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

[Bones]

Just saw this hit:

FDA: Electronic cigarettes contain toxic chemicals

finance.yahoo.com/news/FDA-Electronic-cigarettes-apf-1543561070.html?x=0&.v=8

Why anyone would use Chinese juice is beyond me anyways.

It has nothing to do with where the juice comes from - Those same chemicals are in their precious Nicotrol too - Hell - Some of them are in your Ice-Cream - They are playing with words - It's not that they are there that matters - We knew they were there - What matters is how much is there - FDA tests - skewed as they are - PROVE that e-cigs are 1000 times less harmful than analogs - No one ever said they were 100% safe - What is?

 

[Sun Vaporer]

Bones--et al---just wait till the Docket Sheet update tomm---you will find that this is the case.


Sun

 

[bensteffen23]

Maybe a stupid question but ehre goes anyway . . .


OK, so just taking a leap here, lets say the FDA wins and a defacto ban ensues, this becomes a ban on the shipment of goods for sale right?

What if we all figure out how to make our own and use them but do not sell the items?

Can they bust down my door like any other "drug" user then?

 

[Sun Vaporer]

Maybe a stupid question but ehre goes anyway . . .


OK, so just taking a leap here, lets say the FDA wins and a defacto ban ensues, this becomes a ban on the shipment of goods for sale right?

What if we all figure out how to make our own and use them but do not sell the items?

Can they bust down my door like any other "drug" user then?

Ben--the short answer is no--the FDA is only trying to stop the importation, sale, and marketing. DIY with equitment and liquid is not in play--

Sun

 

[tannerk]

Bones--et al---just wait till the Docket Sheet update tomm---you will find that this is the case.


Sun

Hey Sun,

Off the topic a bit...

If FDA wins, I go back to analogs, few years latter I get sick or worse. Can I sue FDA for negligence on grounds of withholding better life-saving alternative / forcing me to smoke analogs? After all they did the testing, they know the facts.

 

[Sun Vaporer]

Hey Sun,

Off the topic a bit...

If FDA wins, I go back to analogs, few years latter I get sick or worse. Can I sue FDA for negligence on grounds of withholding better alternative / forcing me to smoke analogs? After all they did the testing, they know the facts.

Tannerk--No--there is nothing forcing you to smoke and the FDA's function is to make sure a product within their jurisdiction is reasonably safe for its intended purpose before it goes on the market--remember the FDA does not have to do any testing at all --and the tests done here are, as the FDA states, preliminary and much more testing is needed.

Sun

 

[Sun Vaporer]

Today the Docket sheet shows that Judge Leon, sua sponte, requested another hearing before ruling on SE's request for a Preliminary hearing.

Obvioulsy the Judge has questions and wants to hear from the parties in light of the FDA's findings. The hearing is set for August 17, 2009 at 3PM.

The Judge wants further to discuss the impact of Family Smoking Prevention and tobacco Control Act with regards to the case.


Sun

 

[tannerk]

FDA's function is to make sure a product within their jurisdiction is reasonably safe for its intended purpose before it goes on the market.
Sun

Yes, I understand that, but majority of FDA's approvals are 510(k). This is a process in which FDA looks at "already existing" drugs and/or devices in order to forgo clinical trials & years of study. A streamline process if you will. It is the same process generics go through when getting approvals.

E-cig case is rather unique, there are no existing drug/device combos. There are however, decades of data available to them, including analogs, patches, gum & other garbage "approved" on the market.

So as we sit here (debating the technicalities & legal statues) facts are facts and FDA knows them. E-cigs are life-saving devices, with 5 years of real-market statistics. Not to mention their own data and number e-cigs specific studies.

FDA know e-cigs are "reasonably safe", and yet they refuse to change their "drug/device" position, which prevents the approval. I've tried 510(k), I know.

 

[tannerk]

The Judge wants further to discuss the impact of Family Smoking Prevention and Tobacco Control Act with regards to the case.

That's good news, correct? SE 'new legislation' argument carried some weight?

 

[Sun Vaporer]

That's good news, correct? SE 'new legislation' argument carried some weight?

Tannerk---it is bad news to say the least--the new legislation puts all tobacco products in the FDA's jurisdiction, but leaves a lot of questions open about interperation of the legislative intent. SE aruges that the FDA has to choice one of the two statutory framworks if they want to regulate the e-cig---the only question is --which one.

Sun

 

[Bones]

Today the Docket sheet shows that Judge Leon, sua sponte, requested another hearing before ruling on SE's request for a Preliminary hearing.

Obvioulsy the Judge has questions and wants to hear from the parties in light of the FDA's findings. The hearing is set for August 17, 2009 at 3PM.

The Judge wants further to discuss the impact of Family Smoking Prevention and Tobacco Control Act with regards to the case.


Sun

Well that is interesting - OH GOD THE WAITING -

 

[Sun Vaporer]

Well that is interesting - OH GOD THE WAITING -

It is not good at all Bones--this issue has been briefed and rebriefed extensively and I can only imagine that this hearing is really about the FDA's findings as there really was no need by for another hearing. For the Judge to request a hearing on his own means he wants some answers here.

Sun

 

[tannerk]

Tannerk---it is bad news to say the least--the new legislation puts all tobacco products in the FDA's jurisdiction, but leaves a lot of questions open about interperation of the legislative intent. SE aruges that the FDA has to choice one of the two statutory framworks if they want to regulate the e-cig---the only question is --which one.

Sun

I don't think anyone actually thought FDA lacks the authority to regulate e-cigs. My problem was always with their "new drug/device" nonsense. So I guess in that regard, it's good news.

 

[Bones]

Bones--et al---just wait till the Docket Sheet update tomm---you will find that this is the case.


Sun

Find that what is what case?

I didn't say good - I said intersting

 

[OutWest]

@Sun - thanks for the update. I just finished faxing a letter to his office (c/o his court clerk)

on the positive side, it means that there wont be a ruling until after that date.

Back in the 70's, Carrie Dickerson managed to prevent a nuclear power plant from being built near where she lived simply by buying time - used legal delay after legal delay until a crack developed in the plant's concrete foundation, right where the reactor was to sit. So, a time extension isnt necessarily a bad thing. I know that's a totally different thing, but point is, if you can delay long enough, you can sometimes manage to get the evidence you need to win.

Ideally, it would be classifed as a dietary supplement with no clinical trials needed, but that's not even an option in this case, apparently.

 

[OutWest]

It is not good at all Bones--this issue has been briefed and rebriefed extensively and I can only imagine that this hearing is really about the FDA's findings as there really was no need by for another hearing. For the Judge to request a hearing on his own means he wants some answers here.

Sun

maybe he wants to know why this evidence was withheld? or wants to hear an argument as to why it's not a tobacco product when tobacco-specific nitrosamines were found in the product?

 

[Sun Vaporer]

Find that what is what case?

I didn't say good - I said intersting

Bones--meaning that this "Case' is the case that is going to make or break the e-cig as it is going to define the FDA's jurisdiction over the e-cig one why or the other. So keep a keen eye on this case as it is not about SE or NJOY, but more about FDA authority to regulate e-cigs.

Sun

 

[tannerk]

maybe he wants to know why this evidence was withheld? or wants to hear an argument as to why it's not a tobacco product when tobacco-specific nitrosamines were found in the product?

Or maybe why FDA is not doing it's job by

... advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
​

... or maybe I'm dreaming

 

[Sun Vaporer]

Please take a look at the timing of the Judge's request for a hearing--the day after the FDA releases its study---seems a little to close for comfort.


Sun

 

[Bones]

oh yea - I'm on page with you there - I Thought you were implying that Chinese juice was inherently more harmful - You already broke me of my misconceptions about this case - Still can we rule out the possibility that the judge actually read the amounts found - That seems to be more important -