Overview of CASAA's Action Plan Regarding Proposed FDA Regulations

[kristin]

Two weeks ago the FDA released its proposed regulation attempting to exert regulatory authority over e-cigarettes as tobacco products. To better understand the import of these regulations, please see our summary of the what and why of the deeming regulation and CASAA’s preliminary analysis of proposed regulations.

Early on, we asked CASAA members to be patient and to refrain from making formal comments about the proposed regulations until CASAA leadership had sufficient time to review the regulations and offer guidance. The membership has been patient at a time when every instinct we have is to react, do something -- do anything! -- because we know that these regulations, if enacted in anything remotely resembling their current form, will decimate the industry and destroy the diversity in the marketplace. And, of course, it's the diversity in the marketplace, the ability of customers to customize the experience, that makes this product such an extraordinarily effective alternative to smoking. There is a very real possibility that such regulations would eliminate the entire legal market for e-cigarettes.

The last two weeks, we have spent our days (and nights) analyzing the proposed regulations (241 pages), the FDA's regulatory impact analysis (81 pages), the tobacco Control Act itself, and data about the FDA's operations to assess the real-world implications of the proposed regulations. We have thus far found no reason to believe that these proposed regulations will provide any benefit to consumers, especially in light of the crippling and insurmountable restrictions it will impose on industry, and, by extension, consumers. They appear to be all cost and no benefit.

This is not a battle that is going to be won based solely on comments to the proposed regulations. Accordingly, we are going to attack this on several different fronts. Before the draft regulations were published, we had envisioned a single Call to Action with several suggested actions. However, upon seeing the details, we decided the best strategy to effect positive change is to prepare a comprehensive Action Plan which consists of several Calls to Action issued at staggered dates to maximize effectiveness.
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[sonicdsl]

Thank you Kristin & CASAA!

You saw it here folks... the Action Plan begins!

 

[sonicdsl]

Wow... only 112 views?!?

 

[FACE MEAT]

Comment period extension requested. Thanks for the info Kristin!

 

[Jman8]

We have thus far found no reason to believe that these proposed regulations will provide any benefit to consumers, especially in light of the crippling and insurmountable restrictions it will impose on industry, and, by extension, consumers. They appear to be all cost and no benefit.

Sorry if I'm ruffling feathers by just saying this, but I really think this position needs to be discussed, among members (preferably) going forward. I mainly believe this because current CTA (and ongoing action) is for recruitment of new members to CASAA, and this question could come up from the savvy prospects.

I also ask because I do think there is reason for submitting comments now and observe that substantive comments are already being submitted.

Moreover, organized interests who support the regulations, or who want to suggest that they become even more prohibitionist, will undoubtedly wait until near the deadline to submit; they will take advantage of what they can learn about our arguments by reviewing the early submissions.

From what I'm reading this is at the crux of why not to submit comments sooner than later. The other point regarding "more useful information coming soon" appears to support the myth that we only get one comment, so make it count. As we know this is not the case, then useful information could be submitted on the last day that comments could be handed in, after same person already submitted 50 earlier comments to FDA on the proposed regulations.

Partially what I'm getting at, based on reading of this CASAA piece, is it is challenging to understand when there would ever be a time to respond to the FDA and it has some benefit, with little cost?

The first line of the quote on top of this post reads as if there is now, nor will there ever be, a reason to submit a comment to FDA regarding the proposed regulations. To cut to the chase, it reads as, "FDA will decimate the industry, according to these proposed regulations, and therefore there is no benefit in submitting a response, ever."

I realize the last part isn't said in CASAA pieces to date, but it is implicit. If FDA seeks to establish insurmountable restrictions that downplay all currently available scientific studies, then when would that not be true? 100 days from now?

Here are reasons that I can think of submitting sooner than later:
- at the top has to be that respondents must realize they can submit now and later. This is not an either-or proposition.
- there is chance extension request is not granted
- the scientific data available that deals with eCigs is unlikely to change, substantially in next 60 days, and thus if person has this data organized and ready to go, that data can be submitted now (as attachment to comments)
- submitting now/soon will likely help individuals with dealing with swirling emotions they are experiencing from waiting. It may not lead to complete clarity and total peace with the situation, but it will crystalize ideas up to this moment. Couple with reason at the top, it has benefit of dissipating emotions and confusion around "what is it I really want to say regarding FDA proposals."
- whatever is said, whenever it is said, could rather easily be scrutinized by others and so benefit of waiting isn't actually a substantive benefit.

The bolded part on scientific data is item that leads to this notion that our opposition could see our currently submitted comments and then counter it via their own comments at last second. Yet, unless a legitimate scientific study is released on whatever ends up being last day of comment period, and that study favors ANTZ and is somehow known to ANTZ before it is publicly released, then there isn't a viable scenario where we (pro vapers) couldn't incorporate their scientific arguments or data into our response. As there is currently a bunch of scientific data out there, much of which supports pro-vaping side, none of which ANTZ has successfully countered, then there is little reason to believe they will succeed via comments to FDA to counter it over next 60+ days.

Again, people are already submitting comments to FDA, and of my review of what's been submitted, those who are 'pro-regulations' are not providing substantive arguments, but instead going with simple point of "I support regulations." One would think that ought to be as effective as comment that says, "I am against regulations." I'm very interested in what opposition could actually say, that we in CASAA have not heard/considered before, and that would somehow have great impact on our early comments, to the degree of rendering them as ineffective or of no benefit going forward.

 

[badwolf91]

So to be clear, we can submit more than 1 comment to the FDA? this has been a big word going around to save your 1 comment so I will gladly request an extension on my comment now if I know I can submit a more in depth scientifically backed comment after the CASAA's call to action.

 

[JustJulie]

You are NOT limited to one comment. However, we still think it's important that people not make comments lightly and wait 'til near the end of the comment period to offer substantive comments.

One of the things we'll be doing is highlighting some of the questions that FDA is asking (along with the context in which those questions are being posed). These will be questions that it is not only important for vapers to answer, but absolutely CRITICAL that they answer. We're STILL in the process of combing through the regulations to provide this information for consumers in a coherent fashion so that they can make meaningful comments.

We are waiting to issue our guidance not only because we're still working on it, but also because it makes no sense to offer the ANTZ an early roadmap so that they can further confuse the issues.

Frankly, most of the comments being made at this early stage are, as Jman8 noted, not substantive. But it is important to understand that the FDA comment process is NOT designed to be a poll of whether people are generally opposed or in favor of regulation . . . it is designed to elicit substantive discussion and feedback on specific points raised by the regulations and to specific questions posed by the FDA. Making a comment such as, "I oppose FDA regulation" not only isn't helpful, it demonstrates a lack of understanding of the whole point of the process. (I don't mean that as an insult, but, rather, an explanation for why those types of nonsubstantive comments shouldn't be encouraged.)

 

[Jman8]

We are waiting to issue our guidance not only because we're still working on it, but also because it makes no sense to offer the ANTZ an early roadmap so that they can further confuse the issues.

I did offer reasons why it might make sense to submit comments early. I am curious how ANTZ could confuse the issue(s) in ways that they aren't already doing so? Especially with idea that comments are coming in and that some of them are providing substantive points, i.e. citing scientific data.

Besides reasons I already stated, I can think of two others that would make sense to submit early:

1 - knowing ANTZ will likely try to confuse the issue in response to pro-vaper submitted comments, and their comments must also be submitted, then it might behoove us to comment first and third (last) while ANTZ will only get one shot at commenting under this scenario

2 - also if ANTZ is playing this game, and they are going to wait for our comments that appear substantive, then why not put forth a bunch of disinformation, to intentionally misdirect ANTZ? We get unlimited amount of comments so these could be submitted anonymously and with the intention of solely misdirecting ANTZ, in an orchestrated fashion.

How that would look exactly would be something I could respond to once I understand how legitimate substantive comments could be (mis)used by ANTZ to confuse the issue(s).

But to be clear, there are some reasons to submit early, and the blanket statement that it 'makes no sense' is hard to get behind, support. Though as another ECF member said, now is a good time to be writing our individual comments (and rewriting them), and then we can always sit on the more substantive parts until final days of the comment period. In short, write now, submit later, and take CASAA guidance into consideration before submitting some of our substantive comments.

 

[sky4it]

Two weeks ago the FDA released its proposed regulation attempting to exert regulatory authority over e-cigarettes as tobacco products. To better understand the import of these regulations, please see our summary of the what and why of the deeming regulation and CASAA’s preliminary analysis of proposed regulations.

Early on, we asked CASAA members to be patient and to refrain from making formal comments about the proposed regulations until CASAA leadership had sufficient time to review the regulations and offer guidance. The membership has been patient at a time when every instinct we have is to react, do something -- do anything! -- because we know that these regulations, if enacted in anything remotely resembling their current form, will decimate the industry and destroy the diversity in the marketplace. And, of course, it's the diversity in the marketplace, the ability of customers to customize the experience, that makes this product such an extraordinarily effective alternative to smoking. There is a very real possibility that such regulations would eliminate the entire legal market for e-cigarettes.

The last two weeks, we have spent our days (and nights) analyzing the proposed regulations (241 pages), the FDA's regulatory impact analysis (81 pages), the Tobacco Control Act itself, and data about the FDA's operations to assess the real-world implications of the proposed regulations. We have thus far found no reason to believe that these proposed regulations will provide any benefit to consumers, especially in light of the crippling and insurmountable restrictions it will impose on industry, and, by extension, consumers. They appear to be all cost and no benefit.

This is not a battle that is going to be won based solely on comments to the proposed regulations. Accordingly, we are going to attack this on several different fronts. Before the draft regulations were published, we had envisioned a single Call to Action with several suggested actions. However, upon seeing the details, we decided the best strategy to effect positive change is to prepare a comprehensive Action Plan which consists of several Calls to Action issued at staggered dates to maximize effectiveness.
Read More>>

Thank you also Kristen, for putting a top-notch plan and program of action together. Also, much thanks to you and your laborers at CASAA, for your sincerity and heart with all us vapors in mind. Things have been done so professionally and beyond capacity to reproach from others. Very Special.

 

[patkin]

Wow... only 112 views?!?

I'm going to be the "sacrificial lamb" so to speak. I'm admitting ignorance, with extreme embarrassment, to prove a point. I've been here since November 2012 and DID NOT know there was a CASAA Sub-forum until today when I replied to a "Legislative News" thread and was told Julie was researching over here. Why?... when I've been so active creating my own off-group network of x-smokers, vapers and loved ones of same who do neither.... but never saw this sub-forum and just completed the Daily Action Plan every week day. I've emailed and twittered links to CASAA and forwarded the Daily Action Plan until my fingers hurt. Just sayin to show my interest..... but, like most noobs and, I guess now, other members, I come in here helping "New Members" and reading "Today's posts" and researching to buy products or DIY. There really, really, needs to be link to the CASAA Sub-forum up in the yellow header of every page. Yes, there's a "Call to Action" link there but that's not the same and I'm a good example of why. This is a huge forum and overwhelming to the majority I think so we each develop our selective viewing to narrow things down. Maybe long-time members/creators can't see with the eyes of noobs or even longer members like myself. Reiterating... a link to this Sub-forum needs to be in the yellow at the top of the page and IN CAPS. Just my very embarrassed thoughts.

 

[Ryedan]

I'm going to be the "sacrificial lamb" so to speak. I'm admitting ignorance, with extreme embarrassment, to prove a point. I've been here since November 2012 and DID NOT know there was a CASAA Sub-forum until today when I replied to a "Legislative News" thread and was told Julie was researching over here. Why?... when I've been so active creating my own off-group network of x-smokers, vapers and loved ones of same who do neither.... but never saw this sub-forum and just completed the Daily Action Plan every week day. I've emailed and twittered links to CASAA and forwarded the Daily Action Plan until my fingers hurt. Just sayin to show my interest..... but, like most noobs and, I guess now, other members, I come in here helping "New Members" and reading "Today's posts" and researching to buy products or DIY. There really, really, needs to be link to the CASAA Sub-forum up in the yellow header of every page. Yes, there's a "Call to Action" link there but that's not the same and I'm a good example of why. This is a huge forum and overwhelming to the majority I think so we each develop our selective viewing to narrow things down. Maybe long-time members/creators can't see with the eyes of noobs or even longer members like myself. Reiterating... a link to this Sub-forum needs to be in the yellow at the top of the page and IN CAPS. Just my very embarrassed thoughts.

I couldn't agree more on getting more visibility for these issues patkin. This has for me the highest priority right now:

First Call to Action for FDA Proposed Regulations - Consumer Request for an Extension of Comment Period

I got the email alert from CASAA today, but not everyone is a CASAA member. I've thought about making a thread in the General forum with link back to the thread in this sub-forum but have not done it yet. Is anything planned? An ECF notice in yellow about this would be best. Anyone have any info on this?

 

[badwolf91]

I agree patkin, I just found this thread very recently as it had been linked to in a thread from the FDA regulations area. it does take some poking around to find and I had no idea about it. I think with CASAA being such a big help and massive part of the community that they should possibly simply have their own full on section similar to the new members section. It would be well deserved

 

[Jman8]

I agree patkin, I just found this thread very recently as it had been linked to in a thread from the FDA regulations area. it does take some poking around to find and I had no idea about it. I think with CASAA being such a big help and massive part of the community that they should possibly simply have their own full on section similar to the new members section. It would be well deserved

CASAA does have their own section on ECF. It is within the "Electronic Cigarette News and Campaigning" subforum, just as the "New Members Forum" is part of "The E-cigarette" subforum.

Us CASAA members wish there was more arrows pointing toward CASAA on ECF. But clearly ECF is bigger (in scope) than CASAA, and now that legislation has picked up in 2014, ECF staff have done much to point arrows / highlight items, so hopefully all ECF members will become politically aware.

 

[sonicdsl]

I'm going to be the "sacrificial lamb" so to speak. I'm admitting ignorance, with extreme embarrassment, to prove a point. I've been here since November 2012 and DID NOT know there was a CASAA Sub-forum until today when I replied to a "Legislative News" thread and was told Julie was researching over here. Why?... when I've been so active creating my own off-group network of x-smokers, vapers and loved ones of same who do neither.... but never saw this sub-forum and just completed the Daily Action Plan every week day. I've emailed and twittered links to CASAA and forwarded the Daily Action Plan until my fingers hurt. Just sayin to show my interest..... but, like most noobs and, I guess now, other members, I come in here helping "New Members" and reading "Today's posts" and researching to buy products or DIY. There really, really, needs to be link to the CASAA Sub-forum up in the yellow header of every page. Yes, there's a "Call to Action" link there but that's not the same and I'm a good example of why. This is a huge forum and overwhelming to the majority I think so we each develop our selective viewing to narrow things down. Maybe long-time members/creators can't see with the eyes of noobs or even longer members like myself. Reiterating... a link to this Sub-forum needs to be in the yellow at the top of the page and IN CAPS. Just my very embarrassed thoughts.

Fair point patkin, and don't be embarrassed. As mentioned, it is a huge forum, and trying to get traffic diverted to different areas is difficult, at best. Part of the problem is many people don't read stickies or banners, so we are left trying to figure out better ways to get the message to the masses.

I'll discuss with Roly and the others and see what we can do.

 

[badwolf91]

CASAA does have their own section on ECF. It is within the "Electronic Cigarette News and Campaigning" subforum, just as the "New Members Forum" is part of "The E-cigarette" subforum.

Us CASAA members wish there was more arrows pointing toward CASAA on ECF. But clearly ECF is bigger (in scope) than CASAA, and now that legislation has picked up in 2014, ECF staff have done much to point arrows / highlight items, so hopefully all ECF members will become politically aware.

hey jman, all I meant was that it was right on the front page rather than having to go to the fda regs area or as you said the legislation for the new commers and old alike to have it right on the front for them and maybe more people can learn about it more easily that way. no problem with how it is though, im very glad they have their own section. Just with how much of a part of the community they are I thought maybe they should be a "front page" section. sorry if I was confusing there. all is well though, its not like its hidden away but im sure many have missed it or many people scanning the main page forums that don't know about them would check them out and join

awesome I see that CASAA is on the front page now, I didn't see that before maybe I was missing something

 

[Maurice Pudlo]

Given there is no guarantee that an extension will be granted; what specific actions are being taken to guide/inform consumers on answering the 99 questions directed toward us if a compressed timeline for calls to action is required?

In what order will CASAA be addressing these questions, and how may we provide assistance to CASAA in researching response options?

Simply put, can we be supplied with an order of precedence that will aid us as consumers in preparing to act on short notice if need be?

Thank you,
Maurice

 

[DC2]

Fair point patkin, and don't be embarrassed. As mentioned, it is a huge forum, and trying to get traffic diverted to different areas is difficult, at best. Part of the problem is many people don't read stickies or banners, so we are left trying to figure out better ways to get the message to the masses.

I'll discuss with Roly and the others and see what we can do.

How about...

Your ECF login will be disabled if you don't click this link?
I might be kidding... maybe.

 

[catilley1092]

kristin, glad that you're on our side in this huge battle! It's going to be a tough one, that's for sure.

It's my hope that some extension is granted, normally when there is good cause for such, it usually is. Like you've suggested & so has the CASSA site, this doesn't mean to hit the panic button.

I've began my part by telling my real life experience, using my real name, phone number & email address to look legit. Hopefully more members will do the same. e-cigs has likely added years to my life. We need more of these real life success stories to prove our point.

Cat

 

[patkin]

How do they inform of an extension granted? and how long do they usually take to inform the public yea or nay?

 

[JustJulie]

If FDA decides to extend the comment deadline, they'll likely do it a week or two before the end of the current comment period. It will be widely reported by the media, and we will, of course, make sure folks are aware.