FDA FDA deeming regulation proposals

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Sirius

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The reason why I was a dual-user of both traditional & e-cigs at first, is because the BT cigalikes I was using at the time were extremely inadequate..

If I had my ProVari & some decent juice right out of the gate, I probably would have quit smoking the very 1st day, instead of being a dual-user for 8 months...


I suspect the correlation between dual-use & cigalikes is quite high..

Which is exactly why those studies they use are bunk...

I also started with those cigalikes.. They blow for sure! I didn't completely stop smoking until I started dripping.
 

Thundernoggin

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Me either..I feel we are being ganged up on by the bureaucrats and kidstapo.

Me too. Part of the rhetoric has been about all the marketing to children. I would ask them where this is going on because I have yet to see a single commercial or ad outside of the online vaping communities (populated by adults) and those ads aren't aimed at children.
 

Myk

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the proposed regulation seem to be trying to say both are true.
but they can only regulate as stated in the original 2009 law.
it clearly wasn't written with anything like e-cigs in mind.
i think that is why the proposed regs are so confusing.
the FDA is trying to muddle things up in hope they can try to drive
the proverbial truck through the closed door.
the big problem the FDA has is i don't use my zippo to light the end
of my ego c.
i don't think they can change by new regs what the definition of accessories used in the consumption
a tobacco product to accessories used for the consumption of a tobacco product.
as i said before the lawyers on both sides of this are going to be very busy.
:2c:
regards
mike

FDA can lobby congress to change anything in the law they need changed to make it fair for the bulk of ecig manufacturers. They can also exempt ecigs if they wanted just like they propose to do with rich fat cat cigars to avoid destroying the industry.

Don't believe them claiming their hands are tied.

All the ecig equipment could be handled with GMP, these batteries are safe, these metals are safe, these plastics are safe. They could even do similar with liquids, these ingredients are safe, here is the GMP for mixing.

The problem is when they start saying you have to have your 3 banded stainless drip tip approved and now you want to make a 5 banded stainless drip tip, that needs a separate approval. You mix up 18mg strawberry and get it approved, now you mix up 11mg with the same flavorings and that needs a separate approval.
If stainless is a safe metal for drip tips it is a safe metal no matter who makes it or the design. If strawberry is a safe flavor it is a safe flavor no matter what mg it is, after that it comes down to the conditions it was mixed in.
 

Myk

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i have been trying to find this out also.
i googled "how does the government regulate tobacco pipes?" and variations of that and
found nothing of relevance.
i do remember those little pipe filters though.could be they were considered an accessory used in
the consumption of a tobacco product?
regards
mike

I haven't read every word (mainly skimmed for ecig stuff) but I think this proposal treats pipes like ecigs so every pipe a custom pipe maker does has to be approved. Technically since every piece of briar is unique like a hand rolled cigar every pipe ever made would need separate approval.

Nobody really uses those pipe filters. They were for drug store pipes, drug store "smoking tobacco" (fine cut like the "pipe tobacco" RYO is using to beat the taxes) and people who didn't know how to pack a bowl.
 

aikanae1

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I'm not arguing. I thought the links I posted were relevent to the discussion as far as the process of getting items approved / application process and might be interesting to more than Jman. At least I found them to be. They point out pitfalls. I know many people would like to give the FDA the benefit of the doubt. My experience is that it pays to prepare for the worst case scenerio, build in protections and hope for the best. So for that reason I say we can assume all components are also included until we find out otherwise. That way our ... is covered.

We don't have all the information to act on this immediatley. People with more experience are still looking it over. It's a massive and vague document.

What we can do is be noisy to our reps, make noise against local bans and I just saw CASAA post their total membership is 13,000!!! That's all???? Com'on, there are over 10x's that many unique visitors to ECF in a day! Yes, a membership drive everywhere. It would help immensley to get those numbers up. To be taken seriously, CASAA needs at least 10x's those numbers or they can't say they represent vapers.

That is what we can do NOW.

I'm sorry, I don't have time to read every single post right now.

aikanae1 and Jman... WHY is it you are both still arguing between each other on AN OPEN FORUM...!!! You both are my friend but, ENOUGH...!!!
If you two wanna' argue, then take it to your email... this isn't doing ANY of us any good, it's hurting us all in fact. OR, just let it go... please.

We, as a group HAVE to make our demands so that the CASAA has something to work with. THIS is the core of getting us together in agreement. I'll ban you myself if I can to keep this on a level that supports us all... Seriously, Now is the time we need to do this, as we have the time to do it. If y'all wanna fight, take it elsewhere. Please.

They aren't playing... and we can't be either. This is NO game, this is important to us ALL... and i'm not going to tolerate arguments, about syntax of whatever on an open Forum, such as this. It's ALL viewable through Google. LISTEN...!!! They aren't playing, and neither am I... it matters. Let's get to business again... please. *focused*
 
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mkbilbo

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Outlawing hit men is not the same as making a law who's costs are only affordable to giant corporations. It violates equal protection. It possibly violates protectionism.

I'm oversimplifying of course (not a lawyer, allergies kicking me around, etc. so on ;) ) but...

I mean it's not suffcient to claim a kind of "restraint of trade" in cases when products are dangerous. Such as cigarettes. No questions left on those, they're inherently dangerous. Even when "used correctly". Even when made to high standards of quality. Safety issues override.

(By the way, given the diversity of political opinion around, I intend to keep ducking whether regulation should or should not exist or how much there should be and deal with what is. I'm never agreeing nor disagreeing with the current system, it's just the one that is and has to be dealt with. For the time being, it's necessary to grit our teeth and smile at any and all vapers even if you'd rather being throwing rotten veggies at the for their politics. :) )

So, anyway, that's my probably badly made, very clumsy point. Issues of "trade" are secondary to issues of safety. Which is why the FDA is ducking evidence vaping is radically safer if not just out right safe (relative to life in general that is, I'm more worried about the idiots on the highways than any possible long term effects of vaping... seriously, you should see Austin drivers... urk!... and nothing is perfectly safe)

But the FDA can claim products are so inherently risky, restraining trade is necessary. And something as dangerous as smoking has proven to be, it's even justifiable (legally at least) to restrict production to a handful of companies that can be kept on a tight leash.

My question is whether the courts would go along with the FDA's rather studied "we dunno" about the safety of vaping. I suspect (again, ain't a lawyer) there's a weak spot there. They're rather brazenly saying they have to regulate because "who knows?" how risky the product is. I mean, what if creates black holes and consumes the planet? We don't know!!!

I agree. The regulations only on the nicotine liquid would make some sense. Expanding it to equipment is ridiculous (and the reason it's ridiculous is to had ecigs over to big tobacco). The equipment could easily be covered with GMP, issue a list of metals, plastics and wicks that are OK to use.

Lot of it could be simplified but what's the fun in that? A massive expansion of the FDA means new offices for everybody!!!!
 

aikanae1

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Me too. Part of the rhetoric has been about all the marketing to children. I would ask them where this is going on because I have yet to see a single commercial or ad outside of the online vaping communities (populated by adults) and those ads aren't aimed at children.

Let me remind you that the purpose of the original act was to wipe out smoking. I think it was a goal to have a smoke-free generation by 2020. So I can fully understand this anti-tobacco stance from congress and the FDA. I don't agree with their methods.
 

mkbilbo

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Me too. Part of the rhetoric has been about all the marketing to children. I would ask them where this is going on because I have yet to see a single commercial or ad outside of the online vaping communities (populated by adults) and those ads aren't aimed at children.

Because flavors! Adults never, never, never want flavors! In fact, adults eat cardboard because they detest sweet things and abhor fruit flavors. Why, just this week, I was so offended by the sight of bananas at the store, I like ta puked I tell ya! I mean they were right out in the open! Disgusting!!!
 
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Sirius

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I'm not arguing. I thought the links I posted were relevent to the discussion as far as the process of getting items approved / application process and might be interesting to more than Jman. At least I found them to be. They point out pitfalls. I know many people would like to give the FDA the benefit of the doubt. My experience is that it pays to prepare for the worst case scenerio, build in protections and hope for the best. So for that reason I say we can assume all components are also included until we find out otherwise. That way our ... is covered.

We don't have all the information to act on this immediatley. People with more experience are still looking it over. It's a massive and vague document.

What we can do is be noisy to our reps, make noise against local bans and I just saw CASAA post their total membership is 13,000!!! That's all???? Com'on, there are over 10x's that many unique visitors to ECF in a day! Yes, a membership drive everywhere. It would help immensley to get those numbers up. To be taken seriously, CASAA needs at least 10x's those numbers or they can't say they represent vapers.

That is what we can do NOW.

I'm sorry, I don't have time to read every single post right now.

Yes and that application process would be costly imo. Do we have lobbyist in DC? No not that I know of. BT and the Pharmaceutical Co.s do though. That is why I said before that some big money is behind this FDA decision to crack down on what they call, "The wild west.." of the vaping world. So just to put that into context, remember what happened to the Native Americans. lol
Sorry I couldn't resist. ;)
 

skoony

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FDA can lobby congress to change anything in the law they need changed to make it fair for the bulk of ecig manufacturers. They can also exempt ecigs if they wanted just like they propose to do with rich fat cat cigars to avoid destroying the industry.

Don't believe them claiming their hands are tied.

All the ecig equipment could be handled with GMP, these batteries are safe, these metals are safe, these plastics are safe. They could even do similar with liquids, these ingredients are safe, here is the GMP for mixing.

The problem is when they start saying you have to have your 3 banded stainless drip tip approved and now you want to make a 5 banded stainless drip tip, that needs a separate approval. You mix up 18mg strawberry and get it approved, now you mix up 11mg with the same flavorings and that needs a separate approval.
If stainless is a safe metal for drip tips it is a safe metal no matter who makes it or the design. If strawberry is a safe flavor it is a safe flavor no matter what mg it is, after that it comes down to the conditions it was mixed in.

i do a agree with you for the most part.e-juice with nic is definitely a finished tobacco product.
my full flavor menthol 100's are definitely a finished tobacco product.
in context of the 2009 law it would seem that hardware is not a finished tobacco product
and congress would have to get involved to change something.i am not saying i am right
either,just what i am getting out of all of this.
for instance using google i cant find out anything,how,or why,or if things such as tobacco
pipes or cigarette holders where, or are regulated as that would assuredly establish a
president in how hardware should be handled.
regards
mike
 

Gato del Jugo

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I just saw CASAA post their total membership is 13,000!!! That's all????

Considering their membership was only at 8,900 in January of this year, a 48% increase in just 3 or 4 months ain't too shabby...

I agree, though, that the more the merrier..


Fortunately, I suspect we'll see that number continue to climb... :)
 

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Well, I think I'm done after reading what OMB said. Here's why: I, now, see all too clearly what we're up against. I can't fool myself with thoughts that the major players are just ignorant boob bureaucrats in hopes that they actually intend to listen to public reason be that scientific, testimonial or anecdotal. I know it sounds dramatic, which I'm not in the habit of being, but the word "sociopath" has actually gone through my mind whilst reading and one of those is someone I would never underestimate. My final decision on all of this is that its way beyond my scope. I simply don't have the knowledge nor experience dealing with these types nor the expertise and resources required for navigating the traps and nets laid. I think the wisest thing I can do, which I'm not perfectly happy with as its out of character, is leave this to those who do possess all that's required. I'm going to take the advise of those approaching this first hurdle and lend my monetary support to the ensuing legal battles which are sure to come. Right now, that means CASAA. For those who would counter with leeming accusations... no, I don't think so. As I said, I think its wise. The most successful people in life are those who consult experts in the fields they're unfamiliar with instead of believing they are capable in those. I may not agree with everything they say. I already tend to disagree with Bill for instance as he seems (in the round-table broadcast anyway) to think juice is the main issue while I think its components but I'm going to follow his lead as he's been at this in-depth for many years. I think, putting all politics aside, It would be super egotistical of me to think I know better than he does. That doesn't mean I won't be watching like a hawk no differently than I have lawyers I was paying but had to "trust" and, if or when I have a strong concern, I'll ask for the reasoning. Anyway, that's where I'm at. I am just going to lay this aside and wait for now because the more I read from various sources, including OMB, the more upset I get.
 
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Jman8

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This is what CASAA had to say about it:

CASAA: FDA regulation of e-cigarettes: huge costs, little or no benefit, says CASAA
"It is estimated that as many as a million American smokers have quit or substantially reduced their smoking thanks to e-cigarettes, and many are already making plans for a black market if these regulations take effect."

Big money must be behind this FDA decision to propose regulations. Who knows in two years time the black market may include e-liquids.

For me, the last 2 sentences are a given. Big money is behind FDA decision to propose regulations, who knows what a black market will include in years to come. With this in mind (especially the big money and increasingly negative public perception around eCigs, due to ANTZ propaganda), I am somewhat encouraged that this first round proposal wasn't heavy handed. I do believe we, anyone that responds, including ANTZ, will be significant part of what shapes regulations over next 3 to 5 years. I'd like to take the opportunity to yet again express my utter disdain for (idea of) heavy handed regulations on tobacco products, all of them, especially eCigs. Also disdain for idea that we are in a world, partially due to Soterra judgment, that eCigs are considered a tobacco product. Reasonable regulations I feel open about, but heavy handed ones, that incur high costs are something to fight against, and win on as much as can be won, while also realizing that regulations appear to be inevitable.

The CASAA link cited above highlights the science aspect of the proposed regulations. As I sit and draft my response to FDA, I am waiting on CASAA to provide link to all the science that is a) legitimate and b) is essentially pro vaping. I feel CASAA will cover this, and I feel this is going to be a key part of any and all responses, especially those treated as 'high value' by the FDA. I see FDA being heavy handed with regards to the science, but is just bizarre to me that this can be done in public fashion. It greatly affects credibility of science IMO. Yet, 'tobacco regulations/rights' are likely so low of a consideration by general public when it comes to scientific credibility, that I'm feeling like 75 days to address that, how it ought to be addressed (with lots of scientists everywhere weighing in) is far too short of a time period.

I believe, very strongly, that current scientific data strongly supports the pro-vaper side of the equation. It is definitely part of reason why I advocate for 'vape everywhere' and feel up for that discussion at any time. I grant that strictly going with political correctness while downplaying available science, that 'vape everywhere' is not a constructive position in today's political climate. But, I'd really rather not downplay the science and thus don't see the purpose in being politically correct on this. That continues to show up to me as rolling over and welcoming politically correct regulation that believes now is the time to push for outdoor usage bans as well. As this is our current political fight, and is occurring in dozens of places nationwide, it greatly concerns me that most vapers would rather be politically correct on this issue than deal with what science has said thus far about vapor, particularly secondhand vapor. Greatly concerns me. It reads to me that what they just got doing to smoking, they can, rather easily do with vaping, and many vapers aren't going to fight them on it.

But usage bans aren't found in FDA proposed regulations, and so the current scientific data, that supports pro-vaper side of the equation will be speaking to other things where FDA has put forth, "we don't have enough evidence" and "we seek comments on this." I am hoping that a great number of vaping enthusiasts will organize and produce great number of responses that cite scientific data that is legitimate and provides evidence where FDA is lacking. Arguably we can all include this. Though I see some doing, some not, and some choosing instead to speak without science in mind, per se, and going with response of, "no seriously, eCigs saved my life."

I also concede that scientific data doesn't 100% support pro-vaping side. I don't think it ever will, nor should it be expected to. But for a proposed regulation to even hint at idea that it ought to, otherwise regulations to 'protect the children' must be in place, is partially what we are up against. With that in mind, I think, in the interest of scientific consensus building, that all comments to FDA that are citing scientific data (that is legitimate) ought to be copy/pasted and shared elsewhere, as if there will be public database, open to everyone, that shows this was shared with the FDA way back in 2014. Otherwise, I think it could be seen by 'general public' as something that wasn't widely known in 2014, and that we (humanity) didn't know in 2014 if FDA was actually aware. Politically aware vapers have pretty good idea that FDA does know, even before proposal came out, that scientific data supports pro-vaping side, but have chosen to write up a proposal as if they don't know, for sure.

And that 'we don't know for sure' thing is both troublesome, but really par for the course. I'm a dual user. I use a cigalike. Therefore I fit into dataset that says I will continue to be a dual user, simply because I am using a cigalike. Which for me means you don't know what you are talking about if you spout that nonsense. I've quit cold turkey before. I do not crave smoking right now. For me, the addiction has been broken. Not maybe it has. It has. I choose to dual use. To think science knows something here about my being a dual user that I do not, is intellectually dishonest and would destroy scientific credibility from anyone that wishes to express this, even if they are pro-vaping, and all happy with their larger device that helped them break their own addiction to smoking. But to me, it is fact that cigalikes can break that addiction. As confident as vapers are on the things 'we know' and that scientific data appears to support, I am that confident that cigalikes break the addiction to smoking. Thus, that would be another possible item that pro-vaping side could roll over on, by allowing claim that cigalikes don't work and probably do maintain an addiction to smoking, which is why those types may show up as dual users. Hence, the science, at a certain level is simply confusing and arbitrarily applied. Which is why I don't put all my eggs in that basket going forward in offering a reasonable response to these regulations.
 

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Sirius

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I believe, very strongly, that current scientific data strongly supports the pro-vaper side of the equation. It is definitely part of reason why I advocate for 'vape everywhere' and feel up for that discussion at any time. I grant that strictly going with political correctness while downplaying available science, that 'vape everywhere' is not a constructive position in today's political climate. But, I'd really rather not downplay the science and thus don't see the purpose in being politically correct on this. That continues to show up to me as rolling over and welcoming politically correct regulation that believes now is the time to push for outdoor usage bans as well. As this is our current political fight, and is occurring in dozens of places nationwide, it greatly concerns me that most vapers would rather be politically correct on this issue than deal with what science has said thus far about vapor, particularly secondhand vapor. Greatly concerns me. It reads to me that what they just got doing to smoking, they can, rather easily do with vaping, and many vapers aren't going to fight them on it.
Sorry to cherry pick your well written response Jman. I strongly agree with (in bold) and yes, political correctness along with superficial regulations will harm us immensely.
 

Sirius

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aikanae1

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Yes and that application process would be costly imo. Do we have lobbyist in DC? No not that I know of. BT and the Pharmaceutical Co.s do though. That is why I said before that some big money is behind this FDA decision to crack down on what they call, "The wild west.." of the vaping world. So just to put that into context, remember what happened to the Native Americans. lol
Sorry I couldn't resist. ;)

Yea, I got that association with the "wild, wild west" bs.

The American Vaping Assoc. (Greg Conley's group) formed to lobby Wash DC. I have a feeling it's hitting the ground running. I've seen him in a few meetings and was impressed sorta like "huh, was that a tornado that just hit?". They do accept donations.

I just see a lot of energy right now and it could really be utilized. I hear that people want to "do" something and that's great. I hope they realize that might mean 1) more than an email and 2) getting off the internet. But I think it's a multi-stage thing. First they had to realize this was serious and already our wings have been clipped a bt.

Dr. F. wrote up an interestng post awhile ago asking where the vapers were when these regulations were being drafted. He's proved to be right. Because vapers, esp vendors were so loosely organized, we didn't get a seat at the table per his post.

CASAA really needs to get those numbers up.
 
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Myk

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i do a agree with you for the most part.e-juice with nic is definitely a finished tobacco product.
my full flavor menthol 100's are definitely a finished tobacco product.
in context of the 2009 law it would seem that hardware is not a finished tobacco product
and congress would have to get involved to change something.i am not saying i am right
either,just what i am getting out of all of this.
for instance using google i cant find out anything,how,or why,or if things such as tobacco
pipes or cigarette holders where, or are regulated as that would assuredly establish a
president in how hardware should be handled.
regards
mike

It's the FDA reading (twisting) the letter of the law to expand their powers and defacto ban what they want to ban for no reason than they want to. Pipe smoking was shown by the '64 SG to be healthier than not smoking (pipe smokers lived longer than non-smokers), cigars weren't that bad but if hand rolled cigars should still be untouched pipes and ecigs should be too, but I guess rich people don't like pipes or ecigs.
 
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