Update On The Njoy Vs. Fda Court Case Today

[Christopher]

Taken from Voltec over on ECF. She attended court this morning, this is what she witnessed.

Oral Arguments were heard today in the U.S. District Court of Appeals for the District of Columbia

Judges Garland, Kavanaugh and Williams (Links to their profiles below)

U.S. Court of Appeals - D.C. Circuit - Merrick B. Garland (202) 216-7460

U.S. Court of Appeals - D.C. Circuit - Brett M. Kavanaugh (202) 216-7180

U.S. Court of Appeals - D.C. Circuit - Stephen F. Williams (202) 216-7210

Case # 10-5032 Sottera, Inc. v. FDA 15 min per side

Appearing for NJOY, Gregory G. Garre, Latham & Watkins, LLP. Latham & Watkins LLP - Attorney Biography

Appearing for FDA, Alisa B. Klein, U.S. Department of Justice Georgetown Law - J.D. Adjunct Faculty

The first person I recognized waiting outside the courtroom was everyone's favorite law professor, John Banzhaf, Executive Director of Action on Smoking and Health (ASH). I saw him go over to speak the DOJ attorney representing the FDA. He asked her about the content of her argument, but she demurred, telling him that he should read the brief and that she did not want to "mischaracterize" their position. Next I overheard him making a phone call presumably to his office. He sounded a bit concerned. He told the person on the other end that they needed to get ahold of Michelle because he (Banzhaf) had gotten the time wrong. He thought the arguments started at 10:30 but they actually were starting this case at 9:30. He also said something about a press release.

Lucky him, he got to hang on to his cell phone. Mine was conficated at the security station when I entered the building because I am not an attorney. They did return my phone when I left. It's possible they might have let me hang on to it, had it not been for the fact that it has a camera. No recording devices, visual or audio are permitted in the courtroom, and all electronic devices that the attorneys were permitted to take into the courtroom had to be turned off, including IPods and IPads.

The courtroom isn't huge, but there were 4 wooden pews on each side and these were pretty much filled by the time the judges entered the room. There was a lot of meet and greet going on in the audience before the case got started, and I had the impression that I was one of the few people in the room lacking a law degree.

The DOJ attorney Alisa Klein spoke first. She had not been speaking for more than a few moments when the Judges began interrupting and asking questions. She began by stating that the District Court held that the electronic cigarette is exempt from regulation under the Food, Drug and Cosmetics Act (FDCA) because it is not intended for therapeutic use. The plaintiff's contention that electronic cigarettes should be treated like real cigarettes which, under FDA v. Brown & Williamson, are exempt from regulaton under the FDA is a misunderstanding of that case, she argued.

Judge Kavenaugh then asked whether it had been the FDA's long-held position that the Agency did not have the authority to regulate tobacco products. Klein responded that as the term was used by FDA, these are products that have tobacco in them. She further argued that Brown & Williamson was limited to cigarettes and smokeless tobacco products. Judge Williams commented that the Favor smokeless cigarette was not discussed in Brown & Williamson and that this is "not a good move for an interpretation of Brown & Williamson."

There was then some back and forth among the judges and Klein regarding the interpretation of "tobacco product." The judges thought it reasonable to use the concept of whether a product is marketed with a theraputic claim to determine which of the two Statutes (FDCA or the "Tobacco Act") gave the FDA regulatory authority over a product. Klein disagreed. She cited the example of the nicotine lollipop that FDA chose to regulate under FDCA and stated that the product would have been totally unregulated otherwise. She said that the Supreme Court relied on the FDA's interpretation.

Judge Kavenaugh asked whether the FDA felt that it could ban electronic cigarettes but not (tobacco) cigarettes. Klein commented, "If it could be shown that electronic cigarettes are a safe method of nicotine maintenance, that could be supported." In the new legislation there was a mandate for the FDA to encourage the development of more and better nicotine replacement products. She mentioned that the FDA had written to the Electronic Cigarette Merchant's (sic) Association, encouraging companies to come to the FDA to work with it.

I found it strange that after discussing a section of the Tobacco Act that FDA claimed to be supporting via its correspondence to the ECA, Klein asserted that since the Tobacco Act had not been passed when the original case was filed, it should not apply to this case.

Judge Williams asked about cigars not being covered in the 1996 rule, but that they are specifically covered in the Tobacco Act. The position of the judges appeared to be that even though Brown & Wiilamson did not specify all current and future tobacco products, that it applied a rule of "tobacco products as customarily marketed." Brown & Williamson left a regulatory gap that Congress came and filled in (by passing the Tobacco Act.) Judge Williams reiterated that the presence of absence of therapeutic claims seemed like a good way to determine whether a product shyould be regulated under FDCA. Klein continued to disagree. She said that "There is no reason to think that you could sell a nicotine lollipop and nobody could regulate it.

Judge Garland pointed out that the FDA's order of detention was the only piece of papaer the court has that explains the FDA's position. The order detained the products based on the idea that they were intended for therapeutic use. He asked whether the FDA has an administrative record documenting that NJOY made therapeutic claims. He said that the lower court ruling left the door open for the FDA to come forward with evidence that the products are marketed with claims of therapeutic use. He asked Klein whether the FDA is asking the court for an advisory opinion on what the FDA is limited to. "No, no, no," said Klein. "We don't regard the Tobacco Control Act as ambiguous."

The Judge asked about a "Chevron deference."

ASIDE: I had to look this up when I got home. This is what I found:

Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984)[1], was a case in which the United States Supreme Court set forth the legal test for determining whether to grant deference to a government agency's interpretation of a statute which it administers. Chevron is the Court's clearest articulation of the doctrine of "administrative deference," to the point that the Court itself has used the phrase "Chevron deference" in more recent cases

http://en.wikipedia.org/wiki/Chevron...e_Council,_Inc.

Klein stated that the law provided delegation of authority to the Agency. FDA gets to deem what is or is not a tobacco product. "If all we had were FDCA and the Tobacco Act, FDA would win," she stated. She said that invoking the Brown & Williamson case was the cause of confusion.

Judge Garland noted that the passage of the Tobacco Act has granted the FDA unquestionable authority to regulate tobacco products. He asked whether the FDA's purpose in regulating electronic cigarettes under FDCA was so that it could ban the products.

At this point, Attorney Garre took over the podium, representating the Plaintiff, NJOY. One of the judges asked whether John Banzhaf has, indeed, changed sides and now is one of the plaintiffs against FDA. This brought a chuckle from the courtroom. Garre said that he highly doubted that and that including Banzhaf's name as a co-plaintiff was probably a clerical error.

Garre began by stating that the FDA's position is just wrong, in the same way that FDA sought to regulate all tobacco products in Brown & Williamson. The debate is centered on the interpretation of "tobacco products." He commentd that the FDA gets no deference in interpreting Supreme Court decisions. He said that in passing the Tobacco Act, Congress ratified a line that the FDA advanced in Brown & Williamson. Congress in 2009 saw the need to give the FDA jurisdiction to regulate tobacco products, which it defined as anything derived from tobacco.

One of the judges asked whether this law would apply to street drugs, and Garre responded that it is limited to tobacco products.

There was some discussion of modified risk tobacco products, and how they might differ from tobacco dependence products which would be classified as smoking cessation drugs and devices that would still be regulated under FDCA.

DISCLAIMER:

I apologize to attorneys and the judges if I have misquoted or mischaracterized anything they said. I had to rely on my hand-scratched notes to interpret and report on what I heard.

My feelings about the arguments: Given the hard questions the judges were throwing at the DOJ attorney representing the FDA, I got the impression they are leaning toward the plaintiff's side of the case. But they did pin down NJOY's lawyer with some hard questions as well. Anything can happen, but given what I know and what I understood today, I would say the odds are that the Appeals Court will uphold the injunction. No guarantees, you understand.

AFTERWORD: I happened to run into everyone's favorite law professor upstairs in the Clerk of Courts office where I went to request a transcript of the arguments. I told him that I had been glad to see that he was finally supporting the rights of those of us who would rather use an electronic cigarette than smoke, but was disappointed that he had chosen to go back to the "dark side." He looked quizzical, but he did smile.

[LoriHNC]

By extracting the important stuff, what do you get from this? Seems like it's just dragged out some more??

[Christopher]

Honestly it's hard to say. Right now it's same old same old. Each side is fighting for their cause respectively. I think the 28th will most likely reveal quite a bit more information and possibility an ruling on the appeal.

[LoriHNC]

Honestly it's hard to say. Right now it's same old same old. Each side is fighting for their cause respectively. I think the 28th will most likely reveal quite a bit more information and possibility an ruling on the appeal.

hmmm, I guess we have to sweat it out. I think there are strong arguments favoring ecigs. Let's hope they can be presented the best way possible.

[Roober]

Well, after seeing this article, I am extremely hopeful. The right questions are being asked. The fact that the FDA is looking at it from a therapeutic standpoint, can work to our advantage as long as it stays as a tobacco product... I may have read it wrong, but to me it looks promising

[Popsicle]

Honestly it's hard to say. Right now it's same old same old. Each side is fighting for their cause respectively. I think the 28th will most likely reveal quite a bit more information and possibility an ruling on the appeal.

Thank you for the TL;DR version. I am too A.D.D. to read the whole thing, so I skimmed and got nothing.

I'm still extremely pessimistic. I mean, I would LOVE to be wrong on this one, but I just don't know. I kind of feel like this entire case is already over, they're just holding a hearing for the sake of formality.

EDIT: I just skimmed again. NICOTINE LOLLIPOP?! That EXISTS?! I NEVER want to hear this "electronic cigarettes are marketed to children" argument EVER again.

Edited September 23, 2010 by Popsicle

[JagSol]

Thank you for the TL;DR version. I am too A.D.D. to read the whole thing, so I skimmed and got nothing.

I'm still extremely pessimistic. I mean, I would LOVE to be wrong on this one, but I just don't know. I kind of feel like this entire case is already over, they're just holding a hearing for the sake of formality.

EDIT: I just skimmed again. NICOTINE LOLLIPOP?! That EXISTS?! I NEVER want to hear this "electronic cigarettes are marketed to children" argument EVER again.

I'm still reeling but at least this seems promising. Popsicle, my head is still reeling from the nicotine condoms. Now I'm going to projectile vomit all over the floor...then market it as "Nicotine muck." >.<

And I do agree, marketing to the youngsters arguments are horrid

[NeRo9k]

Thanks for posting this. Voltec makes the back and forth between the FDA and the Judges sound promising towards our cause.

[lightbringer]

OK, I was going to say something about the pros and cons of ecigs being considered tobacco products vs. drug but... there is a nicotine condom? Is it what it sounds like? that just sounds scary.

[Uma]

thanks for posting this Chris

[Burn]

regardless of the ruling, the FDA would still be the regulator and I don't recall anything that specifically states why tobacco regulation would be better than drug delivery device other than it would be "less restrictive". Does anybody know specifically the benefit of being a tobacco product as far as FDA involvement goes?

I would think (but don't know) that their first step in either scenario would be to remove them from the market.

[Popsicle]

OK, I was going to say something about the pros and cons of ecigs being considered tobacco products vs. drug but... there is a nicotine condom? Is it what it sounds like? that just sounds scary.

It is exactly what it sounds like. Think of it as a nicotine patch that you wear on your... well, nevermind.

It's supposed to eliminate the need to smoke after sex.

Which sounds utterly ridiculous to me.

Not sure about the tobacco vs. drug thing. On the surface, I'm assuming that they want it to be a tobacco product, because tobacco isn't ACTUALLY regulated. They'll do things like add fire-safe paper, just for show, but they still aren't safe. If we're in the same category as tar and rat poison, then a simple bottle of liquid containing under ten ingredients should be no problem at all.

Or maybe it's because "drug delivery device" sounds dirty and evil. Bad connotations.

*Shrug*

I don't actually know what I'm talking about, so I'd also like to see an explanation from someone who does.

[NeRo9k]

Drug= banned. Tobacco= able to still be sold although regulated.

[Christopher]

Also if the ecig is classified in the same category as cigarettes, I would imagine there will be no more online sales. But I'd take that over a ban.

[Popsicle]

Also if the ecig is classified in the same category as cigarettes, I would imagine there will be no more online sales. But I'd take that over a ban.

Aren't they one in the same? The only electronic cigarettes I've seen anywhere else are the ones at gas stations, which don't really count. Since they don't actually do much.

[Kragax]

Funny, I haven't seen a lick of tobacco in my Joker. There ARE other way to derive nicotine.

[Kilani]

Aren't they one in the same? The only electronic cigarettes I've seen anywhere else are the ones at gas stations, which don't really count. Since they don't actually do much.

While I'm not entirely happy with them, I DID buy my first ecig, an Njoy at a little smokers store...even out here in slowdeatha TX. I AM moving to online ordering and am anxiously waiting for my e go to come in. Hope the online sales stay available!

[BEERCITYVAPRZ]

Thanks for posting this Chris, hopefully it will be classified as a tobacco product so it doesn't get banned if its classified as a drug delivery device (god I hate using that term), Thank you Voltec!

[miatafrank]

regardless of the ruling, the FDA would still be the regulator and I don't recall anything that specifically states why tobacco regulation would be better than drug delivery device other than it would be "less restrictive". Does anybody know specifically the benefit of being a tobacco product as far as FDA involvement goes?

I would think (but don't know) that their first step in either scenario would be to remove them from the market.

As I understand this, if the FDA is allowed to classify it as a drug, anyone who manufactures a juice would have to have to make submissions to the FDA. They would have to have their so-called drug products tested, many forms would need to be filed to determine methods of distribution (prescription or self-administered), so on and so forth. this would cost those manufacturers so much money that the e-cig would die an agonizing death. As a tobacco product, the regulation would be much more manageable and tolerable by all, and the e-cig could survive.

Someone please correct me if I'm wrong!!!!!!!

[Christopher]

Mita you are correct.

[JagSol]

As I understand this, if the FDA is allowed to classify it as a drug, anyone who manufactures a juice would have to have to make submissions to the FDA. They would have to have their so-called drug products tested, many forms would need to be filed to determine methods of distribution (prescription or self-administered), so on and so forth. this would cost those manufacturers so much money that the e-cig would die an agonizing death. As a tobacco product, the regulation would be much more manageable and tolerable by all, and the e-cig could survive.

Someone please correct me if I'm wrong!!!!!!!

A wise man on King Of The Hill once said: "It's all a conspiracy!"

I honestly do hope something positive will happen where e cigs will survive WITHOUT regulation

[Uma]

Honestly it's hard to say. Right now it's same old same old. Each side is fighting for their cause respectively. I think the 28th will most likely reveal quite a bit more information and possibility an ruling on the appeal.

Today is the 28th... any word yet?

[Christopher]

No nothing yet I'll post as soon as I hear anything. (If I'm by a computer)

I would expect to hear anything until later tonight once the dockets have updated.