American Journal of Law & Medicine

D.C. Circuit rules FDA cannot block e-cigarette imports - Sottera, Inc. v. FDA.

D.C. Circuit Rules FDA Cannot Block E-cigarette Imports--Sottera, Inc. v. FDA (1)--The United States Court of Appeals for the District of Columbia Circuit held that the Food and Drug Administration's (FDA) authority to regulate electronic cigarettes (e-cigarettes) derives from the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Act), (2) rather than from the Federal Food, Drug, and Cosmetic Act (FDCA); (3) thus the FDA lacks the authority to ban the importation of e-cigarettes into the United States.

E-cigarettes are smokeless, flameless, battery-powered devices that vaporize liquid nicotine for the user to inhale. (4) While the nicotine in e-cigarettes is derived from tobacco, the e-cigarette itself contains no tobacco. (5) E-cigarettes thus allow the user to satisfy a nicotine craving without ingesting the harmful chemicals contained in traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. (6)

The plaintiff-appellee, Sottera, Inc. (Sottera), is an importer and distributor of e-cigarettes in the United States. (7) On April 15, 2009, the defendant-appellant, the FDA, blocked a shipment of Sottera's e-cigarettes from importation into the United States. (8) Sottera filed for a preliminary injunction in the United States District Court for the District of Columbia to bar the FDA from regulating e-cigarettes as drug-device combination products under the FDCA and from blocking their importation into the United States. (9)

In blocking the imports, the FDA claimed that e-cigarettes were "adulterated, misbranded, or unapproved drug-device combinations," thereby falling within the FDA's broad regulatory authority over medical devices pursuant to the FDCA, much like nicotine gums and patches. (10) In seeking an injunction against the FDA, Sottera claimed that e-cigarettes were merely tobacco products and, relying on the Supreme Court's holding in FDA v. Brown & Williamson Tobacco Corp., (11) argued that the FDA lacked authority under the FDCA to regulate tobacco products, except those that are marketed with claims of therapeutic effects. (12) Sottera argued that because e-cigarettes serve the same purpose as traditional tobacco cigarettes and are marketed without therapeutic claims, they should be regulated under the Tobacco Act alongside traditional tobacco cigarettes. …

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