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

[Adam]

This is a post I just did in the Private Suppliers forum. I am recruiting suppliers to join in on a group lawsuit against the FDA. One supplier asked to get what the FA agent said in writing to send to the judge and maybe he would amend his ruling to include everyone. her is that post and what the FDA agent said along with a new FDA Agent who is higher up the ranks:

Well, I called and talked to the FDA Agent and tried to get something in writing saying they are only releasing SE/NJOY's products. She said she can't, that maybe the Division of Import Operations..... .... ... ... She talked so damn fast I couldn't write fast enough. I called them and spoke with John. He said that they are waiting from word from the FDA Headquarters in Washington DC to decide what they want to do in regards to all e-cigs. That right now they are taking the hardball approach and just releasing shipments for NJOY/SE. However, he said they have to make a quick decision because they are afraid of being sued again. He told me that if I have anything that is "Detained" that I should ask for a extension citing this case. He told me to call my FDA Agent daily for updates, because the FDA Headquarters has told him that he would have a decision as to how far they want to take it and how this ruling applies to everyone or if it does asap. They can either appeal as much as they can and as long as they can or simply say enough is enough. He told me that expects it to be somewhere in the middle. His phone number is: 1-301-594-3853 and ask your questions and hear from the horses mouth if that will make you feel better about the situation.

Take that as you want. For me, it tells me to not do anything yet formally with the court, but to have everything in place to file a lawsuit should they decide to appeal. Because while the appeal is in place only SE/NJOY will get free reign of imports. So, do with that as you wish, but I strongly urge you to take the precaution and join together as a group of suppliers ready to take action should we need to.

Its very similiar to the grasshopper and the ant. The ant gathers and stores for the winter, while the grasshopper does nothing. Winter comes and the ants are sitting great while the grasshopper who didn't take action is left to die. However in this story the ant saves the grasshopper and shares. Do you really think that SE/NJOY are going to share? Come on, lets be realistic.

Keep Vaping,

Adam

[Vaporer]

Canute,
I asked a few days back abt hardware with blank carts. Since the ruling of not a drug delivery device, hardware shipped seperately IMO should not be touched to any vendor.
I'm having a hard time understanding what grounds the FDA has to seize it. I can plainly see where the courts decision addressed only SE & NJOY, but being the FDA and the Judges definition, only nicotine bearing liquid would be subject to other vendors, not hardware shipped seperately. do they check nuts & bolts too? If I read it correctly, intended use doesnt count.
I only use US vendors so I have no personal money at stake. To me it seems the FDA is testing the court.

[bogiediver]

I have a question I don't think has been addressed before here (but could be wrong - this is a HUGE thread...).

In regard to the 'grandfather date' (something in Feb, 2007 I believe) - would/could that be so restrictive as to apply to only the specific products available prior to that date? Or would it apply to the product concept?

What I mean is if someone comes up with a new variation on the PV theme today (and that seems to be happening rather regularly) - that 'new product' is not covered because it was introduced after the date, even though it is based on the same 'product concept' of battery/atomizer/cart/e-liquid?

*****
@LegalOne

While I understand it has cost SE and NJ the 7 figures, etc. - if it's as relatively painless as Sun implies to join into the suit; would SE and NJ object to other suppliers joining? Wouldn't more parties on the e-cig side make the judge's ruling even stronger (more evidence of additional sales and still no harm reported)?

Just curious...

*****
@Vaporer

I agree with you - if the shipments were 'Li batteries' - that shouldn't be subject to holding. Nor should a shipment of 'Battery powered heating devices (with protective plastic cap)'; or a shipment of 'Pre-printed boxes'. Then the US suppliers assemble their own kits...

Of course, there is a fatal flaw in this thinking - it's called common sense - and it has been proven over & over the powers-that-be preventing this have none...

-bogie

[Sun Vaporer]

Sun (and those with legal expertise and knowledge of tobacco regulation),

So I consider myself to be a relatively intelligent guy but fully admit to having no formal legal training (and sometimes I think even understanding since it often seems that common sense has zilch to do with it!).

E-cigs seem to be spoken of as if they were one single component....meaning battery, atty and a pre-filled cart referred to as one. I'm sure that if I take the time to review all this to the extent that many of you have I can find a clear definition of what is being referenced under the term "electronic cigarette" however I'm guessing you guys can answer this for me (and others I'm sure) quite easily. Is this case and subsequent ruling directed at the hardware alone? Meaning if an incoming shipment from China contained e-liquids only and no actual PV's is it or was it ever under threat of seizure?

Common sense would dictate to me based upon what I am hearing that we are/have been talking about the device itself and whether it was to be considered a drug delivery device. Again if I'm understanding correctly it has been determined that the device itself has been ruled to be a device 'similar in function' to that of a cigarette or recreational tobacco delivery device (pipe etc..).

For the concerns of e-liquid suppliers would I be correct in assuming that the topic of if and how e-liquids themselves are to be regulated is a matter completely separate from this ruling and as of yet not directly under fire? Furthermore would that not eventually have to boil down to regulation of liquid nicotine itself since regulation of PG, VG or artificial flavorings would be ludicrous? As I understand it, liquid nicotine is not considered a tobacco product but rather an over the counter drug legal for purchase by anyone over the age of 18. Is that not correct?

It seems to me that regulation of e-liquid would or could become a sticky conundrum for the FDA. While I may read many articles regarding politicians who clearly have done zero research regarding what ingredients are actually present in the typical e-liquid I would think in court it would quickly become evident that the only component present in e-liquid worthy of regulation would be the nicotine itself. It is my honest belief that none of this has been over the safety of the American people but rather it has been over the preservation of tax revenue and profits of two very powerful industries, big Tobacco and Pharmaceutical. If I am correct in this train of thought then I would think the FDA would not want to touch regulation of nicotine itself due to the impact such regulation would have on both those industries and subsequently revenue generated by their taxation.

So again I'm trying to wrap my head around all this in terms of what it means to us average non-legally educated vapers who want to know what this means in regards to our ability to log into our favorite suppliers website a month, two months or a year from now and order a PV....OR...a prepackaged Chinese manufactured e-liquid...OR...a custom 'mixed in the US' e-liquid. Are these vendors in any way more secure due to this ruling or are they going to have the authorities pounding at their door soon?

Is there a layman's answer to this?

Canute--the problem with this case is that SE and NJOY advance their product to include pre-filled nicotine cartridges that are specifically designed to fit their e-cigs. So it was not fesible for the two to be divided and it was not argued by any of the parties nor did the Judge address it in his ruling.

SE and NJOY want to make money off of the "Disposables"---just like ink jet printers making money off of the ink. Unless another supplier impleads themselfs in and argues that the two are seperate entities (the hardware and the e-liquid). The issue simply can not be addressed unless someone argues it. And SE and NJOY certainly are not going to go down that road.


Sun

[kristin]

SE & Njoy benefit immensly if other retailers & flavored liquids are banned. Just sayin'....

[beingbekah]

Sooo, I almost hate to ask this, but what does this mean for individuals making orders from international suppliers? I know orders were previously getting through with little problem. Do you suppose that the FDA's got its feathers ruffled by the ruling and will now be seizing even relatively small orders of PV's? I hope I'm just being paranoid.

[kristin]

Sooo, I almost hate to ask this, but what does this mean for individuals making orders from international suppliers? I know orders were previously getting through with little problem. Do you suppose that the FDA's got its feathers ruffled by the ruling and will now be seizing even relatively small orders of PV's? I hope I'm just being paranoid.

Maybe... if they can find them. Most e-cig companies in China don't put any labels or call them "electronics" on the packages they export to the States. They'd have to start opening every package from China.

[Bill Godshall]

I believe that a "Petition to Intervene" needs to be filed by any other party(ies) desiring to join the SE v FDA case, and I think that's what NJoy did.

In 1998, I helped organize a coalition of a dozen public health groups that Petitioned to Intervene (in PA Common Pleas Court in Philadelphia) in the lawsuit filed by PA AG Mike Fisher's lawsuit against PM, Reynolds, Lorillard, B&W (after they signed the Master Settlement Agreement). Although the court denied our Petition, we exposed weaknesses of the MSA (that we sought to amend), generated supportive news stories and editorials, and convinced then Governor Ridge, AG Fisher, the PA Treasurer and PA legislative leaders to appropriate 100% of MSA revenue for health programs, including smoking prevention and cessation. But I digress.

As the SE v FDA case proceeds, legal fees will continue mounting for all parties involved until settlement occurs. While costly, intervening in the case may prove a sound investment for competitors of SE and NJoy, as Judge Leon's ruling applies only to SE and NJoy, and also doesn't apply to e-liquid.

Ironically, SE and NJoy would financially benefit if the FDA continues or steps up enforcement actions against other e-cigarette (or e-liquid) competitors. Don't know why the FDA would want to help SE and NJoy finance their litigation (against the FDA), but the FDA has yet to act rationally regarding e-cigarettes.

If the judge's ruling stands, it appears that e-liquid products could similarly be considered as tobacco (if not marketed as a smoking cessation aid), but that would require another lawsuit (and only apply to the party(ies) filing the suit) or future FDA regulatory action (e.g. defining e-liquid, along with e-cigarettes, as tobacco products) for that to occur.

Based upon Judge Leon's ruling, nicotine gums, lozenges, and patches also could be legally considered tobacco products (if smoking cessation marketing claims aren't made). Reynolds may consider to market some of its recently acquired Niconovum NRT products as "modified risk tobacco products", as I suggested several months ago. If any product could meet the criteria to obtain FDA approval as a "modified risk tobacco product", it would be nicotine products that have already been approved and regulated as smoking cessation aids.

If Judge Leon's ruling stands, e-cigarettes also are likely to gain FDA approval to make modified risk tobacco product claims. But once again, those FDA approvals would apply only to the company that submits the applications.

Similarly, under the new FDA tobacco law, companies would need to submit applications and obtain FDA approval before any tobacco company can make a "reduced exposure" claims.

But the FDA cannot regulate e-cigarettes as tobacco products (i.e. hold e-cigarette companies accountable for complying with the FDA tobacco law/regs) unless/until the FDA first recognizes e-cigarettes as tobacco products (which won't happen until FDA settles the SE lawsuit).

[Sun Vaporer]

Bill----NJOY did what any other entity would do, the filed for leave of the Court by way of a Motion to Intervene along with a Complaint and a Motion for a Preliminary Injunction. I do not see this case being a big "fee generator" for Counsel as there simply is no real evidence or testimony that is going to be of real bearing.

As I have said, there really are no genuine issues of material fact in dispute here, rather this is a case of legal interpretation. So there really is not too much more to "jawbone" about.
No one disputes what an e-cig, rather everyone is in disagreement to where they should fit within the current statutory scheme. That is a legal issue, not a factual one.

Sun

[Sun Vaporer]

No filings today on the Docket Sheet today. We are waiting for the FDA to file its Notice of Appeal--and the clock continues to tick. The have until Febuary 15th to file. (checking on that date with the Court)


Sun