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July 21, 2017

Judge Rules for FDA in Nicopure Lawsuit

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.

“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.

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.

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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Emegaz
Emegaz
6 years ago

they wont ban it they’ll just hand it over to Big T to try and keep the states afloat

Sean Hanson
Sean Hanson
6 years ago

Add Amy Berman Jackson to the list of swamp muck to be drained

Jamie
Jamie
6 years ago
Reply to  Sean Hanson

She’s going to hell anyway, her ruling possibly killed 100,000s of people.

Scott Korba
Scott Korba
6 years ago
Reply to  Jamie

The judge really can’t reverse the law of the land – only interpret what the congressional intent and the power given to FDA allows. The hypocrisy resides in the anti tobacco lobby that has full knowledge of the BS “harm reduction” path that is exactly like a cartoon drawing of a road painted on a wall. Looks real, totally fictional. Add the composition of who works at FDA, knowing they basically hate the concept of being responsible for regulating a harmful product, and you have our situation… Protections for cigarettes in an environment where the entire category is hated. Driving… Read more »

KathyG
KathyG
4 years ago
Reply to  Scott Korba

I don’t see anything that bars them from banning toxins sprayed on tobacco leaves, like round-up, or enhancing nicotine. It’s not the tobacco that causes cancer it’s the additives.

Jamie
Jamie
6 years ago
Reply to  Scott Korba

What these people do not understand is that it isn’t up to any Government appointed authority to decide what kind of tobacco product selection can or cannot be available. Knowledgeable e-cig users can route around this over reach but smokers that have not yet transitioned will still be able to get devices just not as easily. The only thing the FDA hates is American Citizens for wanting to take a device away from the market that saves lives and a safer alternative for tobacco. These bias anti-tobacco haters have no business telling Americans how to live their life and no… Read more »

sh1tonagain
sh1tonagain
6 years ago

Big pharma is and has been in the driver’s seat and this ruling just shows what money can buy! This is NOT big tobacco – it’s big pharma. You need to look at who will benefit; big pharma wants to make sure no one is getting a piece of their pie. Vaping reduces their profits from their gum, patches and drugs (Chantix, etc). Not to mention the fact that the government, both state and fed, make a hefty profit from the sales of tobacco and would prefer that you continue to smoke. Smokers know, or should know, that the products… Read more »

Gary Wood
Gary Wood
6 years ago

That is a bizarre note and clearly shows this judge is more advocate for FDA and SIGS than blind justice for people, in my view. Truth will win but how much damage between now and the victory and how many smokers will die due to government interference?

Scott Korba
Scott Korba
6 years ago

One should ask the Judge (and mock NicoPure’s lawyer for not bringing this up): By the logic applied here, DEA could imprison battery makers for selling schedule 1, ‘marijuana products’ which you have now established a precedent for as ‘constituent part of…’ a device intended for use as a joint. Conversely, as FDA isn’t reaching into MMJ regulation beyond some CBD warnings and hasn’t touched the myriad devices that surely have a role in generating carcinogens from cannabis combustion (or vaping); why not call everything an e-joint or e-bong? And since vape shops can’t load or assemble devices anyhow, there’s… Read more »

Jeremy Mann
Staff
Jeremy Mann
6 years ago
Reply to  Scott Korba

Well said!

Taz
Taz
6 years ago
Reply to  Jim McDonald

Yeah except juice =/= tobacco product. Want to argue that the nicotine makes it a tobacco product, I will counter with 0mg juice.

ReyAnne E
ReyAnne E
6 years ago
Reply to  Taz

Or you can counter with a number of other plants that contain nicotine, such as cauliflower, which is considered a healthy vegitable.

Scott Korba
Scott Korba
6 years ago
Reply to  Jim McDonald

I agree – the marketing of a given item that is not, by inclusion of a tobacco ingredient such as nicotine, can spell out the intended use. Market an e-cigalike with a “stop smoking” message and you waltz into cessation products that are more heavily regulated. Manufacturers of devices, PG, VG, flavorants, batteries, etc can split off their sales function into channel specific distribution firms or place an additional layer or two between themselves and the customer to shield some or all of their operations from fees and oversight. Retailers such as convenience stores or marketplaces like eBay have the… Read more »