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D.C. Circuit Court Upholds FDA Regulation of E-Cigarettes

Anjelica Cappellino, J.D.

Written by
— Updated on April 5, 2021

D.C. Circuit Court Upholds FDA Regulation of E-Cigarettes

The regulation of electronic cigarettes—often called e-cigarettes—has yet again come before the federal appeals court. Last week, a unanimous panel of the D.C. Circuit U.S. Court of Appeals ruled that the U.S. Food and Drug Administration had the authority to regulate the sale of e-cigarettes. This decision rejects the argument that such regulation violated the U.S. Constitution’s Appointments Clause and the First Amendment. The decision affirms the district court’s granting of the FDA’s summary judgment motion. The lawsuit, Moose Jooce et al v. FDA, 20-5048 (D.C. Cir.), was filed by a group of shops that sell e-cigarettes (vape shops) as well as manufacturers of the liquid used in the product. Represented by the Pacific Legal Foundation, a conservative legal group, the plaintiffs are considering their next steps.

Case Background

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (TCA) which issued additional regulation on all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Act authorizes the Secretary of the Department of Health and Human Services “to regulate the manufacturer, sale, and distribution of” tobacco products, the definition of which is subject to the Act’s requirements. The Secretary, in turn, delegated this rulemaking authority to the FDA Commissioner. This authority was then redelegated to the FDA’s Associate Commissioner for Policy. On this authority, in 2016, the FDA’s Associate Commissioner for Policy, Leslie Kux, issued regulations that electronic cigarettes, among others, were deemed to be tobacco products subject to the agency’s authority and various manufacturing, sales, and marketing requirements.

The plaintiffs sued the FDA on the basis that Kux’s issuance of the rule violated the Appointments Clause of the U.S. Constitution, explaining that Kux was not appointed by the President “by and with the Advice and Consent of the Senate.” U.S. CONST. art. II. § 2, cl. 2. Pursuant to the clause, Congress may vest the appointment of “inferior Officers” to the president alone. The plaintiffs argued that Kux was not appointed as either an inferior or principal officer. The FDA challenged the argument, noting that two FDA Commissioners had ratified Kux’s rule but the district court rejected the plaintiffs’ arguments.

Appeal to the D.C. Circuit Court

This decision was later affirmed by the D.C. Circuit Court on the basis that ratification by FDA Commissioner Dr. Scott Gottlieb, M.D. effectively cured any potential defects in Kux’s rule-making authority. As stated in Gottlieb’s April 3, 2019 ratification: I hereby affirm and ratify the Deeming Rule [Kux’s rule]…based on my careful review of the rule, my knowledge of its provisions, and my close involvement in policy matters relating to this rule and its implementation, as well as its public health importance.” The appeals court found that Gottlieb’s ratification was neither arbitrary nor capricious and that “nothing in the record” indicated that he failed “to conduct an independent evaluation of the merits,” as required by laws governing ratification.

The First Amendment violations raised by the plaintiffs, namely, that their rights to free speech were violated by the advanced approval requirements of their advertising, were foreclosed because the FDA previously prevailed on the same issue in a prior case. Therefore, the FDA’s motion for summary judgment was granted and affirmed, as it continues to regulate e-cigarettes as it would other tobacco products.

As the Circuit Court notes at the beginning of its decision, the e-cigarette industry has previously challenged its classification as a “tobacco product” subject to the TCA. Less than a year ago, the court rejected three such challenges, holding that it is “entirely rational and nonarbitrary” for the FDA to require that e-cigarettes meet the TCA’s requirements concerning baseline public health issues.

Regulatory Disputes Continue

The D.C. Circuit Court is yet another circuit court that has affirmed the holding that the FDA has the authority to regulate e-cigarettes. In August 2019, Big Tim Vapes Inc. and the United States Vaping Association Inc. sued the FDA in Mississippi’s federal district court, alleging that the FDA’s authority to regulate e-cigarettes was invalid. Specifically, they claimed that the TCA unconstitutionally delegated authority to the Secretary of Health and Human Services. The district court denied their request for an injunction, which was affirmed by the Fifth Circuit Court of Appeals. As the Fifth Circuit found, the delegation of authority is constitutional if Congress “lay[s] down by legislative act an intelligible principle to which the person or body authorized [to exercise the authority] is directed to conform,” and if Congress “constitutionally sufficient if Congress clearly delineates the general policy, the public agency which is to apply it, and the boundaries of th[e] delegated authority.”

If past litigation is any indicator, it is likely the relationship between the FDA and the e-cigarette industry will continue to be challenged.

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