. One of the reason's Dems are throwing this under the bus is that no one has told them otherwise. It's not a party position or issue beyond a handful of grandstanding individuals. What party doesn't have those?

 

[aikanae1]

Frankly, I don't think 'job loss' is any concern to them at all. But you're right, we should tell them anyway.

I posted this regarding 'consumers'....

"And if you think they have the consumer in mind in their regulations:

"We acknowledge that product exit reduces product variety and the range of choices available to consumers, but we do not estimate the value of this loss of consumer choice." "

Their stated purpose is 'health'. Their real purpose is control.

The FDA has stated elsewhere that consumer trends / desires are not important in matters of public health. I don't remember where I read it now though. I think the agency views itself as judge and jury and that consumers are not adequate in determining their own destiny when it comes to addiction. EXCEPT harm reduction is an accepted method of addiction treatment for everything else but nicotine.

The fact they keep saying "science based" and bt repeats comments about the FDA being "science based" pretty much tells me they aren't "science based".

At one time conflict of interest laws prevented industry from taking key positions at agencies they were regulated by. The good 'ol days I guess.

 

[Kent C]

The FDA has stated elsewhere that consumer trends / desires are not important in matters of public health. I don't remember where I read it now though. I think the agency views itself as judge and jury and that consumers are not adequate in determining their own destiny when it comes to addiction. EXCEPT harm reduction is an accepted method of addiction treatment for everything else but nicotine.

The fact they keep saying "science based" and bt repeats comments about the FDA being "science based" pretty much tells me they aren't "science based".

At one time conflict of interest laws prevented industry from taking key positions at agencies they were regulated by. The good 'ol days I guess.

The quote in my post was theirs - shows what they think of consumers. I'm sure it's a 'policy' for reasons you state.

And you're so right about 'everything but nicotine'. When I listen to a Chantix commercial with the side effects droned in the background, I think how in the world did this ever get past the FDA??!!! And when you consider that it did, then you have to ask yourself, is their true purpose science based health?

When someone proclaims 'science', they usually either don't have a clue or are trying to sell snake oil. All the 'new agers' that couch their 'solutions' in science whether it's crystals, pyramids or St. John's Wort - don't have the slightest idea about science. The reason science 'sells' is that it is supposed to be objective - something that it hasn't been since "scientists" have used 'consensus' to "prove" something. It goes back further than global warming and secondhand smoke.

I smoked 3 packs a day for over 30 years and quit smoking a week after being introduced to ecigarettes. I haven't had one cigarette in going on 5 years (Jun 18th). That's as real and as objective as it gets. There are thousands here with the same or similar story.

I loved smoking, I was a smoking advocate. If you would have asked any of my friends or family or co-workers who would be the last person that you think would quit smoking their answer would have been "Kent".

 

[DaveP]

No no no no, the FDA are good righteous people trying to protect us, they are simply giving vendors an EXIT.

I would rather be exited then fired...... I think?

It's like up here they came up with the term Revenue Tool to replace The word TAX.

Sounds much better eh?

Sometimes, I think the government toolbox is overstuffed. Not all can see through the buzz words and too many think our rich Uncle is just looking out for our best interests all the time.

 

[Jman8]

BTW - In the Wake of the FDA's Announcement, it kinda makes all those threads about Vaping Inside Chiles seem Trivial.

Also FDA proposed regulations make all comments about right to vape outdoors in public seem trivial.

Usage bans ought to be a lot easier to ram thru over the next 75 days.