FDA Re. Potential Flavor Ban

[Jman8]

Because you continue to ignore or discount these words...
http://www.e-cigarette-forum.com/fo...ing-why-deeming-reg-would-ban-all-e-cigs.html

That's about 75 hours there. Keep going!

You change anything, and you need studies that show how those changes will affect public health...
And that includes what affect they will have on cessation rates or initiation and usage rates...

How many hours do you think THAT takes?

At super duper most, 500 hours.

But we are talking flavors. I'm glad to run through the precise details of the science, realizing that existing studies would play a role. Though if that seems like I'm trying to wiggle out, I say remove all of them, and 500 hours at the absolute most.

 

[supertrunker]

Zoid - yes that powerful chesspiece. Thanks!

But nobody has addressed why in the light of the comments he made about the apparently increasing disease-causing capabilities of cigarettes those have not been regulated off the market already, if the FDA is doing its job. And if it isn't ....

Here's a candy advert to prove that kids hate flavours - nobody like grandad pocket lint and it stunts language ability.

https://www.youtube.com/watch?v=9sUaD2r11oE


T

 

[zoiDman]

Zoid - yes that powerful chesspiece. Thanks!

But nobody has addressed why in the light of the comments he made about the apparently increasing disease-causing capabilities of cigarettes those have not been regulated off the market already, if the FDA is doing its job. And if it isn't ....

...

The FDA Can Only Exercise Power that is Given to them from Laws made by Congress.

And why On Earth would Anyone in Congress want to Stop People from Selling Cigarettes? I mean the Taxes alone should make them Untouchable. Right?

BTW - Remember when I said we Could do a Lot Worse than Mr. Zeller? Dr. McAfee is a Good Example.

 

[stevegmu]

If it is all about taxes, then vaping will go on, unfettered, with federal and state taxes attached...

 

[zoiDman]

Todays the Day Folks.

http://www.e-cigarette-forum.com/forum/fda-regulations/565571-casaa-fda-call-action-2-a.html

Being Silent is the Same as Say'n that you Want the FDA to Regulate e-Cigarettes and e-liquids however the choose.

Get Up and let People Know what You Want.

 

[aubergine]

If it is all about taxes, then vaping will go on, unfettered, with federal and state taxes attached...

That's how Other Substance rather suddenly became popular among politicians in some states, and the trend is spreading. I'd pay taxes if it were a Provari and my favorite juice being taxed. Wouldn't like it, but that's a trade to be considered, IMHO.

 

[DC2]

At super duper most, 500 hours.

But we are talking flavors. I'm glad to run through the precise details of the science, realizing that existing studies would play a role. Though if that seems like I'm trying to wiggle out, I say remove all of them, and 500 hours at the absolute most.

Have you ever run a study?
I have.

And this is not just one study that is needed, but multiple.
And they are long-term studies that are required.

It's a death sentence for small and medium sized vendors, at the very least.

And no, there are no existing studies I can think of that would play any role whatsoever.

 

[Jman8]

Have you ever run a study?
I have.

Then please explain the hours in detail. Feel free to do it in PM if you prefer. I am very very interested in those details.

And this is not just one study that is needed, but multiple.
And they are long-term studies that are required.

It's a death sentence for small and medium sized vendors, at the very least.

And no, there are no existing studies I can think of that would play any role whatsoever.

As this is related tangent, but different angle you are bringing up, then I'd ask you to cite those items in this thread if you feel they are relevant. Not link me to another thread, but cite them in this thread.

Though I guess I would caution you that we don't know for certain what deeming regulations will be, and what guidance for applications will look like exactly, but I'm okay for sake of this discussion that we go with stuff from say 2011-ish.

I would note that if there is existing study for item that allows BV/BT to satisfy application, that information is pertinent to studies that small to mid-sized businesses could use in their applications. If BT company submits application, pays the fees and small company submits nearly identical application, pays the fees and only one is approved, then that would be grounds for lawsuit that depending on how it goes, could be landmark case going forward.

 

[DC2]

Then please explain the hours in detail. Feel free to do it in PM if you prefer. I am very very interested in those details.

Study design. Recruitment. Administration of study. Analysis. Computer time.
And this is just for a simple study that is NOT long-term, as these studies will need to be.

And it doesn't take into account the massive legal fees required for someone to submit something PROPERLY to the FDA.
That's probably more money right there than the studies themselves.

As this is related tangent, but different angle you are bringing up, then I'd ask you to cite those items in this thread if you feel they are relevant. Not link me to another thread, but cite them in this thread.

It's not a different angle, it's all about post #208 in this thread, which again you continue to discount or ignore.

I would note that if there is existing study for item that allows BV/BT to satisfy application, that information is pertinent to studies that small to mid-sized businesses could use in their applications.

I reject that entire concept as being a fantasy, based again on post #208 in this thread.

 

[zoiDman]

Study design. ...

Isn't this the Entire concept in a Nutshell?

I have seen Hundreds of Posts about Flavored e-Liquid with regards to Studies. But I can't recall anyone giving any Specifics as to how a Study must be Performed. Or the Parameters that must be meet to be Considered Valid for submission to the FDA for Consideration?

I might be able to Perform a Study that has the Same Significance at 1/10th the Time and Cost of what the FDA Requires.

But that Doesn't matter. Because wont an FDA Study have to be done per the FDA's Design?

 

[Jman8]

Study design. Recruitment. Administration of study. Analysis. Computer time.
And this is just for a simple study that is NOT long-term, as these studies will need to be.

This is not citing hours. Why isn't it 10 billion hours then instead of a mere 5000? I'm seeking specifics, not broad headings of areas of a study that seek to silence one like me that is asking for specifics.

And it doesn't take into account the massive legal fees required for someone to submit something PROPERLY to the FDA.
That's probably more money right there than the studies themselves.

Bring money into it, and I'm going to ask for specifics there. I highly doubt legal fees are required from FDA's perspective. If you feel otherwise, do let me know and what you are basing this on.

it's all about post #208 in this thread, which again you continue to discount or ignore.

Post #221 of this thread dealt specifically with wording of #208, and you continue to rely on entirely broad and vague assertions to suggest I am discounting what needs to be done. I am in OPPOSITE direction of discounting and am specifically asking for detailed count of what needs to be done. The more specific the better.

I reject that entire concept as being a fantasy, based again on post #208 in this thread.

Then you've established that you really don't know, don't likely have a clue, and I'll have to find answer to my inquiry elsewhere. Thanks for letting me know this. It does help.

 

[DC2]

This is not citing hours. Why isn't it 10 billion hours then instead of a mere 5000? I'm seeking specifics, not broad headings of areas of a study that seek to silence one like me that is asking for specifics.

I can't give you specifics as every study is different, and I've only done one in my life
And though I have studied how to do studies in college, I'm no expert.

But I can tell you they are a lot more time-consuming than you seem to think, especially when dealing with FDA requirements.
If you choose not to accept that at face value, that is fine.

But I do hope someone comes along who can provide you the in-depth detail you are looking for.

Bring money into it, and I'm going to ask for specifics there. I highly doubt legal fees are required from FDA's perspective. If you feel otherwise, do let me know and what you are basing this on.

There are no legal fees from the FDA's perspective, although there might be application fees but I am still unclear about that.
But if you want to fill out the paperwork correctly, you better have some legal experts helping you out.

I don't have any links to any of that, it's just what I've heard from the many experts and the various vaping podcasts I've seen over the years.
Again, you are free to discount it.

Post #221 of this thread dealt specifically with wording of #208, and you continue to rely on entirely broad and vague assertions to suggest I am discounting what needs to be done. I am in OPPOSITE direction of discounting and am specifically asking for detailed count of what needs to be done. The more specific the better.

Okay, I see where you are going with this.

I listen to and trust the experts that I have listened to and trusted for years.
They have proven themselves and I have no reason to doubt them.

But if you want to figure this all out, starting from scratch and working from the bottom up, I bless you in that effort.
But this forum does not appear to be the place to get the expertise you will need for that effort.

Then you've established that you really don't know, don't likely have a clue, and I'll have to find answer to my inquiry elsewhere. Thanks for letting me know this. It does help.

I think post #208 is pretty damn clear.

 

[Jman8]

I can't give you specifics as every study is different, and I've only done one in my life
And though I have studied how to do studies in college, I'm no expert.

Yeah, me too, I studied studies in college as well, and have been involved with at least one (from administrative end).

But I can tell you they are a lot more time-consuming than you seem to think, especially when dealing with FDA requirements.
You clearly choose not to accept that, which is fine.

But I do hope someone comes along who can provide you the in-depth detail you are looking for.

Me too, because 5000 hours seems as ridiculously high to me as FDA assertion that there are around 1700 total products for all of vaping, seems ridiculously low.

There are no legal fees from the FDA's perspective, but if you want to fill out the paperwork correctly, you better have some legal experts helping you out.

I can see having legal experts on hand for review, but not for the entire process unless you are company that is of size where it would matter to bottom line/liability and other legal matters.

From the OP information that is linked in post #208, I honestly believe a team of pro-vapers that are a) intelligent, b) willing and c) motivated, that a lot could be done in terms of filling out that sort of application. Not all of it, and not to degree that a final application report might be put together by an attorney. But a whole bunch of it is administrative and would greatly benefit from how other applications that were successful appeared (which I'm certain an attorney would be aware of). I see an attorney being necessary for 30 hours of work and depending on the attorney, that being perfectly okay from attorney's perspective.

Again, you are free to discount it.

You keep implying that I'm discounting things. I truly believe I am not. You don't believe anything FDA has to say, but agree that 5000 hours is spot on and not to be questioned. This is basis for a whole lot of discussion on ECF and you aren't curious what it would actually/precisely take to fulfill that requirement?

It seems to be used only as a counter argument for us in way that we don't present with any of our other counter arguments to date. The recent CTA is prime example. We spotted a gross error in their numbers and called them on it.

The way in which I understand the 5000 hours is that is time FDA says it would need per application review/analysis. Yet, I will openly admit that this could be mistaken and yet, doesn't take away from what I'm truly getting at. I would really like to understand precise process it would take for submitter of application to put together a successful application and also understand precise process FDA is using to justify 5000 hours of work.

Let's say menthol is approved eLiquid flavor going forward. By the logic we are all seemingly currently operating under, if vendor were to add cinnamon flavor to that menthol, then this would be process that has to start from scratch and cannot use any information that went into the approved menthol product. Plus also saying FDA would need an additional 5000 man hours to determine all the various different characteristics now found in that new flavor.

And really really saying at this point that there's no reason to question any of this, cause FDA has given us estimates and that ought to suffice going forward.

Okay, I see where you are going with this.

I listen to and trust the experts that I have listened to and trusted for years.
They have proven themselves and I have no reason to doubt them.

And I would like to have that info if you have it.

Trusting 'experts' on this point, IMO, is no different (really) than trusting FDA as experts on regulating tobacco products.

But if you want to figure this all out, starting from scratch and working from the bottom up, I bless you in that effort.
But this forum does not appear to be the place to get the expertise you will need for that effort.

Then it would seem to be a moot point for us to bring it up on ECF, wouldn't it? Why make one of our fundamental points regarding the deeming regulations based on something that no one can cite data on or that asking questions about is treated as 'don't go there, experts have this all covered.' I don't see how anyone at ECF could possibly, remotely, assist mom and pop vendor if this is what we are sticking to.

 

[DC2]

I don't see how anyone at ECF could possibly, remotely, assist mom and pop vendor if this is what we are sticking to.

I don't either, and I think they will pretty much all be gone.
But we've already sort of bet on that question.

This is what I'm trying to do about all that...
http://www.e-cigarette-forum.com/fo...really-easy-people-do-something-positive.html

But I admit it isn't really attacking at the heart of the issue.
It just seems like a good idea.

I'll leave it to the experts to help us understand how to better attack the heart of the issue.


I like what you're trying to do, and I wish you luck.
But if you don't want to rely on the experts in these fields then you're going to have to get a serious education really quick.

I would point you to Azim Chowdhurry and Ralph Tyler to get you started...
Keller Heckman | Professionals | Azim Chowdhury
Venable LLP | Professionals | Ralph S. Tyler

 

[DC2]

The way in which I understand the 5000 hours is that is time FDA says it would need per application review/analysis. Yet, I will openly admit that this could be mistaken and yet, doesn't take away from what I'm truly getting at. I would really like to understand precise process it would take for submitter of application to put together a successful application and also understand precise process FDA is using to justify 5000 hours of work.

Since I just ran across this, I'll throw this in right about here...
http://www.e-cigarette-forum.com/fo...-economic-impact-analysis-9.html#post13276240

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.

It's kind of hard to not see that as being a whole lot of hours.

 

[Jman8]

I don't either, and I think they will pretty much all be gone.
But we've already sort of bet on that question.

This is what I'm trying to do about all that...
http://www.e-cigarette-forum.com/fo...really-easy-people-do-something-positive.html

I thank you for helping me to try and win that bet. I feel confident knowing that you are on my side.

I'll leave it to the experts to help us understand how to better attack the heart of the issue.


I like what you're trying to do, and I wish you luck.
But if you don't want to rely on the experts in these fields then you're going to have to get a serious education really quick.

One can rely on experts while also asking for information that ought to be accessible to everyone involved. This is what CTA #2 was about. We didn't rely on experts to say "there are x amount of products and you need to trust on this information in your comments." Instead, it was information available to all.

Even with that, I keep coming back to "millions of products" while some experts keep saying 100K products. Now, I am not making up my number and do feel it is accurate. To the degree the number I am citing is incorrect, I feel helps our cause. It would mean that while there are 14 million combinations of flavors that a vendor (or my vendor) can make, that FDA really may only view that as say 300 (base) flavors. Thus, if base flavors are good to go, then so are all the combinations. But what I hear experts claiming is that all the combinations create additional (new) products. And if that is the case, then the experts who cite 100K products or less, are pretty much as far off on the number as FDA was. Our experts may say it is about 58 times more products than FDA is claiming exists (at end of 2013). And number I cited is saying it is 140 times more products than what our experts are claiming.

As I personally use/vape a number that is under 200 products, my personal (self serving) interest doesn't particularly care who's right. But on the political points that seek accuracy, I'm going to say the numbers and degree of difference matter significantly.

 

[DC2]

Even with that, I keep coming back to "millions of products" while some experts keep saying 100K products. Now, I am not making up my number and do feel it is accurate. To the degree the number I am citing is incorrect, I feel helps our cause. It would mean that while there are 14 million combinations of flavors that a vendor (or my vendor) can make, that FDA really may only view that as say 300 (base) flavors. Thus, if base flavors are good to go, then so are all the combinations. But what I hear experts claiming is that all the combinations create additional (new) products. And if that is the case, then the experts who cite 100K products or less, are pretty much as far off on the number as FDA was. Our experts may say it is about 58 times more products than FDA is claiming exists (at end of 2013). And number I cited is saying it is 140 times more products than what our experts are claiming.

I will cede to you the point that the experts are way too low in their estimation of products.
But that is all I will cede to you at this point.


However, the experts I am talking about are experts in regulation, FDA, and political matters.
Not necessarily experts in vaping.

 

[Jman8]

Since I just ran across this, I'll throw this in right about here...
http://www.e-cigarette-forum.com/fo...-economic-impact-analysis-9.html#post13276240



It's kind of hard to not see that as being a whole lot of hours.

I agree it's a whole lot of hours.

I find 5000 to be very high. And deserving scrutiny as it is tax dollars we are talking about (if done by FDA) or consumer dollars if we are talking about manufactures/vendors.

I may have found someone that can help, so am prepared to drop this tangent in this thread and will gladly report back any information for anyone that may share the concern I have.

(Like this post if you want me to share that, otherwise, I'll take that information to my grave and it'll remain the secret that only experts and Jman could possibly ever know about.)

 

[DC2]

I may have found someone that can help, so am prepared to drop this tangent in this thread and will gladly report back any information for anyone that may share the concern I have.

Can you clarify the concern you have so that I can figure out whether or not to like your post?


And if you can do it succinctly, I will give you bonus points.
There are some people whose posts have become so long and painful to read that I can't deal with them anymore.

 

[DC2]

Here is another interesting tidbit I just ran across...
Philip Morris International Bets Big On The Future Of Smoking - Forbes

And PMI is heading down a well-worn path with its new heat-driven devices. Reynolds American introduced Premier, a heated-tobacco device, in 1988 but withdrew it months later after the American Medical Association and other groups urged the FDA to ban it or at least regulate it as a drug. Reynolds, which makes Winston and Camel cigarettes, tried again with Eclipse, another heated-tobacco device. Its reward was being sued by the attorney general of Vermont for violating consumer protection laws by describing the new device as safer than smoking. A judge ordered Reynolds to pay $8.3 million in 2013 after determining the company’s extensive scientific research was inadequate because it didn’t include long-term human studies.

The extensive scientific research was inadequate becomes it did not include long-term human studies.