SE, NJoy vs FDA -- Discussion

[JustJulie]

Not surprisingly, no movement on the docket.

As for the 9/28 date that folks were talking about, I have no idea. There is no particular date that the Court of Appeals will announce its ruling.

 

[bogiediver]

For whatever my $0.02 is worth...

I took the time to watch the entire video that Kristin posted of the NY Heath committee session …

While the first portion featuring (disclaimer if I got the names inaccurate) Spike Babain, William Freedman, Bill Gotschall and Ronald Ward was for the most part bringing forth the true facts, there were several statements that are counter to the interests of e-cig users.

Spike & William both, on several occasions, kept making the statement about e-cigs leading to quitting smoking – which clearly infers that is the intention - without making clear, initially, that did not necessarily mean quitting nicotine. Which plays into the hand of the FDA position.

Ron Ward needs to be careful with using the statement regarding exhaling ‘water vapor’ – it is not water vapor.

Bill Gotschall was well spoken and to the point.

I did get a chuckle from William puffing on his e-cig during the presentation.

I hope I’m not alone in thinking the senator didn’t understand the concept of the e-cig. He also didn’t seem to be taking the info seriously. He certainly did not seem able to separate smoking cessation from nicotine cessation.

One question that was not answered clearly at all – the senator asked about the cost. The answer given was the cost of the hardware & starter kit – from which he then jumped to the conclusion that the cost/nicotine was ‘much greater’ than cigarettes. The cost of ongoing usage was not addressed – the cost is significantly less than cigarettes. For me now using 0mg liquid I make myself, my ongoing cost is about $5 a month – that’s not a typo – five dollars a month. I use 50/50 PG/VG with menthol (made from crystals and PG) – using a box mod with a readily available rechargeable battery and, not using nicotine, atomizers last for 6 months before cleaning. Same battery, same atomizer now for 6 months. That question deserved a clearer answer.

Comment on the tobacconists – I feel they shot themselves in the foot with their attitude and mis-statement of facts (“cigars are not inhaled”).

 

[DC2]

Perhaps this is a reference to the UK MHRA meeting with ECITAS which was on the 28th Sep.

That's what I was thinking too.

 

[JustJulie]

Attached is the transcript of the oral arguments. Woo-Hoo!

 

[DC2]

Ron Ward needs to be careful with using the statement regarding exhaling 'water vapor' - it is not water vapor.

After spending the last few weeks trying to understand this question, I think you're right.
I think that "fog" is the best analogy for what the vapor we exhale should be called.

Fog is simply water that has condensed onto particles suspended in the air.
Usually, in natural situations, fog is created by water condensing onto particles of dust or sea salt.

True water vapor, on the other hand, is supposedly not visible.

In our case, the fog is water that has condensed onto particles of propylene glycol or vegetable glycerin.
At least that is the basic conclusion I am coming to for now.

 

[CES]

Attached is the transcript of the oral arguments. Woo-Hoo!

That's great! Thanks for posting it Julie

edited to add:

Well, if we had any doubts that the FDA is concerned about the financial health of BP…

Ms Klein from the transcript:

...if you can just sell electronic cigarettes without having to show safety or ethicacy [sic] and just say, you know, get your nicotine hit from these, you destroy the incentive for a manufacturer to do the clinical studies and go through the work to say use my electronic cigarettes as nicotine maintenance therapy. It just, it wouldn't make economic sense, you'd be undercut in the market…

But there are other FDA approved nicotine products, lozenges, and the nicotine patch, Pfizer sells a prescription inhaler. So, you know, Pfizer spent all that money to invest in – to say, you know, inhale this and use it instead of cigarettes, that's important for the public health, we want companies to be developing those products.

 

[GoodDog]

Thanks, that was excellent! Appears the FDA is seen exactly for what they are!

 

[Chris From Cali]

Thanks for posting the transcript, definitely a good read and great incite as to what's going on.

 

[Our House]

Well, if we had any doubts that the FDA is concerned about the financial health of BP…

Ms Klein from the transcript:

Or even BT:

JUDGE WILLIAMS: So, under your theory then Brown & Williamson left the FDA totally free to regulate under the Food and Drug Act cigars?
MS. KLEIN: You can imagine an argument about cigars that would have been analogous to the argument about cigarettes, there's another regulatory scheme, there's a domestic tobacco industry that we're protecting, it's not an argument that could be made about an isolated nicotine product --

 

[Our House]

Great read.

Correct me if I'm wrong, but did FDA actually make the argument that ecigs aren't harmful enough to be considered tobacco products??? I swear I read that in a part from Ms. Kline about how tobacco products cannot provide pharmacological effects without danger and drug products can...and that's the line FDA chose to draw between the two.

 

[Rothman]

Seems to me that Njoy is trying to have th e-cig regulated as tobacco rather than as a drug delivery device....

 

[Vocalek]

I have posted it on our documents page, too: http://www.casaa.org/files/NJOY Oral Argument Appeal Transcript.pdf

 

[BCB]

After reading that, it seems that Vocalek's rendition of what occurred is spot on! Good work on your summary, Elaine!

 

[markmcs]

Thank you for posting the oral argument text. I really enjoyed reading it! I also looked up FDA vs Brown and Williamson, and it never ceases to amaze me how greed and power, rather than the 'greater good', affect our law.

If the FDA wasn't granted the authority to regulate cigarettes and other tobacco products as a drug in 1999, even though nicotine is a drug and the cigarette was considered a drug delivery "device", then it should follow that they not be allowed to regulate e-cigs as a drug under FDCA.

If cigarettes were treated as a drug, the FDA would have no choice but to ban them completely, and Phillip Morris, R.J. Reynolds, and Congress would never let that happen!! We don't have such powerful friends, but at least we have lawyers and organizations fighting for our rights.

I hope this legal dance drags on long enough for some solid research to come out forcing the FDA to reconsider their suit...or simply lose, like with B+W. At least, I hope that we land somewhere in the middle with reasonable regulation and restrictions, like other 'tobacco products' that don't make therapeutic claims. I hate being so powerless over this. I don't want to lose my vape!!

 

[rolygate]

Seems to me that Njoy is trying to have th e-cig regulated as tobacco rather than as a drug delivery device....

That's correct. These are the possible options:

Option 1 - e-cigarettes to remain as a general food product such as candy or coffee (as currently).
Option 2 - classed as a pharmaceutical (and in effect banned).
Option 3 - classed as (and thus regulated, and most likely taxed in some way as) tobacco.

Option 1, as things are now, is the Golden Age of ecigs and fast coming to a close. Nobody in authority will accept that.

Option 2 is what the FDA want since that means they can in effect ban ecigs.

Option 3 is the least-worst choice for us (community and trade) as it means that for a while at least, the status quo will prevail. Before long though we'll see taxes plus an attempt by the FDA to reduce the appeal of ecigarettes as far as possible, by regulating any and all aspects they can, such as nicotine strength, flavors and so on. There might also be some postal sales implications eventually. This option is simply the lesser of two evils.

There are no good choices. To keep things as they stand would require a politically-significant number of voters + a sympathetic government + a large amount of cash for lobbying and legal costs + a united and well-organised trade association. We don't have a single one of those prerequisites. In ten years time things might be different of course, but the future from +2 years to +10 years or so doesn't look too good. But perhaps I'm just being pessimistic.

 

[maclean]

There are no good choices. To keep things as they stand would require a politically-significant number of voters + a sympathetic government + a large amount of cash for lobbying and legal costs + a united and well-organised trade association. We don't have a single one of those prerequisites. In ten years time things might be different of course, but the future from +2 years to +10 years or so doesn't look too good. But perhaps I'm just being pessimistic.

There are good choices, but the FDA seem determined to ignore them. As pointed out in other threads, some european countries have compromised. E-cigs are legal in Italy under the condition that they contain a minimum level of nicotine and make no health claims. In Germany too, although I don't know the exact conditions they impose. And the Swedes are enjoying their own health boom with SNUs.

But of course, by doing anything like that, the FDA would be excluding BP and BT from making any money, so your pessimism is justified.

mac

 

[rolygate]

Mac, you are right. I should have said "There are no good choices in the USA". In other countries it's different, as the situation varies.

For example, option 1, maintain the status quo, is a realistic choice for authority in the UK since e-cigarettes are very well regulated currently by regional agencies designed to do just this for all consumer products: the Trading Standards offices. These local agencies visit, take away and analyze products from not only main street stores but also internet stores with UK addresses. Fail a safety check from them and you're done.

Although in theory that type of regular and unavoidable safety testing and analysis is operable in the US by the FDA, in practice I am not aware of it being applied on the same regular basis universally at local level as in the UK, since the FDA would need field offices everywhere. The UK is geographically so small that local authorities do cover everywhere.

Therefore in practice the 'leave it as-is' option, for the USA, effectively means no testing, and that is probably a major issue for authority. In the UK, government cannot say e-cigarettes are untested or unregulated because they themselves test and regulate on a daily basis. Hypocrisy may be a staple of government but on that sort of scale would not stand up to legal challenge.

 

[justboringsarah]

I just read the entire transcript(while vaping.of course)and I actually feel a bit better after that. It seems that the FDA was just chasing it's own tail and making very little headway.

 

[JustJulie]

No movement on the docket . . . just a notation that a transcript was prepared.

 

[JustMeAgain]

I just read the entire transcript(while vaping.of course)and I actually feel a bit better after that. It seems that the FDA was just chasing it's own tail and making very little headway.

I read it, too, and I thought that this statement, by Mr. Garre, was a good summary of what it all comes down to.

This Court if it holds that FDA lacks jurisdiction to regulate to electronic cigarettes as a drug, Congress gave it all the authority it thought appropriate in the Tobacco Act.

Is it just me, or does the FDA's case not seem a bit weaker than you'd expect?