FDA The Predicate Product of 2006 for FDA: Meet the Ruyan V8 , Early Innovator and Marketer of E-Ciig Vaping

[Roger_Lafayette]

Yes, we are grinding. There really isn't much more to be said here, among the sane folks posting on this thread.

So I'll just summarize the world as I see it ... YMMV.

1) There is nothing wrong with a "hail Mary" pass (Runyon). The path is very narrow and the chances are slim, perhaps nonextant. But it's all we got. Being sanguine about it would be silly. But why not give it a shot if the evidence can be found? That's huge obstacle #1 out of God-knows-how-many. No one is opposed to the concept in principle, I think.

2) I don't have a problem speculating about whether the FDA will be influenced about comments, whether the final proposed rule will incorporate many of them, or whether comments can be part of a valuable overall strategy. Actually I'll let this guy, who is the former FDA Chief Counsel, now in private practice, speak for me: https://soundcloud.com/vp-live/smoke-free-radio-episode-3

In particular: he seems to think that the final proposed rule will look a lot like the current proposed rule (in other words the FDA isn't going to care much about what we say); but also that comments are important when it comes to building a record for future litigation, if it does result as CASAA (and others) seem to conjecture. And by law, the FDA does not only have to cognize accurate, factual comments, but they also cannot entirely ignore the notion of a MRTP, a modified-risk tobacco product. And it seems highly likely to me that CASAA will ask us to comment regarding that issue. I suspect so based on what I'm seeing both on Bill G.'s comments as well as on C.V's blog (not to mention Siegel's and may others'). And why not? That's the point of THR, isn't it? Cessation is also an issue when it comes to the net health consequences.

An effective commenting strategy may also slow the FDA down, thus giving the vaping market more time to develop, and increasing the chances that the FDA will not end up presenting a final rule before the administration changeover (which usually means that proposed rules die). Bill G. brought up the example of OSHA's attempt to ban indoor workplace combustible tobacco smoking. They proposed a rule in '94, got over a million comments, and presto! nothing ever happened. Having the vaping-as-we-know-it persist for a few extra months will increase the likelihood that we'll have better statistics if/when the final proposed rule goes to congress, where the comments (and FDA's responses to them) will also be helpful in mounting the kind of legislative effort that might make the FDA's life difficult (that could also be done during the final OMB review, if I don't miss my guess).

We've all heard the expression "if we could just save one child." Well, maybe we're talking about thousands or even tens of thousands of smokers who quit in favor of vaping for every month that we can drag this process out. Isn't that a valid reason to try to slow the FDA down - by itself?

3) I would almost be prepared to offer to eat my trackball if CASAA suggests that we can somehow "cooperate" with the FDA or operate in any sort of non-adversarial manner vis-a-vis them. That's ludicrous. But there's more than one way to skin a cat. We could win this over the long run, or at least come out with a final proposed rule that somehow encompases some form or recognition of harm reduction via the public health beneifts calculus or the MRTP exception - both of which FDA is required by law to consider. And which open it up to legal vulnerabiities, as well as both public and congressoinal scrutiny if it does not.

Of course that's the big enchilda there, isn't it? Vaping has always been about improving public health. We are simply taking our "flag" as it were and attempting to plant it on the statute as part of the regulatory process: whether that "planting" occurs in the context of congressional oversight, public scrutiny, or litigation, we can still "win" or at least get something out of the process which serves the cause of vapers and public health to boot. That's what this is all about, I think.

Again, I'd like to think that all the sane people posting to this thread are in general agreement with the above ideas, modulo perhaps a quibble or two about the way I expressed them - i.e. perhaps there's some ambiguity that might lead to a misunderstanding.

 

[tombaker]

“I'm a pessimist because of intelligence, but an optimist because of will.”
― Antonio Gramsci, Gramsci's Prison Letters

It's not gratuitous doom-crying to acknowledge difficult realities.
It's not delusion to look for loopholes there, and a way out.
The problem begins when people, especially people who need to work together, polarize and blame one another and begin to base their reasoning on fixed personal positions rather than on carefully uncovering the facts of the matter, together.

That's when the truth gets buried in ego.

Your post should be a sticky, or maybe I will just lift it for a Sig file.
Well done.

 

[aubergine]

Roger: "but they also cannot entirely ignore the notion of a MRTP"

That.
The others, also.

And now I will sleep, with those little sugarplums of rationally supportable hope dancing in my addled head.

 

[tombaker]

I am seeing almost every thread turn into the same debate.

I agree, and is become more and more of a problem.
This thread was created to be a very specific item, and the original post was tightly written with source information on a possible Predicate Product.

Its the thread is being hijacked into some sort of discussion of CASAA, which it is not, or having posters presenting their personal views in very long posts, as the definition of the world, and what everyone will be doing, and what they should do, according to them. This thread has nothing to do with all of that, its just talking about the product which would be most likely to be a Predicate.

The usage of the "commercially marketed" term has FDA guidance. Yes I read what SmokeyJoe said about the former Ruyan guy said, and it very much something to consider. I started this thread before that comment also. I have been to SFATA before, and listening to as much content from the meeting which has been posted. I also agree that having a pre2007 predicate, might not be the best angle anyway. I prefer Azim's thoughts on a template product standard.

Thankfully there are enough posters looking at the OP for what its worth. Ebay was selling them, for example. What is the definition of selling in the US, since you can say I bought it on Ebay. Lots of legal angles. But I know that I can put a 3 inch diameter round peg, through a 3 inch diamater square box. I know they wanted the square peg down the square hole. I know the square peg is not going down the round hole also.

I will give a reason why some would not want the Ruyan as Predicate, and its a good reason.
http://www.economist.com/blogs/schumpeter/2014/03/e-cigarette-patent-wars

If Blu trys to get regulations in by using the Predicate of Ruyan, they have a hard time fighting off a patent challenge. Its like they are saying, we used it to the FDA, and they did not to the Court. This would require that they invalidate the patent, buy saying the prior art existed. The 1965 patent guy would agree, but if they are not able to invalidate the newer patented, the applications for Predicate could be a real issue. Alternatively, it could just be a cost of doing business.

I hope newer comments can be in line with the OP, and the other On-Topic postings, and avoid further hijacking thread grandstanding.

Lets keep to topic, and its not hard to find a thread which is On-Topic, and if not, create one yourself.

 

[Kent C]

I WAS being mischievous.

Great quote, though.

It is. ................

 

[sky4it]

Yeah, and I for one am not going to live my life in a crisis because of this stuff.

Like SmokeyJoe, I too dislike arguments from authority. This is what you are engaging in.



It has nothing to do with marketing, bringing items to market? Then why does the ruling document say:
The purpose of the Ruyan Electronic Cigarette is to act as a nicotine inhaler that has atomized smoke being forced out of the plastic mouthpiece tip. You state that the these items will be marketed in five, different packages



With that said, I give credence to what SmokeyJoe contributed to this thread.

But ok I will answer this which was directed toward me.

your point 1) I never said I was an authority, niether do I wish to become one. Just so you know, I AM NOT AN AUTHORITY ON ANY OF THIS STUFF, as if its' some sorta gift if one is. All I did was give an opinion, (as in it looked like rotten onions etc.), which certainly isn't authority driven stuff. Niether was it argumentative. And just so I can get a grip on this, I do consider the former President of Ruyan an authority on when his products where marketed/sold in the U.S. It is also rather clear that SmokeyJoe is an authority on lots of this stuff. If SmokeyJoe says that I have made an argument from authority I will apologize to SmokeJoe because he is an authority, because I am not an authority- but not to you. All I did was summarize a remark and have an opinion. For example and here is another one: I did not think SmokeyJoe painted a rosey picture in general about these FDA regs, (this is an opinion about what SmokeyJoe said) but at this point I don't want to summarize or have a remark on anything SmokeyJoe said.


your point 2) You are incorrect, (because that situation has nothing to do with marketing) for the following reasons:
A) It's in your own supine, as in your own attempted proof. Notice the words "these items will be marketed" as in the words "Will be", as in are going to be, about to be marketed. As in not yet. The proof of my position is in the very document which you provide for your posit. which is provable in my point B)
B) When a company wants to import a product, you call a US Customs broker. This is the very first step - to get a product classification code. You have to have one for customs. You do this to find out how much tax that is going have to be paid to the government for duty. You do it as a part of PREPLANNING, when you are PLANNING on importing a product. You do it so you can price your product and determine many things. For example, if duty is 50 percent of the cost of the product, the duty might be so high that you abandon the project. And that is all this document is, is code classification of the product. And it fits perfectly with what Ruyun said, because they where in business to market and sell in May 2007.(According to Ruyun's President.)

Therefore you are wrong.

I also would appreciate it if you wouldn't unsettle or confuse the point by using terms like "bringing the product to market." At this point, they had brought no product to the market. Also, if this is the point (proof) someone is going to make for opining for prior(predicate) products with the FDA, I beg to differ. What you got here is about as useful as some used toilet paper.

Your third point about you giving credence to what SmokeyJoe said. As far as that goes, its none of my business, wether you have or not, and I presume that-that in particular, and the rest of what you posted was directed at others and not to me with a few exceptions about some other stuff:

1) SalemGold, who is really well respected around here,took issue with you on some stuff on TomBakers other thread which is on the tinfoil thread now. I thought she had some really pointed remarks which ?????? Salem Gold's remarks were on post 250 of the thread in tinfoil the following: "Jman8, you seem to continually try to force your views on others here even though most strongly disagree.If it were fact that you truly are just a vaper with wild thoughts that the proposed regs are all good for you, it would be very hard to believe that you would not be relaxing and waiting for all of the good things to come your way instead of posting here trying to make others see things your way.There would be no point in it if what you are saying is true as we will all find out soon enough.The majority of us are here trying to find a way to stop these regs not rejoice about them." And then her post # 259
of Course, she was considerably less frustrated with you then DeadBeatJeff (but that is just my opinion.)
2) DeadbeatJeff, has refused to communicate with you. (Post 441 tinfoil thread- page 45) (And numerous other DeadbeatJeff posts) I believe he did this because you continued to digress.(Thats my opinion) And if you want to call me argumentative when i posted an opinion, if you do it again, I am going to do exactly what DeadbeatJeff did, and refuse to communicate with you. 3)Others also, Salem Gold, "even though most strongly disagree." I don't like to stongly disagree, I would rather just disagree and move on.
BTW, "forced views",& I agree with SalemGold abt that with respect to you,IMO are arguments from authority---- and certainly not mine.


Enough said.

Oh and DC2, thanks for your remarks on the rest of what this guy said, although I really didn't think you had to. To the rest thanks too,,,, It would be nice to hear from SmokeyJoe, on the February date, 2007, as to wether this was a precondition, as in had to be so. ie( He is an authority, I am not.) It's because it just looks preemptive. I was trying to think of a situation where you had retroactive law being installed. I am not sure wether there is a precedent, but perhaps there is. (One that comes to mind is Prohibition in the 20's.)Naturally, when you try and undo something that is already in place, there are going to be casualties.

TomBaker: You got what?????Another thread out there with 600 posts?,Thats drutttts. I did not know that Tom, Tom your are like a walking moving library. No thanks Tom it's ok, I think I will skip that 600 post one that got blacklisted. Tom for real, I think you better just let that old boat sink. ur like a genie without a jinx. I am not going to read all that, I think I 'd rather turn to drinking.

And that means tonight doing something for myself.

Whiskey,Gin and Brandy, with a glass I'm pretty handy............................... buzz for the later............cheers.

 

[Stosh]

.....And that means tonight doing something for myself.

Whiskey,Gin and Brandy, with a glass I'm pretty handy............................... buzz for the later............cheers.

brought some popcorn so you don't slosh while you walk.......

 

[Jman8]

Notice the words "these items will be marketed" as in the words "Will be", as in are going to be, about to be marketed. As in not yet. The proof of my position is in the very document which you provide for your posit. which is provable in my point

I noticed the words "will be" and "marketed" - hence it has something to do with marketing.

When a company wants to import a product, you call a US Customs broker. This is the very first step - to get a product classification code. You have to have one for customs. You do this to find out how much tax that is going have to be paid to the government for duty. You do it as a part of PREPLANNING, when you are PLANNING on importing a product. You do it so you can price your product and determine many things. For example, if duty is 50 percent of the cost of the product, the duty might be so high that you abandon the project. And that is all this document is, is code classification of the product. And it fits perfectly with what Ruyun said, because they where in business to market and sell in May 2007.(According to Ruyun's President.)

Therefore you are wrong.

I asked a question. You are saying it was wrong to ask the question? The bolded parts lead me to believe it has something to do with marketing.

 

[Katya]

I WAS being mischievous.

Great quote, though.

Indeed.

A quote for a quote:

"Don't hurt people and don't take their stuff."

I'm very fond of this one.

 

[aubergine]

You're mischievous, too.

Indeed.

A quote for a quote:

"Don't hurt people and don't take their stuff."

I'm very fond of this one.

 

[Katya]

You're mischievous, too.

Guilty as charged, Your Honor.

 

[Kent C]

heaven gifts was a distributor for Ruyan and at one time had the site name - ruyandirect.com - they weren't actually Ruyan, so at a point when Ruyan wanted to take full control of their name, in Oct. 2011, ruyandirect became 'heaven gifts'. The company had ebay sales going back to August of 2006. I'm awaiting for any information regarding what sales to the US took place.

Ruyan had their own site as well, so the May 2007 date may be just about them, not one of their distributors, ruyandirect.

Wayne at heaven gifts could find no paperwork, ebay or otherwise. He knows of three factories that he knows was in the ecig business in 2006 and he's going to inquire. Could be awhile... he, of course, is concerned... He and many people he knows still hold the US in high esteem, and he's sad that the FDA has taken this course of action. He knows it well.

 

[Roger_Lafayette]

Bank statements? Affidavits? Any alternatives at all?

Factories in China?

We're down to digging up 7-year-old evidence from China?

Wayne at heaven gifts could find no paperwork, ebay or otherwise. He knows of three factories that he knows was in the ecig business in 2006 and he's going to inquire. Could be awhile... he, of course, is concerned... He and many people he knows still hold the US in high esteem, and he's sad that the FDA has taken this course of action. He knows it well.

 

[Oliver]

OK, let's assume, for the sake of argument, that some evidence is dug up for US sales prior to Feb 15th 2007. Let's also say that the exact recipe for the e-liquid, detailed descriptions of the design of the hardware, possibly even actually existing samples of the product and so forth, absolute definite proof that the product was sold in the US, and so forth.

We're still left with a predicate product that's almost totally useless. I simply don't buy this argument that the FDA will bend their existing predicate system (just look at the decisions already taken) and base future decisions on this sort of "adam ecig" and whether it existing products are substantially equivalent to it. And even if they did do that, they're only going to allow it for products that are pretty-damn-similar - i.e. cigalikes.

I guarantee you that no-one was purchasing separate e-liquid back then either.

The fact is, the FDA has stated that SE is unlikely and that future decisions are going to be through the New Products route.

Apologies for not yet having the time to write up the SFATA gig. I will do it very soon, but no promises - I have a young family I was away from for considerable time, and I have to present at two events next Weds in the UK. If I can't do it by Weds, I will be certain to do it by the weekend.

One thing I will say:

Comment to the FDA should be made late, but not too late (to avoid ANTZ rebuttals), and the first action everyone should be taking is to get an extension on the comment period.

 

[2coils]

I think Zellers intentions have been pretty well stated. Not sure where all of the confusion has come from(speaking of those following the situation closely). Not only are his intentions reflected in the proposed rule, we have his own comments, and previous actions of the FDA to go on.

 

[DanFromRioRancho]

Great information here, a big thanks to those that have been digging!

So if I understand what appears to be the most common views on OP's posting:
1. There is a difference of opinion as to whether a product that would be accepted by the FDA as a predicate even exists.
2. If there is no predicate product, then BV has to take the PTMA pathway which is unlikely to succeed due to the required studies.
3. If there is a predicate product, the SE pathway is unlikely to succeed unless the FDA is willing to stop their parochial approach to SE analysis which also seems unlikely.

And yet BV seems confident that their products will be approved.

Makes me wonder if "the fix is in", buried in the FDA request for comments/suggestions on a possible 3rd approval pathway for ecigs. If so, that would make a tidy explanation for the 2-year grace period -- 6 months (give or take a few) for the FDA to officially process the BV suggestions and prep enough of a framework to allow BV to submit their applications, followed by 18 months (give or take a few) for the FDA to actually set up their internal structure and processes and approve the BV submissions (government agency bureaucracies are sloooooow).

It will be interesting to see the comments once the FDA publishes them.

 

[tombaker]

OK, let's assume, for the sake of argument, that some evidence is dug up for US sales prior to Feb 15th 2007. Let's also say that the exact recipe for the e-liquid, detailed descriptions of the design of the hardware, possibly even actually existing samples of the product and so forth, absolute definite proof that the product was sold in the US, and so forth.

We're still left with a predicate product that's almost totally useless. I simply don't buy this argument that the FDA will bend their existing predicate system (just look at the decisions already taken) and base future decisions on this sort of "adam ecig" and whether it existing products are substantially equivalent to it. And even if they did do that, they're only going to allow it for products that are pretty-damn-similar - i.e. cigalikes.

I guarantee you that no-one was purchasing separate e-liquid back then either.

The fact is, the FDA has stated that SE is unlikely and that future decisions are going to be through the New Products route.

Apologies for not yet having the time to write up the SFATA gig. I will do it very soon, but no promises - I have a young family I was away from for considerable time, and I have to present at two events next Weds in the UK. If I can't do it by Weds, I will be certain to do it by the weekend.

One thing I will say:

Comment to the FDA should be made late, but not too late (to avoid ANTZ rebuttals), and the first action everyone should be taking is to get an extension on the comment period.

This thread was started after I was researching if there was a Predicate what would it be. I was happy to find the import duty determination and defined duty rates from the Feds themselves. The Ruyan was being sold via the Internet and in several countries in 2006. We have examinations of what the e-Liquid, and what is in it, and medical assessments of its health effects. I am also finding that there was a lot of good work done on the Ruyan which may be able to be cited to the FDA in other applications. For example http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf 3 different labs looking at the E-Liquid, etc. And http://www.healthnz.co.nz/DublinEcigBenchtopHandout.pdf

I think I am comfortable that if there is a Predicate pre Feb07, its the Ruyan. And it has a chance to work. BUT that does not answer the question you raised, would Ruyan as Predicate be useful to the purpose of taking the existing Vape Industry past the FDA compliance barrier, which we agree is still a moving target.

For that question I think its important to realize that E-Liquid is the E-Cig, and the Cig-alike, and the APV. The mechanism of vaping is not different between an E-Cig and an APV tank. Reservoir of E-Liquid, battery powered coil with Wick. Its all the same. None of the hardware is consumed in vaping. Its just as a pipe, is to Tobacco. Bigger coil, bottom fed, larger battery, even a dripper, its all the same function, and effect. The end result of everything is the myst of E-Liquid. E-Liquid is the everything to the FDA, and vapers. The often used example of rolling papers means clearomizers too, is wrong on the science. The clearomizer is not consumed into the users lungs....the Paper is. If E-Liquid is held in a pre-fill, or its held in a raw bottle, its still the same product that needs to get past the FDA.

So can the E-Liquid of the 2007 Ruyan, which was tested, become the predicate. Jury is out, I would say about a solid 40% chance, that assumes an E-Cig maker would really want to get it in, and work it. BUT, would it help?

If a single predicate with E-Liquid is in, then all E-Liquid will be able to model on it, and because deleting items from an approved product is easy, using the predicate would work out well.

Even with my view of 40% guesstimate, that means that other plans need to happen for the 2 other pathways the FDA describes. Because I view E-Liquid as the Tobacco, and hardware as the Pipe and
I see that Njoy, Blu, V2, and some other major companies be OK with the regulations,
---I have to conclude they think they will get their E-Liquid and E-Liquid filled parts, through the FDA

I absolutely reject the notion that C-Alikes can make it past the FDA, without swinging open the door, WIDE open for the entire APV industry. If V2 is allowed to sell there patented clearomizer cart, introduced 2 weeks ago, everyone just needs to push some paper, and everyone is coming in, who also use good manufacturing processes such as AEMSA


This thread is basically for: if there is a Predicate, this is gonna be it, here is some documentation, here is the FDA guidance for Commercially Marketed. If a Predicate is declared the rest is reasonable effort, paperwork, and industry grows without much of a hitch.
The FDA is about 4 years away from doing anything inside of the real world and markets.

The local bans and zoning/interstate have vapers outflanked, and losing on the flanks every day, without a victory in years. At this rate in 4 years, cops will be pulling over vapers for distracted driving when you thought the last place you could vape was your car, and then they took that, and the FDA will still be 2 years away from anything.

 

[tombaker]

1. There is a difference of opinion as to whether a product that would be accepted by the FDA as a predicate even exists.

Some think no way, others think maybe (I am one of the maybe's) Nobody thinks "for sure we got one"

2. If there is no predicate product, then BV has to take the PTMA pathway which is unlikely to succeed due to the required studies.

BV, which I take is Big Vape, as in Blu, V2, Njoy......if so then, BV does think they will be able to handle the regulations. They are all optimistic and think the FDA hit the ball correctly, in their first comments the day of the announcement by the FDA. They think that either by Predicate, or PTMA, that their businesses will thrive.

A good place to look for real commentary, now that I think about it, will be the SEC filings of Lorillard, which will have to publish a risk statement to their share holders, being a public company and all. If a regulatory action would effect their business they need to disclose.....those disclosures are normally pretty harsh, but there could be some real insight to what NYSE:LO lawyers think they must disclose surrounding their Blu divisions profits going forward.

3. If there is a predicate product, the SE pathway is unlikely to succeed unless the FDA is willing to stop their parochial approach to SE analysis which also seems unlikely.

Sorta Yes and No.....The mechanism of the E-Cig is not critical, the E-Liquid is. If we have a Predicate for an E-Liquid inside a finished product. You could file an SE, by deleting all the hardware, and apply for the subset, the E-Liquid itself sans hardware.

And yet BV seems confident that their products will be approved.

It seems so, and exactly why, is not being queried much.

 

[Kent C]

sub·stan·tial

adjective: substantial

1. of considerable importance, size, or worth.
"a substantial amount of cash"

synonyms: considerable, real, significant, important, notable, major, valuable,

2. concerning the essentials of something.
"there was substantial agreement on changing policies"

synonyms: fundamental, essential, basic

Used with "equivalence", the second definition is more proper. Which is what some have been saying. The 'essence' of an ecig, is that eliquid passes near/around a coil powered by a battery and atomizes the eliquid into a vaper. This is true of 99.9% of all ecigarettes made.

The point, we all know, "that todays ecigs are different in some ways than the earlier ones", is only an 'interesting aside' when talking "substantial equivalence", since the fundamentals, essence, basics have remained the same.

Although I wasn't around ecigs in 2006, I can read about them And some of what I saw when I came on the scene has some common points. The 801, 901, and 510 were prominent players in 2009 and 'cigalikes' in the form of superminis were more recent editions. Not saying some didn't exist before that, just that this article shows an earlier "Golden Dragon Holdings" (2005-2006 and later Ruyan) that looks very similar to what Ruyan sold later as their 'cigar' (at least one type):

I got one of the later ones and it was more the size of a 900mAh eGo. Had cartridges that were refillable.

E-Cigarette History: A Comprehensive Timeline » Aussie-ECigarette-Reviews.com

"Between 2005 and 2006, Golden Dragon Holdings, the company where he worked, changed its business name to Ruyan, which means “resembling smoking” in Chinese. The company then started exporting its products to neighbouring Asian countries. The device was introduced to European countries and the United States in 2006."

Ruyan also had what many of us would know later, as the Janty kissbox. Ruyan's looked very similar and nothing like a cigalikes.

They also had a pipe - Oct. 2004:

If there is evidence of marketing in the US in 2006, it would more likely be in these forms rather than cigalikes. But if substantial equivalence is based on essence and fundamentals, as it should be 'by definition' and as should be argued by any lawyers on our side, it's not going to matter.

 

[DeadbeatJeff]

Interesting, Kent. I'd be interested in seeing what sort of sales went down after that 2006 date. But don't forget: "The second generation e-cigarette, also known as the modern e-cigarette, arrived in 2008."

but: interesting.