SMOKING EVERYWHERE, INC. v. U.S. FOOD AND DRUG ADMINISTRATION et al

Filing 55

ORDER, For the reasons set forth in the Memorandum Opinion, it is this 14th 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 Mo tion 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 9;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 de tain or refuse admission into the United States of NJOY'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 th e 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 Ac tion 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 of Intervenor-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 Plaintiff's Continued Existence 53 are DENIED. SO ORDERED. Signed by Judge Richard J. Leon on 1/14/10. (kc) (see order.)