Why the US vapour industry should fasten its seat-belts for a bumpy ride

One of the oddities of the US system is the political appointment of public officials. With that comes the tendency for each incoming president to put their own nominees not just in political positions, but also in what in other countries would be considered longer-term career administrative posts. That tendency is a large part of what gives the president power – witness the extraordinary turnover of people in leading jobs during the hire-em-and-fire-em presidency of Donald Trump.

No such rapid turnover is likely in the coming Joe Biden administration, once the new man has his team in place. Who makes up that team will determine much about the direction of life in the US over at least the next four years. Which is why everyone from Big Oil to the environment lobby, Big Tobacco to small vape store, will have a keen eye on who Biden picks.

The president-elect has so far named about a quarter of those he hopes to make up the top levels of his administration. They do not yet include his selections to head the enormous Department of Health and Human Services (HHS) or its subsidiary agency the Food and Drug Administration (FDA), which since 2009 has had regulatory authority over tobacco – and, since 2016, when they were “deemed” to be tobacco products, e-cigarettes.

While Trump threatened in February this year to take that responsibility out of the FDA’s hands, Biden is unlikely to do so. Which leaves the position of FDA commissioner as the one of most vital interest to the vapour industry.

 

Favourite for the top job

 

Despite the above remarks, the current incumbent, Stephen Hahn, could stay in the post, at least in the short term. A year into the job, Hahn has been a relatively uncontroversial figure – at least until recent questions on the FDA’s handling of the COVID-19 pandemic, which could yet see him sacked by Trump before the presidency changes hands on 20th January.

Unlike his predecessor Scott Gottlieb, for whom youth vaping was a constantly headline-grabbing topic, Hahn has had little to say publicly on the subject.

That is not the case with the apparent frontrunner to replace him, Joshua Sharfstein (pictured above), a public health specialist who was FDA deputy commissioner between 2009 and 2011 after reportedly being the favourite for the top job. If he gets it this time round, it will not be a popular appointment with the big drug companies, whose marketing practices he has frequently criticised.

Nor with the leading e-cig company on whom he wrote a 2018 paper titled “How do you solve a problem like Juul?

 

A plan to penalise those that appeal to youth

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    A few brief samples from that paper would seem to give a good flavour of Sharfstein’s thinking on the subject of vaping. He says: “Juul is threatening to undo a decade or more of public health progress in teen smoking.” He talks about “the danger that Juul poses to public health” and says the company’s success is “threatening FDA plans to save millions of lives”. And he suggests: “Congress could mandate that each e‐cigarette brand reduce youth use to a small fraction of overall sales, requiring those that fail to do so to pay a penalty.”

    Interestingly, in the current situation, he recalls that a similar plan put forward for combustible cigarettes in 1998 was killed by Republican House leader Newt Gingrich “rather than give Democrats a legislative victory”.

    If all this sounds ominous to the vape trade, Sharfstein does concede: “Unlike combustible tobacco products, if appropriately regulated, e‐cigarettes have the potential to help save the lives of many Americans.”

    He tempers this, however, with a large caveat, concluding: “sacrificing a generation of youth to nicotine addiction with higher rates of cigarette smoking [by which we assume he means to include vaping] is not an acceptable price to pay. The answer to the challenge posed by Juul may, in part, be to reward those e‐cigarette companies that can do one without the other.”

     

    A bumpy ride

     

    That, of course, is exactly what the majority of e-cig companies including Juul already say is their intention. How far they are willing, or able, to fulfil that aim may be questionable. And how any attempt to enforce it through regulation might play out in practice is a highly vexed question.

    If Sharfstein, or any other potential FDA chief who comes at the task from the Democrats’ preferred angle, makes that attempt, the US industry could be in for an interesting and bumpy ride.

    Given that, and particularly given Sharfstein’s apparent unpopularity with big business (The Wall Street Journal reported that there was an “anyone but Sharfstein” movement last time he was up for the job), there may be a difficulty in getting the Senate to ratify his appointment, assuming it remains in Republican control.

    And, of course, whoever is in charge at the FDA will for a time have a bigger task on their plate than e-cig regulation. The small matter of tackling a pandemic that has claimed 280,000 US lives so far and counting.

    Photo: Wikimedia Commons

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    Aidan Semmens