SE, NJoy vs FDA -- Discussion

[MoonRose]

WTG Totally Wicked. Thanks for this great update JustJulie.

 

[Vocalek]

Did you read this part? If their prayer for relief is granted, FDA would be forced to remove e-cigarettes from Import Alert 66-41. This would, in effect, kill the import ban for all companies, since import alerts name the sender and the product, not the recipient.

PRAYER FOR RELIEF
WHEREFORE, Plaintiff respectfully requests that this Court:
A.Enter a temporary restraining order, a preliminary injunction, and a permanent injunction that enjoins Defendants from enforcing any import ban on TWI's electronic cigarettes arising out of their purported classification as a drug, device, or drug-device combination product under the FDCA, or from enforcing Import Alert 66-41 with respect to TWI's electronic cigarettes and electronic cigarette accessories;
B.Enter a declaratory judgment that Defendants are without statutory authority to regulate TWI's electronic cigarettes and accessories as a drug, device, or drug-device combination product under the FDCA, and that the addition of electronic cigarettes to Import Alert 66-41 is invalid, unlawful, and ultra vires of Defendants' authority; and
C.Order the release of any of TWI's electronic cigarettes and electronic cigarette accessories currently detained or seized by the United States pursuant to the FDA's unlawful declaration that it has jurisdiction over electronic cigarettes and electronic cigarette accessories under the FDA's authority to regulate drugs, devices, and drug-device combination products;
D.Award TWI its costs and expenses, including reasonable attorneys' fees; and
E.Award such other and further relief as is necessary and appropriate

 

[Bill Godshall]

TW is using the same lawfirm (Thompson Hines) that Smoking Everywhere hired to sue the FDA, and then failed to pay.

TW's lawsuit basically seeks to prevent the FDA from seizing TW products, but don't know if it would force FDA to remove all e-cigarettes from Import Alert 66-41.

It would be very helpful to find out more details of this lawsuit (e.g. when it was filed).

 

[JustJulie]

TW is using the same lawfirm (Thompson Hines) that Smoking Everywhere hired to sue the FDA, and then failed to pay.

TW's lawsuit basically seeks to prevent the FDA from seizing TW products, but don't know if it would force FDA to remove all e-cigarettes from Import Alert 66-41.

It would be very helpful to find out more details of this lawsuit (e.g. when it was filed).

It hasn't been filed yet. As soon as it is, I'll be adding it to the docket watch, and a copy of TW's complaint will be uploaded to ECF.

 

[tybin]

ditto.

WTG Totally Wicked. Thanks for this great update JustJulie.

 

[classwife]

This move by TW impresses me.

 

[PoliticallyIncorrect]

The only problem I have with it is that when the case is filed, the plaintif (and, by association, the plaintif's vaping customers) will, as a matter of public record, be totally wicked.

I may roll through a stop sign now and again, but I ain't totally wicked.

 

[Vocalek]

The only problem I have with it is that when the case is filed, the plaintif (and, by association, the plaintif's vaping customers) will, as a matter of public record, be totally wicked.

I may roll through a stop sign now and again, but I ain't totally wicked.

OK, then we will call you Partially Wicked.

 

[JerryRM]

Thanks Julie, that's good news.

You can call me "wicked instigator".

 

[Vocalek]

OK, I volunteer to be "Potentially Wicked."

 

[clark8876]

Did you read this part? If their prayer for relief is granted, FDA would be forced to remove e-cigarettes from Import Alert 66-41. This would, in effect, kill the import ban for all companies, since import alerts name the sender and the product, not the recipient.

Elaine, is that how it would work? From my understanding, the same thing should have applied with the decision re Njoy, but it appears the FDA is still locking up other importer's stocks.

Would be a great win if you are correct, but I just don't know.

Mind you I don't profess to have an in depth knowledge of US legislation, I have enough trouble understanding ours.

 

[Thulium]

TW is using the same lawfirm (Thompson Hines) that Smoking Everywhere hired to sue the FDA, and then failed to pay.

TW's lawsuit basically seeks to prevent the FDA from seizing TW products, but don't know if it would force FDA to remove all e-cigarettes from Import Alert 66-41.

It would be very helpful to find out more details of this lawsuit (e.g. when it was filed).

Yeah, I noticed a typo at 66 that's obviously an artifact from Thompson Hines action with Smoking Everywhere: " (c) the FDA's import ban threatens the continued viability of SE, which will be forced to close its doors in the immediate future in the event that it is not able to resume importing electronic cigarettes and accessories."

Oops!

 

[Rosco]

This move by TW impresses me.

what was their alternative? Going bankrupt. When push comes to shove...you SHOVE hard back. I can't stand the entire "tw" thing, but I sure as heck wish them much success and I support the cause.

 

[aubergine]

I'm Post-Wicked. Totally.

 

[Vocalek]

Elaine, is that how it would work? From my understanding, the same thing should have applied with the decision re Njoy, but it appears the FDA is still locking up other importer's stocks.

Would be a great win if you are correct, but I just don't know.

Mind you I don't profess to have an in depth knowledge of US legislation, I have enough trouble understanding ours.

Import Alert 66-41 does not name the person or company receiving the shipment for any of the products on the banned list. Only the shipper and the product is named in that document. TWI has asked to have the products removed from the Import Alert. I believe that this request goes above and beyond the relief requested in the SE and NJOY filings.

It would get rather complicated for the FDA agents to try to sift thorough the seized products to determine the name of the company designated to receive that shipment. The FDA would have to come up with some official way to notify the field agents to treat specified companys' shipments in a different manner from the other shipments covered by the Import Alert.

Eventually the question is bound to come up, "Why should some comapnies get special treatment?" Either the products belong on the Import Alert because they are dangerous, or they don't belong there at all. The same product cannot be dangerous when sold by Company A, but harmless when sold by Company B.

 

[Thulium]

I think Thomson Hines knows they have the winning argument on this issue and they are glad to have Totally Wicked as a client since they had already laid the groundwork, but SE fell apart before the courts could rule. I don't know the legal term for it, but I suspect that this case will be "rolled into" the Njoy case to hopefully give us a final decision on how the FDA will be allowed to regulate e-cigarettes. If that happens, I could see the Supreme Court taking up the case to look at the larger issues of FSPTCA 2009.

 

[Big Sheepherder]

Totally Wicked always is going to have a regulatory problem of some sort until they change their tune. Their marketing was foolishily socially irresponsible. The target audience of devil cartoons is primarily juveniles or just above the age of consent, despite noteworthy exceptions. Here it is important to bear in mind that Federal Courts generally defer to legislative findings on regulations under review. Congressional Finding No. 20 of the FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT states: "Children are exposed to substantial and unavoidable tobacco advertising that leads to favorable beliefs about tobacco use, plays a role in leading young people to overestimate the prevalence of tobacco use, and increases the number of young people who begin to use tobacco." When you couple that finding with the broad regulatory definitions in the Act, you will find that TW inevitably will have problems of its own foolish making. If TW had any sense, they would immediately cease the cartoon campaign. Now for those of you wishing to speculate about the unrelated DC Circuit opinion, it is better to read it. You can find it here: SOTTERA, INC. v. FOOD & DRUG ADMINISTRATION.-.Argued September 23, 2010. Having said all of that, while the "angry bird" approach to e-cig-adverse legislation is of some utility, it pales in comparison to real threats of declaratory judgment actions, coupled with requests (if necessary) for temporary, preliminary and permanent injunctions. The folks who profit the most bear those financial burdens.

 

[MoonRose]

Oh ... so now adults are not supposed to like or appreciate cartoon characters either? Give me a friggen break! I'm getting sick and tired of everyone saying that this or that is being targeted towards minors when we adults also like those types of things too.

 

[Big Sheepherder]

There is nothing new about the regulatory enviroment when it comes to nicotine and cartoons. Remember the Joe Camel outrage? Totally Wicked, despite its disclaimers, is doing the industry an extreme disservice with its cartoon advertising. It is irresponsible and brings the unnecessary attention of legislators and regulators. Bear in mind that Thulium's observations are not quite right, as the legal tacks the FDA can take may vary signficantly from SOTTERA, INC. v. FOOD & DRUG ADMINISTRATION - Argued September 23, 2010.. It is far better for the industry simply not to be deaf, dumb and blind to the concerns of parents when they are so easily avoided. One or more governmental agencies will send Totally Wicked that message, no doubt about it, inasmuch as TW appears too stubborn and/or stupid to do it independently.

 

[MoonRose]

There is nothing new about the regulatory enviroment when it comes to nicotine and cartoons. Remember the Joe Camel outrage? Totally Wicked, despite its disclaimers, is doing the industry an extreme disservice with its cartoon advertising. It is irresponsible and brings the unnecessary attention of legislators and regulators. Bear in mind that Thulium's observations are not quite right, as the legal tacks the FDA can take may vary signficantly from SOTTERA, INC. v. FOOD & DRUG ADMINISTRATION.-.Argued September 23, 2010.. It is far better for the industry simply not to be deaf, dumb and blind to the concerns of parents when they are so easily avoided. One or more governmental agencies will send Totally Wicked that message, no doubt about it, inasmuch as TW appears too stubborn and/or stupid to do it independently.

TW is an UK based company, they are neither stubborn nor stupid. The UK is not .... about adult cartoon based themes like this country is, who thinks that they have the right to control our every thought and action. I'm beginning to think this is no longer the USA but the CSA (Communist States of America).