FDA FDA deeming regulation proposals

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thanswr

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Your also forgetting the few hundreds of millions of smokers who have not had the same opportunity that we have had. They are being prevented from knowing that they don't have to die from tobacco smoke even if they are unable to quit.

I think it's called compassion.

It's time to get serious. If the argument is going to be made that vaping is a valid method to stop smoking, present the evidence to the FDA within the next 75 days.

A good start: http://www.ajpm-online.net/webfiles/images/journals/amepre/AMEPRE3013.pdf

http://www.plosone.org/article/info:doi/10.1371/journal.pone.0066317

http://infinitevapor.com/health-studies/

http://www.ecigalternative.com/ecigarette-studies-research.htm
 
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Katya

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Hmmm...

Funny, that's exactly what Mitch Zeller told me to do in his email. ;)

"We're seeking comments on the proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products, and the potential benefits and risks associated with e-cigarettes.

The opportunity to comment on FDA's proposed rule is now open and comments are due on July 9, 2014. We encourage you to do so, and to provide any data and information you may have to support your comments.
Related links:
• See the proposed rule
• Submit a comment on the proposed rule"

Do you know Mitch?
 

DC2

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It's time to get serious. If the argument is going to be made that vaping is a valid method to stop smoking, present the evidence to the FDA within the next 75 days.
Any manufacturer presenting that argument will be regulated as a drug delivery device under pharmaceutical regulations.
In such a case, the currently proposed deeming regulations will not even apply to them.

Such a path will take far longer and cost far more money.
As far as I know there is only one electronic cigarette manufacturer that is attempting to take that route.

So far it has taken them a few years, and millions of dollars, with no guarantee of approval...
British American Tobacco Acquires Intellicig
 

thanswr

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I didn't know Dr. Farsalinos's report had been published.

There's a wealth of information in there:

IJERPH | Free Full-Text | Characteristics, Perceived Side Effects and Benefits of Electronic Cigarette Use: A Worldwide Survey of More than 19,000 Consumers

The FDA is like every other government agency made up of bureaucrats. They love this stuff. They live for it. Why not give it to them? They want comments so why not make comments filled with data proving one's point?

No, I don't know Mitch. :)

But, as I wrote earlier, I've been dealing with government regulatory agencies and government specifications for about 35 years. The facts and figures are on the side of vaping and vapers. The attempt may be futile, but make it a good attempt.
 

Katya

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I didn't know Dr. Farsalinos's report had been published.

There's a wealth of information in there:

IJERPH | Free Full-Text | Characteristics, Perceived Side Effects and Benefits of Electronic Cigarette Use: A Worldwide Survey of More than 19,000 Consumers

The FDA is like every other government agency made up of bureaucrats. They love this stuff. They live for it. Why not give it to them? They want comments so why not make comments filled with data proving one's point?

No, I don't know Mitch. :)

But, as I wrote earlier, I've been dealing with government regulatory agencies and government specifications for about 35 years. The facts and figures are on the side of vaping and vapers. The attempt may be futile, but make it a good attempt.

It's been given to them. They have it in their files. This and a dozen similar studies.

They refuse to acknowledge it.

They are talking about antifreeze and that vaping looks like smoking.

And the chiiiiiiiiiiiildren.
 

aikanae1

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I'm sure someone will do a clinical III trial that usually takes 4 - 6 years into a span of 75 days and I assume your funding it as well since there's no time to apply for alternative funding.

They haven't accepted any studies so far including reviews such as from Medscape or Cochran.

It's not possible to talk logic to crazy and the FDA is crazy. That's why they are doing crazy.
 
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thanswr

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I'm sure someone will do a clinical III trial that usually takes 4 - 6 years into a span of 75 days and I assume your funding it as well since there's no time to apply for alternative funding.

So what's your solution?

The facts, figures, and studies are there and they're free. The FDA has given people 75 days to comment. One can choose to make an argument to the FDA or not.

That's the bottom line.

Btw, I had thought the purpose of this thread was to share information so one could share opinions and present facts to make a coherent argument to the FDA.

On the other hand, one can decide the sky really has fallen and there's no purpose to any this. Which leads us full circle to
 

aikanae1

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We need the details and opinions that CASSA will give us. These documents are up in the air as to what they really mean based on past performance. Words alone can not be trusted.

I think the first course of action will be to attempt to fight the regulations from becoming official since it's easier to change them before they happen than it is later. That's not in your "bottom line".
 

Katya

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Yes! Join CASAA. Contribute financially if you can. And wait for their Call to Action to be issued on Monday. Their lawyers are working hard.

The comment site is up, but please, as Myrany suggests, sit back, have a vape, do your research, and take your time formulating your comment. (Remember, each individual/entity/group can comment only once.)

Start here: CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

then: http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf
 

DC2

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After reading more information and listening to the FDA teleconference posted earlier in this thread...

It appears that Substantial Equivalence is not going to come into play.
The FDA appears to recognize that there really are no products from 2007 to be used for equivalency.

They seem to be saying that electronic cigarettes will need to take the PMTA route instead...
Applications for Premarket Review of New Tobacco Products
 
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Kent C

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Jman: Please quote where I have said everything is good. Or what you are getting at.

That 'please quote' works only when someone said you quoted something. I didn't :) I "suggest"(ed) (that's my quote) a generalization of what you had said in other posts, not that you quoted that exact phrase. But these quotes might be a good representation of my (admitted) generalization of what you have said.

"For years leading up to yesterday, it was doomsday predictions galore, and people visibly expressing expectations of the worst. Now we have a document that we can all quote from, and it is nowhere near those doomsday predictions...."

"I feel this is good news both in wording of the proposal and in how I honestly see it playing out.."

"but my wager is, at least a little bit, rhetorical as I'm willing to go on record and say that despite FDA proposed regulations, which we now are fairly well aware of, the eCig industry will double or triple its gross revenue from 2014 in next 3 to 5 years. I'm at least 60% confident on that. I'm around 90% confident it'll be about the same or better. And 99.9% confident that the eCig industry will not be decimated." (my emphasis)


Against what = against proposals that seek to regulate eCigs/vaping industry under the tobacco act. FDA doesn't know how to regulate these new innovative products and are seeking comments on this, with a whole bunch of items that one can comment on.

Now "fighting back" was a quote by you, and to me after what is said above, it renders the 'fighting back' part a bit moot. And you had made some disparaging remarks about those fighting back, usually by pointing out they were fear mongers, but I expect that from some, just not you. I was wrong.

I don't think that the "FDA doesn't know how to regulate..." ecigs. But that's just a difference in opinion. I base that on history mainly and what I've read. But who knows maybe ecigs have them stumped.


Vaping community is in prime position to shape things to come. And politically aware vapers know that we have opposition that will be seeking to do the same thing. Thus commenting, in large numbers, that are to some degree organized, is best thing we can do right now, and for next 75 days.

So you see the ANTZ on one side and us on the other and the FDA as an objective referee?

In the part of the 'deeming' doc under "Health Risks of Products" and under #5 Ecigarettes, the FDA, to their credit, does point out it was only one carto in their 2009 study and seem to 'give' on some other substances - formaldehyde, etc. but the summary paragraph reads a bit different, imo:

"Even if such findings are applicable to many products, e-cigarette manufacturers may vary in the quality of production, as discussed in section V.B.5. with respect to contamination with DEG, and as discussed further with respect to significant variability in nicotine content, and such variation may be dangerous. As such, given the existence of toxic chemicals in at least some e-cigarettes and the fact that most contain nicotine, FDA believes that its oversight of these products (which would occur if this deeming ruling becomes final) is appropriate for the protection of the public health. (my emphasis)

And subsequent paragraphs seem to have this same 'format' - give some points that have been shown in studies but then reinforce with a they are in charge here summation.

In other places they are quoting or summarizing Glantz/ANTZ' proclamations, by putting it in the form of 'seeking research regarding' - this is a like the 'have you stopped beating your wife' question in that it inherently suggests the worst." They 'explain' what some studies have shown but then:

"FDA is also seeking research regarding the long-term effects of flavored tobacco product usage including data as to the likelihood of whether users of flavored tobacco products initiate cigarette usage and/or become dual users with cigarettes." (my emphasis)

That isn't particularly damning in and of itself, but the repeated format imo, is.
 

Jman8

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Jman I saw somewhere where you were asking about the applications fees, but I can't find where that was so I'll just put it here.

This comes from a vendor who called the FDA to inquire on the process of getting his own e-liquids registered, and a trusted source. The way he explained it is;

A 2500.00 application fee for small businesses, 1500.00 per ingredient listed, and I'm not sure if this means just each flavoring plus PG, VG and nic or if each of the flavorings have to be broken down, waiting on confirmation for that. The hourly cost of a lawyer to file said application X 360 hours to prepare it per the FDA. I believe the average hourly for a standard lawyer is $284.00 per, but you would need one that's versed in FDA applications and I have no idea what they would charge. I believe the employee this vendor talked to also forgot to mention the testing that e-liquids will need to go through, and I won't even pretend to know what that would to cost. Someone else here might know.

So, for one single flavor liquid we have $2500 + $1500 X 4 (pg, vg, nic & flavor) if all the flavoring ingredients aren't required + $284 lawyer base cost X 360 hours = $110,740.00 plus the cost of chemical testing for 1 juice out of a line. And if any information is left off, the application is denied plus the fees are forfeited. Answer your question?

That does answer the question. Thank you.

I agree that this data represents extremely expensive and entirely unworkable situation for a small/new business.

I would hope we are all in agreement about using this as a talking point. With general idea about specifics as in, "I understand the cost for applications to be tens if not hundreds of thousands of dollars which is cost prohibitive and needs to change for regulation to be fair and still in line with goal of public health."

That's just off the top of my head. But I feel strongly that if enough consumers are saying this, with likelihood that some vendors are for sure going to be addressing this, they'll plausibly address this and look to streamline and/or lower application costs.

When I looked over the application to submit, it honestly didn't look all that challenging. Thus, I'm saying lawyer fees seem steep and yet I realize businesses are likely to go this route, unless FDA changes things. And by that I mean shows that they aren't there just to refuse and scrutinize teeniest of the tiniest details and use that as a bases for rejection. I also realize I'm talking openly to some readers who believe, without any doubt, that FDA will reject most, if not all, applications. I disagree with this, and yet, doesn't really matter today to have that debate as no one is likely to budge from their position that they believe is 'proper perspective' going forward.
 

Kent C

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I'll tell you what, I'll make you a bet.

I'll bet you $1000 that when these regulations are eventually put in place, we'll be left with nothing but cig-a-likes.
Most of which, if not all, will be made by Big Tobacco.

All you have to do is figure out who is going to hold the money.

And if I lose this bet, I'll be the happier than a pig in...

I don't get around much so I don't know your reference to the one poster in your post to me above.... However.......

I did see this:

http://www.e-cigarette-forum.com/fo...ming-regulation-proposals-7.html#post12951151
(#63, if you're not on default)

... so your bet is to the right guy * as he mentions - perhaps you might look at the original wager....
 

Jman8

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I'll tell you what, I'll make you a bet.

I'll bet you $1000 that when these regulations are eventually put in place, we'll be left with nothing but cig-a-likes.
Most of which, if not all, will be made by Big Tobacco.

All you have to do is figure out who is going to hold the money.

And if I lose this bet, I'll be the happier than a pig in...

My first response is, keep your money. I say this because I consider you an online friend. I know we'll discuss this in many ways, including PM. If you (or anyone) is serious about such a bet, then PM me as I'd like to hash out details so we are in agreement about what the actual bet is and what winning and losing actually looks like. Way you have this written, I think would be easy for my position to win.

For purposes of discussion on this thread, I see no way for FDA, given current proposal, to initiate market conditions whereby the overwhelming majority of devices that can be legally sold/marketed (in the U.S.) are cigalikes. I do see it as theoretically possible that application approvals could be rejected leading to the often mentioned defacto ban, but I see that as highly unlikely. I'm at least a little familiar with popular devices, not produced by BT, and I'm at least 90% confident that they'll be in production (or their producers will be in business) 3 years from now. I think the only thing that would reasonably make me conclude otherwise is if say Marlboro bought out Provari.
 

Jman8

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Now "fighting back" was a quote by you, and to me after what is said above, it renders the 'fighting back' part a bit moot. And you had made some disparaging remarks about those fighting back, usually by pointing out they were fear mongers, but I expect that from some, just not you. I was wrong.

And I would've expected you to call that out as well, but I was mistaken.

I don't think that the "FDA doesn't know how to regulate..." ecigs. But that's just a difference in opinion. I base that on history mainly and what I've read. But who knows maybe ecigs have them stumped.

I think they'll quickly learn ways that it could be regulated, but as long as 'everyone' is in agreement that it needs to be banned from kids, then I think they'll fail. Kids gonna vape, and thus whole, underlying purpose, for such regulations will show up, indefinitely, like they don't really know how to regulate eCigs.

I think FDA has some inklings for how regulations could work, hence the proposal. But, if they were to have gone with doomsday predictions, it would've been interpreted by vast majority of vapers as heavy handed and as outright ban. I truly believe some 'leading experts' (of vaping community) were espousing that the proposal would be in that vein. Instead, it contains lots of language with them seeking input, comments, suggestions for how to go about implementing regulations on many of the points. I see the proposal as them wanting to regulate many facets, but not sure, right now how to implement that and make it work.

Vaping community is in prime position to shape things to come. And politically aware vapers know that we have opposition that will be seeking to do the same thing. Thus commenting, in large numbers, that are to some degree organized, is best thing we can do right now, and for next 75 days.

So you see the ANTZ on one side and us on the other and the FDA as an objective referee?

I'm not seeing evidence of any objective players in this game. But FDA has set themselves up as a referee and has thus far not shown allegiance, in their proposed regulations, to ANTZ. I think they lean that way because they are charged with authority of regulation thru Tobacco Act. But, they aren't caught up, like ANTZ is, in hysteria of anti-eCigs. At least, I don't see that as entirely laden in the proposal. From our, less than objective perspective, anything that isn't saying "eCigs are awesome" will be spun by (some of) us as "FDA is anti-vaping." I'm not sure of any way around that with the existence of Tobacco Act and expressed desire for regulating eCigs.

In the part of the 'deeming' doc under "Health Risks of Products" and under #5 Ecigarettes, the FDA, to their credit, does point out it was only one carto in their 2009 study and seem to 'give' on some other substances - formaldehyde, etc. but the summary paragraph reads a bit different, imo:

"Even if such findings are applicable to many products, e-cigarette manufacturers may vary in the quality of production, as discussed in section V.B.5. with respect to contamination with DEG, and as discussed further with respect to significant variability in nicotine content, and such variation may be dangerous. As such, given the existence of toxic chemicals in at least some e-cigarettes and the fact that most contain nicotine, FDA believes that its oversight of these products (which would occur if this deeming ruling becomes final) is appropriate for the protection of the public health. (my emphasis)

And subsequent paragraphs seem to have this same 'format' - give some points that have been shown in studies but then reinforce with a they are in charge here summation.

In other places they are quoting or summarizing Glantz/ANTZ' proclamations, by putting it in the form of 'seeking research regarding' - this is a like the 'have you stopped beating your wife' question in that it inherently suggests the worst." They 'explain' what some studies have shown but then:

"FDA is also seeking research regarding the long-term effects of flavored tobacco product usage including data as to the likelihood of whether users of flavored tobacco products initiate cigarette usage and/or become dual users with cigarettes." (my emphasis)

That isn't particularly damning in and of itself, but the repeated format imo, is.[/COLOR]

I respect your opinion. I see the repetition as satisfying (or attempting to satisfy) legal types going forward and/or covering the bases on their intent and their desire for what comments, of (high) value, will entail.

I think we, of the vaping community (consumers) can speak to this. Obviously it depends on what is criteria for 'long-term' effects, but I think we have enough non-smoking current vapers in our fold that can speak to this particular talking point, and it be effective, to some degree. Cause, I don't think science, today, will be able to reasonably address that point. And so rest of us, can speak to that, in similar ways to which we've addressed similar points, i.e. that lack of scientific knowledge on a point isn't grounds for eradicating the product.

Regarding 'toxic chemicals in at least some eCigarettes' we can, collectively speak to that (citing research), and I think we can, rather easily, win.
 

DC2

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My first response is, keep your money. I say this because I consider you an online friend. I know we'll discuss this in many ways, including PM. If you (or anyone) is serious about such a bet, then PM me as I'd like to hash out details so we are in agreement about what the actual bet is and what winning and losing actually looks like. Way you have this written, I think would be easy for my position to win.
My feeling is that free-roaming nicotine liquids will not be allowed.

They will never pass on either substantial equivalence or via the PMTA process.
And if they do get approved, they will be severely limited in nicotine strength and most likely without flavors.

I believe that such restrictions would leave the general public with only tamper-proof prefilled cartridges.
And that such a result will eventually lead to the elimination of just about everybody in the industry except Big Tobacco.

If free-roaming nicotine liquids are allowed with flavors and reasonable strengths, then that will be enough for me to concede the bet.
And it will also be enough to allow the electronic cigarette market to continue to thrive indefinitely.

Well, other than the taxes that would soon follow.

If I win the bet I would just give the money to CASAA anyway, provided they still exist.
And if I lose the bet it would be well worth it.
:)

PM me your thoughts if interested.
 
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