Home Press New Deeming threat as FDA loses court case to extremists

New Deeming threat as FDA loses court case to extremists

E-cig makers in the USA are about to lose their breathing space, as the FDA prepares to move up the deadline for submitting approval requests. Most small companies won’t have time or money to get the expensive and complex paperwork done on time, and face having to take their products off the market by next autumn. Meanwhile, the Democratic Party in California is tied up in a row over sponsorship money from JUUL Labs, while their colleagues in Washington, DC start another investigation into the company’s marketing practices. All this is happening against a backdrop of falling cigarette sales – but this good news doesn’t stop demented politicians accusing e-cig companies of “stealing” children.

Fergus Mason

June 17, 2019

FDA may bring forward deadline for e-cig approval

The USA’s Food and Drug Administration has been coming under pressure from anti-vaping extremists to toughen up its already draconian licensing process for vapour products – and now they’ve agreed to do it. The agency has proposed a compromise solution that would force manufacturers to spend time and money applying for FDA approval by early next year – two years sooner than the original timetable.

Although the FDA has been consistently hostile to vaping it has, up to now, shown a realistic understanding of the effort involved in applying for a Pre Market Tobacco Authorisation, which will be needed to sell any vaping product developed after February 2007. The deadline had been set at August 2021, giving companies enough time to complete the massive and expensive paperwork required. Unfortunately, a coalition of anti-harm reduction groups took the agency to court, arguing that it had exceeded its authority in setting this date, and the District Court of Maryland upheld the complaint.

The complainants are demanding that a new deadline is set at no later than 120 days after the court ruling – nowhere near enough time. Now the FDA has offered a compromise between its original date and the demand, saying that a new date should be “not less” than ten months after the ruling, with products allowed to remain on sale for a year while applications are processed. Even then, most smaller companies are likely to simply close down or pull out of the US market, as applications cost several million dollars.

Democrats launch another e-cig witch hunt

A new threat to the US vaping industry emerged last week, when a Democrat-controlled committee in the House of Representatives opened a new investigation into JUUL Labs. The committee has written to JUUL demanding that the company turn over details of its advertising policy, social media strategy and internal communications. They also want information on JUUL’s recent deal with Altria.

JUUL is also being harassed by Democrats in California, where there’s a dispute going on between two factions of the party about JUUL’s funding of the party’s state convention. The acting chair of the California Democrats says the party needs funding and shouldn’t turn down JUUL’s money; one of her subordinates claims JUUL “preys on children” and says sponsorship should be refused on ethical grounds.

Anti-vaping hysteria plumbs new depths

A Massachusetts politician managed to out-crazy her competitors in a crowded field last week, when she issued a ludicrous warning to the vaping industry that “We are not letting you steal our children.” Democratic state senator Marjorie Decker claims that her second-grade child has peers who vape, and went on to blame “big tobacco” for the alleged vaping epidemic in American schools.

It’s unlikely that even Decker actually believes vape vendors want to steal her children. A more likely explanation for her hysterical exaggerations is that she’s currently pushing for a 75% wholesale tax on vapour products. Wholesale taxes are particularly destructive to small businesses, as the tax on products has to be paid before they’re sold, but it seems the state legislature has already included hypothetical income from this tax in their budget planning. Decker is probably ramping up the rhetoric to boost support for the tax before it comes to a vote. Meanwhile one of her fellow state Democrats, Rep Danielle Gregoire, has proposed a ban on flavoured tobacco products; as usual, this is aimed squarely at e-liquid manufacturers.

Tobacco companies say US cigarette sales falling fast

All the major tobacco companies say that sales of cigarettes in the US market are dropping rapidly as smokers switch to safer nicotine products. British American Tobacco and Imperial Brands both predict a 4-5% fall in sales this year compared to 2018, while Philip Morris – which is investing heavily in its iQOS heat not burn device – says sales volumes are falling across the industry and all the growth is in reduced-harm products. All three companies are very clear that they see e-cigarettes replacing traditional tobacco, not reinforcing it. Unfortunately, so-called “public health” activists don’t seem able to understand this.