An e-cigarette manufacturer and trade association challenged the deeming rule on constitutional grounds.

Why It Matters for Public Health

This case is yet another challenge to the deeming rule, which established FDA’s regulatory authority over e-cigarettes, cigars, hookah, and other tobacco products. This case challenges the agency’s authority to “deem” tobacco products not listed in the 2009 Tobacco Control Act subject to its authority. While the challenge has been unsuccessful so far, the ongoing litigation illustrates the industry’s tendency to take a “kitchen sink” approach to litigation and tendency to challenge all aspects of tobacco regulation.


The Tobacco Control Act gives FDA authority to “deem” any tobacco products subject to its authority. On May 5, 2016, the FDA issued the final rule deeming all existing and future tobacco products to be subject to the agency’s jurisdiction, including e-cigarettes.

District Court Proceedings

On August 19, 2019, Big Time Vapes, Inc. and United States Vaping Association, Inc., an e-cigarette manufacturer and an e-cigarette trade association, filed suit in the Southern District of Mississippi.

The lawsuit alleged that the Tobacco Control Act’s delegation of authority to the FDA to deem additional tobacco products within its regulatory authority violates Article I of the U.S. Constitution. The plaintiffs sought judgment that the Tobacco Control Act's delegation of authority to the FDA is invalid.

On October 10, 2019, the plaintiffs filed a motion for a preliminary injunction. On November 6, 2019, the FDA filed its response to the motion for a preliminary injunction and a motion to dismiss. On December 13, 2019, the FDA filed notice of the D.C. Circuit’s decision in Nicopure. Shortly thereafter, on December 16, 2019, the court denied the plaintiffs’ motion for a preliminary injunction and granted the government’s motion to dismiss based on the ruling in Nicopure.

Proceedings in the Court of Appeals for the Fifth Circuit

On December 17, 2019, Big Time Vapes filed a notice of appeal in the Court of Appeals for the 5th Circuit. Briefing occurred between February and April of 2020.

On June 25th, 2020, the Court of Appeals issued its opinion, finding that Congress’ delegation of authority to the Secretary of Health and Human Services to deem additional products subject to the Tobacco Control Act is not unconstitutional, upholding the district court’s decision.

Litigation Status

The industry plaintiffs filed a petition for writ of certiorari with the U.S. Supreme Court on December 18, 2020. The Supreme Court denied the petition on June 7, 2021, meaning the case is now closed.

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