E-Cig Companies Say Invalid Appointment Moots FDA Rule

A researcher holds vape pens in a laboratory in Portland, Ore. (AP Photo/Craig Mitchelldyer, File)

WASHINGTON (CN) — Vaping manufacturers and retailers pointed to what they called the Trump administration’s arcade-style handling of agency leadership Wednesday in a D.C. Circuit appeal over e-cigarette regulation.

“This court should absolutely be concerned about FDA’s whack-a-mole approach to the Appointments Clause,” Jonathan Wood, a lawyer with Pacific Legal, said this afternoon at oral arguments held remotely by the Washington court.

Ten companies — among them Moose Joose, Mountain Vapors and Tobacco Harm Reduction 4 Life — brought the challenge here over a final agency rule that the Food and Drug Administration adopted in 2016 to designate vape wares as tobacco products subject to regulation under the Tobacco Control Act. 

Though the rule was signed by Leslie Kux, who was associate commissioner for policy for the FDA at the time, the challengers say the rulemaking process should begin again under the current Commissioner Stephen M. Hahn because Kux was not confirmed by the Senate.

The Senate swore Hahn in December 2019. 

As the three-judge panel voiced alarm over the government’s brushoff of Senate-confirmed officials making decisions, Justice Department attorney Lindsey Powell noted that two different FDA commissioners ratified the rule after Kux signed it, making the rule sound.

“It’s entirely appropriate and indeed commendable for an agency to ratify that action in order to cure any possible defect,” Powell said.

In April 2019 when then-Commissioner Scott Gottlieb ratified the deeming rule, he was “certainly aware of this rule in particular and emphatically agreed with it.”

“It’s entirely appropriate and indeed commendable for an agency to ratify that action in order to cure any possible defect,” Powell said.

U.S. Circuit Judge David Sentelle, a Reagan appointee, pressed the government for case law backing its argument, however, the remaining members of the panel seemed concerned as well.

“It feels concerning and somewhat hollow,” said U.S. Circuit Judge Cornelia Pillard.

“If this is sufficient doesn’t this render the Appointments Clause something of a dead letter?” the Obama-appointed Pillard also said.

The point was one echoed by her colleague, U.S. Circuit Judge Judith W. Rogers. 

“What is left of the limitations in the appointments clause?” the Clinton appointee asked. 

With limited precedent to lean on, the government argued the D.C. Circuit does not have the authority to overturn the vaping rule.

“The validity of a ratification turns on whether the ratifyer had authority, knowledge and intent,” Powell said. “And that intent is intent to approve the thing done, not intent to correct a particular problem with the thing done.”

Pillard meanwhile questioned how the FDA can have individuals who are not duly appointed under the Constitution generating agency actions that are then made valid later on by “periodic blanket ratifications” by appointed officials. 

But Powell insisted that the FDA undertook a robust rulemaking process. 

“I mean there were over 130,00 comments here. And that is the rulemaking record that we have,” Powell said.

Moose Joose and the other companies seek a reversal after the District Court rejected their suit in February at summary judgment. They claim the rule violates the First Amendment by prohibiting them from making “various truthful statements about vaping” unless they first prove their products benefit public health.

“The agency simply can’t show that it is inconceivable that a properly appointed official going through the rulemaking process would not result in material change,” Wood said. 

Moose Joose’s suit is one of a slew of challenges to hit the federal courts in years that followed challenging the FDA’s regulation of e-cigarettes, commonly knocked for being addictive and with unknown health risks

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