As FDA faces a paperwork tsunami, big firms may come out of it best

And then there were “only” 1.5m. The news that the US Food and Drug Administration (FDA) has rejected two thirds of the incredible 6m premarket tobacco product applications (PMTAs) it received can’t really have come as a surprise, especially to those who had already wondered how many of those products existed on the market in any meaningful sense, and quite why the applications were submitted if they didn’t.

But though the number of applications thrown in the metaphorical dumpster is huge, the number of outstanding applications is also still huge, and the question remains how the FDA can possibly deal with all of them. It clearly isn’t going to do so by a deadline of 9th September.

It seems quite probable, as we report this week, that another mass cull could be in the offing. For example, the FDA could internally set a standard for the level of supporting scientific information it wants – indeed it may already have done so – thus enabling it to cast out a further large group of applications without having to examine them too closely.

After all, the PMTA application guidelines that were made public provided some direction for applicants, but were not highly specific; and it’s more than likely that some smaller manufacturers, in particular, will have fallen short on the scientific front.

In this scenario, it is the most thorough and complete who will stand the best chance of getting through to the final stage – evaluation of the actual substance of their applications.
And that inevitably means the big brands, including (but not necessarily limited to) the tobacco-owned ones.

It was always expected that the requirements associated with PMTA filings would, by inherent nature if not by intentional design, favour these companies.

And while this is only speculation at the moment, it now seems possible that not only the cost and effort of preparing comprehensive applications, but also the sheer number of small operators and products on the market, will end up working against the minor players.

That might not be fair – if there were only 15,000 applications left to review as opposed to 1.5m, maybe they could all be given more careful consideration? – but given the pressure on the FDA not to let this process stew for years, it might nevertheless be inevitable.

– Barnaby Page ECigIntelligence staff

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