E-cigarettes

The FDA's Insane Definition of 'Tobacco Product' Drives Vaping Innovation

Two companies try to dodge onerous rules with a system that delivers only synthetic nicotine.

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Next Generation Labs

The Food and Drug Administration's onerous e-cigarette regulations, which are expected to put all but the largest producers of vaping equipment and e-liquids out of business, are based on the counterintuitive premise that tobacco products need not contain tobacco. If they contain nicotine derived from tobacco, as the fluid that e-cigarettes turn into an aerosol often does, that's enough for the FDA to regulate them as tobacco products. But what about the many varieties of nicotine-free e-liquids, sold in disposable e-cigarettes, replaceable cartridges and bottles for refilling vaporizer tanks? Do those liquids and the systems in which they are used also qualify as tobacco products?

As I explain in a recent Forbes post, the FDA seems incapable of giving a straight answer to that question, which is crucial in determining which products are subject to regulatory requirements that will prove prohibitive for most of the companies that currently offer smokers a much safer alternative to conventional cigarettes. It sounds like nicotine-free fluid still counts as a tobacco product if it can be used in vaping equipment that also can be used with fluid that contains nicotine. If so, all e-liquids sold in bottles would be treated as tobacco products, even when they contain neither tobacco nor nicotine. But if that is the FDA's (il)logic, a disposable nicotine-free e-cigarette or a closed vaping system that accepts only nicotine-free cartridges would not qualify as a tobacco product.

What about nicotine that is not derived from tobacco? Various other members of the nightshade family, including eggplant, tomatoes, and green peppers, contain nicotine, which also can be synthesized in a lab. Companies such as Amaranth Vapor advertise e-liquids containing "tobacco-free nicotine." As the Manhattan Institute's Jared Meyer notes at National Review, those liquids, like the nicotine-free versions, apparently are still covered by the FDA's bizarrely broad definition of "tobacco product," because they are used in devices that also can be used to deliver tobacco-derived nicotine.

But what if you had a vaporizer that worked only with "tobacco-free nicotine," combined with liquids that worked only in that device? That is the convoluted idea behind a joint project announced today by the vaporizer company Vapeix and Next Generation Labs, which makes synthetic nicotine under the TFN brand. The press release says the two companies are "leveraging the world's most advanced embedded firmware, software and hardware" to "develop both closed and open system vaping devices for Next Generation Labs' e-liquid brand customers who use TFN Nicotine."

Lack of flexibility is a key selling point. "Through the smart technology embedded in Vapeix Powered devices," says Next Generation cofounder Ron Tully, "the vaporizers will only work with TFN brands—allowing us to create a vape market which is unequivocally disassociated from traditional vaping devices that are intended to be used with tobacco-derived nicotine." Vapeix founder Kyle Newton notes "there's currently a lot of fear in the market as vape businesses and analysts worry that regulation will stifle innovation in the industry." He hopes the joint venture will create "a new product category that will enable future innovation in a narrowing industry."

I suspect the FDA will try to regulate these high-tech contraptions as tobacco products too, although whether the agency's reasoning will be upheld by the courts is another question.  

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  1. See, regulation fuels innovation.

    1. It does! However, before these fine young entrepreneurs can take their place at the grand table of defenders of the regulatory status quo, they’re going to be blocked at the door. I would not invest a nickel in this venture.
      .
      One thing I cannot figure out is why Big Tobacco, which has a long and distinguished record of backing regulatory measures that entrench its market position, is actually fighting the deeming proposals. Especially since this type of overreach and abuse was a very predictable upshot of the decision (enthusiastically backed by Big T) to hand the FDA jurisdiction.
      .
      It’s one of the things that has baffled Dr. Michael Siegel, the highly respected tobacco-control hero-turned-heretic: That Big Tobacco is acting as the good guys here, in apparent defiance of their interests, whereas the FDA is poised to deal a huge blow to the fight against smoking. I don’t have the answer either.

      1. I think Big Tobacco is fighting this because they are trying to break into the vaping market as well. Devices like the Mark V are produced by Phillip Morris. I foresee tobacco companies trying to do a takeover of the industry

        1. I believe the Mark V is grandfathered. The deeming date will wipe out mostly indie manufacturers, leaving mostly the vaping big dogs to play. While Big Tobacco doesn’t dominate the lineup of said big dogs, it certainly also got a lot of products out. I think the later date they are pushing for–to say nothing of overturning the grandfathering entirely–would appear to be a net market share loss for them.

          1. Everything will just shift to China and you’ll have to wait a month to get the exact same products from DHgate you get now from your local vape shop.

            1. Vaping won’t help you, just fool you thinking that you are in the clear. I stopped smoking with the Simpleguided smoking plan after everything else failed.

    2. Exactly! All the wealth we’ll shortly be pouring into automation to protect teenagers from employment is proof that America is on the cusp of another tech revolution.

  2. Vaping causes asthma attacks, therefore it should be banned.

    1. I don’t know about asthma attacks, but it does give some people vapors.

  3. I would say that vape companies should band together and sue the FDA over regulations that are vague and lacking in scientific basis, except that the FDA has unlimited resources with which to fight, baffle, and delay such a suit, and that if it ever does see the inside of a courtroom, the law as written won’t matter in the slightest so long as evil tobacco companies are not permitted to win even a little bit.

    1. They have a decent lobby as far as lobbies go, as far as I know. And for some reason Big Tobacco, though the proposed regs would seem to be in their interest both qua ciggie sector and qua vaping sector, is firmly in their corner here. (I’m not the only one who’s puzzled.) And Big T doesn’t really have a bad track record in court; graphic warning labels have been held up for an eternity, and most of what has gone down in tobacco control (with the exception of taxes, which they seem to care about more than everything else combined) over the years has actually gone down with their agreement.

  4. It’s hardly the FDA’s fault if e-cig’s lobby isn’t big enough to get Congress to rein in an executive branch agency.

    1. Don’t hate me because I’m powerful.

  5. I suspect the FDA will try to regulate these high-tech contraptions as tobacco products too, although whether the agency’s reasoning will be upheld by the courts is another question.

    You know as well as the rest of us that the court will defer to the judgment of a federal agency there.

    1. No, not these days. Remember that the only reason Congress gave FDA jurisdiction over tobacco products was that the agency lost in court over their 1990s interpretation that would’ve had these as medical devices.

  6. My hovercraft is full of eels. You want to come back to my place, bouncy bouncy?

    1. If there’s any more stock film of women applauding, I shall clear the court!

  7. Leave my tomatoes and green peppers alone. { Hides by the garden with a shotgun. }

  8. Fake pot is pot, fake nicotine is nicotine. It would be foolish to be surprised by this. You can shout your “what ifs” to anyone who will listen, you’re not going to change the collective mind of a government body that has already made a decision.

  9. I have no doubt the FDA will redefine tobacco products as anything that simulates the act of smoking, dipping, or vaping and won’t give a shit where the nicotine, or lack thereof, comes from.

    At the end of the day, the regulators, Big Tobacco, nannies, and tax collectors will get their increasingly fat paychecks and the charade will continue until they decide they can make more money by classifying tobacco and related products as narcotics.

    1. No, because the statute precludes consideration of such simulation. In fact it doesn’t even allow for regulation of lobelia products as tobacco products.

  10. If it looks like smoking and the poors are doing it – tax the shit out of it and shame them too. Doesn’t matter what’s inside.

  11. Just thinking now about all the R&D that’s going into defeating the lawyers rather than making new discoveries. Heck, as a consulting scientist right now I’m working with a client on a biological, and much of my work with him consists of that lawyer wanking.

    1. Robert, this may be true for biologics or drugs, but the tobacco section of the FDA is packed with anti-tobacco idealogues, not scientists.

      1. That’s irrelevant to my point. The article describes somebody putting R&D into developing a product that is, if anything, inferior to existing products for the same application, but to get around a possible barrier imposed not by nature but by the food & drug laws. A good deal of my work w my client has similarly been to justify a pathway around a possible hurdle in the food & drug laws, such that our creative interpret’n would make marketing a lot cheaper.

  12. Time for Tomacco?

  13. Synthetic nicotine is not the way to go. Closed vapor systems are ineffectual and not wanted by the vaping community. What is needed is for the stupid fucking government to get out of our lives.

    1. Good luck with that! Especially if we have 4-8 more years with a democrat in the white house (and God help us if they win back Congress too). Not sure that Trump would necessarily be better on this either.

      1. Trump has been campaigning vs. biz regs. You can say that he’d like to impose biz regs in some narrow area of interest of his?making it harder to have products made in other countries, then shipped here?but outside of such a hobby horse, I think he sympathizes very much w biz.

  14. “joint project”
    “joint venture”
    I’ll just leave this here.

  15. We can’t let vaping go unregulated. There’s too much money in it.
    /HRC

  16. Does the FDA not realize or not care that you can buy anything you want from China? Are they also planning on making it illegal to sell or buy PG, VG, flavorings and nicotine separately and make your own e-juice? So you buy your hardware from China, make your own liquids and vape happily ever after.

    1. Before the first ban was lifted on e-cigs by the DC circuit court, the FDA seized a lot of shipments of Chinese e-cig consumables in customs. I imagine they will do the same thing once the deeming regulations are in effect. Will probably monitor purchasing of the ingredients too, to make sure you aren’t brewing your own, like they do with Sudafed that can be used to make Meth.

  17. Molecular biology to the rescue- identify the non-tobacco nicotine synthesis genes in some uncontroversial vegetable like eggplant, CRISPR amplified versions into another, more prolific one, plant harvest, extract and vape.

    Cue calls to felonize vegans who inhale and raise the legal age for potato posession

  18. If i could quit smoking only because of vaping….check my story on vapor-mods.com

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