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

[Kent C]

Well you're right that if there is no predicate product, then it's dead in the water.

I never said that nor intended it. I suppose you could infer almost anything when I say "If" - in this case, toward something positive and then then take the opposite side, but really, to say basically, 'I'm right, that it's dead in the water' is a complete misapprehension of what was said.

As far as the rest of the post, yes I've read several of your other posts that say that same thing.

 

[Kent C]

The way I read substantial equivalence is that all of those things are far from being irrelevant to the FDA.

--They would be concerned that a different battery might provide more power and deliver more nicotine
--They would be concerned that the airflow pattern might deliver more nicotine
--They would be concerned that the wicking material might deliver more liquid and hence more nicotine

Increased nicotine delivery, in their eyes, would require studies to show that this would not cause more addiction.
That it would not cause more people to NOT stop using nicotine.

And then they would apply the same arguments above to the delivery of flavors.

What if the flavors taste better that way?
Would that cause more CHILLLLLDREEEEN to start vaping?
Would that cause more vapers to keep vaping instead of stopping their use of evil nicotine?

The whole substantial equivalence doctrine shows where the FDA's head is at.
And it's the very reason I feel they are not even trying to play fair or consider harm reduction in their equation.


Couldn't agree more. The lawyers gotta throw everything they can at this, and hope something sticks.

Just saying that a lawyer could make a pretty good case on 'essence' as long as specific details of how something HAS to be different isn't stated and like most stuff by the FDA, they weasel in both readings.

 

[aikanae1]

I just want nic to remain available right now. I'm not as concerned about the rest of the stuff. Without nic, where looking at Silk Road, Tor and Bitcoins. Maybe that's about to go mainstream for all I know?

If nic was not restricted, then nic was marketed (I hope) even if it came from a chemical supply company. The FDA doesn't specify that it had to be available ONLY for ecigs. I'm not talking industrial quality either. Would someone at Wizard know about availability of nic pre 2007?

Eliquid stores can sell 0mg flavors. Shady? Maybe. But not so shady to get in trouble. Nic is a different story. That can be stopped at borders. From what I can tell, it could be only by prescription outside of whatever BT has in mind. This is also why I don't believe Ruyan. I'm confident BT has something in mind.

Here's import documents 2006
NY M86437 - The tariff classification of an electronic inhaler from China - United States International Trade Commision Rulings
NY M85579 - The tariff classification of a nicotine inhaler and parts from China - United States International Trade Commision Rulings (Njoy)

2007 http://www.chinadaily.com.cn/china/2007-05/09/content_869081.htm

In 2006, e-smoking devices accounted for 80 percent of Golden Dragon's business, Miu said, with the rest going to ginseng and Chinese medical products produced by other companies that Golden Dragon controls.

Chinese media has called the technology unsafe, claiming one cartridge of Ruyan contains 18 mg of nicotine, compared to about 1.2 mg for a typical cigarette.

Golden Dragon dismissed the charges, arguing it would take much longer to go through one cartridge than a cigarette.

"Obviously we are facing challenges with the tobacco companies," Fraser said.

Chinese e-cigarette helps you stub out the habit | Reuters

The cigarettes sell for around 1,600 yuan ($208) apiece and are already available in China, Israel, Turkey, and a number of European countries, but not yet the United States.

Golden Dragon's competitors include global giants Pfizer and Novartis AG, which sell more familiar nicotine replacement products such as chewing gum, patches, and inhalers.

Ruyan may not have "officially" marketed then to the US until May 2007, but they didn't seem to object to purchases from the US. Search terms have included electronic inhaler, electric hookah, nicotine inhaler

 

[Roger_Lafayette]

Huh?

All I was trying to say there initially was that you were emphasizing the need to have a predicate product in the first place, in order to even be talking about substantial equivalence. That's pretty simple Horse has to come before the cart.

And so I (basically) said "Yup, you're absolutely right, Kent. Horse has gotta come first! Cart comes next!"

In other words, no predicate product means that this quest is dead in the water. You don't disagree, I presume. No one could.

(So I'm assuming there was some kind of misundestanding there.)

I never said that nor intended it. I suppose you could infer almost anything when I say "If" - in this case, toward something positive and then then take the opposite side, but really, to say basically, 'I'm right, that it's dead in the water' is a complete misapprehension of what was said.

As far as the rest of the post, yes I've read several of your other posts that say that same thing.

 

[tombaker]

Bill Bartowski, former president of Ruyan America, confirmed at SFATA's conference yesterday that the earliest product on the US market was May 2007. There are no SE predicates.

I think you are jumping to a legal conclusion, that can not be stated as fact because it is based interpretation of law, that is completely untested.

It can NOT be declared, that was NOT a predicate product commercially marketed.

Marketed is not the same as Sales. The FDA has guidance on what can be used to show Marketed, but that list is not exclusive.

You have an application granting the right to bring the product in, in 2006. And we know that the product was sold in the United States. If you have information that the actual current players, NJOY, BLU, V2, and on and on, are not going to specifically use the Ruyan as Predicate, I would like to see it, and hopefully you can post it.

Until then, saying there is no Predicate, is speculation, especially because it will be a question at law. They Ruyun was being sold at the right time, the Patent's reflect that, the request for import duties was granted. And the product was certainly being sold in other countries also.

Again Marketed is not a specific translation to only Sales. It does NOT mean the parent company MUST be the importer.

Here are examples of what the FDA says can be used to establish commercially marketed, it does not mean all have to be shown, it does not mean these are the only methods to show it.
• dated copies of advertisements;
• dated catalog pages;
• dated promotional material;
• dated trade publications;
• dated manufacturing documents;
• dated bills of lading;
• dated freight bills;
• dated waybills; and/or
•complete copies of any supporting information that demonstrate (individually or collectively) that the tobacco product was commercially marketed in the United States on February 15, 2007.

Let not try to snatch defeat out of the jaws of victory.

 

[tombaker]

What might be helpful is to get an FDA ruling for a definition of 'marketed in the US'. That doesn't mean 'made' in the US, but it may mean either available by stores/vendors in the US or able to be shipped to the US from elsewhere. A broad reading would include the latter. I've contacted heaven gifts to see if there were any products shipped to the US before the Feb 2007 date. Or if they had an US 'partners' that sold their products at that time. Requested invoices with names and street addresses redacted but leaving the city, state, country and date.

It's Draft, not final. Comments to the FDA now, would be helpful, in creating a reasonable means to have an agreement. Declaring there is no SE, is not helpful in this legislative matter still being finalized.

http://www.fda.gov/downloads/TobaccoProducts/ResourcesforYou/ForIndustry/UCM252235.pdf

 

[tombaker]

Well you're right that if there is no predicate product, then it's dead in the water......snipped commentary unrelated to Predicate Product

The date to be used for Predicate Product, is still in question. Can a law function with a retro-active date, years prior to passage, and even more years since a category of products is declared part of a class that the law covers. (i.e. E-Cigs are not yet part of the FDCA Act.)

Because the FDA is asking for comments the question remains open. They said in their Draft that they do not believe they can change the date, but comments, especailly from regulatory lawyers, could change their current view of the dates.

The Sottera court opined that the specific products before their court could be controlled by the FDCA if they were brought in, it MIGHT be possible to ask them if they view the interpretation is intending on using, in line with their ruling. The FDA was certainly aware of the products, in 2009, in 2014 the FDA is wanting to act as the court directed them, but is using a 2007 date. You can not just backdoor authority, to overturn the intent of the appellate court. Double emphasis on might.

 

[Roger_Lafayette]

God forgive me for trying to answer this post ... I already am getting a headache from trying to figure out what is being claimed here as the basis for (apparently) concluding that there is any "flexibility" at all in the 2/15/07 date

I "believe" that two plus two is four. As a matter of fact I know that it is. When the FDA said that they didn't "believe" they could change the date, what they meant was that they were certain. It's hard-coded in the statute.

Can they decline to exercise their authority in some way, as far as enforcement goes? Yes. They've said as much, that's what the two-year window is all about.

But the statute is the statute, and only Congress can change its wording. And this date issue doesn't have anything to do with Soterra.

Is there something about the statute which is open to question because it referenced a date prior to its enaction? No, statutes do that all the time. A criminal penalty cannot be enacted after the fact, this violates the ex post facto clause. There is some question about whether this can apply to a civil sanction.

But to the extent that Congress chose to place products that were on the market prior to date A in a different regulatory scheme from those that were on the market subsequent to date A, in a statute that was passed on date B (where B is later than A) ... well of course Congress can do so. That's called grandparenting (or grandfathering if you prefer) and it's done all the time.

Geez, I'm gonna be sorry that I replied to this ... *sigh*

The date to be used for Predicate Product, is still in question. Can a law function with a retro-active date, years prior to passage, and even more years since a category of products is declared part of a class that the law covers. (i.e. E-Cigs are not yet part of the FDCA Act.)

Because the FDA is asking for comments the question remains open. They said in their Draft that they do not believe they can change the date, but comments, especailly from regulatory lawyers, could change their current view of the dates.

The Sottera court opined that the specific products before their court could be controlled by the FDCA if they were brought in, it MIGHT be possible to ask them if they view the interpretation is intending on using, in line with their ruling. The FDA was certainly aware of the products, in 2009, in 2014 the FDA is wanting to act as the court directed them, but is using a 2007 date. You can not just backdoor authority, to overturn the intent of the appellate court. Double emphasis on might.

 

[Oliver]

I think you are jumping to a legal conclusion, that can not be stated as fact because it is based interpretation of law, that is completely untested.

It can NOT be declared, that was NOT a predicate product commercially marketed.

Marketed is not the same as Sales. The FDA has guidance on what can be used to show Marketed, but that list is not exclusive.

You have an application granting the right to bring the product in, in 2006. And we know that the product was sold in the United States. If you have information that the actual current players, NJOY, BLU, V2, and on and on, are not going to specifically use the Ruyan as Predicate, I would like to see it, and hopefully you can post it.

Until then, saying there is no Predicate, is speculation, especially because it will be a question at law. They Ruyun was being sold at the right time, the Patent's reflect that, the request for import duties was granted. And the product was certainly being sold in other countries also.

Again Marketed is not a specific translation to only Sales. It does NOT mean the parent company MUST be the importer.

Here are examples of what the FDA says can be used to establish commercially marketed, it does not mean all have to be shown, it does not mean these are the only methods to show it.
• dated copies of advertisements;
• dated catalog pages;
• dated promotional material;
• dated trade publications;
• dated manufacturing documents;
• dated bills of lading;
• dated freight bills;
• dated waybills; and/or
•complete copies of any supporting information that demonstrate (individually or collectively) that the tobacco product was commercially marketed in the United States on February 15, 2007.

Let not try to snatch defeat out of the jaws of victory.

I'm not jumping to any conclusions. I sat through a day's worth of presentations from lawyers, regulation standards experts, tobacco people, e-cig professionals and e-cig advocates.

Every single one of them, to a man (and woman), was in no doubt whatsoever that there is no SE predicate; that there is no chance of the FDA changing the date of SE grandfathering; that even if either were the case, it actually helps in any case since it totally decimates this industry and removes the products that consumers are currently using to remain smokefree.

If you think you have another perspective that supersedes the absolute unanimous opinion of yesterday's landmark gathering of genuinely interested professionals, I'd love to hear it.

I hate arguments from authority - and I do hope you don't think that's what I've just been doing. I hope you watch the presentations once SFATA publishes them.

 

[Stosh]

I sat through a day's worth of presentations from lawyers, regulation standards experts, tobacco people, e-cig professionals and e-cig advocates. ....

Without jumping out a window...God Bless You! That's amazing....

 

[KODIAK (TM)]

If you think you have another perspective that supersedes the absolute unanimous opinion of yesterday's landmark gathering of genuinely interested professionals, I'd love to hear it.

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. I think they just damn well know it can't change and that wording is just a subtle way of saying, "Hey, it ain't our fault. Talk to Congress."

 

[Oliver]

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. I think they just damn well know it can't change and that wording is just a subtle way of saying, "Hey, it ain't our fault. Talk to Congress."

Well, if they couldn't figure out an alternative legal interpretation in three and a half years it would seem provident to assume no-one else will in 75 days.

The simple answer is that the spirit of the law applies to the type of tobacco product that existed at the time of the drafting of the law. The letter of the law says that it applies to all products deemed to be tobacco products. There's a massive gulf between the two, and the resolution to this gulf is entirely political in nature. The FDA is very smartly positioning itself to be free of responsibility.

That's how I read it, anyway.

 

[Oliver]

Without jumping out a window...God Bless You! That's amazing....

It was much, much more interesting than it sounds, and I wish dearly that several posters in this thread could have been there.

But thanks for your sentiment

I'll report more thoroughly when I've had time to get over the jetlag. To my mind, the SFATA conference was a landmark event, and the take home message is that the deeming proposal is as bad as anyone has described it hitherto. Further, that coordination between SFATA, CASAA, vapers, thought leaders and international organisations is essential for vaping to stand even the dullest glimmer of hope of surviving beyond 3 to 4 years from now. From an industry perspective, everyone needs to put their full weight behind SFATA (whatever their personal/commercial misgivings). CASAA is ready, willing and capable to lead vapers. International co-ordination is happening. Vapers need to become discerning about the companies they purchase from. Thought leaders need to monitor their pronouncements carefully, and make sure they take their lead from people who actually know what the hell they're talking about.

I'm sorry if any of that sounds bleak: I really don't mean it to be. I'm, personally, putting on my "energised optimist" hat, because there's nothing else to do. But we have to accept reality - this is going to be a tough fight.

 

[Roger_Lafayette]

Wow. Someone in another thread asked me to look at a few hookah sites last night, and I was amazed at the complexity of their situation. Got up this morning and watched 20 Youtube vids on the hookah movement - needless to say I was unprepared for the myriad nuances.

And now I read this ...

Suffice to say that my head is about to explode.

And I'm not happy to hear that bad prognostications of the vaping situation are justified, even though I suppose I have been responsible for my share.

Food for much thought.

[Quoting Stosh in #30]

It was much, much more interesting than it sounds, and I wish dearly that several posters in this thread could have been there.

But thanks for your sentiment

I'll report more thoroughly when I've had time to get over the jetlag. To my mind, the SFATA conference was a landmark event, and the take home message is that the deeming proposal is as bad as anyone has described it hitherto. Further, that coordination between SFATA, CASAA, vapers, thought leaders and international organisations is essential for vaping to stand even the dullest glimmer of hope of surviving beyond 3 to 4 years from now. From an industry perspective, everyone needs to put their full weight behind SFATA (whatever their personal/commercial misgivings). CASAA is ready, willing and capable to lead vapers. International co-ordination is happening. Vapers need to become discerning about the companies they purchase from. Thought leaders need to monitor their pronouncements carefully, and make sure they take their lead from people who actually know what the hell they're talking about.

I'm sorry if any of that sounds bleak: I really don't mean it to be. I'm, personally, putting on my "energised optimist" hat, because there's nothing else to do. But we have to accept reality - this is going to be a tough fight.

 

[aubergine]

Really grateful for the update and clarification, Smokey. Good to clear as much fog as possible, even if the emerging outlines are really discouraging.

And... gak.

 

[aikanae1]

I'm really looking forward to hearing more. I think a lot of people are putting their energy into finding the "bright side" of this when their energies could be focused on doing something more productive.

 

[Jman8]

Well, if they couldn't figure out an alternative legal interpretation in three and a half years it would seem provident to assume no-one else will in 75 days.

The simple answer is that the spirit of the law applies to the type of tobacco product that existed at the time of the drafting of the law. The letter of the law says that it applies to all products deemed to be tobacco products. There's a massive gulf between the two, and the resolution to this gulf is entirely political in nature. The FDA is very smartly positioning itself to be free of responsibility.

That's how I read it, anyway.

Why not help FDA with the bolded part.

FDA asks: What other policy options should FDA consider if, in fact, no predicate is available?

Vapers could advocate for: Exemption from TCA as a policy option, as this technology and product is unlike all others up for regulation.

IOW, beat them at their own game of "predicate" language. You (FDA) are right, there is nothing like it around and therefore is very likely not a tobacco product. Thus the sensible thing would be to exempt it from TCA and to not have FDA in charge of regulating a product that, by FDA's own admission has no predicate, and that uses hardware whereby its users may never come into contact with nicotine.

Why wouldn't we at least try for this given that FDA asked. Even if FDA won't listen to this argument, perhaps others (i.e. Congress) might.

 

[KODIAK (TM)]

IOW, beat them at their own game of "predicate" language. You (FDA) are right, there is nothing like it around and therefore is very likely not a tobacco product.

That's what's been said all along. And here we are.

It's all smoke and mirrors.

Right now, I think getting an extension for the commenting period should be #1 priority. There are just too many wheels turning at this time.

 

[Oliver]

That's what's been said all along. And here we are.

It's all smoke and mirrors.

Right now, I think getting an extension for the commenting period should be #1 priority. There are just too many wheels turning at this time.

This * 1000

 

[aikanae1]

http://www.khlaw.com/webfiles/What_To_Expect.pdf

It does not appear, however, that the FDA has the legal authority to change the grandfather date set forth in the Tobacco Control Act for the newly deemed products. Rather, the more likely scenario is that the agency will use its “enforcement discretion” to adjust the requirement for e-cigarettes to prevent the collapse of the market. For example, the FDA may allow e-cigarette and e-liquid companies to continue selling their products already on the market, as long as they submit a premarket application (i.e., a substantial equivalence report) for those products before some deadline in the future (e.g., 21 months after the NPRM is published). Those applications will remain pending until the FDA has a chance to review them (which could take years) in the same way that tobacco companies were allowed to file provisional substantial equivalence reports for their products marketed after Feb. 15, 2007, but before March 23, 2011.

That appears to be what the FDA has done. I've also read that the FDA can create exemptions, say for enviromental anyalisis for a broad section of products, but they can't exempt everything and they wouldn't want to. We already know they want to add more regulations (flavors) and that does have public pressure behind it. Misguided maybe but that is an arguement we need to win in the media and with Congress. We should have been writing to local, state and nat'l reps on this awhile ago.