Courtroom drama: the battle begins to save vaping

Attorneys sparred in federal court over the future of the vapor industry, but the real battle will probably be in Congress


The vapor industry had its day in court Tuesday — or, perhaps, the first of many days. Attorneys representing Nicopure Labs and the Right to be Smoke-Free Coalition faced off with Justice Department lawyers who spoke for the FDA in the U.S. District Court for the District of Columbia, and each side summarized its arguments and answered questions from the judge presiding over the case.

The lawsuits by the plaintiffs — Nicopure Labs (maker of Halo E-Liquid), and the E-Vapor Coalition, an alliance of 11 vaping advocacy groups, led by the Right to be Smoke-Free Coalition — were combined on June 28 by Judge Amy Berman Jackson. Two sets of lawyers spoke for the plaintiffs, laying out the vapor industry arguments. Azim Chowdhury and Eric Gotting of Keller and Heckman LLP represented the Right to be Smoke-Free Coalition, and Nicopure Labs was represented by Benjamin Block and Kevin King of Covington & Burling LLP.

“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?”

The judge listened to the presentations and asked questions of attorneys for both sides. Judge Jackson is an Obama appointee to the bench, but earlier this year ruled against the administration on another case. She is a graduate of Harvard Law School.

The arguments


According to Law360, the judge seemed skeptical of the vapor companies’ arguments, and aimed most of her questions at Benjamin Block, the counsel representing Nicopure Labs. Noting that Nicopure and the FDA agree that most of the vapor market consists of tobacco products that are subject to regulation (that is, they contain nicotine derived from tobacco), she asked why the FDA should not keep its authority just because some consumers may use nicotine-free liquids.

“Congress did not say, 'We are giving you the keys to the kingdom'"

“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 the Nicopure attorney. The FDA contends it may regulate devices because they are intended to be used with nicotine-containing e-liquid.

Block argued that the Tobacco Control Act (the law that grants the FDA its “deeming” authority) does not give the agency the power to define a product as tobacco based on its intended use. Block, describing vaping devices, said that “an open system, that is neither made or derived from tobacco or for human consumption, is not subject to the regulation.”

“We’re dealing with a plaintiff whose name is Nicopure"

He told the judge the agency cannot extend its authority to products that do not contain nicotine, or those that contain non-tobacco-derived nicotine. “Congress did not say, ‘We are giving you the keys to the kingdom; you can do whatever you want,’” Block told Judge Jackson.

“We’re dealing with a plaintiff whose name is Nicopure,” said counsel Daniel Crane-Hirsch, representing the FDA. “Clearly their very reason for existing is to deliver nicotine to consumers.”
The attorneys speaking on behalf of the FDA — Crane-Hirsch and Eric Beckenhauer — were from the U.S. Department of Justice.

Judge Jackson challenged the government attorneys on the time required to produce studies that could satisfy a premarket tobacco application (PMTA). Dimitris Agrafiotis of the Tennessee Smoke Free Association, one of the coalition plaintiffs, thinks that is a potential point for our side. If the judge rules that the two-year window to submit a PMTA is insufficient, she might impose a different standard or throw out that part of the rule.

Agrafiotis also noted that she didn’t seem to understand the difference between open- and closed-system products, and was misinformed about the size of the open-system market. She has the typical outsider’s view of a vapor “wild west” of bathtub products containing who knows what. He thought the attorneys should have taken some time to demonstrate and instruct.

The judge asked whether the number of e-liquid companies that could not comply with the rules wasn’t itself a point in favor of regulations, according to Law360. She also noted that the predicate date of 2007 is required by the Tobacco Control Act and not subject to FDA discretion. “I don’t see the authority for the FDA to change a congressionally mandated compliance date,” she said.

The waiting is the hardest part - so don't wait!


That is precisely why vapor advocates are working so hard to get the Cole-Bishop amendment included in the budget bill that Congress will pass later this year. Without a change to the predicate date, it’s unlikely that the vaping industry will survive long enough to fight for a long-term solution, like separating e-cigarettes from the Tobacco Control Act.

Sure, maybe the judge will force the FDA to give PMTA applicants more time. That means a couple extra years before small companies are killed. It won’t solve the problem. Only Congress can stop the slow motion destruction of the market.

If vapers don't stay strong and continue to fight, we'll lose.

As we wait for Judge Jackson’s decision, which is unlikely to come before early next year, vapers should be doubling down on the push for a predicate date change. We need to continue to share the link with friends and family, speak to non-vapers about the FDA’s overreach, write letters to the editor of local newspapers, and contact our own house members and senators.

Those are things that can have real effects. We can’t wait for Judge Jackson — or any judge — to save us. If vapers don’t stay strong and continue to fight, we’ll lose. So, please, write a letter. Make a call. Talk to someone who doesn’t understand.

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.
  • seminolewind

    I’d like to thank those involved with passing this information on to vapers .

    I would like to know if the judge or congress knows that what they are passing/discussing restricting rules on is made of pg, glycerin, food flavoring and with or without nicotine? Pg and glycerin has already been tested and deemed safe for human consumption. PG is or has been used in respiratory therapy in hospitals. What I’m getting at is do these “deemers” and decision makers realize that this is all mostly about benign products? Tested and not known to cause harm or illness? I know people are surprised when I tell them the e-liquid ingredients.

    • Jim McDonald

      The judge will decide the case based on the legal points argued by the two sides. None of those rests on the relative safety of the products. She has an amicus briefs from several supporters of the plaintiffs that address some health issues, but those are not primary concerns in this case.

      PG and VG have been deemed safe for consumption in food products, but not for regular inhalation. There are still no long-term studies on the effects of regular vaping.

  • Asylumsix

    if there’s no nicotine in it how the fuck is it tobacco? EG: Devices, Cotton, Phone apps, wire etc etc etc…………………… dot dot dot………. dot.. dot dot….

    • seminolewind

      I don’t know. Nicotine is not exclusive to tobacco and is not tobacco. Vaping products are sold as tobacco free meaning carcinogen free meaning an alternative to using tobacco. If nicotine is extracted from tobacco and replaced at the mg/cigarette they want, does this make it a stand alone chemical?

      The bottles are supposed to be precise about what’s in them. I think it’s honest practice to put TOBACCO FREE on the label because it is. The defendant’s lawyers claim the name “Nicopure” reflects the intent-to provide nicotine. It can also be looked at as Nicopure meaning the nicotine is pure from cancer causing toxic tobacco. Not boasting nicotine but boasting the “Pure” as in tobacco free. I wish one of us could be at the round table of discussion. We were never asked or invited to be an important part of the goal of these regulations fitting what’s needed. Instead the BT was asked for guidance. I am angry that the vaping products of today were not created by tobacco companies, but were stolen from our very own vaping geniuses and manufactured. I think that our own people should take their creations and have them patented. There’s too many vaping products created from utilizing some of our members free of charge.

      Just remember that time is ticking away for those FDA members getting toward retirement age and younger people taking their places who can reason in today’s world .

      I get real tired of our movement being referred to as Yahoos or being treated as tho we are simple minded and certainly are incapable of a suit for an extremely important issue and suing for regulations that do not fit the product. Just the judge referring to us as Yahoos and the movement compared to the “wild west” shows that the judge is already biased and should be replaced with someone who takes this seriously or has actually done their homework so they really understand what this is all about.

      • Asylumsix

        I’m more or less talking about the devices themselves…. I can roll a cigarette with a piece of birch bark right? But does that make birch bark a tobacco product?

        • Jim McDonald

          If the bark is being sold to roll cigarettes, yes. The FDA defines vaping devices as “tobacco products” based on whether they can be used with other “tobacco products.” That’s how they get away with defining zero-nic liquids as tobacco products.

          • Asylumsix

            and quite literally a farce.

          • John Songer

            The regulations also state a non nicotine liquid must state MADE FROM TOBACCO, isn’t that just a trap since the whole false labeling thing? FDA had some inside help designing these regulations. Betting all these “help us understand vaping” surveys and etc we all did here and there helped them as well.

  • seminolewind

    PG has been or still is used today as a liquid carrier for medications given by aerosol or vapor, mainly pulmonary meds. Who approved that?

  • John Songer

    I don’t know how many of you know that Dimitri is being accused of stealing money that was intended for other vaping advocacy groups. The Vaping Legion Network had him on a few times and confronted him about it. They also brought up the companies he represent released a complete closed system line the same day the talks of them came public. Allegedly, while him and Phil were in China meeting with Kanger, Aspire etc they told them these other advocacy groups were going under and basically told them just to fund them. The Vaping Legion Network videos are on YouTube. Just don’t see how the guy is credible or worthy to represent us if it’s true. He would take a bribe and crash our way of life.

    • Jim McDonald

      This is an insane conspiracy theory. Dimitris works for Mountain Oak Vapors, an e-liquid manufacturer that doesn’t make any devices at all. And he works for SEVIA USA, which represents Kanger, Aspire, Innokin, and other Chinese companies that make lots of open-system products. And he is an officer at the Tennessee Smoke Free Association, which represents Tennessee vaping businesses, most of which are small shops.

      People who spread these ridiculous rumors need to find a new hobby. Dimitris hasn’t done anything but fight hard for all of us for as long as he’s been vaping.

      • John Songer

        Hince why I posted who is saying it. I don’t know one way or other, I do know the Vaping Legion Network seems to look down their noses at pretty much all but the higher end devices as well. Used to like the guys because they “called people out” on their BS. But beginning to see it as “If you don’t represent Faircloth you must be corrupt” kind of thing. Seems like they only care about Jersey. Currently, I been donating to r2B smoke free. I actually donated what I had saved to go to Vape Mania this year to them. As a lowly reviewer with my 30 followers I wish I could find a group here in Texas to fight for us down here like it seems everyone out east has. Sorry if I stirred a hornets nest up. But that’s why I used words like Allegedly, and if it’s true, was so maybe someone could educate me. Allegedly, it was Phil Busardo’s company who dropped the complete line of closed system stuff and now they saying Dimitri’s people dropped some closed system tanks for the said system. I’mma make it clear as I can, I have no idea if there is any truth in this at all, someone who knows more than I should go educate those guys.

        • Jim McDonald

          Thanks. There is no truth to it at all. Period. Thanks for donating to the Right to be Smoke-Free Coalition. I think the Texas SFATA chapter has done excellent work in that state, by the way.