The FDA Keeps Us Guessing About the Scope of Its E-Cigarette Regulations

Are nicotine-free e-liquids covered? Maybe. What about synthetic nicotine? Dunno.


Next Generation Labs

Next Generation Labs, which makes synthetic nicotine for e-cigar­ettes, argues that a recent statement by the Food and Drug Administration shows the agency does not plan to regulate e-liquids as tobacco products unless they contain ingredients derived from tobacco. I don't think the statement shows anything of the kind, but I can't be sure. Like the FDA's other pronouncements on the subject of what is covered by its potentially ruinous e-cigarette regulations, the statement cheered by Next Generation Labs is hard to decipher.

Here is what the FDA said last month in response to Nicopure v. FDA, a lawsuit by a company that sells e-liquids and vaporizers:

Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a "component or part"—that is, if it is "intended or reasonably expected" either "(1) To alter or affect [a] tobacco product's performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory."…An NFL that is intended or reasonably expected to be mixed with liquid nicotine would qualify as a "component or part."

The FDA is quoting from its own interpretation of the Family Smoking Prevention and Tobacco Control Act, the 2009 law that gave it authority over tobacco products. Since that law says a tobacco product must be "made or derived from tobacco," you might think it's obvious that an e-liquid is not a tobacco product if none of its ingredients is derived from tobacco. But the FDA says that e-liquid still might be a tobacco product because someone—a distributor, a retailer, or a consumer—could add nicotine to it later.

Even if the e-liquid never contains nicotine, it would seem to qualify as a "component or part" of a tobacco product if it is consumed in a vaporizer that also can be used to inhale nicotine. By the FDA's reasoning, that vaporizer is a component of a tobacco product, meaning it is itself a tobacco product. Hence any e-liquid used with that vaporizer, whether or not it contains nicotine or any other tobacco derivative, is also component of a tobacco product.

As far as I know, the FDA has neither endorsed nor rejected this understanding of the law, despite many opportunities to do so. But the interpretation is consistent with the agency's broad view of its authority under the Tobacco Control Act. Assuming the FDA reads the law this way, an e-liquid could escape regulation as a tobacco product only if it was part of a closed system that was incompatible with e-liquids containing nicotine. If a company specializing in nicotine-free liquids packaged them in cartridges that could be used only in that company's e-cigarette, the liquids presumably could not be considered components of a tobacco product. That approach would also avoid the possibility that nicotine added to the e-liquids by someone other than the manufacturer would retroactively transform them into tobacco products, as suggested by the FDA in its Nicopure brief.

What does all this mean for e-liquids that contain synthetic nicotine? The possibility that someone would add tobacco-derived nicotine to them seems remote, so Next Generation Labs needn't worry about that (I think). But e-liquids containing its TFN-brand nicotine could still be deemed tobacco products if they work with multipurpose vaporizers. The company is therefore collaborating with Vapeix to develop a "cloud-connected smart vaporizer platform" that works only with e-liquids containing TFN nicotine. Next Generation cofounder Ron Tully says the alliance aims to "create a vape market which is unequivocally disassociated from traditional vaping devices that are intended to be used with tobacco-derived nicotine."

Legally, it seems like that strategy could work. But I can't see how the FDA statement cited by Tully's company, which addresses (or avoids addressing) nicotine-free e-fluids and is similar to maddeningly vague statements the agency has made before, makes the project any more promising.

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  1. But the interpretation is consistent with the agency’s broad view of its authority under the Tobacco Control Act.

    Is this another situation where the regulatory agency’s interpretation of a law is the only thing that matters?

    1. What Jacob describes is consistent w how it works w medical devices, so why wouldn’t FDA act analogously w the authority Congress later gave them over “tobacco prods.”? It’s like, “Congress knew how the agency acted under previous enabling legisl’n, they would’ve written it differently if they didn’t want this stuff treated similarly.”

      1. You’re right about med devices Robert and Congress, or the authors of the FSPTCA at least, knew exactly what they were doing. Their goal always has been to regulate out of existence, or at least protect the cigarette monopoly and the tax revenue it brings in.

    2. I keep hoping against hope that some groups will come together and throw their weight behind cases designed to start chipping away at Chevron.

  2. This is really unfortunate, seeing as how I know many people that have quit smoking using a vape product. I would really think any vape product would be better than cigarettes.

    1. “I would really think any vape product would be better than cigarettes.”

      Any person with at least 2 brain cells they can rub together for warmth would think that. But we are talking about people so stupid, the only job they could get hired is in the government.

      1. This is very true. And obviously I dont think they really give a shit about public health either.

        1. Yes. They are not stupid. They are evil.

    2. Europe has a progressive stance on Vaping for this reason. FDA is more interested $$$

  3. I wonder how many votes the FDAs idiocy about e-cigs has cost the dems? I know vapers are a small minority, still outnumbered by smokers, but looking at the margins in places like FL, MI, WI, and PA, they might not be such an insignificant factor.

    1. I voted for my incumbent Republican rep. because he co-sponsored a bill to roll this shit back despite the fact that there was a Libertarian on the ballot. So yeah.

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  5. So sad that R&D has to be diverted into developing devices that specifically disable machinery in certain ways just to avoid legalities. Like the technologies that are used to skirt Jewish Sat. restrictions.

    1. Except that nobody is forcing anyone to be Jewish or to “observe” the sabbath. OTOH, you cannot opt-out of those government regulations.

  6. So water (possibly used in a hookah with tobacco) is a tobacco product?? (welcome to newspeak)
    Synthetic nicotine is not a food, it is not tobacco, so butt out.
    (I neither smoke nor vape, I just hold to the fantasy this country was founded on individual freedom)

  7. Vagueness is a feature not a bug. The thing that really gets them off is saying something is “legal”, then changing their minds and making a company stop producing their previously permitted product. For extra fun, they make the company they are destroying try to buy back the products they already sold at the company’s expense.
    How many times have the various three letter agencies done this already?

    1. You beat me to it. Its all designed around what is meant TODAY. Yesterday was yesterday. As you state, it is to be used as a weapon.

      Sounds like we need some of that “common sense reform” at the FDA. After all, that’s how we got the Family Smoking prevention and Tobacco Control Act. Common sense reform that had no ill affects, remember? At least the only sincere word is right in the title. Control.

  8. Typical government speak. Nothing fixed, nothing you can point to and say “But you said…” Keep the maximum possible fluidity because you never know what company or product you might want to go after in the future. The rule of law is unimportant and is actually an impediment to a “properly” regulated economy.

  9. E-Cigarette business to hit 10 billion by 2017.

    What new prohibitive FDA regulations will actually do is consolidate the sprawling, dynamic vaping industry into the hands of two Tobacco giants!

    1. That’s the plan. The only real hope for vapers is that Trump will shut this shit down. To date, I have no idea where he might stand on the issue.

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