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

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Thanks for the heads up SmokeyJoe. Both for this and the other posts. Very informative, appreciated.

Just one quick question if you got a moment, SmokeyJoe. Do you know if there was any reason provided by the FDA,or your sources did they suggest, just why or what reason the FDA picked that February 2007 date? I mean they had to provide some reasoning as to why that was significant? I mean they didn't just pick the date out of hat?, it looks like a suppository.

Also, your quote above, yeah, I am quite certain the former president of Ruyan would know when they "marketed" their products here. In one line you decimated the first OP thread, thanks, for doing it the short way. (That stuff kind of looks like rotten onions now.)

But it is fun, to go through TomBaker stuff, it's like a crossword puzzle with no vowels. <snip> [bold added]

Thank you for that. It broke me up - "a crossword puzzle with no vowels" :laugh: :lol:

And although I'm not SJ, I'll take the liberty of answering your query. The 2/15/7 date is hard-coded in the statute. I think Kent pointed out that this was the date-of-introduction of the legislation.

Regardless of how the date came to be, Congress has made that decision, and the FDA can't change the law. So we can play silly semantic games all day long about what the FDA meant when they used the word "believe." Depends on one's idea of "fun," I suppose.
 

Jman8

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Also, your quote above, yeah, I am quite certain the former president of Ruyan would know when they "marketed" their products here. In one line you decimated the first OP thread, thanks, for doing it the short way. (That stuff kind of looks like rotten onions now.)

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

1) Tombaker says "application granting the right to bring product in, in 2006." Tom, the document you are referring to is a US Customs classification of product document. IT IS NOT AN APPLICATION for anything. It has nothing to do with selling or marketing. I know cause I used to import products.

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 not to point that it means there is no hope for this tangent.

And frankly, since around 4/30/14, I've been operating under impression, without an appeal to authority from our side, that says the SE path is dead going forward. That NTPMA is the way, going forward. I don't know that it is, but it sure seems likely given what has been provided to us.

Which then brings us back to how will vaping consumers address the FDA proposal. Will we maintain defeatist attitude because of FDA track record and general lack of trust in the process? Will we downplay all ideas going forward, unless it is from expert on our side? I remain curious as to whether expert on our side will 'open up a doorway' in which it is seen there is a constructive path going forward and reason to connect with FDA, on the proposal. Only slightly curious about this, as I think this is a given. More curious whether that experts guidance/suggestions will be met with same level of scrutiny and defeatist attitude as is prevalent right now on the forum?

I'm guessing, it will not be.
 

tombaker

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Do you know if there was any reason provided by the FDA,or your sources did they suggest, just why or what reason the FDA picked that February 2007 date? I mean they had to provide some reasoning as to why that was significant?

Post 14 of this thread explains it, Date Bill was introduced.

I am quite certain the former president of Ruyan would know when they "marketed" their products here. In one line you decimated the first OP thread, thanks, for doing it the short way. (That stuff kind of looks like rotten onions now.)

I posted this, before the meeting took place,, and there is nothing in the OP that is anything beyond linking up some information about the first E-Cigs coming into the US, so I don't understand how that information is decimated or rotten. Subsequently I posted the information on how the FDA defines "Commercially Marketed", because it is a legal term as used by the FDA. I then posted the actual guidance from the FDA on that exact topic. I do play Chess, and understanding what is on the board is important regardless if it can actually be used successfully or not.

If Ruyan was marketing the E-Cig, and it was being sold by importers, and if you look at the text of what the FDA has written, IT REMAINS possible that the FDA could agree that the Ruyan could be used as predicate. They have some incentive to do so, as it simplifies problem areas for them, but lets them retain control of what the Predicate is. By including the Ruyan as Predicate, based off whatever set of information can be obtained, they also avoid legal challenges to the law asserting the law is not a valid law, because it planned implantation is a backend banning of Tobacco Products, where an entire Category being legally sold today.

Without granting a predicate, the legal challenges are strengthened.


1) Tombaker says "application granting the right to bring product in, in 2006." Tom, the document you are referring to is a US Customs classification of product document. IT IS NOT AN APPLICATION for anything. It has nothing to do with selling or marketing. I know cause I used to import products.
I refer you to the guidance link I posted. And reiterated that the actual determinatizon my or may not be the defintion being used by former Ruyan Employees. It may be the old CEO is right, but before he is, there is an oppertunity to argue for the Ruyan as Predicate. Up to the point it is rejected specifically. This is why I asked if there is any knowledge if V2, BLU and the rest are going to use this. They have legal teams working obviously, and their first reaction is We can live with these regs. The diacotomy between the large E-Cig makers reaction, compared to the little vendors.
2) Tombaker says "They Ruyun was being sold at the right time, the Patent's reflect that,.." Tom, once a product is announced or people become aware of its existence, a company only has one year to file a patent or they lose there patent rights. It is proof of nothing when it comes to "the product being sold at the right time." I know this because I have filed a patent application before.
Again I refer you to the FDA guidance on the defintion. The Ruyan was certainly on the worldwide radar in 2006. It was being brought into the USA also. Ruyan was doing interview with publication talking about their future plans. Distributors were bring it in. My reading of the actual FDA document, does not even list out Sales figures. So I can not just assume that sales numbers are required, BY THEIR DEFINITION. You are leaping to say Sales = Marketing, when the actual document does not reflect that at all.
My point is simply it worth the test, put it to the FDA, they could accept it or reject it, but you won't get a date unless you ask the girl out.

4) Tom, you gave a source of a company selling ecigarettes and ejuice THAT WAS IN CHINA. The FDA proposed regs somewhere on or in page 11, says "commercially marketed in the United States." And it would not matter if Ruyun marketed their products in Bolivia in 2004. In means, in the United States Tom.
The WWW offers a English website that will deliver products to you. Before giving up, I would attempt it. My method of not precluding an option is far safer than you saying the option does not exist.

And 4 wrongs do not make a right. And now Tom you are 0 for 2. I tried, Tom down in the tinfoil section, I offered my assistance to polish this up, to get the rough edges ironed out, but you didn't respond. Look Tom, I might have some time over on the Tinfoil thread latter this weekend or next week. If you want I will try and help.

I'll go back and check my original analysis thread, I don't know why it was removed, it has over 2000 likes 13K views and 600+post, most not being mine.....I did not see what you wanted me to reply to, the thread is impossible to find. I spent good effort on it, the thread being black listed is insulting.
 

aikanae1

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From the news articles, it appears that Ruyan did not officially market their product until May 2007 (apx). That would be the official roll out to the US. They were in several other countries by then. However it appears that distributors were selling to the US and people were buying. So I don't think "commercially marketed" is so clearly defined. Wouldn't a website, in english and USD, from a place like Heaven's Gifts be considered "commercially marketed"? I suspect there might even be a case made for an Ebay listing, although not as easily.

I think someone mentioned earlier that Heaven's Gift used to be Ruyan's website, but I don't know about that. If true, I think that would make the issue even murkier. This is a global economy. Some don't like it and don't want to see it that way, but it doesn't change the fact that it is. I know the trade department considers 'anything made available and sold to US customers in USD' as a definition for enforcement actions. That's not the same, but it does muddy the water.

I guess my thing is, why not? I'm not even sure what could be done if something were found. Maybe nothing, but that would be a conversation for later. At least we tried. Otherwise there is little choice but to turn the market over to BT and BP. Roll over dead on this. That's not something I find comfortable or easy.

BTW: Requesting comments is a regulation and the regulatory language is prescribed. That is not symbolic of a deep desire to work with the ecig market or that the FDA "believe's" in us. Seriously? They don't even "believe" consumer trends mean anything; remember. 'anecdotal evidence isn't data'. :facepalm: Look at the economic outlook and the FDA isn't at all concerned about 'small and medium business exiting' from the market. Based on that alone is enough to form the belief that they DON'T intend to work with us.
 
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Kent C

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From the news articles, it appears that Ruyan did not officially market their product until May 2007 (apx). That would be the official roll out to the US. They were in several other countries by then. However it appears that distributors were selling to the US and people were buying. So I don't think "commercially marketed" is so clearly defined. Wouldn't a website, in english and USD, from a place like Heaven's Gifts be considered "commercially marketed"? I suspect there might even be a case made for an Ebay listing, although not as easily.

I think someone mentioned earlier that Heaven's Gift used to be Ruyan's website, but I don't know about that. If true, I think that would make the issue even murkier. This is a global economy. Some don't like it and don't want to see it that way, but it doesn't change the fact that it is. I know the trade department considers 'anything made available and sold to US customers in USD' as a definition for enforcement actions. That's not the same, but it does muddy the water.

I guess my thing is, why not? I'm not even sure what could be done if something were found. Maybe nothing, but that would be a conversation for later. At least we tried. Otherwise there is little choice but to turn the market over to BT and BP. Roll over dead on this. That's not something I find comfortable or easy.

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.
 
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DC2

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JDo you know if there was any reason provided by the FDA,or your sources did they suggest, just why or what reason the FDA picked that February 2007 date?
That date is hardcoded into the FSPTCA and is basically tied to when that "agreement" was put into action by Congress.

But it is fun, to go through TomBaker stuff, it's like a crossword puzzle with no vowels.
:lol:
 

DC2

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Which then brings us back to how will vaping consumers address the FDA proposal. Will we maintain defeatist attitude because of FDA track record and general lack of trust in the process? Will we downplay all ideas going forward, unless it is from expert on our side? I remain curious as to whether expert on our side will 'open up a doorway' in which it is seen there is a constructive path going forward and reason to connect with FDA, on the proposal. Only slightly curious about this, as I think this is a given. More curious whether that experts guidance/suggestions will be met with same level of scrutiny and defeatist attitude as is prevalent right now on the forum?

I'm guessing, it will not be.
The guidance will be discussed in great detail.
I don't understand why you think it would not be.

But waiting for that guidance is crucial.
 

Jman8

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The guidance will be discussed in great detail.
I don't understand why you think it would not be.

But waiting for that guidance is crucial.

Do you think it'll be scrutinized in great detail, along lines of:
- don't listen to this advice because we simply can't trust the FDA; they will just ignore our comments anyway; they don't care about comments and will do whatever they want; therefore submitting any comment is pointless
- this guidance is putting forth scenarios that are pure speculation and fantasy, thus it must be ignored and ridiculed; better yet, who exactly wrote this, and let's shoot the messenger rather than talking about the message
- way this guidance is written, it is clear that CASAA is really a BT shill; how can you not see this?

I think anyone that engages in that will be shot down, and personally, I won't mind. But then take the more fair ways that guidance could be scrutinized, and I'm still thinking that will get shot down.

Because an appeal to, or allegiance with, authority is that powerful.

IMO, CASAA guidance will have magical effect of taking prevalent defeatist attitude and transforming that into: there is some hope on some things within this proposal.
 

DC2

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Do you think it'll be scrutinized in great detail, along lines of:
- don't listen to this advice because we simply can't trust the FDA; they will just ignore our comments anyway; they don't care about comments and will do whatever they want; therefore submitting any comment is pointless
In my opinion our comments will be ignored.

But that does not in any way lessen the importance of us making those comments.
There are MANY reasons to do so, regardless of whether or not they pay any attention to them.

I can (and probably will in the future) make additional posts to outline why it is important to make those comments no matter what.

- this guidance is putting forth scenarios that are pure speculation and fantasy, thus it must be ignored and ridiculed; better yet, who exactly wrote this, and let's shoot the messenger rather than talking about the message
Only one or two people think the guidance will be fantasy and speculation.
And I trust that this entire forum will blast those people for their ridiculous arm-chair lawyer interpretations and misrepresentations of the guidance.

There are people that are trying to screw this up.
And they will be rightly ignored.

- way this guidance is written, it is clear that CASAA is really a BT shill; how can you not see this?
Nobody in their right mind thinks this.

And if they do, they don't need to help us because we don't need their help.
By all indications, they are probably nuts, and of no help to our cause.

IMO, CASAA guidance will have magical effect of taking prevalent defeatist attitude and transforming that into: there is some hope on some things within this proposal.
I'm sure that is what will happen with the guidance as well.
It will be the focus point that we can all start from in order to take action.

Some may agree with some of it.
Some may agree with all of it.

And some may agree with none of it.

But it's a start, and it will contain valuable tips for making your voice heard and you comment count.
 

aikanae1

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You can't say on one hand CASAA won't be professional and then say they are a shrill for BT. There are so many contridictions in your comment that your post doesn't deserve sincerity or response. Start another thread if you want to waste time playing debate games.


Do you think it'll be scrutinized in great detail, along lines of:
- don't listen to this advice because we simply can't trust the FDA; they will just ignore our comments anyway; they don't care about comments and will do whatever they want; therefore submitting any comment is pointless
- this guidance is putting forth scenarios that are pure speculation and fantasy, thus it must be ignored and ridiculed; better yet, who exactly wrote this, and let's shoot the messenger rather than talking about the message
- way this guidance is written, it is clear that CASAA is really a BT shill; how can you not see this?

I think anyone that engages in that will be shot down, and personally, I won't mind. But then take the more fair ways that guidance could be scrutinized, and I'm still thinking that will get shot down.

Because an appeal to, or allegiance with, authority is that powerful.

IMO, CASAA guidance will have magical effect of taking prevalent defeatist attitude and transforming that into: there is some hope on some things within this proposal.
 

Jman8

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In my opinion our comments will be ignored.

But that does not in any way lessen the importance of us making those comments.
There are MANY reasons to do so, regardless of whether or not they pay any attention to them.

I can (and probably will in the future) make additional posts to outline why it is important to make those comments no matter what.

I'll be interested in hearing those reasons, given the assertion that our comments will be ignored.

I do not believe our comments will be ignored. I also don't think only 'pro-vapers' will be the ones commenting. So if pro-vapers don't get everything we want, it is plausible to conclude our comments were ignored, or (more) plausible to realize that others have a hand in shaping what the final rule will look like.

Only one or two people think the guidance will be fantasy and speculation.
And I trust that this entire forum will blast those people for their ridiculous arm-chair lawyer interpretations and misrepresentations of the guidance.

There are people that are trying to screw this up.
And they will be rightly ignored.

Here is where we differ. I'm saying there is defeatist attitude that is downplaying all current guidance, and I wonder if that same attitude will shine thru when CASAA gets around to providing guidance? I ask this rhetorically as I noted previously that the defeatist attitude will be mitigated simply because CASAA has said anything. Not what they say, but that they have finally spoken, will likely change the narrative here on ECF.

CASAA could say exact same thing as what has already been said on the forum, and downplayed/scrutinized, but I see that being forgotten and a general acceptance of that information being in play, simply because CASAA said it, but partially cause defeatist attitude can't go on forever.

Nobody in their right mind thinks this.

And if they do, they don't need to help us because we don't need their help.
By all indications, they are probably nuts, and of no help to our cause.

Would you say the same of people who currently throw around words of "BT shill" and "mole" without being able to back those assertions up besides just 'a feeling they have?'

If these people are being consistent with their rhetoric, they'd possibly say similar stuff about CASAA. But I think we both know they won't, and I'll know they aren't being consistent with their rhetoric.

I'm sure that is what will happen with the guidance as well.
It will be the focus point that we can all start from in order to take action.

Some may agree with some of it.
Some may agree with all of it.

And some may agree with none of it.

But it's a start, and it will contain valuable tips for making your voice heard and you comment count.

It's a start for a viable strategy, I agree with. But vaping consumers have been 'starting' since 4/24/14. Some with defeatist attitudes that downplay any suggestion about going forth with reasonable comments to the FDA, and some with optimistic attitudes that don't favor regulations, but see them as inevitable, and part of the process/future of vaping.

Which is what CASAA item posted today (May 8th) just said. An excerpt of that:
There is no point in trying to argue that these products are not technically tobacco (they clearly meet the definition of “tobacco products” in the TCA), nor that FDA cannot do this (they can). There are, however, arguments to be made that FDA should not exercise its available authority (either in whole or in part).
 

DC2

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Here is where we differ. I'm saying there is defeatist attitude that is downplaying all current guidance, and I wonder if that same attitude will shine thru when CASAA gets around to providing guidance? I ask this rhetorically as I noted previously that the defeatist attitude will be mitigated simply because CASAA has said anything. Not what they say, but that they have finally spoken, will likely change the narrative here on ECF.

CASAA could say exact same thing as what has already been said on the forum, and downplayed/scrutinized, but I see that being forgotten and a general acceptance of that information being in play, simply because CASAA said it, but partially cause defeatist attitude can't go on forever.
I don't like the entire concept of speculating what CASAA will or will not say.
And I like even less the idea of deciding how to react to their guidance before they issue it.

To me, such speculation is a distraction at best.
And a willful attempt to divide us at worst.

Would you say the same of people who currently throw around words of "BT shill" and "mole" without being able to back those assertions up besides just 'a feeling they have?'
If these people are being consistent with their rhetoric, they'd possibly say similar stuff about CASAA. But I think we both know they won't, and I'll know they aren't being consistent with their rhetoric.
I take no stance on these matters.

People will say what they feel they need to say.
It is up to each of us to weigh what is said and respond or not respond as we feel is appropriate.

Beyond that, it is up to the moderators and forum owner to decide what they feel is appropriate content.

It's a start for a viable strategy, I agree with. But vaping consumers have been 'starting' since 4/24/14. Some with defeatist attitudes that downplay any suggestion about going forth with reasonable comments to the FDA, and some with optimistic attitudes that don't favor regulations, but see them as inevitable, and part of the process/future of vaping.

Which is what CASAA item posted today (May 8th) just said. An excerpt of that:
Again, no point in discussing the CASAA guidance until it has been offered.
 

Kent C

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

We are grinding* at this point..... need new stuff :) Probably should return to News/Media which was nearly abandoned :laugh:

*grinding - for those who don't know - repetitive actions with no new results. Happens a lot in philosophy/politics boards.
 
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aubergine

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“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.
 

Kent C

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

I've read him and about him. Just for others from Wikipedia:

"The Communist intellectual Antonio Gramsci (1891–1937) developed the theory of cultural hegemony to further the establishment of a working-class worldview."

"In Marxist philosophy, the term Cultural Hegemony describes the domination of a culturally diverse society by the ruling class, who manipulate the culture of the society..."

If he were alive, sounds like a perfect replacement for Mitch Zeller at the FDA.
 

aubergine

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I WAS being mischievous.

Great quote, though. :) :)

I've read him and about him. Just for others from Wikipedia:

"The Communist intellectual Antonio Gramsci (1891–1937) developed the theory of cultural hegemony to further the establishment of a working-class worldview."

"In Marxist philosophy, the term Cultural Hegemony describes the domination of a culturally diverse society by the ruling class, who manipulate the culture of the society..."

If he were alive, sounds like a perfect replacement for Mitch Zeller at the FDA.
 
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