I slipped out a while ago (there is no bar at the FDA -- there are bars elsewhere) and skipped the enviro nonsense. But to put in a random comment about batteries: On his birthday, my son received two cards that play "music" when you open them. They are each powered by two watch-size batteries and also include a little circuit board and speaker. Tons of these are sold now. Most people will throw these away within days. They will not remove the batteries or the little bitty computer for electronics/battery disposal. Where is the outcry against these complete frivolities. (Needless to say, don't bother trying to answer that.)
FDA FDA e-cig workshop starts 8AM (Eastern US time) on Dec 10, agenda stacked with staff from FDA and other federal agencies and many ANTZ
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Thanks. Here it is on the AVA website.
AVA Gives Public Comment at FDA E-Cigarette Workshop - The American Vaping Association
I agree completely. Re: ...never in their life made a serious study or thought project of ethics or general American civics. Their ethics if you could even call it that, is 'everything is relative', and the grasp of American civics - I could go on about this but won't - is skewed by their ideology and the revisionist history by historians, similarly skewed.
The monumental task of correcting that history is analogous to (but greater than) what Greg says above on how the TC group has adulterated and corrupted the science and the conclusions and normative pronouncements from it.
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I'll give it a try anyway...
re:bold - they are not connected to someone's political agenda.................. yet
So... Having watched as much of the farce as time would allow, a few observations from a lay advocate:
1. We were not at the table, we are on the menu.
2. The regulatory echo chamber is reaching for the tools and issues it knows best and will apply them like a child does a hammer (i.e. everything is a nail).
3. Deeming is a foregone conclusion (sorry Bill & Carl). There is only ONE way this will not happen: The current president signs legislation brought forth and passed by the new Congress before the regulations are published (Not going to happen unless porcines begin aviating).
4. We can expect strict regulation and labeling as further barriers to entry ABOVE what PMTA paperwork requires.
5. All Speaker Bonner's (sp) letter does is request a change in the grandfather date (see #3) and until/unless law is passed FDA will ignore it and proceed.
6. If we are going to change things it is going to take getting the President to sign legislation, which we will have to have support for in Congress and we have absolutely no demonstrated will to do so as a whole body of users (vis dismal response to Deeming public comments, funding of research to refute ANTZ lies, presence to oppose state/local ban legislation).
7. When deemed a Tobacco Product legally no amount of science will change that designation, thus taxation will begin in earnest and further place vapor products out-of-reach.
Therefore Dorothy, Vaping is going bye-bye.
Hate me for saying it sure, that does not mean I will quit trying to change things. But there better be a damn sight more folks at my side if we're really going to have a chance.
1. We were not at the table, we are on the menu.
2. The regulatory echo chamber is reaching for the tools and issues it knows best and will apply them like a child does a hammer (i.e. everything is a nail).
3. Deeming is a foregone conclusion (sorry Bill & Carl). There is only ONE way this will not happen: The current president signs legislation brought forth and passed by the new Congress before the regulations are published (Not going to happen unless porcines begin aviating).
4. We can expect strict regulation and labeling as further barriers to entry ABOVE what PMTA paperwork requires.
5. All Speaker Bonner's (sp) letter does is request a change in the grandfather date (see #3) and until/unless law is passed FDA will ignore it and proceed.
6. If we are going to change things it is going to take getting the President to sign legislation, which we will have to have support for in Congress and we have absolutely no demonstrated will to do so as a whole body of users (vis dismal response to Deeming public comments, funding of research to refute ANTZ lies, presence to oppose state/local ban legislation).
7. When deemed a Tobacco Product legally no amount of science will change that designation, thus taxation will begin in earnest and further place vapor products out-of-reach.
Therefore Dorothy, Vaping is going bye-bye.
Hate me for saying it sure, that does not mean I will quit trying to change things. But there better be a damn sight more folks at my side if we're really going to have a chance.
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In a world where even potatoes can be adulterated, draconian regulation of ecigs and eliquid is all but a foregone conclusion. This FDA kangaroo "workshop" solidified my opinion that FDA is pushing forward with the deeming and already has lined up several follow-up moves that will further restrict vaping products, gear, and accessories. Currently I think vaping will be regulated more strictly than combustibles, somewhere along the lines of having the double regulatory burden of both tobacco and medical products.
You look all of 16 in that pic.
Do your parents know you went into the belly of the Beast and brought Order to chaos?
Given what you wrote, what chance is there to change things? Please explain that part.
Wow. Just wow. I signed up to see it live, but was too busy and am only listening to the audio now.
All I'll say is that [the] FDA will absolutely piss their pants if they find out I'm using an unregulated (read: mechanical) mod to vape liquid I mixed myself.
Psst, don't tell them I'm using low voltage but high power or they might just suffer a confusion stroke
All I'll say is that [the] FDA will absolutely piss their pants if they find out I'm using an unregulated (read: mechanical) mod to vape liquid I mixed myself.
Psst, don't tell them I'm using low voltage but high power or they might just suffer a confusion stroke
As I said in the OP, there is ONE way to change things... Get the new Congress to write legislation that 'un-deems' ecigs and have enough votes to support a veto override if necessary. That will take an concerted effort on the part of every vaper and vendor to make it happen. CASAA is already working a CTA to get congress to change the grandfather date (which is spitting into the wind insofar as a solution to the problem BUT it *is* as necessary first step to discover support). If that goes well, it is hopeful that we can get further consideration. If no-one participates in this CTA I don't hold much hope for vaping's future.
Bruce--I actually have a great deal of hope for vaping's future . . . so long as we can get vapers mobilized to take advantage of the strength our ever-increasing numbers give us.
The CTA on the grandfather date is, as we all know, not a long-term solution. The TCA was designed to make it almost impossible to bring a new product to market and also to make products less appealing to consumers in an effort to reduce use. The grandfather date change would alleviate the first problem (but not fix it since any grandfather date will have the effect of freezing technology at some point), but we'd still be faced with the almost certainty that FDA would regulate us so as to reduce product effectiveness and satisfaction . . . flavors, nicotine strengths, online sales, refill liquids, advertising all would be on the chopping block once FDA gains jurisdiction over us as "tobacco products."
So we ask for the grandfather date change while at the same time pushing for a long-term solution, namely, a different regulatory framework for e-cigarettes that recognizes their promise and regulates for basic quality control and genuine consumer interests. (And Bruce is correct that part of what is happening with the CTA is a gauging of support.)
But to do this, we need to mobilize the masses so that they (1) understand the threat, and (2) stand up and fight.
So far, here are the numbers:
Call to Action asking for a change in the grandfather date: 2,539 advocates have participated thus far, generating 7,976 emails.
Thank you letter to Boehner, McCarthy, and Upton: 2,962 advocates have joined CASAA's thank you letter.
(We also asked people to call and/or send a personal thank you note to the Boehner, McCarthy, and Upton, but we have no way of tracking that. I suspect, at best, a handful have made a call or written a personal note.)
Granted, the CTA (and thank you note) were only released Tuesday (12/9/14), so it's still in the early stages, but I personally find the numbers disappointing, especially given how little time it takes to participate. We need to do much better than this if we are to have any hope of effecting change.
I apologize for being a bit off-topic here, so to make this post more on-topic with the subject of the thread, if anyone listened to that workshop and still holds any hope that FDA will seek to regulate us with a light touch and with full appreciation for the promise that e-cigarettes hold as an incredibly low-risk alternative to smoking, you weren't paying attention.
The CTA on the grandfather date is, as we all know, not a long-term solution. The TCA was designed to make it almost impossible to bring a new product to market and also to make products less appealing to consumers in an effort to reduce use. The grandfather date change would alleviate the first problem (but not fix it since any grandfather date will have the effect of freezing technology at some point), but we'd still be faced with the almost certainty that FDA would regulate us so as to reduce product effectiveness and satisfaction . . . flavors, nicotine strengths, online sales, refill liquids, advertising all would be on the chopping block once FDA gains jurisdiction over us as "tobacco products."
So we ask for the grandfather date change while at the same time pushing for a long-term solution, namely, a different regulatory framework for e-cigarettes that recognizes their promise and regulates for basic quality control and genuine consumer interests. (And Bruce is correct that part of what is happening with the CTA is a gauging of support.)
But to do this, we need to mobilize the masses so that they (1) understand the threat, and (2) stand up and fight.
So far, here are the numbers:
Call to Action asking for a change in the grandfather date: 2,539 advocates have participated thus far, generating 7,976 emails.
Thank you letter to Boehner, McCarthy, and Upton: 2,962 advocates have joined CASAA's thank you letter.
(We also asked people to call and/or send a personal thank you note to the Boehner, McCarthy, and Upton, but we have no way of tracking that. I suspect, at best, a handful have made a call or written a personal note.)
Granted, the CTA (and thank you note) were only released Tuesday (12/9/14), so it's still in the early stages, but I personally find the numbers disappointing, especially given how little time it takes to participate.
We need to do much better than this if we are to have any hope of effecting change. I apologize for being a bit off-topic here, so to make this post more on-topic with the subject of the thread, if anyone listened to that workshop and still holds any hope that FDA will seek to regulate us with a light touch and with full appreciation for the promise that e-cigarettes hold as an incredibly low-risk alternative to smoking, you weren't paying attention.
......I apologize for being a bit off-topic here, so to make this post more on-topic with the subject of the thread, if anyone listened to that workshop and still holds any hope that FDA will seek to regulate us with a light touch and with full appreciation for the promise that e-cigarettes hold as an incredibly low-risk alternative to smoking, you weren't paying attention.
Thanks for the update, hoping it makes a difference.
As far as off topic, if the ECF mods rated what was discussed at the FDA workshop with the reality of vaping this whole thread would have to be moved to the Lounge in the Outside.
I don't fully get how reclassifying eCigs as not tobacco products would automatically give us long term solution. I get how it would offer us hope and likely help, but our adversaries would realize that tactic (probably already do) and I could see them spinning that in a way that would be highly negative while our side spins it as positive and great. Also, as long as the nicotine is derived from tobacco, or that perception is out there, I don't think it will be an easy switch. Akin to how other stuff devices are not treated by 'people in the know' as must only be seen as a device that is for tobacco use.
IMO, if truly focussed on long term, then the rhetoric / politics around smoking has to change. Vaping can still enjoy status of many times safer and benefits that likely come from that. But as long as "they are right about smoking" is in play, then I think for the foreseeable future they stand to benefit from "and are probably not entirely wrong about vaping" especially as 'people in the know' realize it does come down to what will long term data show everyone.
And given that FDA (along with ANTZ and even some in THR) feels absolutely righteous on tobacco smoking, I think it is safe to assume that for a very long while vaping will face an uphill battle. Though we do seem to live in a time when whatever was considered absolutely correct just 50 years ago isn't only being viewed through that prism, so I don't see those who hang onto the meme of "smoking kills" as enjoying much benefit from that going forward. And the side that disputes this, which I am proudly on, really has nothing to lose while the other side, arguably, has everything to lose if that meme is challenged and shown for the farce that it is.
IMO, if truly focussed on long term, then the rhetoric / politics around smoking has to change. Vaping can still enjoy status of many times safer and benefits that likely come from that. But as long as "they are right about smoking" is in play, then I think for the foreseeable future they stand to benefit from "and are probably not entirely wrong about vaping" especially as 'people in the know' realize it does come down to what will long term data show everyone.
And given that FDA (along with ANTZ and even some in THR) feels absolutely righteous on tobacco smoking, I think it is safe to assume that for a very long while vaping will face an uphill battle. Though we do seem to live in a time when whatever was considered absolutely correct just 50 years ago isn't only being viewed through that prism, so I don't see those who hang onto the meme of "smoking kills" as enjoying much benefit from that going forward. And the side that disputes this, which I am proudly on, really has nothing to lose while the other side, arguably, has everything to lose if that meme is challenged and shown for the farce that it is.
I don't really see it as a "smoking is bad, don't treat vaping like smoking" argument, I see it as the FDA's policies on tobacco control are designed to keep cigarettes static and from becoming more harmful and as such, do not promote innovation. Vapor products, if regulated under these same policies, would become stagnant.
Greg Conley has a great voice too - sounded twice as loud and just the right speed to make you wake up and listen without fealing sure you were being yelled-at.
Has anyone seen an overview on the british and french standards in development referred to?
Inhalation Toxicology - is that all about combustion products? He referred to prior art like it was worth looking at but the whole field sounded like smoke inhalation studies.
Has anyone seen an overview on the british and french standards in development referred to?
Inhalation Toxicology - is that all about combustion products? He referred to prior art like it was worth looking at but the whole field sounded like smoke inhalation studies.
I agree with you Julie.
What Jman8 parsed out of context was "If no-one participates in this CTA I don't hold much hope for vaping's future." Perhaps it would have been better written "If too few participate..." but that's water-over-the-dam now.
I'm happy that we have the numbers we do at this early stage, but they need to keep growing. I'm spending time at shops getting the word out, and fielding "I'm not political" responses... That's very discouraging, especially when you and CASAA have made this effort as 'push-button' simple as it can be. But the effort will continue because it is important and I can do it.
I'm disappointed that there are those who believe that Dr. Farsalinos suggesting e-liquid standards is tantamount to endorsing deeming. They are separate issues. Deeming is all but a foregone conclusion at this point. It doesn't matter one wit one or several persons endorsement, what matters is law and that means Congress. As for e-liquid standards, Dr. Farsalinos made a reasonable suggestion and I'd be hard pressed not to find the kernel of his idea already embodied in AEMSA's standards.
I'm disappointed that Tom Eissleman was taken to task when the context and what he was saying was clearly intended to promote his and his partner's work to discover if there may be a 'sweet spot' that could 'pleasure' a smoker but not a non-smoker in regards to nicotine bio-availability (flux in his terminology). That had nothing to do with flavors or preference, the context was clear.
We have to become more open minded listeners. It's hard when we're presented with what FDA considers relevant (e.g.: RCRA, 21CFR201.66, etc.). What we're being shown is their direction. We have to grow a thicker skin. We have to be the Better Man. We have to counter them and their proposals, in Congress, that means we have to address these areas with our own reasonable alternatives (e.g.):
- If they want medical device/drug labelling we have to have something more than just fine print.
- If they want RCRA we have to have proposals and the science to back it that says e-liquid in certain amounts does not need RCRA regulation.
- If they want particle size limits at a certain level (following Glanz et.al.) we need to have proposals and the science that says there's a better alternative standard that makes e-cigarettes more effective as a smoking alternative and minimizes the likelihood of addicting the non-smoking public. [Saying that nicotine is not addicting is akin to saying God doesn't exist. Despite the lack of evidence or evidence to the contrary it is a belief well rooted in the voter's mind that is not going to change soon enough to make a difference to our present circumstance.]
- If they want device materials standards we have to have proposals and the science to back it up that the materials and processes are safe.
- If they want batteries to meet a medical standard for safety we have to counter that the devices are not life-critical medical devices and are as safe as laptops, cell-phones, MP3 players, etc.
- If they want "childproof" packaging we have to show ISO 8317 compliance and show evidence of effectiveness already exists.
So listen again, listen to what is being said, understand the context and imagine alternatives that are feasible, reasonable, and saleable to your neighbor across the street who neither smokes nor vapes and has two kids; one a toddler the other in high school. If we can come up with something this person would agree was a good idea we can capture a good percentage of voters, and that gives us Congress. To do that we need boots on the ground, and heads on our shoulders.
What Jman8 parsed out of context was "If no-one participates in this CTA I don't hold much hope for vaping's future." Perhaps it would have been better written "If too few participate..." but that's water-over-the-dam now.
I'm happy that we have the numbers we do at this early stage, but they need to keep growing. I'm spending time at shops getting the word out, and fielding "I'm not political" responses... That's very discouraging, especially when you and CASAA have made this effort as 'push-button' simple as it can be. But the effort will continue because it is important and I can do it.
I'm disappointed that there are those who believe that Dr. Farsalinos suggesting e-liquid standards is tantamount to endorsing deeming. They are separate issues. Deeming is all but a foregone conclusion at this point. It doesn't matter one wit one or several persons endorsement, what matters is law and that means Congress. As for e-liquid standards, Dr. Farsalinos made a reasonable suggestion and I'd be hard pressed not to find the kernel of his idea already embodied in AEMSA's standards.
I'm disappointed that Tom Eissleman was taken to task when the context and what he was saying was clearly intended to promote his and his partner's work to discover if there may be a 'sweet spot' that could 'pleasure' a smoker but not a non-smoker in regards to nicotine bio-availability (flux in his terminology). That had nothing to do with flavors or preference, the context was clear.
We have to become more open minded listeners. It's hard when we're presented with what FDA considers relevant (e.g.: RCRA, 21CFR201.66, etc.). What we're being shown is their direction. We have to grow a thicker skin. We have to be the Better Man. We have to counter them and their proposals, in Congress, that means we have to address these areas with our own reasonable alternatives (e.g.):
- If they want medical device/drug labelling we have to have something more than just fine print.
- If they want RCRA we have to have proposals and the science to back it that says e-liquid in certain amounts does not need RCRA regulation.
- If they want particle size limits at a certain level (following Glanz et.al.) we need to have proposals and the science that says there's a better alternative standard that makes e-cigarettes more effective as a smoking alternative and minimizes the likelihood of addicting the non-smoking public. [Saying that nicotine is not addicting is akin to saying God doesn't exist. Despite the lack of evidence or evidence to the contrary it is a belief well rooted in the voter's mind that is not going to change soon enough to make a difference to our present circumstance.]
- If they want device materials standards we have to have proposals and the science to back it up that the materials and processes are safe.
- If they want batteries to meet a medical standard for safety we have to counter that the devices are not life-critical medical devices and are as safe as laptops, cell-phones, MP3 players, etc.
- If they want "childproof" packaging we have to show ISO 8317 compliance and show evidence of effectiveness already exists.
So listen again, listen to what is being said, understand the context and imagine alternatives that are feasible, reasonable, and saleable to your neighbor across the street who neither smokes nor vapes and has two kids; one a toddler the other in high school. If we can come up with something this person would agree was a good idea we can capture a good percentage of voters, and that gives us Congress. To do that we need boots on the ground, and heads on our shoulders.
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I agree with this, but all these things you list are manufacturing concerns. A consumer can speak on these, but can only go so far until someone (may be a fellow vaper) says something along lines of "why not manufacture, and sell, your own vape gear?"
But consumers are stakeholders too. Arguably the most important stakeholders. Without demand, this market would stagnate. As consumers we pay more attention to ANTZ media/hype probably more than anyone in the game. All these things you write about could be things that are trappings to have industry fall in line and then criticized down the road based on technicalities or just plain old deception/propaganda.
If ANTZ and anti-smoking rhetoric weren't in the picture, I believe we would show up a lot more open minded. As they are in the picture and the neighbor across the street who neither smokes nor vapes can be influenced (or brainwashed) by ANTZ rhetoric, then our job is to let them know "you are being brainwashed, and I ask that you keep an open mind. Don't believe you are being brainwashed? Here, let me show you how they are lying to you."
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