SE, NJoy vs FDA -- Discussion

[DC2]

If I remember their initial filing, they seemed to be ready to fight a war that would help everyone.
And if they back off the pursuit of their initial goals, while I wouldn't blame them for that, it leaves the war humming along.

There are not a lot of companies out there with a business model we support who have the money to fight that war.
I'm not even sure Totally Wicked has that kind of money, but I guess I was hoping they would push this all the way.

 

[JustJulie]

If I remember their initial filing, they seemed to be ready to fight a war that would help everyone.
And if they back off the pursuit of their initial goals, while I wouldn't blame them for that, it leaves the war humming along.

There are not a lot of companies out there with a business model we support who have the money to fight that war.
I'm not even sure Totally Wicked has that kind of money, but I guess I was hoping they would push this all the way.

But what we may be looking at is a pretty big concession. The whole issue revolves around whether we're regulated as tobacco or pharma. There is no way that TW can swing a deal that qualifies them as a pharma product at this point. So any deal that TW swings will almost have to reflect the FDA accepting that TW is tobacco . . . and once the first e-cig company is tobacco, then we have something to build on.

 

[JerryRM]

While we would be better off with the e-cig classified as a tobacco product rather than a drug/device, the question remains as to how the FDA will regulate it. They could regulate it so severely as to render it pretty much useless. I know this has been discussed before, but I wish we had a third option.

 

[JustJulie]

While we would be better off with the e-cig classified as a tobacco product rather than a drug/device, the question remains as to how the FDA will regulate it. They could regulate it so severely as to render it pretty much useless. I know this has been discussed before, but I wish we had a third option.

I couldn't agree more, Jerry.

 

[DC2]

But what we may be looking at is a pretty big concession. The whole issue revolves around whether we're regulated as tobacco or pharma. There is no way that TW can swing a deal that qualifies them as a pharma product at this point. So any deal that TW swings will almost have to reflect the FDA accepting that TW is tobacco . . . and once the first e-cig company is tobacco, then we have something to build on.

So would any "backroom deal" they make become public?

 

[kristin]

We do - a black market. And we need to keep reminding the legislators of that, so they don't regulate e-cigarette users right into it just as they are doing to the cigarette users.

Unlike heavily regulated NRTs, the black market for e-cigs would be pretty fast and furious. Supply and demand and all of that.

While we would be better off with the e-cig classified as a tobacco product rather than a drug/device, the question remains as to how the FDA will regulate it. They could regulate it so severely as to render it pretty much useless. I know this has been discussed before, but I wish we had a third option.

 

[JerryRM]

I agree, Kristin and I was thinking the same thing, it would be like Prohibition in the 1920s.

 

[Rosco]

Since there isn't a single good thing I can think of to say about tw, since I got thrown under the bus by him, I'll just continue to read this thread and thank Julie and CASAA all together for your efforts on all our benefits.

 

[JustJulie]

So would any "backroom deal" they make become public?

I'm a little reluctant to call it a "backroom deal" since settlement of litigation is a fairly common thing. But to answer the question, I really don't know. Maybe someone with more experience in federal litigation can weigh in. I'm thinking, though, that TW isn't exactly publicity averse, so we'll probably hear a fair amount from TW.

 

[cobaltblue]

The devil made you say it Julie.

TW aside for a moment, I'm curious what the FDA's motive for settling off the books might be since wasting taxpayer dollars doesn't seem phase them. Less chance of a precedent being set that eases the path for all suppliers?

What do you think their reason might be?

 

[PoliticallyIncorrect]

The devil made you say it Julie.

TW aside for a moment, I'm curious what the FDA's motive for settling off the books might be since wasting taxpayer dollars doesn't seem phase them. Less chance of a precedent being set that eases the path for all suppliers?

What do you think their reason might be?

Maybe relevant, maybe not...but my brother works for the Federal Government (Army Corps of Engineers, specifically), and he's been telling me that budget cutbacks are very real and widespread at all levels.

 

[JustJulie]

The devil made you say it Julie.

TW aside for a moment, I'm curious what the FDA's motive for settling off the books might be since wasting taxpayer dollars doesn't seem phase them. Less chance of a precedent being set that eases the path for all suppliers?

What do you think their reason might be?

Well, it's well known that I'm a bit of a Pollyanna, but I'm thinking that this isn't really about "backroom deals" or "settling off the books." Maybe someone can help me out, but I just don't see how the FDA can reach a settlement with TW without acknowledging that TW's product is a tobacco product.

The FDA has taken the position that e-cigs are subject to pharma regulations. Period. There has been no wiggle room in the FDA's position. If the FDA intends to maintain that position and not back off, I simply don't see how it can reach any kind of settlement with TW other than perhaps agree that the preliminary injunction that NJOY won (that stops the FDA from seizing NJOY's shipments during pendency of the case) will also apply to TW. In that event, there would still be litigation, but while the litigation is ongoing, TW would have its shipments protected.

But to totally resolve the matter without litigation would require some acknowledgment from the FDA that TW's product is tobacco. And, like I said, once one vendor is "blessed" with a tobacco classification, it provides some safe harbor for other vendors to get the same treatment if their marketing/advertising is similar enough.

And honestly, the FDA really doesn't lose much by regulating e-cigs as tobacco products. The bad eggs out there (those making health claims) will get nasty-grams from the FDA (or worse), telling them that their business practices have placed them in a pharma category (which wouldn't be good at all for those vendors--they'll have to most likely pull their products or adopt different marketing/advertising). As for those vendors who would fall within the tobacco classification, the FDA will be able to regulate the hell out of them.

I guess what I'm saying is that however you look at it, the FDA will be able to flex its regulatory muscle over e-cigs, so it probably makes sense for the FDA to bow to the inevitable and just start trying to figure out how to regulate e-cigs within a tobacco framework.

Then again, I could be all wrong.

 

[JerryRM]

Julie, let's just hope that those in power at the FDA find themselves unemployed in two years, or should I say, unemployed by the Federal Government.

 

[DC2]

Maybe someone can help me out, but I just don't see how the FDA can reach a settlement with TW without acknowledging that TW's product is a tobacco product.

I think maybe why both of us have asked this question is that we are thinking of something along the lines of a sealed settlement agreement where there would certainly be a lot of capitulation by the FDA, but nobody else would know about it because the terms would not become public. I'm not really clear on to what extent that would help others. Obviously others would likely be emboldened to try the same thing, but they would still have to file a lawsuit to make the FDA stop seizing their shipments.

On the other hand, if I understood correctly what Totally Wicked was originally asking for, it would have amounted to a public capitulation by the FDA that electronic cigarettes are not drug devices and that the FDA no longer has any business seizing them from Totally Wicked, or anybody else for that matter.

Of course I may be totally wrong in my understanding of any of this, as I am no lawyer, nor did I sleep at a Holiday Inn.

 

[cobaltblue]

Maybe relevant, maybe not...but my brother works for the Federal Government (Army Corps of Engineers, specifically), and he's been telling me that budget cutbacks are very real and widespread at all levels.

They are, no doubt with employees eventually ending up getting the brunt of it because of the same types of distorted "facts" that the FDA uses against PVs/liquids. In the case of employes, the distortions are for wage comparison/education levels, including the large percentage employees already pay towards overpriced healthcare policies, retirement plans etc. that the public is unaware of, but I have a feeling the cuts you're speaking of are probably agency dependent.

The reason I have a hard time believing cuts are straight across the board is the FDA/goverment isn't going to look good if they let someone's partially defunct pacemaker or shoddy prescriptions slide and it doesn't make their med watch list. So who knows how even same-agency funding/cutting fits in with all of this. Not sure how/if they determine budgets for litigation.

 

[JustJulie]

I think maybe why both of us have asked this question is that we are thinking of something along the lines of a sealed settlement agreement where there would certainly be a lot of capitulation by the FDA, but nobody else would know about it because the terms would not become public. I'm not really clear on to what extent that would help others. Obviously others would likely be emboldened to try the same thing, but they would still have to file a lawsuit to make the FDA stop seizing their shipments.

On the other hand, if I understood correctly what Totally Wicked was originally asking for, it would have amounted to a public capitulation by the FDA that electronic cigarettes are not drug devices and that the FDA no longer has any business seizing them from Totally Wicked, or anybody else for that matter.

Of course I may be totally wrong in my understanding of any of this, as I am no lawyer, nor did I sleep at a Holiday Inn.

I see what you're saying, and I guess the answer is I don't know. I suppose it's possible that the FDA could enter into a settlement agreement with TW, then TW could dismiss the lawsuit with the settlement agreement never being filed. That would certainly make sense in many types of lawsuits, but it would seem kind of an underhanded thing for the FDA to do in this case. As I said, the only settlement possible (to resolve ALL litigation with TW) would be an agreement that TW's products are tobacco--and if the FDA is going to go that route with TW, then that's how they need to proceed with other vendors (vendors who are not making therapeutic claims). To do anything less would be abusive, imo.

Then again, seeing as we're talking about the FDA . . .

 

[cobaltblue]

Well, it's well known that I'm a bit of a Pollyanna, but I'm thinking that this isn't really about "backroom deals" or "settling off the books." Maybe someone can help me out, but I just don't see how the FDA can reach a settlement with TW without acknowledging that TW's product is a tobacco product.

The FDA has taken the position that e-cigs are subject to pharma regulations. Period. There has been no wiggle room in the FDA's position. If the FDA intends to maintain that position and not back off, I simply don't see how it can reach any kind of settlement with TW other than perhaps agree that the preliminary injunction that NJOY won (that stops the FDA from seizing NJOY's shipments during pendency of the case) will also apply to TW. In that event, there would still be litigation, but while the litigation is ongoing, TW would have its shipments protected.

But to totally resolve the matter without litigation would require some acknowledgment from the FDA that TW's product is tobacco. And, like I said, once one vendor is "blessed" with a tobacco classification, it provides some safe harbor for other vendors to get the same treatment if their marketing/advertising is similar enough.

And honestly, the FDA really doesn't lose much by regulating e-cigs as tobacco products. The bad eggs out there (those making health claims) will get nasty-grams from the FDA (or worse), telling them that their business practices have placed them in a pharma category (which wouldn't be good at all for those vendors--they'll have to most likely pull their products or adopt different marketing/advertising). As for those vendors who would fall within the tobacco classification, the FDA will be able to regulate the hell out of them.

I guess what I'm saying is that however you look at it, the FDA will be able to flex its regulatory muscle over e-cigs, so it probably makes sense for the FDA to bow to the inevitable and just start trying to figure out how to regulate e-cigs within a tobacco framework.

Then again, I could be all wrong.

Thanks so much for that Julie! For some reason I had it in my mind that somehow litigation could be bypassed by the FDA/TW in order to keep it out of the court records.

Now I want to call Pillbox and ask him what's going on at TW. I don't do twitter...so somebody needs to tweet him.

 

[JustJulie]

NJOY v. FDA:

Nothing for Court of Appeals.

District Court: MINUTE ORDER granting Unopposed Motion for Extension of Time to Respond to Intervenor's Complaint. It is hereby ORDERED that defendants' motion is GRANTED. Defendants shall file a response to intervenor plaintiff's complaint no later than 30 days following the final resolution of the appeal. Signed by Judge Richard J. Leon on 03/03/2011. (lcrjl1) (Entered: 03/03/2011)

TW v. FDA: Nothing to report.

 

[JerryRM]

Thanks, Julie. It's getting a bit interesting, now.

 

[Our House]

And honestly, the FDA really doesn't lose much by regulating e-cigs as tobacco products.

This is something I (as someone who isn't legally behind the scenes) am having a lot of trouble wrapping my head around. It's hard to come up with a reason for why the FDA is fighting so intently against a position that doesn't matter much either way.