FDA FDA to BAN/RESTRICT Vaping UNLESS...

[Kent C]

My hesitation about the FTV site was that my comments to Congress are very different than comments to FDA. Elected reps are going to be much more interested in personal stories and the FDA is somewhat immune, will adopt unpopular positions for 'the greater good' in their minds, so my comments are going to be dry, clinical with references. The FDA also has a list of about 99 questions they are looking to consider and as far as I can tell, deeming of ecigs and compents is a done thing or they wouldn't be doing their jobs (in their mind). Congress on the other hand, has oversight. Two very different perspectives. If there were to be any change in FDA's mandate, it would need to come from Congress.

I also don't think CASAA's suggested letters are 'forum letter's' in the true sense, they are responding to member requests for guidlines on what to say. Sure many probably do cut and paste without many changes - but they are changeable. I've seen letters appear for other causes that attempt to prevent changes from the original before sending. Those are the true forum letters.

I tend to think any vaper that has signed up with CASAA, following CTA's or Daily Action Plans, is not going to be fooled into thinking a 15 minute forum will "do it all". I mean, many of us find we (ME) spending hours every day - or at least as much time as possible on vaping related stuff. It takes me longer to buy a drip tip than to fill out FTV's forum.

From my understanding, the FDA issues extensions at the very last and there are strategic reasons to wait until the last few days to submit.

I agree with everything you say here, esp. about the difference between what Reps need and what FDA needs although there is some crossover when it comes to details of the deeming doc and others.

I'm glad CASAA offers the suggestions in the way of a form letter, even though for most of us here, there will be very few that look anything alike. I don't know if that will be a majority though. But like Katya and others, I'd like to get the show on the road.

 

[Talyon]

This bold part is reason why I'm waiting at all. Every organization looking out for consumers paints a picture that suggests FDA proposed regulations mean doom and gloom. They don't mince words on this. IMO, they use lots of superlatives to make sure anyone listening realizes that the deeming regulations will end vaping as we know it.

To this day, I disagree with this take. I still see proposed regulations as rather tame, and because of the amount of questions (approx. 100) asked and wording, I feel very confident that FDA is many years away from having a decent grasp on what the heck to even regulate.

If anything is needing to be submitted to FDA, it is to answer the questions in a way where FDA would have even tougher time claiming 'we just don't know' or 'there is no evidence.' Our side's experts routinely point out that they (the FDA) do know, and have been given the evidence already. Still, comments offer opportunity to make that case again, and in numbers, plus perhaps an opportunity for consumers (as stakeholders) to speak to what is reasonable going forward. I.E. - most vapers consider it reasonable to ban sales to minors, so that would be something that FDA and majority of consumers have in common.

Yet, with FTV's hype on what's at stake, and what I've heard thus far from CASAA, I would say there is ABSOLUTELY NO REASON WHATSOEVER to submit comments to the FDA as a consumer. Based entirely on the rhetoric used about the regulations, I see that as the case. If you (in general) are so certain the currently proposed regulations spell an end to vaping, then I am very curious what you think you could submit that would change the FDA's collective mind going forward?

And again, I do disagree with this take on things, which is why I wrote the 2nd paragraph as I did. Yet, if you have the other take on things, the doom and gloom one, then I say completely ignore the FDA and only write to congress. Tell them your story or what have you. But if the doom and gloom take is accurate, then Congress is our only reasonable hope before the rule goes into full effect. If you are an expert or someone that feels differently, I am very interested in an explanation on how submitting comments to the FDA will counter the certainty of doom and gloom?

Failure to explain or even address that makes me want to ignore your CTA that suggests now is as good of time as any to submit comments to the FDA.

Here, fill out this form.

To try and generalize or even rationalize ones fears and hopes is futile. But indeed it's what all this comes down to. Most fear yet some don't, and it doesn't matter who says what, some will try and some won't try but hope just the same. But quite frankly the most are very capable of making their own decisions despite their own hopes and fears. One may try to calm those fears or punish those for having them, or perhaps push the hope no matter ow frail it is. What I know is this, I'll never follow blindly and for sure will not become prey to wordsmiths...

Time tells all, tick tock tick tock..... A little birdie told me so.

 

[Racehorse]

we don't want to advise our members to take shortcuts.

Speaking of shortcuts, I prefer to submit my own comments to FDA, and do so under my own steam. Is there a link to show how the document should be formatted, and what pertinent points should be addressed per CASAA's advice?

I can deliver the document to my rep also, directly in his living room, since they are neighbors.

I just prefer to do things like this very directly and/or as personally as possible, and do not feel I need a middleman who will submit my comments for me, like FV for instance.

The fact that their domain ownership information is not being made public made me decide that tit for tat, you don't get to know more about me unless I know more about you. Sorry, but that is the way I feel.

I don't do telemarketing political surveys either, until i know exactly who is calling me......then I asked them to call me back, after I have looked up who they are and who they get paid by, etc.

I am delighted to give my time and energies and thoughts to any orgnanization but I have to know who "wants to know" LOL

Given a choice, I do prefer to wait for CASAA's rendition as at least I know who they are and who their board of directors, etc. are and know i have no problem with them as an advocacy org.

Meanwhile, a question, will FV or CASAA have manpower to sort thru and / or proofread any of these things, .....in other words, what is the plan for Quality Control on these form submissions?

Considering the paranoia for ANTZ spies, how can FV assure for instance, that thousands of forms will not also be submitted by anti vaping forces?

 

[kristin]

Racehorse,

To answer your question, CASAA isn'the using any forms that can be pre-screened. The FDA comments CASAA members submit go through the FDA comment system. The CTA's CASAA issues provides background info about that specific comment (ie. request for extension, final comment, etc) and suggested points to choose from or act as guidance to writing your own points or you can just write your own opinion on the topic of the CTA, having been fully informed of what the FDA is seeking and the intent of that particular comment.

For the Congress emails, CASAA will offer similar overview of the "ask" and explain why we are making the request. Then members can use the CQ Roll Call system, which simply helps them send to their own representatives. Some will be pre-written with spaces for personal comments (yes a "form") but these will be separate and specific requests to Congress for specific actions to be taken and there will be more than one. Members can submit all or none. These will overlap with the FDA comments but not be the same exact thing because CASAA believes what the FDA wants (comments addressing the proposed rule) is different from what we will want to ask of our representatives. Those won't have check boxes or comment areas that can be messed with, because they are going to be very specific requests. They are similar to a petition, but different in that they will be written to be specific, accurate and valid requests that include complete contact info for the person submitting the form and gets targeted to that person's representatives as a constituent.

They are "form letters" in that sense, but only because they are meant to be targeted and concise and there will be more than one request. It is a lot of work, but CASAA believes the extra effort required from our members is necessary or we wouldn't be going through all of the trouble to set it up.

For the record, because I've seen it mentioned, CASAA isn't "making" people wait. Our members want this guidance from CASAA leadership and we are asking THEM to give us time to provide it for them and not to panic. In the meantime, we are asking our members to get their personal stories prepared so they are ready. We won't let them miss their opportunity to comment.

All of the "I'm waiting for CASAA" and "you should wait for CASAA to tell us what to say" is coming from CASAA members in a well-meaning attempt to get people to join and follow CASAA's guidance. In no way has CASAA leadership told the general vaping community that they have to do as CASAA says. Our CTAs are intended as guidance for our membership and anyone else who wants to use it, not as a directive to the whole community. It pains us to see it portrayed that way by some folks. Of course, we'd love the support because there is strength in numbers, but we know we aren't the only advocacy group nor do we think we know everything or have all of the answers. We are just a grassroots group of vapers and ST users who have been working towards this day for years now and want to fight bad regulations and bad laws. We appreciate any support we get.

 

[AndriaD]

I feel very confident that FDA is many years away from having a decent grasp on what the heck to even regulate.

I agree with this completely; they have no farking clue what an e-cigarette even IS, nevermind a PV. But, I hate to say it, but I'm afraid that ignorance has never stopped anyone in gov't from doing stupid things. Could they not have foreseen what would happen as a result of prohibition? Really? No one in gov't saw that organized crime would step into that vacuum to fulfill a long-established "need"?

most vapers consider it reasonable to ban sales to minors, so that would be something that FDA and majority of consumers have in common.

I know it's politically correct and all, and if we don't support this idea, then we're evildoers out to enslave The Chuldren, but I really don't find it reasonable at all. Cigarettes have been banned to minors for a long time, but I can't see that that ban has had much if any effect. I started smoking at 13; granted, they're a little more vigilant now with regard to checking IDs, but somehow kids still get cigarettes. That being the case, I think it would be a lot more reasonable to NOT ban e-cigs to kids -- smoking harms kids more than it harms anyone else, and e-cigs are HARM REDUCTION, right?

But if the doom and gloom take is accurate, then Congress is our only reasonable hope before the rule goes into full effect.

I agree with this 100%... but unfortunately our lawmakers have proven themselves in the 21st century to be stupid, venal, and easily corrupted by Big Business -- completely on-the-take as far as I can tell, to judge from the fiasco to the housing industry and the entire economy along with it. So where does that leave ANY of us, not just vapers? I think it leaves this country ripe for revolution. The aristos in France could never imagine what happened to them at the end of the 18th century -- and that arrogance was their undoing. Poor people will only stay poor, oppressed and trampled by the super-rich, for so long, before they rise up with the old WE'RE NOT GOING TO TAKE IT ANYMORE!

Just my own
Andria

 

[sky4it]

All of the "I'm waiting for CASAA" and "you should wait for CASAA to tell us what to say" is coming from CASAA members in a well-meaning attempt to get people to join and follow CASAA's guidance. In no way has CASAA leadership told the general vaping community that they have to do as CASAA says. Our CTAs are intended as guidance for our membership and anyone else who wants to use it, not as a directive to the whole community.

And that is all 100 percent completely accurate. I wouldn't worry abt that tho Kristen. Many people, myself included, simply do not have time to keep up on all the current rhetoric/media circus, completed by FDA movements from week to week. Which is why guidance is warranted.

BTW I heard some scuttlebutt, from a person that on some TV talk show there where rumors floated abt ecigs being just as harmful as stinkies. If true, and I do know this person watches the tube like they were born to do it, this is the type of stuff that hurts.

Is it possible, that some thread could be started documenting- date,time, where the information was seen, and what the information was? That way alot of this is easier to follow, in addition, CASSA and other brokers for vaping are going to need all this information in summary form down the road. no?

 

[kristin]

CASAA isn't telling the community they cannot use the FTV website.

We do ask that if CASAA members do use it to submit a well-thought and informed comment and share the link to FTV, please ALSO do the CASAA Calls to Action and share a link to our plan overview: CASAA: Overview of CASAA's Action Plan Regarding Proposed FDA Regulations and each Call to Action. Doing one is not the same as doing the other.

CASAA is not affiliated with FTV, so cannot speak to any concerns expressed about the website, but as far as we are aware the organizers are considered by many to be respected members of the vaping community and have no ill intent.

 

[DC2]

This thread has blown up in all the wrong ways

At some point you have to agree to disagree... Does this action cause more harm than good? Does that action cause more harm than good? OMG, is this thread now doing more harm than good?!?

What does arguing over how one chooses to be involved matter? Is it helping the cause? Just be active d@mmit!! Save your time and energy; stop debating CASAA vs FTV and have more conversations that encourage other people to get involved HOWEVER they feel comfortable.

All this arguing is keeping the thread bumped and giving more attention to the FTV efforts.

Don't worry, it's all good.

 

[DC2]

If you are an expert or someone that feels differently, I am very interested in an explanation on how submitting comments to the FDA will counter the certainty of doom and gloom?

I don't care whether or not my comments to the FDA will have any effect.
All I care about is that I can look myself in the mirror and know that I did what I could.

Because if I don't, then I'm part of the problem.
And I am no longer comfortable with being part of the problem.

 

[Stosh]

For the record, CASAA isn't telling people NOT to use the FTV website.

We do ask that if you do use it and share the link to FTV, please ALSO do the CASAA Calls to Action and share a link to our plan overview: CASAA: Overview of CASAA's Action Plan Regarding Proposed FDA Regulations Doing one is not the same as doing the other. To cover all of the bases, it would be best to do BOTH......

I have to disagree, but only very, very slightly, both isn't good enough. I keep up with the CTAs and love CASAA, but....

People need to let their views known to every petty bureaucrat and politician through whatever means available. Deluge them with emails, snail mail, fax, phone, telegram, texts, twitter, facebook, carrier pigeon, or chiseled on stone tablets, to every federal, state or local elected Representative. The squeaky wheel gets the grease, let our voices be heard.

We need all groups, CASAA members, FTV supporters, the ECF'ers, other forums users, the reddit crowd, twitterers, facebook addicts, you-tube watchers, even newspaper readers, to contact as many of the dimwits making decisions as often as possible.

Right now, go to your to your window, open it and lean out - shout at the top of your lungs...
I'm mad as he<double hockey sticks> and I'm not going to take it anymore, leave my vaping alone!!

 

[aikanae1]

Originally Posted by Jman8
If you are an expert or someone that feels differently, I am very interested in an explanation on how submitting comments to the FDA will counter the certainty of doom and gloom?

IMO comments can modify current regulations as well as point out areas the FDA is not informed of or offer altenative points of view. I'm pretty sure as a regulatory agency they believe they should be beyond public opinion but they are reacting to other pressures; mainly congress and industry. I think outcry from the public could exert pressure too since the regulations openly ban an entire segment of the market and hand it off to an industry that has had nothing to do with it's development / market manipulation. And that is not part of their mandate. I also think they will see a rise in the sale of traditional cigarettes again which is counter to their objectives. There is quite a bit wrong with the way the FDA is proposing to impliment deeming that is short-sighted and industry driven. They need to rethink that.

 

[AndriaD]

I have to disagree, but only very, very slightly, both isn't good enough. I keep up with the CTAs and love CASAA, but....

People need to let their views known to every petty bureaucrat and politician through whatever means available. Deluge them with emails, snail mail, fax, phone, telegram, texts, twitter, facebook, carrier pigeon, or chiseled on stone tablets, to every federal, state or local elected Representative. The squeaky wheel gets the grease, let our voices be heard.

We need all groups, CASAA members, FTV supporters, the ECF'ers, other forums users, the reddit crowd, twitterers, facebook addicts, you-tube watchers, even newspaper readers, to contact as many of the dimwits making decisions as often as possible.

Right now, go to your to your window, open it and lean out - shout at the top of your lungs...
I'm mad as he<double hockey sticks> and I'm not going to take it anymore, leave my vaping alone!!

Also to health professionals -- I have a feeling that a lot of nurses, if not doctors, figure prominently among the ANTZ. When I visited my mom in the hospital, chatting to a nurse, I mentioned that about 3 months ago I quit smoking using e-cigarettes, and you should have seen her face contort -- you could just SEE that she wanted to argue with me about e-cigs, but in the face of "I quit smoking using them," all she could come up with was a very grudging 'well it's good that you quit.'

The more people who hear "I QUIT SMOKING USING E-CIGARETTES", the better; eventually it WILL carry the day, that e-cigs are useful to get off of smoking tobacco, which they've been haranguing us about for so long.

Yeah, BT above all others probably hates to hear that, but tough cookies. And tough cookies to BP too, with their cessation products that make you want to kill yourself. Of all the goofy symptoms people have reported as being "caused by e-cigs," "suicidal ideation" is NOT one of them.

Andria

 

[Racehorse]

Racehorse,

members want this guidance from CASAA leadership and we are asking THEM to give us time to provide it for them

Thank you for the very indepth explanation.

The way I look at it, guidance makes my job "easier" so I will wait and use whatever pointers are suggested.

I prefer my submission to be the most effectively-targetted response it can be.

Not my style as some here to participate in willy nilly duplication of efforts and/or what amounts to "spamming" the FDA and Congress because I've worked behind the scenes and know a little about how that works. Not criticizing anyone who does, just saying that a certain amount of spinning your wheels is required there, and not something I have time or interest to do.

A carefully-targetted and well written response has far greater impact and that is true of any communication, whether it be activism or a simple office memo.

 

[Jman8]

I don't care whether or not my comments to the FDA will have any effect.
All I care about is that I can look myself in the mirror and know that I did what I could.

Because if I don't, then I'm part of the problem.
And I am no longer comfortable with being part of the problem.

Interesting. Would seem that if one broadcasts that comments to the FDA will be ignored / thrown in the trash, that sentiment is plausibly part of the problem. But if they are accurate in that assessment, then it would seem that submitting comments to the FDA is without any purpose whatsoever.

 

[Jman8]

IMO comments can modify current regulations as well as point out areas the FDA is not informed of or offer altenative points of view.

Again, I'm very curious how comments can modify current regulations. Remember, you would be conveying this to one who would be prone to agree with this attitude. I currently think best consumer can do is inform FDA on items where questions were asked. I like to think modification is possible, but when I expressed as much on 4/25/14 here at ECF, I was on an island all by my lonesome being told that these proposals as written will end vaping as we know it. Not maybe end it. Not might someday. But as written, these proposals will end it. So, again, I'm very curious how another ECFer thinks comments to the FDA, from consumers, can modify current proposed regulations.

 

[DC2]

Interesting. Would seem that if one broadcasts that comments to the FDA will be ignored / thrown in the trash, that sentiment is plausibly part of the problem. But if they are accurate in that assessment, then it would seem that submitting comments to the FDA is without any purpose whatsoever.

Already addressed this previously.

Yes, it appears that our comments are NOT being thrown in the trash, like they were last time.
So yes, I was wrong to say that, since apparently this time they are posting them for some reason.

Sorry I didn't know they would change their approach to our comments.
If you'd like to keep bringing that up, feel free.

But I'm really starting to tire of you, and your attempts to discredit me.
And that's what that is.

 

[Kent C]

Again, I'm very curious how comments can modify current regulations. Remember, you would be conveying this to one who would be prone to agree with this attitude. I currently think best consumer can do is inform FDA on items where questions were asked. I like to think modification is possible, but when I expressed as much on 4/25/14 here at ECF, I was on an island all by my lonesome being told that these proposals as written will end vaping as we know it. Not maybe end it. Not might someday. But as written, these proposals will end it. So, again, I'm very curious how another ECFer thinks comments to the FDA, from consumers, can modify current proposed regulations.

One quick way to find out what they're actually requesting is to search 'request' in the pdfs. I searched both the deeming doc:

https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf

.. and the impact doc

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

...and while not every hit will be what you're looking for, most of them are "We request comments on...." Here's one that is important to me (as a consumer): "We request comments on the specific challenges and costs unique to small business in complying with the proposed rule."

If someone hasn't already done it, I could make a list of all the 'requests for comments'. But I think someone has already - although I haven't seen it.

 

[Burnie]

If someone hasn't already done it, I could make a list of all the 'requests for comments'. But I think someone has already - although I haven't seen it.

Come to think of it Kent, I haven't seen a FULL list either. Anyone know of a link to the list of JUST the "Requests for Comments"?
Thanks

Vape On
Burnie

 

[Kent C]

Come to think of it Kent, I haven't seen a FULL list either. Anyone know of a link to the list of JUST the "Requests for Comments"?
Thanks

Vape On
Burnie

aikanae mentions the idea here:

http://www.e-cigarette-forum.com/fo...n-restrict-vaping-unless-16.html#post13384062

... but not sure if it was just her own estimate. I may PM her. I know some are not real specific. 'We request comments on this section', etc. so some may not be that helpful.

 

[kristin]

That list of requests is what CASAA is working on right now. It's a tedious and time consuming task to search the proposed rules, weed out the FDA requested info and craft responses to each. We've asked a few volunteers to help us weed out the FDA requests. I'm not sure where they are at with that. I know quite a few have been found and there are at least 99 (one number I've heard so far in the Skype chats.)