FDA Economic Impact Analysis

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Jman8

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The role of an economic impact analysis vis a vis the proposed FDA regs, has engendered much confusion (I know it's bedeviled me since I started to explore the issue and post on this thread). So, for whatever it's worth, here goes ...

While I don't know what the FDA can legally do regarding the "alternatives," after some research I do have a better understanding why they included the alternatives in the first place, i.e., they are legally required to do so.

From my understanding of this tangent (the alternative), I don't think of it in terms of what the FDA can/can't do. And the why, from FDA perspective concerns me very little (given my understanding of what). I see 'what' coming from them who wrote/passed FSPTCA. And while they are not the easiest to organize on any issue, much less 'vaping rights,' I do think SBA could literally be an advocate for the alternative, and either exert pressure on Congress, the Executive Branch, or possibly FDA. All of whom may blow off the argument/position, but all of which I think must (absolutely) be brought up by politically aware consumers in the comments to FDA. For that is matter of public record, and depending on how things shake out, it will be well known that FDA had information on how it could've been, before black market took over and reigned supreme. (Hypothetically speaking, on that last point.)

I see FDA as simply going through the motions of the alternative, and likely not really wanting to go in that direction, but also don't see FDA as wanting proposed regulations. They just have 'duty of service' to implement FSPTCA to best of their agency's ability and thus proposed regulations are best they could come up with, based on what they were given.

2007 date is arbitrary, but is also what statute says. From FDA perspective, they probably don't really care what date is in place, but if 'not wasting tax payer money' is of any value to them, I would think the later the date, the better from their perspective. From ANTZ perspective and those who cater to 'ultimate good of public health' perspective, I think 2007 is date to stick with, and ignore any discussions that seek to poke holes in 'ultimate good of public health.'

But a key thing that 2014 as grandfather date does do is make SE many times easier for all businesses. Easy because predicate products will then surely exist and easy because those predicate products are already allowed. Thus denial of applications if done in droves would show up as based zero on science and 100% on politics (of ANTZ). They might get away with that for a few months, but not much longer. Would be grounds for removing that agency from regulation if they went in that direction. I think assuming they will go in that direction is between foolish and defeatism.

Thinking FDA could just ease up on enforcement is interesting, but seems very naive in a world where ANTZ, ACS, ALA and MSM are all calling for tougher enforcement on eCigs. All these people are seemingly less happy with the proposed regulations than consumers, if you can imagine that. Obviously, the alternative would be 'even worse' from their perspective, but as reality of proposed regulations already allows products to stay on market (for 24 months), then all that is really changing is making eCigs have a level playing field with other tobacco products based on the 'predicate product' argument. And as all those organizations I mentioned above appear to be asleep at the wheel, they either knowingly or unknowingly are asking for only BV and BT to be allowed in the game, and somehow they will be better off. Perhaps they are correct, but IMO, they likely haven't thought that far ahead, like we constantly are doing in our discussions since 4/24/14. And frankly, given their public messages on vaping prior to 4/24/14, I think all of them have become poor resources for effective prevention of abusive (hardcore) smoking.
 

Kent C

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I didn't go back, but if a post is deleted, all following posts will move up in number.

my post #13 "Technical Problem with image attached" Obiwan gif. :)

The text:

Help me Grandfather, you're our only hope.

I see some leeway here - but you should read and evaluate for yourselves:

Pg. 57
3. Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming Regulation

And... pg 69

4. Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming Regulation [Regulatory Alternative 3]

The table shows the reduced burden for cigar manufacturers but this alternative would provide even greater relief for small businesses producing electronic cigarettes.

------
 

Kent C

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From my understanding of this tangent (the alternative), I don't think of it in terms of what the FDA can/can't do. And the why, from FDA perspective concerns me very little (given my understanding of what). I see 'what' coming from them who wrote/passed FSPTCA. And while they are not the easiest to organize on any issue, much less 'vaping rights,' I do think SBA could literally be an advocate for the alternative, and either exert pressure on Congress, the Executive Branch, or possibly FDA. All of whom may blow off the argument/position, but all of which I think must (absolutely) be brought up by politically aware consumers in the comments to FDA. For that is matter of public record, and depending on how things shake out, it will be well known that FDA had information on how it could've been, before black market took over and reigned supreme. (Hypothetically speaking, on that last point.)

I see FDA as simply going through the motions of the alternative, and likely not really wanting to go in that direction, but also don't see FDA as wanting proposed regulations. They just have 'duty of service' to implement FSPTCA to best of their agency's ability and thus proposed regulations are best they could come up with, based on what they were given.

2007 date is arbitrary, but is also what statute says. From FDA perspective, they probably don't really care what date is in place, but if 'not wasting tax payer money' is of any value to them, I would think the later the date, the better from their perspective. From ANTZ perspective and those who cater to 'ultimate good of public health' perspective, I think 2007 is date to stick with, and ignore any discussions that seek to poke holes in 'ultimate good of public health.'

But a key thing that 2014 as grandfather date does do is make SE many times easier for all businesses. Easy because predicate products will then surely exist and easy because those predicate products are already allowed. Thus denial of applications if done in droves would show up as based zero on science and 100% on politics (of ANTZ). They might get away with that for a few months, but not much longer. Would be grounds for removing that agency from regulation if they went in that direction. I think assuming they will go in that direction is between foolish and defeatism.

Thinking FDA could just ease up on enforcement is interesting, but seems very naive in a world where ANTZ, ACS, ALA and MSM are all calling for tougher enforcement on eCigs. All these people are seemingly less happy with the proposed regulations than consumers, if you can imagine that. Obviously, the alternative would be 'even worse' from their perspective, but as reality of proposed regulations already allows products to stay on market (for 24 months), then all that is really changing is making eCigs have a level playing field with other tobacco products based on the 'predicate product' argument. And as all those organizations I mentioned above appear to be asleep at the wheel, they either knowingly or unknowingly are asking for only BV and BT to be allowed in the game, and somehow they will be better off. Perhaps they are correct, but IMO, they likely haven't thought that far ahead, like we constantly are doing in our discussions since 4/24/14. And frankly, given their public messages on vaping prior to 4/24/14, I think all of them have become poor resources for effective prevention of abusive (hardcore) smoking.

1000 likes. And the bold part expresses my sentiments exactly. I've 'hinted at it' in other posts but that is exactly why I'd pursue this line.

Your 'The key thing' is also quite good and we're of the same mind there. People who don't get that aren't paying attention. And it is why this line is better, imo, than any other. It doesn't cave in to the threats/proposals and it allows for the whole industry to evolve as well to prove itself as an effective alternative. If years down the road there is new stuff that might not fit into SE, these proposals can be repealed, but in the interim, this will allow for growth of new products that tweak what is now pretty workable.
 

Katya

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And frankly, while I hope that Bill G and CASAA would chime in on this and perhaps they have a reason why this wouldn't be the case. I will compose my comments along these lines. I can read. I can understand what Zeller said. I can make the case to them and they can accept or reject it or not even read it. Those things are beyond my control. What is in my control, is what I can comment to them :)

And I can't control what others may do but the point of all this discussion is to make people aware of what is in the docs and what argument could be made according to the data that we have.

When you do, let us know, will you? I'd like to see your argument(s).
 

JustJulie

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Not exactly on point with the discussion in this thread, but nonetheless related . . . .

As folks know, there is an interim deadline for comment to OMB/OIRA, namely, in connection with the Paperwork Reduction Act. That comment period deadline is tomorrow, 5-27-14.

CASAA issued a Second Call to Action in connection with the Paperwork Reduction Act, asking consumers to make comment. For those who haven't yet done so, please respond to that Call to Action: CASAA: Second Call to Action for FDA Proposed Regulations - Consumer Comment on Paperwork Reduction Act

CASAA emailed its comment to OMB/OIRA this evening: CASAA: CASAA's Comment to OMB/OIRA regarding Paperwork Reduction Act and FDA Deeming Regulation
 

Kent C

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Not exactly on point with the discussion in this thread, but nonetheless related . . . .

As folks know, there is an interim deadline for comment to OMB/OIRA, namely, in connection with the Paperwork Reduction Act. That comment period deadline is tomorrow, 5-27-14.

CASAA issued a Second Call to Action in connection with the Paperwork Reduction Act, asking consumers to make comment. For those who haven't yet done so, please respond to that Call to Action: CASAA: Second Call to Action for FDA Proposed Regulations - Consumer Comment on Paperwork Reduction Act

CASAA emailed its comment to OMB/OIRA this evening: CASAA: CASAA's Comment to OMB/OIRA regarding Paperwork Reduction Act and FDA Deeming Regulation

Hi Julie..... ♥

Just sent off the comment. I included some of the stuff in this thread - as a way to 'reduce paperwork' :)
 

Jman8

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Not exactly on point with the discussion in this thread, but nonetheless related . . . .

<snip>

CASAA emailed its comment to OMB/OIRA this evening: CASAA: CASAA's Comment to OMB/OIRA regarding Paperwork Reduction Act and FDA Deeming Regulation

I think it is very relevant to this thread what CASAA emailed to OMB/OIRA.

Good reading, IMO. I'd score it at around 94% or an A minus.

Carl is citing 100,000 as more accurate number for total amount of vaping products. If flavors count, and I have every reason to believe they do, then his numbers are off by 13 million 900 thousand. Thus, all the points he makes based off the 100K figure, would need to be adjusted.

Yet, those points stand, and are well argued and reasoned all the way through.

I also downgrade slightly for not asking for the grandfathering extension as it is way to bypass much of what is in the letter. I think we can all agree that voiding the proposed regulations is entirely implausible. Can't say I wouldn't love to see that occur, but feel it realistic to say it won't occur. So, other option presented is for FDA to get accurate, update proposal and issue a revised version from which everyone can comment on. IOW, asking for delay in comment period, while also calling FDA to task on the de facto ban that appears to be at work in the proposed regulations.

Yet, I see the grandfathering as most reasonable position put forth at this moment. Supremely reasonable from consumer/vendor perspective, while likely treated as hurtful to the ANTZ cause. Yet, FDA proposed regulations are currently deemed hurtful to ANTZ cause due to the 'significant delay.' And as no one from ANTZ or FDA camp can provide reasonable justification for 2007 date as that relates to eCigs/vaping, but may find huge benefit if that date sticks, then it behooves consumers/CASAA to provide the rationale for why grandfathering adjustment must change, which also happens to reduce a whole bunch of paper work when the rule goes into effect.
 

Jman8

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I did not, so bonus points for you. On hindsight, I wish I did. But there's still the other comment period, and unless CASAA comes up with great reason (that is open to discussion) for not including that in comments, I fully intend to, and fully intend on making that case to as many republican congresspeople that I can, plus likely to SBA.

But am very happy to see you did include it, as it is relevant to this CTA.
 

bigdancehawk

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I think BT's role as Market Dominator was all but carved in stone when the Supreme Court told the FDA that they had the Legal ability to Regulate e-Cigarettes as a "Tobacco Product".

BT may be the Great Evil in many people's eyes. But to the US Government I think they are Viewed as Constant Source of Tax Revenue.

All the talk about ANTZ and "Bad Science" Studies I don't think effected the course that e-Cigarettes have and will take on the Federal Level. Some of the Propaganda about 2nd Hand Vapor may have an effect on Local Indoor Bans. But I don't think it had any Real Effect on the Direction the FDA was going to go.

E-Cigarettes, or more precisely - e-Liquids, were Never going to be Banned. Nicotine delivery method will Probably change. ie: No more Liquid e-Liquids, Limited Flavors, Reduced mg Levels, etc. But the FDA/Government Never intended to Ban e-Cigarettes. That would be Silly from an Accounting Standpoint.

I believe a lot of what we here in the Media is for the Benefits of the ANTZ. To make it sound like the FDA is more Concerned about "Health" than they are about Ensuring the Right People receive Profits. And that a Constant Tax Stream is maintained.

I'm curious to learn why you needlessly capitalize so many words in your posts. It makes them difficult to read.
 

Kent C

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While I have stated this earlier, I've come to the conclusion that the 'deeming doc' really does eliminate the alternatives from the 'impact doc'. I will still be arguing along the 'impact doc' lines, if only to show how asking for comments should have been 'before' the deeming doc when actual options were open and to point out how the deeming doc rule is only a 'proposed' rule.

The 'impact doc' although only released (as the OP) in late April, it appears to have been written earlier.

The second letter from the Dem Senators was April 7, 2014:

Senate Dems want crackdown on e-cigs | TheHill

And the deeming doc - Apr. 24, 2014. And so the data on the impact doc that shows the effects of various alternatives - something that, imo, would be more open for 'comments' about the impact on vendors, etc. is trumped by the deeming doc, no doubt in a response to the Senators' letter to the FDA. The deeming doc IS the 'crackdown' that the Senators demanded. And that fact is likely more operative than anything that has come after or before. This is the power of gov't and while the FDA likely agrees already, the idea that the process is still open, is only a propaganda ploy to appear to be fair, when there is actually no 'fairness' involved - only force.

I intend to point out this 'timeline', and how it reduces 'comments' to something along the line of a web poll or emails or tweets to a news station. It turns the commenting period into a "venting" rather than an engagement of ideas that would be open to consideration, because the alternatives under consideration in the impact doc are shut down.

The 'options' that Zeller mentions in the hearing, while they do involve cigars and ecigs, are not the alternatives in the impact doc, although he makes like they are when he states: "And we are in a rule making period now and we need to wait for all the comments to come in and we will then consider our regulatory options in large part informed by the information (he gets interrupted) that comes in...." IOW, Sen. Alexander will likely get his 'premium cigars' but ecigs....?? I think Bil G has a good grasp and his last 'comment' reflects that.

http://www.e-cigarette-forum.com/fo...a-re-pra-fda-reg-proposal-4.html#post13269282
 

Jman8

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While I have stated this earlier, I've come to the conclusion that the 'deeming doc' really does eliminate the alternatives from the 'impact doc'. I will still be arguing along the 'impact doc' lines, if only to show how asking for comments should have been 'before' the deeming doc when actual options were open and to point out how the deeming doc rule is only a 'proposed' rule

I highly disagree with your conclusion in first statement. I understand it, but the deeming doc is clearly written like, "duh, we no understand eCig. Pleaz help us regulate it."

Plus written with assertion that 'we' (FDA) don't understand how to change the grandfather date.

Which to me, makes FDA irrelevant on the grandfather adjustment, while also answering a whole bunch of questions asked in deeming doc, and easing up burden of possible new applications for vaping stuff. Ultimately, those burdens fall on tax payers. I would think average non-vaping citizen (that is not aligned with ANTZ) would say if you are going to keep these items on market for 24 months, then just grandfather those items, and proceed to regulate accordingly. While small segment of non-vaping citizenry (that is aligned with ANTZ) would be like, "great job FDA in purposively getting rid of all the little guys. Hopefully the big guys will fall some day. I heard eCigs were worse than smoking, so I'm happy this is now being regulated harshly. Cut 'em off now, and let 'em die a good death."

I honestly believe momentum is on our side, even while us who keep up with this daily get to see setbacks way more often than average non-vaping citizen does.

Anyway, I think Republican congresspeople absolutely must be brought in to wage this battle as it is clearly attacking small businesses, hurting private economy and seeking justification for extra tax burden. Doing all this in the name of "smoking kills" and all the deceptive bull pucky that meme has allowed to do to American way of life. While hoping the misdirection from banning legal existence of eCigs (and its usage) will slip right on by the American people and perhaps larger population that is rest of the world (concerned with this issue). Bringing in Republicans is especially necessary here in an election year.

Plus, I'm not certain what SBA stands for, but if this argument is not up their alley, then I'm really not sure why we (Americans) need an SBA in terms of advocacy. I think they ought to be brought in on this issue or at least presented with argument as we consumers recognize it, and let SBA decide accordingly on how it would like to proceed.

Do I think the alternative is a shoo in? Hard to say right now, but easy to sit here and dismiss it. I do think it is pro-vapers best hope going forward given all that FDA has provided so far and with what our opposition has said so far in response to that.

But keep in mind, I am not even a little bit shy about talking black market as next logical step of final rule turns out to be harsh and I stand by notion that if FDA/opposition push on closing all small businesses, that it will signal check mate against them. Not say in next 3 years, but really, once that ball starts to roll, they will have essentially lost on what is there stated bottom line: to prevent minors from getting involved with a lifelong process of tobacco/vaping.

Either way, I feel comfortable going forward, but clearly one option is a reasonable response, and the other option is, how you say disastrous to those who believe harsh regulations may just be the answer.
 

Kent C

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Jman8:I highly disagree with your conclusion in first statement. ("I've come to the conclusion that the 'deeming doc' really does eliminate the alternatives from the 'impact doc'. ")

I say that because none of the other alternatives in the impact doc are listed in the deeming doc.

I understand it, but the deeming doc is clearly written like, "duh, we no understand eCig. Pleaz help us regulate it."

Plus written with assertion that 'we' (FDA) don't understand how to change the grandfather date.

I agree.... it's going to take congress to do that. Perhaps enough comments along the line to ask for Regulatory Alternative 3 in the impact doc might get the FDA to ask Congress, but I'm not that confident in that route. Going directly to Congress is likely better... which I've done already, but plan more.


Anyway, I think Republican congresspeople absolutely must be brought in to wage this battle as it is clearly attacking small businesses, hurting private economy and seeking justification for extra tax burden. ...

Plus, I'm not certain what SBA stands for, but if this argument is not up their alley, then I'm really not sure why we (Americans) need an SBA in terms of advocacy. I think they ought to be brought in on this issue or at least presented with argument as we consumers recognize it, and let SBA decide accordingly on how it would like to proceed.

Agreed.

Do I think the alternative is a shoo in? Hard to say right now, but easy to sit here and dismiss it. I do think it is pro-vapers best hope going forward given all that FDA has provided so far and with what our opposition has said so far in response to that.

But keep in mind, I am not even a little bit shy about talking black market as next logical step of final rule turns out to be harsh and I stand by notion that if FDA/opposition push on closing all small businesses, that it will signal check mate against them. Not say in next 3 years, but really, once that ball starts to roll, they will have essentially lost on what is there stated bottom line: to prevent minors from getting involved with a lifelong process of tobacco/vaping.

Also agree and I think showing that the FDA has virtually ignored the Exec Order 12866 and the RFA (flexibility act) even though they say in the deeming doc, that they think they've conformed with both... that this is an avenue for court actions. The whole idea of the exec order and RFA is the impact on small businesses and nothing impacts it more than the deeming doc proposed rule.


Either way, I feel comfortable going forward, but clearly one option is a reasonable response, and the other option is, how you say disastrous to those who believe harsh regulations may just be the answer.

I'm not sure I'm going with "reasonable response" :) It's likely to be more of a condemnation of the path they have chosen vs. what paths were available.
 

Bill Godshall

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My apologies for not participating in the discussion on this thread so far, but I've been swamped dealing with state/local battles, compiling/analyzing research and news stories, dealing with the Senate HELP Cmte hearing two weeks ago.

If Kent C (or anyone else) would like to communicate directly with me, my e-mail is BillGodshall@verizon.net and my phone is 412-351-5880.

If Kent (or anyone else) knows which document and page number the following citation came from, please post (as I've been looking for it in the Deeming Reg proposal and the Ecomonic Impact document).

"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.

If FDA acknowledged that one vendor claims to sell over 1,000 different e-cig products, I don't understand how the FDA could also
estimate there currently are 1,675 e-cigarette formulations and 1,717 electronic cigarette UPCs

There are clearly more than 10,000 e-cig products currently on the US market, and Carl Phillips' assertion that there are more than 100,000 is probably correct (or at least it will be by the time FDA issues the Final Rule). If a vape shop mixes 50 types of e-liquid flavorings at 4 different nicotine levels, with 4 different ratios of PG/VG, that's 800 different e-cig products made by just one vape shop.

Regarding Kent's urging of FDA to extend the SE grandfather date from 2007 to the date of issuance of the Final Rule (or even to 2014), while I think its a good idea to urge FDA to do so, the agency is highly unlikely to do so because the last thing Zeller wants to deal with is another several thousand SE applications for e-cigs (especially considering that FDA has only approved 17 of the 4,000+ SE applications that have been submitted since 2011, and a key reason Mitch Zeller replaced Lawrence Deyton was because Deyton didn't process any SE applications). But if FDA decides to not extend the 2007 grandfather date, of course they'll claim its because the the 2007 date is written into the statute. While that may be true, I don't know anyone (except perhaps Banzhaf or another ANTZ lawyer) who would sue the FDA claiming the grandfathering date must remain 2007).

It also would be helpful for vapers and vendors (in comments urging FDA to scrap its proposed deeming regulation) to suggest a compromise that FDA apply the same exemption it has proposed for Premium Cigars to e-liquid products and Premium Vaporizers (AKA mods, tanks, open systems). Premium vaporizers and e-liquid products share many of the same characteristics as the FDA cited in proposing to exempt premium cigars (i.e. hundreds/thousands of small manufacturers, lots of new/different products made every year).

And of course, everyone should be urging FDA to extend the 75 day comment period (because even those of us who have worked on this issue 50-60 hours per week cannot address in just 75 days the FDA's gross misunderstandings of the e-cig industry, FDA's dozens of false and misleading claims and assumptions regarding scientific evidence, and the many dozens of completely different questions and issues FDA has requested comments on).

When I sent my comment to OMB yesterday at
http://www.e-cigarette-forum.com/fo...action-alert-omb-oira-today.html#post13271148
I hadn't had a chance to read the FDA's economic impact document nor any postings on this thread (so my comment was based solely on the FDA deeming reg).

I think FDA estimated cost of 1,500 hours (costing $333,554) for each new product application submission is far below the actual costs of submitting a new product application, especially since the proposed Deeming Regulation states (on page 179 of the printed version)

“We are clarifying here that a PMTA may require one or more types of studies including chemical analysis, nonclinical studies and clinical studies. FDA expects that chemical and design parameter analysis would include the testing of applicable HPHCs and nonclinical analysis would include literature synthesis and, as appropriate, some combination of in vitro or in vivo studies, and computational analyses. For the clinical study component, one or more types of studies may be included to address, as needed, perception, use pattern, or health impact.“

FDA's estimate that each new product application will take just 5,000 hours is only 2.5 FTE (full time equivalents) employed for one year.
The actual cost of submitting each new product application would be more than $1 million, and perhaps more than $5 million.

Unfortunately for public health and >99% of e-cig companies, the FDA would prefer to deal with (i.e. regulate) no more than a dozen e-cig products marketed by just several different companies (as has been the case with FDA regulated NRT products for the past 20 years).
 
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