Overview

• The Supreme Court issued a 7-2 ruling overturning the FDA’s effort to centralize marketing denial challenges and allowing companies to select their preferred appeals court.
• Justice Amy Coney Barrett wrote the majority opinion enabling R.J. Reynolds and its retail partners to pursue review of the FDA’s Vuse Alto denial in the 5th U.S. Circuit Court of Appeals.
• Justices Ketanji Brown Jackson and Sonia Sotomayor dissented, arguing that only manufacturers have statutory standing to sue over FDA marketing denials.
• The 5th Circuit, which covers Louisiana, Mississippi and Texas, has a track record of decisions favorable to vaping firms, unlike the 4th and D.C. Circuits.
• The case returns to the lower courts, where R.J. Reynolds must still overcome substantive hurdles to gain approval for its flavored Vuse Alto products.