SE, NJoy vs FDA -- Discussion

[kai kane]

J"I want to go back to my little grass shack".

One of my favs. And where I'm heading in about 30 minutes! (but it's on Kauai and not in Kealakekua!)

 

[Bovinia]

Oh my Vocalek! I haven't thought about Leon Redbone in years...thank you for the link and the memories it brings back!

 

[JerryRM]

Glad to hear that you weren't hit too hard with the tsunami, Kai.
I hope everyone has a nice weekend, even Julie.

 

[rothenbj]

Thanks Julie for spending almost $13 and 20 hours a year checking the dockets as well as many hours saying "your welcome" to all "thank you".

Elaine, Leon lives about 45 minutes from me in good traffic. He normally gets booked once a year at the local music venue and I've seen him at least three times there over there last decade. Every time I hear him sing "I want to be seduced" reminds me of one of my closest/dearest friend/coworker's that I worked with for almost 20 years. I was on a business trip to Italy, returned on a Wednesday, took Thursday off and sat goodnight to her at the end of the day Friday. She called in sick Monday and by Tuesday, 1 in the morning she was dead at just over 40. She loved that song and was always worried about turning 40 and I never asked her why that age bothered her.

 

[rothenbj]

Roscoe nailed it! with the exception of "kakahi'aka" for 'everyone.

We had to evacuate last nite at 1am for the Japan tsunami, which, luckily, only hit a couple spots in the islands with any real damage. Just now getting back home at 1pm. They evacuated all the ground floors of the hotels statewide........

Ya know, if I was staying in a hotel where they were evacuating the ground floor, I wouldn't feel any more comfortable about being on any of the other floors either! Just sayin

 

[Vocalek]

My uncle, a Portugese Hawaiian, taught me how to play the ukelele and to sing "I want to go back to my little grass shack" when I was 11 years old. When my mother married for the second time, my cousin (his son) and I sang a duet of the "Hawaiian Wedding Song." I finally made it over to to Maui around 2003. Hawaii is every bit as beautiful as everyone says.

 

[JustJulie]

Nothing new at the district court level with either njoy or TW . . . new filing in the njoy Court of Appeals case . . . the Alphabet Soup Group has substituted counsel. Nothing significant, though . . . looks like the old attorney has switched law firms and has withdrawn as counsel. The Alphabet Soup Group is being represented by a new lawyer with the old law firm.

 

[JustJulie]

Nothing new in any of the courts.

 

[Vaporologist]

Thank you Julie, for today and yesterday!

 

[JerryRM]

Since it embarrasses you, I'm not going to say "thank you, Julie". Nope I'm not going to do it and that's final.

 

[Our House]

Since it embarrasses you, I'm not going to say "thank you, Julie".

****k you Julie!

 

[JerryRM]

I was counting the asterisks on that one, Our House.

 

[Rosco]

I was counting the asterisks on that one, Our House.

No kidding....

 

[JonnyVapΣ]

That was awesome.

 

[JustJulie]

Sorry so late with the update . . . .

Only thing new on the docket is a status report in TW v. FDA . . . doesn't really tell us anything we don't know . . . basically TW is submitting materials to the FDA for review, and a status report will be filed by April 7th.

Oh, yeah . . . and everyone is welcome.

 

[JerryRM]

You can "welcome" me all you want, Julie, I'm still not going to say "thank you".

 

[JustJulie]

You can "welcome" me all you want, Julie, I'm still not going to say "thank you".

 

[Vocalek]

I notice that this document is signed by THOMPSON HINE L.L.P. So whatever happened to Flory?

Thompson Hine traces its origination back to 1893 when Amos Burt (A.B.) Thompson, an enterprising, self-taught attorney, was admitted to the Ohio Bar and established a commercial law practice in downtown Cleveland. Mr. Thompson went into partnership first with Charles P. Hine and later, in 1911, with Walter L. Flory, whereupon the firm adopted the name it kept for 90 years, Thompson, Hine and Flory.

TH & F was one of the law offices I temped at during summer vacations when I was in college (Cleveland OH office).

 

[Bill Godshall]

The Food Drug Law Institute (FDLI) conference promotional cites the SE/Sottera v FDA as one of the top cases in 2010 that will be discussed (but I don't know any of the four law professors who will discuss). I also highlighted (below) other conference sessions on FDA tobacco and nicotine regulatory issues. Scott Ballin and Dave Sweanor are both tobacco harm reduction advocates, and both will talk about e-cigarettes and smokeless tobacco during their presentation. Hopefully, Deyton will stick around after his presentation to hear Scott and Dave speak. BTW, the conference costs $1500 unless you work for government or a university.

Top Court Cases of 2010 to be Discussed at Annual Conference, April 5-6

In conjunction with the release of FDLI's publication, Top 20 Food and Drug Cases, 2010 & Cases to Watch, 2011, this panel will present three of the most watched cases from this past year. The session will also include an update on last year's Top 20 Cases and a preview of the cases to watch in 2011. Cases to be discussed include: Matrixx Initiatives, Inc. v. Siracusano (SEC and a drug company's nondisclosure of adverse event reports), Bryant v. Medtronic, Inc. (the first major appellate post-Riegel ruling), and Smoking Everywhere and Sottera Inc. v. FDA (electronic cigarette ruling). Presenters are all leading academics teaching food and drug case law.

John B. Reiss, Partner, Saul Ewing LLP (Moderator)
Lewis A. Grossman, Professor of Law, Associate Dean for Scholarship, American University, and Of Counsel, Covington & Burling LLP
William M. Janssen, Assistant Professor of Law, Charleston School of Law
Margaret Sova McCabe, Professor of Law, University of New Hampshire School of Law
Jordan K. Paradise, Associate Professor of Law, Seton Hall University School of Law
Register for the FDLI Annual conference today.

2011 FDLI Annual Conference

TUESDAY, APRIL 5, 2011

2:00-3:30 p.m.
Concurrent Breakout Sessions:

E. Tobacco Products
Lawrence R. Deyton, MSPH, MD
Director, Center for Tobacco Products (CTP), FDA
- - -
4:00-5:30 p.m.
Concurrent Breakout Sessions

E. Development and Regulation of Tobacco Products, Nicotine
and Alternative Tobacco Products under the Family
Smoking Prevention and Tobacco Control Act and Beyond
Under the Family Smoking Prevention and Tobacco Control Act ("Tobacco Control Act"), FDA has broad authority to regulate tobacco products, but cannot ban tobacco products or nicotine. Rather than permit FDA to regulate all tobacco, nicotine, and alternative tobacco products in a single center or as its own group of products, the Tobacco Control Act created a regulatory scheme that fragmented these products into different FDA centers of responsibilities-tobacco products, drugs, foods, or combinations of these products. Recently, FDA has faced challenges determining how to classify and regulate e-cigarettes and will undoubtedly face more challenges with definitions created by the Tobacco Control Act such as "cigarette" or "tobacco product", as the tobacco industry creates hybrid products, such as cigarillos, or new products including noncombustible tobacco products, such as dissolvable tobacco. During this thought-provoking session, the panelists will create a dynamic forum for the audience to listen and react to concerns raised by the panelists about the Tobacco Control Act and its effect on the development and regulation of tobacco, nicotine, and alternative tobacco products and proposals for how FDA may address these issues in the coming months and years. In particular, the panel will raise issues about how FDA and Congress can better address the public health concern to develop more reduced risk tobacco, nicotine and alternative tobacco products, as well cope with the requirements set by the Tobacco Control Act to define limits for harmful constituents in tobacco products and ban or reduce the limit of substances used to make tobacco products more addictive or palatable and thereby encourage new or continued use.

Moderator Roseann B. Termini
MEd, Professor, Widener University School of Law

Speaker/Panelists
Scott D. Ballin
Health Policy Consultant

Brian J. Malkin
Partner, Frommer Lawrence & Haug LLP

David T. Sweanor
Adjunct Professor, Faculty of Law, University of Ottawa

 

[Bill Godshall]

JustJulie wrote:

Nothing new at the district court level with either NJOY or TW . . . new filing in the NJOY Court of Appeals case . . . the Alphabet Soup Group has substituted counsel. Nothing significant, though . . . looks like the old attorney has switched law firms and has withdrawn as counsel. The Alphabet Soup Group is being represented by a new lawyer with the old law firm.
Attached Files
Alphabet Soup - Substitution of Counsel in Ct.App. SE:NJOY case.pdf (16.2 KB, 5 views)

Per e-mail below, William Schultz left Zuckerman Spaeder to go work for the US DHHS (which includes FDA)

From: "Schultz, William B." <WSchultz@zuckerman.com>
To: "Bill Godshall" <smokefree@compuserve.com>
Sent: Wednesday, March 16, 2011 7:24 PM
Subject: Out of Office: Tobacco Harm Reduction Update (3/16/11)

> Effective March 15, 2011 I will be leaving Zuckerman Spaeder to join the General Counsel's office of the Department of Health and Human Services. This email account will become inoperative in 30 days.