LAKEVILLE, Minn. -- Three federal lawsuits were filed simultaneously late last month against the U.S. Food and Drug Administration (FDA) over the agency’s deeming rule that went into effect in August 2016, according to Lakeville, Minn.-based 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, Silver Spring, Md., the authority to regulate electronic nicotine delivery systems (ENDS), including electronic cigarettes and e-vapor products, as tobacco products.
The plaintiffs’ primary argument asserts 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 officials said in the organization's monthly newsletter.
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 lawsuit seeks injunctive and declaratory relief barring the enforcement of the rule. A previous lawsuit to these three actions was filed by other plaintiffs challenging the agency’s authority to issue the rule, but the federal court in that case ruled that the FDA had the proper authority from Congress to issue the deeming regulations, NATO said.
These three new lawsuits are the first actions to argue the burden-shifting violation of truthful speech under the First Amendment and also challenge the validity of the rule based on an FDA employee issuing the deeming regulations rather than an appointed constitutional officer such as the Secretary of the Department of Health and Human Services, NATO said.
- In the Washington, D.C., lawsuit, the plaintiff companies are Moose Jooce, Lake, Mich.; Mountain Vapors, Sonora, Calif.; Rustic Vapors, Marquette, Mich.; and Dutchman Vapors, Grand Forks, N.D.
- In the Texas lawsuit, the plaintiff is Rave Salon Inc., doing business as Joosie Vape, Mesquite, Texas.
- In the Minnesota lawsuit, the plaintiffs are Jen Hoban, doing business as Masterpiece Vapors, Perham, Minn.; The Plume Room LLC, Minneapolis; J.H.T. Vape LLC, Maplewood, Minn.; Lakes Vape Supply LLC, Brainerd, Minn.; and Tobacco Harm Reduction 4 Life, Pueblo, Colo.
In all three cases, the defendants named are the FDA itself; Dr. Scott Gottlieb, FDA commissioner; and Alex Azar, secretary of Health and Human Services.
The Pacific Legal Foundation, Sacramento, is serving as legal counsel to the plaintiffs in the lawsuits.