New Court Filing Challenges FDA Regulatory Power and Deeming Rule

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New Court Filing Challenges FDA Regulatory Power and Deeming Rule

There’s another legal challenge to the U.S. Food and Drug Administration’s Deeming Rule and the agency’s regulatory authority over tobacco products including vape and e-cigarettes. This case, Moose Jooce, et al. v. Food and Drug Administration, et al., takes on the FDA and its handling of tobacco regulations by asking a very specific question: Does a government official have the power to validate so-called unauthorized actions of other officials, specifically the doctrine of ratification?

In the petition for writ of certiorari, the plaintiffs question the validity of deeming regulation over the name that appears in the Federal Register notice for the deeming regulation, calling out the fact that the FDA employee whose name appears is not a principal officer or inferior officer, which they allege is a violation of the Appointments Clause of the Constitution. The plaintiffs state that “the D.C. Circuit applies the doctrine of ratification to uphold government action otherwise unconstitutional under the Appointments Clause” and that “such ratification will be upheld even if it is a mere ‘rubberstamp’ that does not comport with the procedural and substantive limitations normally applicable to the agency action being ratified.”

The lawsuit also brings into question the inability for vapor companies to use unauthorized modified risk claims, which it states that unconstitutionally restricts speech, a violation of the First Amendment.