Three federal lawsuits were filed simultaneously earlier this year against the FDA over the agency’s deeming rule that went into effect in August 2016, according to NATO.
The lawsuits were filed in federal courts in Minnesota, Texas and Washington, D.C., on Jan. 30, with the plaintiffs in each lawsuit representing vaping industry retailers or manufacturers, as well as a nonprofit tobacco harm-reduction organization in the case of the Minnesota lawsuit. Plaintiffs are contesting the rule that grants the FDA the authority to regulate ENDS, including electronic cigarettes and e-vapor products, as tobacco products.
The plaintiffs argue that the FDA’s deeming rule is unconstitutional because it violates the First Amendment, prohibiting vapor retailers from communicating truthful, nonmisleading information to their customers due to the onerous and costly FDA approval process their nontobacco products are now subjected to, NATO said.
Under the rule, all ENDS, e-cigarettes and vaping products dating back to 2007 must be approved by the agency for manufacturers and retailers to market their products as a less harmful alternative to traditional tobacco. However, a regulation on truthful speech is presumed unconstitutional, and the government carries the burden to overcome that presumption, not the entity or person that is marketing the product, NATO said. So the plaintiffs argue that the deeming rule approval process unconstitutionally shifts that burden from the government to industry members.
Plaintiffs go on to argue that the FDA incorrectly promulgated the rule because it was issued by an associate commissioner at the agency, instead of an agency executive with constitutional power nominated by the president and confirmed by the U.S. Senate pursuant to the Appointments Clause of the Constitution.
Each of the three lawsuits seek injunctive and declaratory relief barring the enforcement of the rule.