FDA FDA deeming regulation proposals

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Jan 19, 2014
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You seem to believe that this entire thing can be approached from first principles. All we have to do is read the proposal, right? The history of the FDA's actions in the Tobacco Control context (including what they've said and done regarding vaping), Congress' clear intent in setting up this regulatory framework, and the behavior/affiliations of the people in positions of authority appear to be factors that you are entirely unwilling to consider.

It's as if you exist in some kind of analytical vacuum ... just you and the reassuring words in this PDF, off in some sort of parallel universe that has no actual connnection with the contextual reality and documented history of the world in which we exist.

The reason that these reg.s are a royal PITA to satisfy is because Congress was doing everything it possibly could when it passed the FSPTCA to make it darned near impossible for BT to introduce new cigarettes. It was assumed that BT had super-deep pockets and that any regulatory framework had to be as daunting as can be.

Now, this series of flaming hoops is being put in front of every little company that makes a glass drip tip (Trippy Tips). And it's being administered by the same folks who did everything they can to ban vaping, and who have engaged in a series of misleading and often downright fabricated series of public relations actions (including recent press releases) designed to terrify an ignorant public about vaping. Not to mention the completely irresponsible (and entirely intentional) obfuscation and/or omission of all the evidence that vaping is incomparable to cigarette smokng in terms of is potential harm to users. Oh yes, and have you forgotten about their junk '09 "study" that they left on their web site for years, which practically every cub reporter in the country has cited when writing their "vaping 101" survey pieces (you know, diethlyene glycol)? You read Bill G's letter, right? Every single syllable in there is true as written. It's not exaggerated, it's not hyperbole, it's not in any any way overstated. Finally does it matter to you that the CTP is chock-full of people with BP industry ties, such as (to pick one random example) Mitch Zeller himself?

So-o let's see ... we're supposed to focus on the text of this PDF and all the reassuring words that it provides, without looking at the background of the FSPTCA, the recent history of FDA applications, the FDA's own recent actions surrounding vaping (the outright ban attempt, the junk studiy, and the bogus press releases), Zeller's own ridiculous comments about vaping, and - oh yes - the fact that this very document treats vaping as something which could be just as dangerous as smoking tobacco cigarettes? No "proven" cessation value, long-term dangers unknnown, blah blah? And ignore Zeller's own BP lobbyist background to boot? (Hamburg's BP backround too, if my memory serves me correctly.)

This is not about the glass being half-full versus half-empty. It's as if there's one little lousy water molecule in it, and you seem to be suggesting that it's dripping over the sides. Good grief.

If you really want to look for a reason to be optimistic, think about how slow the FDA has been with so many things in the past, and/or the very real possibility that they'll never come out with these reg.s. Or that they won't do so prior to Jan '17, which is usually a death-blow for all pending agency rules, even if the presidency remains in the same party's hands.

There may be other reasons for optimism. But none that would involve the text of this document, nor the current crew of folks who are going to be responsible for implementing it (or quite likely, their successors).

I'm done. There is nothing more that I can say to you.


I'm sure this can't apply to the people in this thread offering up constructive comments about what we might write or talk about in response.

Doomed thinking seems be other's motives. Don't do anything in response, ecigs are dead/buried. BT took over. By design.

Or wait, we might respond, but only after Bill G. and CASAA have told us to. Until then, let's opine about just how horrible this is. Let's not quote from the proposal, but instead just what we think it is saying and FDA's track record and how regulation stinks. Can't get enough of that.
 
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Danoman

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Looking at all the comments stated in this entire thread... I believe we are all seeing the 'reality' of what we are facing. We argue it, some hoping, some ignoring the facts but... in the end, it's what the FDA is putting in front of us all. It isn't pretty, it's NOT going to be easy and it's certainly not fair, to anyone of us that truly believe in our vapes. Bottom line is, when we all realize the truth that we are staring in the face of those that oppose us, WE have to make a choice in the end. What is that going to be...? We all speculate what's coming... but we are all in the same room, seeing things in a different way. The facts are the facts... (those facts ARE, we must decide as a massive group what we are willing to give up and what we are going to fight for, tooth and nail to the end) <.... this is a fact.
 

Kent C

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Agreed that 5000 hours is estimated, per application response.

We also know that they are asking for comments that could change these estimates / requirements that are for new tobacco product applications. Whether or not they act on those, we don't know. But that they asked, we do know.

Another thing we know:

" The Tobacco Control Act gave the FDA authority over tobacco in 2009. In the time since, it has received approximately 4,000 applications for new tobacco products. With over four years in operation and currently more than 150 employees working on reviews, the FDA has managed to rule on only thirty-four of them, a slow pace it blames on deficiencies in the applications. The hold up has halted the release of new products and protected big tobacco companies from competition, an outcome that has implications for the cigar and e-cigarette industries that the FDA may target next."

FDA Cigarette Regulations Protect Big Tobacco, Not Public Health - Reason.com
 

Danoman

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I'm tired of reading the opinions... we ALL already know what those are. So, what are WE, as a group going to do...? At SOME point, (and I believe it to be NOW) we need to bond together and make a serious list of our demands that we will not bend on no matter what, some provisions we agree with and those we can use to use as collateral, if nothing else works. I, personally don't trust the FDA... as I've said many ties before BUT... WE need to decide on what we are willing to give up and what we aren't willing to give up, as a bottom line. We've got to get out act together NOW...!!! Believe me, in two years... it goes very quickly. Let's get ourselves in alignment and make a list of things that we demand... this way, the CASAA has something bonified to work with as it goes to court. (as I think it will)


Listen, these people aren't playing... and neither should we. They WILL take this from us all if we aren't careful... it's like a land grab to them. I'm NOT giving my rights of choice to them and I KNOW we all feel the same way. It's not acceptable and can't be allowed...
 
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Jman8

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If a product takes years to get approved it will be obsolete and it won't matter if it's approved or turned down.

I'm sorry, but still not understanding for sure what you are saying. Are you referring to products that come out after the grace period, and then go to FDA before they can go to market... and then after years of not getting any word one way or another, they'll run the risk of having submitted application to the FDA on a product that is later obsolete?

If this is close to what you're asking, I don't see how it relates to most of what I was saying in post #475 about products that will be on the market during the grace period, and after it, or until FDA says otherwise.

I did talk about what was written. The FDA pretends they can't do anything. If they couldn't do exactly what they'd need to do to amend the law they wouldn't have been able to lobby to get tobacco in the first place.

I guess I don't see where this discussion gets us, though I do agree it is an important point to raise. Probably even better to not (only) raise it to the FDA, as FDA is pretending they are powerless to amend the statute.
 

Danoman

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I'm sorry, but still not understanding for sure what you are saying. Are you referring to products that come out after the grace period, and then go to FDA before they can go to market... and then after years of not getting any word one way or another, they'll run the risk of having submitted application to the FDA on a product that is later obsolete?

If this is close to what you're asking, I don't see how it relates to most of what I was saying in post #475 about products that will be on the market during the grace period, and after it, or until FDA says otherwise.



I guess I don't see where this discussion gets us, though I do agree it is an important point to raise. Probably even better to not (only) raise it to the FDA, as FDA is pretending they are powerless to amend the statute.


Let's get over this... i'm saying the same thing to him too.

We have to work as a massive group, my friend... (whether I agree or not) in the issues you and them have, please, don't make it on a public forum such as this. Argue it out on your email between the both of you, I plead it...

We all agree we have some very serious issues facing us, correct...? Then let's tackle them... one at a time. (ALL issues besides needs to be in EMAIL ONLY) and NOT on the open Forum here. Can we ALL agree on this...?

CAN we all agree on this...? (a serious question because, I can google this easily and SEE your comments and arguments between us all. We don't want that... agree'd...? You never let the enemy know what's going on in the ranks... no matter HOW bad it is, if you do, you have already failed...

So, can we begin...? LET'S set OUR standard, realistically... agreed...?
 

Danoman

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Believe me... our friends at the CASAA will agree with what out demands are. Because they also believe in this as much as WE do. I trust them and i'm a member of them as well. SO... here we go.

What are your demands against the FDA...? What can the CASAA pull from your post that will make a difference, beyond opinion, the facts...? I'd question, how many people that you know of that have put analog cigarettes down and only vape now because of your influence, juices or in trust, we need facts and testimonies of those that have put them down. A signed petition possibly...? I've seen, those removed from the slavery are VERY quick to sign petitions like this. (Get them... as we'll need them)
 

ElectricalSocket

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Clearly there is one major issue we have to fight against, the FDA approval part. If they get that, we're screwed. It doesn't matter if the language in the proposal makes it sound like "all you gotta do is submit an application, we aren't banning anything so no worries!'

"The Tobacco Control Act gave the FDA authority over tobacco in 2009. In the time since, it has received approximately 4,000 applications for new tobacco products. With over four years in operation and currently more than 150 employees working on reviews, the FDA has managed to rule on only thirty-four of them, a slow pace it blames on deficiencies in the applications."

This WILL happen with ecig applications. I'd wager that the few applications that get through will be big tobaccos BS products. So, THAT is what we HAVE to fight. No FDA approval on products.
 

Danoman

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I'm sorry, but still not understanding for sure what you are saying. Are you referring to products that come out after the grace period, and then go to FDA before they can go to market... and then after years of not getting any word one way or another, they'll run the risk of having submitted application to the FDA on a product that is later obsolete?

If this is close to what you're asking, I don't see how it relates to most of what I was saying in post #475 about products that will be on the market during the grace period, and after it, or until FDA says otherwise.



I guess I don't see where this discussion gets us, though I do agree it is an important point to raise. Probably even better to not (only) raise it to the FDA, as FDA is pretending they are powerless to amend the statute.

I clearly see both points of view you both express... I really do. This NOW is a point that you both HAVE to work together, all differences between you both put on hold. By all means, express those in your emails between each other but... on open forum, it can't be allowed. AS this is as serious at it is... and our enemy, the FDA and their scouts will see our dilemmas and I promise, will use it against us at some point. (You know the drill...)

One thing, unexpected can change the entire thing... agree'd? Please...?
 

Danoman

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On a new direction... I guess i'll post first. (what matters to me personally)

1. limitations on the application 'rule' according to the regulations, in cost for that application.
2. Limitations on the 'cost' in dollars of $100 per flavor submitted for evaluation to the FDA... *and*
3. Those denied have a 6 month "grace" period that, at no charge in monetary funds to fix what the FDA deemed as 'sub standard' in any vaping juice, at any degree. (this allows free trade)
4. The e-juice being submitted will be tested and will have complete sellable value, unless it's in the state of being subjected into an arena that it's considered tainted by KNOWN impurities. (which will have to be stated on a every news source as their means)
5. All juices and vapable machines are considered safe, until proven by the FDA that they aren't, and the proof of that disclosure has to be shown to the public for investigation..
6. Individual parts of the designs aren't labeled as something related to tobacco... as the aren't anyway, in common sense.

Opinions...? these are the very basic rules I can think of... WE need to make the laws and regulations, not someone who has no clue and being paid by the Lobbyists.
 

Jman8

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I think we do have to take in consideration the FDA's history.

I agree.

I do think smoking regulation and eCig regulation will be different and base this on what is in current proposal. Examples from the proposal (I'm adding page number in parentheses):

- prohibition against characterizing flavors established in the Tobacco Control Act applies to cigarettes only (p. 10)
- We do not currently have sufficient data about these products to determine what effects e-cigarettes have on the public health. Accordingly, FDA is seeking comment in this proposed rule as to how such products should be regulated (p.10)
- FDA recognizes that there may be the potential for varying levels of harm and negative effects on public health for different categories of tobacco products. FDA is considering whether it might be appropriate for the protection of the public health to stagger the compliance dates for certain provisions for different categories of products. FDA seeks comment on this issue. (p.12)
- FDA is seeking comments, including supporting research, facts, and other evidence, as to whether all tobacco products should be required to carry an addiction warning and, if yes, whether different warnings should be placed on different categories of products. (p.12)

Just going to stop there cause I think the point has been made. Main reason I make this point is if taking into account history of FDA, I'd want to take into account the utter disdain that vast majority of Americans (including many vapers) have for BT/smoking, and how TCA and 'new product approval' might relate to that. Best way I can put this is I believe traditional cigs are always going to be in category of tobacco products that will be treated most harshly under the regulations and very few people will care to fight it.


I looked at all these links. Some I was familiar with. Thanks for posting them.

Based on what I said above, I find the 2nd one most relevant to discussion for this thread, even while I realize that if we are considering FDA track record and how it may hinder the 'little guy' then all of them seem pertinent. I just strongly believe 'new smoking products,' regardless of who makes them, are going to be treated differently/more harshly, and feel this proposal already signals that.

This doesn't mean "we are home free!" Nor does it mean that I don't think FDA will become rather insane and try to prohibit a bunch more down the road, after 'foundation' has been set. I'm all but counting on it. I thought they'd probably try to do it now. That they didn't, I do think, is reason to be a little hopeful for the long term of vaping. For the short term, I think it is reason to rejoice. They are not going after flavors right now. If they want to, they will. But that'll be years from now when that goes into effect, and that is for me, very huge issue. I will not relent on that issue if they move in that direction. I anticipate that they will at some point. That they didn't already is, for me, reason to rejoice in the short term. Given all comments I've made on ECF or other vaping forums, in past 2 years, I kinda sorta think I put the flavors issue higher than anyone else. I feel I've explained myself in detail here that I don't think, even a little bit, that we are home free from these proposals. But also think FDA does show up as rather clueless how to go about regulating eCigs. While searching for the quoted lines above, I was struck by one I know I read before, but it hit me differently in this moment. It reads:

all tobacco products containing nicotine are addictive, and FDA is not currently aware of any tobacco products that do not contain nicotine

And is found right above item I listed above, from p.12. I realize "components" are way around whatever wishful thinking I may have about how this is worded and what it means when talking about "regulating tobacco products." Yet, for me, it just shows up as clueless. I do not think the FDA is clueless, but they have managed to write a proposal that makes them look that way, and that does mean they must come up with another proposal, and thus certain items are years away.

I also just think the components tangent is, as several others have said, a legal nightmare. Yes, for manufacturers, but far more so for FDA. Cause manufacturers, in some cases, for some components, will circumvent TCA. Perhaps not forever, but I'd say for at least the next 5 years. And who knows what other 'components' may come about that even vapers today wouldn't recognize as 'component for vape gear.' Thus if hanging your hat on the 'component' tangent as backdoor way for banning, I think it will actually lead to innovation. I've seen plenty of threads on ECF that provide ways to circumvent gear prohibitions (and thus overcome component bans). Many of these threads I was seeing in 2012. I'm guessing they've been around since 2008.

While industry could play heck trying to keep up with FDA ever evolving rules on components and compliance standards, I very much see FDA (and ANTZ and anything that is opposed to eCigs) playing 10 times the amount of heck to try and keep up with innovative manufacturers who produce non-nicotine products. If federal government were winning the war on drugs, perhaps I'd feel differently. As they are utterly failing / have failed, I think they don't stand a chance if they try to go after every conceivable 'component' that is now available and for sure will become available down the road.

Not to mention how this all would play out economically and politically if FDA were to put eggs in basket of getting heavy handed on gear, when probably everyone that is aware of TCA would be wondering why not just focus on tobacco products that actually contain nicotine and stop hounding the rest? Especially as they will likely continue to show up losing, if they go in that direction with gusto.
 
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Danoman

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aikanae1 and Jman... WHY is it you are both still arguing between each other on AN OPEN FORUM...!!! You both are my friend but, ENOUGH...!!!
If you two wanna' argue, then take it to your email... this isn't doing ANY of us any good, it's hurting us all in fact. OR, just let it go... please.

We, as a group HAVE to make our demands so that the CASAA has something to work with. THIS is the core of getting us together in agreement. I'll ban you myself if I can to keep this on a level that supports us all... Seriously, Now is the time we need to do this, as we have the time to do it. If y'all wanna fight, take it elsewhere. Please.

They aren't playing... and we can't be either. This is NO game, this is important to us ALL... and i'm not going to tolerate arguments, about syntax of whatever on an open Forum, such as this. It's ALL viewable through Google. LISTEN...!!! They aren't playing, and neither am I... it matters. Let's get to business again... please. *focused*
 
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Jman8

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On a new direction... I guess i'll post first. (what matters to me personally)

1. limitations on the application 'rule' according to the regulations, in cost for that application.
2. Limitations on the 'cost' in dollars of $100 per flavor submitted for evaluation to the FDA... *and*
3. Those denied have a 6 month "grace" period that, at no charge in monetary funds to fix what the FDA deemed as 'sub standard' in any vaping juice, at any degree. (this allows free trade)
4. The e-juice being submitted will be tested and will have complete sellable value, unless it's in the state of being subjected into an arena that it's considered tainted by KNOWN impurities. (which will have to be stated on a every news source as their means)
5. All juices and vapable machines are considered safe, until proven by the FDA that they aren't, and the proof of that disclosure has to be shown to the public for investigation..
6. Individual parts of the designs aren't labeled as something related to tobacco... as the aren't anyway, in common sense.

Opinions...? these are the very basic rules I can think of... WE need to make the laws and regulations, not someone who has no clue and being paid by the Lobbyists.

My apologies. I didn't see your "let's get over this" post (#506) until after I had posted #514.

I read over your list, and not sure about 4, 5 and 6, but don't disagree with what you are getting at.

I see 1 thru 3 as biggest item I'd like to organize around and address, very strongly, in written response to the FDA.

My thoughts are that if some companies come before others in the 2 year grace period and are approved for their flavor product, that businesses after them, citing either identical ingredients or very very similar ones, ought not have to go thru the umpteen additional research items that would not technically make for 'new product analysis.' FDA can save likely 4000 of the 5000 hours (perhaps more) if they understand and go along with this.

"My thoughts" in above paragraph are not how I would respond to FDA, but just putting it out there as item for discussion. I'm more prone to say something along lines of costs / and hours for preparing applications absolutely must be lessened for certain products seeking market approval, especially for smaller businesses.

I very much agree that if FDA rejects application based on missing information that was otherwise 'complete' (to best knowledge of applicant) that applicant ought not to incur any additional costs for re-submitting or updating their application. IMO, that's on the FDA, not on the applicant. I'm not sure if that's what you were saying in point #3, but it's how I was filtering it, and how you have it phrased, I am fairly certain I agree with it as a talking point to emphasize.

I'd also say if item doesn't contain nicotine, then I see no reason for it to be removed from the market under slight technicalities that the FDA may find in an application. Gear ought to stay in market until such a time that FDA has proven, based on it's 5000 man hours of review (hopefully much less) that it is unsafe for public health. Gear that is a 'finished tobacco product' (or includes nicotine) would be subject to removal from the market, but not the non-nicotine products. Not until they are proven unsafe, defective or otherwise hazardous.

I don't know if I have other pressing issues at this time. I can think of other items brought up in proposal that I intend to speak to, but none that rise to the level of the above mentioned.
 

Myk

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I'm sorry, but still not understanding for sure what you are saying. Are you referring to products that come out after the grace period, and then go to FDA before they can go to market... and then after years of not getting any word one way or another, they'll run the risk of having submitted application to the FDA on a product that is later obsolete?

If this is close to what you're asking, I don't see how it relates to most of what I was saying in post #475 about products that will be on the market during the grace period, and after it, or until FDA says otherwise.



I guess I don't see where this discussion gets us, though I do agree it is an important point to raise. Probably even better to not (only) raise it to the FDA, as FDA is pretending they are powerless to amend the statute.

You're the one that brought up things being allowed to be sold until they were turned down. I thought you knew about it.
I make an ecig the day before regulations go into effect. I get to enjoy 2 years of selling it. By then it's obsolete and doesn't really matter what they say about it.

When the FDA got around to ruling on a recent Bidi and turning it down (they treated it like a huge victory, they finally ruled on something) the company was in a different business and those Bidis were no longer sold (well yeah, but the point is now they can't be sold, touted the FDA in triumph).

I plan on raising the go to Congress to amend issue with the FDA. I also plan on raising that they don't have to put equipment through the approval process and just like hand rolled cigars, custom made pipes and ecig equipment going through that process would destroy the business. If they're going to excuse rich people's cigars they've set the precedence to excuse pipes and mods.
 

Danoman

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My apologies. I didn't see your "let's get over this" post (#506) until after I had posted #514.

I read over your list, and not sure about 4, 5 and 6, but don't disagree with what you are getting at.

I see 1 thru 3 as biggest item I'd like to organize around and address, very strongly, in written response to the FDA.

My thoughts are that if some companies come before others in the 2 year grace period and are approved for their flavor product, that businesses after them, citing either identical ingredients or very very similar ones, ought not have to go thru the umpteen additional research items that would not technically make for 'new product analysis.' FDA can save likely 4000 of the 5000 hours (perhaps more) if they understand and go along with this.

"My thoughts" in above paragraph are not how I would respond to FDA, but just putting it out there as item for discussion. I'm more prone to say something along lines of costs / and hours for preparing applications absolutely must be lessened for certain products seeking market approval, especially for smaller businesses.

I very much agree that if FDA rejects application based on missing information that was otherwise 'complete' (to best knowledge of applicant) that applicant ought not to incur any additional costs for re-submitting or updating their application. IMO, that's on the FDA, not on the applicant. I'm not sure if that's what you were saying in point #3, but it's how I was filtering it, and how you have it phrased, I am fairly certain I agree with it as a talking point to emphasize.

I'd also say if item doesn't contain nicotine, then I see no reason for it to be removed from the market under slight technicalities that the FDA may find in an application. Gear ought to stay in market until such a time that FDA has proven, based on it's 5000 man hours of review (hopefully much less) that it is unsafe for public health. Gear that is a 'finished tobacco product' (or includes nicotine) would be subject to removal from the market, but not the non-nicotine products. Not until they are proven unsafe, defective or otherwise hazardous.

I don't know if I have other pressing issues at this time. I can think of other items brought up in proposal that I intend to speak to, but none that rise to the level of the above mentioned.


NOW, my friend... we are talking. :)
This is the entire point I've been trying to make... WE, even if we disagree on some points have TIME to get what we can all agree with and dispose those we don't. If we disagree, even violently, let's do this in emails and not on an open Forum like this. I'm on YOUR side bud... and I also KNOW, you're on mine. THIS is how we get our act together and come to something we can all agree on. Thank you... :)

THIS works... :)
 

Gato del Jugo

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Been thinking..


There's probably going to be a lot of fairly similar comments submitted to the FDA...

In which case, I'm considering "burning" my one shot & going a different & probably somewhat unique route, aiming to stand out a bit from the rest in a certain way, by putting some creative writing skills to work & reaching deep into a part of my mind that can be quite sick & disturbing... :D


Oftentimes it gets me in trouble, as evidenced throughout my life, whereby I conjure such bizarre thoughts, images & scenes, using just the right words & phrasings, worming into the reader's psyche & oftentimes evoking some pretty strong psychological reactions & haunting memories...

Although I prefer not to use this "gift" too often these days, I certainly have the experience, and have only honed my craft over the years..

I won't go into any particulars here for this FDA comment, as I'm already formulating some bits & pieces, and I'd prefer not to share here in fear of having my post yanked or getting banned (I like ECF too much :))...


But in my response, I'd paint an extremely dark & bleak world of what a post-FDA ruling would look like where only cigalikes are legally available to those who were once used to much, much more.. Think something along the lines of the Prohibition era -- but instead for nicotine... I already know that history fairly well, and some pretty gruesome things happened to the common man looking to get a little tipsy, with unfortunate results...


I understand it's a bit unorthodox, and probably not publicly recommended by some.. But it is my choice & my right, and I personally see nothing wrong with giving them a taste of their own medicine by using a little psychological warfare, myself..


Basically, I want my comment to give these guys nightmares.. :D

And in doing so, it could potentially help make them think twice...


Then again, their sick sociopathic minds might actually get a kick out of it..

Either way, I think it might be worth it to me...
:evil:
 

Danoman

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My apologies. I didn't see your "let's get over this" post (#506) until after I had posted #514.

I read over your list, and not sure about 4, 5 and 6, but don't disagree with what you are getting at.

I see 1 thru 3 as biggest item I'd like to organize around and address, very strongly, in written response to the FDA.

My thoughts are that if some companies come before others in the 2 year grace period and are approved for their flavor product, that businesses after them, citing either identical ingredients or very very similar ones, ought not have to go thru the umpteen additional research items that would not technically make for 'new product analysis.' FDA can save likely 4000 of the 5000 hours (perhaps more) if they understand and go along with this.

"My thoughts" in above paragraph are not how I would respond to FDA, but just putting it out there as item for discussion. I'm more prone to say something along lines of costs / and hours for preparing applications absolutely must be lessened for certain products seeking market approval, especially for smaller businesses.

I very much agree that if FDA rejects application based on missing information that was otherwise 'complete' (to best knowledge of applicant) that applicant ought not to incur any additional costs for re-submitting or updating their application. IMO, that's on the FDA, not on the applicant. I'm not sure if that's what you were saying in point #3, but it's how I was filtering it, and how you have it phrased, I am fairly certain I agree with it as a talking point to emphasize.

I'd also say if item doesn't contain nicotine, then I see no reason for it to be removed from the market under slight technicalities that the FDA may find in an application. Gear ought to stay in market until such a time that FDA has proven, based on it's 5000 man hours of review (hopefully much less) that it is unsafe for public health. Gear that is a 'finished tobacco product' (or includes nicotine) would be subject to removal from the market, but not the non-nicotine products. Not until they are proven unsafe, defective or otherwise hazardous.

I don't know if I have other pressing issues at this time. I can think of other items brought up in proposal that I intend to speak to, but none that rise to the level of the above mentioned.

Why #5...? It clears all our batteries in any form... and doesn't allow them to 'item' each part of our machines as a 'tobacco' "TYPE" product...
 
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