Venue for Flavored E-Cigarette Cases

ACS CAN worked with tobacco control partners in filing numerous amicus briefs supporting the Food and Drug Administration (FDA) in cases across the nation in which the agency issued marketing denial orders (MDOs) for flavored e-cigarette products as part of the premarket review process. FDA has won the majority of these challenges, and eight different circuit courts have upheld MDOs while only two circuits have vacated them. But notably, the full en banc panel of the US Court of Appeals for the Fifth Circuit ruled against FDA.

After the adverse ruling by the Fifth Circuit, manufacturers of flavored e-cigarettes all began to file their legal challenges to FDA's MDOs in that venue. FDA v. R.J. Reynolds Vapor Co. concerns where an e-cigarette manufacturer can properly sue to challenge an FDA MDO. The Tobacco Control Act allows "any person adversely affected" by a denial order to sue in the D.C. Circuit or the circuit in which the person resides or has its principal place of business. When Reynolds received denial orders for its menthol Vuse e-cigarettes, it did not sue in the D.C. Circuit or its home Fourth Circuit, both of which had previously upheld FDA MDOs for flavored e-cigarettes. Instead, Reynolds added retailers located in the Fifth Circuit that sold menthol Vuse and sued in that circuit; the court allowed them to do it. However, the Supreme Court granted FDA's petition to review the Fifth Circuit's venue holding. ACS CAN and tobacco control partners filed an amicus brief supporting the FDA.