A federal judge has decided for the FDA and against several small vape businesses in three consolidated lawsuits challening the agency’s Deeming Rule. The actions were filed in 2018 with legal help and funding from the Pacific Legal Foundation.

The cases were originally filed in U.S. District Courts in Minnesota, Texas, and Washington D.C., but were eventually consolidated to the D.C. district. Judge Christopher Cooper handed down his ruling Tuesday in three separate but identical memorandum opinions.

The vaping industry plaintiffs had challenged the Deeming Rule on two separate grounds. First, they claimed that regulations carrying the force of law must be signed by a Senate-confirmed U.S. government officer. Since the Deeming Rule was signed by FDA Associate Commissioner Leslie Kux—a career civil servant—they asserted that it violates the Appointments Clause of the Constitution. Second, they claimed that the Deeming Rule violates the First Amendment by prohibiting businesses from sharing truthful information about relative risk with customers.

But Judge Cooper found against the plaintiffs and for the FDA on both claims.

Regulations not signed by a Senate-confirmed official can still be constitutional, he said, if they are later ratified by such an official. Judge Cooper cited previous court rulings that have “consistently held that a rulemaking ‘that would otherwise be unlawful due to procedural or technical defects . . . can be cured through a subsequent lawful ratification of that action’.”

Two FDA commissioners—Robert Califf and Scott Gottlieb—have ratified the Deeming Rule since its issuance, said the judge, and “the D.C. Circuit has repeatedly held that an agency’s ratification of a prior decision or action cures any potential Appointments Clause violation.”

On the First Amendment argument, Judge Cooper deferred to precedent set by the December 2019 U.S. Circuit Court of Appeals decision in the Nicopure Labs vs FDA case. In that appeal, a three-judge panel unanimously upheld the 2017 ruling against the vapor industry on First Amendment grounds issued by D.C. District Court Judge Amy Berman Jackson.

“The Circuit [Court of Appeals] quite clearly held that placing the burden on manufacturers to substantiate their marketing claims does not violate the First Amendment,” Judge Cooper wrote. “Bound by that precedent, the Court holds that the Tobacco Control Act’s premarket review provisions do not impermissibly burden speech.”

Time is running out and the losses are piling up

Last month, a federal court in Kentucky dismissed another lawsuit against the FDA. The Vapor Technology Association (VTA) and Kentucky-based e-liquid manufacturer Vapor Stockroom had challenged the agency’s May 11 deadline for manufacturers to submit Premarket Tobacco Applications (PMTAs).

However, since the new deadline was ordered by a Maryland federal court—rather than arrived at through the mandated rulemaking process by the FDA itself—the judge ruled that the VTA did not have standing to sue the agency. The vaping industry plaintiffs had failed to show why the FDA should be accountable for the Maryland court’s decision, said the court.

Keller Heckman attorney Azim Chowdhury is leading an appeal of the Maryland decision by a coalition of vaping trade groups, which could result in the FDA being allowed to set its own PMTA deadline through rulemaking or guidance. However, the FDA has indicated that it will not change the May deadline even if an appeal is successful. Amicus briefs supporting the appeal have been filed by the Washington Legal Foundation, CASAA, and Dr. Michael Siegel.

In December, a Mississippi federal district court ruled against Big Time Vapes and the United States Vaping Association (USVA) in their lawsuit challenging the Tobacco Control Act itself. The judge rejected the plaintiffs argument, based on the doctrine of nondelegation, that Congress cannot delegate its Constitutionally defined legislative authority to executive agencies like the FDA.

The USVA attorneys have appealed the case, and say they are filing a brief in the next week and will ask for an expedited decision. They say they may also ask for an injunction to halt the PMTA deadline, if May 11 approaches without a decision on the case.

While all of the recent court losses can theoretically be appealed, appeals court decisions could take a year—or two years, or even more. The PMTA deadline is just three months away, and vape shops are already in deep trouble. Between general uncertainty over the future of the industry and the business volume lost because of the recent vaping-associated lung injuries, time is running out for the vaping industry.

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