The Court of Justice of the European Union (ECJ) has ruled against the British e-cigarette company Totally Wicked in its quest to overturn article 20 of the EU Tobacco Products Directive (TPD).
The court ruled against Totally Wicked on every issue in the case, which – if it had succeeded – would have put the future of TPD-based regulations across Europe in doubt just two weeks before they are due to come into effect.
Dismissing Totally Wicked’s claims that article 20 is disproportionate, threatens the e-cigarette industry and places e-cigs at an unfair disadvantage compared to tobacco, the court said the EU directive was reasonable and justified, and found several flaws in the company’s reasoning.
Several crucial parts of the judgement relied on making a distinction between e-cigarettes and combustible tobacco products. Totally Wicked – like many e-cig advocates – had argued that e-cigs should be regulated more gently than tobacco products because they are less harmful.
For example, it said, it was unfair for the nascent e-cig sector to have its ability to advertise severely limited, while tobacco was historically able to advertise freely for decades.
But the European court, while agreeing that e-cigarettes are not the same as tobacco products, concluded that the difference meant e-cig regulation could not even be compared with tobacco regulation and Totally Wicked’s attempts to draw parallels were invalid.
“A comparison between the rules applicable to tobacco products and those relating to electronic cigarettes and refill containers is irrelevant,” it added. “The fact that tobacco products have been able to benefit for many years from advertising campaigns cannot under any circumstances constitute a reason requiring the EU legislature to allow such campaigns also for electronic cigarettes.”
Will the real tobacco product please stand up?
Similarly, the argument that e-cigarette companies had to report data that tobacco companies did not was also irrelevant, the court said. Tobacco products have been on the market long enough for detailed information to be collected, but e-cigarettes are a novel product and as should be the subject of increased scrutiny, it ruled.
Moreover, as many aspects of the data that e-cigarette companies must supply to authorities will be of value in their own businesses, it is likely to be collected anyway so is not an excessive burden, the court said.
Totally Wicked’s claim that article 20 was not precise enough in its requirements for consumption data was also turned down. Companies are not required to provide specific measurements on consumption but only minimum, average and maximum levels expected from normal use.
Furthermore, article 20 is actually less strict than the regulatory regime controlling tobacco products, the court added. For example, it only requires e-cig companies to notify the relevant authorities about a new product six months before it is launched; by contrast, a new tobacco product would have to wait to receive authorisation before being allowed to hit the market.
The court also held that regulatory restrictions on e-cigarettes were not disproportionate and were justified because authorities could not be sure that e-cigarettes were safe or even 95% safer than conventional cigarettes.
It quoted well-known concerns surrounding e-cigarettes – for example that they might create nicotine addiction, lead to poisonings, act as a point of entry to smoking, or fail to be a large contributor to smoking cessation due to the number of people dual-using tobacco and vaping products.
“Under such circumstances, the EU legislature had to take account of the precautionary principle, according to which, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent,” the court said.
“Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk…the precautionary principle justifies the adoption of restrictive measures.”
Due to this uncertainty, a six-month waiting period for authorities to review submitted data is not excessive, the court said, or likely to undermine innovation.
Products in other sectors, such as medications and medical instruments, must undergo lengthy notification periods yet innovation in those areas has not noticeably suffered as a result, the court added.
These two arguments underlined most of the court’s claims for rejecting other Totally Wicked objections to article 20. For example, the decision that comparison with tobacco regulation is invalid was used to reject Totally Wicked’s claims that it was unfair for e-cigarette companies to have to provide information leaflets with products when tobacco companies do not.
Further objections to areas such as the maximum strength of nicotine liquid (20 mg/ml) and the maximum size of tanks as well as containers (2 ml and 10 ml respectively) were also rejected by the court under the justification of scientific uncertainty.
Regulators used different scientific studies to those presented by Totally Wicked when calculating the best limits for human safety, the court said.
“All of those elements [of information from scientific studies] show that the EU legislature balanced the various interests by taking several factors into account and without exceeding the limits of its broad discretion,” it added.
Other claims were rejected because the court felt Totally Wicked – which brought the case under its business name of Pillbox 38 – had misread the directives of the TPD. The court twice suggested Totally Wicked’s reading of the TPD was “manifestly erroneous”, implying that it was protesting against restrictions that the TPD does not actually impose in the form the company maintains.
For example, the firm said that the legislation was drafted in such a way as to prevent online sales, when there was no such similar legislation for tobacco products. But the court observed that the directives only give member states the discretion to enact such restrictions if they so choose.
In a separate judgement, the ECJ also rejected a number of other challenges to the tobacco-related elements of the TPD. In a case brought by Philip Morris, British American Tobacco (BAT) and others against the TPD on packaging laws, cross-border tobacco sales and flavour bans, the court again fully upheld the TPD.
EU member states have the right to enact regulations on packaging and cross-border sales beyond what was mandated in the TPD, and the EU has the right to ban the sale of flavoured tobacco, the court said.
In another part of the judgement, it held that merely being factually accurate is not a sufficient justification for being allowed to display a statement on tobacco packaging –factually accurate statements can still promote smoking in a way that is undesirable for public health.
Further challenges to tobacco packaging laws, most notably the imminent requirement for plain (non-branded) packaging in the UK, are still under way in several national courts as well as the World Trade Organization (TWO).
What This Means: The article 20 decision is clearly a disappointment for Totally Wicked and others in the sector; but it is far from unexpected, especially given the report of the court’s advocate general late last year.
There is still room for Totally Wicked to appeal or to challenge some individual measures in national courts if it chooses – or for others to do so.
In the meantime, it appears nothing will now stop TPD-based legislation coming into force across the EU on 20th May.
– Freddie Dawson ECigIntelligence staff
Photo: Sean MacEntee
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