FDA Discussion of SFATA conference & FDA proposal on VP Live radio

[Kent C]

.....

It's "Kent" not "Kurt". Not that I care, but Kurt might

No sorry needed. You're not the first.

 

[aubergine]

Oh never mind.

 

[Sirius]

I believe this aired on Tuesday (click the orange & white Play button)..

https://soundcloud.com/#vp-live/cen...-dimitris-cisco-and-kevin-on-fighting-the-fda


Sounds like there will be more on it when the replay of Wednesday's show comes out...

https://soundcloud.com/#vp-live



I've been really digging these shows..

Thanks, guys.. Keep 'em coming!

Thank you Gato for this thread. I am listening now to the audio while reading comments from our contributors. I will reserve my comments for now,(until I have listened to the whole of the audio) Good debate so far guys!

 

[Sirius]

Yes well I'm with Demmi and a few others here that e-cigs should be in their own classification. The tobacco product classification the the FDA has put e-cigs into is their only way to regulate e-cigs. Flavors shouldn't even be an issue IMO. What's in those flavors, well yes I agree those compounds should be listed by e-liquid manufacturers.
Even though as a 40 year cig smoker, I always thought I was smoking just tobacco. Then I noticed how much quicker those things burned up and started listening to some of the ANTZ reports on cigarettes.
Even after finding out there was much more than just tobacco in cigs that didn't discourage me from smoking them.
I would just advise us all to tow the line and help in any way we can folks. Act on the calls to action that CASAA send us in our emails and fight this.
We sure could use more people like Demmi for sure. He's doing a wonderful job! Oh, and a genius 12 YO to find a way to derive nicotine from other sources in an economical way. LOL

 

[Sirius]

Yes they are:

http://www.e-cigarette-forum.com/fo...l-diacetyl-acetoine-help-24.html#post13142619

http://www.e-cigarette-forum.com/forum/diy-e-liquid/554391-my-tfas-choice-list.html#post12902844

And more will follow if we demand that they do. The industry has been successfully self-regulating so far and I'm sure the trend will continue.

Thnx Katya -- It's all very confusing to me since vendors don't disclose if they were in the testing and that their juices are Diacetyl and AP free, I guess we just have to trust that they are. I only buy from three vendors and you better believe I will be emailing them to encourage them to self regulate in order to be prepared for FDA regulations. I suggest we all do that. For DIY I only buy Inawera. I saw they are in the thread you posted.
I liked that guys statement,"Don't let regulations kill the golden goose!"

 

[Sirius]

Why do you continue to misrepresent the fact that CASAA is NOT ignoring the local/state level laws? (Note the yellow banner at the top of the forum with CASAA CTAs.)

We still ask members to alert us to proposed ordinances and laws, collect information on them and then issue Calls to Action to people who live in those areas. We also coordinate with local groups in helping them fight the laws and are setting up the CQ Roll Call system for federal AND state level advocacy efforts. However, there is only so much we can do on our end. Multiple laws are being proposed on the city, county and state level EVERY DAY - equalling dozens of new proposed lawes every week - which are nearly impossible to keep up with. It's up to the vapers who live in those places to take action and fight in their city/state. The CASAA directors cannot do that for them.

What more do you expect the 8 of us to do?

Bingo! I just wished there was a way we could all pull together on this Kristin.

 

[zoiDman]

Responded to correct a wrong view of Kristin, and answer her question. CASAA is an advocate for Smokeless Tobacco, like Chewing Tobacco, and have dual loyalties to those concerns in the Deeming, as well as being a supporter of E-Cigs.

The feedback should have been clear, I am sorry that you can not understand it. But there are lots of people that post icons of themselves covering their eyes. So should I even expect you to see anything covering your face from seeing......probably not. Try to keep up though

My Dad used to have a Saying that "If Someone is Willing to Wash your Car for Free, Don't Whine about them Not Doing a Good Enough Job."

It seems that the Majority of the People on the ECF would rather go On and On and On Posting about how Terrible things are. And to Debate the Finer Points of All Things e-Cigarettes to Infiniti while Doing Nothing. Akin to Having a Debate about the Fire Department while the House Burns Down about their Heads.

I don't see how Advocating that CASAA should Stop working on Our Behalf, or that People should Stop Supporting CASAA is Going to make Anything Any Better?

If CASAA did not Exist, I truly believe, that All Most people would do is Sit Around and Take about Things. And just Talking About things Doesn't Get Anything Done. Action Does.

CASAA is out there Doing what they Can with the Tools they have. And should be Applauded for their Actions. Which is More than I can Say for Many People.

 

[Jman8]

Again, I understand the realities and we/CASAA should do what we can. Moving the grandfather date forward would solve a lot of problems- for now anyway. I wouldn't be in favor of compromising any principles which deal with a person's right to vape and they type of equipment and ejuice that they choose to use. I wouldn't be in favor of a tax. Rather, I'd support any subsequent suit against the FDA if they go forward with any regulation.

Again, we agree.

And you seem to be saying, "if vendor is bad (making bad product) sue them, and this will lead to overall better market, based on free market principles."

Yes. Sue them or shun/boycott them as you suggest.

And this is a form of regulation. It's not 'official bureaucratic regulation' but it is consumer using means to control/influence. If it is one person realizing it for themselves as personal course of action, I would not emphasize that as regulation. But teaching people to do this, organizing a boycott, would be a way to regulate the market. Not for the long haul, but that boycott could have long term implications.

 

[Sirius]

The vendors that are in it for the short term will no doubt bank and get out in order to save themselves the money and trouble of upgrading to what Demmi was talking about. That's all fine with me, but who will we be left with? I sure hope some of the top shelf vendors will take their business serious enough to at least keep records, lot numbers, samples and label properly in order to have something to at least show the FDA that they are trying to self regulate.
But without us complaining to them will they do it on their own? Who knows at this point. I just had never looked at it this way before. I think it would be a great idea to submit suggestions to vendors on preparing for the regulations that are coming. And coming they surly are.

 

[Jman8]

Read the approved rules the FDA site Tobacco Check approved Rules Final Draft, read the comments and responses.

Again, please cite the examples. A link to a page titled "Tobacco Products" is not sufficient as an example.

The personal stories have nothing to do with the regulations, and will not be able to be addressed by the FDA. Its the law given by Congress, they are implementing it.

Perhaps you misread what I said, "Personal stories in submitted comments that I've read so far do speak to what FDA is asking for in the proposal."

Yes, and that's factual, its not a personal story. A finished Tobacco Product contains Nicotine, it must. A component intended for inclusion of a FINISHED Tobacco Product is also included. The example they Give is Prefilled cart, as a component.

A personal story comment can include factual information, plus sound reasoning that demonstrates to FDA that the story being told deals squarely with what FDA is seeking comments on. If it is only, "don't regulate cause eCigs save my life," then I agree with what you are saying. But as I've read enough comments by now, I'm telling you that personal story submissions are including facts, and that the personal stories add credence to what is being said. I get that you believe the personal story information has zero influence on the deeming regulations, but like most written pieces, sometimes personal story telling influences the way in which the facts are being conveyed.

Wrong.
And everytime you mention my name and try to characterize or paraphrase my position, you get it wrong. When you do the same for CASAA, I don't think you are being fair to them also. Perhaps, you can just speak for yourself?

What I have said, is current law can not apply flavoring regulations to E-Cigs, because the FDA states it applies only to Analog Cigs. I just won't join you in proclaiming the moot points apply to what you want them to apply to on your every whim.

Still stand by my point. You are saying current proposed regulations do not apply to eCig flavorings. And I agree. But after the FDA has deemed full authority over eCigs, they stand a very good chance to go after all flavors, at some point. You appear to be on record saying they never will. That is how I am characterizing your update position. Feel free to update things so as to either reassert the validity of what I said before or to agree with what I am saying now is your apparent take on the matter.

none of them have manufacturing experience, work with ISO standards, or have FDA regulatory expertise beyond whatever is being done inside of CASAA.

You honed in on "our experts" to downplay what the actual point was about, understanding in great detail what the 241 page regulations are putting forth. While portions are aimed at manufacturers, other areas are not, and I cited this previously.

umm NO! I speak for MYSELF, ONLY.

I can prove otherwise.

Jman8, for the above, and other times where you represent me as saying things I have not, or say what I am trying to say, its simplest to update my settings
where I select which messages of yours are able to be viewed.
I won't be reading much going forward,

That's okay, I'm sure your ignorance will be deemed blissful.

so please I ask that you stop portraying you in any way speak for me, or interpret what I am conveying.....let me do that.

Going to continue to interpret what you are conveying as that is the nature of discussion. And I'll continue to let you do that as well.

 

[Sirius]

Sound, effective, appropriate reasoning or fallacious reasoning no matter Jman. Where these FDA regulations are concerned anyway. I think the main thing we should be concerned with now is whether vendors will be prepared for them. They are headed our way and probably in less than two years time. I think the vendors that intend on staying in business could well use that time to upgrade a bit.

 

[kristin]

Kristin, you are commenting on "Meanwhile the local bans are really starting to hurt, can you imagine 6 more years of that. CASAA is going to near zero effect on the regulations for manufacturers, personal stories are wonderful and all, but those are for politicians, not the regulators who are just working what Congress told them to do."

1. Personal stories by CASAA members to the FDA won't have any impact. Nobody in the FDA is elected (a couple at the top get rubber stamp Congressional Confirmations, still not elected) When I say they won't have any impact on the regulations, I say that after reading other deeming rules, that became finalized, and years after CASAA came into existence. Manufacturers are mostly where the FDA regulations come in, unless you want to change the law, then its Politicians. This is why I say that CASAA is wasting all the time it spends on the the FDA. The FDA is not on the Consumer side.

If CASAA wants to change the FDA, its only resource is the Congress. Manufacturers, SFATA, and other Trade Groups are in the right spot to address the FDA. So with all the focus that CASAA gives to the FDA, all of the wait before you comment to the FDA, all that attention and focus on the FDA......its nearly all a complete waste of time.

With that waste of time, you could be spending it on Local and State Bans. Which seemingly are getting nothing much more than google searches for localities which local newspapers have published agendas. This is why CASAA puts out next day notices of hearings. When I was looking for local issues and found Hayward, which was not on the CASAA radar. I was asked what automated search I used in Google to pick it up. I was not searching News feeds.

I know that CASAA is made up of Volunteers, and the theory is if the post a Call to Action, the local people will go forward and handle it all. I have read over and over that the CASAA results are only as good as the Voluntary efforts of 8 people. CASAA says it.

What do I expect? Well right now I expect that if CASAA is in the outfield saying the got it they got it, the ball is going to hit the ground first. They do what they can when they can, and when it comes to focus, it the FDA first.

What could CASAA do, if you are asking.
1. Don't waste anytime at all on the FDA, that's right NONE. Figure out who you think is best able to handle the FDA, and point people in that direction. Say we are handling the consumer side, and NNNNN is handling the FDA.

While some say it should be SFATA, I am not quite sure if I would agree, after hearing the FDA's man in charge of going after Sottera, was a featured speaker, and had the same amount of insight that got him two losses in court. Now that guy is advising SFATA??? Get the opposition sides Lawyer that Lost the Cases, and bring them over to your side to give you advise, like a kid will make Nicotine out of a Chair, or the FDCA of 2009 is only supposed to be for combustibles.-------well I just am not yet comfortable with SFATA as of yet​

But whoever that CASAA wants to subcontract out the handling of the FDA to, they should pick it, and point people to them.

2. Right now, what CASAA puts out for Vapers to do anything, is a bunch of boilerplate information. Pretty much everything they can think of all shoveled together. More or less, just read all this stuff to them, give it to them, its so obvoius they will all get understand.

How's that working out. ITS NOT. People go in, say it, and they vote against. You would get more Vapers attending the meetings if they had a method that was going to work.

3. Take the money you have been keeping for a rainy day, and are currently planning on spending (I believe I heard) on a Lobbyist and instead get some experts in State and Local LEGISLATIVE AFFAIRS.....not Lobbyists for new Bills.

The local bans don't need any new laws, they just use the ones they got, and vote in their own zoning's or regulations.

4. Work, consult, or buy, a model that will begin to work with local bans. When you come up with that, then share it. Again, right now there is NO Known, best method to fight off City Halls on the Local bans. State bans, someone from CASAA shows up, with many others. Was it the many others, or CASAA....well I look at the link of Successfully campaigns on the CASAA website....of the 5 total, they all are from YEARS AGO, and arguable at that if it was CASAA also talking, that made all the difference in EVERYONE who was there talking.

So instead of misreading me, for hurt feelings....I am saying

1. Stop the waste of time on FDA, hand that over to someone skilled.
2. Figure out a model that can ACTUALLY fight the Local Bans....it could take time and effort.
3. When you have that Best Known Method, tested to Work.....give that out to everyone.
4. Understand, that objectively CASAA is losing the fight, and saying we are just a bunch of Volunteers is a deserves when you are out there calling "I got it, I got it" and the ball hits the grass.
5. Recognize what you can do, and what you can not, and don't tell people you are working hard on stuff you can not do, like the FDA.

I realize there is an entire generation where there teachers were afraid to tell students they didn't finish the project, required for the grade.....but give them the grade.

If you don't want to hear this type of critique, which is what I think your defensiveness is, all ego based, I can simply be told you are done with feedback, and not waste the time....otherwise....the above is real advice

You are very good at offering criticism (with no offense taken on my part at all) but you are pretty light on offering viable solutions.

If we could figure out the "model that can ACTUALLY fight the Local Bans," do you not think we'd already be doing it?

All you have offered above is "You're doing it wrong. Figure it out." If you cannot find a clear solution to fighting these local bans beyond what we are already doing, what makes you think we can?

Do you have any idea what hiring a lobbyist costs? A retainer for a lobbyist costs $5,000 to $20,000 PER MONTH and you have to have someone registered in each state. CASAA does not get the kind of donations to afford a registered lobbyist to work in every state (the funds we currently have wouldn't pay for more than one or two states for 5 - 20 months) and there are already industry-funded groups taking that route, such as SFATA and VISTA, and the AVA formed to hire a publicist. This is what should have been happening 4 years ago.

CASAA was not created as an organization to act as legislative lobbyists or fight legal battles in every town, county, city and state. We took up that job by default, because the industry wasn't organizing and fighting the bad laws. We expected to get a lot more support from vapers and vendors, but haven't. Even though we've asked for help, most people are content to let us do all of the work, from finding out about proposed legislation, to analyzing it, to writing and distributing Call to Action. No matter what system we come up with, it still comes back around to vapers and vendors doing their part - whether that be monitoring their area for legislation or opening up their wallets so CASAA can hire professionals. Without one or both of those things happening, there is nothing more that CASAA can do than what we are doing now.

Our mission is to ensure the availability of effective, affordable and reduced harm alternatives to smoking by increasing public awareness and education; to encourage the testing and development of products to achieve acceptable safety standards and reasonable regulation; and to promote the benefits of reduced harm alternatives.

That "Successes" web page hasn't been updated in a while, but even if it was, it would mostly be intangible results. It's hard to clearly show how many laws we've stopped as a community - like the fact that all of the proposed state-level laws failed to pass this year. But the local/city bans that passed likely would have passed no matter what we did - their minds were made up before we ever heard about them (although quite a few were stopped or favorably amended as a direct result of the involvement of the vaping community.) Can you point to how we could have stopped the laws that passed? You can say "alert people sooner," but that doesn't solve how we can find out about them sooner nor how to change the minds of those lawmakers.

Unless you can offer a better solution for stopping these local bans and laws, our only option is to keep doing what we have been - relying on members to watch their areas and tell us about them, alerting people as soon as we get the information, giving them guidance and the facts to present and encouraging them to contact their lawmakers to oppose the laws. Even if we dropped all of our activities fighting the FDA, that wouldn't change what we can achieve on the local level with the lack of more community support - and hiring lobbyists, spending hundreds of thousands of dollars, is no guarantee, either. Lawmakers may listen to "representatives" (ie. lobbyists) from the "respected" organizations like the ALA or ACS, but a lobbyist representing a group that encourages the use of e-cigarettes or "the industry?" Not so much.

What it comes down to is no one, including you, is offering any real, alternative solutions to fighting these local laws and what we've been doing HAS worked. Maybe not EVERY time or even MOST of the time, but it HAS worked.

But just telling us "what you've been doing doesn't work, so find a solution" is not exactly helpful.

 

[zoiDman]

You are very good at offering criticism (with no offense taken on my part at all) but you are pretty light on offering viable solutions.

If we could figure out the "model that can ACTUALLY fight the Local Bans," do you not think we'd already be doing it?

...

Don't let Tom bring get you Down.

The World is Full of People like Him. Quick to Criticize Other People's Actions, while Offering None of His Own.

You, or Anyone involved with CASAA, shouldn't have to Defend Yourself Against the Naysayers.

Because the Entire CASAA Team has had the Greatest Positive Impact on the Vaping Community. And Frankly, I am Amazed that it was All Done with Very Little Resources and on a Volunteer Basis.

Keep Up the Good Fight. And Know that there are Many who are Thankful for the Time, Effort and Sacrifices that You and Everyone Else who has been involved with CASAA have Made.

 

[Sirius]

That "Successes" web page hasn't been updated in a while, but even if it was, it would mostly be intangible results. It's hard to clearly show how many laws we've stopped as a community - like the fact that all of the proposed state-level laws failed to pass this year. But the local/city bans that passed likely would have passed no matter what we did - their minds were made up before we ever heard about them (although quite a few were stopped or favorably amended as a direct result of the involvement of the vaping community.) Can you point to how we could have stopped the laws that passed? You can say "alert people sooner," but that doesn't solve how we can find out about them sooner nor how to change the minds of those lawmakers.

I hear ya Kristin -- Like the way they slipped in that US Senate Help Committee today and ya'll had one day to notify us. That won't generate much from the media either because of all that's going on with the VA today. Legislators have become genius at slipping these things under the carpet before anyone even knows what's going on haven't they. John Lennon once said,"A conspiracy of silence speaks louder than words."

 

[Sirius]

Don't let Tom bring get you Down.

The World is Full of People like Him. Quick to Criticize Other People's Actions, while Offering None of His Own.

You, or Anyone involved with CASAA, shouldn't have to Defend Yourself Against the Naysayers.

Because the Entire CASAA Team has had the Greatest Positive Impact on the Vaping Community. And Frankly, I am Amazed that it was All Done with Very Little Resources and on a Volunteer Basis.

Keep Up the Good Fight. And Know that there are Many who are Thankful for the Time, Effort and Sacrifices that You and Everyone Else who has been involved with CASAA have Made.

Well said zoiDman!

 

[Kent C]

Again, we agree.



And this is a form of regulation. It's not 'official bureaucratic regulation' but it is consumer using means to control/influence. If it is one person realizing it for themselves as personal course of action, I would not emphasize that as regulation. But teaching people to do this, organizing a boycott, would be a way to regulate the market. Not for the long haul, but that boycott could have long term implications.

I agree however, this is why I like to make that distinction. Take a case where a company is reported as polluting. An individual or neighborhood or a community or even a city could sue that company, (to invoke DC2) IF harm can be shown. And not just junk science harm, real harm. And if that is the case, the business should handle the medical bills, pay for any damage, etc. etc. and stop whatever what was the cause. I have what would be considered a very un-libertarian solution for those that can't afford to sue - to have a crew of lawyers available at gov't expense - not just some 'public defender' type but well paid crew, that takes these type of cases. While this sounds like a type of welfare, Justice is one valid part of the Constitution. (whereas welfare is not).

But what we have is something along what happens here locally. A landfill violates some regulation, they end up, not paying citizens who may be harmed, but the Ohio or perhaps the Federal EPA in fines. Basically a 'wrist slap' by the regulatory agency, who ends up with the money on top of the money we pay to support them. I say bring it back to the consumer level for the same reasons I posted above - you get better and more informed consumers. Those who don't want to get informed, pay that price over and over until they either get on it or end up on Onion in the Darwin Awards. And like some would allow death panels in healthcare, I'd be willing to lose a few from their own actions or inactions but the public (again, in times of Mach speed communications) would learn rather fast.

Like welfare or income tax or the central bank, if you go back before any of those existed, we didn't have mass death, continuous depressions or lack of funds. Somehow we figured it out, without those. And not only that, welfare has only institutionalized poverty rather than decreased it; many can make good arguments that it was the Federal Reserve that brought about (or at least didn't avoid) the Great Depression - the reason (it was said) that it was created in 1913 - to 'smooth' the boom/bust cycles of business (which are pretty much short term 'natural' effects) - yet it exacerbated them.

So that gives you just a bit on why I make that separation.

 

[Gato del Jugo]

We've already seen it happen too many times, and people should be mindful of trying not to get sucked in too much..


It just ends up being a waste of time & energy that could be utilized on more important things..

If you think about it, that might just be the goal of all this...

 

[Sirius]

I think Bill Godshall and a few others have it right. The game plan as Demmi said should be to write, call, email, your state senators and house representatives. This is after an important election year. Tell them your story and why vaping is important to you. That's an importsnt step we all need to stick together on. It's a start anyway, untill we can come up with something better.

 

[Sirius]

...and a personal favorite:

 

[Gato del Jugo]

We've already seen it happen too many times, and people should be mindful of trying not to get sucked in too much..


It just ends up being a waste of time & energy that could be utilized on more important things..

If you think about it, that might just be the goal of all this...

Sin Bin?