March 2009: FDA adds electronic cigarettes to Import Alert 66-41 and directed the USCBP to reject the entry of electronic cigarettes into the United States.
FDA Law Blog: FDA Explains the Import Alert Process in Electronic Cigarette Company Suit
March 2009: FDA notifies Smoking Everywhere that their shipments have been refused entry into the U.S. The FDA purports that electronic cigarettes "appears to be a combination drug-device product that requires preapproval, registration and listing with the FDA."
April 2009: Smoking Everywhere files a federal complaint seeking an injunction against the FDA with respect to the FDA's attempts to ban the import of Electronic Cigarettes. Smoking Everywhere contends that the FDA has no authority over electronic cigarettes, as they are a "tobacco product" and the FDA's attempt to regulate them infringes on Congress's intent to withhold FDA jurisdiction over tobacco products. They contend that electronic cigarettes are not "drugs," "drug delivery systems," or "drug device combinations" under 21 U.S.C 321(g).
http://www.casaa.org/files/smoking-everywhere---complaint.pdf
May 2009: NJOY joins Smoking Everywhere lawsuit against FDA
May 2009: FDA files a brief in opposition to Smoking Everywhere's motion
http://www.casaa.org/files/FDA%20brief%20in%20opposition.pdf
May 2009: FDA tests 2 brands of electronic cigarettes, NJOY & Smoking Everywhere. 18 cartridges are tested. Tests reveal trace amounts of tobacco-specific nitrosamines, which may cause cancer in large amounts. One cartridge contains approx. 1% diethylene glycol, a potentially toxic substance. Cartridges labeled as 0mg nicotine are shown to contain nicotine.
http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf
July 2009: FDA files a supplemental brief, in the Smoking Everywhere lawsuit, referencing the Family Smoking Prevention and Tobacco Control Act. The FDA contends that it still has authority over electronic cigarettes and they stand behind the decision to label it a drug-device combination and that the "FDA found, after examining the product, the claims made in the product labeling, and information SE submitted to FDA, that SE's product met the definition of both a drug and device under the FDCA."
U S Food and Drug Administration Supplimental Brief
July 2009: Two months after testing, the FDA issues a press release discouraging the use of electronic cigarettes and repeating previously stated concerns that electronic cigarettes may be marketed to young people, lack appropriate health warnings and that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.
Electronic Cigarette Statement
July 2009: FDA's May 2009 study is reviewed by scientific consulting firm Exponent, Inc., in a report commissioned by NJOY. Some of the criticisms in Exponent's report are poor standards of documentation and analysis and failure to perform relevant comparisons to FDA-approved nicotine replacement therapy products, which Exponent claims contain TSNA levels comparable to those of electronic cigarettes. The study concludes that the FDA's claims of potential adverse health effects were not supported by the study.
http://www.casaa.org/files/Exponent Response-to-the-FDA-Summary.pdf
August 2009: John Banzhaf of Action on Smoking and Health, files an Amicus Brief with the court; Smoking Everywhere files in opposition
http://www.casaa.org/files/ASH Amicus Brief.pdf
September 2009: The Alliance of Electronic Smokers (an ad hoc group) files an Amicus Brief
http://www.e-cigarette-forum.com/fo...alliance-electronic-smokers-amicus-brief.html
January 2010: Judge Leon grants the injunction sought by Smoking Everywhere
http://www.casaa.org/files/SE-vs-FDA-Ruling.pdf
http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf
March 2010: Appeallate Court grants the FDA's request for a stay and denies Smoking Everywhere/Njoy's motion to strike pending appeal
Smoking Everywhere, Inc., et al., Appellees v. Food & Drug Administration, et al., Appellants (PDF) ($$)
March 2010: The American Association of Public Health Physicians submits two Citizen Petitions to the FDA, one asking for reclassification of e-cigarettes to 'tobacco product' and the other asking for a follow up statement to the July 2009 press conference.
http://www.casaa.org/files/FDA-2010-P-0095-0001[1].pdf
http://www.casaa.org/files/Citizen ... 22 2009 Press Conference on E Cigarettes.pdf
April 2010: Washington Legal Foundation files intent to participate as amicus curiae in opposition to the FDA
April 2010: The American Academy of Pediatrics, American Cancer Action Network, AHA, ALA, American legacy Foundation, AMA, Campaign for Tobacco-free Kids, AND Public Citizen file a motion requesting to participate as amicus curiae in support of the FDA.
September 2010: Oral arguments are scheduled to be held this month in the U.S. Court of Appeals
Watch for more updates - we'll post them right here in this first post, so you don't have to search for them!
FDA Law Blog: FDA Explains the Import Alert Process in Electronic Cigarette Company Suit
March 2009: FDA notifies Smoking Everywhere that their shipments have been refused entry into the U.S. The FDA purports that electronic cigarettes "appears to be a combination drug-device product that requires preapproval, registration and listing with the FDA."
April 2009: Smoking Everywhere files a federal complaint seeking an injunction against the FDA with respect to the FDA's attempts to ban the import of Electronic Cigarettes. Smoking Everywhere contends that the FDA has no authority over electronic cigarettes, as they are a "tobacco product" and the FDA's attempt to regulate them infringes on Congress's intent to withhold FDA jurisdiction over tobacco products. They contend that electronic cigarettes are not "drugs," "drug delivery systems," or "drug device combinations" under 21 U.S.C 321(g).
http://www.casaa.org/files/smoking-everywhere---complaint.pdf
May 2009: NJOY joins Smoking Everywhere lawsuit against FDA
May 2009: FDA files a brief in opposition to Smoking Everywhere's motion
http://www.casaa.org/files/FDA%20brief%20in%20opposition.pdf
May 2009: FDA tests 2 brands of electronic cigarettes, NJOY & Smoking Everywhere. 18 cartridges are tested. Tests reveal trace amounts of tobacco-specific nitrosamines, which may cause cancer in large amounts. One cartridge contains approx. 1% diethylene glycol, a potentially toxic substance. Cartridges labeled as 0mg nicotine are shown to contain nicotine.
http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf
July 2009: FDA files a supplemental brief, in the Smoking Everywhere lawsuit, referencing the Family Smoking Prevention and Tobacco Control Act. The FDA contends that it still has authority over electronic cigarettes and they stand behind the decision to label it a drug-device combination and that the "FDA found, after examining the product, the claims made in the product labeling, and information SE submitted to FDA, that SE's product met the definition of both a drug and device under the FDCA."
U S Food and Drug Administration Supplimental Brief
July 2009: Two months after testing, the FDA issues a press release discouraging the use of electronic cigarettes and repeating previously stated concerns that electronic cigarettes may be marketed to young people, lack appropriate health warnings and that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.
Electronic Cigarette Statement
July 2009: FDA's May 2009 study is reviewed by scientific consulting firm Exponent, Inc., in a report commissioned by NJOY. Some of the criticisms in Exponent's report are poor standards of documentation and analysis and failure to perform relevant comparisons to FDA-approved nicotine replacement therapy products, which Exponent claims contain TSNA levels comparable to those of electronic cigarettes. The study concludes that the FDA's claims of potential adverse health effects were not supported by the study.
http://www.casaa.org/files/Exponent Response-to-the-FDA-Summary.pdf
August 2009: John Banzhaf of Action on Smoking and Health, files an Amicus Brief with the court; Smoking Everywhere files in opposition
http://www.casaa.org/files/ASH Amicus Brief.pdf
September 2009: The Alliance of Electronic Smokers (an ad hoc group) files an Amicus Brief
http://www.e-cigarette-forum.com/fo...alliance-electronic-smokers-amicus-brief.html
January 2010: Judge Leon grants the injunction sought by Smoking Everywhere
http://www.casaa.org/files/SE-vs-FDA-Ruling.pdf
http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf
March 2010: Appeallate Court grants the FDA's request for a stay and denies Smoking Everywhere/Njoy's motion to strike pending appeal
Smoking Everywhere, Inc., et al., Appellees v. Food & Drug Administration, et al., Appellants (PDF) ($$)
March 2010: The American Association of Public Health Physicians submits two Citizen Petitions to the FDA, one asking for reclassification of e-cigarettes to 'tobacco product' and the other asking for a follow up statement to the July 2009 press conference.
http://www.casaa.org/files/FDA-2010-P-0095-0001[1].pdf
http://www.casaa.org/files/Citizen ... 22 2009 Press Conference on E Cigarettes.pdf
April 2010: Washington Legal Foundation files intent to participate as amicus curiae in opposition to the FDA
April 2010: The American Academy of Pediatrics, American Cancer Action Network, AHA, ALA, American legacy Foundation, AMA, Campaign for Tobacco-free Kids, AND Public Citizen file a motion requesting to participate as amicus curiae in support of the FDA.
September 2010: Oral arguments are scheduled to be held this month in the U.S. Court of Appeals
Watch for more updates - we'll post them right here in this first post, so you don't have to search for them!
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