The FDA has announced its initial regulatory intent with ecigarettes:

Health warnings would also be required and the sale of the products in vending machines would be prohibited. Initially, the only health warning required for e-cigarettes would be about the potential for addiction to nicotine.

Manufacturers would be required to register all their products and ingredients with the FDA. They would only be able to market new products after an FDA review, and they would need to provide scientific evidence before making any claims of direct or implied risk reduction associated with their product.

Companies would also no longer be allowed to give out free samples.

After the public comment period and once the proposed rules are finalized, manufacturers will have 24 months to submit an application to allow their products to remain on the market or submit a new product application.

E-cigarettes deliver nicotine to the user as a vapor. They are usually battery-operated and come with a replaceable cartridge that contains liquid nicotine. When heated, the liquid in the cartridge turns into a vapor that’s inhaled.

As someone who was expecting our own regulatory proposals to mirror Europe’s, I am honestly quite relieved. Counterproductive in some areas, but in others I don’t think they went far enough. Yet, that is. Which is the caveat. The indications are that there will be more to come.

What they should have done, and did:

They restricted purchasing to minors. This may have been a non-issue, but if nothing else this will save countless jurisdictions across the country from having to pass their own laws and ordinances.

They prohibited free samples and restricted vending machines. This was not a problem yet, but was a potential future problem. There are people we want to get ecigarettes, and there are people we would rather not get them. While – except for the case with minors – I don’t want the law determining who can and cannot get them, I think it’s probably good not to encourage it for everybody when it’s just a subset of the population that we want to go that route.

They requited companies to register their ingredients. This is going to drive up costs of ejuice, which I don’t like. Ultimately, though, quality control is sadly a necessity. If left unbound, it’s pretty easy to imagine that companies will start needlessly putting more chemicals into the juice to ramp up addiction and/or increase performance in unnecessarily unhealthy ways. There is, I should point out, only very little evidence that this has happened thus far. Rather, there is evidence that some have, but not that it is particularly widespread. Cigarettes contain over 1100 carcinogens, and the “damning” study of ecigarettes found nine.

What they should have done, and did not do:

Restricting general advertising: My primary worry with advertising is the extent to which the ecigarette companies are going to shoot themselves in the foot and justify future regulation later. Since I don’t want ecigarettes to be a general-use product, I think there are good arguments for letting this primarily work through word-of-mouth. When I was in Vegas, I actually talked to a couple of people who were wondering what it was I was smoking. That’s probably the best way for expansion to occur. This is especially true given that ecigarette companies can’t advertise on the basis that I would want them to. Moe on this later.

Bottling requirements: As Lain has grown taller and her fine motor skills have improved, I’ve been scrambling to figure out what to do with the ejuice that would be toxic for her if she got a hold of it. Many of the fears in this domain are overwrought, and arguably the lack of child-proof containers has made me more vigilant about keeping it all out of her reach than I otherwise might be (falsely assuming that child-proof actually means child-proof). However, it’s still poison and I would like this issue removed from the table as a basis to prevent ejuice sales. From my own standpoint, among the last things I want is for the industry to be limited to hard-packed cartridges. It’s one of the few things that could have me smoking again.

What they should not have done, but did anyway:

They went overly restrictive on health claims: At least, I think they did. I understand the concerns of overstated health claims. They’re legitimate. The end result of this, though, is that ecigarette makers cannot market the product for what we want it used for (smoking cessations and alternatives) and will have to market it on the basis of what we don’t want. That it’s cool, sexy, and so on. As Dr. Siegel said: [T]his is going to force companies to rely on other methods to pitch their products, such as using sexy models, emphasizing that e-cigarettes can be used where tobacco cigarettes are allowed, and relying on celebrity endorsements. The FDA is literally forcing e-cigarette companies to lie about their products and instead of pitching them as safer alternatives to smoking, to pitch them with non-health-related benefits. The rules are so stringent that they theoretically cannot even make the factual claim that ecigarettes do not emit smoke.

Requiring pre-approval for new products: This makes more sense for cigarettes than it does for ecigarettes. We want ecigarette device manufactuers to improve their product and this will make innovation more difficult. Had this been passed ten years ago, we probably would not have the effective devices that we do now that helped me quit smoking. Better devices mean more flexibility with ingredients, which in turn means that the FDA can more tightly regulate what goes in the ejuice without affecting performance. This one may have been a necessary evil, though instead of punting regulations about advertising to some future date, I wish they’d shown more flexibility here. On the upshot, they are not requiring pre-approval for two years. I wish they had made it five. (Devices over the next two years will require approval, but can sell in the meantime.) Or put more simply, this is something that probably did need to be done, but did not need to be done this early.

What they should not have done, and did not do:

They did not restrict online sales (for adults): This was one of the things I was most afraid of and one of the things that health activists were asking for. Restricting online sales would have either required me to transition back to the cartomizers (cartridge-based devices like Blu or NJoy) or drive an hour to the nearest vaping shop. It would have increased costs considerably and in the case of cartomizers would have more than wiped out the price advantage. I switched away from cartomizers in good part because when I did the math, the Blus were not actually saving me money compared to Camels. That was with online sales. Without, Blus would have been more expensive. Further, knowing that I would be able to order products online as well as getting them at supermarkets was one of the things that convinced me that ecigaettes were available enough for me to make the transition. (I can elaborate on this if anyone is curious).

Restricting tank sizes: This one was of the more inexplicable things that the EU did in their own Tobacco Prime Directive. In and of itself, it is not actually all that big of a deal. For me personally, it would likely have resulted in my having to toss all of my current devices and start again from scratch. This would have been a huge hit for me personally, though not an end-of-the-world thing. What would have really disturbed me about it is that it serves absolutely no purpose and would have signaled to me that the government was primed up to toss out regulations that sounded effective but had little basis in how the product was actually used.

They do not require health warnings that are false or misleading. There were calls for ecigarettes to contain the exact same health warnings as cigarettes, where they clearly do not apply. Anti-ecigarette activists are becoming increasingly insistent that ecigarettes are, health-wise, the equivalent of regular cigarettes. (Do they really think that if I can’t quit, I should just go back to smoking?). Instead, the only required warning is that nicotine is addictive. This is sufficiently uncontested as to be unobjectionable. In between what the activists wanted and what actually occurred (or didn’t occur), I was also fearful that they would simply find potentially misleading but technically true disclaimers (“The FDA has not determined that ecigarettes are any less dangerous than conventional cigarettes”). But they haven’t done anything except stick to nicotine-is-addictive, which is good.

They do not ban the use of flavoring. One of the more irritating aspects of the debate has been the insistence that the only reason the ecigarette companies use flavoring is to attract children. But adults like flavoring, too. Nicorette uses fruit flavoring. It also provides a unique advantage of ecigarettes over the conventional sort. These are helpful because they prevent relapsing. They also provide a barrier to “gateway” concerns. If you’re puffing on fruit flavors, that’s something that conventional cigarettes can’t deliver on. If what you’re puffing on has to taste like tobacco, then it’s a much shorter leap to conventional cigarettes. I am personally not remarkably concerned about gateway effects to analogs, but critics of ecigarettes are. If they are, then this should be welcome.

As just about any regulation would, this will comparatively favor the major producers. In this case, it means the tobacco companies that have the money and the distribution networks. However, this doesn’t come close to the sort of standardization requirements I had feared that could have – if taken to excess – pushed the industry into the cartomizer storefront segment and away from more effective devices that may succeed (in helping people to quit smoking) where the cartomizers fail. One of the important things about being flexible here is that smoking cessation is so tricky that you want as many avenues as possible. That includes not just the existence and availability of ecigarettes, but other things like flavoring and a variety of delivery devices.

The long and short of it is that this is probably the best I could have hoped for. They got some things right and other things wrong, but this is actually probably better than we would have gotten under President Romney or President McCain. The big thing here for regulators is the FDA taking ownership here. This allows them to fight future battles and pile on at a later date if they muster the support (popular or scientific). Even if I don’t agree with all of it, the fact that there is at least a basis for doing what they did – in contrast to the EU – and they are genuinely taking a wait-and-see perspective gives me hope that a reasonably good precedent has been set. Some degree of regulation was necessary, and this starts it off on something resembling the right foot.


Category: Statehouse

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4 Responses to The FDA Finally Moves on eCigs

  1. A 4 says:

    I hope you are planning to comment on the proposed rulemaking. It’s never clear if it makes a difference, but if you make cogent points, they have to pay attention enough to at least respond, and so you can get inside someone’s head at FDA. Pointing out unintended consequences is particularly useful – even if they seem obvious, they may not have been thought of by the rule writers.

    I think the point about advertising is particularly good. FDA has a history of not allowing statements regardless of truth (red wine, e.g.), but it’s worth a try.

    You’re already most of the way there with this post.

    • Will Truman says:

      I suspect that the advertising is probably the last changeable thing since i would be stepping on the toes of the FDA’s drug standards (that anyone wanting to make health claims has to prove it to the FDA’s satisfaction.

      They might be more flexible on some of it, though. Apparently the ecig makers are actually barred from saying that ecigs do not emit smok.

      • A 4 says:

        It seems so strange to me that the industry won’t be able to mention harm reduction, which seems like the big value to e-cigarettes, much more that stopping smoking, which the stats suggest is not that likely.

        I don’t know how they calculate quitting stats, though – if I switch to e-cigarettes, does that count as stopping smoking, even though I’m still addicted to nicotine?

        I can see regulating these as a nicotine delivery device (a drug, like the gum) more so than a tobacco product, but I don’t know which is worse for the industry.

        • trumwill says:

          It seems so strange to me that the industry won’t be able to mention harm reduction, which seems like the big value to e-cigarettes, much more that stopping smoking, which the stats suggest is not that likely.

          The official line is, smoking reduction does not produce health benefits… but increasing smoking increases them. I kid you not. That’s the message they’re trying to convey and have no problem making both arguments.

          The data on it is actually mixed. It seems like there is a really low threshold where volume starts to matter less.

          According to the New Zealand study, it is as effective or more effective than the patch. Which is less effective than many had hoped, but still isn’t nothing. I also wonder if the numbers look better further out. The timeframe the NZ study looked at was not particularly long. If I recall, it would have tagged ecigarettes as a failure for me. The transition just took a while.

          The studies showing that it’s completely ineffective and/or counterproductive are (as far as I’ve seen) pretty flawed. No random assignment, for example.

          I’m sincerely glad I made the effort before the naysayers started working to convince everybody that it was not an effective device. They might have talked me out of it.

          I don’t know how they calculate quitting stats, though – if I switch to e-cigarettes, does that count as stopping smoking, even though I’m still addicted to nicotine?

          Yeah, that counts. While nicotine is dangerous, it’s not dangerous on the same level that smoking is. Of course, cardiologists see things differently.

          I can see regulating these as a nicotine delivery device (a drug, like the gum) more so than a tobacco product, but I don’t know which is worse for the industry.

          Drug delivery device is much worse. The pharmaceutical companies are (kind of) understandably pissed off that they had to jump through all of these hoops that the ecigarette industry doesn’t.

          The counterargument is that it’s important not to make these things less accessible than cigarettes. That’s hard to do if they’re regulated as MDD’s. The other factor is that it’s not clear that anybody in the ecigarette industry would actually jump through the required hoops, as nobody has a patent on the basic mechanism. So they wouldn’t be able to reap the rewards after spending millions on compliance and certification.

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