This morning I gave a presentation as part of a panel talking about U.S. FDA regulation of tobacco, specifically the upcoming discussion of possible regulation of quantities of chemical constituents (e.g., how many arsenic atoms per quantity). Since that talk is posted behind a pay wall at TMA, and most of you cannot access it, I thought it would be useful to present my key points here.
1. There is no reason to believe that minor changes in concentrations of individual chemicals will have any appreciable health effect for users of cigarettes or smokeless tobacco.
This is a fairly simply point that I suspect most of my readers already know, but basically the harm from smoking comes from smoking, not what is being smoked. Yes, there will inevitably be some reduction in risk to the user by limiting the concentration of known harmful chemicals. Contrary to the usual rhetoric and Official Conventional Wisdom, some cigarettes are less harmful to smoke than others (it boggles the mind that anyone could actually believe otherwise). But minor chemistry changes are not going to produce results that are big enough to ever be detected.
The story might be different for huge changes in the way that tobacco is processed, with wholesale removal of many harmful constituents. When products with these changes come to market, it is quite possible that the effects will be big. But big is still a matter of tens of percent reduction in risks, not an order of magnitude reduction. Compare this to the two orders of magnitude (factor of 100) reduction from switching to smokeless tobacco (or, probably, e-cigarettes).
As for the effects of chemistry regulation on smokeless tobacco, to the extent that ST causes any health risks at all (and the evidence is not definitive about this), there is no reason to believe that there is any measurable risk from any chemical other than nicotine (which, as a mild stimulant, creates some cardiovascular risk). If a few cases of cancer are caused by other chemicals and those chemicals are reduced or removed, that is certainly good. But since we cannot even detect that any such cases are being caused, we certainly will never detect the reduction.
2. In spite of Point 1., consumers will learn about any chemical changes that are mandated and implemented, and interpret them as being major reductions in health risks.
The regulators have the idea (which would be rather comical if it were not illustrative of their belief that they can and should control people's fundamental freedoms) that they can keep secret the fact that such changes are made. No doubt they can keep the manufacturers from making claims that the products are "now healthier!"; it is less clear they can stop them from simply reporting the changes without making health claims (at least not in societies where free speech is protected). It is completely obvious that they cannot stop the press from finding the changes to be interesting and reporting on them, let alone having the information go viral on new media. After all, the U.S. government cannot stop classified secret movies of it blowing up Iraqi civilians from becoming public, and for any product chemistry changes, the basic information will be open and public.
Once the information is out, we have ample research to show that consumers will almost certainly conclude that the changes represent major improvements in risk. Our research (e.g., see ch.10) and others' shows that a large portion of smokers think that particular ingredients (often non-existent ingredients supposed added by manufacturers) account for the largest part of the risk from smoking. This is due to a remarkable failure to understand just how bad breathing concentrated smoke (no matter what is burning) is, as well as the tendency (largely created by activists and the alarmist media) to attribute risks to particular chemicals (which when used in this context is intended to sound like it is a synonym for poisons). The anti-tobacco activists have contributed mightily to this misperception (as our and others' research shows) by creating propaganda that talks about individual chemicals and vilifies the tobacco plant itself, rather than honestly communicating that smoking it is the only important risk.
I proposed some research that could be done to confirm these predictions more precisely and that perhaps that could help head-off harmful rule changes, or at least provide some useful "I told you so" ammunition later. However, I was pessimistic that demonstrating that the possible regulation did far more harm that good would actually change anything because:
3. The FDA regulation of tobacco is not a normal regulatory regime; it is intended by all those in positions of influence over it as sabotage.
For quite a while, I avoided direct involvement with the FDA regulation, not jumping on the bandwagon of offering advice on the matter. My reasoning was that I wanted to stick to science and communicating with the people, and leave inside-the-beltway bickering to others who knew more about it. But I am starting to think that I have more critical insight than I gave myself credit for. Other commentators/consultants/pundits seem to be treating this system as if it were a normal regulatory regime, where the regulators want compliance and recognize that imposing costs (mostly on consumers, and to a lesser extent absorbed by producers) is a necessary downside of ensuring better products. Their advice naively follows the script that would be appropriate if this were really the case.
But it is not the case. Rather than thinking that this is like FDA regulation of pharmaceuticals, a better model is that it is like border control laws in a corrupt country. That is, the rules about chemical constituents, and others, are being made intentionally to make it difficult to comply. Rules like that are great for border guards, because they can always collect bribes to look the other way. Of course, there is no one to grease for the case of tobacco regulation.
As evidence of this view, observe how the combination of the congressional actors who made this happen, FDA itself, its science advisory committee, and others have created a crazy-quilt of stated goals and requirements. People who influence the decisions are committed to a lot of different goals and theories, and it appears that the method for dealing with prioritization or even contradictions is to just do everything that anyone calls for. Have you ever participated in a community group meeting where some political platform is being created and the organizers employ the strategy of just adding anything that anyone in the room says? It's like that. There is no indication that there is any consideration of the costs of compliance.
If this sounds familiar it is because this is exactly what commentators who oppose all regulation often say about regulation in general. Usually this assessment is very wrong; even if the regulation is not optimal, it almost always results in a better product than would exist in the absence of all regulation. But for the case of FDA regulation of tobacco, we are not seeing a case of incompetent inefficient bureaucrats who cannot help but muck everything up (as the standard story goes), but one where the mucking up is welcomed by those who created the situation.
Perhaps even better than the border guard metaphor is the classic notion of Kafkaesque laws that are intended to just hurt those subject to them or impossible to comply with (as judged by those in power). As I pointed out earlierthis year, the FDA has the authority, and perhaps even the mandate, to do anything that lowers the quality of cigarettes (and they would likely extend this to smokeless tobacco, though they obviously should not). Thus, taking out menthol can be justified simply because some people like it. Why? Because the total public health impact of smoking depends mainly on how many people smoke, and if menthol is banned then a few people who really liked it will quit smoking. It would probably be very few, but that does not affect the mandate. Jeff Stier from ACSH, who was on the panel, confirmed this from the lawyer's perspective. He also confirmed another of my observations about the Kafkaesque nature of the situation, that the FDA gets to define the rules of decisions (i.e., the science), akin to a prosecutor getting to decide the rules of evidence. That is, as I emphasized in a talk this spring, there can be no appeal to "science based policy" because a group of activists who already know what policy they want are the ones who get to decide what the science says. It has also been pointed out that the regulations for introducing products and making claims in pursuit of low-risk alternatives to cigarettes basically require that the products already be widely used (to produce data) before they can be promoted (and thus will never be widely used).
As further evidence of the Kafkaesque situation, consider how FDA objected when manufacturers complied with their rule banning labeling cigarettes as "light" and the like. As I explored from a different perspective a few weeks ago, FDA itself lashed out at companies who rebranded these products according to the rules. This was not a case of outside activists who thought that the rule did not go far enough, but the government actors who created the rule themselves. It is as if, upon enacting a speed limit, the police started pulling over people who were obeying it, fuming that they were getting away with something. Recall our corrupt border guard: When someone complies with the rules, he is much less happy than when they cannot. He might even try to punish them for doing so.
This is not too surprising, of course. Those with all the power over this process are committed to destroying the products and companies they are regulating. It appears that no one in power is committed to the normal regulatory goal that is demanded by principles of good governance, to maximize the value of the product to society. Unlike most regulatory systems, that are quickly captured by the industry they supposedly regulate, and thus favor it too much, this regime was pre-captured by a different interest group, the anti-tobacco industry. What is worst about this for public health is that because they are the anti-tobacco extremists, they are even more committed to preventing harm reduction than they are to reducing smoking. And what could be better for damaging the market (the legal market anyway) than to require expensive and foul-tasting alterations to products, pretending that this is intended to make them healthier.
In short, the seeming randomness and pointlessness of what FDA is doing and proposing is creating costs, but those costs are not just the price that has to be paid for the real goals of regulation. Those costs are the real goals of this regulation. This is not the case of regulation putting a bit of sand in the gears, as it inevitably does; it is not sand in the gears, but sabots. So far, it looks like industry is treating this as a case of honest regulation rather than sabotage, but I do not see anything useful coming out of that. As Stier pointed out this morning, the industry representatives were basically disinvited from the FDA science board meeting about constituents because no one was interested in what they had to say. If Kafka were writing today, you could just imagine the defendant in The Trial being told that he could just listen to the proceedings over the webcast (as industry was advised) because nothing he had to say mattered.
Many years ago, I analyzed how in regulatory regimes like that presided over by the FDA, the industry has the role of speaking up for what people want. That is, the normal part of FDA is concerned only with safety and health effects, and there is no government Agency for Promotion of the General Welfare so the only hope was that people wanted to buy something and so industry wanted to sell it, and so would make a case for that. But I observed when FDA banned the very popular decongestant phenylpropanolamine (PPA), the industry did not resist at all because they really did not make much money from selling it (since anyone could produce and sell it, there were no monopoly profits), even though the loss to consumers was huge. We can see something similar occurring now with the moves to ban BPA -- no one makes enough money from it to want to fight very hard, even though the costs to consumers are going to be substantial. But since those of us promoting public health (and thus regulation that promotes the use of low-risk products), general welfare, and personal freedom have so little voice, and consumer advocates have been systematically driven away from defending tobacco products, the industry are the only ones who can push back against the anti-tobacco extremists.
This could work out better than the PPA or BPA cases, since the industry clearly has an incentive to protect these product lines. But so long as industry actors follow the script that has been handed to them, acting as if the FDA process is an honest effort at regulation, there will be no push-back. In theory, sabotaging the legal market for tobacco products could be good for public health, and perhaps some of the FDA-backers actually believe it. A more realistic prediction, I think, comes from looking at what a wonderful effect driving the market for other drugs underground has on public health and social functioning. Clearly sabotaging the market is bad for overall welfare (unless you are regulating land mines or ground glass), and it obviously is bad for the regulated industry. Perhaps it is not too late for the industry to act based on these impacts (or at least the last of them) and adopt a strategy that slows FDA's efforts to turn tobacco into Drug War II.