A handful of calendar dates have dominated recent regulatory developments in the world’s biggest e-cigarette markets, as well as our headlines over the past weeks – but nobody knows exactly what those dates are.
In the U.S., of course, the deeming regulations of the Food and Drug Administration (FDA) are the great “known unknown”.
The FDA is committed to a June release of its long-awaited – and some claim much-delayed – deeming regulations on e-cigarettes and other tobacco-related products, the agency’s departing commissioner Margaret Hamburg assured senators recently; “I can tell you that it is my strong commitment and that of the team,” she said.
But whether that June deadline will be met, and if so with what, remains to be seen.
Meanwhile, as activity on the deeming rules presumably continues behind the scenes, the FDA – now under temporary leadership since Hamburg packed her bags – may have given a few signals lately on its attitudes to e-cigs, though they’re difficult to read.
Most importantly, a panel advising the agency has rejected attempts by Swedish Match to claim that snus is less harmful than cigarettes – yet some members did accept its assertions of reduced risk.
And the FDA has also ordered three e-cigarette suppliers to stop falsely claiming that it endorsed their products.
In Europe, the outlook is unclear in a different way. The deadline for EU member states to implement the Tobacco Products Directive (TPD) in their domestic legislation is unambigous – May 2016 – but exactly how and when they’ll do that remains open to question, with it looking likely that many will take the opportunity to enact restrictions on e-cigs beyond the strict requirements of the TPD.
In France, for example, the parliament is currently considering a health bill which includes new rules for e-cigarettes among a wide array of broader changes to health policy; it would prohibit vaping in certain public places, but still make a distinction between e-cigarettes and tobacco. It would also allow the government to transpose the TPD into French law however it chooses, without further debate.
The Netherlands has also moved closer to implementing the TPD with a proposal for fuller legislation, while in the Baltics two countries illustrate the very different approaches that could be taken.
New legal restrictions on the use of e-cigarettes which came into force in Estonia recently are far more lenient than those imposed in neighbouring Latvia. The Estonian regulations equate e-cigarettes with tobacco, yet place virtually no tobacco-style restrictions on public vaping; indeed, the main impact for the industry may be a ban on advertising, although further legislation will still have to be drafted to fully localise the TPD.
The Latvian government, by contrast, is considering implementing some of the toughest restrictions on e-cigarette use in the European Union, requiring all products to have a medical licence.
As the world turns
Governments elsewhere in the world have an even wider choice of policy responses to the challenge of e-cigs. Hong Kong could prohibit the products altogether following a recommendation from a public health watchdog, we recently reported, while Canada is taking the first steps toward much-desired federal regulation of e-cigarettes with the release of a parliamentary committee report making detailed recommendations on the shape of national law.
Echoing the French approach, it emphasises that an entirely new model of regulation should be devised for e-cigs – rather than placing them within existing tobacco or pharmaceutical regimes.
For better or worse
Even if regulatory uncertainty prevails, however, the industry is hardly sitting still. In the UK, new data suggests that e-cigs are continuing to take sales from nicotine replacement therapy (NRT) products, while in both Spain and France our reports reveal signs of life in the bruised vape store sector.
The Spanish e-cigarette business has hit bottom and is stabilising again, vape store owners believe, though they expect little or no improvement over the coming year. And though vape stores next-door in France did not escape the epidemic of small-business failures last year either, there are still positive signs of life in the sector and it can survive by differentiating itself from non-specialist retailers, a new study suggests.
On the other side of the Atlantic, the growth of the industry is epitomised by the fortunes of Electronic Cigarettes International Group (ECIG), the U.S. company behind brands such as FIN, Vapestick, Victory and VIP. The firm’s latest financials showed that it increased its sales nearly 15-fold during 2014 but still recorded a loss approaching $400m.
One area where ECIG’s costs increased was marketing and advertising – and of course that’s where much potential conflict lies between the industry (trying to build brands) and the regulators (trying to silence campaigns which they believe are aimed at youth).
A noticeable result of this in recent months has been an upsurge in the quantity of formal research into e-cig advertising, though interestingly the studies haven’t focused on minors, despite purported youth appeal being the biggest reason for advertising restrictions.
TV and radio advertising has a strong effect on consumer perceptions of e-cigarette safety, one study suggests. Indeed, attitudes to e-cigarettes and tobacco appear to be influenced by factors as diverse as warning labels, TV ads, individual smoking habits and even levels of numeracy, says another.
And vaping in TV commercials may increase smokers’ urge to reach for a cigarette and decrease optimism among those that quit tobacco, according to a third.
Not directly related to advertising, but perhaps undermining industry claims that kids can’t access e-cigs, was yet another research project from the University of North Carolina at Chapel Hill. Online e-cigarette retailers in the U.S. are not checking customers’ ages thoroughly enough to meet expanding regulations, it found; of 98 online e-cig sellers where purchases were attempted by minors, only five retailers rejected them.
Still, e-cigs’ opponents can employ powerful publicity tools too. A new campaign from the U.S. Centers for Disease Control and Prevention (CDC) sent shock waves through the e-cigarette sector, with many claiming it demonstrates official bias against the products.
However, the federal agency says matters aren’t so simple, and that its real concern isn’t with e-cigs as such – but with the way they may encourage some people to continue smoking through dual use.
A study testing whether anybody at all picked up on this nuance probably doesn’t need to be conducted.
All in the family
The question of the kids looms large in clinical and public health science, too. A recent British study on youth vaping caused sensationalist headlines with its comparisons of the demographics, tobacco use and alcohol use of 14-to-17-year-olds who reported using or purchasing an e-cigarette, though some pointed out that it was not comparing like with like, by implicitly equating ever-use (or even just purchase) of an e-cigarette with a variety of tobacco and alcohol use levels.
Indeed, U.S. researchers found the picture to be much more complex. They saw that while those who smoke cigarettes are of course very likely to also try e-cigs, use of “other, non-cigarette tobacco products appears to be a key covariate”, and they suggest that susceptibility to smoke cigarettes is also associated with the previous use of other tobacco products (such as cigars, hookah, or snus) as the first nicotine experience, and also “other risky health behaviours” (alcohol and marijuana).
Yet despite the clamour over casual teen vaping, the biggest scientific questions remain whether the products do have a health impact on regular users, in terms of tobacco cessation or physical well-being. The lack of long-term scientific studies has been a common complaint, inevitable given the e-cig’s short history, but the University of Wisconsin’s Center for Tobacco Research and Intervention (CTRI) is now starting to address that through a multi-year investigation.
It’s backed by funding from the FDA and the National Cancer Institute. And though the Wisconsin project is unlikely to produce results in time to affect the deeming regulations, let alone the already-passed TPD, maybe the next big regulatory efforts in e-cigarettes can finally be based on solid science.
– Barnaby Page ECigIntelligence staff