Sottera, Inc. v. Food & Drug Admin.

In April of 2009, Sottera, Inc., an importer and distributor of electronic cigarettes (“e-cigarettes”), sought a preliminary injunction barring the FDA from denying their products entry into the United States. E-cigarettes are “battery powered products that allow users to inhale nicotine vapor without fire, smoke, ash, or carbon monoxide.”[1] The nicotine in each e-cigarette is derived from tobacco plants. The FDA denied Sottera’s e-cigarette shipments entry into the U.S., asserting that e-cigarettes were unapproved drug-device combinations subject to their authority under the Federal Food, Drug, and Cosmetic Act (“FDCA”).[2] The FDCA gives the FDA authority to regulate drugs, devices, or drug/device combinations.

In 2000, the Supreme Court decided in FDA v. Brown & Williamson, that the FDA did not have the FDCA authority to regulate tobacco products as customarily marketed, meaning tobacco products marketed without claims of therapeutic effect.[3] In 2009, the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) finally gave the FDA the authority to regulate customarily marketed tobacco products. The Tobacco Act defines tobacco products to include “all consumption products derived from tobacco except articles that qualify as drugs, devices, or drug-device combinations under the FDCA.”[4]

Sottera relied on Brown & Williamson to argue that e-cigarettes should be considered customarily marketed tobacco products such that the FDA has no authority under the FDCA to deny their products entry into the United States.[5] The FDA asserts that Brown & Williamson barred the FDA from regulating only those tobacco products that existed at the time the case was decided, and that e-cigarettes are properly regulated by the FDCA as a drug/device combination.[6]

The United States District Court for the District of Columbia granted a preliminary injunction barring the FDA from regulating e-cigarettes as drug/device products.[7] The Court held that Brown & Williamson precluded the FDA from treating e-cigarettes as a drug/device combination because e-cigarettes were customarily marketed tobacco products.

The D.C. Court of Appeals affirmed the District Court’s injunction barring the FDA from regulating e-cigarettes under the FDCA. The court held that e-cigarettes should be regulated as tobacco products under the Tobacco Act. The Court of Appeals stated that the holding in Brown & Williamson extended to all customarily marketed tobacco products.[8] Additionally, the court noted that the Tobacco Act specifically states that it does not “affect, expand, or limit” the FDA’s jurisdiction under the FDCA.[9] The Court of Appeals stated that,

 Together, Brown & Williamson and the Tobacco Act establish that the FDA cannot regulate customarily marketed tobacco products under the FDCA’s drug/device provisions, that it can regulate tobacco products marketed for therapeutic purposes under those provisions, and that it can regulate customarily marketed tobacco products under the Tobacco Act.[10]

 Thus, the Court of Appeals sided with Sottera, holding that e-cigarettes are customarily marketed tobacco products subject to FDA authority under the Tobacco Act, not the FDCA.

The FDA indicated it will not appeal the decision and will move forward with e-cigarette regulation through the Center for Tobacco Products.