‘Significant progress’ – but the US FDA’s biggest decisions are still to come

The dog didn’t eat all the FDA’s homework – just 7% of it. But there will be those who argue that the missing 7% was the crucial bit all along.

Robin Koval of The Truth Initiative, ever prominent among anti-vape voices, spoke for many when he complained: “Postponing decisions on those with the lion’s share of the market further empowers the big, rich, tobacco companies to continue to grow their business and profits on the backs of young people, putting millions at risk for a lifetime of nicotine addiction.”

There, in a nutshell, is the popular objection to the US Food and Drug Administration’s admission last week – as the court-imposed deadline passed for it to rule on all 6m-plus applications it received for market approval of vapour products – that it still had some to decide on. An admission that opens the agency up to the risk of legal action from the Campaign for Tobacco-Free Kids and/or perhaps others.

You have to feel for the FDA, caught between a rock and a hard place on e-cigarettes while simultaneously having to deal with the rather more pressing issue of Covid-19. No doubt swatting away 93% of those premarket tobacco product applications (PMTAs) within the allotted time felt like a good way to be able to claim “significant progress”.

As Koval suggested, though, that 7% of outstanding applications represents a lot more than 7% of the market. With big boys Juul, Vuse and Njoy still awaiting the FDA’s verdict and political pressure intensifying it could fairly be said that the whole future of the US e-cigarette market still hangs in the balance.

That makes it an interesting time for Juul Labs to announce plans to open a new research facility in the Research Triangle Park in North Carolina, one of the leading centres for high-tech R&D in the US. (The choice of North Carolina, the state with which Juul came to a $40m out-of-court settlement in June over its supposed role in promoting youth vaping, is also interesting, and perhaps canny.)

Is this Juul showing confidence, bravado, or just tightly crossed fingers? And what of the 93%, condemned cannon fodder, already almost swept out of the public conversation?

It appears so far that we got it right four weeks ago in predicting a mass cull of the smaller operators, to the ultimate benefit of the big boys.

Aidan Semmens ECigIntelligence staff

Photo: Girl.in.the.D

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