Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[CJsKee]

Sun...It's been so long and so much has been going on that I've kind of lost sight of the original petition. My question is if the FDA test results are even relevant to this suit. I was thinking it was strictly to determine the FDA's authority to stop SE's shipments. Is it more involved (convulted?) than that? I just can't remember (CRS! ya know )

 

[miller]

In federal court, even though civil procedure mat seem limiting, federal judges will broadly interpret the law to suit their wants. Moreover judges have been known to "encourage" parties/lawyers in whatever way they want. Recognize that we are dealing with a powerful and empowered judiciary at the fed court level.

 

[lvlninety9]

I see what you mean Sun but the question at hand was whether or not the electronic cigarette is a tobacco product or a drug delivery device. The FDA study was regarding the chemicals contained there in. The study wasn't to establish if the electronic cigarette is a drug delivery device or tobacco product. The study really has no relevance to the matter of the case. In light of such the study wouldn't become a requirement. If there is no relevance there is no grounds to admit it. If you want to use fancy lawyer talk then one could derive that the study could be admitted into evidence on the grounds that it does show that nicotine liquid is a drug. In fact it's already been established that nicotine is a drug in which case the fact that the liquids contain nicotine would in fact prove even further that the electronic cigarette is more of a drug delivery device then it is a tobacco product.

Really it could go either way, but I would rather see this study left out of the case. The fact that a known drug (nicotine) was in fact found in the cartridges pretty much prove the FDA's case.

 

[OutWest]

The study really has no relevance to the matter of the case.

One could argue that because the FDA found tobacco-specific nitrosamines (nitrosamines that only appear in tobacco), that they just proved that it is indeed a tobacco product.

I think the release of the information was intended to sway the court in the FDA's direction and to sway the public into pressuring the FDA for a total ban, complete with seizures of property from retailers. Which, in turn, would make the FDA look like the good guys, since they would simply be doing what the public demanded.

 

[Sun Vaporer]

I see what you mean Sun but the question at hand was whether or not the electronic cigarette is a tobacco product or a drug delivery device. The FDA study was regarding the chemicals contained there in. The study wasn't to establish if the electronic cigarette is a drug delivery device or tobacco product. The study really has no relevance to the matter of the case.

Iv--to the contrary, that study, as well as any study has well as an study does is very relevent to the case---the drug v. tobacco argument is only one aspect of FDA jusrisdiction. Inconclusive and conflicting evidence is going to even further try to sway Judge Leon to use deferance and hold that the FDA is in fact the Agency that should be regulating the e-cig. I not think for one minute that the release of that study by the FDA did not have anything to do with this case or the outcome.


I would hope, and expect the SE conducted a study like NJOY to refute the FDA study---but then again a "battle of the studies" and "the experts" is what the FDA wants Judge Leon to see and conclude that further studies need to be done before any embarko will ever be lifted.

Sun

 

[Angela]

One could argue that because the FDA found tobacco-specific nitrosamines (nitrosamines that only appear in tobacco), that they just proved that it is indeed a tobacco product.

Don't know the legalities in the US, but, if Njoy or SE believed that to be the case, couldn't they introduce the report into evidence themselves, since the report has been published and therefore now in the public domain?

 

[lvlninety9]

One could argue that because the FDA found tobacco-specific nitrosamines (nitrosamines that only appear in tobacco), that they just proved that it is indeed a tobacco product.

I think the release of the information was intended to sway the court in the FDA's direction and to sway the public into pressuring the FDA for a total ban, complete with seizures of property from retailers. Which, in turn, would make the FDA look like the good guys, since they would simply be doing what the public demanded.

While that is true, it could also be argued the other way as well. I'm not sure if they clarified it or not but it is rumored that some of the cartridges contain artificially made nicotine. Hence the drug aspect of it. At this point I think it's hard to say for certainty who uses artificial and who doesn't. If those same nitrosamines are found in the cartridges that contain artificial nicotine as well then it defeats the purpose of arguing it as a tobacco product. Given that the FDA now has jurisdiction over tobacco it's become a lose lose situation. In that case I not sure what exactly would happen. I do agree with you in the aspect that the study was used to sway public opinion however.

 

[miller]

There is no question that FDA had jurisdiction over ecigs. The only question is whether they will be regulated as drugs & devices or tobacco products. The new law sets forth an approval process for tobacco products however it is expected that the requirements will be less complex that the d&d route. Regulation isn't bad, in fact I encourage it. No refutes are needed by either party at this point, the ingredients are the ingredients, if people read the results of the study as opposed to just the headlines they will find no exceptional risk; no more than going to the beach without sunscreen on- let us not forget the sun is a carcinogen.

 

[miller]

No one is using artificial nicotine. US pharma won't sell it to ecig companies yet.

 

[Sun Vaporer]

No one is using artificial nicotine. US pharma won't sell it to ecig companies yet.

Miller--Johnson Creek uses synthetic nicotine.

Sun

 

[lvlninety9]

I'm pretty sure the US isn't the only place that produces artificial nicotine.

 

[TheIllustratedMan]

I would hope, and expect the SE conducted a study like NJOY to refute the FDA study---but then again a "battle of the studies" and "the experts" is what the FDA wants Judge Leon to see and conclude that further studies need to be done before any embarko will ever be lifted.

Sun

As far as I'm concerned, the FDA's toxicology report (can we please not call it a study?) was fairly consistent with previous reports. The HNZ study showed 8 ppb TSNAs in the highest nicotine liquid. Since the FDA's LOQ was at least 21 ppb per TSNA, the SE carts coming up as ND (for the most part) is in line with that. Clearly, the NJoy carts were higher than HNZ indicated, but since we don't know for sure how much higher, we can't say for sure that the different is significant. 8 ppb vs 141+ ppb seems like a wide margin, but is it really? A mass compilation of all the data into a thorough study would answer that question.

Of course, do I think that more testing needs to be done? Absolutely. I just don't see the FDA's results as being inconsistent with earlier findings.

 

[Sun Vaporer]

As far as I'm concerned, the FDA's toxicology report (can we please not call it a study?) was fairly consistent with previous reports. The HNZ study showed 8 ppb TSNAs in the highest nicotine liquid. Since the FDA's LOQ was at least 21 ppb per TSNA, the SE carts coming up as ND (for the most part) is in line with that. Clearly, the NJoy carts were higher than HNZ indicated, but since we don't know for sure how much higher, we can't say for sure that the different is significant. 8 ppb vs 141+ ppb seems like a wide margin, but is it really? A mass compilation of all the data into a thorough study would answer that question.

Of course, do I think that more testing needs to be done? Absolutely. I just don't see the FDA's results as being inconsistent with earlier findings.

Illustrated--We surely hope that the testing squares, but that is why it begs for regulation in the FDA's mind. Even if it is clean as a whistle like Nicotine water is--The FDA still considers it a drug subject to its regulatory powers.

Sun

 

[TheIllustratedMan]

Unfortunately, after this, I don't see how they're going to be able to regulate it without something changing. They've come out and said "it causes cancer!!" and the media spread that like wildfire. If they were to come out now and say "we're going to approve it for OTC use" there would be an uproar. The way I'm seeing it, manufacturers will have to switch to the purest synthetic nicotine they can and make damn sure there's nothing else in there, and public opinion will have to be swayed.
The repercussions of all of this (the case, the release, everything) are stockpiling by the minute.

 

[Sun Vaporer]

Unfortunately, after this, I don't see how they're going to be able to regulate it without something changing. They've come out and said "it causes cancer!!" and the media spread that like wildfire. If they were to come out now and say "we're going to approve it for OTC use" there would be an uproar. The way I'm seeing it, manufacturers will have to switch to the purest synthetic nicotine they can and make damn sure there's nothing else in there, and public opinion will have to be swayed.
The repercussions of all of this (the case, the release, everything) are stockpiling by the minute.

Illustrated---it can be made safe as we see with the nicotrol inhaler that uses PG as its suspension---hence it can be regulated. NJOY has been sitting on its study and could have struck first---but for whatever reason it did not. And not a word out of SE? No Studies from the company that charges $150.00 for an e-cig. We should expect more.

We have to remember that we are all going to pay the piper for this type of conduct should Judge Leon rule for the FDA. They, with their profits and we with our hindered ability to obtain product with the embargo.

Sun

 

[riddle80]

No Studies from the company that charges $150.00 for an e-cig. We should expect more.

Agreed. You'd think they would be more prepared. My fingers are crossed for the NJOY studies!

 

[TropicalBob]

This blunt truth gets lost here. Thanks for again saying it.

Even if it is clean as a whistle like Nicotine water is--The FDA still considers it a drug subject to its regulatory powers.

And that's the bottom line. The FDA handwriting -- 10 feet tall -- has been on the wall since the first warnings long ago. Our products cannot continue to be sold without approval. Don't care if it's NRT or not. Don't care if it's a novelty or not. It uses a mix that includes an addictive and poisonous drug to treat a medical condition known as nicotine addiction. The patents spell it out!

No approval? As Sun wrote, how can the FDA now turn around and say, "Oh my, lots of people want this, so I guess we'll just keep on keeping on." That is not going to happen.

 

[lvlninety9]

About the only thing that can work now is a complete discrediting of the FDA and their poor excuse for testing that they have done. And to be honest I really don't see that happening. Right now the FDA is the controlling power and regardless of their countless failures people are still going to believe what they say about e-cigarettes no matter how flawed their testing. It's already happening. No matter what studies are being done what kind of reports are being compiled it still falls down to the FDA approval process like Tbob is saying. The FDA is the biggest joke of an organization with countless failures. Makes me wonder how they are still even around.

 

[Our House]

I had questions about the last few posts and Nicotine Water vs ecigs, but didn't want to derail this thread so...

New Thread In The Law Forum

 

[Sun Vaporer]

I had questions about the last few posts and Nicotine Water vs ecigs, but didn't want to derail this thread so...

New Thread In The Law Forum

Our House--Nicotine water does not derail the thread--to the contrary--Nicotine water is right on point as to where this case is headed.


Sun