The vapor industry has been dealing with the FDA’s Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, 81 Fed. Reg. 28,973 (May 10, 2016) (the “Deeming Rule”) for some time now. Is it constitutional?

Litigants in two cases challenging the constitutionality of the Deeming Rule have asked the Supreme Court to weigh in. The cases are Big Time Vapes, Inc., et al. v. FDA, et al., No. 20-850, and Moose Jooce, et al. v. FDA, et al., No. 20-1203.

Big Time Vapes

In Big Time Vapes, the challengers petitioned the Supreme Court for a writ of certiorari on December 18, 2020. The case involves the claim that the statute purportedly authorizing the Deeming Rule is an unconstitutional delegation of Congress’ legislative power.

  • The challenged statute provides that the Family Smoking Prevention and Tobacco Control Act “shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the [FDA] by regulation deems to be subject to this [Act].” 21 U.S.C. § 387a(b) (emphasis added).
  • Article I, § I of the Constitution provides that “[a]ll legislative Powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives.”

The challengers initiated their case in the U.S. District Court for the Southern District of Mississippi. The court granted the FDA’s motion to dismiss and denied the challengers’ motion for preliminary injunction, No. 1:19-cv-531 (S.D. Miss. Dec. 16, 2019), and the Fifth Circuit affirmed, No. 19-60921 (5th Cir. June 25, 2020).

Moose Jooce

On February 26, 2021, the Moose Jooce challengers filed their petition asking the Supreme Court to take up questions related to their challenge to the Deeming Rule under the “Appointments Clause” in Article II, § 2 of the Constitution:

  1. May a regulation be ratified if the Appointments Clause prohibited the purported agent’s exercise of rulemaking authority?
  2. If so, must the ratification comply with the constraints that would normally govern an officer’s rulemaking, such as the Administrative Procedure Act’s “reasoned decision-making” requirement?

According to the challengers, the authority to issue the Deeming Rule could only be exercised by a principal officer within the meaning of the Appointments Clause. The FDA’s Associate Commissioner for Policy issued the Deeming Rule and the FDA Commissioner later purported to ratify the Deeming Rule on two occasions. The district court and court of appeals held that these circumstances did not render the Deeming Rule invalid. Moose Jooce, et al. v. FDA, et al., Nos. 1:18-cv-203, 1:18-cv-1615, 1:19-cv-372 (D.D.C. Feb. 11, 2020), aff’d, Nos. 20-5048, -5049, -5050 (D.C. Cir. Dec. 1, 2020).


The FDA will have the opportunity to respond to the challengers’ petitions before the Supreme Court acts on them. Review “is not a matter of right, but of judicial discretion,” and the petitions “will be granted only for compelling reasons.” Sup. Ct. R. 10. Whatever the ultimate outcome of the litigation may be, in the meantime (at least) vapor businesses are still subject to the Deeming Rule.

We will continue to monitor for further developments.