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FDA E-Cig Rule Constitutional Despite Challenged Official’s Role

Dec. 1, 2020, 5:42 PM

Former FDA Commissioner Scott Gottlieb effectively ratified a rule subjecting electronic cigarettes and other tobacco products to the same requirements as conventional cigarettes, eliminating any potential constitutional problem with the rule’s original approval by a lower-ranking official, the D.C. Circuit said Tuesday.

And a First Amendment challenge to the rule is foreclosed because the Food and Drug Administration prevailed on the issue in a prior case, Judge Judith W. Rogers said for the U.S. Court of Appeals for the District of Columbia Circuit.

Moose Jooce and several other e-cigarette makers and retailers, along with nonprofit group Tobacco Harm Reduction 4 Life, sued the agency over its 2016 rule “deeming” certain products to be “tobacco products” subject to the FDA’s authority.

They argued the rule’s issuance by Leslie Kux, then the FDA’s associate commissioner for policy, violated the U.S. Constitution’s Appointments Clause. Kux wasn’t appointed as either an inferior or principal officer, making the rule she issued void from the beginning, they said.

But Gottlieb ratified the rule in April 2019 amid litigation over Kux’s authority, according to the court. “I undertake this action 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,” Gottlieb said.

The timing wasn’t a problem under D.C. Circuit precedent, Rogers said for the appellate panel. And Gottlieb’s ratification after three years without considering additional evidence wasn’t arbitrary and capricious, she said.

The challengers also argued that subjecting e-cigarettes to advance approval requirements for “modified risk” advertising violated their free speech rights because it put the burden on them to show their claims were accurate before they made them.

But the D.C. Circuit approved the requirements in Nicopure Labs LLC v. FDA, Rogers said.

Judges Cornelia T.L. Pillard and David B. Sentelle also served on the panel.

Pacific Legal Foundation represented the challengers. The Departments of Justice and Health & Human Services represented the FDA.

The case is Moose Jooce v. FDA, D.C. Cir., No. 20-5048, 12/1/20.

To contact the reporter on this story: Martina Barash in Washington at

To contact the editors responsible for this story: Rob Tricchinelli at; Patrick L. Gregory at