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

[tombaker]

This is informational, its not the only resource, it is just what I gathered, feel free to add CONTENT.

Starting with the best, which could by itself, be smoking gun enough for purposes.

A.
This is a ruling by the United States International Trade Commision on August 22, 2006
1. It says they are bringing them in to Market them.
2. It describes the parts.
3. Informs on Nicotine and PG
4. Sells as Kits. and replacement Cartridges
5. Coming in for sales, with I's dotted, T's crossed, above board

So we have the animal, the type, that it is to be sold, the approved duty rates for the various items, which are different. Very very Predicate.

NY M85579 - The tariff classification of a nicotine inhaler and parts from China - United States International Trade Commision Rulings

August 22, 2006

CLA-2-85:RR:NC:N1:112 M85579

B.
United States Patent for above, issued in Sept 7 2006 Patent US20060196518 - Flameless electronic atomizing cigarette - Google Patents

C.
Posted Ruyan E-Cigarette on the November 8th, 2006
2006 November | e-Cigarettes - Electronic Cigarettes
The Ruyan E-cigarette is a patented sophisticated electronic device that atomizes purified, liquid nicotine and produces a vapor that, when inhaled, satisfies a smoker’s craving for nicotine

D.
Ruyan E-Cigarette on the December 16th, 2006

2006 December | e-Cigarettes - Electronic Cigarettes

E.
Early German Analysis of e-liquid circa March 2006

original http://www.e-zigi.de/Gutachten-Uni-Graz.pdf

Decent but not perfect Translation Safety of an Electronic Cigarette | e-Cigarettes - Electronic Cigarettes

As food additive it carries the designation E 1520. Apart from allergischen reactions, which can be released by almost all materials, and easy irritations of the Konjunktiva propylene glycol is toxicological harmless.

F.
A Ruyan Infomercial posted on Youtube on June 9, 2007 In 2007 posting on youtube was an afterthought, it surely was used and made prior to the posting date.

https://www.youtube.com/watch?v=ia2997x_kog



you're welcome

 

[MikeNice81]

The big problem is, if forced back to under performing cig-a-likes many people will revert. If I hadn't upgraded from a Halo G6 to a regulated Evod battery and tank system, I would be smoking American Spirits Periuqe right now.

 

[Elizabeth Baldwin]

The big problem is, if forced back to under performing cig-a-likes many people will revert. If I hadn't upgraded from a Halo G6 to a regulated Evod battery and tank system, I would be smoking American Spirits Periuqe right now.

I agree. We already know cigalikes will get passed through, its the more advanced devices we are worried about.

 

[tombaker]

The big problem is, if forced back to under performing cig-a-likes many people will revert. If I hadn't upgraded from a Halo G6 to a regulated Evod battery and tank system, I would be smoking American Spirits Periuqe right now.

.

The is no functional difference between a APV and an E-Cig, they use the same juice, they heat the juice with a electric coil, the juice is held available for the coil. Raw empty APV hardware is outside of the scope of the FDA regulations, because they do not contain Nicotine, and if nothing else, are used commonly for things that never contain nicotine. Specifically Zero-Nic E-Liquid, which many people use.

Specifically under the Tobacco Control Acts, the FDA can not regulate E-Liquid without Nicotine. Its only the nicotine that makes it a Tobacco-Product, and only nicotine sourced from tobacco.

The importance of a predicate product is mostly the E-Liquid, and secondarily the device. I certainly don't want to argue if small E-Cig is better or worse than APV world, both work well.

 

[MikeNice81]

People keep saying that. I've never seen an eGo battery used for anything else. I haven't seen a Pro Tank being used to vaporize herbs. That is not their main purpose and are used mainly as juice and nicotine delivery systems. That will make them subject to regulation much the way paper and glue can be regulated if it is intended to manufacture a cigarette.

As far as functionally the same, that is like saying a Chevette anda Cadillac are functionally the same. It is true, but ignores a world of differences that make for a better experience.

 

[FireDragon1138]

I don't see zero nicotine e-liquid not being regulated the same as other e-juice. If you think the government wouldn't have a problem with it being marketed to minors, can you say "gateway"?

 

[pamdis]

I don't see zero nicotine e-liquid not being regulated the same as other e-juice. If you think the government wouldn't have a problem with it being marketed to minors, can you say "gateway"?

That's one of the amusing things about all this. They can't regulate zero nicotine e-liquid, because, even Mitch Zeller admits, by definition, it's not a tobacco product.

 

[Kent C]

You're welcome.... for a few of the links.

 

[DrMA]

Nice post. Thank you, tombaker.

 

[Oliver]

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.

 

[Kent C]

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.

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.

 

[Road_House]

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.

{MODERATED} did their homework. It's obvious the Feb 2007 date was not just pulled out of a hat.

 

[Roger_Lafayette]

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.

Hmm, wouldn't that have to do w/ Congress' intent? Seems to me that legislative history would be helpful.

Here's the FDA definition: http://www.fda.gov/TobaccoProducts/...Evaluation/SubstantialEquivalence/default.htm

In General. In this section and section 905(j), the term 'substantially equivalent' or 'substantial equivalence' means, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product

(i) has the same characteristics as the predicate tobacco product; or

(ii) has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health.

And here: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm262073.htm#910_A_3_B

Characteristics: In subparagraph (A), the term 'characteristics' means the materials, ingredients, design, composition, heating source, or other features of a tobacco product. In subparagraph (A), the term 'characteristics' means the materials, ingredients, design, composition, heating source, or other features of a tobacco product.

***

So here's the prob. If it doesn't have the same "characteristics" (which it certainly wouldn't) then it must not raise "different questions of public health."

This is a minefield, because demonstating that something which could be marketed today - whther it's a cigAlike, an e-liquid, or a piece of "advanced" equipment (even a drip tip), doesn't "raise different questions of public health" ... is practically impossible.

I'd say this predocate product pathway is on life support, if not basically kaput.

 

[Kent C]

MoFos did their homework. It's obvious the Feb 2007 date was not just pulled out of a hat.

February 15, 2007 is the date that Henry Waxman (CA -D) introduced the bill - HR 1108 - FDA Regulation of Tobacco.

 

[Kent C]

Hmm, wouldn't that have to do w/ Congress' intent? Seems to me that legislative history would be helpful.

Frankly I'm not optimistic unless the seller/distributor was actually located here.

The other Q is what "equivalence" means. In the context of tobacco cigarettes, I believe they have to be pretty close.

There are many products 'marketed in the US' even right now that aren't from US companies. But what the FDA means by it, could be different. I've looked at many FDA docs and so far none have answered that question. As I said in a previous post where someone thought that meant 'made' in the US, I mentioned there was no definition stated on 'commercially marketed' and in those cases, the definition defaults to common usage.

 

[Roger_Lafayette]

Was editing my post when you posted yours - scroll up to #13.

There are many products 'marketed in the US' even right now that aren't from US companies. But what the FDA means by it, could be different. I've looked at many FDA docs and so far none have answered that question. As I said in a previous post where someone thought that meant 'made' in the US, I mentioned there was no definition stated on 'commercially marketed' and in those cases, the definition defaults to common usage.

 

[Kent C]

Was editing my post when you posted yours - scroll up to #13.

The question wasn't about the products but what 'commercially marketed in the US as of Feb. 15, 2007'. That is all I was addressing. IF there were predicate products then the whole discussion of what is substantially equivalent comes up. First things first, even though I know some people don't think that it matters anyway. I think a good lawyer (if there was a predicate) could make a case (as Zoidman suggested a while back) that it is 'still a coil with a wick' and it produces vapor (with or without nicotine). What battery runs the coil is irrelevant, what the airflow path is irrelevant, how the eliquid gets to the wicking - irrelevant. The eliquid itself isn't necessarily irrelevant, but it could be as some suspect, only PG/VG, nic and flavorings - which IF there is a predicate, would have the same things minus what the FDA put in some of the cartos for their 2009 study

Btw, I'm not, like some, saying this with total certainty, but only as a possibility for some lawyers to look into. If they didn't, I'd fire them.

 

[aikanae1]

Well one of the original importers is now Njoy. That we know.

Patent US20060196518 - Flameless electronic atomizing cigarette - Google Patents
"The recipes of nicotine solution used for the electronic spray cigarette in accordance with the present invention are as follows:

1. 6% nicotine, 85% propylene glycol, 2% glycerol, 2% essence, 1% organic acid and 1% anti-oxidation agent;

2. 4% nicotine, 80% propylene glycol, 5% glycerol, 1% butyl valerate, 1% isopentyl hexonate, 0-6% lauryl laurate, 0.4% benzyl benzoate, 0.5% methyl octynicate, 0.2% ethyl heptylate, 0.3% hexyl hexanoate, 2% geranyl butyrate, 0.5% menthol, 0.5% citric acid and 4% tobacco essence;

3. 2% nicotine, 90% propylene glycol, 2.5% citric acid, 1% essence and 4.5% tobacco essence;

4. 0.1% nicotine, 80% propylene glycol, 5% glycerol, 8% alcohol, 2.9% water, 1% essence, 1% tobacco essence and 2% organic acid."

Such low doses! That wouldn't make a lot of people very happy. We might be better off forgeting it. This would be Lik Hon's (Ruyen) and I don't know if it made it to market. But I am curious (uh oh) if such a listing qualifies for equivilency if it did.

I wouldn't believe anyone who might be a stakeholder in this. It's kinda like a gold miner telling someone where they found the gold at this point. Anyone claiming SE for nic wins the game. I'm more convinced it's there when someone mentions it out of context.

http://www.e-cigarette-mart.com/ Was that domain active / owned in 2006? That's where the ecig blog links to.

Another thought - would Ebay have archives to 2007? I vaguely recall looking for ecigs on ebay way early on, when I first heard about them. I know they weren't banned until the FDA took action in 2009. That would be an example of "marketplace". Same thing for Amazon or Deal Extreme (they had early cheapies) and I'm thinking Green Smoke was early.

There's more than that. I'm just out of time.

 

[Roger_Lafayette]

The question wasn't about the products but what 'commercially marketed in the US as of Feb. 15, 2007'. That is all I was addressing. IF there were predicate products then the whole discussion of what is substantially equivalent comes up. First things first, even though I know some people don't think that it matters anyway. I think a good lawyer (if there was a predicate) could make a case (as Zoidman suggested a while back) that it is 'still a coil with a wick' and it produces vapor (with or without nicotine). What battery runs the coil is irrelevant, what the airflow path is irrelevant, how the eliquid gets to the wicking - irrelevant. The eliquid itself isn't necessarily irrelevant, but it could be as some suspect, only PG/VG, nic and flavorings - which IF there is a predicate, would have the same things minus what the FDA put in some of the cartos for their 2009 study

Btw, I'm not, like some, saying this with total certainty, but only as a possibility for some lawyers to look into. If they didn't, I'd fire them.

Well you're right that if there is no predicate product, then it's dead in the water. But the "impact on public health" standard may be about more than functinality from an engineering standpoint. You've read some of these public health papers, I'm sure (we all have). There's a point of view there which is very far removed from these construction/engineering issues.

Just take flavors for example. Will flavor A have a different impact on pubic health than flavor B in terms of smoking prevalence (cessation, minor uptake, etc.)? I don't know how that Q could be answered in the abstract - the FDA would demand studies. And it pains me to say this, but I think any such requirement would be compatible with the intent behind the FSPTCA. After all, if some flavor is so irresistable to a large percentage of people that it encourages many never-smokers to take up smoking (or vaping), that's significant. And it can only be analyzed with controlled studies.

This is (I think) also why the FDA insists that tobacco cigarettes be described down to the millimeter. Subtle differences in products can have signficicant impacts on consumer preferences. And - whether we like it or not - Congress passed FSPTCA and incorporated these standards with an eye to applying this kind of public health research to consumer preferences, and (in particular) Congress wanted to stop BT from introducing new tobacco cigarettes that might have negative impacts on tobacco cigarette smoking prevalance. This is particularly true in the context of minor uptake, which I think is why the word Family is at the beginning of the Act's name.

Whatever disdain we may have for this kind of junk public health "sciience" or the posturing involved in the passage of this legislation, it really is the law, and if the FDA expands its jurisdiction to vaping under that law, then it has to require public health studies that refer to prevalence of tobacco product use, whether that's in the SE context or the new product arena.

I think C.V. wrote in a blog at one point that if vaping is 100 times less harmful than tobacco cigarette smoking, then 100 never-vaper/never-smokers would have to take up vaping to balance the harm reduction from just one smoker who quit in favor of vaping. Sadly, I don't think that's how the statute works. New tobacco product users are a bad thing, period. And quite likely, smokers who convert to vaping don't count (we're a "wash," because we've switched from one "tobacco product" to another, just as somone who quits smoking tobacco cigarettes in favor of snus would be considered a "wash").

I'm not going to stand up and cheer for that - but I suspect it's what Congress intended, and that the legislative record would reflect it.

What did Congress mean by the term MRTP? (Modified risk tobacco product?) I don't know. ( Modified Risk Tobacco Products ).

Although the SE test (similar public health consequences) must be satisfied independently of the MRTP requirements, as far as I can tell. That's part of the reason perhaps why products like snus and other smokeless OTPs are not considered MRTPs (even though the public health data is fairly consclusive: combustible tobacco kills users in signficant numbers, smokeless tobacco doesn't).

Bottom line, the best attorney in the world couldn't substitute their arguments for the public health research that I believe Congress wanted, and which the FDA has clearly indicated that it will demand.

 

[DC2]

What battery runs the coil is irrelevant, what the airflow path is irrelevant, how the eliquid gets to the wicking - irrelevant.

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.

Btw, I'm not, like some, saying this with total certainty, but only as a possibility for some lawyers to look into. If they didn't, I'd fire them.

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