The contention is that the 'modern ecigarette' is substantially equivalent to the first generation - in basic form, use and anything essential except for cosmetics, which shouldn't be a factor.
FDA The Predicate Product of 2006 for FDA: Meet the Ruyan V8 , Early Innovator and Marketer of E-Ciig Vaping
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The contention is that the 'modern ecigarette' is substantially equivalent to the first generation - in basic form, use and anything essential except for cosmetics, which shouldn't be a factor.
I'm wondering if you have had a chance to read this thread?
http://www.e-cigarette-forum.com/fo...ing-why-deeming-reg-would-ban-all-e-cigs.html
They also have the resources to hurdle these obstacles, while their emerging competition does not.Tom said:
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The difference, of course, is that CASAA is very clear about where they stand, and they don't cherry-pick people's arguments to confuse the issue and make it seem that pretty much everything will be OK, which is what you used to do. Now you're kinda still playing damage control, I think, and working the fair-and-balanced angle. I imagine at some point in the future you'll try to transition back to using people's posts to advance a preexisting agenda, and trying to make readers focus on the wrong part of the story. Just a guess.Jman said:
And, rhetoric is not simply having a point about something and using words to describe it. Rhetoric is the use of words to influence people's perception of information. Like, on one level we can describe someone as having a preconceived, blatantly interested agenda, and on another we can describe this same person as a BT schill. The perlocutionary effects of the two are different, even though they could both be used denote the same fact.
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jman said:
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all guidance? Really? Or just the guidance that says these rules aren't that bad, they can't touch 0-nic juice or hardware, and the fact that x, y, and z vendors 'like' them means there is nothing to worry about.jman said:
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very curious, no? Almost like it's being purposefully steered into unproductive discourseaikanae said:
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Unless I'm wrong, and I'm certainly no authority here:jman said:
A prospective plan to market something is not tantamount to marketing it, and submitting forms so that you can get the numbers you need to form a business plan is not the same thing as putting that plan into action on a tangible, cite-able, precedent-setting level.
But, regardless of your intent here, you have to see how this sort of suggestion, twisting of the language, and cherry-picking of posts makes it seem that you have some ulterior motive,.
Which is why Sky has become frustrated at this point. You're not addressing the facts he raised, just using them to present an alternative narrative, and doing some damage control along the way. Unless Sky is completely misrepresenting the documents in question, they are proof of nothing useful to us at all. To read what he said, not disagree outright, quote a portion of it, and still suggest that the docs are good for something like SE, is absurd.
Also, to say that the fact that he mentioned he once filed a form like this means he is fallaciously appealing to authority is insulting. His argument stands, so long as we acknowledge what the document actually is, which has nothing to do with the fact that he mentioned he'd submitted one before. He simply used that to establish that he can identify the document in question, not to premise any claim about it he subsequently made. So, unless you were contesting his ability to identify the document, unless you are claiming the document is something else entirely, I think you owe Sky an apology.
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I had read the original post and a few replies. First, the FDA document that is linked states that reports that have "inadequate" or "insufficient" information for the FDA to determine SE won't be allowed. And while Bill G. concludes "that delineates why NO e-cigarette product currently on the market could be approved as “Substantially Equivalent” to a product that was on the market prior to Februay 15, 2007 (unless FDA exempts e-cigs from the 2007 grandfather date in Section 910)." ... I would come to a different conclusion.
First, there is no mention of electronic cigarettes in that particular document. So I think Bill's conclusion is a bit of a stretch. If he were just trying to gain attention as to the seriousness of the proposal, I'd accept that, but there was nothing in the doc that showed how ecigs would not be allowed, but just a general 'summary' of HOW certain products would not be allowed and then only in terms of insufficient and/or incomplete information given for the FDA to conclude Substantial Equivalence. Ok... then... PROVIDE adequate and sufficient information with regards to ecigarettes - again, using their definition of substantial equivalence that would only require, using the common usage of the terms, that the essence of the product is the same or similar to the predicate product.
Now I'm wondering if you read the doc....
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No, I'm not talking about the "inadequate" or "insufficient" stuff, nor Mr. Godshall's conclusion...
I'm talking about the kinds of reasons given by the FDA for making the determination that something is NOT substantially equivalent.
If the FDA applies that level of scrutiny and uses those kinds of reasons, there's going to be a problem.
Actually you are talking about insufficient and inadequate information. Whoever made the application was lacking, and the FDA points out on what points. That doesn't mean we have to make the same mistake.
Look. Do I think the FDA has a preplanned idea of how this should go? Yes.
Do I think that EVEN IF someone showed SE, that the FDA could say it didn't? Yes
Could I add ten more 'substantially equivalent' questions to the ones above showing my utter disgust and distrust of the FDA? Yes
But, did that doc tell us why NO ecigs will be so declared SE? No
I believe you missed the point of what I was quoting from. I was talking about the people who criticize guidance, and here you are making my point about my stance on FDA regulations compared to CASAA's. Hence, the cherry-picking you are alluding to is found in your point right here.
Yes, all guidance. Put forth a piece of guidance right now that is a positive way to address FDA regulations. I predict it will be downplayed with a defeatist attitude. An example, to me, would be we could be submitting comments that cite scientific studies where FDA proposed regulations are saying the evidence is lacking. The defeatist attitude says things like, "doesn't matter, FDA will ignore those comments," or "they already have that info. There is no point in conveying it again, as they obviously didn't pay attention to it before they wrote the proposal."
And this is being aimed at the people who are suggesting productive discourse, which is most fascinating. Unless in line, squarely, with the defeatists, there really is nothing to be said. Gradually, this is changing. I predict it will change nearly 180 when CASAA's CTA's come to fruition. The ones that are currently on hold until a couple weeks before final deadline date to submit comments.
But the plans to market have something to do with marketing which is the point that was being addressed.
I'm already on record on this thread as saying predicate tangent appears dead to me. I hope I'm wrong about this. But this tangent and discussion is another where defeatism is allowing to reign supreme. I like the posts where people are striving on this tangent, as it could positively help going forward. I may not agree with it as a viable tangent, but I don't see how defeatism helps with comment period that is currently live. The counter point and defeatism strategy is saying it doesn't even matter if we find a predicate product, FDA is going to screw us anyway on this. Stop wasting your time.
And I find all this fascinating that the person with optimism and reason is deemed to have ulterior motive. There is lots of twisting of language occurring all over via "components of finished tobacco product" points up for discussion. Even on this thread with regards to marketing. Whole ECF discourse on FDA proposal has been cherry-picking statements/sections from the entire document to spin things; either to clarify just how screwed we will be, or to indicate how loopholes galore will exist should FDA think they have a leg to stand on if this is what final rule looks like.
I welcome anyone reading this to do whatever they feel they can to establish an ulterior motive that I may have which would be shown to be undermining the pro-vaping cause.
Given that I support zero of the proposed regulations, but do seem them as tame, what we expected for last 2 years, and not entirely unreasonable, I again am fascinated that I'm one that is viewed as plausibly not working toward core desire of vaping cause. If I'm not ready to roll over on usage bans, and willing to tackle that with reason, I would be as clear as possible that I won't roll over on FDA regulations. Which is partially why I have optimism, confidence going forward.
And I observe Sky misrepresented the documents by saying they have nothing to do with selling and marketing. No one in this thread has said those documents, alone, are sufficient for SE application. Thus the strawman argument is not applicable to point you are raising.
I agree that would be insulting. But this isn't where I lodged the assertion of appealing to authority. Hence your cherry-picking and twisting doesn't apply and so the insult-claim is not warranted.
I agree with that.
I just wanted to make sure you had seen some of the reasons they have given for "No substantial equivalence" determinations in the past.
Even if it was for products other than electronic cigarettes.
I understand. The examples can be a guide as to 'what not to do'.
I also acknowledge that both you and Bill did note that ecigs weren't mentioned in the doc in the earlier thread.
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If there is no predicate product, then I'm not vaping on an e-cigarette, nor is it a tobacco product.KODIAK;13076886 said:I'm still trying to wrap my head around this FDA gem:
What other alternative marketing pathways or policy options should FDA consider if, in fact, no predicate is available? Are there other legal interpretations of the substantial equivalence grandfather provision that FDA should consider?
Knowing full well 2007 is carved in stone, I don't know how in god's name they can expect anyone to "legally interpret" it any other way.
They could alternatively just regulate eliquid as the tobacco product, and retire the idea of regulating the device as an accessory.
I would prefer and suggest that the FDA stick with regulating the drug nicotine, and keep its focus there.
Maurice
This dispute about what SE actually means to the FDA, or could mean under the statute according to a court, is irrelevant until there is some reason to believe that the existence of a predicate product available in the US could be proven to the satisfaction of the FDA or at least a court.
It's a bit like arguing about whether a pig can fly, without first showing that it has wings (or some other aerodynamic attribute).
Speaking of winged pigs, I have to wonder how and why BT has never managed to successfully challenge the FDA's interpretation of SE, as applied to tobacco cigarettes. Perhaps this is because FDA has not yet rejected such an application? (Really, I don't know - I'm just asking. The only case that I can think of off the top of my head involves the four types of "bidis" - those Indian mini-cigars, whch were already off the market by the time the FDA rejected the application.)
All I can say for sure is that there are definitely winged pigs in the case of tobacco cigarettes, and if there is any group of entities out there with both the deep pockets and the financial incentives to try to get a court to make them fly, it's BT.
But for heaven's sakes - please show me the wings first - i.e. the evidence which could be used to convince a court that the statutory conditions for a predicate product were satisfied. Only then might I be inclined to pariticipate in a discussion about whether the porkers-in-Q are capable of taking flight - i.e. whether a court could be convinced that the FDA's existing approach to SE might be incompatible with the law.
It's a bit like arguing about whether a pig can fly, without first showing that it has wings (or some other aerodynamic attribute).
Speaking of winged pigs, I have to wonder how and why BT has never managed to successfully challenge the FDA's interpretation of SE, as applied to tobacco cigarettes. Perhaps this is because FDA has not yet rejected such an application? (Really, I don't know - I'm just asking. The only case that I can think of off the top of my head involves the four types of "bidis" - those Indian mini-cigars, whch were already off the market by the time the FDA rejected the application.)
All I can say for sure is that there are definitely winged pigs in the case of tobacco cigarettes, and if there is any group of entities out there with both the deep pockets and the financial incentives to try to get a court to make them fly, it's BT.
But for heaven's sakes - please show me the wings first - i.e. the evidence which could be used to convince a court that the statutory conditions for a predicate product were satisfied. Only then might I be inclined to pariticipate in a discussion about whether the porkers-in-Q are capable of taking flight - i.e. whether a court could be convinced that the FDA's existing approach to SE might be incompatible with the law.
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I was thinking about this. Cigarettes went first under the act for regulation. It seems they should have been first with SE and new product applications too (backlog) and they'd be the first to challenge or define the pathway for other products. But that hasn't happened.
Correct me if I'm wrong here, but weren't cigs grandfathered in as of Feb 2007? Then there was an SE period between 2007-2011 (FOUR years) and anything after 2011 had to file new product applications.
Idk. Just seems like a lot of inequities in this.
Correct me if I'm wrong here, but weren't cigs grandfathered in as of Feb 2007? Then there was an SE period between 2007-2011 (FOUR years) and anything after 2011 had to file new product applications.
Idk. Just seems like a lot of inequities in this.
I think you know I'm not gonna give you more opportunities to mislead people than are absolutely necassary.
I only showed up here 'cause someone asked me to come by. I have no illusions that you intend to debate in good faith.
the points in my post stand, and you know it.
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Oh, Oh, I know this one...the SE interpretation used by the FDA kills off the smaller cigarette, rolling paper, snus manufacturers. BT can afford to wait 2-3 years to get a "new" cig approved all the while selling millions of packs of Marlboro and Camels...
BT doesn't need new products so long as people are as hooked on their current offerings as we were.
Oh, Oh, I know this one...the SE interpretation used by the FDA kills off the smaller cigarette, rolling paper, snus manufacturers. BT can afford to wait 2-3 years to get a "new" cig approved all the while selling millions of packs of Marlboro and Camels...
BT doesn't need new products so long as people are as hooked on their current offerings as we were.
Point taken about BT being satisfied with the other products' lack of approval.
But BT isn't waiting "2-3 years" for their own products to be approved - at the rate the FDA is going, I think we're looking at decades if not centuries.
You're right that they don't have much incentive to care about that. Although why they're even bothering to file the applications is beyond me. Perhaps they're hedging their bets.
It could be that they can't sue until the FDA rejects one.
BT can wait decades, even if they get a product approved, the can't advertise it almost anywhere. This latest deeming may crack down even further on their advertising. If nobody knows about the "new & improved" it's tough to affect sales.
Pretty sure some new products were allowed before the Mar. 2011 deadline and only a handful since:
Lorillard Gets FDA Approval for New Cigarettes (LO)
and:
How the FDA Is Keeping New Cigarettes Off the Market - Jacob Grier - The Atlantic
There's still the signage at retail outlets. The current proposed rule does not affect tobacco cigarettes in any way that I can see.
Probably the most efficient sentence I have read on ECF. I would say how well it comprehends everything, but I could not do it so briefly.
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