FDA FDA to BAN/RESTRICT Vaping UNLESS...

[sky4it]

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.)

huh, about all i can is i am a bit stunned. Stunned that they couldn't simply put the 99 questions in (or whatever the number is in a subsection under the tab FDA requests.) Well you learn something new everyday.

So this is disingenuous of the FDA to do this, (intent), but the opposition will argue necessary because you can't understand the question unless you understand the (proposed) law? <<<<< Preposterous, when you need a lawyer to respond to requests that pretty much defeats the purpose of the request for most of us. <<<< They know that too. {I got my lawyer, they better get there lawyer, its just another day at the office in leprechaun land.}

And where are these people (FDA) really? If they were concerned for us vapers here you'd think they could send out a factory rep, aka(lawyer), out to at least solicit and be helpful.

So that, when some people are called extreme in there view of this, I think they miss the point...... really.

Talyon in post 162 calls it "wordsmiths." And I do think, Talyon has hit paydirt. Its like one word is worth a thousand pictures. So blacksmiths are to horses as wordsmiths are to FDA lawyers? <<< Lets be fair to ourselves, Talyons right, that is what this is.

......./

Thanks for pointing that out Kristen.

 

[Bill Godshall]

The title of this thread is totally inaccurate (as the FDA isn't going to ban or restrict vaping anywhere, but rather FDA's proposed deeming regulaiton would ban >99% of e-cig products on the market, and give the entire e-cig industry to Big Tobacco companies (and perhaps NJOY).

I also don't understand why FTV (or anyone else that wants vapers to send comments urging the FDA to reject its proposed deeming regulation) would include a questionnaire and ask vapers to respond to the following questions, as answering Yes to any of these questions is likely to be misinterpreted by anyone who sees the results (including FDA bureaucrats and/or any members of Congress) as endorsing at least some of the FDA's proposed Deeming Regulations.

Do you support the FDA proposed warning labels regarding the addictive properties of nicotine? Yes No
Do you agree with the FDA proposal that there will be no sales of electronic cigarettes to anyone under the age of 18? Yes No
Do you feel that all eliquid bottles should have childproof caps? Yes No
Do you support AEMSA's standards in regards to making juice? Yes No

Besides, there is no evidence that e-cigs have ever created daily dependence in any nonsmoker (which is contradicted by FDA's proposed warning label for e-cigs about nicotine), and 36 states have already banned e-cig sales to minors with the other 14 likely do so in the next year (rendering the FDA's proposed e-cig sales ban to minors as duplicative and double jeopardy for violators). Also note that FDA has already conducted > 100,000 law enforcement sting operations against retailers using deputized youth who try to buy cigs. Do any vapers really want FDA conducting similar stings on vape shops and Internet vendors on a monthly basis?

Also, the FDA didn't even propose childproof caps for e-liquid or AEMSA standards in its deeming regulation. But anyone answering Yes to those questions is basically indicating that they think more regulation of e-liquid is necessary.

So it seems like the folks at FTV are confusing a vaper survey with public comments to the FDA.

If FTV hand delivers these comments to FDA (as Grimm Green said in his video endorsing FTV), the FDA will simply put all of those comments in one pile and label the pile as "FTV comments".

While I think it is imperative than tens of thousands of vapers submit comments to the FDA, and while I urge all vapers to send their FDA comments to their members of Congress (as FTV says it is doing), I don't understand why FTV included unhelpful and potentially contradictory questions for vapers to answer on its website.

 

[Jman8]

10 characters

 

[Kent C]

The idea of bans on the sale to minors and some labeling isn't that different from CASAA's views. Perhaps they were attempting to be just as 'reasonable' and to show that. I liked the fact that it gave a yes or no choice. I chose 'no' on all accounts. How effective? Who knows.

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

1.The proposed regulation of non-combustible tobacco products, particularly including e-cigarettes, does almost nothing to address any real problems. With the exception of ingredient labeling requirements, which benefit consumers, and bans on sales to minors, which we also support, this appears to be a classic case of a solution in search of a problem.

CASAA: Call to Action: SUPPORT Ohio Bill to Ban E-Cigarette Sales to Minors -- HB 144 (UPDATED -- Now in Senate)

"Call to Action: SUPPORT Ohio Bill to Ban E-Cigarette Sales to Minors -- HB 144"

CASAA: Call to Action! Illinois Bill Would Ban Sale of Liquid for E-Cigarettes Until Illinois Department of Public Health Establishes Packaging Standards

"While HB 5689 is being promoted as a bill to sensibly require childproof caps on e-cigarette liquids, the truth is that this bill would BAN the sale of all e-cigarette liquid products..."

I understand those are states, but to me it sends the same "signal' to state regulatory agencies.

But perhaps that's what you meant by "or anyone else".

And while you likely have better info on the 14 other states 'likely to do so' - the "36 states have already banned e-cig sales to minors with the other 14 likely do so in the next year (rendering the FDA's proposed e-cig sales ban to minors as duplicative and double jeopardy for violators). " ... is never a cinch. There are many states (sometimes in the 30's and 40's) with issues they have passed that aren't federal law - concealed carry, gay marriage, certain drug provisions, etc. for example.

 

[Bill Godshall]

Since its creation in 2009, CASAA has supported the enactment of nearly all of the 36 existing state laws that banned the sale of e-cigs to minors. BTW Three other state legislatures (FL, MO, DE) have enacted bills banning e-cig sales to minors, which are now awaiting their governor's signature.

The reason why many of the other 11 states haven't enacted these laws yet is because Big Pharma funded CTFK, ACS, AHA, ALA and their allied THR opponents in state health departments (who supported FDA's unlawful 2009 ban and who are campaigning for FDA's proposed deeming regulation) have criticized and opposed the state legislation that's been introduced to ban e-cig sales to minors as "protecting Big Tobacco", and have urged those governors and state legislatures to also ban vaping, tax e-cigs, ban Internet/mail order sales, license e-cig retailers/wholesalers, etc. in any bill that bans e-cig sales to minors.

Anyone who urges FDA to ban e-cig sales to youth is (either naively or intentionally) urging the FDA to issue a Final Rule for the proposed deeming regulation (as the FDA cannot legally ban e-cig sales to minors unless/until the deeming regulation is approved and implemented).

The only reason I campaigned to enact the Synar Act in 1992 (requiring all states to enact/enforce laws banning cigarette sales to minors or lose federal funds) and the 1996 FDA regulation (banning cigarette and smokeless tobacco sales and target marketing to minors, which was struck down by the SCOTUS in 2000) was because cigarette smoking among youth and cigarette sales to minors were huge public health problems at the time (as 30% of teens smoked and >50% of tobacco retailers were selling to youth).

Recent teen smoking survey data and Synar Act data, and data from the 2009 FDA regulation (that implemented the 1996 FDA reg banning sales to minors) show record low teen smoking rates that continue falling annually and just 4%-6% of retailers were caught selling cigarettes to youth in recent years.

Although FDA credits itself for protecting children from tobacco marketing and sales, youth smoking and retailer sales to minors had already been sharply declining (due to smoking bans, the MSA, cig tax hikes, and the 1992 Synar Act) before Obama signed the Tobacco Control Act into law in 2009.

But since virtually no nonsmoking youth use e-cigs, there is no justification for an additional federal regulation (piled on top of existing state laws that are working fine) that would ban >99% of all e-cig products and give the entire industry to Big Tobacco (under the deceitful guise of "protecting children").

 

[Kent C]

So.... you do mean "anyone else". Thanks for the further explanation. It is part of the reason why I chose 'no' on those questions. And FTV should consider editing them out.

 

[tw33k]

A PBusardo Video - FreeToVape.org - Take Two

 

[Kent C]

A PBusardo Video - FreeToVape.org - Take Two

Thanks for posting. I think the "How dare you?" part expresses the point well, as to how individuals can respond. It opens up all avenues.

 

[Jman8]

I think the PBusardo vid (update) is good. Helps the cause.

I also think and have thought for awhile that one significant drawback of FTV is that is both signals to our opposition a game plan, but allows them to participate in our delivery system. I think this is what Bill G. is touching upon. The list of 12 or so questions can be answered in many different ways (combinations of total responses) that it can be confusing. And not speaking with singular voice. And if our opposition does use that to deliver comments, then confusion in message from FTV goes up. I'm under impression that one of the primary reasons CASAA is waiting til near the end of comment period is to not signal to opposition what our message is. Be that as it may, even before FTV site came about, many vapers have submitted comments to FDA, and some of these are well written, using scientific data to support their reasoning, and thus speaking to what FDA precisely asked for. I'm yet to see an FDA public comment that covers all umpteen dozen questions that were requesting information in FDA doc. FTV doesn't do this. CASAA is saying they will.

I almost feel like FTV would've been more effective, as it is right now, if it removed FDA from who respondents are submitting info to. If I fill out FTV form, which I'm yet to do, I'd indicate that this response is not intended for FDA, even while I recognize that could happen. From my perspective, it doesn't matter as you can say whatever you want to FDA as often as you like. So, not a huge deal to have these responses go to them, but big enough deal that these comments, because of the form questions, will appear like they are in vastly different directions. As an example of what I'm getting at, if I were to speak to the yes/no questions, and answer both honestly and with reasoning that makes sense to me (but isn't explained, as form doesn't necessarily call for that), I'd go with:

- Yes I am familiar with the current proposed FDA regulations regarding hardware
- No I do not support the FDA proposed warning labels regarding the addictive properties of nicotine
- No, I disagree with the FDA proposal that there will be no sales of electronic cigarettes to anyone under the age of 18
- No, I do not you feel that all eLiquid bottles should have childproof caps
- No, I do not feel that having a variety of eLiquid flavors has helped me quit traditional tobacco cigarettes
- Yes, I support AEMSA's standards in regards to making juice

And I reckon this would be different answers than arguably all other respondents using FTV, and for sure feel it is different than the majority. And yet, I am willing to discuss reasons as may be desired, but form isn't made to have that discussion. Nor am I sure that I'd want to stress to FDA how utterly confident I am that sales of electronic cigarettes to anyone under the age of 18 will occur.

 

[Gato del Jugo]

Sorry if this is a bit off topic, but I would like to see more action now. But that's just me.

Not to pick on you specifically, as many others here & elsewhere have said something similar...


But what action are people looking for? Nobody is stopping anybody from submitting FDA comments now!


At the very core, please at least read pages 39 through 44 of the document...

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

It's an overview of what they're requesting comments on..


I can submit, you can submit, anybody can submit -- right now..

And be sure to save what you write to your own files.. Perhaps some of it will overlap what CASAA will eventually guide on, and you'll have yours already half-written ahead of time...


Here's another thing: Throughout the deeming regs, the FDA cites certain research studies..

Since the FDA claims they're very "science-based," pick a study (or 3) which they cite & read up on it, then tear it apart in your comment.. Perhaps the study is bogus for the simple fact that it's from 2009 & the subjects were vaping on garbage cigalikes & couldn't quit because of their weak batteries, or because of their nasty-tasting e-liquids in those cigalike cartridges.. And during the past 6 years since that study, there have been tons of improvements & advancements in this industry, which are better able to assist smokers to switch from combustible tobacco in 2014...

They want science? Give them science -- and scientifically bash those bogus studies that they're using which are designed from the start to demonize e-cigs.. Find any & all faults you can with them... Get on record that the FDA is relying on bogus studies, and perhaps include some studies which are more objective & more favorable to vaping, which the FDA is intentionally ignoring...


Another thing perhaps wrong with these studies the FDA is citing? They don't include personal choice... Some people like the ProVari, while others like the MVP 2 -- why? Because it works for them, for whatever reasons (battery charging, form factor, convenience, etc.)... Just as certain e-liquids work for them, whether it be PG/VG ratios, nic strengths, flavors, certain vendors, etc.. And getting that information, education & support -- perhaps via forums -- is crucial in helping people get off & stay off combustible tobacco, and perhaps eventually even off that "evil" nicotine...

All of this works because we as vapers currently have the option of a wide variety of personal choices -- none of which I highly doubt is present in many of those studies that the FDA is relying upon, and practically none of which will continue if the FDA gets their way...


Anyway, this wasn't hard to do..

And I didn't need CASAA or FTV or whoever else to think of this or submit such comments..

Neither does anybody else, if they truly feel the need to do something now...

 

[Bill Godshall]

Jman wrote

I'm under impression that one of the primary reasons CASAA is waiting til near the end of comment period is to not signal to opposition what our message is.

I can't speak for CASAA, but I can assure everyone that is not a reason why CASAA hasn't issued more recommendations for deeming regulation comments.

The reason is because FDA's proposal is so vast, contains so many inaccurate and misleading statements, request comments on many dozen different issues, and is yet so vague and contradictory, that it takes lots of time to deal with those issues.

 

[Katya]

Jman wrote

I'm under impression that one of the primary reasons CASAA is waiting til near the end of comment period is to not signal to opposition what our message is.

I can't speak for CASAA, but I can assure everyone that is not a reason why CASAA hasn't issued more recommendations for deeming regulation comments.

The reason is because FDA's proposal is so vast, contains so many inaccurate and misleading statements, request comments on many dozen different issues, and is yet so vague and contradictory, that it takes lots of time to deal with those issues.

This is from CASAA:

CASAA: Overview of CASAA's Action Plan Regarding Proposed FDA Regulations

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.

For these reasons, CASAA has decided to wait to issue its guide for consumer comments until only a few weeks before the deadline. Submitting comments earlier than that has no benefit and might have substantial costs.

 

[Katya]

Not to pick on you specifically, as many others here & elsewhere have said something similar...


But what action are people looking for? Nobody is stopping anybody from submitting FDA comments now!

Anyway, this wasn't hard to do..

And I didn't need CASAA or FTV or whoever else to think of this or submit such comments..

Neither does anybody else, if they truly feel the need to do something now...

It may not be hard for you, but it is for me. I don't speak the legal language required by the FDA and I'm afraid that I'll miss something important (like a docket number ) and invalidate my response in the process.

Even CASAA made a mistake it their second CTA:

http://www.e-cigarette-forum.com/fo...action-alert-omb-oira-today.html#post13267936

Very Important
Please include the agency name, Docket No. and RIN (as cited below) at the top of all comments submitted to OMB/OIRA and FDA (per instructions in proposed regulation) at
Regulations.gov

Food and Drug Administration

[Docket No. FDA- 2014-N-0189]

RIN 0910-AG38

If you already submitted a comment to FDA or OMB per CASAA's Call to Action, please resubmit it with the agency name, Docket No. and RIN (if your previous submission didn't include those items as cited above). Note that CASAA will making this change (to include agency name, Docket No. and RIN on all submitted comments) on its Call to Action and OMB/OIRA submission shortly today.

Many here on ECF missed that late update and their comments will not be accepted.

There's a lesson to be learned here, folks. When you're writing to the government (especially the Executive Branch), *ALWAYS* include *every single* coded reference you can get your hands on! This includes Public Laws, CFR (Code of Federal Regulations), "As Amended by," file numbers, form numbers, document numbers, etc. It never hurts and in some cases, like this one, came make or break your document.

 

[Kent C]

It may not be hard for you, but it is for me. I don't speak the legal language required by the FDA and I'm afraid that I'll miss something important (like a docket number ) and invalidate my response in the process.

Even CASAA made a mistake it their second CTA:

http://www.e-cigarette-forum.com/fo...action-alert-omb-oira-today.html#post13267936



Many here on ECF missed that late update and their comments will not be accepted.

The fact that you're the second person that said (well.. posted) that this was a mistake, and a rather big one, imo, shows something. Why does CASAA get a pass and FTV doesn't? (with some people)

 

[Katya]

The fact that you're the second person that said (well.. posted) that this was a mistake, and a rather big one, imo, shows something. Why does CASAA get a pass and FTV doesn't? (with some people)

I don't know, Kent.

I remember that I just happened on this alert in the last minutes--literally minutes--before the deadline, as you recall. I just saw North's post and then Roly's.

I want to do the right thing, but it seems we're spending more time discussing what different groups are doing and whether it's good or bad, rather than coordinating our efforts and coming up with a coherent plan of action.

As of today, we have less than 4 weeks left and 99 issues to address--if the extension is not granted.

 

[Jman8]

Jman wrote

I'm under impression that one of the primary reasons CASAA is waiting til near the end of comment period is to not signal to opposition what our message is.

I can't speak for CASAA, but I can assure everyone that is not a reason why CASAA hasn't issued more recommendations for deeming regulation comments.

Post #192 backs up my assertion.

FDA's proposal is so vast, contains so many inaccurate and misleading statements, request comments on many dozen different issues, and is yet so vague and contradictory, that it takes lots of time to deal with those issues.

With that much hyperbole at work, I would think it would lead to plausible realization that there is zero reason to submit comment to FDA and instead to go directly to writers of FSPTCA (Congress) to let them know, via CTA, that FDA has made a mess of things by creating a proposed regulation that is "so vast, contains so many inaccurate and misleading statements, request comments on many dozen different issues, and is yet so vague and contradictory."

 

[Talyon]

Post #192 backs up my assertion.

Feel better?

Again indeed, brilliant...... But GL getting anyone but a few to hold off on submitting comments to the FDA, that would of course be just plain wrong.

 

[patkin]

I want to do the right thing, but it seems we're spending more time discussing what different groups are doing and whether it's good or bad, rather than coordinating our efforts and coming up with a coherent plan of action.

As of today, we have less than 4 weeks left and 99 issues to address--if the extension is not granted.

+1 .

Where I'm at, personally, at this point: Its each "man" for themselves now and we deserve what we get. Sad.

 

[sky4it]

Jman wrote



I can't speak for CASAA, but I can assure everyone that is not a reason why CASAA hasn't issued more recommendations for deeming regulation comments.

The reason is because FDA's proposal is so vast, contains so many inaccurate and misleading statements, request comments on many dozen different issues, and is yet so vague and contradictory, that it takes lots of time to deal with those issues.

yeah and Bill, what your saying was summed up well enough by Kristen in post 180, then echoed by me in a latter post. I am not criticising you here at all. The post you responded to came withal, right after Kristen said so. Yeah that Kristen, the one from CASSA themself. (And I do emphasize by Kristen "well enough")

As usual, we have to start all over again. Or have someone correct what we ought to already know. Since I am not an "authority", apparently its lifeless. But to contravene what Kristen said who is an authority, then to have to have another authority such as yourself, (right after Kristen said it) smacks of at a minimum indifference to CASSA themselves. But lets put it on overdrive and call it what it is: Improper.

And what it smacks of is bickering. Because:

BTW, for yalll, assertions are not reasons. Assertions are placement of stated fact, for people to consider. Reasons are purely for reactionary purposes, to give people the idea behind why someone proceeds. When someone makes assertions it is done to displace or contravene thought. This is done precisely like this in the accounting world so that there can be no coattails. When someone argues a reason to be "the reason" to be asserted as a statement of fact for what happened, you cannot disagree without an allegation that you are wrong. And you ought to consider this as precursory in nature. JFR dude JFR.

Neither did CASSA assert such and such, they simply reasoned it for pliable reasons. etc etc etc...(and other things)

Your honor I object..... to bickery......if confusion was not the reason for the where withal, then why are we stuck with this drama?

DRAMA>>>>> to be continued later.

And by the way Bill you are still 100 percent correct "that is not a reason why CASAA hasn't issued more recommendations for deeming regulation comments." as you said. The reason supplied that there was so much stuff to go through. This was derailed by the idea of "CASSA, waiting til near the end of comment period." CASSA in that letter dated May 8th, never did imply it was a "primary" reason. That is clear from the entirety of that letter, and clear from Kristen. The letter uses the word MOREOVER, to attach the statement. Moreover means "to boot", "whats more." Its was an auxiliary remark, not meaning to convince but to help conclude what they were going to do. It was an informative letter, not a strategic point. Also, these are two completely separate issues. For example, people could prepare their responses, but they do not have to send them in until the time they want to. To imply from that letter this was a primary reason, is flat out wrong. Certainly, Kristen and friends DO NOT sit around and think, "well we better not give some guidance to these bird brains before we want it sent in, otherwise it will be wishful thinking..."

Wordsmithing wordsmithing yah think Taylon?

 

[AndriaD]

It may not be hard for you, but it is for me. I don't speak the legal language required by the FDA and I'm afraid that I'll miss something important (like a docket number ) and invalidate my response in the process.

Even CASAA made a mistake it their second CTA:

http://www.e-cigarette-forum.com/fo...action-alert-omb-oira-today.html#post13267936



Many here on ECF missed that late update and their comments will not be accepted.

Well, that just blows. I never saw that update, so the comment I submitted was just tossed in the virtual trashcan.

Andria