A series of challenges to the Deeming Regulations has recently been filed by several vapor-product manufacturers, retailers, and a non-profit supporting the industry. These are constitutional challenges, advanced with representation from the Pacific Legal Foundation (“PLF”). The cases are Rave Salon, Inc. v. Gottlieb, et al., No. 3:18-cv-237 (N.D. Tex.); Hoban, et al. v. Food & Drug Administration, et al., No. 0:18-cv-269 (D. Minn.); Moose Jooce, et al. v. Food & Drug Administration, et al., No. 1:18-cv-203 (D.D.C.).

In PLF’s own words, “On behalf of small vape business owners and harm reduction clients, PLF has taken the bold and unique step of filing three lawsuits in three different federal courts—at the same time—asking the courts to find the Deeming Rule unconstitutional under the Appointments Clause and the First Amendment, and to stop the rule’s enforcement.”

The cases proceed under the two primary theories. Under the Constitution’s Appointments Clause, the plaintiffs contend that an FDA employee unlawfully issued the Deeming Regulations – rather than a principal “Officer[] of the United States,” as anticipated by the Constitution. Under the First Amendment, the plaintiffs contend that limitation on truthful and non-misleading health claims, through the FDA’s “modified risk” approval process, constitutes an impermissible prior restraint on speech.

It will be interesting to see how these challenges fare. The argument under the Appointments Clause has not yet been tested. And, although other courts have considered the Deeming Regulations under the First Amendment, those decisions are not binding on the PLF cases.

Stay tuned for further developments.