FDA Economic Impact Analysis

[aikanae1]

IMO, if we push this, we push for the language in the alternative and don't look at this as something that needs to be negotiated with FDA. They've already precluded themselves from that sort of alteration.

Burr has been at this longer than many in Congress (arguably longer than anyone else). He understands the technological point and harm reduction. Thus, he has authority to make the push to amend, but obviously it would be an item that would take congressional act. Still, we are a community that is making huge deal out of this point (that small businesses will be exited) and so we have enough motivation from consumers (many but likely not all) and from vendors (plausibly all of them). And as this stands fairly decent chance of being a partisan issue, we could assume that all Republicans in congress would be on side of 'small business' whereas dems would be on side of 'safety first.' Yet, Burr addressed that in hearing yesterday and in my view Zeller and Harkin came up empty or hemming and hawing on the harm reduction tangent. Harkin clearly has an agenda, but Zeller isn't as overt on that sort of agenda, and again, doesn't really matter what FDA feels right now, as this issue is one for Congress to debate/work out.

I think this stands very good chance and if defeatist attitude from our end is saying not even worth trying, then I think we deserve FDA proposal as is. Sorry if that offends anyone, but I say drop the defeatist attitude. What do we have to lose by pushing for this?

Burr has a long history of advocating for THR that I wasn't aware of before. He's introduced legislation in support in the past. It might be interesting to see how far it got and who co-sponsors and co-signers were. I would like to hear more from him because I think he probably has the language down to get his point accross.

That stupid bad report (above) has filtered down to the states and cities (wanna make a bet it was designed to incite legislation?)
The interest level in Congress is low on both sides, so it's unlikely to become a partisan issue.

This is a big issue; 16 million smokers in the US and 70% of those want to quit. They will pay more to quit (per studies). That's big money. There's also the complication of taxes and the push is on for those; i.e. so that "substitution" won't occur between the different nicotine delivery products. Yup, that's the way it's framed. Cigarette taxes are for our own good ya' know.... But that's what I mean by getting the language right.

 

[aikanae1]

And btw, for the same reason that I feel 'obligated' to point to the politics because this is really what it is about, is the same reason that Zeller feels 'obligated' to invoke "the public good" - his politics.

That's utter idiocy. It's in your collective mind's that projects that image. The "great divide" is not as wide as you'd like to believe. If I say more, this thread will get locked. So knock it off.

FYI: an ECF member did get a personal phone call from a Dem this week (shock) in response to a flood of emails about this "industry" they had no idea existed. The member said they sounded sincere and asked a lot of questions, didn't realize adults vaped, vape shops, etc. All they knew was in the same stupid report that Harkin used.

 

[DC2]

I thought Zeller seemed to indicate that this 'deeming' is 'in process', not nailed down, so this option may be still open.

The "deeming" is most definitely "in process" as you say...

The current version of the deeming regulations is only a proposal.
It can be rejected by the OMB, just as the last one was.

And it can be changed by the FDA in any way they want after the comment period and before the final rule is issued.
Any such changes may be for the better, or they may be for the worse.

I think it sucks that they can seek comments on the proposal and then issue altered regulations without a comment period.
It seems like a bad way to go about governing and/or regulating.

 

[Kent C]

That's utter idiocy. It's in your collective mind's that projects that image. The "great divide" is not as wide as you'd like to believe. If I say more, this thread will get locked. So knock it off.

FYI: an ECF member did get a personal phone call from a Dem this week (shock) in response to a flood of emails about this "industry" they had no idea existed. The member said they sounded sincere and asked a lot of questions, didn't realize adults vaped, vape shops, etc. All they knew was in the same stupid report that Harkin used.

The "great divide" is not as wide as you'd like to believe. It is what got us to where we are today. Zeller agreed that vaping may be good for certain individuals but not for the public good. And for him, the 'public good' trumps individual harm reduction.

I was simply pointing out what the problem is in moving him off that point. If it would be a minor tweak of a grandfather date, that's one thing, but it deals with his basic ideology, and the goal of his agency with the same goal. He explained it rather clearly in that one segment to Sen. Burr.

 

[DC2]

Digression: It's worth mentioning that they don't need a blanket policy in the FRegs on flavors to simply reject all the applications for any flavor besides tobacco and menthol (or even just besides tobacco). All they have to say is that the public health evidence doesn't support a particular use of flavors in a specific application - in terms of the overall statistically expected effect on the population. (For that matter, they could reject all applications that way.) This broader public health standard is built into the FSPTCA, and explains why the statute makes it almost impossible to approve any new tobacco product. Zeller referred to it at least twice when discussing vaping, in answer to Qs about harm reduction asked by Burr. So all this talk about whether they're going to explicitly ban flavors might miss the point: they don't have to ban them, they just don't have to approve any.

This is the whole issue with the proposed regulations, substantial equivalence, and New Tobacco Product applications that few seem to recognize.
The burden of proof for the overall statistically expected impact on the population is where the vaping industry will be destroyed.

It's the very nuts and bolts of how they will crush us.

 

[Kent C]

The "deeming" is most definitely "in process" as you say...

The current version of the deeming regulations is only a proposal.
It can be rejected by the OMB, just as the last one was.

And it can be changed by the FDA in any way they want after the comment period and before the final rule is issued.
Any such changes may be for the better, or they may be for the worse.

I think it sucks that they can seek comments on the proposal and then issue altered regulations without a comment period.
It seems like a bad way to go about governing and/or regulating.

Well that was the only 'opening' I saw or thought I saw

 

[Kent C]

The burden of proof for the overall statistically expected impact on the population is where the vaping industry will be destroyed.

It's the very nuts and bolts of how they will crush us.

And the burden of proof is reversed from regular rationality. We like this stuff. They say it's harmful. It's their burden to prove that, not ours. In fact, we don't really make that assumption that it is not, to anyone but ourselves really. Although we might suggest that others interested might try it out. That's about it. Free consensual actions on one hand, force on the other.

 

[Kent C]

That's utter idiocy. It's in your collective mind's that projects that image. The "great divide" is not as wide as you'd like to believe. If I say more, this thread will get locked. So knock it off.

And look, whether you actually knew it or not, likely just second nature to you now, but you got into politics when you mention the 'Marlboro Protection Act'.

 

[Jman8]

This is the whole issue with the proposed regulations, substantial equivalence, and New Tobacco Product applications that few seem to recognize.
The burden of proof for the overall statistically expected impact on the population is where the vaping industry will be destroyed.

It's the very nuts and bolts of how they will crush us.

Unless we push for the alternative.

The alternative would be huge win for us, but say 4 years from now, all that we are debating will be front and center again. Either way, it'll be 4 years away (maybe as soon as 2 and certainly not much more than 6).

This alternative buys us (really vendors) acceptability into the market right when the rule goes into effect. But FDA is already granting that a degree of acceptance without the alternative and so we then, under that scenario, speculate if FDA will be ruling with iron fist and decimating things within 2 to 4 years, or ruling with velvet glove (and bureaucratic backlog) and get around to decimation some 6+ years from now.

Yet, the alternative carries with it the idea that SE will then be established as a pathway, while also allowing FDA ability to govern as harshly as it may see fit. If vapers are looking for that avenue that will allow us to have everything and ANTZ gets zero, I currently see that as impossible. The alternative is more like a 50/50 split, but huge enough victory that ANTZ would likely spin it, over next months or couple years as FDA just sided with BT and nicotine drug pushers.

 

[DC2]

That's utter idiocy. It's in your collective mind's that projects that image. The "great divide" is not as wide as you'd like to believe. If I say more, this thread will get locked. So knock it off.

FYI: an ECF member did get a personal phone call from a Dem this week (shock) in response to a flood of emails about this "industry" they had no idea existed. The member said they sounded sincere and asked a lot of questions, didn't realize adults vaped, vape shops, etc. All they knew was in the same stupid report that Harkin used.

I've had similar experiences talking with local legislators here in San Diego.
They never had a basic clue until I talked to them.

It's just so damn frustrating how this works.

 

[Kent C]

Unless we push for the alternative.

Like I was saying..... btw, I edited the one response on aikanae's (and A.Ania's) plea.... the link, aikanae gave http://www.khlaw.com/webfiles/What_To_Expect.pdf ... has another alternative. Of course this isn't any stated or authorized alternative but something I intend to push in comments. It is in the "Establishing a baseline predicate product" section:

Rather than requiring that companies find a specific
predicate product on their own, the FDA could establish
threshold specifications (e.g., product standards)
for a baseline e-cigarette against which companies could
make the case that their products are substantially equivalent.
Until the FDA has had time to develop such
e-cigarette product standards supported by sound science
(and promulgated via its rulemaking procedures), it may
consider either delaying publication of the deeming regulation
or the effective date of the rule.

And it helps to read the whole doc to really understand why this undercuts all the rest, and why such a standard would help each side achieve what they say they want to achieve.

I know that some who know me from the eGo-type forum might think I'm shilling for Joyetech but suggesting a 'baseline' for say ego type batteries, taking the Joye eGo-c upgrade batt would be a good choice, for example. Our techies here, who are good at this, have tried to blow up this battery, unsuccessfully. With other batts they're quite successful. It has the best short and charge protection for that line of batts. This actually came about by an accident with a Joye eGo-t batt that got hot during charging, exploded, burnt the kitchen floor. The user was given info to contact Joyetech, which she did. I contacted Wayne at heaven gifts to have him contact the Joye engineers who hang out there. And in the end, Joyetech replaced the kitchen floor and the batts for the user, but also developed the eGo-c and eGo-c upgrade batts with the extra protection as a direct result of this incident (sorry for those that knew the story already).

But this is the type of safety that the FDA might want to have in a 'baseline predicate product'. The same could be said for the carto to clearo path that pretty much was 'engineered' on our Dangerous Carto thread and the people there (Katya, the 'host'). One could point to the Vision clearos or the Kanger clearos as the 'model' for filler free vaping, bypassing the 'dangerous/burning filler' stuff that was the subject of that thread.

I could make the case for eliquids as well, but you get the point. Rather than an arbitrary date, it makes much more sense to have a "baseline e-cigarette" (or baseline components) as Chowdhury suggests. IOW, why not start with something that has been the result of an evolution with some of the most knowledgeable vapers on the planet who themselves have had an eye on safety for their own self-interest - a much better motivator. When you know it's going to affect you, you pay attention. (and aikanae- that's the main point of my earlier comment). What we've seen happen here is a 'decentralized' model where knowledge and information is spread by the people using the products, not from some centralized authority who has little knowledge of what the actual market is doing at any particular time.

 

[aikanae1]

The "great divide" is not as wide as you'd like to believe. It is what got us to where we are today. Zeller agreed that vaping may be good for certain individuals but not for the public good. And for him, the 'public good' trumps individual harm reduction.

I was simply pointing out what the problem is in moving him off that point. If it would be a minor tweak of a grandfather date, that's one thing, but it deals with his basic ideology, and the goal of his agency with the same goal. He explained it rather clearly in that one segment to Sen. Burr.

BS. The problem that got us here was allowing business conflicts of interest to take control of national policy decisions. An outgrowth of the neo-cons starting with the secret energy meeting in late 2000. Why is it so hard to consider that both sides are complaining about the same things?

As I said, don't go there.

 

[Kent C]

BS. The problem that got us here was allowing business conflicts of interest to take control of national policy decisions. An outgrowth of the neo-cons starting with the secret energy meeting in late 2000. Why is it so hard to consider that both sides are complaining about the same things?

As I said, don't go there.

I'll go where I want. Just like everyone else here does in their varied ways. The neo-cons are part of the same problem - they're the progressive arm of the party. They actually came from there, they just didn't like Carter.

 

[aikanae1]

Like I was saying..... btw, I edited the one response on aikanae's (and A.Anna's) plea.... the link, aikanae gave http://www.khlaw.com/webfiles/What_To_Expect.pdf ... has another alternative. Of course this isn't any stated or authorized alternative but something I intend to push in comments. It is in the "Establishing a baseline predicate product" section:

Rather than requiring that companies find a specific
predicate product on their own, the FDA could establish
threshold specifications (e.g., product standards)
for a baseline e-cigarette against which companies could
make the case that their products are substantially equivalent.
Until the FDA has had time to develop such
e-cigarette product standards supported by sound science
(and promulgated via its rulemaking procedures), it may
consider either delaying publication of the deeming regulation
or the effective date of the rule.

And it helps to read the whole doc to really understand why this undercuts all the rest, and why such a standard would help each side achieve what they say they want to achieve.

I know that some who know me from the eGo-type forum might think I'm shilling for Joyetech but suggesting a 'baseline' for say ego type batteries, taking the Joye eGo-c upgrade batt would be a good choice, for example. Our techies here, who are good at this, have tried to blow up this battery, unsuccessfully. With other batts they're quite successful. It has the best short and charge protection for that line of batts. This actually came about by an accident with a Joye eGo-t batt that got hot during charging, exploded, burnt the kitchen floor. The user was given info to contact Joyetech, which she did. I contacted Wayne at heaven gifts to have him contact the Joye engineers who hang out there. And in the end, Joyetech replaced the kitchen floor and the batts for the user, but also developed the eGo-c and eGo-c upgrade batts with the extra protection as a direct result of this incident (sorry for those that knew the story already).

But this is the type of safety that the FDA might want to have in a 'baseline predicate product'. The same could be said for the carto to clearo path that pretty much was 'engineered' on our Dangerous Carto thread and the people there (Katya, the 'host'). One could point to the Vision clearos or the Kanger clearos as the 'model' for filler free vaping, bypassing the 'dangerous/burning filler' stuff that was the subject of that thread.

I could make the case for eliquids as well, but you get the point. Rather than an arbitrary date, it makes much more sense to have a "baseline e-cigarette" (or baseline components) as Chowdhury suggests. IOW, why not start with something that has been the result of an evolution with some of the most knowledgeable vapers on the planet who themselves have had an eye on safety for their own self-interest - a much better motivator. When you know it's going to affect you, you pay attention. (and aikanae- that's the main point of my earlier comment). What we've seen happen here is a 'decentralized' model where knowledge and information is spread by the people using the products, not from some centralized authority who has little knowledge of what the actual market is doing at any particular time.

I think I was starting to go down a similar path with 'modified risk products' in that as far as I know (so far) there hasn't been a serious attempt with one. That might allow some new standards specifically geared towards ecigs.

One thing any agency, politican, business etc. hates to do is admit error. I tried to find the original statement from the director of FDA (2004?) basically saying it would be impossible for the FDA to approve ANY tobacco product because all tobacco is bad (only using a lot more words, saying the same thing over and over and over). This is basically what these regulations are stemming from; a basic concept that all tobacco is bad in any form or delivery. And back then, that was more true than it is now (well, I didn't know about snus).

Anyway, I was looking for a way to create a seperate category for ecigs, that would allow for documentation and research on a continuim of risk (all things Zeller has agreed with) without underminning the core object to eliminate smoking and protecting the children (and all the other gobbly .... language), i.e. without admitting error.

However, the standards are already set by the IOM. Every sentence contains the phrase of "wide range of scientific research and studies" blah-blah. So once again, there are pre-set standards that do not take into account the nature of electronic cigs (pre development) with an attitude of "not possible". Otherwise known as a brick wall. Why do they even bother with having that category?

It just doesn't seem like the lowly Ego will pass their standards, by design.

You betcha the pharmeciticals are behind this and this is a war with tobacco companies. Ecigs are caught in the middle. I use the word ecigs to describe the vaping industry because it was all the small businesses that developed this product, without capital financing or payment processing or advertising. With no help. And now the corporates want to be handed the industry on a silver platter with no effort of their own. That's BS!!!

They also are in for a low blow because their products do not work and current sales are not sustainable. Several have already seen a stall in sales, some haven't produced profit yet and bad press based on Vuse's roll out during SXSW. Yet they want to hand the ecig market over to the same bad actors that produced the need for the act in the first place - all to protect NRT investment. That's the biggest fish.

Flavors is important because it destroys the myth that these are for children among other things. It's a major reason people choose to vape rather than smoke. Chances are the eventual goal is to only allow single use cartridges with protections against DIY at some point. However they also have the goal of 100% smoke free by ---- (the date keeps moving forward). So realism isn't high on their agenda anymore than scientific is.

Can you imagine what the ecig industry could do with a billion dollar investment towards producing a safer product? Yup. That's what the FDA is investing in 'scientific' research that'll produce only their little bubble of studies. The fact they are NOT accepting from a wide body of studies is also questionable per their own regulations.

I get too ticked off about this sometimes.

We need to develop a core body of legislatures in congress to push back some of this crap.

 

[aikanae1]

I'll go where I want. Just like everyone else here does in their varied ways. The neo-cons are part of the same problem - they're the progressive arm of the party. They actually came from there, they just didn't like Carter.

WHAT???!!! That's crazy. I see them as conservative extremists = the western extension of the Taliban (really). Have you ever seen the Power of Nightmares by Adam Curtis? Good start.

 

[Kent C]

WHAT???!!! That's crazy. I see them as conservative extremists = the western extension of the Taliban (really). Have you ever seen the Power of Nightmares by Adam Curtis? Good start.

We must be talking about different neo-cons. Just look up neo-conservatism in wiki as weak as that can be sometimes, it gets most of it right. History section and click on some main players early on.

"In 1973, Michael Harrington coined the term "neo-conservatism" to describe those liberal intellectuals and political philosophers who were disaffected with the political and cultural attitudes dominating the Democratic Party and were moving toward a new form of conservatism"

 

[aikanae1]

We must be talking about different neo-cons. Just look up neo-conservatism in wiki as weak as that can be sometimes, it gets most of it right. History section and click on some main players early on.

"In 1973, Michael Harrington coined the term "neo-conservatism" to describe those liberal intellectuals and political philosophers who were disaffected with the political and cultural attitudes dominating the Democratic Party and were moving toward a new form of conservatism"

Your right, that's weird. I've thought the same way pre-73. I've heard some twisted views on what progressives are that are downright laughable.

The roots go back further than that. You also have to remember that left/right and conservative/liberal are used differently in other areas of the world. I have a hard time with Central and S. American history because of that confusion.

Seriously, BBC's Power of Nightmares -> internet archive (among other places). The rest of the world has seen major broadcasts of it at least 5x's now (UK and Canada). Might as well.

Have you seen this? I'm not sure what to make of it largely because I've been on the computer to long.
April 16-18, 2014: Written Submissions from the Public

 

[Kent C]

Your right, that's weird. I've thought the same way pre-73. I've heard some twisted views on what progressives are that are downright laughable.

The roots go back further than that. You also have to remember that left/right and conservative/liberal are used differently in other areas of the world. I have a hard time with Central and S. American history because of that confusion.

.... and in different times. Classical liberalism is now libertarianism. And the old left/right scale is really of no use other than shorthand for some, but it's contradictory in many views. This, while still simple, gets closer:

http://www.nolanchart.com/images/advocates.png

World's Smallest Political Quiz

Zeller is more likely in the bottom sector rather than left. And it what basically drives him and the agency.

Just in case the RFA has any effect whatsoever on the decision, I'm going to go with the "threshold specifications for a baseline ecig" for a predicate product. It's the only one that makes sense imo - it addresses safety issues and prevents mass exit. IF the intent is solely to establish cigalikes and their makers, then any comments that don't address/support that will be moot anyway.

 

[Kent C]

Have you seen this? I'm not sure what to make of it largely because I've been on the computer to long.
April 16-18, 2014: Written Submissions from the Public

I tried it but it was like accessing ecf after 6:40pm yesterday I'll try again.... and intend to check out 'nightmares' later.

 

[Roger_Lafayette]

Let's go back to this point by Azim:

Rather than requiring that companies find a specific predicate product on their own, the FDA could establish threshold specifications (e.g., product standards) for a baseline e-cigarette against which companies could make the case that their products are substantially equivalent. Until the FDA has had time to develop such e-cigarette product standards supported by sound science (and promulgated via its rulemaking procedures), it may consider either delaying publication of the deeming regulation or the effective date of the rule.

I can find precious few clues about what standards - if any - the FDA uses to evaluate SE, besides that list which is already in the statute. Pages like this: Substantial Equivalence and this:
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm271242.htm provide essentially no information.

However SE is a widely-used term in the food and therapeutic arenas: substantial equivalence site:wikipedia.org - Google Search

So this suggestion (and whatever comments you might suggest that we make, Kent) raises some interesting Qs:

1) Does the FDA have the authority to do something like this? We all know that it's an easy out for them to claim that they don't. It would be very helpful to discover how this process works in the context of both food and medical products, as well as in the tobacco area.

2) If the FDA were to do such a thing, could anyone complain about it? For ex., could a manufacturer of (say) combustible or even non-combustible OTPs argue that the FDA was either exceeding their authority, or perhaps sue them on other grounds based on different treatment of variegated classes of tobacco products? After all, they're all regulated under the same statutes.

3) On the other side, could the FDA be forced to promulgate such rules? (The chances of this may be remote. It's hard to force an agency to engage in rulemaking, methinks.) And if so, who would have legal standing?

BTW #2 and #3 are related to #1. For ex., if the FDA could argue that other tobacco products might be inappropriately treated by providing a "special status" to vaping that congress may not have intended, then presumably they lack the authority to do so (so some answers to #2 lead to #1). And if in fact no one can force them to engage in thsi kind of rulemaking, this may also mean that they shouldn't do so under some aspect of the APA (administrative proc. act).

These are deep and complex questions, as far as I can tell right now.