FDA’s snus PMTA approval — what it seems to mean

by Carl V Phillips

FDA issued its first ever approval of “new” tobacco products under the PMTA process that I have discussed before (most recently a few days ago in the context of their proposed ban of all existing e-cigarettes). If you were to read the FDA’s press release about it or the news stories — which basically amounts to the same thing, given the quality of health science reporting — you might come away thinking that this was something major. And it kind of is, just not for the reasons FDA wants people to believe.

The details, as best as they can be pieced together, are explained by Larry Waters, whom I trust on these matters. Basically, Swedish Match wanted to upgrade the eight snus products they sell via bricks-and-mortar stores in the U.S. market, from the 2011 versions of these products to improved current versions that are the same as (or at least more similar to — the public is not told of such details) what they are selling in Sweden now. They apparently applied through both the PMTA (premarket tobacco application) and SE (substantially equivalent) processes, and were granted the former. Note: This should not be confused with Swedish Match’s MRTP application to change the warning labels on their products, which is an entirely different matter. However, I saw a claim that the PMTA application was quietly piggybacked on their MRTP application, making it much easier for them than it would normally be — but I am really not sure of the details there.

What does the the granting of this permission mean in terms of products? Basically nothing. Despite the naive headlines about “NEW products!!!”, this is merely an incremental improvement in existing products. For Swedish Match it means a bit of publicity, which for a niche player in the US market who is trying to expand their market and visibility is not unimportant, and perhaps some cost savings so that they do not have to keep operating old steam-powered factories manned by oompa loompas to make obsolete versions of their products. (I might be wrong about the steam engines and oompa loompas — as I said, the details are rather obscure and largely secret.)

But what does it really mean?

You might be thinking, “wait a minute, isn’t this what the SE process, rather than the PMTA process, is supposed to do?” And you would be right. But remember that, as I explained last week, FDA regulation of tobacco under the Tobacco Control Act (TCA) has nothing that could genuinely be called a process. There are basically no rules or standards that govern FDA’s decisions, and so every nontrivial decision they make is purely an arbitrary unilateral policy decision. In many cases including this one, the policy seems to be all about optics and political maneuver.

FDA has (intentionally) made the SE process opaque and utterly arbitrary, and has demonstrated that they will reject applications for even the lowest risk products on the thinnest of pretenses. But the PMTA process is more daunting still, so much so that during the six years of the TCA regime — which banned any product that did not exist eight years ago in the absence of PMTA approval — there have been few instances of a manufacturer even bothering to try, and no approvals. This is rather an embarrassment for FDA, which plans to ban all e-cigarette products but assures naive observers that this is not really a ban because, hey, they all have the PMTA option. Yeah, right.

Anyone observing FDA’s behavior will find this not even a little bit surprising. FDA’s only really substantive SE approvals were for non-menthol versions of Lorillard’s flagship cigarettes, so that FDA could then ban menthol cigarettes (which they did not do, of course, but were seriously considering) without having to admit that they would be putting a major corporation out of business. (Never mind that “new and improved Newport — now without menthol!” did not seem to promise great longevity for the company.) Most SE approvals have been for packaging changes, which FDA does not actually have jurisdiction over, but some manufacturers applied and FDA thought, “great, if we approve these, it establishes that we have jurisdiction.” In that spirit, they have officially granted a PMTA approval, and can trumpet it.

Except they really did not approve a new product. They granted an SE approval via a PMTA ruling. Did they arrange for Swedish Match to file the PMTA, rather than just an SE application, in order to be able to do just this? That seems reasonably likely. Perhaps FDA even quietly communicated the application would get a positive reception. We will only find out when someone publishes their honest memoir. (Yeah, I know — just kidding.)

A similar application for these “new” products would not be possible for a manufacturer of a genuinely new product. Because it was really an SE application, swapping in new and improved versions for existing products, Swedish Match could just present information about the incremental changes. Because Swedish Match had already stepped up to file their nightmarish (130K page) MRTP application, they could do it fairly easily. The “new” products are already being used by millions of people, providing data about them. Presumably the upgrades are all uncontroversial, including reducing (probably unimportantly) the quantity of ostensible toxicants.

But most important, this application could deal with the FDA “guidance” for applications that says that a manufacturer should provide evidence that the product will not attract new consumers who do not currently use tobacco products or keep would-be quitters from becoming abstinent. As I have pointed out before, this is literally impossible for a new or substantially improved product, and not just because it requires knowing the future behavior of a very complex system: Simple economics tells us that any real improvement in a product or advantage of a new product — including it being lower risk — will attract new consumers. There are a lot of people out there, so at least one of them is right on the cusp of deciding to use or keep using tobacco products, such that the advantages provided by a new or changed product tip them over. If FDA requires this condition be met and makes a reality-based assessment (and, again, FDA can do and does do whatever they want, but pay lip-service to this condition), it prohibits any important improvements.

So what is the poor agency that wants to “prove” PMTA is a real option to do? Aha! Approve “new” products that (a) are already mass produced on the market elsewhere by a major multinational who can afford the application effort, especially when it is en passant, (b) already have an existing market in the U.S. such that the manufacturer would consider the effort worthwhile, and especially (c) represent only small incremental improvements that no one other than existing consumers — indeed, only highly-informed enthusiast consumers — will even know happened. No one is going to be attracted by the “new” products because they are not new, and the improvement is so subtle it will not be noticed. This has absolutely no value as a precedent for real new product applications. But it lets FDA say there is precedent for PMTA approval, and anyone who is genuinely or intentionally ignorant will believe that this means everything is all ready for proper e-cigarette regulation.

Well played, FDA.