FDA Says Nicotine-Free E-Liquids Are Tobacco Products in 'Certain Circumstances'

Manufacturers will have to guess which circumstances those are, because the FDA won't say.


Smoke NV

This week, responding to one of the lawsuits challenging its e-cigarette regulations, the Food and Drug Administration (FDA) further muddied the question of whether those regulations apply to products that do not contain tobacco-derived nicotine. The lawsuit, which was brought by Nicopure, a manufacturer of e-liquids and vaping systems, argues that such a result would be unfair, illogical, and illegal. In response, the FDA says Nicopure has failed to show that any of its nicotine-free liquids are actually covered by the regulations and therefore has no standing to challenge that aspect of the rules. At the same time, the FDA concedes that "e-liquids marketed as 'nicotine-free' may properly be considered tobacco products—or components or parts thereof—under certain circumstances."

What circumstances are those? "Some e-liquids 'claiming to be nicotine-free actually contain[] high levels of nicotine," the FDA says, quoting its regulations. "Others are tobacco flavored, and are thus 'made or derived from tobacco' regardless of their nicotine content."

Does that mean e-liquids are not subject to the FDA's burdensome, prohibitively expensive regulations as long as they do not contain nicotine or any other tobacco derivative? No, because the FDA's definition of "tobacco product" does not require nicotine or any other tobacco derivative.

The Family Smoking Prevention and Tobacco Control Act, the statute that gave the FDA authority over tobacco products, defines them as products "made or derived from tobacco that [are] intended for human consumption, including any component, part, or accessory of a tobacco product." In deeming e-cigarettes to be tobacco products, the FDA defined "component or part" as "any software or assembly of materials intended or reasonably expected…to alter or affect the tobacco product's performance, composition, constituents, or characteristics" or "to be used with or for the human consumption of a tobacco product." Hence vaping equipment, whether a closed, disposable e-cigarette or an open system with a refillable tank and parts that can be switched out, is a "component or part" of a tobacco product, which means it is also a tobacco product.

Does that mean a nicotine-free e-liquid is a "component or part" of a tobacco product—i.e., the vaporizer? The FDA can't or won't give a straight answer to that question. "The only nicotine-free e-liquids that the rule brings under the FDA's regulatory authority are those that are made or derived from tobacco (such as tobacco-flavored varieties) or that otherwise meet the definition of a 'component' or 'part,'" it says. "Thus, nicotine-free e-liquids not made or derived from tobacco are subject to the deeming rule only where they meet the definition of a 'component or part.'…Whether nicotine-free e-liquids meet this definition 'will be evaluated on a case-by-case basis.'"

That means a company like Nicopure cannot know ahead of time which of its products are covered by the regulations. It can only find out by asking the FDA about each one, a process that will carry its own costs, even if they do not rise to the hundreds of thousands or millions of dollars that each "premarket tobacco product application" is expected to cost. The FDA's position is that Nicopure can't challenge the potential regulation of its nicotine-free e-liquids because it does not know whether they will actually be regulated. Never mind that it doesn't know because the FDA won't say.

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  1. Seriously, f*ck every three letter agency sideways.

    1. ^This.

  2. “Tobacco-free” means you’re not selling in the tobacco market and therefore fall under the purview of the FDA’s tobacco market regulation. Just like my socks are fat-free, sugar-free, gluten-free, and contain no peanut allergens and therefore the FDA can regulate them, too. If the guy raising wheat to feed his chickens is involved in interstate commerce on the grounds that he’s not involving himself in interstate commerce, not selling tobacco products is involving yourself in the tobacco market. What’s so hard to understand? I smoke cigarettes, you don’t smoke cigarettes – we’re both affecting the cigarette market equally, aren’t we?

  3. The FDA can’t or won’t give a straight answer to that question.

    The very best regulations are the ones you don’t even know you’re breaking.

  4. I used E-cigs (and eventually Chantix) to quit and these IDIOTS are costing lives with this crap.

    1. No they aren’t.

      1. What did you learn your style of argument from watching 2 minutes of Monty Python sketches before they explained the joke?

        1. I’m just wondering if he knows I am decrying the FDA???

          1. The FDA is not responsible for your nicotine addiction. Saying that they are costing lives or killing people doesn’t become not stupid through repetition.

            1. Sigh … OK — have it your way.

            2. Exactly, kind of like how if the government bans you from buying a gun, and you get killed by your ex because you can’t defend yourself. The government isn’t responsible for your bad relationship choices.

            3. HuffPo comments are about 30 IQ points higher than this. Jesus fuck.

              1. It’s definitely been getting derpier than usual the past few months.

          2. I was ripping on the other guy defending the FDA.

            You seem like a cool enough fellow. Much love to you. I’ll toss you a pint, since you seem cool.

            Can’t really do much to argue against non-seqiuiters.

            1. That’s for sure. And “OMG! The FDA is responsible for every smoking related death!” is quite a non sequitur.

              1. “OMG! The FDA is responsible for every smoking related death!” is quite a non sequitur.

                True. It’s also not what anybody actually said.

                Banning products that make it easier to quit smoking undoubtedly makes it more difficult for some people to quit smoking. Failing to quit smoking is, at the very least, worse for their health than the alternative. Since the FDA primarily works on banning life-saving drugs, it’s pretty minor by comparison, but still indefensible.

              2. Except that is not what I said. I can be 100% responsible for my addiction (which I was) and still be harmed by small-minded bureaucrats attempting to keep a helpful product away from me.

              3. Didn’t we have this argument the other day?

                The simple fact of the matter is that smokers have picked a way to stop smoking that wasn’t FDA approved. So some smokers have gone with a non FDA approved smoking cessation method, so now the FDA has to shut that down,

                1. We did, and someone said the same thing over and over and over.

                2. As some nitwit was helpful enough to point out above, if I say you can’t have a gun and then somebody else kills you am I responsible for your death? Did I “cost you your life”?

                  The other day, some yahoo made the claim that the FDA is literally killing people. Unless the FDA has some kind of hit squad, and they might, they aren’t literally killing people.

                  If you’re going to insist that the FDA is responsible for people dying, then you should be willing to insist that a doctor who failed to operate on a patient has killed the patient.

                  1. The doctor is controlling his own actions, the FDA and gun banners are controlling others actions. There’s a difference between “I refuse to give you a pill to save your life” and “I will ban something to save your life and out you in prison if you try to obtain it”.

                3. some smokers have gone with a non FDA approved smoking cessation method, so now the FDA has to shut that down,

                  They didn’t ask permission first or follow orders.

                4. And in a free society, what right does the FDA have to determine what smoking cessation product works best for me? If I want to lose weight, there are hundreds of different diets and supplements on the market to assist me in doing so, none of which are regulating by the FDA. Some of those supplements may be harmful to my health. Still not regulated. The fact remains this is a classic case of crony capitalism, and revenue protection, and nothing more. And I will ask again, why is the onus on the market to prove their products are safe? Is it not the duty of the government to prove a product is unsafe? Do we not operate on a presumption of innocence in this country?

                  1. Yes, in a just and free world the FDA would not exist. Making it harder, not impossible, to get an option, not the only option, makes them a pack of giant dickheads. It does not make them responsible for people dying.

              4. If they regulate a safer alternative out of existence, they are responsible.

                1. If they regulate a safer alternative the only option out of existence, they are responsible.

                  1. This is not difficult; there are two world lines: one where you physically prevent people obtaining a product that helps some percentage of them avoid smoking themselves to death, and one where you don’t. You are the only variable differing between the two, so you are responsible for that percentage.

                    If your part was passive rather than active, this would not be the case.

  5. The FDA’s position is that Nicopure can’t challenge the potential regulation of its nicotine-free e-liquids because it does not know whether they will actually be regulated. Never mind that it doesn’t know because the FDA won’t say.

    Reminds me of the EPA in the Sackett case. You can’t sue because we haven’t yet demanded payment for the $75k per day in fines that we are threatening you with…

    1. Does that logic make sense to anyone who is not a lawyer!

      1. Not a lawyer, here, but it makes complete sense from gubmint’s POV.
        Regulations, even some laws, are wonderful to use as a threat, to get you to conform, but not so wonderful if they get to a point where a court can declare it complete bullshit. That sets a precedent and they don’t get to use it as a threat, anymore.
        So, a great deal of what gubmint does, is come up with ways to avoid actually proving the veracity of its regulations, while using them, to the best of their ability, to force compliance.
        Getting around the laws, through encouraging lawsuits, by organizations the statists like, and the coming to a “settlement” that allows gubmint to violate its own laws, under the guise of a “court order”, is another tactic.
        Does anyone think government is on the up-and-up?

  6. The FDA’s position is that Nicopure can’t challenge the potential regulation of its nicotine-free e-liquids because it does not know whether they will actually be regulated. Never mind that it doesn’t know because the FDA won’t say.

    I’m sure they’ll just have to make a reasonable effort to make sure they’re following the law. “Reasonable” being whatever a judge and jury decide after the fact is reasonable. Just like with all the anti-discrimination and equal-access and public accomodation laws.

    1. I’m old-fashioned enough to think “fairness” in the law is a matter of drawing a bright line so everybody knows ahead of time what is proscribed – “Speed Limit 35 MPH” is clear, it doesn’t matter how skilled a driver or how good the reasons for going faster, you’re breaking the law if you go over 35 mph. Speed limit signs that just say “Don’t Drive Too Fast” are useless in determining beforehand whether you are breaking the law. But we’re getting vague laws you can get busted for breaking and – Hillary Clinton’s experience to the contrary – “I didn’t intend to break the law, I didn’t know I was breaking the law, I’ll stop doing that now that I know it’s unlawful” ignorance of the law is no excuse. Even – especially – when the law is made in such a way that ignorance of the law is a foregone conclusion baked right in. Why make a law people would be able to see ahead of time what is unlawful and exploit the loophole of avoiding doing what is unlawful? These sorts of laws fix that particular problem of not being able to prosecute law-breakers just because they didn’t break any laws.

      1. I’ve long grappled with the concept of “ignorance of the law is no excuse for breaking it.” I think that would be a fine enough precept if laws were simple and easy to follow. When it is virtually impossible to live without violating some law because legislatures just keep making more laws and the bureaus and agencies that make “regulations”, I think that ignorance of the law becomes a valid excuse.

        Break a law that is clearly posted or one that your parents told you not to do as a child (don’t kill, rape, steal, endanger others, etc.), pay the price. Break some obscure law that even the govt. didn’t know it had on the books until they wanted a creative way to punish you since they couldn’t find something obvious, that deserves jury nullification and a repeal of said obscure law and re-enactment.

        An idea I’ve had for quite a while is that the legislative branch should be tied up in busy work to keep them out of trouble. Most laws need to have sunset clauses. Legislatures should be required to repeal a certain percentage of old laws in order to pass new ones. Wrap up disparate laws into more comprehensive packages and repeal a bunch that are now covered by the new law. We also need to do this to get rid of the practice of charge-stacking. When someone commits a crime, it doesn’t need a special consideration that a firearm was used. It doesn’t need a special consideration that it was during the sale of drugs.

        1. Don’t forget that SCOTUS has even recently ruled that an unjustified stop based on the officer’s ignorance of the law is still a legal stop. The police are not responsible for knowing the laws they are enforcing, but a citizen is responsible for knowing the law he is breaking. Sounds about right.

        2. “Ignorance of the law can be no excuse” is a maxim which is really only just or moral under something resembling a common law. In places like California, where there is literally not one person alive who has read and grokked the entirety of the penal code, this maxim (and its necessity to the lawful enforcement of endless legislation) underlines the fundamental immorality of legislation not derived from common law.

      2. These sorts of laws fix that particular problem of not being able to prosecute law-breakers just because they didn’t break any laws.

        “Say, that’s a nice e-liquid company you’ve got here, be a shame if something happened to it.” Something tells me Nicopure will be able to avoid any hassles with a few envelopes of cash discreetly delivered to the right people.

  7. And yet, when I suggest that the FDA is a pointless agency that should be eliminated, people look at me like I’m crazy. Because apparently the FDA is the reason people don’t eat rotting meat with poop on it or something.

    1. The ONLY reason evil KKKorporations are not selling people rotting meat with poop on it is because the FDA won’t let them.

      1. Doesn’t the FDA allow a certain % of foreign material in most food products?

  8. the FDA’s definition of “tobacco product” does not require nicotine or any other tobacco derivative.

    It’s Kafka’s world, we’re just living in it (lucky us).

  9. That means a company like Nicopure cannot know ahead of time which of its products are covered by the regulations. It can only find out by asking the FDA about each one, a process that will carry its own costs,

    Feature, not bug. I’m pretty sure the FDA’s goal here is to regulate e-cigs out of existence. Because it’s so much better if people smoke real cigs, apparently. What a bunch of cunts.

    1. Well, it is more profitable for the government, anyway.

  10. And thus we arrive at the conclusion, using the FDA’s logic, whereby if a thing tastes like tobacco it must therefore be tobacco. We have arrived at a post-logic regulatory scheme. We’ve been there for a while, actually, but E-Cigarettes have made the mask fall all the way off.

  11. If only Obama knew about this gross abuse of Federal regulation.

  12. They have mastered the way of the Doublespeak. They will soon reach enlightenment.

    1. Eventually the dollar bills will say “This note is legal tender for all private debts and select public debts.”

  13. Sometimes an e-cigar is just an e-cigar.

    1. Sometimes it’s vapor gum.

  14. This is the exact opposite of reality and science. So perfect government.

  15. Sounds like typical bureaucratic double talk,aka Miedra del torro

  16. Review of history and fact: FD(+CTP)A, by law, has power to regulate tobacco products. Other laws give oversight on food and drugs. If there’s confusion (lawsuits, of which there’s 1000s of examples), then courts and judgements clarify, set precedent.

    So, ecigs or eliquids are what? Are you DTF? Means one thing on tinder, another in this context. Not T? Then say you’re a Drug. Start clinical trials. If you market your product to be used like a smoker uses cigarettes, then not D (‘drug’ path). Make no cessation or reduced harm claims and stay on the market without clinical trials (T path).

    I like the F path, personally. These products are for human consumption. Sottera defined the drug/tobacco turf & nicopure has lawyers billing by the hour without knowing wtf the goal is. Nicopure needs a spin off with different name as they, not the FDA, by precedent and their own marketing activities (not to mention a pointless suit) place themselves under the tobacco ctbanner. FDA can’t tell how you’ll fall under their regs – the maker, by message or claim determines that.

    For the 3 souls who’ve read this far and are relevant in the industry: If you want to get out of the path of the FDA / CTP train and on the train I just hinted at… Leave your email or LinkedIn link.

  17. The Abyss and i love it .

    One of my 3 ADV’s. I could write 50 pages about this juice but you really need to try it for yourself!!! To DOMINICK HEALEY, who said CC is expensive, at VapeTen’s website it’s only $18.88 & get 25% off with code: vc10. So that makes it $14.16 for a 30mL. I highly recommended you buy all 3 flavors.


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