No smoke without fire (From left) Catherine Ryan, Andrew Washbourne and Leon Alegria all use e cigarettes and fear the WA ban will spread nationally. Photo Wolter Peeters

  • Retailers face tough new restrictions

They arrived in black station wagons, pouncing with the purpose and precision of a crack undercover police team.

Within 90 minutes, a suburban home in Perth had been turned upside down, the officers emerging with large garbage bags full of hardware.

Puff daddies E cigs deliver nicotine in vapour. Photo Wolter Peeters

It was a scene reminiscent of a counter terrorism raid. But this was the West Australian Health Department swooping on small time electronic cigarette supplier Vincent van Heerden who, they claimed, was in breach of the Tobacco Products Control Act.

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Two years on, that sting has sparked a landmark legal test case that made Western Australia the first territory in the world to outlaw the sale of electronic cigarettes.

The move contrasts with the approach of other places such as London, where a new cafe, The Vape Lab, not only sells e cigarettes but rents them by the hour, offering 19 different flavours including bubblegum and custard.

Advocate Leon Alegria says the ruling lacks focus. Photo Sahlan Hayes

“We just don’t need e cigarettes here,” said Cancer Council Australia’s director of advocacy, Paul Grogan, last week. ”There are already approved services for people who claim they need these types of things to quit tobacco.”

Users of e cigarettes currently need to sidestep local restrictions and import ”personal amounts” of nicotine from overseas. But it was thought unlikely that the actual devices would fall foul of tobacco legislation, mainly because they don’t use tobacco. Then came the controversial Western Australian Supreme Court decision which, on April 10, ruled that if an e cigarette device involves ”a hand to mouth action” and results in the ”expulsion of vapour”, then it resembles a tobacco product and is therefore illegal.

The ruling has been celebrated by anti tobacco lobbyists. Australian Council on Smoking and Health president Mike Daube told the media that the decision was an important step in the continuing battle against smoking.

Unnecessary Becky Freeman says aids aren’t needed. Photo Marco Del Grande

In turn, it has shocked the community of Australian e cigarette users many of whom are former smokers who now fear a blanket ban.

”I’ve been trying to get off tobacco for 15 years, and having found something that works, I’m finding a rabid push to shut it down,” says Owen Phillis, of Botany. ”I’m scared that I, and thousands of others, will wind up back on tobacco and a cancerous end if this avenue is closed.”

According to a recent worldwide survey of more than 19,000 users, 81 per cent of respondents reported having completely substituted smoking with e cigarettes. But while users may no longer be pumping up to 4000 different chemicals and carcinogens into their bloodstream, there remains no long term studies about the actual health effects of filling lungs with vapour, morning, noon and night. On Thursday, the US Food and Drug Administration announced that all electronic cigarettes are to carry health warnings under new rules aimed at bringing e cigarettes in line with tobacco. The regulations will also cover pipe tobacco and cigars two products that somehow had previously been treated more leniently.

The changes follow a rise in complaints from US e cigarette users that, according to Reuters, included trouble breathing, headache, cough, dizziness, sore throat, nosebleeds, chest pain or other cardiovascular problems, and allergic reactions such as itchiness and swelling of the lips. One woman wrote that her husband began smoking e cigarettes liberally in his car and at home after being told they were safe and that the vapour was ”just like water”.

”E cigarettes are products that prey on the most vulnerable,” Sydney pharmacist Paul Melas says. ”Who are the most vulnerable? Those that fear early death brought on by tobacco related diseases.”

He claims the ”perception of safety” around e cigarettes demotivates a person from ”quitting completely”, and instead allows them to think they have more time to ”sort themselves out” before actually making the move to quit. ”E cigarettes do not have a place in current therapy because they do not have established safety profiles,” he says.

Sydney University lecturer in public health Dr Becky Freeman agrees ”The reality is, most people who quit smoking don’t need any quitting aid, be that gum, patches or e cigarettes &#8230 they wake up one day and think ‘Yes, I’m done with this’.”

In the aftermath of the WA ruling, ”vaping” forums have been asking how authorities can outlaw a product on the basis that it mimics another product that is legal and kills you? ”It just doesn’t add up,” says Leon Alegria, who runs the Sydney based e liquid website Delicious Monsta and is an advocate for the industry to be ”regulated”. ”Aren’t we losing focus on the ultimate goal? To have fewer people consume tobacco products?”

But Grogan says the biggest threat from e cigarettes is not necessarily the threat they pose to individual health, but their role in normalising smoking again.

“We Cancer Council Australia are most concerned about the aggressive way these things are being marketed to young people in particular. It’s really naive not to see them as something commercial interests would like to proliferate,” he says.

Grogan says when he was growing up, it was normal to see teenagers smoking. “But I’ve got kids now, one in high school, and it kind of seems weird to them when they see someone smoking,” he says. “It has been a generational change, and we have got so much to lose if we start making smoking normal again.”

The user Still hooked but happy

Catherine Ryan was the epitome of a typical heavy smoker.

After becoming hooked at the age of 16, she developed a 25 a day habit that jumped to as many as 40 on a ”big night out”. She languished in that cycle for 20 years.

”In all that time I never once tried to quit because I loved it so much,” she says.

”My addiction was so bad, I would walk hours for a cigarette. But then last year, a friend gave me an electronic cigarette starter kit. I have never looked back.”

Today, a phone app informs Ryan she is now on her 315th ”smoke free day” and it calculates the money she has saved as being almost $8000.

”I feel so much better physically and I’m still a little shocked that I was able to move away from a habit which I had no intention of addressing.”

Ryan believes electronic cigarettes successfully helped her quit because, unlike patches or lozenges, it replicates the habitual hand to mouth action. ”It feels like I’m smoking,” she says.

While acknowledging she is ”still hooked on nicotine”, Ryan says ”I’m now down to consuming a third of the nicotine I was absorbing as a smoker. I actually see a day now when I will stop altogether.”

The legal issues Case watched closely

All eyes are focused on Perth resident Vincent van Heerden, who has three weeks to appeal the landmark ruling by the WA Supreme Court effectively banning e cigarettes in the state. Van Heeden’s company, Heavenly Vapours, was prosecuted for selling dispensers and nicotine free ”e juice” through a website.

Some believe the decision could trigger a nationwide ban on electronic cigarettes.

Van Heerden told Fairfax Media he wants to fight the decision, but will ultimately be guided by legal advice. ”What happens next has repercussions not just here, but internationally,” said van Heerden. ”The sale of hardware has now been outlawed in Western Australia. Once that spreads to other states, importation will be classed as some form of loophole that also needs to be blocked. Then Australia will be known as the
first country to have completely banned e cigarettes. And, of course, other countries will follow.”

In 2011, the WA Health Department targeted van Heeden over alleged breaches to section 106a of the Tobacco Products Control Act, which prohibits the sale of anything such as food or toys that mirrors a tobacco product. But in September last year, a magistrate’s court judge dismissed the case ruling there was insufficient evidence that the e cigarettes in question looked anything like traditional cigarettes or cigars, adding they resembled a ”fountain pen”.

But to van Heeden’s surprise, the WA Health Department lodged an appeal that proved successful. In her judgment, Justice Janine Pritchard stated ”In my view, the evidence &#8230 supports the conclusion that the items were designed to resemble a tobacco product because they were intended to be used to inhale vapour in a manner very similar to the inhalation of tobacco smoke when using a cigarette.”

The signs appear ominous for e cigarette users in NSW. The Health Department confirmed last week it was ”continuing to monitor” the case and waiting to see ”whether the decision may be appealed”.

The health implications Vapour warnings

E cigarettes may not contain the same lethal chemicals and carcinogens as cigarettes, but health experts warn there is still no comprehensive research into the risks of frequently inhaled vapour.

Earlier this month, a US study on the effects of e cigarette vapour on human lung cells found it could potentially change gene expression in a similar way to tobacco. Presented at the annual meeting of the American Association for Cancer Research in California, the research analysed human bronchial cells that contained mutations found in smokers at risk of lung cancer. It found that cells grown under medium exposure to e cigarette vapour changed in a similar fashion to those exposed to tobacco smoke. However, researchers acknowledge the work is only at a preliminary stage.

In the meantime, most research points to e cigarettes being a safer alternative to the old fashioned gasper. Last year, a US study of 12 e cigarette brands found that while certain toxicants were present, levels were between nine and 450 times lower than smoke created from combusted tobacco. Another study, led by Chris Bullen at the University of Auckland, recruited 657 smokers who wanted to quit smoking. Two groups were given a 13 week supply of either patches or e cigarettes that delivered nicotine vapour. Another 73 were given e cigarettes without nicotine. The success rate among the nicotine e cigarettes was 7.3 per cent, compared with 5.8 per cent in the patch group and 4.1 per cent in the non nicotine e cigarette group.

While no e cigarette users fell ill from using the product, researchers said its long term safety was unclear. ”E cigarettes, with or without nicotine, were modestly effective at helping smokers to quit, with similar achievement of abstinence as with nicotine patches, and few adverse events,” said the study, published in The Lancet. But, it adds ”Uncertainty exists about the place of e cigarettes in tobacco control, and more research is urgently needed to clearly establish their overall benefits and harms.”

The US has announced all electronic cigarettes will carry health warnings. Users have reported headaches, dizziness, cardiovascular problems and allergic reactions.

The role of big tobacco Giants scrap for e cig market

The introduction of plain packaging had many predicting the end for Big Tobacco. Then along came a smoke free product that some saw as an opportunity to reinvent themselves.

Most big tobacco companies have already muscled in on an industry that generated a reported $US2 billion in sales last year in the US. There are an estimated 5 million users in the US alone.

Lorillard, manufacturer of the Newport brand, forked out $135 million to buy Blu the US’s leading e cigarette. Reynolds, which makes Camel, has unleashed a product called Vuse. Philip Morris International, meanwhile, has joined forces with rivals Altria, makers of Marlboro, to launch and market several new designs, including MarkTen.

It is this rapidly changing landscape that, in recent days, has prompted the national regulation agency in the US to announce a crackdown on the sales and marketing of e cigarettes. The Food and Drug Administration will force manufacturers to disclose ingredients.

However, firms will still be allowed to advertise e cigarettes as long as they do not feature health claims. Companies will also be allowed to continue offering flavours perceived by anti tobacco lobbyists as an attempt to target teens.

How they work Range of ‘tanks’ creates new fashion

”E cigarettes”, or personal vaporisers, are battery powered devices that deliver nicotine through a solution that is heated into vapour, then inhaled and exhaled.

”Vapers” presently have to buy their nicotine in ”personal amounts” from overseas because it remains classified as a ”dangerous poison” and can only be sold within Australia, in the form of cigarettes, under licence.

Fairfax Media reported last year that Australian e cig community has 4000 members who swear by the gadgets, with one devotee saying ”e cigs are the greatest innovation in health since the invention of penicillin”.

The cheapest ”tanks” can be bought for as little as $20, with some designed to look like traditional cigarettes complete with glowing tip. But as the industry has developed, so has the range of devices and accessories. Fairfax Media caught up with several vapers last week whose habit has become their hobby, spending thousands of dollars on handcrafted limited edition tanks from around the world, complete with luxury ”drip tips” the mouthpiece attached to the top of device.

And the latest undisputed king of tanks? The ”Piston Steampunk Mod” built by SteampunkVapors in Albuquerque, New Mexico. At $700, it comes with its own hand stitched leather case.

eduff

Fda announce proposal to regulate e-cigarettes – medical news today

Cigarette — wikipedia

The US Food and Drug Administration have announced a proposal to extend current tobacco regulation to include e cigarettes. The proposals will mean that minors under the age of 18 will not be able to purchase them.

The e cigarette industry has come under major scrutiny in recent months after concerns have been raised regarding the health implications of the devices.

Traditionally marketed as smoking cessation aids, studies have suggested that e cigarettes may actually encourage conventional cigarette smoking, particularly in adolescents who are prime users of the devices.

A study from the Centers for Disease Control and Prevention (CDC) reveals that e cigarette use more than doubled among middle and high school students between 2011 and 2012, from 4.7% to 10%.

In addition, research has indicated that the vapors produced by e cigarettes may cause damage to the lungs an effect commonly associated with traditional cigarettes. A more recent study from the CDC reveals that the number of e cigarette related calls to US poison centers have soared.

Such concerns have led to calls for the devices to be regulated a topic that was discussed in a recent spotlight feature from Medical News Today. Now, it seems that the Food and Drug Administration (FDA) have listened to these calls.

Proposed age and marketing restrictions

At present, only e cigarettes that are marketed for therapeutic purposes are regulated by the FDA Center for Drug Evaluation and Research (CDER), while the FDA Center for Tobacco Products (CTP) regulates conventional cigarettes, cigarette tobacco, roll your own tobacco and smokeless tobacco.

Under the new proposal, youths under the age of 18 will be banned from buying e cigarettes.

Now, the FDA plan to extend such regulations to include e cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe/hookah tobacco and dissolvables that are not already regulated.

The new proposition would mean that minimum age and identification restrictions would be applied to the purchase of these products an individual will need to be aged 18 or over to buy them.

The products will also be required to include health warnings, and a prohibition will be placed on vending machine sales unless the machine is in a facility that does not admit persons under the age of 18.

The manufacturers of these newly deemed tobacco products will not be banned from marketing them, but they will be required to

  • Register with the FDA and disclose product and ingredient listings of their products
  • Only market their products after they have been reviewed by the FDA
  • Only make direct and implied claims of reduced risk if the FDA confirms there is sufficient scientific evidence to support them and that marketing the product with benefit overall public health, and
  • Not distribute free samples of their products.

Commenting on the new proposal, FDA commissioner Dr. Margaret A. Hamburg says

“Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products.

Science based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth.”

Mitch Zeller, director of the CTP at the FDA, notes that tobacco related disease and death is one of the most “critical” public health challenges that the FDA face.

“The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health related claims,” he adds.

The FDA are taking public comments for the proposed rule for 75 days. In particular, they are looking for comments as to whether all cigars should be subject to regulation, and views as to how products that do not involve burning of tobacco such as e cigarettes should be regulated.

But in a statement from the American Association for Cancer Research (AACR), chief executive Dr. Margaret Foti says it is “imperative” that the FDA regulate all tobacco products, including e cigarettes and cigars.

“We do not know the nature of the long term health consequences of these devices or what effect they will have on smoking continuation or uptake by adults and youth,” adds chair of the AACR Tobacco and Cancer Subcommittee, Dr. Roy S. Herbst. “Therefore, FDA regulation of these products is appropriate and welcomed by the AACR.”

Written by Honor Whiteman

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