Big Time Vapes, Inc., et al. v. U.S. Food and Drug Administration (2019)

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No. 1:19-cv-00531 (S.D. Miss.)
No. 19-60921 (5th Cir. Dec 18, 2019)

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 alleges 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 seek judgment declaring 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. The plaintiffs reply regarding their motion for a preliminary injunction was filed on November 13, 2019. The plaintiffs filed their response to the FDA’s motion to dismiss on November 20, 2019. On December 13, 2019, the FDA filed notice of the D.C. Circuit’s decision in Nicopure. Shortly thereafter, on December 16, the court denied the plaintiffs’ motion for a preliminary injunction and granted the government’s motion to dismiss based on the ruling in Nicopure. On December 17, 2019, Big Time Vapes filed a notice of appeal in 5th Circuit Court of Appeals. The appellants’ opening brief was filed on February 19, 2020, and the FDA filed its brief on March 19, 2020. The appellants’ reply was filed on April 9, 2020.

On June 25th, 2020, the 5th Circuit 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.