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Confusion still reigns over e-cigs

The European Union and US are huge e-cig markets with regulatory models in place. 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., 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.”

United States

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.”


EU Court Upholds Tough Tobacco Law On Packaging, Flavors, E-Cigarettes

Tobacco companies, led by Philip Morris International, lost an appeal in the European Union’s top court Wednesday against strict packaging rules for cigarettes. The Court of Justice for the European Union also dismissed appeals by Poland and Romania to the EU decision to ban flavored cigarettes, such as menthol.

In the matter of flavored cigarettes, the court reasoned that tobacco products with menthol or another “pleasant flavor” makes them “more attractive to consumers and that reducing the attractiveness of those products may contribute to reducing the prevalence of tobacco use and dependence among new and continuing users.”

In a statement on the official EU website, the court also said that the EU legislature was right in forming the law in 2014, which guards against divergences in different rules of various member states, especially when it came to health matters.

In a setback to tobacco companies, led by Philip Morris and British American Tobacco, the court also ruled in favor of EU regulations on cigarette packaging, which mandate a message and a color photograph — covering at least 65 percent of each packet’s front and back — warning of the dangers of smoking. The court said that “the EU legislature did not go beyond the limits of what is appropriate and necessary,” and added that individual countries could impose stricter rules, such as plain packaging without any branding.

The court also upheld new limits on e-cigarettes, despite manufacturers claiming they should be dealt with under a different law because e-cigarettes were not actually tobacco products. A limit on maximum nicotine content, of 20 mg/ml, was declared valid, along with requirements of specific warnings and leaflets, and a prohibition on advertising.

“The identified and potential risks linked to the use of electronic cigarettes have led the EU legislature to act in a manner consistent with the requirements stemming from the precautionary principle,” the court said.

The ruling by the Court of Justice for the European Union cannot be appealed.

Flavored e-cigs irritate lungs, Roswell study finds

A team led by a Roswell Park Cancer Institute researcher recently reported that high levels of a respiratory irritant were detected in the vapor from most flavored nicotine products they studied, with the highest concentrations in vapor from cherry-flavored products.

The team, led by Maciej Goniewicz, analyzed 145 electronic-cigarette flavored products and found that many e-cigarette users may be exposed to benzaldehyde, a chemical compound used in many foods and cosmetic products. While it appears safe when ingested or applied on the skin, it has been shown to cause airway irritation in animals and humans, and may have different effects when heated and inhaled, Roswell officials said.

The authors, who include researchers from the Institute of Occupational Medicine and Environmental Health and the Medical University of Silesia, both in Poland, measured benzaldehyde levels using an automatic smoking simulator and calculated daily exposure to users from 163 e-cigarette puffs. Their analysis detected benzaldehyde in the vapor from 108 (74 percent) of the flavored products studied, and found concentrations of the chemical that were 43 times higher in cherry-flavored products than in other flavors.

Goniewicz, the paper’s senior author and assistant professor of Oncology in Roswell Park’s Department of Health Behavior, noted the research was focused on a single toxicant and should be interpreted as a first step in understanding the potential health effects from flavored e-cigarettes.

“Health care professionals should be asking patients not just whether they smoke tobacco cigarettes but also whether they vape e-cigarettes, and whether they are using flavored products,” he said in a news release. “For e-cigarette users, it’s important that they pay attention to how the products are affecting them. If they notice irritation, maybe a cough or sore throat, when they use e-cigarettes, they might want to consider switching to a different flavoring. And it’s also important to keep these findings in perspective. The potential harm, if any, from inhaling flavored e-cigarettes would probably not even approach the dangerous, deadly effects of tobacco.”

The study, “Cherry-flavoured electronic cigarettes expose users to the inhalation irritant, benzaldehyde,” is available online at

British American Tobacco turns to ecigarettes to stay ahead but share price closed on five-day low

British American Tobacco (BAT) yesterday signed a conditional agreement to buy ecigarette manufacturer CHIC for an undisclosed sum.

BAT hopes to extend its reach through Europe and expand beyond its tobacco cigarettes to make the most of the growing ecigarette movement – which are widely viewed as a healthier option.

CHIC, Poland’s e-cigarette market-leader, makes brands including Volish and has an e-liquids production plant as well as research and development labs.

The proposed acquisition is subject to approval from the Polish anti-trust authority.

BAT also announced it has signed a vapour products research and technology-sharing deal with R.J. Reynolds Tobacco.

Vapour technologies provide nicotine via aerosols in products.

The alliance provides a framework for mutual cross-licensing of vapour product technologies up to 31 December 2022. The collaboration also includes joint R&D projects.

Investors were less convinced by the move, and BAT shares closed down 2.8 per cent, a five-day low.

Contrasting academic and tobacco industry estimates of illicit cigarette trade: evidence from Warsaw, Poland



To compare two different methods for estimating the size of the illicit cigarette market with each other and to contrast the estimates obtained by these two methods with the results of an industry-commissioned study.


We used two observational methods: collection of data from packs in smokers’ personal possession, and collection of data from packs discarded on streets. The data were obtained in Warsaw, Poland in September 2011 and October 2011. We used tests of independence to compare the results based on the two methods, and to contrast those with the estimate from the industry-commissioned discarded pack collection conducted in September 2011.


We found that the proportions of cigarette packs classified as not intended for the Polish market estimated by our two methods were not statistically different. These estimates were 14.6% (95% CI 10.8% to 19.4%) using the survey data (N=400) and 15.6% (95% CI 13.2% to 18.4%) using the discarded pack data (N=754). The industry estimate (22.9%) was higher by nearly a half compared with our estimates, and this difference is statistically significant.


Our findings are consistent with previous evidence of the tobacco industry exaggerating the scope of illicit trade and with the general pattern of the industry manipulating evidence to mislead the debate on tobacco control policy in many countries. Collaboration between governments and the tobacco industry to estimate tobacco tax avoidance and evasion is likely to produce upward-biased estimates of illicit cigarette trade. If governments are presented with industry estimates, they should strictly require a disclosure of all methodological details and data used in generating these estimates, and should seek advice from independent experts.