MAGELLAN TECHNOLOGY, INC. v. UNITED STATES FDA

No. 21-2426. August Term 2022.

70 F.4th 622 (2023)

MAGELLAN TECHNOLOGY, INC., Petitioner, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Respondent.

United States Court of Appeals, Second Circuit.

Decided: June 16, 2023.


Attorney(s) appearing for the Case

Eric N. Heyer ( Joseph A. Smith , Jessica Tierney , on the brief), Thompson Hine LLP, Washington, D.C., for Petitioner Magellan Technology, Inc.

David H. Hixson , Trial Attorney, Consumer Protection Branch ( Brian M. Boynton , Principal Deputy Assistant Attorney General, Civil Division, Arun G. Rao , Deputy Assistant Attorney General, Civil Division, Gustav W. Eyler , Director, Consumer Protection Branch, Hilary K. Perkins , Assistant Director, Consumer Protection Branch, on the brief), U.S. Department of Justice, Washington, D.C. ( Samuel R. Bagenstos , General Counsel, U.S. Department of Health and Human Services, Wendy S. Vicente , Acting Deputy Chief Counsel for Litigation, U.S. Food and Drug Administration, William D. Thanhauser , Associate Chief Counsel, Office of the Chief Counsel, U.S. Food and Drug Administration, Silver Spring, MD, of counsel), for Respondent United States Food and Drug Administration.

J. Gregory Troutman , Troutman Law Office, PLLC, Louisville, KY, for Amici Curiae 38 National and State Electronic Nicotine Delivery System Product Advocacy Associations, in support of Petitioner.

Mary G. Bielaska , Zanicorn Legal PLLC, New York, NY, for Amici Curiae Dr. David B. Abrams, Clive D. Bates, and Professor David T. Sweanor, in support of Petitioner.

Shawn Naunton , Zuckerman Spaeder LLP, New York, NY, for Amici Curiae Medical and Public Health Groups, in support of Respondent.

Before: Jacobs, Pérez, and Merriam, Circuit Judges.


This case concerns the United States Food and Drug Administration's (the "FDA") efforts to regulate electronic nicotine delivery systems ("ENDS") products, more commonly known as e-cigarettes. ENDS are a relatively new type of tobacco product that deliver aerosolized liquid containing nicotine derived from tobacco...

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