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

[Kent C]

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.

I've been in touch with Wayne at heaven gifts. Here's one of his comments:

"Actually we started selling eCigarettes through ebay in August 2006. Maybe we can contact eBay to get those early transaction details."

Now I don't trust the FDA and they could change definitions, etc. but the idea that there was no predicate products is just wrong. And others' posted links to Ruyan, etc. show this as well. Whether or not they'd consider it a predicate or what would have to be done to show substantial equivalence, I know... ... is another question, but the fact that ecig products were available before Feb 15, 2007 shouldn't be in question.

 

[Stosh]

The question then would be "are any of the companies producing those ecigs still in business"?
Followed by, are they still producing anything that is substantial equivalent, or even in any way equivalent?

I know in the few years I've been vaping, equipment has changed drastically, to the point where items I liked are no longer produced or available. A case for "Somewhat equivalence" could be made for a CE-2 and Vivi-Nova, substantial equivalence might be a bridge too far...

It would seem the innovation and rapid change of the market will work against us. Necessitating a New Tobacco Product for anything used today.

I've been in touch with Wayne at heaven gifts. Here's one of his comments:

"Actually we started selling eCigarettes through ebay in August 2006. Maybe we can contact eBay to get those early transaction details."

Now I don't trust the FDA and they could change definitions, etc. but the idea that there was no predicate products is just wrong. And others' posted links to Ruyan, etc. show this as well. Whether or not they'd consider it a predicate or what would have to be done to show substantial equivalence, I know... ... is another question, but the fact that ecig products were available before Feb 15, 2007 shouldn't be in question.

 

[Roger_Lafayette]

I've been in touch with Wayne at heaven gifts. Here's one of his comments:

"Actually we started selling eCigarettes through ebay in August 2006. Maybe we can contact eBay to get those early transaction details."

Now I don't trust the FDA and they could change definitions, etc. but the idea that there was no predicate products is just wrong. And others' posted links to Ruyan, etc. show this as well. Whether or not they'd consider it a predicate or what would have to be done to show substantial equivalence, I know... ... is another question, but the fact that ecig products were available before Feb 15, 2007 shouldn't be in question.

As you know Kent, the FDA doesn't have unlimited discretion over the standards of proof. They can't demand invoices written on stone tablets in Sumerian hieroglyphs

E-bay records aren't the end-all/be-all. Properly-authenticated business records might very well work and could be combined with bank statements and/or affidavits if needed. Backup tapes? Lots of options there. The Q is whether there's enough evidence to convince a court.

Our back is right up against the wall right now. Even though I think this option is "on life support," I think anything besides (say) sending flowers to Mitch Zeller is worth nudging forward We got nothing to lose by exploring this.

Godspeed as the Brits would say. PM me if I can help. I'm good for some phone calls and other misc. legwork.

 

[Roger_Lafayette]

Most of what you say is true, except that I don't think the manufacturer has to be still in business. It can be any manufacturer's product, so long as a court would agree that the statutory requirements are satisfied for a predicate product.

The question then would be "are any of the companies producing those ecigs still in business"?
Followed by, are they still producing anything that is substantial equivalent, or even in any way equivalent?

I know in the few years I've been vaping, equipment has changed drastically, to the point where items I liked are no longer produced or available. A case for "Somewhat equivalence" could be made for a CE-2 and Vivi-Nova, substantial equivalence might be a bridge too far...

It would seem the innovation and rapid change of the market will work against us. Necessitating a New Tobacco Product for anything used today.

 

[Stosh]

I hope you're right, reading from the FDA website directly, the wording (depending on what the "deem" the words to mean) seem to want the manufacturing specs, ingredients, processing specs. That would be a stretch for a company that didn't have access the another company's records.

Most of what you say is true, except that I don't think the manufacturer has to be still in business. It can be any manufacturer's product, so long as a court would agree that the statutory requirements are satisfied for a predicate product.

 

[Kent C]

Stosh:The question then would be "are any of the companies producing those ecigs still in business"?

Njoy, Ruyan and heaven gifts (formerly ruyandirect) are all still in business.

Followed by, are they still producing anything that is substantial equivalent, or even in any way equivalent?

This is something that has to be argued but 'substantial equivalence' could be that there is a coil, wick and eliquid that gets atomized into a vapor, with a battery charging the coil and a tank of some sort holding the eliquid. There is no definition given by the FDA that substantial equivalence has to be 'totally different'. In fact, that is the opposite concept of substantially equivalent.

I'm not saying they couldn't 'decide otherwise' but the best way to defeat someone is to use their own words - their words not your interpretation of them. IOW, "if you didn't mean "substantially equivalent" then you should have used another word!' It's YOUR word. Either make a mockery of it's concept or change it. lol.


I know in the few years I've been vaping, equipment has changed drastically,

Not that drastically really - there's still a wick, coil, tank, batt, airflow path.

to the point where items I liked are no longer produced or available. A case for "Somewhat equivalence" could be made for a CE-2 and Vivi-Nova, substantial equivalence might be a bridge too far...

It would depend on what 'substantially equivant' addresses. Function? - pretty much the same. Cosmetics? - different in some cases. It would be a bit like panatelas vs. churchills in cigars. Light it up and smoke it. The panatelas are shorter, so what?

It would seem the innovation and rapid change of the market will work against us. Necessitating a New Tobacco Product for anything used today.

Again basic function or looks. If they were regulating 'fashion' I might tend to agree


And understand - my position isn't that this is a lay up, like some have implied. We'll have to fight for every inch.

 

[Kent C]

Roger_Lafayette: As you know Kent, the FDA doesn't have unlimited discretion over the standards of proof. They can't demand invoices written on stone tablets in Sumerian hieroglyphs

E-bay records aren't the end-all/be-all. Properly-authenticated business records might very well work and could be combined with bank statements and/or affidavits if needed. Backup tapes? Lots of options there. The Q is whether there's enough evidence to convince a court.

I'm aware of the listed (not a complete listing btw as they state) of all the forms that could be presented - I've posted them a few times now, so I'm well aware of what the document states. However, a 'finished' auction with the item and price sold is not only a widely accepted source but is also used to determine market price and a valid way within a time period, I might add. If you're bidding on an item, you'd be a fool not to see what 'substantially equivalent' items actually sold for.

Our back is right up against the wall right now. Even though I think this option is "on life support," I think anything besides (say) sending flowers to Mitch Zeller is worth nudging forward We got nothing to lose by exploring this.

First appeasement doesn't work - bribes can, though, and you're right we're closing in on that 'nothing left to lose' point. Thank you Kris and Janice

 

[aikanae1]

I've been in touch with Wayne at heaven gifts. Here's one of his comments:

"Actually we started selling eCigarettes through ebay in August 2006. Maybe we can contact eBay to get those early transaction details."

Now I don't trust the FDA and they could change definitions, etc. but the idea that there was no predicate products is just wrong. And others' posted links to Ruyan, etc. show this as well. Whether or not they'd consider it a predicate or what would have to be done to show substantial equivalence, I know... ... is another question, but the fact that ecig products were available before Feb 15, 2007 shouldn't be in question.

That would be fantastic if he could help provide any records - ebay, invoices, to prove products were shipped to the US. If those items aren't acceptable as "proof" then they could lead to something else that is. We've got nothing to loose. What would be esp helpful if there were msds / identification of contents in the nicotine, a sample???? We'll figure out the details later.

My primary focus is nicotine. How and where was it sold in 2006.

 

[Stosh]

Substantial equivalence of function might take a protracted court case to be realized. As the FDA is using it today would seem to make it very much a dead end.

For example, a successful substantial equivalence application was approved after a little over two years, and there would seem to be no change in function, simply 'fashion' differences.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM370742.pdf

KEY DIFFERENCES BETWEEN NEW AND PREDICATE TOBACO
PRODUCTS

The new tobacco product has the following key differences compared to the
predicate tobacco product:
x Increase in package size (from 32 to 50 rolling papers)
x Decrease in paper length
x Decrease in paper width

 

[Jman8]

My primary focus is nicotine. How and where was it sold in 2006.

From July 31st, 2001 - Liquid Nicotine

Excerpt:

KICKING THE HABIT: Researchers at Duke University Medical Center have patented a nicotine solution and are testing to see if it can help people quit smoking. The nicotine solution can be added to coffee, tea, soda, beer, lemonade or other acidic beverages and consumed several times a day in place of smoking. In a small pilot study, the solution proved effective. Twenty-five smokers chose a date to quit and were given the solution to mix into their beverages with instructions to use it as needed for smoking urges during a 12-week period. Participants drank between 2.5 milligrams to 10 milligrams of the solution per beverage. Abstinence rates reported by participants were 28 percent at 4 weeks, 24 percent at 3 months, and 20 percent at 6 months. Side effects of the oral solution were minimal. Only one participant dropped out of the study, complaining of a burning sensation at the site of dental work.

From March 23rd, 1983 - SNUFF, TRADITION THAT STILL PERSISTS (NY Times)

Excerpt:

''We found that taking a small amount of the liquid snuff in each nostril gave the same nicotine buzz as one cigarette in about the same time,'' Dr. Russell continued. ''We hope that, eventually, smokers will be able to use the drops as a substitute and then gradually wean themselves off the nicotine habit.''

From June 19th, 1987 - Nicotine Replacement in Smoking Cessation: Absorption of Nicotine Vapor From Smoke-Free Cigarettes

Excerpt:

The rate of nicotine absorption was slow and resembled that obtained from nicotine chewing gum, suggesting that most of the nicotine was deposited in the mouth, throat, and large airways and did not reach the lung alveoli. Despite the slow absorption, the plasma nicotine levels produced could be of therapeutic value as an aid to smoking cessation.

 

[aikanae1]

So as long as nicotine is owned by a cartel, then it's ok.

 

[Kent C]

Substantial equivalence of function might take a protracted court case to be realized. As the FDA is using it today would seem to make it very much a dead end.

For example, a successful substantial equivalence application was approved after a little over two years, and there would seem to be no change in function, simply 'fashion' differences.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM370742.pdf

Come on Stosh - the new product was a hemp paper and the predicate was Republic Tobacco papers (which I used by the way, in my RYO tobacco days).

All the redactions refer to the hemp vs. paper.... and I'm guessing that there is a built in bias on hemp by gov't (whether there should be - others can decide that). And yet it was approved! Something much simpler like using 26 kanthal vs. 28 kanthal, wouldn't even cause a blink, but cotton vs. silica wicks may, but even that is a stretch. Not that good of 'example' imo.

 

[Roger_Lafayette]

Stosh, you seem to be suggesting that manufacturing specifics are relevant to the definition of SE. I'm not sure - Congress put this language in the statute, and "SE" also has a long history in the therapeutic area. So ultimately the Q is what Congress intended, not what the FDA might say.

On the Q of delays: Having gone through that PDF today for the hookah thread, I'm presently fed up with it. Does their promise not to enforce until an application is rejected or the two year window is over (whichever is later?), apply to SE or just to new products? If it applies to all applications, then delays are not an issue.

That said, I doubt the FDA is going to roll over dead on this, if it ever happens. So whoever does this is going to have to have deep pockets for both the application and the court battle. They have to be prepared for the possiblity that the application will be rejected on the first day after the two-year window closes, and that it may take years to get a successful result from the courts.

WANTED: high roller for lots of potential reward qualfied by massive risk and significant delays. Oh, I know ... how about Altria, Lorillard, or R.J. Reynolds?

Flowers not good enough for Mitch Zeller? (Rats, I thought it was the thought that counts.)

If we have to bribe him, then we have to at least match what he's going to get for his next private sector job. Seven figures, or eight? Let me check my piggy bank.

 

[RosaJ]

Maybe Donald Trump is willing to invest in ecigs mods, etc. It certainly is a sound investment, he'll get his money back and then some.

 

[Stosh]

Come on Stosh - the new product was a hemp paper and the predicate was Republic Tobacco papers (which I used by the way, in my RYO tobacco days).

All the redactions refer to the hemp vs. paper.... and I'm guessing that there is a built in bias on hemp by gov't ....

LOL - didn't realize the hemp factor, it's been a very long time since I used rolling papers. (they weren't regulated at all at the time) Lately the hemp should have gotten them approved on a fast track....

There seems to be a few others that are similar, among the few approvals ever given....
Tobacco Product Marketing Orders

 

[aikanae1]

... how about Altria, Lorillard, or R.J. Reynolds?

They've already had years to prepare. What was in the deeming regs was no surprise to them.

 

[Roger_Lafayette]

LOL - didn't realize the hemp factor, it's been a very long time since I used rolling papers. (they weren't regulated at all at the time) Lately the hemp should have gotten them approved on a fast track....

There seems to be a few others that are similar, among the few approvals ever given....
Tobacco Product Marketing Orders

I hate to cite this but remember that products introduced before 3/11/11 can be marketed while their SE applications are under review:

http://www.tobacco.ucsf.
edu/fda-removes-first-4-tobacco-products-market-3513-go

So basically BT doesn't care that the FDA has sat on its duffer w.r.t all these appls. BT had 18 months or so to introduce new tobacco cigarettes between the passage of FSPTCA and March '11. Now the market is effectively "frozen," but it doesn't matter to them.

The same thing would be true for any SE vaping appls submitted before the 2-year window closes, right?

BTW it's interesting to obseve that in all likelihood the vaping market will also be essentially permanently frozen after the FDA lets in the small handfull of cigAlikes that it will most likely do in the future. So in the year 2040, the commercial availability of both tobacco cigarettes and vaping products will be identical to what was around in the year 2020. (Assuming that all nicotine isn't banned by then.)

 

[tombaker]

Substantial equivalence of function might take a protracted court case to be realized. As the FDA is using it today would seem to make it very much a dead end.

For example, a successful substantial equivalence application was approved after a little over two years, and there would seem to be no change in function, simply 'fashion' differences.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM370742.pdf

Nice contribution, reading the source document gave some insight on the logic that was actually used by the FDA in the approval of the SE.

 

[tombaker]

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*

Rodger, you pretty much are advocating from a defeatist paradigm, unable to see outside of a box you have entirely determined is a lost cause. Ignoring argument comprised entirely of cutesy emoticons....the Deeming proposal says they "believe" because they "believe" Believe is emblematic of there current knowledge and understanding. Your biggest error is not math, its reading the Deeming proposal only for cherry picking items, that fit into your "its all over" box. That box is just your perspective, which seems entirely unable to accept other information.

Your math example that you "believe" the answer is 4, is in fact different than "knowing" it. This thread is talking about Predicate Products, much of what you are talking about belongs in the "common misconceptions" your started.

I can say that I don't share your conclusions, and I don't think its just a loss, that Boogie Man BT wins it all. The deeming regulations will be done, it a matter of how its going to happen.

It would seem that you do not believe the FDA can be worked with, I actually do.

After the FDA said it BELIEVES, it says something very important.
"FDA is specifically seeking comment on whether and, if so, how FDA should consider a different regulatory mechanism for newer proposed deemed tobacco products that cannot, as a practical matter, use the SE pathway."
I take it as it reads, and want to work with them. Putting them as the opposition precludes co-operation, that's not helpful always.

Agreeing on a single predicate could be useful, or perhaps not. But please read the first post, and if you are able to explain why that information along, with the FDA guidance link I posted here on the determination of "commercially marketed" would not be sufficient to gain FDA agreement that the product was being marketed in the US at the time, please do so

Otherwise you have plenty of On-Topic threads to for the apocalypse future

BTW it's interesting to obseve that in all likelihood the vaping market will also be essentially permanently frozen after the FDA lets in the small handfull of cigAlikes that it will most likely do in the future. So in the year 2040, the commercial availability of both tobacco cigarettes and vaping products will be identical to what was around in the year 2020. (Assuming that all nicotine isn't banned by then.)

 

[sky4it]

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.

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.

The long way:

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.

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.
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.
3) Tom, Waybills, bills of lading and freight bills are proof of products moving as in being imported, sold, and or in inventory. You say "marketed is not the same as sales." Tom, marketing is proof of sales or attempted sales. And proof that product exists. You don't market a product unless you have goods to sell. You got the buggy pulling the horse. You have to have the horse pulling the buggy.
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.

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.