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Amicus Briefs

Cigar Association of America v. FDA

NCLA urges the U.S. Court of Appeals for the D.C. Circuit to reject the “remand without vacatur” doctrine, which allows administrative agencies to continue enforcing rules the court has just declared unlawful. The doctrine creates a legal category unknown to the law: Unlawful but enforceable rules.

The U.S. District Court for the District of Columbia concluded FDA’s Final Deeming Rule regulating tobacco products was “arbitrary and capricious” with respect to premium cigars because FDA failed to account for evidence regarding the potentially differential health effects between premium cigars and other tobacco products. This, the court decided, meant the agency acted “arbitrarily and capriciously” when it included premium cigars in the Final Deeming Rule, so the court set the rule aside to the extent it addresses those products. The FDA now asks the D.C. Circuit to either reverse the district court’s ruling, or at least allow it to continue enforcing the unlawful rule under the “remand without vacatur” doctrine while it considers its options.

Without taking a position on whether the FDA’s conduct was arbitrary and capricious, NCLA argues that the Administrative Procedure Act requires courts to set aside unlawfully promulgated rules. This duty necessarily follows from the basic principles underlying both the rule of law and the Constitution, which provide that our government has only powers it obtains with the “consent of the governed.”

“We the People” haven’t consented to the creation of arbitrary and capricious rules, and courts have no authority to grant that consent on our behalf—even temporarily—through the “remand without vacatur” doctrine. When a court concludes an administrative agency improperly promulgated a rule, it must be set aside. NCLA encourages the D.C. Circuit to uphold the rule of law by reinforcing the foundational principle that we should never countenance the enforcement of an unlawful rule.

John J. Vecchione
Senior Litigation Counsel
Daniel Kelly
Senior Litigation Counsel

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