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 won the majority of these challenges, with  eight different circuit courts upholding MDOs while only two circuits vacated them. But notably, the full en banc panel of the US Court of Appeals for the Fifth Circuit ruled against FDA in the case of FDA v. Wages and White Lion Investments.

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. concerned 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; that court allowed them to do it. The US 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.

Subsequently, the Supreme Court overruled the Fifth Circuit’s FDA v. Wages and White Lion decision, upholding the agency’s MDOs and its scientific review of the products at issue.  This 9-0 victory for public health means the Fifth Circuit no longer has a precedent that creates a more favorable venue for e-cigarette manufacturers in these cases.  Although the agency ended up losing FDA v. R.J. Reynolds, the impact of that ruling should be limited given the larger win in Wages and White Lion.