Way to enable some serious backsliding.
Bought a pack of smokes in the UK recently? If so, you’ll have noticed that Brits are now being sold cigarettes in an underwhelming mud-brown packaging. This initiative—alongside standardized brand fonts and more extensive health warning labeling—is all part of the EU Tobacco Products Directive (TPD). The directive, which came into effect in May of last year, is a part of TPD’s aim to further reduce tobacco consumption across EU member states, thereby cutting down on those combustion-related diseases that we are forever reminded of on our cigarette boxes.
On the surface, the TPD’s name suggests that it solely targets tobacco products. However, its reach extends beyond cigarettes and rolling tobacco towards the hazy realm of vapes. Naturally, this has ruffled a few feathers among British e-cigarette enthusiasts. The TPD introduces legislation that limits tank sizes to 2 ml, refill bottle sizes to 10 ml and nicotine strengths to 20 mg/ml—this means that vapers will need to refill their tanks more often with multiple bottles.
Refilling a vape is already more work-intensive than reaching for a quick cig and this requirement creates extra hassle for vapers. More strikingly, the cap on nicotine levels may in fact discourage smokers from switching to vaping, as research indicates that vapers may initially start with high levels of nicotine and then gradually reduce the strength. Indeed, a number of vape consumer and trade advocacy groups have critiqued these regulations, claiming they thwart successful smoking cessation efforts.
But the TPD doesn’t stop there. Manufacturers of e-cigarettes and e-liquids are now required to test their products at least six months prior to selling them and submit a notification of the results to their national health regulatory agency. While some member states have not yet introduced fees, this notification process can cost anything from £150 ($191) per product in the UK to 36,900 kroner ($5,538) per product in Denmark.
Of course, the process of testing products on health and safety grounds is not ostensibly a bad thing. Testing vapes ensures existing vapers that their products have met MHRA’s [Medicines & Healthcare Products Regulatory Agency] regulations, says the chief executive of the Independent British Vape Trade Association (IBVTA), Richard Hyslop. “In the same way, this should provide smokers with greater confidence to switch from smoking to the significantly less harmful alternative of vaping.” This view is shared by Farhan Mirza, a 22-year-old student from London, UK who has vaped for four years. “I do believe it’s good that we now know that the e-liquids are not being cut with anything, and that regulation is important.”
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At first glance, paying £150 to sell a tested vape to a broad domestic market doesn’t seem particularly prohibitive. Nonetheless, it’s worth remembering that vaping owes part of its popularity to the seemingly endless range of flavors and devices. This in turn gives consumers the freedom to indulge in their sweet tooth and develop a distinctly customized vape style. “One consequence of the significant financial investment required by the testing and notification regime is that the price of some vape products will have to rise,” Hyslop says. “This will make it difficult for some existing vapers and may put off some smokers from switching to vaping in the first place. Brick and mortar shops that sold in-house liquids can no longer afford to sell their work, further decreasing the variety available to consumers.”
The TPD’s remit only affects EU vapers. However, around the same time it went into effect last year, the US Food and Drug Administration (FDA) introduced a deeming rule to its Federal Food, Drug, and Cosmetic Act (FD&C) which extended their authority to the cloudy heights of vaping. The act includes a stipulation that requires manufacturers to obtain individual approval for all components of vape products that have been on sale since February 15th 2007. The FDA estimates that a PMTA could cost anywhere between $117,000 to $466,000.
While the TPD is already starting to be enacted across the EU, the FDA has delayed the decision of PMTA requirements until August 8, 2018. In the meantime, this has led to Rep. Duncan Hunter proposing an amendment via a Vaping Bill, as well concern among vapers that they’ll struggle to get their smoke-free nicotine hit.
“Nearly ten thousand small and medium-sized businesses across the country are threatened by the FDA’s new rules,” says Gregory Conley, president of the American Vaping Association (AVA), a non-profit advocacy group. “Many existing consumers of vape products will seek out black and gray market alternatives. Whether it is making their own e-liquid or importing from overseas, there will be no shortage of ways for driven consumers to access these products. However, for those less motivated or less knowledgeable, returning to cigarettes may end up being their ultimate decision.”