Smoking Everywhere v. Food & Drug Administration

Two electronic cigarette distributors sued the Food and Drug Administration (FDA) to stop the agency from blocking shipment of their products into the U.S. The FDA prohibited entry of the shipments because they believed the e-cigarettes were unapproved “drug-device” combinations. The court granted the e-cigarette companies’ request for a preliminary injunction prohibiting the FDA from refusing entry of the e-cigarette products or from regulating e-cigarettes as a drug-device combination. The court believed that the FDA was not likely to succeed in regulating the e-cigarettes as a drug-device combination. Instead, the court said that e-cigarettes are more likely subject to FDA regulation as a tobacco product under the 2009 Family Smoking Prevention and Tobacco Control Act, unless the e-cigarettes are marketed for therapeutic use. Additionally, the e-cigarette companies were entitled to a preliminary injunction because of the risk of irreparable financial harm if their products were not allowed to enter the U.S.


Smoking Everywhere, Inc. v. U.S. Food and Drug Admin., 680 F.Supp.2d 62 (2010).

  • United States
  • Jan 14, 2010
  • U.S. District Court, District of Columbia



  • Smoking Everywhere, Inc.
  • Sottera, Inc., d/b/a NJOY


  • Kathleen Sebelius, HHS Secretary
  • Margaret Hamburg, FDA Commissioner
  • U.S. Department of Health and Human Services
  • U.S. Food and Drug Administration

Legislation Cited

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product