Nicoccino : Reglering av Nikotin - en global utmaning

MALAYSIA isn't the only country struggling with how to deal with e-cigs.

In the Philippines, e-cigs are regulated as a tobacco-medicinal product, says Philippine E-cigarette Industry Association president Joey Dulay.

In terms of advertising and marketing, tobacco regulations apply. But other regulations are similar to those imposed on medicinal products, meaning that only big pharmacies can afford to sell e-cigs, he says. And while legislation is in place, it hasn't been fully implemented yet.

'We're fighting for a new category of legislation specifically for e-cigs - not too lenient and not too strict. What's important is that consumers are protected by a safety standard.'

Popularity of e-cigs in Hong Kong has been rising since 2012, with sales doubling in the past two years, the Asian Vape Association observes. E-cigs without nicotine are legal there but anything with more than 0.1% nicotine must be registered as a pharmaceutical product.

The Hong Kong Government has, however, proposed a ban on e-cigs, association founder and chairman Nav Lalji states, adding that a lot of vapers strongly oppose the move as it would force them to go back to tobacco cigarettes.

'Most users vape because they like how e-cigs replicate the inhaling and exhaling sensation of smoking. It's a satisfying and realistic alternative to quitting. Nicotine is important - it's the reason they use e-cigs. In Hong Kong, they're forced to pick up zero nicotine liquids. These satisfy the psychological dependency but not the physical craving. So they switch back to tobacco,' he says, speaking to Sunday Star during a symposium on vaping in Hong Kong last month.

Asia is very fragmented in e-cig policies. Compared to the West, we have a lot of catching up to do, he feels.

'The Hong Kong Government has a great opportunity to be a leader in Asia in regulating e-cigs. Many want it to be categorised as a consumer product but a deeper debate is needed.'

The first step, he feels, must be to make sure it's safe to consume before determining which category the product falls under.

'It shouldn't be categorised as a pharmaceutical product. We must have an open dialogue with the Government, show them the facts and discuss how to regulate it for the Hong Kong market.'

The situation in Australia is very similar to Hong Kong. Unless it's by prescription or sold as tobacco cigarettes, nicotine products are illegal. E-cigs with nicotine are sold as a cessation device there, strategic public policy consultant Terry Barnes, shares.

He, however, thinks this will fail in helping the country's smokers quit because nicotine is seen as a medicine. Smokers don't want to feel like they need a doctor's approval to vape, he offers. So for smokers to view e-cigs as a viable alternative, it cannot be slapped with a label that screams 'medicine'.

Sensible regulation must recognise that no product is free from harm. Take advantage of innovation to reduce harm, he pleads.

Also commenting on how big tobacco companies are starting to invest in e-cigs, he says this is not necessarily a negative.

'They realise that traditional cigarettes will be a thing of the past. If they're going into harm reduction with e-cigs, it's good. Even if e-liquid contains tobacco, it's still better than smoking. When innovation makes things better, you can't shut it down,' he says, pointing to how innovation has run way ahead of regulation.

A balance between growing businesses and protecting consumers must be struck. Policy makers and politicians must keep an open mind, he says. It's good policy and good politics to reduce harm. Don't overdo it but don't under regulate either, he says.

As far as protecting passive vapers go, he says it's more a question of etiquette, mutual respect and civic consciousness.

Most adult smokers in the region want to know more about vaping, factasia.org co-founder John Boley says.

A survey to gauge consumers' views on vaping, he shares, saw a whopping 93% of adult smokers agreeing that if a new product is scientifically proven to reduce the risk of smoking, they should have access to this information.

The survey, conducted among some 3,000 respondents in Malaysia, Hong Kong, Macau, Singapore, Australia, Taiwan and New Zealand, found that 75% say it's wrong for governments to prevent or delay the introduction of less harmful alternatives to cigarettes for adult smokers. The results were announced during the symposium.

'Most smokers know something about vaping. Some 70% say they'll consider switching to e-cigs if they were legal, met quality and safety standards, and were conveniently available like regular tobacco products.'

He says the main reasons smokers aren't using e-cigs more is because of price and accessibility. Those who buy e-cigs mainly get them from specialist stores, with only 14% buying them online, he adds.

With so much controversy swirling around the device, it's unsurprising that despite having product knowledge, the legality remains hazy among many. He says 34% of the survey's respondents are unsure whether e-cigs are legal in their country.

The EU Tobacco Products Directive, he predicts, is not the last word on vaping.

'Why shouldn't e-cigs be treated as a consumer product? The word 'e-cigarette' is misleading. It's used by anti-smoking campaigners to alarm the public. The device must be clearly distinguished from combustible tobacco products. Malaysia is struggling like everybody else but some form of regulation is needed.'

Factasia.org co-founder Heneage Mitchell thinks endorsing e-cigs is the only way for governments to see positive results in national public health policy. Describing vape as the 'greatest opportunity' for policy makers to reduce smokers, he says legislating for the entrepreneur-driven industry is only possible by looking at the facts. Smokers shouldn't be denied access to nicotine if it's what they want, he argues.

The EU recognises the value of e-cigs, points out Greek cardiologist Dr Konstantinos Farsalinos, which is why they have not been banned there.

The researcher at the University of Patras Onassis Cardiac Surgery Center in Greece, and the University Hospital Gathuisberg's Medical Imaging Research Center in Belgium, has been studying e-cigs since 2011.

'Efforts to legislate are ongoing in the US. In the UK, people want more lenient legislation than what's going to be enforced in the EU this year. There's a lack of understanding of e-cigs even among tobacco experts.'

Many studies use outdated e-cig products to identify modern vaping patterns. Legislators, he says, are using theoretical arguments to ban, not facts. Claiming that public health policy makers don't like people using e-cigs to get nicotine, he reminds that their role isn't to judge but to reduce harm.

The Tobacco Vapour Electronic Cigarette Association (TVECA) - an international nonprofit trade association - doesn't want e-cigs to be sold 'next to dishwashing powder or a bicycle pump' because it's a tobacco product.

Its CEO Ray Story, an American e-cig distributor, sued the US Food and Drug Administration and won in 2010, arguing that the e-cig is a tobacco product, not a drug delivery device. He also defeated the Dutch ministry's attempt to ban e-cigs and is working with the EU Parliament to allow the devices to be sold openly with responsible regulations.

In 2008, e-cigs were categorised as a medicine in the US. This resulted in a de-facto ban because vapers had difficulty accessing e-cigs until we proved that it isn't a medicine, he explains.

To be a medicine, you must show that the nicotine and e-cig can stop, cure or mitigate the course of a disease. But nicotine, like caffeine, are stimulants that don't provide any pharmacological effect.

'It would also be absurd to call it a cessation device because smokers don't think they're sick. They just have a habit and we're trying to provide them with an alternative that removes all the negatives of smoking except nicotine which is found in everything - even potatoes. So to ban it, you'd have to ban vegetables like potatoes and that, in my opinion as a potato lover, is going too far!'

Neither, he says, can nicotine be regulated as a consumer product, alongside everything from milk to chewing gum, because these items don't need age verification. The conclusion, he says, is clear. E-cigs, which have nicotine derived from a tobacco plant and mimics smoking, can only fit into the tobacco category where age verification rules and the like apply.

'Tobacco is a dirty word but Governments and regulatory bodies gladly take the taxes. Let's call a spade a spade. E-cigs are vastly less harmful than smoking but it is, by definition, a tobacco product. So regulating it as a tobacco product makes it available in a way that's consistent with the law,' says Story.

TVECA's EU chief political officer Renato Addis agrees. You have to carve out e-cig regulation from the rules of conventional tobacco smoking - this, he says, was done in the EU.

'E-cigs have found a home in Article 20 of the Tobacco Products Directive. So clearly in the EU, medicinal regulations are not applicable to e-cigs.'

From May this year, e-cigs and other nicotine vapour products will be regulated in Europe under the Tobacco Products Directive. Strict regulations, including of bottle sizes, tank sizes and nicotine strength, will be imposed. To continue selling e-cigs not meeting these new regulations, retailers can apply for their products to be registered as medicines.

But this is an extremely costly route, according to Britain's The Guardian newspaper. Britain, Story observes, 'still can't make up it's mind' so they have it in the tobacco, consumer and medicinal categories. That, he feels, is a recipe for disaster because there is no uniformity.

'It creates enormous confusion, so it's a de-facto ban on the product because it's inaccessible.'

He expects US tobacco product regulations for e-cigs to be in place by 2017. The Bill there, he says, is ready.

'If the law is too restrictive, we may have to sue. Otherwise, we'll work with regulatory bodies on its implementation.'

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