No. 10-5032.

627 F.3d 891 (2010)

SOTTERA, INC., doing business as NJOY, Appellee, v. FOOD & DRUG ADMINISTRATION, et al., Appellants.

United States Court of Appeals, District of Columbia Circuit.

Decided December 7, 2010.

Attorney(s) appearing for the Case

Alisa B. Klein , Attorney, U.S. Department of Justice, argued the cause for appellants. With her on the briefs were Ronald C. Machen, Jr. , U.S. Attorney, Mark B. Stern and Samantha L. Chaifetz , Attorneys, Ralph S. Tyler , Chief Counsel, United States Department of Health and Human Services, Eric M. Blumberg , Deputy Chief Counsel, and Karen E. Schifter , Associate Chief Counsel. Drake S. Cutini , Attorney, U.S. Department of Justice, entered an appearance.

William B. Schultz was on the brief for amici curiae American Academy of Pediatrics, et al. in support of appellants.

Gregory G. Garre argued the cause for appellee Sottera, Inc. With him on the brief were Richard P. Bress , John R. Manthei , and Jessica E. Phillips.

Deborah M. Shelton and Christopher M. Loveland were on the brief for amici curiae Smokefree Pennsylvania, et al. in support of appellee.

Daniel J. Popeo , Richard A. Samp , Coleen E. Klasmeier , and Rebecca K. Wood were on the brief for amicus curiae Washington Legal Foundation in support of appellee.

Opinion concurring in the judgment filed by Circuit Judge GARLAND.

WILLIAMS, Senior Circuit Judge:

Sottera, Inc., which does business as NJOY, is an importer and distributor of "electronic cigarettes" or "e-cigarettes," a product that enables users to inhale vaporized nicotine. The question before us is whether Congress has authorized the Food and Drug Administration ("FDA") to regulate e-cigarettes under the drug/device provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 351 et seq., or under...

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