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July 21, 2017

Judge Rules for FDA in Nicopure Lawsuit

Jim McDonald

The vaping industry has lost its first major legal challenge to the FDA’s deeming regulations.

Judge Amy Berman Jackson has ruled against Nicopure Labs and the Right to be Smoke-Free Coalition and its fellow plaintiffs, and granted the FDA’s motion for summary judgement. The case was heard in the U.S. District Court for the District of Columbia, in Washington, D.C.

That means that unless the vaping industry plaintiffs appeal, the deeming rule will stand. Of course, the regulations could be eliminated or changed through other means. They are also being attacked through Congress, and by direct appeals to the Trump administration.

“We are still reviewing Judge Jackson's opinion," said Gregory Conley, president of the American Vaping Association (a plaintiff in the case). "The legal and legislative processes are both long roads with plenty of bumps along the way. The fight to save vaping is far from over." Attorney Azim Chowdhury, representing the Right to be Smoke-Free Coalition, said in a tweet that they are considering appeal options.

Nicopure Labs filed suit on May 10, 2016 — just two days after the FDA announced its draconian regulations that will bankrupt the majority of independent vaping businesses in the United States. The Right to be Smokefree Coalition and 10 other vapor organizations filed suit soon after. In June last year, the judge consolidated the suits, and they were argued together.

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"“The Court wishes to reassure the many worried vapers who followed these proceedings closely that this case is not about banning the manufacture or sale of the devices.”"

During oral arguments, observers noted that the judge seemed especially skeptical of the vapor industry’s arguments. “Is there anything else in the universe that anyone would do with a vaping device than put a liquid in it and vape with it?” Judge Jackson asked Nicopure attorney Benjamin Block.

Part of the Nicopure argument was that the FDA has no jurisdiction to regulate non-nicotine containing hardware as “tobacco products.” But the judge dismissed that contention, and it seems all the other vapor industry arguments too.

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Judge Jackson included in her decision a bizarre note directed at vapers:

“The Court wishes to reassure the many worried vapers who followed these proceedings closely that this case is not about banning the manufacture or sale of the devices,” wrote Judge Jackson. “That is not what the Deeming Rule does or what it was intended to accomplish. In the Deeming Rule, 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.”

Vapers understand that, your honor. That’s precisely the problem. Vapor products aren’t anything like conventional cigarettes, and they shouldn’t be regulated the same way.

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Jim McDonald

Vaping for: 13 years

Favorite products:

Favorite flavors: RY4-style tobaccos, fruits

Expertise in: Political and legal challenges, tobacco control haters, moral panics

Jim McDonald

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue 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’m a member of 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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