The European Union and US are huge e-cig markets with regulatory models in place.
By AsiaOne.com | July 25th, 2016
With Malaysia expected to table it’s vape laws soon, Sunday Star headed to Warsaw, Poland, for the recent Global Forum on Nicotine 2016, to see what’s happening globally.
In May, e-cigarettes and other nicotine vapour products in the European Union (EU) were placed under the regulation of its Tobacco Products Directive (TPD).
In the United States, the “deeming” rule kicks in next month, meaning that e-cigs and vaping will be “deemed” to come under the aegis of the strict Family Smoking Prevention and Tobacco Control Act of 2009 (TCA).
Both these decisions have been challenged by vapers, manufacturers and NGOs that feel the regulations will stifle growth of a product that they claim is less harmful to health than regular cigarettes and that could help smokers give up the much more destructive habit.
However, the TPD and TCA don’t seem to take this into consideration and treat e-cigs and vaping the same way they treat regular cigarettes.
We spoke to industry reps and NGOs at the Global Forum on Nicotine 2016 held in Warsaw recently to survey their opinions on the regulations.
The TPD is meant to harmonise the market but there’s disharmony in its implementation and enforcement, says Gerry Stimson, emeritus professor Imperial College London, forum coordinator and formerly part of Britain’s National Institute for Health and Care Excellence working group that prepared guidelines on tobacco harm reduction.
According to Stimson, each EU member nation must still pass its own legislation to adopt the TPD.
Britain is doing the barest minimum but Poland and Spain are adding a ban on online and cross-border sales.
“That will kill e-cigs because everybody buys things on the Internet these days,” he sighs.
He expects the TPD to result in an e-cig industry dominated by large companies, with vapers seeing fewer products and less information in the market.
“The US ‘deeming rule’ is a magnification of the TPD’s problems. Looking at what we have now, perhaps Malaysia can come up with a better model for Asia to follow,” he says.
ECigIntelligence.com, the Britain-based independent resource that tracks regulations and market information for the e-cig sector, agrees that the TPD is not being implemented or enforced consistently. Barnaby Page, its editorial director, discusses the impact of some of the regulations at the forum.
“The TPD lists e-liquid ingredients that aren’t allowed so manufacturers follow the same standards across Europe. Then you get to Germany, and the list is more extensive with lots of small print.”
And while the under-18 sales ban is widely accepted, the approach to online sales differs among EU members, Page points out: member states can either ban, permit or only allow online sales within their respective borders.
Advertising on TV and radio and in print and online are outlawed but in-store and outdoor advertising (like billboards), are allowed. But, as with online sales, there is a mosaic of approaches across the continent, says Page: some countries, like Slovenia, allow outdoor but not in-store advertising while it is the reverse in Austria.
Furthermore, “E-cig taxation isn’t mandated by the TPD but there’s a huge variation in rates in the countries that impose a tax. In Serbia, the tax is €0.03/ml (S$0.04) while it is nearly €0.40/ml in Italy,” he says.
While the TPD recognises that non-nicotine products are not the same as nicotine, many countries still equate vaping with smoking.
According to Dr Miroslaw Dworniczak, Poland is among Europe’s top three e-cig markets, thanks to the lack of regulation.
The former scientist and lecturer at the Department of Chemistry, Adam Mickiewicz University, was a smoker for 35 years before he started Poland’s first vaping blog six years ago.
The Polish Government, he says, already has a draft legislation that will be implemented soon that goes even further than the TPD restrictions.
He worries particularly that a ban on online sales will deny those in smaller cities and the villages access to e-cigs. An online ban will halve the number of vapers, he predicts.
Poland, he says, is aiming to be a nicotine-free country by 2030 but for now, e-cigs can be sold everywhere and to everyone, including minors.
“But soon, e-liquids and every e-cig component, like the battery and atomiser, must be registered.
“Product approval will take at least six months but e-cigs evolve rapidly. By the time retailers can sell the product, something new would have come along,” he says.
Poland’s largest e-cig supplier was bought over by a big tobacco company last year. And he foresees smaller shops being swallowed up soon when the regulations cause costs to soar.
Vapers there are trying to call for a public hearing to amend the draft legislation before it becomes law.
“The law should be as short as possible but the EU loves long legislations. The TPD should only have a ban for minors, a requirement for e-liquid analyses and proper labelling. Enough,” he argues.
The TPD isn’t ideal nor is the EU ready to regulate the industry but at least there’s something in place, observes Dr Farsalinos with a shrug.
“The transition period for implementation of the TPD is until November. But there’s still no submission system for product analysis and testing reports.
And there are some unnecessary restrictions that have nothing to do with quality or safety.”
Like Dr Dworniczak, he feels the six-month waiting period before a product can be released into the market is too long. Two to three weeks, he argues, is sufficient.
While he agrees that the TPD will slow down product innovation, the researcher at the Onassis Cardiac Surgery Center and University of Patras in Greece doesn’t think hefty cost complaints are justified.
“Yes, it costs money to implement but so does every other regulation. Companies should invest in the safety and quality of what they put out.”
Dr Farsalinos believes the TPD is much more sustainable and realistic than US regulations.
The problem, he explains, is the use of the Family Smoking Prevention and Tobacco Control Act (TCA) to govern e-cigs in the United States. This is because the TCA focuses mainly on preventing new tobacco products from being developed and marketed.
“When you apply a law like that to e-cigs, it’s effectively a ban on vaping. That’s why everyone’s taking the government to court.”
Patricia I. Kovacevic is the general counsel and chief compliance officer of an American e-liquid and vaping device manufacturer; she also sits on the Global Tobacco and Nicotine Forum advisory board and the Vapour Technology Association board.
Generally, she says, the TCA gives the US Food and Drug Administration (FDA) the authority to regulate tobacco products. Through the “deeming rule”, however, the FDA has extended that authority to include things not derived from tobacco – like e-cig devices and non-nicotine e-liquids – because of the way they might be used with nicotine.
Since the FDA’s deeming rule was published in May, “All e-cigs and vaping products in the US are categorised as new tobacco products so pre-market applications for every items – including e-cig parts like coils and mouth pieces – must be filed with the FDA.
“It’s not realistic. Many will go out of business as innovation comes to a screeching halt,” she says, adding that other deeming rule requirements include filing product health effect reports, having nicotine and tobacco warning labels, as well as bans on sampling and modified exposure claims.
The deeming rule will come into force next month but the requirements will be implemented in stages.
The biggest problem, she feels, is the lack of product standards and good manufacturing practices.
“The FDA’s concern isn’t to make safer products for consumers but rather to take most products off the market,” she feels.
At least five lawsuits challenging the deeming rule have been filed in the United States, she says.
“The courts can either rule that no changes be made, set aside the deeming rule and force the FDA to go back to the drawing board, or set aside parts of the deeming rule or of the TCA.
“The cases could even end up in the Supreme Court on appeal.”
Dismissing the use of the EU’s TPD and America’s TCA to regulate e-cigs as “rubbish”, Clive Bates says they have resulted in an outcome that’s “worse than doing nothing”. He is the director of Counterfactual Consulting, a Britain-based public interest consultancy and advocacy practice.
As an example, he questions the sales ban to those under 18: This, he feels, is a political rather than a public health benefit decision because studies show that smoking has declined at a slower rate in states that ban e-cig sales to those under 18.
That, he says, is an example of an unintended consequence of a well-meaning policy.
Stressing that regulations must benefit consumers, he insists that the main objective of any government must be to reduce disease and promote informed choices.
Regulators must be rigorous about unintended consequences of policy interventions, he warns.
“So before you intervene, make sure you’re not making things worse.”