FDA Loses Appeal, Can’t Ban E-Cigarettes as unapproved therapy (yet!)

[Corrected Version — see end]

A U.S. Court of Appeals today issues a judgment prohibiting the FDA (and thus the police powers of the U.S. government it was employing) from keeping NJOY (and thus others) from importing e-cigarettes into the country as an unapproved medical device/drug.   This is good news indeed for public health.

But let’s not get too excited yet. No one wants to rain on a parade, in particular when most of the news regarding this truly remarkable alternative to smoking tends to be either composed from fabricated health concerns or just dismissive.   Had this ruling gone the other way, e-cigarettes in America would truly have been in jeopardy.   So the first instinct is to be elated (and you will find plenty of that in almost every other blog about this, we would guess) but, and the metaphors are starting to pile up here, the war is not yet won.

Law and facts can change.  The appeals court emphasized that FDA had produced no evidence that anyone had ever been harmed by an e-cigarette, but the extremists tend to find whatever they are looking for, whether it is there or not, so though the evidence may not change, the “evidence” may change and another case might follow. As the appeals court pointed out, Congress can always choose to change the law so that e-cigs can be regulated however the FDA prefers, or could even ban them outright.

The law is what it is, and need not have anything to do with what is good for people. Eventually in free societies most laws find their way to being good for people, but there can be a lot of detours on the way. The court said that the law says that FDA’s new authority over tobacco means that they can only regulate e-cigs as they do other tobacco products, not as therapeutic devices (so long as the manufacturers do not make therapeutic claims). Kind of an amusing irony. But our amateur reading of the law suggested that interpretation was far from certain, and we will admit that we are not entirely sure whether an appeal to the Supreme Court or some new case might change this.

We as scientists, policy analysts, educators, and THR advocates have strong opinions about what the law should say in this matter, but find it unclear what the law actually does, let alone will, say. We were asked to file a brief in this case but declined because the decision was about what is allowed under regulatory law –something that we have some knowledge about, certainly, but cannot claim expertise. Though public health concerns entered the discussion, this was not a decision about what is right for public health or liberty.

From a public health and good government perspective what FDA did was unconscionable anti-tobacco extremism, and Americans’ health, welfare, and liberty were well served by this decision.  But the same FDA that wanted to ban these products will be regulating them as tobacco products, and is likely to target them to discourage THR and to flex its muscles, especially after being embarrassed the first time around. Among the FDA arguments leading to the decision was

“The FDA has also offered a consequentialist argument, namely, that understanding Brown & Williamson in this fashion leaves the FDA severely thwarted in any effort to nudge e-cigarettes toward relatively healthful forms (or at least away from relatively unhealthful ones).”

On the face of it, this is a rational argument for making products safer which would be to the public good. But the power to regulate is the power to destroy, and FDA can easily create safety regulations that effectively bring about the ban they wanted. Moreover, we already know that in tobacco regulation the FDA seems intent on focusing on products in isolation, making cigarettes a little bit safer and perhaps making smokeless tobacco a little bit safer, but ignoring the fact that all smokeless tobacco (or e-cigarettes) are safer than all cigarettes. In other words, the FDA claims to want to promote harm reduction at the product level but not at a user or population level. And the extremists still call the shots there, and they are far more intent on stopping people from discovering low-risk products than they are about reducing use of high-risk products.

In summary, the news is good even if it is not perfect. This has been a very good day for e-cigarette users, for smokers, and for public health in general. Let’s hope it is more than just one good day.

[This version reflects a correction of an error: We thought that this decision meant that there had to be one more final decision in the legal process to confirm it, rather than it being the final world as it is (unless the Supreme Court weighs in). This is further evidence that we should not be offering opinions about what the law says!  We will stick to assessing what it should say.  That and our main points here: our concern that the law could easily change and the concern that FDA still gets the last word.]

– Carl V. Phillips