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D.C. Circuit: E-Cigarettes Are Tobacco Products, Not Medical Devices

WASHINGTON, D.C. - (Mealey's) Electronic cigarettes, which deliver a dose of nicotine vapor without flame or smoke, are for regulatory purposes tobacco products, not medical devices, the District of Columbia Circuit U.S. Court of Appeals ruled Dec. 7 (Sottera, Inc., et al. v. U.S. Food and Drug Administration, et al., No. 10-5032, D.C. Cir.).

The court majority found that the Family Smoking Prevention and Tobacco Control Act of 2009 demonstrated that Congress meant any tobacco product to be regulated under that act unless the product had a claimed therapeutic purpose, in which case it is regulated under the federal Food, Drug, and Cosmetic Act (FDCA).  The court said the Tobacco Act, while addressing regulatory gaps identified in the U.S. Supreme Court's prohibition of tobacco regulation under the FDCA in FDA v. Brown & Williamson Tobacco Corp. (529 U.S. 120 [2000]), specifically does not expand the agency's FDCA power.

"The Tobacco Act itself states that it does not 'affect, expand, or limit' the FDA's jurisdiction to regulate products under the drug/device provisions of the FDCA, . . . and the district court and parties themselves appear to agree that the Tobacco Act did not expand the category of drugs, devices, and combination products subject to FDCA jurisdiction in the wake of Brown & Williamson," the court said.  "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," the majority said.

The opinion was by Senior Circuit Judge Stephen F. Williams, with Judge Brett M. Kavanaugh concurring and Judge Merrick B. Garland agreeing with the outcome for different reasons. 

Judge Garland said it is not necessary to invoke Brown & Williamson, which uses the term "tobacco product" to mean products containing tobacco and cannot be read to bar the regulation of a product category the Supreme Court never contemplated.  Instead, the judge said, the Tobacco Act itself encompasses e-cigarettes by stating that it regulates "any product made or derived from tobacco that is intended for human consumption." 

Two importers of e-cigarettes, Smoking Everywhere Inc. and Sottera Inc., doing business as NJOY, had sought an injunction to overturn the U.S. Food and Drug Administration's denial of entry to a shipment of their products.  Smoking Everywhere later voluntarily dismissed its underlying complaint without prejudice, mooting its appeal.

[Editor's Note:  Full coverage will be in the December issue of Mealey's Litigation Report: Tobacco.  In the meantime, the opinion is available at or by calling the Customer Support Department at 1-800-833-9844.  Document #04-101215-005Z.  For all of your legal news needs, please visit]

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For more information, call editor Michael Lefkowitz at 215-988-7732, or e-mail him at