Time is Running Out: Another Vaping Industry Court Loss

A federal judge has decided for the FDA and against several small vape businesses in three consolidated lawsuits challenging 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 rule-making ‘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 pre-market review provisions do not impermissibly burden speech.”

Update: Following @WLF's amicus brief, Dr. Michael Siegel and CASAA have filed amicus briefs with the Fourth Circuit in support of our PMTA deadline appeal: @mbsiegel: https://t.co/5CX1vhqnnM@CASAAmedia: https://t.co/IhbnWCfEOA@WLF: https://t.co/m4zV7qAHfE https://t.co/4wMttZkppu

— Azim Chowdhury (@ECIGattorney) January 31, 2020

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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Article Author: Jim McDonald