Smoking Everywhere, Inc. v. U.S. Food and Drug Administration

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

SMOKING EVERYWHERE, INC., ) ) Plaintiff, ) ) and ) ) SOTTERA, INC., d/b/a NJOY, ) ) Intervenor-Plaintiff, ) ) v. ) Civil Case No. 09-771 (RJL) ) U.S. FOOD AND DRUG ) ADMINISTRATION, et at., ) ) Defendants. )

ORDER ~

For the reasons set forth in the Memorandum Opinion, it is this 11 day of

January, 2010, hereby

ORDERED that Smoking Everywhere's Motion for Temporary Restraining Order

and/or Injunctive Relief [#2], which the Court has converted to a Motion for Preliminary

Injunction (Minute Order dated May 1,2009), and NJOY's Motion for Preliminary

Injunction [#24] are GRANTED; it is further

ORDERED that FDA shall not detain or refuse admission into the United States

of Smoking Everywhere's electronic cigarette products on the ground that those products

are unapproved drugs, devices, or drug-device combinations under the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seq.; it is further

ORDERED that FDA shall not detain or refuse admission into the United States

ofNJOY's electronic cigarette products on the ground that those products are unapproved

drugs, devices, or drug-device combinations under the FDCA, absent a proffer of

evidence, consistent with the Court's Memorandum Opinion, that NJOY's products are

intended to have a therapeutic effect; it is further

ORDERED that the Combined Motion for Leave to Submit a Brief Amicus

Curiae and Brief Amicus Curiae in Support of Defendant FDA by Action on Smoking

and Health [#47] and Alliance of Electronic Smokers' Motion for Leave to Participate

and File Brief as Amicus Curiae [#49] are GRANTED; and it is further

ORDERED that the Motion ofIntervenor-Plaintiff Sottera, Inc. d/b/a NJOY for

Leave to File Reply to Defendants' September 17th Response to Proposed Amicus [#52]

and Plaintiff Smoking Everywhere, Inc.'s Motion for Leave to File Instanter a Status

Report Concerning Recent Events Which May Impact Plaintiffs Continued Existence

[#53] are DENIED.

SO ORDERED. ~

~l~N RlCHA .. EON United States District Judge