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December 11, 2019

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.

In the D.C. district, three lawsuits filed by small vaping vendors with the help of conservative/libertarian public interest law group the Pacific Legal Foundation have been consolidated into one. This suit contends that regulations carrying the force of law must be signed by federal employees who have been appointed by the President and confirmed by the Senate. The Deeming Rule was signed by a career civil servant—a similar angle the Big Time Vapes lawyers are pursuing, but not exactly. The PLF suit also challenges the Deeming Rule on First Amendment grounds, claiming the FDA has no right to prevent vape shops from telling their customers the truth about vaping’s relative safety.

In addition to those and other challenges to the Deeming Rule and Tobacco Control Act themselves, the Vapor Technology Association (VTA) has sued to prevent the FDA from enforcing the May 2020 PMTA submission deadline. The new date was imposed by a federal judge in Maryland earlier this year, and in fact the FDA recently announced it too would appeal that decision.

In the current atmosphere, it’s hard to envision a time when small vaping businesses will be able to simply serve their customers without the constant fear of persecution and extinction. Such a time can come, but reaching it will require determined, focused efforts by everyone who cares about vaping. Lobbying, public education, protest, discussion with regulators and legislators, and legal challenges will all be necessary to get there.

Most lawsuits fail, but remember to thank the businesses and organizations that try. They put their time and money and faith into efforts they know are unlikely to succeed, and they do it because they know it can’t happen unless someone steps up and takes the chance.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

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Ed B

It’s all about the lost revenue from combustible cigarettes.Its not about people getting sick or dying or about the youth..If it was truly about teens vaping then they would have made that it issue years ago.Thats just the excuse their using.

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