FDA The Predicate Product of 2006 for FDA: Meet the Ruyan V8 , Early Innovator and Marketer of E-Ciig Vaping
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To recap,-(Before the quip above)You asked this question (It has nothing to do with marketing, bringing items to market?) , followed by this question {Then why does the ruling document say:} followed by the remark on a US Customs document. The remark was posited as the answers to your questions. (This is known as sarcasm and/or a rhetorical remark by you). For if not,(as in you disagree), there is absolutely no reason to ask me the questions at all in the first place. Because the question is "why does the ruling document say:". I have no clue-(Other then the fact that is exactly what happened.) You know that too. That is why it is the answer to your questions and a rhetorcical and/or sarcastic remark to me. IF NOT, go ask Customs why it is there on a piece of paper not me. Go find out why it says that yourself, why it doesn't say blonde panties or green teddy's or something else ON this US Customs document. (BECAUSE I DIDN'T WRITE THE DOCUMENT SO I DUNNO KNOW WHY IT SAYS THAT EXACTLY, THERE IS THAT A LITTLE MORE CLEAR TO ANSWER IT, IF ALL YOU DID WAS ASK A QUESTION)
The guy asks a question followed by a question (word why enclosed with no question mark in the second question), then when you turn it into a remark as in a statement because it has no question mark, then he pleads to the question as the prerogative for your error. IMO sneaky business. All he did was ask a question, I dunnnnoooooooooooooo!
So you support zero of them, but regard them as tame. ie(seem them) The last time I personally supported 0 policies of any particular agenda, I regarded it as hostile, or at least just flat out bad. And I do not wish to bicker with you about how it could have been worse.Nor do I wish to entertain suggestions from you, which to me are nothing more than patronizing for posturing. The regulations the way they are written give unlimited authority to the FDA over Ecigs. I don't personally see how the FDA could possibly be granted more authority.(My opinion) I suppose then if the FDA were to knock at my door and try to seize my ecig personal vape gear, this would be moderate. Which is why I am going to my receipts for vape gear during the "legal period."
Thirdly, its about that question above, and I will answer it. you know it is not wrong to ask a question. So do I. Of, course it is not wrong to ask a qustion. So there you have it! I answered your question. I will NOT however respond to you in these forums forthwith. (to me its about being a good ECF citizen.) (Just like DeadBeatJeff did before back on the 50 cent thread), For I refuse to respond to someone who asks me such a lopsided question. ie*(You are saying it was wrong to ask a question? ) {It's like a jumping Lima bean, "You are saying it was wrong" - statement "to ask a question?" -there found the question.}
To anyone who is interested, I posted down in tin foil on TomBakers other thread some information On Ruyun's patents. It's about how Ruyun's patents could actually be used to hurt our cause rather then help it. To those of you who don't like long winded stuff,(I know I don't) the summary is laid out in the last paragraph.
Ottttaaa here, clap hands, palms forward (like a black dealer) I don't have a trick in my pocket. But it is a good thing, I got 15 credits of Greek, enough to see the skinny on this batch of smoke and mirrors. time spent on a road to no where.
Appreciate you coming over Jeff, although it won't surprise me if you take a back seat, then bolt, in this parlour.
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If you read the Subject, and the first post, you will see the topic here. There are other threads for whatever that stuff is
Correct on the rhetorical assertion, incorrect on the sarcasm.
Yes, I knew exactly that the document brings up the word "market" regarding an eCig product, prior to 2006, and was then using a rhetorical question to understand why you, or anyone, would assert that the document has nothing to do with marketing.
This would then be where we disagree. Compared to what was being discussed prior to 4/24/14 on this forum, in dozens of threads about the topic of FDA deeming regulations, I see current proposal as tame. I'm not alone in this take, but also realize I'm in a minority on ECF whereby majority sees it as hostile and wholly negative, likely leading to decimation of eCig industry and/or end of vaping, to the tune of 99% of what is currently on the market will be gone, legally, within say 5 years.
I believe everyone reading this knew prior to 4/24/14 that FDA would be exercising full authority to regulate vaping products once their deeming regulations came out. In round 1 of the proposals, I see what they put forth as tame, and base this on way the proposal is worded, the items they chose to include for regulating vaping products and more importantly what they didn't include, but what many of us thought they may for sure include. Rounds 2 or later may in fact include those things. Round 1, did not.
Knowing you will not respond to this post pleases me. I consider this tangent slightly off topic as it is yet another time of calling into question the character of those who see reason for optimism in the proposal or ways to be positively proactive with regards to FDA proposals. As I feel I have squarely addressed this tangent and now realize there is no intent to debate on this tangent in good faith, then I am pleased that it is hopefully ended with this post by me.
The document clearly has something to do with marketing of eCig products.
/end side tangent
Patent US2721551 - Tubular mouth inhaler simulating a smoking device - Google Patents
There are a wide range of other patents but I have no idea if any were marketed prior to the date we wish for them to be.
It's been said everything has already been done, maybe not.
Maurice
There are a wide range of other patents but I have no idea if any were marketed prior to the date we wish for them to be.
It's been said everything has already been done, maybe not.
Maurice
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Wow, there are a lot of other links from this one that seem substantially similar to eCigs.
Exactly, there are a whole slew of them, some well prior to my time on this earth, and most well prior to the internet.
I may have to dig through my old as dirt popular mechanics magazines and see if there is any reference to them there. I don't exactly expect to find anything but its a good excuse to pull them out. I might get lucky.
For fun you can Google each design in images to see the drawings (at least on some) Kinda cool.
Maurice
I'm kinda jumping in here, so I hope I'm not too far off base. I think my point was that ALL the current cigarettes were grandfathered in on such-n-such date (I'm thinking it was 2007-2009). No approval, just registering. I couldn't find the timeline to make sure. Anyway, that's probably too good to hope for.
I haven't been able to spend too much time on ECF lately, but I think someone posted a couple of links to nicotine that might have been available pre 2007. What are the chances of getting something like that through SE application process? Hopefully they would have import records, invoices, tax records, MSDS, COA's, testing ..... would that make pigs fly?
Understood. What cigarettes were grandfathered only relates to IF a predicate could be found and then only remotely - you did it for cigs, why not ecigs?
Nic base is another story. And I haven't found a good source on that. And while I still hold out hope, heaven gifts haven't come back on the 'three factories' that could have sold to the US in '06. pigs not even on the tarmac.....
I'm thinking if nicorette or patches were available back then, then nicotine was used to make them. They aren't ground up cigarettes or KY-21 leaves.
Somebody correct me if I'm wrong here, but it seems as if the FDA has blocked all routes of an easy out, leaving the difficult to traverse new product application process as the only way to go. For their purpose, whatever that may be, it seems to put everything in our industries hands and out of court.
We know very well most if not all of what we use today didn't exist in 2007, so our search for a predicate product is as much a futile effort as any.
While some legal wrangling might preserve the cig-a-like I'm absolutely certain that everything else will become antiquated products within hours of e-cigarettes becoming regulated. Any manufacture of e-cigarettes in the US will for all intents and purposes be for export only. Even the all mighty Provari.
Maurice
Somebody correct me if I'm wrong here, but it seems as if the FDA has blocked all routes of an easy out, leaving the difficult to traverse new product application process as the only way to go. For their purpose, whatever that may be, it seems to put everything in our industries hands and out of court.
We know very well most if not all of what we use today didn't exist in 2007, so our search for a predicate product is as much a futile effort as any.
While some legal wrangling might preserve the cig-a-like I'm absolutely certain that everything else will become antiquated products within hours of e-cigarettes becoming regulated. Any manufacture of e-cigarettes in the US will for all intents and purposes be for export only. Even the all mighty Provari.
Maurice
I'll have to hunt down those links. This subject got seperated out into several threads for awhile. I don't seriously expect to match a 2" diameter log from 2007 (although, if the competition was Blu or Vuse I'd consider it), I'm looking at this for the source of nicotine because people were dripping almost as soon as ecigs appeared.
And I haven't read anything that the nic needed to be headline banner for ecig use. It can be for any use, but on the "market" (available for purchase). Even undiluted since anyone can buy PG. This is very idealistic, and it's looking for a needle in a haystack. However, the gains would make whatever the FDA did irrevelent (until they deemed nicotine). This may turn into a game of 'whack-a-mole' and every mole counts, i.e. 3 to 10 years additional time.
This was from 2008 and it appears the study authors didn't mention users dripping into cartridges http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
And I haven't read anything that the nic needed to be headline banner for ecig use. It can be for any use, but on the "market" (available for purchase). Even undiluted since anyone can buy PG. This is very idealistic, and it's looking for a needle in a haystack. However, the gains would make whatever the FDA did irrevelent (until they deemed nicotine). This may turn into a game of 'whack-a-mole' and every mole counts, i.e. 3 to 10 years additional time.
This was from 2008 and it appears the study authors didn't mention users dripping into cartridges http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
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I don't claim to be an expert on dissecting the FDA regulations, but...
It seems to me that any such products would need to be marketed as a tobacco product to be used as a predicate.
In other words, there is no doubt that pharmaceutical nicotine was available for use in NRT products, but that doesn't help us.
I'd love to be wrong, but a predicate product seems clearly to mean a predicate tobacco product.
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Correct. See the top of p.18: http://www.fda.gov/downloads/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm237080.pdf
It has to be a tobacco product and commercially marketed.
It has to be a tobacco product and commercially marketed.
But per FDA, all nicotine is derived from tobacco. Obviously we don't want industrial nicotine (insecticide) but vapable stuff. I betcha the FDA will say it doesn't matter what industry it's for. So we can say the same. If they say it's not, well then we have a source of unregulated nic. Win-win. It might even take them another 3 years to figure it out = stalling avoids the regulatory ban.
... in the US. And liquid nicotine for pesitcides is both.
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