“ORDER, For the reasons set forth in the Memorandum Opinion, it is this 14th day of January, 2010,
hereby ORDERED that Plaintiff Motion for Temporary Restraining Order and/or Injunctive relief , which the Court has converted to a Motion for Preliminary Injunction (Minute Order dated May 1, 2009), and Plaintiff’s Motion for Preliminary Injunction are GRANTED; it is further ORDERED that FDA shall not detain or refuse admission into the United States of Plaintiff’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 of Plaintiff’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 Plaintiff’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 and Alliance of Electronic Smokers’ Motion for Leave to Participate and File Brief as Amicus Curiae are GRANTED; and it is further ORDERED that the Motion of Intervenor-Plaintiff Sottera, Inc. d/b/a PLANTIFF for leave to File Reply to Defendants’ September 17th Response to Proposed Amicus and Plaintiff Motion for Leave to File Instanter a Status Report Concerning Recent Events Which May Impact Plaintiff’s Continued Existence are DENIED.
SO ORDERED. Signed by Judge Richard J. Leon on 1/14/10.
“FDA contends that the public interest in health and safety weighs in favor of denying preliminary relief because, by enforcing the FDCA as it sees fit, FDA protects the public from unsafe and ineffective drugs. FDA further contends that the potential harm to other interested parties or to the public interest, should the court grant the preliminary injunction and allow the unapproved electronic cigarettes into the market, would far outweigh the economic harm to plaintiffs, should the court deny the preliminary injunction.”
(Judge Leon Reply)
“I disagree. While FDA’s interest in protecting public health and safety is, in the abstract, paramount to plaintiffs’ purely economic interests, given the particular facts and circumstances of this case, I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Plaintiff’s have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health”
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