Vaping

Kellyanne Conway Says the FDA Has No Jurisdiction Over Vape Shops. The FDA Disagrees.

The distinction the presidential adviser draws between e-cigarettes and other vaping devices contradicts the FDA's understanding of its authority.

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Presidential adviser Kellyanne Conway suggested yesterday that the Food and Drug Administration (FDA) may decide to exempt vape shops from its pending ban on flavored e-cigarettes. There is a certain logic to that, since those shops, unlike other retailers, do not admit minors, and curbing underage vaping is the rationale for the ban. But it's not clear that approach would be legal. Furthermore, Conway's assertion that the FDA "do[es] not have jurisdiction over vaping and vape shops" is puzzling, given how the agency understands its regulatory authority.

The FDA derives its authority over vaping products from the Family Smoking Prevention and Tobacco Control Act, which allows it to regulate "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product." Although e-cigarettes do not contain tobacco, they typically deliver nicotine that is derived from tobacco, and in 2010 the U.S. Court of Appeals for the D.C. Circuit agreed that is enough to make them subject to FDA regulation.

But the Tobacco Control Act also says the FDA may not "prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets." On its face, that provision means the FDA may not ban sales of flavored vaping products in convenience stores while allowing them in vape shops.

That is how the National Association of Convenience Stores reads the law. "The Tobacco Control Act is clear that the FDA can't discriminate against one type of retail outlet, and that's what they're trying to do here," Doug Kantor, a lawyer for the trade group, told The New York Times when the issue came up last year. "There is a very good chance this will end up in litigation."

Conway seems to be suggesting a way around that obstacle by arguing that the FDA simply does not have jurisdiction over open-system vaporizers (as opposed to cartridge-based products such as Juul) and the e-liquids used in them. But that is plainly inconsistent with the way the FDA has interpreted its regulatory authority under the Tobacco Control Act.

According to the FDA, any device that can be used to deliver tobacco-derived nicotine qualifies as a tobacco product, and so do the e-liquids used with such devices. The agency says even a nicotine-free e-liquid (NFL) can count as a "component or part" of a tobacco product. "Assuming an NFL is not made or derived from tobacco," the FDA says, it is still subject to the agency's e-cigarette regulations "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.'" Hence "an NFL that is intended or reasonably expected to be mixed with liquid nicotine would qualify as a 'component or part.'"

Contrary to Conway's comments, the FDA plainly believes it does "have jurisdiction over vaping and vape shops," which is consistent with the interpretation upheld by the D.C. Circuit. And if open-system vaping devices and the e-liquids used in them are indeed tobacco products subject to FDA regulation, the Tobacco Control Act seems to preclude a flavor ban that is selectively applied to "a specific category of retail outlets."

Perhaps what the FDA plans to do is ban flavored cartridges everywhere, based on the premise that Juul-like products are the ones preferred by teenaged vapers, while allowing flavored e-liquids used in open-system devices. But that distinction would not draw a line between different categories of retailers, and it would not rely on a new understanding of the agency's authority.

Last year the FDA proposed a rule that would allow sales of flavored e-liquids in stores that do not admit minors (i.e., vape shops) or that put those products in "a section" that "adequately prevents entry of persons under the age of 18," as long as the products "are not visible or accessible to persons under the age of 18 at any time." Although that approach notionally allows convenience stores to continue selling flavored e-liquids, the segregation requirement probably would be prohibitive in practice. It is therefore not clear such a rule would pass muster under the Tobacco Control Act. While allowing adults to continue buying flavored e-liquids from some sources is certainly preferable to a blanket ban, I'm not sure how that policy can be reconciled with the law.

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  1. The federal government has no constitutional authority to ban products or services.

    States dont have plenary powers and no state constitution, that I have seen yet, provides for the power to ban products and/or services.

    There is the power to regulate. As evidenced by the 18th Amendment passage by Prohibitionists, regulation was not their goal but a ban, which required a constitutional amendment.

    1. They don’t ban them, they just make it illegal to buy or sell certain things without the proper tax stamp, of which they issue none.

      1. That’s a de facto ban.

        Either the super majority agree that the government derives its powers from a Constitution or we don’t.

        If we don’t agree, then lets quit this charade of “United” States of America. If we can’t agree on the most basic common principles of how our government works, then lets end this Union.

    2. Nah. By the time the 18th Amendment was passed, many individual states had already passed bans and were allowed to because it was considered to have fallen under their state regulatory powers. The reason the 18th Amendment was needed was because the federal gov’t only has the authority to regulate interstate commerce.

      If you’re wondering why this didn’t apply to the FDA, its because FDA powers were created over time with 21 different acts of Congress, under different rationales and auspices. Originally, under the Pure Food and Drug Act (1906), it did only apply to interstate commerce. It later incorporated provisions under the Biologics Control Act (1902) which regulated biological agents which had interstate implications. The major expansions happened under FDR in the 1938 and 1944 after Prohibition had ended; the first was constructed to try to apply interstate powers to intrastate regulation, by targeting drugs that were said to be used or produced in more than one state, and the second was quarantine authority. The 1938 act has been argued Unconstitutional, though, because of the way it loosely applied the interstate commerce clause, and it also had provisions in it that were expanded to give the FDA more power than was clearly stated in the original act.

      1. Those state bans were unconstitutional too. Which is the point made here.

        If most of the states had bans then why would the federal government need a national ban? Because the local bans were not good enough. Local police could not stem the tide of booze from non-dry jurisdictions. Turns out they were unconstitutional too.

        1. You’re talking about the local bans being ineffective, not unconstitutional.

          There are some libertarian arguments that the bans themselves are unconstitutional ; but regardless, at that time in history, the ability to ban certain forms of commerce had already been widely considered an acceptable use of regulatory powers (there are many examples), and if the Congress just sought to ban interstate sale and trafficking of alcohol, they would have been able to pass that without it being given Constitutional scrutiny.

          1. Btw, I hope we’re on the same page in talking about commercial bans rather than total bans. Prohibition did not ban personal use of alcohol. As the 18th Amendment describes, it allowed a ban on “manufacture, sale, or transportation” of alcohol.

            1. Commercial ban was effectively a personal ban.

              Not everyone knows or is able is able to manufacture intoxicating beverages. The goal of the Temperance movement (women progressives) was to force personal compliance with alcohol free life by cutting off the supply of alcohol.

              It was a de facto national ban on alcohol and failed. Just like the war on drugs failed.

          2. Im talking about both. The ban of alcohol (and currently drugs) are unconstitutional and the local bans of alcohol in cities were ineffectual so the Prohibitionists sought a US Constitutional amendment to bring the hammer down on nascar drivers 😉


        2. Those state bans were unconstitutional too. Which is the point made here.

          That’s less clear given that the federal constitution leaves it somewhat open as to what the specific powers of the states are. Just like it’s somewhat open as to what all specific rights people have are.

          The fed is empowered to regulate interstate commerce, but obviously the fed’s definition of what constitutes ‘commerce’ is expansive enough to drive an aircraft carrier through.

          1. While the expansiveness of interstate commerce is open to wide latitude, there are still basic defining characteristics. INTRASTATE commerce is not under federal authority.

            Alcohol created by a non-multistate business and never crosses state lines is intrastate commerce. The federal has zero authority to regulate that product.

    3. I don’t think you are right about this. Where does it say that states are limited to powers enumerated in their constitutions? That’s explicit in the federal constitution.

      1. You are putting the cart (state power) ahead of the horse (state constitutions).

        The horses give the carts their power to move forward.

  2. I can see someone developing a subspecies of pepper or tomato that contains high amounts of nicotine, so then the it need not be derived from tobacco

    1. Some guy already did; inspired by the Simpson’s Tomacco episode.

      Google: Simpsons Plant Seeds of Invention , Wired article (I’d link but Reason hates me).

    2. The FDA has been down that road. Search “FDA synthetic nicotine” and you’ll find their answer. I tried to link it, but my comments keep getting eaten by squirrels. I’ll quote it below.

      “Q: The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?”
      “A: The definition of “tobacco product” includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA’s tobacco control authorities.
      However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”

      1. So they conflate a thing containing nicotine to a tobacco product even if the nicotine comes from something else other than tobacco because it conceivably could or something.

      2. That makes no sense. Couldn’t they just as well argue that they can regulate paper and water as tobacco products because they are components of cigarettes?
        Are they actually arguing that anything that looks like smoking can be regulated as a tobacco product? Almost seems that way.

  3. When did a federal agency ever see something it didn’t want to regulate? Of course they disagreed.

  4. It’s already illegal to sell vape to minors in my state. Here’s a thought. Enforce the laws you already have before mucking with anymore. Applies to so many things it’s ridiculous.

    1. But enforcing existing laws would be common sense, so we would not need bureaucrats.
      Also, their goal is to ban all vape products, so even if you restrict access, there will always be the potential that a 12 year old could get their hands on them, just like they can get into mom and dad’s liquor or medicine cabinet. But for some reason, I don’t hear anyone calling to ban flavored alcohol

  5. I have to admit, as with most regulation I have no idea what’s going on here. This comment serves to put everyone here on notice that that is the case.

  6. There is at least one manufacturer who get their nicotine from eggplant leaves. No tobacco. The liquid is put into a vape tool. No smoke.
    Still under FDA control of tobacco and smoking products?

  7. “According to the FDA, any device that can be used to deliver tobacco-derived nicotine qualifies as a tobacco product, and so do the e-liquids used with such devices. The agency says even a nicotine-free e-liquid (NFL) can count as a “component or part” of a tobacco product. “Assuming an NFL is not made or derived from tobacco,” the FDA says, it is still subject to the agency’s e-cigarette regulations “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.'” Hence “an NFL that is intended or reasonably expected to be mixed with liquid nicotine would qualify as a ‘component or part.'”

    Fucktard Proggie Nannystaters gonna Nannystate.

  8. “According to the FDA, any device that can be used to deliver tobacco-derived nicotine qualifies as a tobacco product?”

    So when does the FDA plan on starting to regulate gum and do they intend to ban the sale of flavored gums to minors?

    1. An eternal question with no answer. Essentially the FDA likes to make carve outs for ‘cessation’ devices, even if I know tons of people that just switched from cigarettes to gum even before e-cigarettes came on the market. It’s a flimsy justification at best.

      1. Perhaps, a carve out for cessation “devices”.

        However, by the FDA’s reasoning here because nicotine gum exists, all gum of any flavor is legally a tobacco product.

  9. “contradicts the FDA’s understanding of its authority”

    It never ends well when government is allowed to ‘understand’ its own authority.

  10. FDA’s interpretation of the statute is total horseshit as any rational person knows. It seems that Trump wants to mitigate the harm these vape bans will create. I am hopeful he will succeed. And just a reminder to those suffering from TDS. Obama’s FDA was poised to essentially ban vaping altogether. If HRC were president it would have been a done deal by now.

    1. So you are saying that if Turmp’s FDA bans flavors people who depend on those flavors to cease smoking should be grateful and vote for Trump again because the other team would have banned harder?

      Not sure I like my odds in this horse race, think I’ll pass.

      1. He sent his talking Barbie doll out to make the vape ban less onerous. Not all bad.

      2. Also, it’s an open question if Trump’s FDA decides to go forward with the ban he could be obstructing justice by firing or stopping them from doing so.

        /sarc, if it wasn’t clear.

        1. You may think it’s sarc, but some group would sue to stop FDA’s mitigation of their ban as arbitrary and capricious. It really does look like, once an agency takes a position that the law is such-and-such, that it would take an act of Congress to turn that around. See the automobile passive restraints fiasco of the 1980s, when the Reagan administration tried to mitigate what the DOT took as a mandate.

          1. I’m sure there’d be similar litigation against DOJ (with the president leaning on them) transferring marijuana to a less restrictive control schedule, saying the known facts hadn’t changed since DEA said it had such high potential for abuse and no accepted medical use.

  11. We all know the FDA shouldn’t exist so what are we really talking about?

    1. reason wont admit that the US Constitution provides no authority to form the FDA let alone the power to ban products or services.

      Hence the wacky pro government power articles around here.

  12. Stop the ban on intermate commerce.

    What? Wait. Oh? Nevermind.

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