Judge rules for FDA in Nicopure lawsuit

Judge Amy Berman Jackson denies motions from the vapor industry and lets the deeming ban stand

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fda_vs_nicopure

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.

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Jim McDonald
I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.
  • Emegaz

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

  • Sean Hanson

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

    • Jamie

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

      • Scott Korba

        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 price up, selection down is the only real tactic they can take, given the law that forbids a ban on tobacco use.

        • Jamie

          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 Judge paid to make a ruling will ever stop people from using or obtaining e-liquids and devices. The war on drugs has not caused less drugs to be available, more like it made them more available and popular. I just had a 22 year old in my clinic get treatment for the damage he did to himself while using heroin. They can’t stop this poison and are not even trying. Priorities are not in the best interest of our pathetic and power grabbing left wing progressive evil deed pushers. Fact is, with these devices, Big Pharma has a lot of profits to lose. So does the corrupt progressive left, money paid to them by big Pharma to push their decision making in their favor. This Judge could have easily ruled for Nicopure but the fact is, the money and influence given to her was too much to decline. These people don’t care about the human condition, only how much money they can make off of the misfortune of others plain and simple. My question is with ever case in the past about e-liquids and everything vaping, why is it that every single time, the judge making decisions has been a corrupt progressive leftist? Their day is coming and it won’t end well for them.

    • Jim McDonald

      She has a lifetime appointment to the federal bench.

  • sh1tonagain

    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 put out by big pharma have very little success rates, thus, ensuring return customers. And, hey, wth, they’ll profit from any health issues as a result of smoking as well. It’s a win/ win for them. Please quit blaming big tobacco – it’s not them.

  • 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

    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 not much FDA would be able to do with the section of the shop dedicated to, ahem… ‘Non-tobacco product vaping hardware (for medical MJ use, presumably)’.

    • Jim McDonald

      It’s a matter of intent. If a business is dedicated to selling products for vaping, their products are tobacco, and it can be assumed that the products are intended to use with other tobacco products (i.e., e-liquid). The FDA is not — yet — venturing into the cannabis universe.

      • Scott Korba

        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 freedom to say little about intended use, and zero nic e-liquid, vaping gear and components, absent a marketing message would be tough to “capture” given the huge population of adults who may be legal MJ consumers. Vape shops do, as you point out, have the problem of giving the Judge’s query about “what else possibly could be the purpose” the weight of law if they don’t answer that question.
        I’ve been pitched on deals in the vaping space, MMJ space, CBD to consumer space and have read the rulings that are material to all, going back to before Sottera. How firmly and how far back into the chain of production and distribution the regulatory reach and grasp might be is, largely, a matter of perception and marketing language. Selling liquid nicotine from a business called “Vape-r-us” leaves little wiggle room, but a 7-11 or a “vape shop” across the street from a $5m medical marijuana collective ‘store’ has a very defensible position available that requires some simple, $0 actions.
        The marketing message for vape shops anywhere, and in particular, MJ legal states, provides an answer to the Judge. I’m fairly sure the number of potential customers for legal, non-tobacco use swamps and overlaps vaping use in states covering almost 2/3 the US population. The message can be (long form to give you the compete scenario):

        ‘This cabinet has vaping gear and accessories for use by, or gifting to legal users of medical MJ, essential oils and herbs, and are not currently regulated or taxed by agencies that have authority over tobacco products (those cabinets 10′ away possibly). We respect your right to privacy in regard to you or your loved ones’ medical conditions and will neither ask for nor record information about compassionate use of MJ or holistic herbal therapies. Absent knowledge that (you), the customer intend to use this new item for consuming a tobacco product, store employees can assemble, demonstrate and sell these items as non-tobacco purchases. Please be aware that you may not vape medical or recreational MJ products – however they are defined by relevant government bodies – on this property”.

        Liquor stores sell cigarettes. They’re a tobacco retailer even if that’s not where 80% of the revenue comes from. Same story with Kroger. Some retailers have ‘the counter’ separate from any age-unrestricted area and some, like vape or liquor stores may have the whole store subject to some ID verification process. That, more than the product mix inside, makes a vape shop less a 7-11 and more in need of a specific change to their marketing message. Sell some breath mints next to the 18650’s.
        Thoughts?

      • Taz

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

        • ReyAnne E

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

    • Well said!

  • Keith Dionne

    While I totally disagree with the Judge’s ruling. She brought up a valid point. Vape shops sell mods that are dedicated to vaping dabs, THC liquid and dry herb, that’s a fact and I can walk into a lot of vape shops in NYC and find them. Usually in the front display for all to see and you can find their vape counterpart that they are modeled after a few feet away. Just like vapers who lack basic cloud etiquett and think it’s cool to vape out a restaurant, we become our own enemy. little things like that are what lead to people misunderstanding what vaping is really all about. Seems like our best hope is the current administration and members of the house and senate using science and reason as guide to fair FDA regulations before the industry gets its legs taken out.

  • Teresa James StanleyFeaster

    My son in in law and I was intentionally ran off the road by a semi in Cincy on our way to a Brick and Mortar, the police met us in front of the store and before he ask us about the semi he asked us about our liquids. Then he asked us if he tested it would there be MJ in it. We were like really? We called you. He asked to test our liquid we told him we are literally in front of a Vape Store we obviously was on our way here.on But yes, we indeed let him, because he was unaware of vaping, he said, But yes he pretty much assumed. Not to mention he said he couldn’t even take a report because where we were ran off the road was not in his jurisdiction. It was a half a mile out. Just slapped twice!!

    • Jim McDonald

      Unbelievable!

  • Daniel Henschel

    Intent is part of many laws. In fact, most criminal offenses include intent as a necessary element of the crime.