FDA’s Low-Nicotine Cigarettes Rule Is A Dire Threat To Vaping

Carl V. Phillips | Contributor

The FDA has officially released the advance notice of proposed rulemaking for the plan they have been hyping for most of a year, mandating very low nicotine content for cigarettes. There will be much to report about this over the coming weeks. But it is worth starting with the not-so-simple question: What would this rule (if it happens, and that is a huge “if”) mean for vaping? A simplistic analysis suggests it would be positive, but after thinking a few moves ahead it looks quite dire.

The goal of the proposal is to make cigarettes unappealing. It is dressed up in other claims, particularly making them “non-addictive,” but that is just rhetoric. Eliminating the nicotine from cigarettes — and all signs point to the FDA requiring such a large reduction it might as well be described as eliminating — dramatically lowers their quality as a consumer product. Nicotine is not the only appeal of smoking, but it is most of the appeal for most smokers.

Implementing this rule would cause many smokers to switch to black-market cigarettes and many others to stop smoking. Those who quit will not magically lose their taste for nicotine, and so the rate of switching to vaping and other products will increase dramatically. Those who find the black market inconvenient — despite it being much cheaper in most jurisdictions and its inevitable dramatic expansion to accommodate the new demand — would also have the incentive to consider switching.

A dramatic expansion in demand is usually good for consumers. So, is this good news for vaping?

Here is where it begins to get complicated. Increases in demand are good for consumers because they lead to new producers entering the market, innovation and increased economies of scale. These mean better and cheaper products. But the FDA has already effectively banned innovation in the vapor product market, and most potential entrants will be scared off by the approaching 2022 blanket ban of vapor products. (Technically it is an application filing deadline, but the applications are astronomically costly and will almost all be denied.) If the low-nicotine policy is implemented, following natural delays and probably temporary injunctions by courts, it will take effect close to that deadline. The main effect on the vapor product market will be producers enjoying a last flurry of profits before shuttering their operations. They will ramp up production as much as they can without making unrecoverable investments, but mostly they will take advantage of the increased demand to improve their margins (i.e., raise prices).

Of course the plan — or perhaps it is better called a hope — is that an act of Congress or a change of heart at the FDA will eliminate the 2022 doomsday as currently codified. Indeed, even if smokers do not manage to organize to fight the low-nicotine proposal, the influx of angry ex-smokers into the activist vaping community could tip the scales for stopping the near-ban. The cry, “We quit smoking just like you demanded, and now you are doing this?!” is already a fairly potent political argument, and it will become even more so.

That would be good news for vaping. Except things are even more complicated.

Presumably the cigarette manufacturers who do not exit the market would try to limit the reduction in quality to the one mandated change, lower nicotine. So if consumers could figure out how to reverse that one change, they would have a product that is almost as good as the original. If only there were some easy way to obtain nicotine in a form that could be added to a cigarette.

Long before the cigarettes on the shelves lose their nicotine, smokers will be able to go online and learn the best way to use e-liquid to re-nicotinize their cigarettes (and even more easily, their rollies). It will no doubt take some experimenting with different techniques and liquids to perfect this. It might take dedicated tinkerers a whole week to figure it out. The optimal liquids might not be favorites for vaping, but they would certainly become bestsellers. That could be a serious windfall for whatever producers made them.

Except even the FDA was able to figure this out. Specifically, their ANPRM includes this paragraph:

Another possible countervailing effect of setting a maximum nicotine level for cigarettes could be users seeking to add nicotine in liquid or other form to their combusted tobacco product. Therefore, FDA is considering whether any action it might take to reduce nicotine in cigarettes should be paired with a provision that would prohibit the sale or distribution of any tobacco product designed for the purposes of supplementing the nicotine content of the combusted tobacco product (or where the reasonably foreseeable use of the product is for the purposes of supplementing the nicotine content). FDA is also considering other regulatory options to address this concern.

E-liquids are not, of course, designed for this purpose. Presumably there is some other liquid that could be designed to serve the purpose better. But that is a red herring. The FDA would never allow any such “new tobacco product” onto the market. What really matters is the “reasonably foreseeable” clause, which they try to downplay as a mere parenthetical. It is not just reasonable to foresee the use of e-liquid to re-nicotinize cigarettes. It is trivially easy to predict. The only apparent “regulatory options to address this concern” involve banning refill liquid. At the very least, whatever application process might replace the 2022 blanket ban seems likely to include the question, “Can this product be used to add nicotine to cigarettes?” Any refill liquid manufacturer would have to answer “yes,” which might result in an automatic rejection. Nothing short of cartridges made from welded steel with an RFID interlock could meet this standard.

Would the FDA really allow vaping to become collateral damage in this way? The low-nicotine proposal is — as a result of some combination of scientific illiteracy, idealism, messiah complexes and improper financial influence — the FDA’s top pet project. The FDA Commissioner may have made more public statements about it than all pharmaceutical issues combined, and undoubtedly more than all food issues, even though those are the FDA’s primary missions. Commissioner Gottlieb has described it as the agency’s “#1 priority.” Whatever damage is required to pursue this, the FDA will inflict it if they are allowed. Moreover, the FDA has always wanted to eliminate open-system vaping. It is far too complicated for the Center for Tobacco Products to regulate. They are not even competent to regulate the much simpler cigarette or closed-system vaping markets. They would welcome this as an excuse to ban open systems should they not be able to carry out the current scheduled ban.

Then there is the impact on those who collect most of the profit from the sales of cigarettes: state governments. Presumably they will soon realize that the FDA’s proposal is a huge threat to their budgets and many of them will join, or perhaps even lead, the pushback against this proposal. But if the rule does go through, where will states look to make up the shortfall? Taxing vapor products, of course, at a level high enough to try to recoup their lost cigarette revenues. Currently taxes on vapor products are somewhat constrained by concern about driving people back to smoking, as well as the continuing revenue from cigarette sales. Once those constraints are gone, taxes on vapor products will skyrocket.

Finally there is the issue of precedent. If the FDA succeeds in this effort, having rationalized it primarily with rhetoric about the “addictiveness” of nicotine, their obvious next step will be to impose similar limits on vapor products and smokeless tobacco. Even if that is not already their goal, they will be under enormous pressure by anti-tobacco extremists who will be able to point out that FDA already declared that removing nicotine is a good idea. Prohibition of proper cigarettes (for there is no other way to accurately describe this proposal) could quickly be followed by prohibition of all nicotine-containing products (with a carve-out for ridiculously expensive and unappealing pharmaceutical products, of course).

None of this is simple, let alone certain, but almost every way this could play out is extremely bad for vaping. Vapers should hope, just as desperately as they hope the 2022 deadline is eliminated, that this proposal is shot down.

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Carl V. Phillips



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