As PMTA deadline passes, is it the point of no return for vaping in the US?

Is this week’s PMTA deadline the beginning of the end for the US vaping industry? No – but it’s probably the end of the beginning.

The huge cost and complexity of fulfilling all the US Food and Drug Administration (FDA)’s requirements for a premarket tobacco product application (PMTA) is well illustrated by the 125,000 pages and 110 scientific studies of Juul Labs’ submission.

Few if any small vape manufacturers could begin to compete with that level of investment of time, resources or cash. If that’s the only way to continue in business, most small companies could be expected to curl up and die, leaving the field entirely free for the big boys mostly those backed by Big Tobacco.

Some observers have even suggested that might have been the FDA’s intention all along, from the moment the infant vapour industry was “deemed” to be producing tobacco products. Conspiracy theory, perhaps.


Leeway for the little guy?


There have been various hints, though, that the agency may allow some small manufacturers leeway with submissions that fall short of the outlined requirements even after the last-minute request for another six-month deadline extension for small firms was turned down.

In response to that request, the Center for Tobacco Products (CTP) said: “FDA intends to take individual circumstances into account as it considers your premarket tobacco product applications that are submitted by the September 9, 2020, deadline.”

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    This suggests that small businesses that got something in by the deadline may avoid enforcement, even if the agency has not completed review of their application by the end of the one-year grace period.

    CTP director Mitch Zeller, apparently overwhelmed by the volume of paperwork he and his 950 “tirelessly working” staff are facing (though his “400 million products” is surely an over-statement plucked from the air), notably admitted: “Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low.”


    The danger of doubt


    In some ways all this just adds to the uncertainty and uncertainty itself is a danger to business. It’s hard to plan when you can’t predict what lies in even the fairly near future.

    More vape shops have been closing than opening in the US for some time now. Those still operating will not be forced out of business by the PMTA deadline, but there’s clearly a risk in the medium to long term of them being left with a lot of stock they can no longer legally sell. Perhaps the very stock their customers most value them for those specialist products that can’t be found in the supermarket or convenience store.

    For stores that are also manufacturers, or have their own brand, the potential perils are that much greater.

    It seems inevitable that, to some extent at least, the PMTA process will lead ultimately to a consolidation of the market, with fewer, bigger operators the only survivors. The only legal survivors, anyway. For another near-inevitability is that a by-product of restrictions will be an increase in the black market.

    Artwork: John Martin

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    Aidan Semmens