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

[Maurice Pudlo]

https://cleansmoke.com/vaping-101/history-of-electronic-cigarettes/#

Claims that electronic cigarettes were marketed in Europe and the United States in 2006. This would place e-liquid on United States soil prior to the February 15, 2007 date.

Granted my Google skills are not all that great, but I find it very interesting that I am pretty much drawing a blank when it comes to finding anything, and I do mean ANYTHING of value* prior to February 15, 2007.

Interestingly enough, I'd like to point out that in the document found here http://www.fda.gov/downloads/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm237080.pdf on [pg. 20, sub-paragraph (B), line (v)] "(B) Requirements.-- The Secretary shall (v) not require any small tobacco product manufacturer to comply with a regulation under subparagraph (A) for at least 4 years following the effective date established by the Secretary for such regulation.

Maurice

 

[Stosh]

Granted my Google skills are not all that great, but I find it very interesting that I am pretty much drawing a blank when it comes to finding anything, and I do mean ANYTHING of value* prior to February 15, 2007.

Interestingly enough, I'd like to point out that in the document found here http://www.fda.gov/downloads/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm237080.pdf on [pg. 20, sub-paragraph (B), line (v)] "(B) Requirements.-- The Secretary shall (v) not require any small tobacco product manufacturer to comply with a regulation under subparagraph (A) for at least 4 years following the effective date established by the Secretary for such regulation.

Maurice

Sounds like this would be a field day for the lawyers, the law and regulations were passed in 2009, the deeming e-cigs to be included under the regulations 2014. How this section might be applied is any lawyer's guess (I'm not a lawyer, and didn't stay at a Holiday nn Express last night)

 

[Maurice Pudlo]

I agree, the intent as I read it is to allow such small business a measure of time to comply with complex regulations. While I may well be off on this it seems a reasonable enough interpretation to argue in court.

Maurice

 

[Roger_Lafayette]

... in the US. And liquid nicotine for pesitcides is both.

Actually now that I think about it - "tobacco product" refers to the definition in the statute. So pesticides don't qualify.

 

[Stosh]

I agree, the intent as I read it is to allow such small business a measure of time to comply with complex regulations. While I may well be off on this it seems a reasonable enough interpretation to argue in court.

Maurice

I wholeheartedly agree, but that leaves the "small tobacco product manufacturer" with a large pile of court costs, for a very long time before any resolution. I worry what may be possible to do within the court system, may be outside the price a small fry is willing or able to pay.

 

[DC2]

I agree, the intent as I read it is to allow such small business a measure of time to comply with complex regulations.

It refers to the regulations in subparagraph (A) which appear to be in regards to the manufacturing process.
It talks about things like quality control, packing and storage.

 

[Maurice Pudlo]

Right, e-cigarettes have yet to be deemed tobacco products, thus no predicate product existed on the market to establish substantial equivalency of any e-cigarette against regardless of manufacture date.

There would seem to be all kinds of catch 22 laced into this.

Maurice

 

[Maurice Pudlo]

It refers to the regulations in subparagraph (A) which appear to be in regards to the manufacturing process.
It talks about things like quality control, packing and storage.

Yes, I know, it is just a small step toward the whole of it all. How it relates to the predicate product issue may be unclear, but I think it could act as a delay until the question of predicate product is answered (if ever).

Maurice

 

[aikanae1]

It refers to the regulations in subparagraph (A) which appear to be in regards to the manufacturing process.
It talks about things like quality control, packing and storage.

Well I know Lorilland talked about spending the last 2 years getting their "GMP's" in order. GMP appears to refer to "good manufacturing practices" whatever that is. IMO that's evidence they had a head start, leaked regulations. That was taken from an interview within 48 hours of regulations being released. I don't know specific laws around that, but I think allowing some stakeholders, even if they may have prior experience with similar regulations, advance notice is enough to take this whole thing down - at least with the public war in the media.

Yes nicotine is still sold as insecticide, but I think it's restricted to proffessionals (i.e. landscapers etc.). What it's class was prior to 2007, I don't know. I wouldn't vape industrial quality nicotine, but you know that others will if they attempt to restrict it and from the way this is going, I wouldn't be surprised that DIY style nicotine will be off the market ASAP. Maybe even before flavors. I think they are both neck and neck when it comes to priority levels.

And it's not all FDA or Congress either. They are both responding to heavy pressure from outside groups such as ACS, ALA, Tobacco free Kids, etc. This is one reason why CASAA needs numbers in order to have an equal voice. We need to out vocalize them.

Anyway, back to the nicotine. Right now it doesn't matter the source / industry / country or origin. Those arguements can be figured out later. All we need is was it available to consumers to purchase prior to 2007 and can we prove it. That might be enough to throw a monkey wrench into the FDA's plans. It sure would tick them off if they had to approve it based on SE. That makes me smile anyway.

I don't understand why nic suppliers aren't looking for this themselves. All I've heard so far is assurance that their labs meet FDA standards - which is kinda BS if nic is restricted that equals a ban. It also seems kinda silly and precarious that they should even attempt a new product application. I'm pretty sure I read there isn't a 2 year window guarentee for new products; their app could be reviewed and denied by 160 days. Only SE has MAYBE (probable) a 2 year window. If it were me, I'd be filling on the last allowable day anyway.

But finding any nic to go through the SE process is the prefferred path. It's simple enough that most manufacturers / importers can match it. Then if the FDA wants to restrict it, they would need to make new ruling sorta like with menthol and that's taken over 3 years so far.

I imagine there are a number of catch 22's built into these regs. However even the FDA admits the SE application is the simplest, most assured route to go in. The only thing that can qualify is pure vapable DIY style nicotine and I know it wasn't restricted prior to 2007.

 

[Jman8]

Anyway, back to the nicotine. Right now it doesn't matter the source / industry / country or origin. Those arguements can be figured out later. All we need is was it available to consumers to purchase prior to 2007 and can we prove it. That might be enough to throw a monkey wrench into the FDA's plans. It sure would tick them off if they had to approve it based on SE. That makes me smile anyway.

I don't understand why nic suppliers aren't looking for this themselves. All I've heard so far is assurance that their labs meet FDA standards - which is kinda BS if nic is restricted that equals a ban. It also seems kinda silly and precarious that they should even attempt a new product application. I'm pretty sure I read there isn't a 2 year window guarentee for new products; their app could be reviewed and denied by 160 days. Only SE has MAYBE a 2 year window. If it were me, I'd be filling on the last allowable day anyway.

But finding any nic to go through the SE process is the prefferred path. Then if the FDA wants to restrict it, they would need to make new ruling sorta like with menthol and that's taken over 3 years so far.

In my research from yesterday, I couldn't find "nicotine base" or "liquid nicotine" or "pure nicotine" or about 5 other combinations that were commercially marketed to consumers. A couple times, I felt I was close, but not enough to put it up for posting. It seemed to me, during that research, that prior to say 2007, nicotine was treated as 'hazardous toxin' and only filtered through that sort of language which after awhile, I realized because of that sort of language, I'm unlikely to find some place that was openly marketing it.

I also recall seeing 'nicotine lollipops' from the 1990's going through a similar path that eCigs are up against, though I'm thinking with far fewer numbers. But essentially, FDA ruled they were (made from) an unapproved drug, and thus illegal. And it wasn't the general term of 'nicotine' that made them illegal, but the form the nicotine was in that it seemed how FDA was able to assert that. I kept coming up against different formulations of nicotine (all of which were hazardous toxins) and thinking one of those had to be available for purchase somewhere as there are clearly products all around (even before this century) that are using nicotine, and aren't strictly used in smokes.

But alas, I couldn't find that.

And since we are now in a world where anyone can buy liquid nicotine, and FDA hasn't put the hammer down on that, nor intends to in say the next 60 days, then I'm thinking that bodes well, if for no other reason than an underground market will be/has been established whereby virtually anyone can get this. To think that no one would be able to, would mean such control measures ought to work to win the War on Drugs in rather short order.