URGENT - NYS Outright Sales Ban On the AGENDA Again

[Sassyonemeis]

I do not believe that an OPINION is the same as a RULING/ORDER.

I have been trying to point this out for days now. In Judge Leon's OPINION, he states that there is considerable weight to njoy's case that e-cigarettes are NOT drug devices nor have they been marketed as smoking cessation devices. Judge Leon goes on to state that the FDA cannot consider e-cigarettes as drug devices but that the FDA CAN regulate them as tobacco products under the tobacco Act. AGain, an opinion is NOT a ruling as far as I know... it's just an opinion on which they base the merit of whether to hear the case that is before them. In this case, he found it did have merit, it was heard and judged upon in the court and the rulings made that the FDA cannot sieze shipments on the basis that the FDA is considering them drug devices.

Judge Leon further states that classifying them as drug devices is NOT out of the question, but that the FDA would have to take to Congress to get that classification legally recognized.

All that being said... the NY Bill reads as such
"TITLE OF BILL: An act to amend the public health law, in relation to prohibiting the sale of electronic cigarettes to minors and in relation to prohibiting the distribution or sale of any item containing or delivering nicotine that is not defined by law as a tobacco product or approved by the United States food and drug administration for sale as a tobacco use cessation or harm reduction product emphasis added

PURPOSE OR GENERAL IDEA OF BILL: This bill seeks to ban the sale and distribution of items containing or delivering nicotine that are not currently classified as tobacco products or approved as tobacco use cessation or harm reduction products by the U.S. Food and Drug Administration (FDA) and also to prevent minors from purchasing these products.The bill would amend the Public Health Law by amending Section 1399-cc to include electronic cigarettes in each subsection and defining an electronic cigarette in subsection (d).

SUMMARY OF SPECIFIC PROVISIONS:The bill would also amend the Public Health Law by adding a new Section 1399-mm-1. The section provides that products containing or delivering nicotine and intended for human consumption shall not be distributed or sold unless the FDA has given approval. The section further provides that the attorney general may issue an order compelling compliance with this provision and further grants the court the ability to impose a civil penalty for violations of this law."

e-cigarettes are NOT legally classified as EITHER a tobacco product nor an approved tobacco cessation or harm reduction product. And if you pay attention to the wording, if it does NOT fall into either of these categories, then it can be banned.

I think the best way to proceed is for the manufacturers to petition to get the classification of tobacco product ASAP.

Maybe this will help too:

Njoy and Smoking Everywhere filed an injunction - basically asking Judge Leon to stop the FDA from seizing their product while the case was ongoing, because they would go out of business and not have money to pay their lawyers. (To put it very simply.)

Judge Leon's ruling was only on the injunction, in which he agrees that the FDA had to stop seizing Njoy and Smoking Everywhere shipments while the case was ongoing.

The FDA argued that they had every right to seize the products, because the were unapproved drug devices.

Judge Leon disagreed that the FDA had justification for seizing the shipments as unapproved drug delivery devices and gave the opinion that he agrees with Njoy et al. that what Njoy and Smoking Everywhere sells and advertizes are tobacco products.

It's basically an order to the FDA to stop seizing Njoy and Smoking Everywhere products during the trial.

The FDA filed an appeal with the DC Appellate Court, which kept Judge Leon's ruling from taking effect (stopping the seizures of property).

Then the DC Appellate Court agreed with Judge Leon and refused to let the FDA keep seizing Njoy and Smoking Everywhere products during the court case. Now, the FDA has to stop seizing Njoy and Smoking Everywhere products by claiming they are unapproved drug devices while the case is still ongoing.

None of this ruling has any impact on OTHER companies not involved in the lawsuit or their seized goods. However, it sets a precedence if any other companies want to sue the FDA for the same reason.

Next, so long as the FDA doesn't try to take it to the Supreme Court, the case goes back to Judge Leon's court and he'll rule on whether or not the FDA should regulate Njoy and Smoking Everywhere products as drug devices or tobacco products. But based on his comments in his ruling on the injunction, we pretty much know which way he is leaning!

 

[MoonRose]

Next, so long as the FDA doesn't try to take it to the Supreme Court, the case goes back to Judge Leon's court and he'll rule on whether or not the FDA should regulate Njoy and Smoking Everywhere products as drug devices or tobacco products. But based on his comments in his ruling on the injunction, we pretty much know which way he is leaning!

Of course when/if Judge Leon makes the ruling that pv's are to be regulated as tobacco products, we will begin the process all over again with the FDA appealing the rulings. In effect, it could still be months or years before any final ruling is made depending on how quickly things move through the system.

 

[kristin]

I do not believe that an OPINION is the same as a RULING/ORDER.

He DID make a ruling. He ruled that the FDA had to stop seizing Njoy and Smoking Everywhere products during the trial based on their assertion that they are drug devices.

Here is that RULING: http://www.casaa.org/files/SE-vs-FDA-Ruling.pdf

The judge rejected the assertion that the products were drug delivery devices in his RULING.

Along with this ruling, he gave his OPINION about drug devices vs. tobacco products: http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf

Edited to add: Nowhere did I state that e-cigarettes have been RULED a tobacco product. My post was simply meant to clarify what was actually ruled and to whom it applied. So I'm not sure why you quoted my post?

 

[markfm]

Is Gummy Bear's post (253) wrong? It read (in part):
THAT ARE NOT TOBACCO PRODUCTS, AS DEFINED IN SECTION THIRTEEN HUNDRED NINETY-NINE-AA OF THIS ARTICLE

The above is not the same as requiring a US-level classification as a tobacco product -- it points at NY 1399-AA for definition, which is where I see the "nicotine water" statement (as something defined as a tobacco product).

Again, just curious -- people keep jumping at the need for an FDA classification, but Gummy Bear's post indicates that what went through the Assembly also points to NY definition as to what constitutes "tobacco product".

Thanks!

 

[kristin]

Nicotine water is a specific, pre-existing product. It's bottled water with nicotine added. E-cigarette liquid is propylene glycol or vegetable glycerine based.

But as yolanda has already pointed out, the definition in NY for "tobacco product" IS murky and could leave openings for future litigation.

And furthermore, everyone keeps ignoring the language of the bill, as quoted above, that specifically refers to the NEW YORK STATE defintion of "tobacco product" (I have posted about this before).

Products "THAT ARE NOT TOBACCO PRODUCTS, AS DEFINED IN SECTION THIRTEEN HUNDRED NINETY-NINE-AA OF THIS ARTICLE". That article being the NY Public Health Law.

Not that this wouldn't create potential legal challenges based on whether the federal defintion should control, if it conflicts, since the bill then proceeds to defer directly to the FDA, but in any event, as Moonrose and DC2 correctly observed, the federal issue is still not finally decided yet.

Finally, there are also potential legal issues to be raised based on the interpretation of NY's defintion of "tobacco product".

Is Gummy Bear's post (253) wrong? It read (in part):
THAT ARE NOT TOBACCO PRODUCTS, AS DEFINED IN SECTION THIRTEEN HUNDRED NINETY-NINE-AA OF THIS ARTICLE

The above is not the same as requiring a US-level classification as a tobacco product -- it points at NY 1399-AA for definition, which is where I see the "nicotine water" statement (as something defined as a tobacco product).

Again, just curious -- people keep jumping at the need for an FDA classification, but Gummy Bear's post indicates that what went through the Assembly also points to NY definition as to what constitutes "tobacco product".

Thanks!

 

[yvilla]

1399-AA 5. "Tobacco products" means one or more cigarettes or cigars, bidis,
chewing tobacco, powdered tobacco, nicotine water or any other tobacco
products.

"Nicotine water" sounds like it might already inherently apply to any e-juice containing nic? So, is this much ado about nothing, in that per 1399-AA nic-containing juice is already nominally classified as a tobacco product in NY?

(Just curious, not asserting this is the case.)

Shhh. I've posted about this too Markfm, but quietly. And that was exactly what I meant above, when I said there were "potential legal issues" based on the NY definition of "tobacco product" Actually, I've been lying in wait on this one since last year, as our legislators in NY don't seem to be aware of how badly worded this bill is.

Nicotine water itself would not cover eliquid, as it is a specific product with its own composition far removed from eliquid, but it certainly shows how broadly worded the NY definition of "tobacco product" is. More significantly, that last catchall at the end of the definition would certainly seem to cover ecigs. HOWEVER, none of us want to have to fight a sales ban in the courts based on this legal wrangling over the interpretation of the statute, as that could indeed take years to settle the question!

Edit: Posted without seeing Kristin's post.

 

[markfm]

Thanks for the clarifications!

 

[Clinton]

I hope I did this right. I do not have MS Word, so I couldn't use the .DOC file from CASAA. So I emailed all of those people my own letter:

To whom it may concern,

My name is Clinton Wilson. I am an electronic cigarette user residing in California. It has come to my attention that there is an e-cig ban being voted on in New York. I felt compelled to write you and tell you a little about my experience with the e-cigarette.

I have been a smoker for about 25 years. It is a nasty, smelly, dirty habit that offends others and affects their health as well your own. There is an argument that e-cigs are being marketed as a stop-smoking device, and I can tell you, this simply is not true. When I learned about these and wanted to purchase one, I shopped around and did a whole lot of research before finally making a purchase. Not once did I see the e-cig being advertised as a quit smoking device. It is being offered simply as a different method for smokers to get their 'nicotine fix' in a different way. The fact that the e-cig does NOT contain the over 4000 chemicals found in cigarettes is just a bonus. I feel better. I breath better. I have more energy. My clothes and my house don't stink and my wife isn't choking on my second hand smoke. I am a 40 year old adult, and let me tell you, these things have been a blessing for me. The stink and mess of cigarettes is gone and there are no more ashtrays all over the house. It is a WONDERFUL, non-offensive alternative to smoking!

This country is founded on freedom. Please allow the people of New York to have the FREEDOM to choose to be rid of the nasty habit of smoking and switch to the much cleaner and safer e-cig. There is no burning tobacco so fires caused by people falling asleep while smoking will be all but a thing of the past as well.

Thank you so much. God bless you and god bless America!

Most sincerely,
-Clinton Wilson
--------------------------------------------------------------------------------------------

I hope I did OK and didn't sound stupid. Most of all I hope I helped. Good luck New York!

 

[n2xe]

God bless you Clinton! It's perfect. Thank you.

 

[Sassyonemeis]

Because in your earlier post you wrote "Judge Leon disagreed that the FDA had justification for seizing the shipments as unapproved drug delivery devices and gave the opinion that he agrees with Njoy et al. that what Njoy and Smoking Everywhere sells and advertizes are tobacco products. " which can lead people to believe that this was ruled upon to be a tobacco product. I have seen several posts that confuse the ruling with the opinion, and when you lump them together in one sentence it could appear as though that was part of the ruling (even though you you used the word opinion). I am just trying to clear up the confusion that I see happening over the classification of e-cigs.

He DID make a ruling. He ruled that the FDA had to stop seizing Njoy and Smoking Everywhere products during the trial based on their assertion that they are drug devices.

Here is that RULING: http://www.casaa.org/files/SE-vs-FDA-Ruling.pdf

The judge rejected the assertion that the products were drug delivery devices in his RULING.

Along with this ruling, he gave his OPINION about drug devices vs. tobacco products: http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf

Edited to add: Nowhere did I state that e-cigarettes have been RULED a tobacco product. My post was simply meant to clarify what was actually ruled and to whom it applied. So I'm not sure why you quoted my post?

 

[Clinton]

God bless you Clinton! It's perfect. Thank you.

You are very welcome. Anything I can do to help my fellow vapers.

VAPE ON!

 

[n2xe]

Vape on my friend!

 

[JonnyVapΣ]

I do not have MS Word...

Free awesomeness!
OpenOffice.org - The Free and Open Productivity Suite

 

[MoonRose]

Free awesomeness!
OpenOffice.org - The Free and Open Productivity Suite

Love using my Open Office program, it's even easier to use and navigate through than MS Word is.

 

[Clinton]

Free awesomeness!
OpenOffice.org - The Free and Open Productivity Suite

Cool. Thanks man! I've heard about that...

 

[yvilla]

New thread on "Next Steps" for NY ban bill:

http://www.e-cigarette-forum.com/fo...ew-york-sales-ban-next-steps.html#post2558697

The same as new CASAA NY Call to Action page:

CASAA.org