FDA Proposed regulation is available

[hoogie76]

Never underestimate the forces that drive fanaticism and ideology. (I think we're all agreed that FDA is *not* producing science-based regulations, aren't we?)

I'd say.. did you see the references they used at the end of the document? All hand picked for a negative portrayal. What fascinates me most is that some are as recent as March 2014. Surely they've seen some of the other studies and chose to ignore them?


Because e-cigarettes are not currently subject to FDA jurisdiction (unless they are marketed for therapeutic purposes), FDA currently lacks the authority to collect vital information about these products. Deeming these products would permit us to collect information about their ingredients to ensure that other potentially harmful constituents are not present. Deeming would also allow us to collect information regarding health and behavioral effects of these products.

How were they able to include any references at all and make conclusions from them?

hoog

 

[Anybody]

Just did a follow up with the AP.

The reporter totally understands the SE process, and how it is almost unworkable for ecigs...

He said that he just got off the media call and Non-Nic items are NOT under FDA jurisdiction

That they said they "only have authority to regulate nicotine as a tobacco product"

which he seemed to think, means pre-filled, cig-a-like and liquid are the only things the FDA can regulate here....

mods, Attys, tanks, Etc, Etc, Etc don't contain nicotine

Thats sorta my take on it too. I can't buy a prefilled Protank, so how could they regulate it as a tobacco product?

 

[Jman8]

Seems everyone is celebrating the regulations to ban the sale of e-cigs to minors, both in person and via the internet. Makes sense if you consider the total ban for minors of regular cigarettes, alcohol, illegal drugs, prescription drug abuse, underage driving, youth gangs and graffiti markers to be a rousing success.

To me, this is the biggest issue of them all. Restriction/forbidding use by minors. It literally rules all other provisions in the deeming regulations.

Politically, I advocate staying neutral on this one. But alas, that doesn't seem to be the case and instead overwhelming majority of adults rather act as ageists and feel such a ban is a great thing for all involved. In reality, I'm not neutral on this topic, and am not just playing devil's advocate when I oppose such a ban. IMO, you favor a ban to minors, and you've just paved the way to massive regulations for adults. You made that bed, now lie in it.

Nowhere in my short review of the FDA proposal do I see what impact deeming regulations may have on use by minors. Lots of supposition about what regulation could do for 'public health' and preventing youth from getting into the habit that is vaping. But world don't work like that. Instead, because it will be seen as 'forbidden,' it'll be all the more appealing to kids and something that is undeniably cool if you are able to get your hands on it and are under 18. Thus, the black market, is already in place and will, IMO, get much stronger than it is currently. Night and day stronger.

Everyone I know that has smoked, started under 18, and for almost all of those same people, it was forbidden/illegal to do so. Didn't matter to us. Not even a little bit. All these stories of "smoking kills" are a great myth when you're under 25, but so far removed from reality that only a naive fool would believe. When you're under 20, if something is said to kill you later on in life, you (or I) tend to look at that as, 'cool, I get to do this for a few more decades, which is longer than I've currently been alive!' Plus you have peers, all around you, who are using, and staying active, winning football games, dancing, making new friends, and doing alright for themselves.

I'm thinking I'm not going to sway popular opinion on this issue regardless of what I say here. But I do believe, strongly, that the cool factor will go up a notch with an FDA ban toward minors. IOW, the opposite effect of what is intended will occur. As if this generation of adults has somehow tapped into something that the previous 3000 years of adults didn't already consider, try and previously failed at.

 

[vapero]

if the FDA ends up banning flavors in nicotine the sellers would just sale flavorless and also sale their flavors for "baking" just add 7% once you receive your order! there won't be an issue there, they will probably charge you extra for the extra bottle but that's it

 

[tommy2bad]

The thing is this regulation isn't designed to take away our ecigs, well maybe some of them, it's designed to stop further uptake of ecigs.

 

[Schwiggiddy]

brought peace?

oh shut up!

 

[Fulgurant]

Plus, when you're proven mostly or completely right, it's hard to argue a lack of "common sense" and "caution."

Events have proven no such thing. It is irrational to evaluate a position or a decision based on what happened afterwards; all that matters is the information available at the time. If I bet my entire life savings on a horse race, would that decision suddenly become sensible in retrospect just because I happened to win?

The FDA has shown it doesn't have our best interest at heart. The FDA is directed by demonstrably unreasonable quangos and special interests -- you know, people who want to ban/restrict/tax the snot out of everything from cigarettes to sugar, simply because they need excuses to expand their power and draw (often public) funding. If you wish to argue (either retrospectively or prospectively) that the FDA isn't the biggest threat we face, then sure, have at it. I might even agree with you.

But to sit smirking on the sidelines as you watch various people tie themselves in knots, on your behalf, in an effort to ensure that the FDA doesn't overstep its bounds -- and then to criticize those same advocates for their alarmism at the very first sign that they might have succeeded in preventing the worst-case scenario -- well let's just say I think that's in bad taste. We're all on the same side here. We should all be aware that although the FDA seems to have punted today with regard to the particulars, the FDA nevertheless asserted near-absolute authority over the ecig industry going forward.

What's worse is that FDA's superficially light touch allows all of the various local/pressure-group nutjobs to continue screaming that ecigs are under-regulated. In that sense, one could argue that FDA's proposal is an extraordinarily deft anti-ecig maneuver. If the assaults keep pace in the media and in state/local legislatures, there may not be a whole hell of a lot left in two years for the FDA to regulate.

 

[DanFromRioRancho]

Doubtful. This is likely to impact cig-alikes far more than our PVs, actually. With separate units, our batteries are NOT nicotine delivery devices as they can be easily used to vape 0 nic liquids.

Only medical devices fall under the FDA's umbrella, to my knowledge. The FDA just deemed these as tobacco products--and they do not currently require approval of every type of tobacco pipe on the market, nor hookahs.

As mentioned earlier, it's for this reason head shops can legally sell items as long as illegal substances are never mentioned. That interesting device? Jelly bean holder.

Don't think you have it quite right.....there are multiple sections in the proposal that go to great lengths to distinguish between "accessories" and "components" and a bit of whining about the Soto decision (medical device exclusion issue). The proposal is specific as to coverage/inclusion of "components" as part of the deeming which allows for a nice end-run around the Soto decision and opens the door to causing grief for the battery/atty/etc. manufacturers as well as increased expense for the consumer.

 

[patkin]

I haven't read the whole thread so if its been addressed... sorry. I don't understand why they're going after free samples. Maybe there's some history I don't know. I know I've gotten free sample packs of smokes. Are they going after people like Njoy or are the going after B&M juice sampling? I can't get my brain around any reason for a ban pertaining to health. Maybe it has to do with future taxing?

 

[Kent C]

If I bet my entire life savings on a horse race, would that decision suddenly become sensible in retrospect just because I happened to win?

Agree with your whole post, but that was special. lol....

 

[MorpheusPA]

Events have proven no such thing. It is irrational to evaluate a position or a decision based on what happened afterwards; all that matters is the information available at the time. If I bet my entire life savings on a horse race, would that decision suddenly become sensible in retrospect just because I happened to win?

Tish-tosh. If you evaluate the probabilities and the events work that way, it's hardly irrational to have arrived at that conclusion. I, for instance, wouldn't bet on the Sun going nova tomorrow given what I know of fusion processes and solar stability. It would be foolish (on several levels) to bet that it will.

The horse analogy is inaccurate; you weren't running a probability and finding it in your favor. Or if you were, available data contradicts you.

The FDA has shown it doesn't have our best interest at heart. The FDA is directed by demonstrably unreasonable quangos and special interests -- you know, people who want to ban/restrict/tax the snot out of everything from cigarettes to sugar, simply because they need excuses to expand their power and draw (often public) funding. If you wish to argue (either retrospectively or prospectively) that the FDA isn't the biggest threat we face, then sure, have at it. I might even agree with you.

The FDA isn't the biggest threat, and while I certainly don't think they have my best interests at heart consistently, I'm also not a raging paranoiac.

But to sit smirking on the sidelines as you watch various people tie themselves in knots, on your behalf, in an effort to ensure that the FDA doesn't overstep its bounds -- and then to criticize those same advocates for their alarmism at the very first sign that they might have succeeded in preventing the worst-case scenario -- well let's just say I think that's in bad taste. We're all on the same side here. We should all be aware that although the FDA seems to have punted today with regard to the particulars, the FDA nevertheless asserted near-absolute authority over the ecig industry going forward.

So you're claiming you hobbled all the other horses in the race so that this horse would win? [citation required]

Edit: I also call you to task for your assumption that I've done nothing. [citation required]

What's worse is that FDA's superficially light touch allows all of the various local/pressure-group nutjobs to continue screaming that ecigs are under-regulated. In that sense, one could argue that FDA's proposal is an extraordinarily deft anti-ecig maneuver. If the assaults keep pace in the media and in state/local legislatures, there may not be a whole hell of a lot left in two years for the FDA to regulate.

Bosh, they couldn't possibly win with you, could they? They said that with no regulation. They'd say that with any level of regulation short of complete ban. But you'd complain of over-regulation at anything other than a ridiculously low level. In no case will the two ever reach a point of stability. And since you've said above the light touch is "superficial," you already think they're going to regulate harder.

When there's no winning scenario, it's unsurprising that you feel the sting of a loss.

 

[MorpheusPA]

I haven't read the whole thread so if its been addressed... sorry. I don't understand why they're going after free samples. Maybe there's some history I don't know. I know I've gotten free sample packs of smokes. Are they going after people like Njoy or are the going after B&M juice sampling? I can't get my brain around any reason for a ban pertaining to health. Maybe it has to do with future taxing?

At times, samples of e-cigs have been handed out for free. This is not legal at the moment with cigarettes, there's no reason for it to be legal at this time with vaporizers. While harm reduction (not that the FDA currently admits that), they are not harmless.

 

[BostonVape]

Politics at its finest: Make something so incredibly long and complex that no one can understand let alone take 2 weeks off of work to read its entirety.

 

[MorpheusPA]

Agree with your whole post, but that was special. lol....

Also a logical fallacy in and of itself.

 

[Dave_in_OK]

The most amazing line in the whole paper...



We don't know, so ergo it must be deemed harmful until proven otherwise....

That's like the cops searching your house to prove you haven't broken any laws

 

[Jman8]

But to sit smirking on the sidelines as you watch various people tie themselves in knots, on your behalf, in an effort to ensure that the FDA doesn't overstep its bounds -- and then to criticize those same advocates for their alarmism at the very first sign that they might have succeeded in preventing the worst-case scenario -- well let's just say I think that's in bad taste. We're all on the same side here. We should all be aware that although the FDA seems to have punted today with regard to the particulars, the FDA nevertheless asserted near-absolute authority over the ecig industry going forward.

What's worse is that FDA's superficially light touch allows all of the various local/pressure-group nutjobs to continue screaming that ecigs are under-regulated. In that sense, one could argue that FDA's proposal is an extraordinarily deft anti-ecig maneuver. If the assaults keep pace in the media and in state/local legislatures, there may not be a whole hell of a lot left in two years for the FDA to regulate.

First paragraph here relates to me, cause I am smirking on the sidelines. And I am criticizing some advocates for their alarmism as worst case scenario hasn't played out from the FDA thingy we were all anticipating for years (not months mind you). Lots of chatter was occurring about the worst case scenario who several posts stickied just to be sure you realized how bad it was going to be.

Yet, I sit here reading this thread and your last paragraph reminds me of what tombaker was saying in other thread(s). That the local / state issues are far bigger / badder issues that we are up against. FDA was never going to be doing the enforcing, but state and local people were and are. What fuels them, IMO, is decades of ingrained hatred against BT and stench of smoking. We got plenty of vapers to add fuel to that fire, seemingly not realizing that they, or we, are shooting ourselves in the foot.

I believe many vapers thought when FDA released this report, it would put the vaping community in check. Not checkmate, but be scary enough that we'd witness, in words, the decimation of the eCig industry. Today, to me, that doesn't seem anywhere near the case. Instead, it is closer to them moving a rook to take a knight. We still have several other pieces on the board to play with, and our king and queen seem to be unmoved.

Yet, I have just enough of a conspiracy mind to think that FDA and its cohorts are thinking 10 moves ahead, and that their knights (media and ANTZ), and bishops (politicians) and queen (BP) are going to be going keep us in check, before any FDA regulation goes into effect. State regulations continue to be my main concern, and thus far in 2014, they are showing all signs of an all out offense. Causing vapers and vendors to stay on the defensive while they roll out their next attack, in what looks a little, or a lot, like an orchestrated campaign.

 

[MorpheusPA]

Politics at its finest: Make something so incredibly long and complex that no one can understand let alone take 2 weeks off of work to read its entirety.

Not really. Definitions that would stand up in court and be applicable to regulators must be incredibly exact. They aren't intended to be read by the Common Folk as they lack the educational specifics and background to do so. They're intended to be read and interpreted by regulators and by the court.

It's unreasonable to expect plain English as it isn't nearly exacting enough. Try reading a fully formal science paper on a topic about which you aren't completely familiar. It reads pretty much the same way.

 

[patkin]

At times, samples of e-cigs have been handed out for free. This is not legal at the moment with cigarettes, there's no reason for it to be legal at this time with vaporizers. While harm reduction (not that the FDA currently admits that), they are not harmless.

Okay, IC.... still ridiculous in my view. So belly up to your local B&M juice sampling bar and lay your penny down or add one to your vendor order if you want a"not-for-free" sample or hand the clerk a penny for that Njoy?

 

[Kent C]

Also a logical fallacy in and of itself.

For me it's like when someone who says "I knew that would happen" only because it was one scenario of the thousands that went through their head. After the fact, they assign an importance to that one. "See?"

My last comment on it....

 

[MorpheusPA]

First paragraph here relates to me, cause I am smirking on the sidelines. And I am criticizing some advocates for their alarmism as worst case scenario hasn't played out from the FDA thingy we were all anticipating for years (not months mind you). Lots of chatter was occurring about the worst case scenario who several posts stickied just to be sure you realized how bad it was going to be.

This, to a point. I rarely smirk. But I never expected the FDA to flat out ban; the backlash would be severe, immediate, and quite damaging to them.

I believe many vapers thought when FDA released this report, it would put the vaping community in check. Not checkmate, but be scary enough that we'd witness, in words, the decimation of the eCig industry. Today, to me, that doesn't seem anywhere near the case. Instead, it is closer to them moving a rook to take a knight. We still have several other pieces on the board to play with, and our king and queen seem to be unmoved.

And yet the fear-mongers are still yelling that This Is The End. That remains to be seen, and I can think of several counter-moves even a pawn can make that would help.

Yet, I have just enough of a conspiracy mind to think that FDA and its cohorts are thinking 10 moves ahead, and that their knights (media and ANTZ), and bishops (politicians) and queen (BP) are going to be going keep us in check, before any FDA regulation goes into effect.

Never attribute to malice what can be adequately explained by stupidity. Individuals can be quite cunningly malicious, companies can by extension as they have a CEO or the like. Bureaucratic agencies, much less so. They're more tuned to the status quo.

Witness the sheer amount of time this took. Just in that time period, vaping has progressed from a statistically insignificant number to one that's now actually becoming politically relevant. If they wished to kill it, it called for a full frontal attack quite quickly, not moving a bishop and calling it done for now.

As time goes on, those numbers continue to rise. By the time the FDA can get another set of regs out--figure 2017 to 2018--they'll have a much more powerful group to deal with.

And if this was a maneuver to shove the Little Guy out of the business, the probability of backfire is assured. In doing so, they'll concentrate power among several larger vaping companies, who will be able to fuel lawsuits and wield considerably more power.

If this move were in a game of chess, it would show evidence of not looking ahead.