FDA Sued Over Electronic Cigarette Embargo

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Jim Davis

Vaping Master
ECF Veteran
Mar 16, 2009
4,260
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Retired in Houston, Texas / USA
For all the rant they got from many of us here on this forum, isn't it Ironic how they were the ones to step up to the plate and actually file a lawsuit?

I'm sure it's to save their business but now is the time for all suppliers to put competition (and their differences) to the side and join forces with Smoking Everywhere in this lawsuit.

United we stand, Divided we fall.

Ya snatched the words right out of my mouth Max.
 
do you think that with the pending suit that the fda may ease up on the seizures?
That would be cool :d

philadelphia,pa, us
04/15/2009 9:41 a.m.
ups is processing shipment for future submission to the food/drug admin and/or dept of ag ppq

04/15/2009 9:25 a.m. ups is processing shipment for future submission to the food/drug admin and/or dept of ag ppq

04/15/2009 9:11 a.m. shipment pending release from clearance agency / brokerage released shipment. Shipment is submitted to clearing agency for further clearance

philadelphia,pa, us
04/11/2009 6:04 p.m. shipment pending release from clearance agency 04/11/2009 6:03 p.m. shipment pending release from clearance agency 04/11/2009 4:37 p.m. import scan
04/11/2009 12:17 p.m. arrival scan

Unfortunately for me, I have this very large shipment of e-liquid
still sitting with the FDA, and all they say in todays email is:
"Hold Designated"
Items are in review as of the 15th of April, 2009.
And I can get no straight answer out of US Customs or the FDA other than they have looked at every bottle, are "Interested", and will get back to me at some point!?
Just thought I would pass this along, as I know there have been a lot of speculations, so I will let you know of anything tangible like this occurs.

Sincerely,
P.
 
I wish them luck. Is the U.S. District Court for the District of Columbia a good venue for this??

Being an ignorant Brit I guess that is in Washington DC?????

C.

I still think you are lovely!

That's Federal District Court in Washington DC. Not the Supreme Court... if it ever goes that far. Hope not... this could take many months if not years as it is.

But this is the spark that would light the fire...

How about a documentary of vintage cigarette ads and commercials, court settlement checks interspersed with seriously ill smokers and ex-smoker's (as in dead or alive) family members with the Doors "Light My Fire".....?

Add a marquee counter of how many are dying in real time and how much money is being made in real time....





 

Faethe

Super Member
ECF Veteran
Feb 12, 2009
338
2
Orlando, Florida
Does anyone have a copy of the actual complaint filed by Smoking Everywhere?

Litigation can be a double edged sword, as a court ruling against Smoking Everywhere could embolden the FDA to embargo even more of the products, and perhaps ban them as well.

Oh hey I read your letters and communications and stuff :) Hi! Good time for you maybe to file a friend of the court brief or offer to? Smoking everywhere might just be pushing to get a judge to stay the seizures. If the Waxman thing goes through, that's the end of the road, I think.
 

OutWest

Unregistered Supplier
ECF Veteran
Feb 8, 2009
1,195
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www.alternasmokes.com
Does anyone have a copy of the actual complaint filed by Smoking Everywhere?

Litigation can be a double edged sword, as a court ruling against Smoking Everywhere could embolden the FDA to embargo even more of the products, and perhaps ban them as well.
Yes, I just got a copy of it via email. PM me your email addy and I'll forward it to you. Same for anyone else that wants a copy.

edit to add: I've uploaded the document I received
http://www.alternasmokes.com/SE-Memo_in_Support_of_TRO.pdf

and here's the link to the filings that dc2k08 found and posted http://www.courthousenews.com/2009/04/29/Smoking.pdf


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Here's the case file summary.... please note the email addresses and phone numbers of the defendants (hint).

The actual complaint is over 25 pages so I will post a link to it shortly....

Actual Smoking Everywhere vs. FDA/HHS Case Files

1:09-cv-00771-RJL SMOKING EVERYWHERE, INC. v. U.S. FOOD AND DRUG ADMINISTRATION et al
Richard J. Leon, presiding
Date filed: 04/28/2009
Date of last filing: 04/29/2009

Case Summary
Office: Washington, DC Filed: 04/28/2009
Jury Demand: None Demand:
Nature of Suit: 890 Cause: 28:1331 Fed. Question
Jurisdiction: U.S. Government Defendant Disposition:
County: 88888 Terminated:
Origin: 1 Reopened:

Lead Case: None
Related Case: None Other Court Case: None
Def Custody Status:
Flag: TYPE-D

Plaintiff: SMOKING EVERYWHERE, INC. represented by Christopher Kip Schwartz Phone: (202) 263-4157
Fax: (202) 331-8330
Email: kip.schwartz@thompsonhine.com

Defendant: U.S. FOOD AND DRUG ADMINISTRATION represented by Drake S. Cutini Phone: (202) 307-0044
Fax: (202) 514-8742
Email: drake.cutini@usdoj.gov

Defendant: JOSHUA M. SHARFSTEIN represented by Drake S. Cutini Phone: (202) 307-0044
Fax: (202) 514-8742
Email: drake.cutini@usdoj.gov

Defendant: MARGARET HAMBURG represented by Drake S. Cutini Phone: (202) 307-0044
Fax: (202) 514-8742
Email: drake.cutini@usdoj.gov

Defendant: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES represented by Drake S. Cutini Phone: (202) 307-0044
Fax: (202) 514-8742
Email: drake.cutini@usdoj.gov

Defendant: CHARLES JOHNSON represented by Drake S. Cutini Phone: (202) 307-0044
Fax: (202) 514-8742
Email: drake.cutini@usdoj.gov

Defendant: KATHLEEN SEBELIUS represented by Drake S. Cutini Phone: (202) 307-0044
Fax: (202) 514-8742
Email: drake.cutini@usdoj.gov

1:09-cv-00771-RJL SMOKING EVERYWHERE, INC. v. U.S. FOOD AND DRUG ADMINISTRATION et al
Richard J. Leon, presiding
Date filed: 04/28/2009
Date of last filing: 04/29/2009

Case Summary
Office: Washington, DC
Filed: 04/28/2009
Jury Demand: None
Demand:
Nature of Suit: 890
Cause: 28:1331 Fed. Question
Jurisdiction: U.S. Government Defendant
Disposition:
County: 88888
Terminated:
Origin: 1
Reopened:

Lead Case:
None
Related Case:
None
Other Court Case: None
Def Custody Status:

Flag: TYPE-D

Plaintiff: SMOKING EVERYWHERE, INC.
represented by
Christopher Kip Schwartz
Phone:
(202) 263-4157
Fax:
(202) 331-8330
Email:
kip.schwartz@thompsonhine.com

Defendant: U.S. FOOD AND DRUG ADMINISTRATION
represented by
Drake S. Cutini
Phone:
(202) 307-0044
Fax:
(202) 514-8742
Email:
drake.cutini@usdoj.gov

Defendant: JOSHUA M. SHARFSTEIN
represented by
Drake S. Cutini
Phone:
(202) 307-0044
Fax:
(202) 514-8742
Email:
drake.cutini@usdoj.gov

Defendant: MARGARET HAMBURG
represented by
Drake S. Cutini
Phone:
(202) 307-0044
Fax:
(202) 514-8742
Email:
drake.cutini@usdoj.gov

Defendant: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
represented by
Drake S. Cutini
Phone:
(202) 307-0044
Fax:
(202) 514-8742
Email:
drake.cutini@usdoj.gov

Defendant: CHARLES JOHNSON
represented by
Drake S. Cutini
Phone:
(202) 307-0044
Fax:
(202) 514-8742
Email:
drake.cutini@usdoj.gov

Defendant: KATHLEEN SEBELIUS
represented by
Drake S. Cutini
Phone:
(202) 307-0044
Fax:
(202) 514-8742
Email:
drake.cutini@usdoj.gov

COMPLAINT against U.S. FOOD AND DRUG ADMINISTRATION, JOSHUA M. SHARFSTEIN, MARGARET HAMBURG, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, CHARLES JOHNSON, KATHLEEN SEBELIUS ( Filing fee $ 350, receipt number 4616020180) filed by SMOKING EVERYWHERE, INC.. (Attachments: # (1) Civil Cover Sheet)(td, )

MOTION for Temporary Restraining Order and/or injunctive relief by SMOKING EVERYWHERE, INC. (td, )

LCvR 7.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by SMOKING EVERYWHERE, INC. identifying Corporate Parent NONE for SMOKING EVERYWHERE, INC.. (td, )

MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Walt Linscott, :Firm- THOMPSON HINE LLP, :Address- One Atlantic Center, 1201 West Peachtree Street, NW, Suite 2200, Atlanta, Georgia 30309-3449. Phone No. - (404) 541-2900. by SMOKING EVERYWHERE, INC. (td, )

MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Matthew Ridings, :Firm- Thompson Hine LLP, :Address- 3900 Key Center, 127 Public Square, Cleveland, Ohio, 44114-1291. Phone No. - (216) 566-5561. by SMOKING EVERYWHERE, INC. (td, )

MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Brian Lamb, :Firm- THOMPSON HINE LLP, :Address- 3900 Key Center, 127 Public Square, Cleveland, Ohio, 44114-1291. Phone No. - (216) 566-5590. by SMOKING EVERYWHERE, INC. (td, )

4/29/2009

SUMMONS (8) Issued as to U.S. FOOD AND DRUG ADMINISTRATION, JOSHUA M. SHARFSTEIN, MARGARET HAMBURG, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, CHARLES JOHNSON, KATHLEEN SEBELIUS, U.S. Attorney and U.S. Attorney General. (kb)

NOTICE of Appearance by Drake S. Cutini on behalf of U.S. FOOD AND DRUG ADMINISTRATION, JOSHUA M. SHARFSTEIN, MARGARET HAMBURG, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, CHARLES JOHNSON, KATHLEEN SEBELIUS (Cutini, Drake)





 
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OutWest

Unregistered Supplier
ECF Veteran
Feb 8, 2009
1,195
1
Oklahoma USA
www.alternasmokes.com
thanks for finding that. The pdf I got via email was the Memoradum in Support of Plaintiff's Motion for Temporary Restraining Order and Preliminary Injuction that was filed with the court, which shows the argument about ecigs not being under the FDA. Your find goes well with it. I assume I could put it up on the web since i was told that it was public record, but I really hate assuming things ;)
 

ISAWHIM

Senior Member
ECF Veteran
Apr 15, 2009
195
1
48
Jacksonville, Florida
www.isawhim.com
Nice - Unfortunately, If/when the Waxman Bill passes in the senate, the FDA will have regulatory authority over tobacco ciagarettes...then what?

Don't get me wrong, I like the news...I like it a lot!!!

Since there is no tobacco (plant) in the electronic devices, and only some juices have tobacco extracts... That does not qualify "All devices", as being a "Tobacco product".

Tobacco is specifically a plant-substance, not an extract (Which is a derivative of tobacco.), and not synthetic creations which do not contain any tobacco.

Water is a component of tobacco... so that would assume that the FDA has the ability to control water, if it was allowed for them to say that this gives them the right to control nicotine extracted from tobacco.

In essence... that would also give them the ability to control tomatoes and potatoes... since they also contain nicotine and water... So the law/bill they pass, will have no legal impact on electronic-cigs, other than the ones which state that they are "Cigarettes", or state that they are for use of "Tobacco". (Such as vaporizing bongs, hookahs, etc.)

These devices are for vaporizing ANY non-oily or low-oil liquids. Nicotine delivery is not the primary or only indicated use. Tobacco is not even a suggested or advertised use. (With the exception of similar names for flavored juices, which are not a direct reflection of the contents within the product.)

If they said they were going to control "Nicotine"... that would be something to worry about... actually... that would be a good thing to demand. However that is the district of the DEA, and the DEA does not have concern with this low-threat substance. (Well, they don't enforce the control of it, other than age limits for certain specific products.)

If the DEA are the equivalent of street police... (Figuratively speaking.)
The FDA are the equivalent of school crossing-guards...
 
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Caesarea

Vaping Master
ECF Veteran
Mar 12, 2009
3,053
8
UK
I still think you are lovely!

:oops: Crumbs!

That's Federal District Court in Washington DC. Not the Supreme Court... if it ever goes that far. Hope not... this could take many months if not years as it is.

But this is the spark that would light the fire...[/QUOTE]

Will the link
http://www.courthousenews.com/2009/04/29/Smoking.pdf

follow the progress of the proceedings?

How about a documentary of vintage cigarette ads and commercials, court settlement checks interspersed with seriously ill smokers and ex-smoker's (as in dead or alive) family members with the Doors "Light My Fire".....?

Add a marquee counter of how many are dying in real time and how much money is being made in real time....






Yes the moment for strategic fight back seems to be here. As well as lawyers, have PR/media people been hired do you think?
C.
 

jmoney

Senior Member
ECF Veteran
Mar 12, 2009
130
0
36
Texas
this is good for so many reasons...for the most part nobody knows what an electronic cigarette is, or has ever even heard of one...most people who smoke have been looking for something like this for many many years...hoping for it really, I would say expect more and more back orders from suppliers because this could really be what brings esmoking into the light
 
Bold, colors and italics added....

PreliminaryStatement

1. This is an action for declaratory and injunctive relief pursuant to 28 U.S.C. §2201 and 5 U.S.C. §702 et seq.to stop the FDA from improperly exceeding its delegated authority by attempting to regulate electronic cigarettes - electronic products that are derived from tobacco and allow a user to inhale a liquid nicotine vapor for the purpose of "smoking" pleasure.

The FDA has further exceeded its properly delegated authority by adding, without opportunity for public notice and comment, electronic cigarettes to an FDA "importalert, "whichalerts FDA field offices and the United States Customs and Border Protection ("USCBP") to the attempted entry of certain products into the UnitedStates, resulting in their refused admittance. By including electronic cigarettes on the FDA's import alert, several shipments of SE's products have been wrongfully refused entry into the UnitedStates. The FDA's conduct is ultra vires of its authority under the Food, Drug,and CosmeticAct ("FDCA"), 21 U.S.C. §§301 et seq., and by failing to engage in mandatory public notice and opportunity for comment, the FDA's conduct further violates the notice and comment procedures codified at 5 U.S.C. §553.

Read the whole complaint, it's a good read!!!!!

Big issues on the table. All of them covered? Hmmmm.....





 
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MaxxVapor

Unregistered Supplier
ECF Veteran
Apr 23, 2009
161
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Al USA
www.saveasmoker.com
Bill, please share your thoughts after reading the case files.

Also, does anyone know how soon or probable a decision could be made concerning SE's requested relief (to let Electronic Cigarettes through customs) until conclusion of the suit?

At the very least it seems the FDA broke the law in not adding their addition to the national register.

There are reasons I'm not a lawyer!!!!
 
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planetofthevapes

Super Member
ECF Veteran
Feb 28, 2009
476
3
Pandhandle of Nebraska
Ok, so, what happens if the FDA gains control over cigarettes then...the regular ones? Would we need an Rx to smoke? That would be ODD....hmm..."doc, I'm considering committing a 50 yr suicide attempt, could you hook me up...lung cancer sounds fun!" If the FDA gains control over cigarettes but then continues a ban on the e-cigs...that would really show how messed everything is these days! I'm cheering SE on right now...I'm very excited that somebody found a ruling and is trying to use it to get our products back from being seized (so far I've been lucky, but I bite my nails every time I have to order from China because people stateside are out of what I need/want). GO SE!
 
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