Time’s up for the US FDA to make up its mind – now where do PMTAs stand?

Today’s the day. A year has passed since the deadline for e-cigarette makers to submit premarket tobacco product applications (PMTAs) to the US Food and Drug Administration (FDA); the year’s grace period during which the products concerned could continue to be sold while the FDA mulled the applications is therefore over; so now, either the FDA says they can stay on the market, or they have to go.

 As I write this, we don’t know what will happen. It’s a reasonably safe bet that the amply-documented applications from the biggest companies will stand the best chance of getting through the process, and a similarly safe bet that products in exotic flavours will stand the least chance. And already, of course, the FDA has rejected many applications (first 4.5m, then tens of thousands more, then still more).

But the fact that those appear to have been rejected pretty much out of hand suggests that many of the remaining applications do have something going for them, at least. So the most important of the presumably imminent revelations on the outcome of the process will be a picture of just how demanding the FDA has been, in judging the very loose question of whether a given product is beneficial or deleterious to the public health.

Has its approach been so stringent that it was led to reject applications by second-tier companies even when they did provide some convincing support for their cases, just because they fell short of the full bells-and-whistles packages supplied by the biggest applicants? Or did it give them the benefit of the doubt?

 

The great known unknown

 

What all this points to is a more fundamental unknown. Has the agency been starting with the view that the products probably are undesirable from a public-health point of view, and leaving it up to companies to persuade the FDA that they aren’t…or has the presumption been that e-cigarettes in general are good things, and only specific drawbacks (like allegedly kid-friendly flavours) should count against them?

It’s too late to change the FDA’s position when it comes to e-cigs, of course, but this is important beyond that category. A very similar question will apply to products like heated tobacco and nicotine pouches when they come to be judged.

And then the biggest question of all is not about the merits of particular products or product types, or the FDA’s views on them. It’s about whether the PMTA process, designed for conventional combustible cigarettes (with many fewer applications and only incremental changes in technology), is really appropriate to entirely new categories.

After all, both the FDA and the e-cigarette industry have been drowning in paperwork as a result of the requirement that applicants must prove their products satisfy a very broad, and far from fully defined, test.

Wouldn’t it be easier for everyone if the FDA could do as the EU did with its Tobacco Products Directive (TPD), and spell out acceptable product characteristics? Perhaps a PMTA-like process could then be offered to those suppliers wanting to deviate from the pre-approved criteria, but the burden on both the industry and the agency would be greatly lessened, and at no obvious risk to public health.

– Barnaby Page TobaccoIntelligence staff

Photo: Pxfuel

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