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US: DC Court Upholds FDA Decision to Regulate E-Cigs as Tobacco Products

The D.C. Circuit U.S. Court of Appeals has rejected an appeal saying that the Food and Drug Administration's decision to regulate e-cigarettes as tobacco products violates the Constitution's Appointments Clause.

Diane Caruana

December 9, 2020

Represented by the Pacific Legal Foundation, a conservative legal group, Michigan-based e-liquid manufacturer Moose Jooce, argued that the FDA’s then-associate commissioner for policy Leslie Kux, who issued the 2016 rule deeming e-cigarettes to be tobacco products, lacked the authority to do so because she was a career employee, not a principal officer appointed by the president.

The FDA countered that while the authority had been delegated to Kux by the agency’s commissioner, it did not even matter since the regulation was ultimately ratified by two different FDA commissioners, most recently FDA Commissioner Scott Gottlieb in April 2019.

The appeals court said that the deeming rule is constitutional

The judge agreed that Gottlieb should have conducted a new review before ratifying the rule, however, she added, there was no evidence that he had not.

Ruling in favour of the FDA, a unanimous panel of the D.C. Circuit U.S. Court of Appeals, said that the regulation did not run afoul of the Constitution’s Appointments Clause because the FDA official who promulgated it was not appointed by the president and confirmed by the Senate.

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“The Appointments Clause is an essential constitutional protection for democratic oversight and accountability,” he said. “Yet the court’s decision all but assures that agencies will suffer no consequences when they violate this clause.”

U.S. District Judge Christopher Cooper in Washington, D.C. agreed that the ratification overcame any Appointments Clause issues, and Circuit Judge Judith Rogers, agreed rejecting the plaintiffs’ appeal’s arguments that Gottlieb should have conducted a new review before ratifying the rule. She added that however there was no evidence that he had not. “Commissioner Gottlieb’s ratification, for the reasons discussed, cured any potential Appointments Clause defect arising from Associate Commissioner for Policy Kux’s issuance of the Deeming Rule.”

FDA pressured to ban menthols

Meanwhile, a coalition of over 60 US organizations, including the American Dental Association (ADA) and Campaign for Tobacco-Free Kids, are urging the Food and Drug Administration (FDA) to ban menthol-flavoured tobacco products.

“The scientific evidence strongly establishes that the availability of menthol cigarettes both increases the level of smoking initiation and decreases the level of smoking cessation,” wrote the coalition in a November 10 letter to FDA. “There is a growing body of evidence that the elimination of menthol cigarettes would lead a substantial number of current menthol smokers to quit smoking rather than switch to non-menthol cigarettes in response to a prohibition on menthol cigarettes.”

Most importantly, noted the coalition, the 2011 FDA Tobacco Products Scientific Advisory Committee Report had recommended pulling menthol cigarettes from the market, and the FDA itself “has consistently found that the scientific evidence establishes that menthol as a characterizing flavor in cigarettes is harmful to public health.”

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