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