Yesterday 3 Judges from the U.S. Court of Appeals heard oral arguments on the latest legal action in the case #10-5032 of Sottera, Inc v. FDA.

This news is incredibly hot and thankfully an e-cig forum veteran was in Washington DC to witness the proceedings and…

Reported statements made by the FDA’s attorney confirms some of my suspicions surrounding the FDA’s intentions when it sent 5 e-cig companies warning letters Sept. 9th 2010. New information also came available to me making the FDA’s statements during the Sept. 9th media brief more clear.

I want to provide a few important highlights of the proceedings followed by my reprinting of the full report posted on The ECig Forum, but first I need to give full credit to VocalEK, who is an e cigarette veteran and also writes her own blog: The Truth About Nicotine.

VocalEK went to Washington DC and worked very hard to make notes of the proceedings (since recording devices were not allowed) and then publish the report on The ECF that is the source of the information for this blog post. Thank you VocalEK!!

VocalEK’s blog is incredibly informative and packed with facts on nicotine. Be to check it out!

Here are my highlights of the proceedings from the report.

Sottera, Inc (NJOY) v. FDA – Oral Argument Highlights

U.S. Court of Appeals Judges D.C. Circuit:

• Judge Merrick B. Garland
• Judge Brett M. Kavanaugh
• Judge Stephen F. Williams

Attorneys

• Appearing for NJOY, Gregory G. Garre, Latham & Watkins, LLP
• Appearing for FDA, Alisa B. Klein, U.S. Department of Justice

Purpose of Oral Arguments

These oral arguments are the first step in the process to figure out if the stay on Judge Leon’s preliminary injunction against the FDA detaining e cig shipments will stick or if it will be removed while the case is being decided.

To decide if the stay on the injunction remains it must be determined if the e cigs should be classified as a tobacco product regulated under the Family Smoking Prevention and Tobacco Control Act (Tobacco Act) signed into law last year or should e cigs be classified as a drug / device to be regulated by the Food, Drug and Cosmetic Act (FDCA).

If e cigarettes get classified as a drug / device to be regulated under the FDCA then the stay on the injunction will likely remain.

Mistakes and Shady Acts By Others in Attendance

Law professor John Banzhaf, Executive Director of Action on Smoking and Health (ASH) was in attendance. He became a major e cigarette antagonist since he started publishing dozens of self-aggrandizing anti-e-cig propaganda press releases for ASH.  His press-releases are based mostly on half truths (or stretching the truth) and scare tactics. You can read some of them here if you would like:

http://pressroom.prlog.org/ASHORG/

He may be better known for advocating legal action as a weapon against obesity by suing fast food companies so you can see where he derives his roots.

VocalEK reported hearing him unsuccessfully try to extract information from the FDA’s attorney on the content of her argument. Then, he made a cell phone call and reportedly mentioned getting the time of the case wrong and another press release while on the call.

Letter to Electronic Cigarette Association Mentioned in Case

I didn’t know if the FDA’s attorney would actually mention the letters written to the 5 e cig companies and the Electronic Cigarette Association (ECA) in the court case, but she reportedly did. Here’s why:

The Family Smoking Prevention and Tobacco Control Act (referred more conveniently to as “The Tobacco Act”) reportedly has a mandate in it that the FDA encourage the development of more and better nicotine replacement products.

So when the FDA’s attorney was asked by Judge Kavenaugh if the FDA felt it could ban electronic cigarettes, but not (tobacco) cigarettes she was ready to answer that the FDA wrote letters to the merchants and the association to encourage them to work with the FDA.

Also the FDA’s statements made during the media briefing are a little more clear now. In the media briefing 2 weeks an FDA representative, Michael Levy said:

We have not decided to remove all e cigarettes from the market.

The FDA doesn’t want to give the impression that it is not acting within the mandate in the Tobacco Act. An outright ban on e cigs could not be seen as “encouraging” the development of more and better nicotine replacement products.

Unfortunately, the mandate was under the Tobacco Act and NOT the FDCA so if the FDA trys to take that position then they tend to align more with the Tobacco Act. VocalEK mentions this as “strange” in her commentary.

The Judges Do Not Buy the FDA’s Argument

In several instances one or more of the judges mentioned the presence or absence of therapeutic claims as being a good way to determine whether a product falls under the category of a tobacco product or FDCA which are both under the FDAs regulatory power anyway.  The FDA’s attorney disagreed each time.

The judges also referenced the Supreme Court Case of the FDA v. Brown & Wiilamson establishing a rule of “tobacco products as customarily marketed” to determine whether e cigs could be considered a tobacco product or a drug and how to regulate them.

Judge Garland then hammered the defense regarding its order of detention of NJOY’s e cigs asking for any evidence documenting that NJOY made therapeutic claims. The report reveals no such evidence brought to bear in the case.

Less To Report from the Plaintiff’s Side

VocalEK didn’t have as much to report from the plaintiff’s side except more debate on the Brown & Williamson Supreme Court case and that they also did discuss distinctions between modified risk tobacco products and smoking cessation drugs and devices. The latter are subject to FDCA regulation as a drug.

VocalEK’s gut reaction to the proceedings is that the Judges seem to be siding with NJOY, the plaintiff in this case.

I now republish the full report from VocalEK that can be found on the E-Cig Forum here:

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 confiscated 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 regulation under the FDA is a misunderstanding of that case, she argued.

Judge Kavanaugh 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 paper 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, representing 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.