You are on page 1of 5

Case 1:11-cv-00387-RJL Document 12 Filed 05/13/11 Page 1 of 5

UNITED STATES DISTRICT COURT


FOR THE DISTRICT OF COLUMBIA

)
TOTALLY WICKED-E.LIQUID (USA), INC., )
)
Plaintiff, )
)
v. ) CASE NO. 1:11-cv-387 (RJL)
)
U.S. FOOD AND DRUG ADMINISTRATION, )
et al., )
)
Defendants. )
)

NOTICE OF VOLUNTARY DISMISSAL WITHOUT PREJUDICE

Plaintiff, Totally Wicked-E.Liquid (USA), Inc. ("TWI"), by and through its undersigned

counsel, pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(i), hereby files this notice of

dismissal of the above-captioned case without prejudice. In support of its notice, TWI states as

follows:

WHEREAS, on or about October 8, 2010, at the direction of the Food and Drug

Administration (FDA), U.S. Customs and Border Protection detained a shipment of electronic

cigarettes and accessories being imported into the United States through Miami International

Airport by TWI; and

WHEREAS, on or about October 26, 2010, TWI received a "Notice of FDA Action"

relating to the shipment that advised that the electronic cigarettes contained in the shipment were

"subject to refusal" pursuant to the Federal Food, Drug & Cosmetic Act ("FDCA"), 21 U.S.C. §§

301, et seq. because they appeared to be misbranded drugs or devices in violation of FDCA

Section 502(o) [21 U.S.C. § 352(o)] and because they appeared to be unapproved new drugs in

violation of FDCA Section 505(a) [21 U.S.C. § 355(a)]; and


Case 1:11-cv-00387-RJL Document 12 Filed 05/13/11 Page 2 of 5

WHEREAS, TWI submitted a formal response to the Notice of FDA Action on

November 29, 2010, and follow-up correspondence to the FDA on December 1, 2010, in which

TWI challenged the FDA's authority to regulate TWI's products as a "drug," "device," or

"combination product" pursuant to Chapter V of the FDCA; and

WHEREAS, on February 15, 2011, TWI commenced the instant action by filing its

Verified Complaint and Motion for Temporary Restraining Order and Preliminary Injunction;

and

WHEREAS, in its Verified Complaint and Motion for Temporary Restraining Order and

Preliminary Injunction, TWI requested that the Court enjoin FDA from enforcing any import ban

on TWI's electronic cigarettes arising out of their purported classification as a drug, device, or

combination product and enter a declaratory judgment that FDA is without statutory authority to

regulate TWI's electronic cigarettes and accessories as a drug, device, or combination product;

and

WHEREAS, in its Verified Complaint and Motion for Temporary Restraining Order and

Preliminary Injunction, TWI requested that the Court order the release of TWI's electronic

cigarettes that had been detained by the United States pursuant to FDA's determination that it has

jurisdiction over TWI's electronic cigarettes under the FDA's authority to regulate drugs, devices,

and combination products; and

WHEREAS, following the filing of the Verified Complaint and Motion for Temporary

Restraining Order and Preliminary Injunction, the FDA entered into settlement negotiations with

TWI regarding resolution of the instant action and the continued detention of TWI's electronic

cigarettes that had been detained since October 8, 2010; and


Case 1:11-cv-00387-RJL Document 12 Filed 05/13/11 Page 3 of 5

WHEREAS, FDA asserted that TWI's marketing materials contained statements that

constituted therapeutic claims and TWI denied such allegations, yet still revised various of its

marketing materials to comply with FDA's requests;

WHEREAS, as part of the settlement discussions, TWI submitted marketing materials to

FDA for FDA's review in March and April, 2011; and

WHEREAS, on April 25, 2011, FDA issued a public letter to stakeholders in which FDA

advised that it would no longer attempt to regulate electronic cigarettes as "drugs" or "devices"

unless they are marketed for "therapeutic purposes"; and

WHEREAS, upon conclusion of the settlement discussions, on May 9, 2011, the Director

of FDA's Florida District advised that, upon the completion of certain conditions, FDA "does not

intend to detain or refuse future shipments of TWI's electronic cigarettes under the FDCA's

drug/device provisions"; and

WHEREAS, on May 10, 2011, FDA rescinded its refusal of TWI's shipment of electronic

cigarettes and released the shipment that had been detained since October 8, 2010;

NOW, THEREFORE, as FDA has, upon the completion of certain conditions, disavowed

any intent to detain or refuse future shipments of TWI's electronic cigarettes under FDA's "drug"

or "device" authorities under Chapter V of the FDCA, and further modified its regulatory stance

as reflected in the April 25, 2011 letter to stakeholders, it appears that there are no remaining

issues to be resolved in the instant action, all substantive relief requested by TWI in its Verified

Complaint and Motion for Temporary Restraining Order and Preliminary Injunction having been

provided, TWI does hereby voluntarily dismiss this action without prejudice to refiling in the

event that FDA fails to comply with its promised course of conduct with respect to TWI's

electronic cigarette products.


Case 1:11-cv-00387-RJL Document 12 Filed 05/13/11 Page 4 of 5

THOMPSON HINE LLP

Dated: May 13, 2011 By: /s/ Eric Heyer


Kip Schwartz (D.C. Bar No. 444650)
Eric N. Heyer (D.C. Bar No. 500095)
1920 N Street, N.W., Suite 800
Washington, D.C. 20036
Telephone: (202) 331-8800
Fax: (202) 331-8330
kip.schwartz@thompsonhine.com
eric.heyer@thompsonhine.com

Counsel for Plaintiff Totally Wicked-


E.Liquid (USA), Inc.
Case 1:11-cv-00387-RJL Document 12 Filed 05/13/11 Page 5 of 5

CERTIFICATE OF SERVICE

I, Eric Heyer, hereby certify that on this 13th day of May, 2011, I caused the original of

the foregoing Notice of Voluntary Dismissal Without Prejudice to be electronically filed and

served via the Court's ECM/ECF system on the following:

Drake Cutini, Esq.


Office of Consumer Litigation
United States Department of Justice
P.O. Box 386
Washington, D.C. 20044

Counsel for Defendants

Dated: May 13, 2011 /s/ Eric Heyer


Eric N. Heyer (D.C. Bar No. 500095)
THOMPSON HINE LLP
1920 N Street, N.W., Suite 800
Washington, D.C. 20036
Telephone: (202) 331-8800
Fax: (202) 331-8330
eric.heyer@thompsonhine.com

You might also like