Monday, June 17, 2024

Deeming Rule Challenge Rejected by Federal Appeals Court


A federal appeals court today upheld a lower court’s rejection of a challenge to the FDA Deeming Rule brought by several small vaping businesses. The case, Moose Jooce, et al v. Food and Drug Administration, had previously failed in a federal district court in February.

A three-judge panel of the U.S. Circuit Court of Appeals for the District of Columbia upheld the earlier decision by U.S. District Court Judge Christopher Cooper. The appellants (plaintiffs in an appeal) can now request a rehearing by the full Circuit Court, or apply to appeal the case to the Supreme Court.

The lawsuit, which consolidated three separate complaints brought by small vaping businesses and Minnesota-based non-profit group Tobacco Harm Reduction 4 Life, challenged the FDA Deeming Rule on Appointments Clause and First Amendment grounds. The legal action was bankrolled and argued before the courts by the Pacific Legal Foundation, a conservative-libertarian public interest law group that fights government overreach.

The vape industry plaintiffs had claimed that because the Deeming Rule wasn’t signed by a government officer appointed by the President and approved by the Senate, that it violated the Appointments Clause of the Constitution. Like many federal regulations, the Deeming Rule was signed by a career civil servant, in this case Associate FDA Commissioner Leslie Kux.

But Circuit Court Judge Judith W. Rogers, writing for the panel, said that because the Deeming Rule was later ratified by then-FDA Commissioner Scott Gottlieb in 2019, any defect in the regulation was cured. The panel rejected all arguments against Gottlieb’s after-the-fact endorsement of the rule.

The vapor industry appellants had also challenged the Deeming Rule on First Amendment grounds, asserting that claims by vape shop employees about the relative safety of vaping cannot be preemptively censored by speech limitations imposed by the FDA’s “modified risk” approval requirements.

In the original decision, Judge Cooper said that he was bound by precedent set by the 2019 U.S. Circuit Court of Appeals decision in the Nicopure Labs LLC vs FDA appeal. In that case, the appeals court agreed with the original 2017 district court decision, in which Judge Amy Berman Jackson found that the FDA’s speech restrictions on the vaping industry were appropriate.

Today, Judge Rogers also said the argument was “foreclosed” to the appellants, meaning that precedent set in the Nicopure Labs decision prevented further consideration of the First Amendment claim.

The three appeals court judges were appointed by three different Presidents: Judge Rogers by Bill Clinton, Judge David B. Sentelle by Ronald Reagan, and Judge Cornelia T.L. Pillard by Barack Obama.

Vaping360 reported in September on oral arguments before the circuit court.

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