More on the FDA and MRTP

by Carl V Phillips

In the previous post, I linked to CASAA’s comment to the FDA re Swedish Match’s MRTP application, wherein they ask to be able to change the “warning” labels on their smokeless tobacco products to not “warn” about risks that do not exist and to move a bit(!) closer to communicating the low risk of these products as compared to smoking. Clive Bates also weighed in on this, via this post and his own comment to FDA on the application. It is worth following up on some of his points and some others.

The first thing to keep in mind is that FDA’s regulation of tobacco was authorized under something called the Smoking Prevention and Tobacco Control Act (TCA). (The word “Family” officially appears at the start of that, but I refuse to offer recognition of such blatantly Orwellian wording of the laws of my country.) The phrasing is accurate: The law was not just called the “Tobacco Act” (as with the “Food, Drug, and Cosmetic Act”), let alone the “Tobacco Consumers Protection Act”. This law, and the actions that FDA are taking based on it, are designed to control and prevent, and are motivated by the impacts of smoking. This is not regulation any more than invading Afghanistan was regulation. It is just another piece of the Drug War — a militarization of efforts to impose the moralistic goal of a minority on the rest of the population. The FDA did not have to interpret the law in such a militaristic fashion. But because the leadership there comes from the same special interest group that wanted to militarize anti-tobacco efforts in the first place (and this will remain the case at least until the next presidential election), they are doing so.

Even if controlling the people of a free society to prevent smoking is justified (though there are certainly strong arguments against even that), this clearly does not extend to the use of smoke-free products that present risk levels that are no greater than many foods and cosmetics, let alone drugs. This is why the proposed FDA regulation of e-cigarettes under the TCA, whatever the details of it, is ethically inappropriate and harmful to society. It is also why this MRTP process is such an absurdist muddle.

Clive points out that for the manufacturer of a smokeless tobacco product to request permission(!) to stop putting blatantly misleading “warnings” on their product, they have to go through an incredibly expensive and onerous process. Moreover, they are far from guaranteed success. This will only happen if a business decides it would be highly profitable to be able to make that change on their own products (only). Chances are pretty good that no one else is ever going to decide this is worth attempting even if SM succeeds; if they fail, it will almost certainly never be attempted again. We have to ask, how did we end up with such an absurd regulatory policy in this country?

Clive suggests some ways that the system can be changed so that this is no longer the case. It ought to be possible for public interest groups to apply to make changes like this across a category, and to do so without spending millions of dollars to support claims that are obviously true. However, given that the TCA is not about imposing proper regulation or helping consumers, it seems likely his suggestions will fall on deaf ears.

Clive also mentions the inappropriateness of appeals to “precaution”. He does not go into details about this and what is being claimed, but a common absurd ANTZ argument is to appeal to what they mistakenly refer to as the precautionary principle. The term “precautionary principle” is misused with approximately the same prevalence as are the words “literally” and “epicenter”. While the principle literally has no clear and accepted definition, to the extent that there is a definition it clearly does not mean “do not allow any changes in the world that have any chance of causing any harm”, which is how it is usually misinterpreted. Rather, the principle is about shifting the burden of proof toward those who would impose an exposure on the population to show that it is not likely to be harmful, rather than defaulting to allowing it until someone makes an affirmative case that there is harm.

The origins of the concept are found in the context of introducing new chemical exposures into the environment, where the default has tended to be to force third parties to show harm. Moving away from a bias in that direction is a very defensible principle. So, you could argue that the principle could have been legitimately invoked in 2008 to require e-cigarette manufacturers to do more to affirmatively demonstrate the lack of unacceptable risks. That is no longer the case since there is now ample evidence that such harms do not exist, but it was a defensible position at the time the exposure was introduced.

Thus, the real precautionary principle does not represent an argument against the label change. First, it does not even apply since we are not talking about creating a new exposure here. The physical exposure (smokeless tobacco) already exists, and the question is merely whether people are going to be lied to about it. Indeed, there is a good argument to be made that the imposition of the false “warning” labels in the first place is what violated the precautionary principle. It had the potential to do great harm — by telling people they might as well smoke, rather than using a low-risk alternative — but the action was taken without any evidence that it would not cause harm. Instead, the burden of proof was placed entirely on those who wish to show that the action is indeed harmful. This is a violation of the real precautionary principle.

Second, even if you were to extend the principle to count ceasing to lie as an “exposure”, the requirements are met: The principle says that those who would impose this “exposure” cannot just say “until it is shown to be bad, we are allowed to do it”, but rather must be able to support the claim that it is not bad. That burden is easily met for the reasons that SM, CASAA, and Clive presented. There is ample evidence that the effects of this change would be positive. Someone could argue against this evidence, of course, but it is a lie to pretend it does not exist, which is what crying “precautionary principle!” basically does.

That brings up the question of what about ceasing to lie could be considered bad. Clive answers that by dissecting the Popova and Glantz comment to FDA about the MRTP. The evil duo are bothered by the fact that changing the labels to stop lying about risks that do not exist will cause people to perceive the risks as being closer to what they really are. Um, yeah. That is kind of the point. But they imply this is bad and so is a basis for rejecting the application. Why? Well, given that they are so horribly ethically challenged, it is not surprising that they do not actually attempt to explain why. Instead, their “argument” consists merely of the unsupported assertions that moving consumers closer to accurate risk perceptions:

…might benefit current exclusive smokers, [but] the effects might not be beneficial for dual users (by promoting continued dual use) and would not be beneficial to non-users of tobacco (by encouraging them to start using snus).

We can start with the factual absurdity: It is dual users who are most likely to benefit from this information and do the “right” thing (as defined by the “public health” people), as we detailed in CASAA’s comment. They are the smokers who have demonstrated an interest in using smokeless tobacco, but might not be aware that one of the product categories they switch between has risks that are much lower than the other. If they knew, they might stick to the low-risk choice. It is not clear what Popova and Glantz are even trying to claim (chances are, given that they are as challenged intellectually as they are ethically, they do not know either — they are just throwing out words). The only way that better information could keep someone dual using is if he might have switched to just smoking but, upon learning, decided to stick to substituting the low-risk alternative for some of his smoking. It is simply remarkable what passes for analysis and arguments at the University of California.

As for nonusers, just why might knowing the risk is lower not be beneficial to them? Popova and Glantz make no argument to support this claim, of course. The unstated intermediate step in this “argument” must be that if someone makes the free choice to use a low-risk product based on accurate information, that is bad for them because…. I honestly have no idea how to finish that sentence. I guess it has to be something like “…because the only thing that matters about people is their health and longevity, and so any choice made by human beings in pursuit of other preferences, which might theoretically cause harm to health (though there is actually no affirmative evidence that smokeless tobacco does this), is not beneficial to them, even though they freely chose it.” This is an example of the “public health” pseudo-ethic that I previously discussed in detail. The fact that Popova and Glantz do not even attempt to make this argument suggests that either they recognize how absurd it is or that they are so immersed in its unethical implications that it does not even occur to them that most people do not agree with this “reasoning”. Or both.

Of course, they still have a factual problem too. As I noted in CASAA’s comment, the change in the label is so tepid compared to the reality that few consumers would interpret the risk as being nearly as low as it is. This means (a) that there would be very few new users and (b) anyone who did start using smokeless tobacco based on this information would be getting a lot more net benefit than he thought he was. He would be basing his decision on the assessment that the benefits were worth the lower but non-trivial risks implied by the new label, when the reality is that the risks are trivial.  Thus the total benefits are actually greater than the perceived benefits that motivated the choice.

Of course, being responsive to this line of reasoning depends on someone actually caring about people, real benefits, and proper regulation, rather than just control and prevention.