FDA pseudo-regulation of e-cigarettes: what possible benefit?

by Carl V Phillips

Continuing the assessment of FDA’s proposed regulation (as far as we can anticipate what it says). For background, see the CASAA newsletter and the recent posts here. As already noted, the proposed “regulation” is really a ban on sales of all existing e-cigarettes with a provision that will probably (but might not) allow a handful of closed-system products, that FDA hand picks, back on the market. But whether regulation or ban, it can only be justified in order to solve problems. So what problems is it ostensibly solving? To understand the proposal or respond to it, it is necessary to identify those — as a separate point from looking at the downsides — and address what benefits might result.

Child-resistant packaging and warning labels

This is the only new real regulation that FDA has proposed, which they floated as a draft rule. As we commentated on that proposal, if done right it would be beneficial taken in isolation. But as we pointed out, the potential benefits are quite modest and thus it clearly does not warrant imposing a massively burdensome regulatory regime, let alone a ban. This would be an easy rule to implement as stand-alone legislation.

Inspections, oversight, and imposing good manufacturing practices

As we noted in our comments on the draft deeming regulation, FDA is palpably frustrated that they lack the authority (and information) to swoop in on a manufacturer — to shut them down and gather information — if there is an “outbreak” situation (e.g., poisonings from a batch of liquid) or other serious concerns about a major manufacturing problem. This is a reasonable concern in principle, though it has never been a problem in practice. To the genuine surprise of many observers, there has never been a detected case of an important contamination event for e-cigarettes like occurs in food production on an almost daily basis. So basically we are talking about an ostensible solution to a problem that definitely can be imagined but does not actually happen. If there had been a spate of such incidents, or even a few, some action to solve the problem might be justified.

On the other hand, it is not as if existing authorities could not deal with such an event. If there were evidence that a manufacturer made a dangerous batch of liquid, state or local authorities would be quick to intervene, as would the CDC’s EIS. Perhaps their exact legal authority for doing so might be a little fuzzy, but no one would try to stop them. Moreover, of course, any moderately reputable manufacturer would voluntarily do what they could to fix the problem, communicate the news down their supply chain, and recall the faulty products. The existing social media networks would get work out to consumers and retailers faster and more effectively than any government agency could.

Of course, it is better to make sure procedures are followed to avoid such incidents, rather than to respond to them (and, as noted, the lack of such incidents shows that this is being done). FDA would like us to believe they could ensure such procedures, thereby protecting consumers and ensuring that high-quality producers are not at a competitive disadvantage due to a “lemons” problem. But how would FDA do that? They have proposed no procedural standards and have provided no evidence they know what standards would make sense. Yes, they could just codify as law some of the industry-generated practice standards that are floating around. These are controversial and often characterized as being thinly-veiled protectionist efforts, but it could be done. But the details of the policy only matter if enforcement is even possible. Even government units whose entire job consists of enforcing standards on industry are not very effective at it — just read any news story about foodborne outbreaks or energy industry accidents — and there is no reason to believe that FDA, with its numerous other priorities, would do better.

The previous paragraph describes the challenges of a real regulation. But it is actually moot for this proposed rule. Long before FDA could develop the skill to create and enforce manufacturing standards, and perhaps even before they could manage to adopt third-party standards, the grace period for existing products would expire and all that manufacturing would be banned, with the possible exception of a few hand-picked major manufacturers. So FDA can posture about creating and enforcing standards while knowing that they will never need to actually develop the capacity.

But this does not solve the (to date, nonexistent) problems of manufacturing disasters, but rather makes them all the more likely.

This is because manufacturing and the supply chain would go underground and overseas and into do-it-yourself production. As I have discussed extensively, such alternative markets are both inevitable and dicey. Eliminating legal supply would not eliminate demand, and supply will be created to fulfill that demand, as occurs for other products that consumers want (especially when they do not feel that the particular bans have any legitimacy). In the new market, the illegal and borderline-legal supply chains would be murky. In contrast with the current situation, authorities would have a rather difficult time finding manufacturers if they needed to. The type of people attracted to the business would be rather less concerned about brand equity or possible repercussions of errors, and probably less concerned about the health of their customers. Standards would be unenforceable and, indeed, undetectable. Dealers of currently illicit substances obviously have some interest in their reputations and the well-being of their customers, but they are not exactly known for being overly committed to them. Do-it-yourself manufacturing is unlikely to cause any major outbreak-type incidents, but it is far more likely to hurt people at either the production or consumption stage.

Thus, while enabling responses to errors and creating manufacturing standards would be good — though largely moot given that there is no history of problems that need such a solution — the proposed regulation would not actually bring those about. Instead, it would alter the structure of the market in such a way that such problems would inevitably start occurring. The proposed regulation would cause these problems, not prevent them.

Regulating HPHCs and other product issues

Regulatory authority over e-cigarettes (by anyone) could lead to restrictions on ingredients for e-cigarette liquid, as well as standards for batteries, coil temperatures, etc. Once again, this could theoretically be good for consumers and reputable producers, but the specific proposed regulation will undoubtedly do more harm than good.

Consider the easiest e-cigarette components to regulate, batteries and chargers. Very safe versions of these ubiquitous devices are available, which reduce the risk of both hardware problems and operator error, and reputable e-cigarette manufacturers use such products. It is also quite possible to buy shoddy equipment that produces needless levels of risk for fires or other problems (still not a huge risk, but needless), just as it is possible to buy a third-party charger that will incinerate your iPhone. Depending on the details of the proposed regulation and how much latitude courts grant for interpreting the Tobacco Control Act, FDA might have no authority over these hardware components, making the issue moot. If FDA were able to assert jurisdiction, however, this would result in elimination of the legal market for the shoddy products, but also for the high-quality products (with the possible exception of the hand-picked approved products, though these are almost certain to be disposables). Thus, the market for battery systems would be served entirely by shady alternative markets, almost certainly resulting in a reduction in the average quality of what was sold. Quality could only be assured by individual consumers gaining sufficient expertise to know what to buy.

Other hardware standards are also potentially beneficial if they could be imposed, such as by governing maximum temperatures to reduce hazardous pyrolysis products. Again, there is the reasonable possibility that FDA could not regulate these devices, making the matter moot. If they could, the result would be elimination of the above-ground manufacturers of higher-quality products, almost certainly resulting in a net reduction in average quality. But even setting aside this fatal error in the plan, what standards?

Battery systems are well understood by manufacturers, regulators, and third-parties observers. But knowledge about what characteristics of e-cigarette hardware matter for health and safety is extremely limited. Any such standards imposed in the near future would be largely arbitrary and there are no obviously beneficial rules that do not merely prevent problems that consumers already choose to avoid (e.g., leaking tanks, extreme overheating). Neither FDA nor the researchers it funds have shown the interest or the capacity to research how to improve hardware quality. Advancing knowledge about these points comes only from industry. That advance can only be hurt by eliminating most of the manufacturers who can contribute to such efforts.

The e-cigarette component that FDA clearly has jurisdiction over is the liquid (at least if it contains nicotine), and reduction of harmful ingredients is potentially beneficial for consumers and high-quality manufacturers. FDA ostensibly already regulates “hazardous and potentially hazardous constituents” (HPHC) in tobacco products. However, in reality the HPHC process exists in name only, and FDA has taken no action in that area regarding the tobacco products it already regulates. They have a reasonably good excuse for this: In spite of the lip service that they and others given to this process being important and useful, no one knows what attainable changes in the chemistry of traditional tobacco products would actually matter in terms of health outcomes. Those who have pushed for product standards under the HPHC process appear to be primarily motivated by just making the products more expensive to make or lower quality for consumers, rather than providing any basis for suggesting the changes would benefit consumers.

There is more knowledge about how to avoid needless hazard from e-cigarette liquid. But this is mostly limited to the rather obvious restrictions (e.g., do not use lead acetate as a flavoring agent, and it is almost certainly better to stick to ingredients that are approved as food additives). Beyond that, the knowledge base runs fairly thin. Once again, FDA and the researchers it funds have contributed nothing useful to that knowledge base, and it is advanced mainly by industry. Thus, HPHC regulation would be potentially beneficial, but there would be no prospect of it actually happening in the short to medium term. It seems likely that any such regulation would start with FDA jumping on the bandwagon to ban the half-dozen flavoring agents that have become controversial, such as diacetyl. The problem with this is that there is not actually very compelling evidence that these are causing harm.

In any case, the apparent inability of FDA to engage in evidence-based regulation on this point is once again moot, because they are proposing a ban, not regulation. Much of the current de facto regulation of HPHC ingredients would be lost with the replacement of major reputable producers with a shady supply chain with far less quality control and expertise. The net result would clearly harm the goal of making e-cigarette liquid less hazardous rather than advance it. Hypothetical real regulation would also tend to do some of the same. A ban on a single popular flavoring agent would result in some consumers adding it themselves and/or acquiring products via the black market. FDA’s more likely approach, banning all ingredients other than a short list that are explicitly approved, would create alternative markets almost as effectively as would an out-and-out ban of the products.

Discouraging underage use

FDA is clearly trying to sell this proposal primarily on the basis that it would reduce use of e-cigarettes by minors. FDA, CDC, and other political actors have been deluging the press and public with alarmist claims about underage use to bolster support for the proposed e-cigarette ban. There are two problems with this: There is no reason to believe the proposal would accomplish this goal, and it is not actually clear it would be a good idea if it did.

FDA has highlighted that this proposal would implement a nationwide ban on e-cigarette sales to minors. This is redundant with state-level laws in almost every state, and not selling to minors always been the practice of reputable merchants. (It is worth noting that the only resistance to state-level bans on sales to minors has come from anti-ecig activists who were trying to use the lack of such sales bans as an excuse for imposing draconian regulations like the proposed FDA ban. CASAA, along with the industry, have universally supported state and local bans on sales to minors.) Since minors who obtain e-cigarettes now almost always do so personally from legal purchasers or via purchasing, usually illegally, from less reputable suppliers, it seems difficult to see why this rule would make any difference. Minors have little difficulty obtaining cigarettes if they want them, after all.

Once the market is driven underground, however, minors will presumably find it easier to buy from same suppliers that spring up to supply adults with illegal products. Illegal suppliers tend to not hesitate to sell to any interested customer. It is not difficult for minors to obtain cannabis and other outright-banned substances.

The other step FDA seems likely to take, as an act of pure regulatory theater, is to ban flavors that are (inaccurately) characterized as “kid friendly”. There is a rumor that such a ban is included in the proposed regulation and will take effect well before the grace period expires and all products are banned. But whether or not this is true, FDA has made clear that they are interested in eliminating flavor options. There is no evidence that minors are attracted to e-cigarettes due to interesting flavors beyond, perhaps, wanting to sample them once. Of course, anything that lowers the quality of a product like this will dissuade some marginal consumers from using it, including some minors. But it is a myth, supported only by repetition rather than evidence, that eliminating product flavoring options will cause any substantial reduction in underage use. In particular, it seems likely that minors most likely to be affected are those who are interested only in the flavors, rather than the nicotine, are thus are not using nicotine-containing liquid in the first place (and thus their products of choice might not even be within FDA jurisdiction).

Banning flavors that adult vapers like — and they do like them a lot, probably more than minors do — would immediately create the alternative supply chains, with their greater ease of underage purchasing. Moreover, teenagers are just as capable as adults of doing do-it-yourself flavoring, and every interested teenager will be able to find instructions in minutes. Creating a culture of e-cigarette liquid crafting among high-schoolers seems likely to have exactly opposite the intended effect.

Thus, there is no evidence that the specific rules would discourage use by minors, even in the absence of black markets, and there is little doubt that black markets will facilitate access by minors. No one has presented even a prima facie argument explaining how the rules would actually accomplish the goal. But this begs the question of whether this is even a wise goal.

In a world where minors did not smoke or use other drugs, it might go without saying (based on widespread notions of how minor status should limit freedom) that minors should be prevented from vaping. But in the real world, e-cigarettes are often a substitute for much more harmful behaviors among minors, just as they almost always are for adults. There is woefully little evidence about this, despite all the rhetoric and claims. But what evidence there is all suggests that e-cigarettes are widely used for THR among teenagers, just as they are among adults. In addition, someone who is vaping is not — at least at that very minute — engaging in an alternative behavior that is potentially even more harmful than smoking a cigarette. We do not know how often that is the case, but this also means we have no idea whether discouraging vaping among teenagers does more good than harm. It is, at a minimum, very conceivable that it does not.

Similarly, the claims that e-cigarettes should be discouraged because they are a “gateway” to smoking or other substantially harmful behavior among minors is based on no evidence whatsoever. What is claimed to be evidence of such effects merely shows that the same individuals who use one such product are more likely than average to use another. This provides no support for the gateway claim, that one product is causing use of another. It does, however, strongly support the contention that e-cigarette use reduces the frequency of the other behaviors, at the very least because someone cannot use more than one product at a time.

The goal of discouraging use by minors is presented as if it is self-evidently good. But given that it has obvious potential downsides — we are not exactly wanting for examples of drug war, anti-harm-reduction, or status offense policies that did more harm than good — it is incumbent on those who would use muscular policy to pursue that goal to provide some support for this claim. They have never done so.

Discouraging harm reduction by adults

A list of the ostensible benefits of banning e-cigarettes cannot be complete without recognizing that many tobacco controllers and temperance-style moralists consider the discouraging of THR to be a feature, not a bug. For reasons that I have documented elsewhere, many of those with influence in this area do not support the proposed ban in spite of it causing more people to stay smokers, but in part because it would cause that. It is useful to understand this to understand why there is so much support for a proposal that seemingly has no benefits. These activists are not doubting that the predicted catastrophic outcomes will occur — they are counting on it.

Needless to say, most people do not share their opinion that this impact is a benefit, and indeed would consider their goal unconscionably unethical if it were recognized. Thus, this goal is never openly stated and such results are never defended as a benefit. In particular, FDA insists that it supports THR and has never suggested that the anti-THR effects of the proposal are a benefit. Thus, for purposes of evaluating the policy, the anti-THR effect should be considered entirely a cost in spite of the fact that a vocal extremist minority secretly considers it a benefit.

Conclusions

There is no reason to believe that the proposal will accomplish any of its stated or implicit goals, other than the child-resistant packaging rule whose benefits appear very small and which could easily be achieved by stand-alone legislation that would pass without opposition. Even without considering the enormous costs imposed on e-cigarette consumers and producers, this policy does not seem to pass a cost-benefit test.

Of course someone could argue that we are wrong about one or more of these assessments of what would really occur under the policy. But no one has done so, ever. We are aware of no policy analysis that supports the claim that this action will make e-cigarettes safer or reduce use by minors. There is not so much as a laying out of the steps that lead from implementing the rule to the ostensible effects, let alone a substantive argument that each step would work out exactly as planned. The proponents of the policy act as if the stated goal of a specific policy action will be accomplished by that action simply because it is the stated goal.

In summary, this tremendously costly policy proposal offers approximately zero apparent benefits, and indeed there is every reason to believe that it will create further costs in the areas where it is supposed to be creating benefits.