FDA Proposed regulation is available

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Jan 19, 2014
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[...] I believe that even if the FDA ultimately wishes us harm, it's a tactical error on their part to let the ecig market breathe for the next two years -- or even for the next few months. The longer the genie's out of the bottle, the better for all of us. [...] We know that our opponents in the faux-public-health lobby will do or say anything to promote their irrational crusade against so-called non-communicable diseases. We also know, from past history and from the FDA's own statements in the very proposal that is our topic du jour, that the authorities are not friendly to our cause; even now, the FDA refuses to acknowledge the vast bulk of the evidence in the ecig's favor. There are any number of battles to come, and although we have the truth on our side -- although I believe we will eventually win -- we do ourselves a disservice if we devalue our own efforts to effect that victory. [...]

I agree w/ you that the FDA wishes us harm, but I think we need to be careful about why. There's a government-industrial complex here, which BP, the FDA, the CDC, and to some extent even BT and BV are part of. No conspiracy, just cooperation among individuals who are each pursuing their own personal desires for career advancement and compensation. (After all Mitch Zeller was a BP lobbyist before he became CTP head. And once he leaves the FDA, he'll probably end up somewhere back in the H/C or BP area. Tom Frieden at the CDC probably will have a similar story. It's all about the money.)

Technology is moving too fast for the government-industrial-complex's way of doing things. As a smoker, I used to just co-miserate with other smokers, huddled like lepers in a corner. I just assumed that everyone who wasn't a smoker would look down on me, and I'd have to find weird alternatives like RYO to get around the tightening noose of Tobacco Control. Vapers don't seem to have that culture, we seem to be a good deal less inclined to accept our fate. The next generation of products will probably not involve nicotine, and their adherents will be drawn from our ranks (former smokers, then vapers). They'll probably be even less willing to get beaten up. 3D printers may come to the rescue for hardware, and more and more multiple-use inputs will become part of the process. After all, if you don't have tobacco, there's nothing that you can do: you're dependent. The same goes for nicotine. (Although both tobacco and water-soluable nic. will develop humongous black markets in the future: even now, there's essentially no room left for some US states to raise their cigarette taxes).

The pressure is now on Glantz to fake more "research" that attribute all the major "tobacco-related" problems to vaping. But once the new technology emerges (whatever it is), he'll again be on the horn to his friends at JAMA every day, trying to get more baloney in print. It's interesting to note that Dutra & Glantz (the junk minor gateway-to-tobacco) "study" didn't make it into the FDA's PDF. Neither did the Grana et al. "vaping doesn't help smokers quit" garbage survey, nor the S.J. Park jimmied junk research with "immortalized" lung tissue that had been pre-mutated as it were (the bogus "cancer link").

Whatever the next technology is, it won't be called a "cigarette," or probably generally use nicotine. Vapers will be open to it, because we already gather in huge numbers on the 'net, and have already migrated from one technology (cigarettes) to another (vaping). The next step will thus have a built-in potential base of "early adoptors," (namely: us), and of course move the disciplines of science, statistics, and public health into new cesspools of irrational mendacious hysteria. In the meantime, public health consequences from tobacco cigarette smoking will plummet, and eventually the funding for the Tobacco/Nicotine/Vaping/Whatever Control Industry will run out. The MSA only has 9 more years left, and most of the states have already allocated the money anyway.

That said, a decent all-metal RDA and mech mod are designed and built to last forever :)
 

DanFromRioRancho

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I'm not really concerned about that paragraph as things stand now, because 1) it attempts to exert authority that's plainly outside the parameters of the agency's power, and 2) no judge, however scientifically illiterate, or vaping-naive, is going to accept the argument that a PV and its constituent parts have no conceivable purpose except the delivery of inhalable nicotine. The very existence of zero-nic liquid, and the sizeable market share it currently enjoys, renders this argument a non-starter.

If the deeming regulations are accepted and signed off by the legislature, the parameters of the FDA's authority and power will be expanded. I suspect the legislature will be okay with that because the expansion is limited and specific. As such, the majority of complainants attempted arguments to the courts would be considered irrelevant.

Edit for clarification: the deeming regulations create the authority that the FDA currently lacks.
 
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Nate760

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DO we have hard numbers on how big the 0 nic industry is? I have never seen them from a credible source?

I haven't seen any hard industry-wide numbers either, but having informally surveyed the owners of the half dozen or so vape shops in my local area, they all peg the number at between 25% and 30%, and their product displays seem consistent with this figure. Granted, it's a tiny sample size, but I don't see any reason why the percentage would be drastically different anywhere else.
 
--Do I understand the proposed regulation correctly, that ecigs will require warning labels?

--It's still unclear to me whether hardware is regulated if it doesn't contain nicotine (or isn't derived from tobacco). Blank cartridges, atomizers, driptips, batteries, tanks...

Quote: "tubes, papers, pouches, AND FLAVORINGS are considered components" as they are intended to be used in the consumption...
 

pamdis

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--Do I understand the proposed regulation correctly, that ecigs will require warning labels?

--It's still unclear to me whether hardware is regulated if it doesn't contain nicotine (or isn't derived from tobacco). Blank cartridges, atomizers, driptips, batteries, tanks...

Quote: "tubes, papers, pouches, AND FLAVORINGS are considered components" as they are intended to be used in the consumption...

That's because the regs are unclear. They state that components are covered under the scope of the regs, but don't intend to define them, and they are also asking for comments regarding whether and how they should define them.

Appears that defined or not, they are covered. Clear as mud.
 

pamdis

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The one question I have right now is; how will the FDA determine something can remain on the market or deny it?

More vagueness:

The FDA is required to deny .... if the FDA finds that:
  • The manufacturer has not shown that the product is appropriate for the protection of public health,
  • the manufacturing methods, facilities, or controls do not conform to manufacturing regulations issued under section 906(e) of FD&C Act,
  • the proposed labeling is false or misleading, or
  • the manufacturer has not shown that the product complies with any tobacco product standard in effect under section 907 of the FD&C Act.

How does one show that the product is appropriate for the protection of public health?

Haven't had time to look up the manufacturing regulations.

Their definitions of 'false or misleading labels' are very interesting reading all on their own.

I haven't found that the FDA has ever issued any tobacco product standard, so at least that should not have to be worried about.
 

DeeLeeKay

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More vagueness:



How does one show that the product is appropriate for the protection of public health?

Haven't had time to look up the manufacturing regulations.

Their definitions of 'false or misleading labels' are very interesting reading all on their own.

I haven't found that the FDA has ever issued any tobacco product standard, so at least that should not have to be worried about.

I am not questioning you. I am just very confused about how these manufactures can even get their products approved unless someone "proves" that e cigs are not harmful. It seems like a lose/lose situation all around for e cig manufactures. How much more troublesome would be to get flavors approved.
 

pamdis

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I am not questioning you. I am just very confused about how these manufactures can even get their products approved unless someone "proves" that e cigs are not harmful. It seems like a lose/lose situation all around for e cig manufactures. How much more troublesome would be to get flavors approved.

I agree - lose/lose all around.
 

Schwiggiddy

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I am not questioning you. I am just very confused about how these manufactures can even get their products approved unless someone "proves" that e cigs are not harmful. It seems like a lose/lose situation all around for e cig manufactures. How much more troublesome would be to get flavors approved.

Basically, they would have to have long-term testing, which of course is hard to do when your product isn't available for retail sale. The burden of proof, is on the manufacturer; otherwise it appears that the FDA will assume that it's just as bad for you as smoking. Except for "premium cigars,' which appear to have some special magical powers that make them not as bad.
 

DeeLeeKay

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Basically, they would have to have long-term testing, which of course is hard to do when your product isn't available for retail sale. The burden of proof, is on the manufacturer; otherwise it appears that the FDA will assume that it's just as bad for you as smoking. Except for "premium cigars,' which appear to have some special magical powers that make them not as bad.

That is exactly my point. These "regulations" are designed to kill the APV(Advances Personal Vaporizers) industry. The burden is too heavy to over come with their preconceived notion that these devices are just as bad if not worse then smoking.
 

DanFromRioRancho

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Basically, they would have to have long-term testing, which of course is hard to do when your product isn't available for retail sale. The burden of proof, is on the manufacturer; otherwise it appears that the FDA will assume that it's just as bad for you as smoking. Except for "premium cigars,' which appear to have some special magical powers that make them not as bad.

The theoretical loophole is "substantial equivalency". A manufacturer has the opportunity to demonstrate, to the satisfaction of the FDA, that a product is substantially the same as an existing product.
 

Boiler

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The theoretical loophole is "substantial equivalency". A manufacturer has the opportunity to demonstrate, to the satisfaction of the FDA, that a product is substantially the same as an existing product.

Yes, what's so hard about substantial equivalence?

A coil that vaporizes a liquid in 2007 is a coil that vaporizes a liquid in 2014.

Or not?
 

DanFromRioRancho

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Last comment for tonight -- I suspect that the FDA is asking for as much as they can reasonably expect to get in the current political climate but most of the tools that they actually end up getting will be stowed away for a rainy day. I'm willing to risk a prediction that the hammer they use after final approval of the deeming regulations will be stringent control of juice -- third party analysis of the content for manufacturers that can not afford an in-house certified and audited laboratory, mind-numbing and expensive paperwork for approval of any particular juice, proof of sourcing for the raw materials, expensive labeling/packaging requirements including child-proof caps and, most importantly, restrictions on the nic content with limits being established as equivalent to the therapy products (patch, gum, etc) until such time as new studies adequately demonstrate that higher content levels are acceptable.

This is the easiest path for the FDA, and would be accepted by most politicians and their constituents, due to it's being done in the name of protecting the consumer and protecting the children.

That simple action won't stop grey or black market activities. It will, however, create an extremely significant slow-down of the retail market development process, perhaps even stop it except for a handful of big $ players.

My :2c:
 

LDS714

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The song remains the same:

I had a dream. Crazy dream.
Anything I wanted to know, any place I needed to go

Hear my song. People won't you listen now? Sing along.
You don't know what you're missing now.
Any little song that you know
Everything that's small has to grow.
And it has to grow!

California sunlight, sweet Calcutta rain
Honolulu Starbright - the song remains the same.

Sing out Hare Hare, dance the Hoochie Koo.
City lights are oh so bright, as we go sliding... sliding... sliding through.

(I don't think I have to attribute those lyrics :)

Why bother? They gave absolutely no credit to Willie Dixon despite using his lyrics for the majority of the songs on their first two albums. Follow their lead, take them for your own.
 

Jman8

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My reading of it is that manufacturers will have 2 years to submit an application and their products can stay on the market while the application is being reviewed.

I don't believe any new products can be introduced after the rule is final without an application submitted and approved first. EDIT: Re-read the regs and you can still introduce new products in the first 2 years as long as you also submit an application and continue to keep selling until the application is reviewed. After 2 years, no new product can be put on the market without an approved application.

Have you seen the requirements for a new product application? None have ever been approved yet.

People are saying these regulations are good news because they didn't see any outright ban in the document, but the ban is this: Submit an application, we'll never approve it, de facto ban.

Your last statement, I can see why you, and several others, would believe that line of logic, given FDA's track record. Hard to dispute that.

But in this proposal, they are clearly stating that based on the statute (determined by Congress), they feel correct interpretation (all along) has been to use the 2007 date. I think this would explain why no approvals to date. In this proposal, they are allowing for 3 paths to get a product approved, and with this proposal asking (I'd say urging) anyone and everyone to comment on THAT. So, a new track will be established and a clean slate will begin.

As one who consistently touts free market (and I honestly believe I'm more free market than most people), I feel this is good news both in wording of the proposal and in how I honestly see it playing out. IMO, the 'defacto ban' types, are mostly to only basing their logic on FDA track record through 4/24/14. And neglecting idea that FDA was operating under 2007 as the date by which to establish SE. (Proposed) rules done changed, and with that change comes, I believe, good reason to be optimistic.

Yes, our opposition is strong, well funded, better organized. But we are going to get stronger, likely better funded, hopefully better organized. If science is truly on our side, we have far less to be concerned about than we did prior to today.

The fact that Glantz didn't like this proposal ought to be sign enough that there is reason to celebrate, at least a little bit. Even a tiny bit?

Tonight we enjoy a small victory. Tomorrow we continue the good fight.
 
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