Federal Court Rejects Nicopure Appeal; What's Next?

A federal court has denied the vapor industry’s appeal of a lower court decision that upheld major provisions of the FDA Deeming Rule. Whether the decision will be appealed further hasn’t yet been decided.

A three-judge panel of the U.S. Circuit Court of Appeals for the District of Columbia unanimously rejected the arguments of the Right to be Smoke Free Coalition and Nicopure Labs. The original Nicopure lawsuit was filed less than a week after the FDA announced the Deeming Rule in May 2016.

The appeal was narrowly crafted to challenge the Deeming Rule on the grounds that FDA violated the Administrative Procedure Act (APA) by failing to consider a less burdensome pathway for vapor products than premarket tobacco applications (PMTAs), and that the Modified Risk Tobacco Product (MRTP) provision of the Tobacco Control Act and the Deeming Rule restriction on free samples violate the First Amendment.

The Court of Appeals denied all three arguments, calling the FDA’s imposition of a public health standard for e-cigarette marketing approval through the PMTA route “entirely rational and nonarbitrary,” and agreeing with the FDA, which said in the Deeming Rule that “FDA is not authorized to deviate from this statutory standard.”

In other words, if you don’t like the Deeming Rule, your quarrel is with Congress, not the FDA.

The history of the lawsuit

The FDA announced the Deeming Rule on May 5, 2016. This legal challenge to the FDA’s vaping regulations began with a lawsuit filed by Nicopure Labs on May 10. On June 20, a group of vapor industry organizations and the Right to be Smoke-Free Coalition (R2B) filed suit. Both actions were filed in the U.S. District Court for the District of Columbia, and were consolidated a week later into a single case.

A year later, Judge Amy Berman Jackson ruled against the vapor industry plaintiffs, denying every argument made by both Nicopure and R2B. Jackson’s ruling included a bizarre message, supposedly intended to mollify vapers, that accidentally betrayed her deep misunderstanding of the issue.

“In the Deeming Rule,” Jackson wrote, “the FDA simply announced that electronic cigarettes, or electronic nicotine delivery systems (“ENDS”) would be subject to the same set of rules and regulations that Congress had already put in place for conventional cigarettes.”

In August, the plaintiffs filed notice of appeal, and in February 2018 they filed their opening brief in the D.C. Circuit Court of Appeals. Oral arguments were held Sept. 11, 2018—and that’s the last anyone heard of the case until today.

What happens next?

The Court of Appeals is the second-highest federal court in the country. The next step would be an appeal to the U.S. Supreme Court, which is rarely successful. The Supreme Court accepts only about one percent of the appeals submitted to it. So the Nicopure/R2B case is probably finished.

The likely end of the Nicopure/R2B litigation does not, however, mean that the vapor industry’s legal hopes are over. Since Nicopure v FDA was filed in 2016, multiple plaintiffs have filed lawsuits challenging the FDA’s authority, and several are still under consideration in federal courts.

In the Mississippi federal district court, Big Time Vapes and the United States Vaping Association are challenging the Tobacco Control Act itself, claiming that Congress unconstitutionally delegated its own proper authority away to the FDA. That case is still in progress, with the plaintiffs and FDA trading motions.

The case is based on the doctrine of nondelegation, the legal theory that Congress cannot delegate its own legislative authority to executive agencies (like the FDA). Nondelegation is a popular idea among conservatives who want to limit the authority of unelected bureaucrats. A recent Supreme Court decision, Gundy v United States, indicated that the high court may now be willing to take a serious look at nondelegation.