E-Cigarettes: Drug-device combo or mere tobacco product?

Since the fall of 2008, the U.S. Food and Drug Administration has routinely refused to allow the importation of electronic cigarettes, or “e-cigarettes,” into this country. A recent opinion might require a change of that policy. In Smoking Everywhere, Inc. v. U.S. Food & Drug Admin, No. 09-771(RJL), 2010 WL 129667 (D.D.C. Jan. 14, 2010), the U.S. District Court for the District of Columbia granted the Plaintiffs’ request for a preliminary injunction prohibiting the FDA from denying entry of e-cigarettes into the United States and from regulating e-cigarettes as a drug-device combination.

The plaintiffs in this action, Smoking Everywhere, Inc. and Sottera, Inc., are importers and distributors of e-cigarettes. These products are designed “to replicate the adult experience of smoking without combustion or the use of cancerous by-products.”Id. at *1. They import their products from manufacturers located overseas. However, their shipments were denied entry into the United States by the FDA on the basis that the shipments “appear to be adulterated, misbranded or otherwise in violation” of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. Id. at *2.

Due to the action’s procedural posture, the court analyzed the likelihood of the Plaintiffs’ success on the merits, whether the Plaintiffs would suffer irreparable injury were an injunction not to be granted, and whether an injunction would further the public’s interest. Id. at *3. The court’s analysis required it to consider federal tobacco legislation, the FDCA, and the landmark decision of U.S. Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), wherein the Supreme Court held that tobacco products were not subject to FDA regulation as a drug or device.

The Smoking Everywhere court rejected the FDA’s arguments that the term “tobacco product” should be narrowly defined and that e-cigarettes were drug-device combinations. The court stressed that due to the marketing of the e-cigarettes “for customary recreational use, those products (just like traditional cigarettes) are properly excluded from the meaning of drug or device under the FDCA.” Id. at *8. As such, the court determined that the Plaintiffs were “substantially likely to succeed on their claim that the FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA.” Id. The court also determined that the Plaintiffs had suffered irreparable harm due to the FDA’s refusal to allow the importation of their e-cigarette shipments. Id. at *10. In the court’s final analysis, the factors weighed in the Plaintiffs’ favor, and therefore, the court granted the Plaintiffs’ request for an order enjoining the FDA from refusing admission into the U.S. e-cigarettes on the basis that such products are unapproved drugs, devices or drug-device combinations under the FDCA.