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SMOKING EVERYWHERE, INC. v. U.S. FOOD AND DRUG ADMINISTRATION et al: Docket Report ($$) 

04/28/2009 1 COMPLAINT against U.S. FOOD AND DRUG ADMINISTRATION, JOSHUA M. SHARFSTEIN, MARGARET HAMBURG, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, CHARLES JOHNSON, KATHLEEN SEBELIUS ( Filing fee $ 350, receipt number 4616020180) filed by SMOKING EVERYWHERE, INC.. (Attachments: # 1 Civil Cover Sheet)(td, ) (Entered: 04/28/2009)

04/28/2009 2 MOTION for Temporary Restraining Order and/or injunctive relief by SMOKING EVERYWHERE, INC. (td, ) (Entered: 04/28/2009) . . .

05/01/2009 MINUTE ORDER. Based on a conference today with counsel for both parties, the Court will treat plaintiff's 2 motion for a temporary restraining order as a motion for a preliminary injunction. The following briefing schedule shall apply: defendants' response to plaintiff's motion due by close of business 5/11/2009; plaintiff's reply due by close of business 5/14/2009. A hearing on plaintiff's motion is set for 5/15/2009 4:00 pm in Courtroom 18. Defendants' 8 motion to establish briefing schedule for preliminary injunction is DENIED as moot. Signed by Judge Richard J. Leon on 5/1/2009.(lcrjl1) (Entered: 05/01/2009)

05/04/2009 Set/Reset Deadlines/Hearings: Defendants' response to plaintiffs' motion due by COB 5/11/2009. Plaintiff's reply due by COB 5/14/2009. Motion Hearing set for 5/15/2009 at 04:00 PM in Courtroom 18 before Judge Richard J. Leon. (kc) (Entered: 05/04/2009)

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1:09-cv-00771-RJL SMOKING EVERYWHERE, INC. v. U.S. FOOD AND DRUG ADMINISTRATION et al: History ($$) 

10

Filed & Entered: 04/30/2009

Docket Text Memorandum in Opposition

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Filed & Entered: 05/01/2009

Docket Text Order on Motion for Order

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Filed & Entered: 05/04/2009

Docket Text Set/Reset Deadlines/Hearings

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1:09-cv-00771-RJL SMOKING EVERYWHERE, INC. v. U.S. FOOD AND DRUG ADMINISTRATION et al: Case Summary ($$) 

Richard J. Leon, presiding

Date filed: 04/28/2009

Date of last filing: 05/04/2009

Case Summary

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• Electronic Cigarette VS FDA 

Smoking Everywhere, Inc. filed a federal complaint today seeking an injunction against the FDA with respect to the FDA's recent attempts to ban the import of Electronic Cigarettes. The company believes the use of inhaled nicotine in a form and purpose similar to traditional smoked tobacco cigarettes is outside of FDA's jurisdiction under the Federal Food Drug and Cosmetic Act. The Supreme Court of the United States determined in 2000 that the FDA lacked authority under the FDCA to regulate traditional tobacco cigarettes as a drug/medical device combination and it is Smoking Everywhere's position that the same legal rationale should apply to its electronic cigarette product.

United States District Court for the District of Columbia Smoking Everywhere, Inc. vs. U.S. Food and Drug Administration Case no 09-cv-0771

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• SULLUM: FDA to Ban Electronic Cigarettes - 

Bill Godshall of Smokefree Pennsylvania reports in a mass email message that the Food and Drug Administration plans to proceed with a ban on electronic cigarettes, devices that deliver nicotine vapor without tobacco or combustion products. Godshall reproduces the following message from Heather Zawalick of the FDA's Office of Legislation, which says the agency will announce enforcement actions against the three largest e-cigarette distributors on Tuesday:

Subject/Headline: FDA Takes Enforcement Action on Electronic Smoking Products

Planned Release Date: May 5

Driving Event: Compliance action

Rollout Plan: Extensive rollout planned including press conference at HHS, press release, fact sheet, video for upload to YouTube, podcast, consumer article, consumer Q &A, key message points, internal media Q & A, Op-Ed, photos of products for posting on Internet.

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• FDA Sued Over Electronic Cigarette Embargo 

A Florida company that imports and distributes so-called electronic cigarettes has filed suit yesterday against the Food and Drug Administration, claiming the agency is illegally blocking imports of its product into the United States.

The suit, filed by Smoking Everywhere in the U.S. District Court for the District of Columbia, argues that the FDA has overstepped its regulatory authority by banning shipments of the devices and insisting they need to go through the drug approval process. . . .

Smoking Everywhere’s lawyers from Thompson Hine point out that in 2000, the Supreme Court ruled that the FDA did not have the power to regulate ordinary cigarettes. Therefore, it shouldn’t be allowed to clamp down on their high tech counterparts, the lawyers argue.

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