E-cigarettes: regulation – tobaccotactics

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  • 1 Bans in Public Places
  • 2 UK Regulation
  • 3 EU Tobacco Products Directive Revision
  • 4 FDA Regulation in the USA
  • 5 WHO s Position on e Cigarettes
  • 6 Other TobaccoTactics Resources
  • 7 Notes

Bans in Public Places

Due to a lack of regulations concerning e cigarettes, local authorities and commercial enterprises have started introducing their own rules. In the USA, the number of cities banning the use of e cigarettes in public places, such as bars, nightclubs and restaurants, and therefore treating them similarly to traditional cigarettes, is growing.

Boston, Chicago, New York and Los Angeles City Council have all voted to ban them. In the UK, different companies have adopted varying positions. The pub chains Wetherspoons and the Slug & Lettuce have banned the use of them insider their establishments, so has the fast food chain McDonald s. Some train operators, including First Capital Connect, have imposed a complete ban on passengers using the devices. 2

Meanwhile, Wales could be the first part of the UK to ban smoking e cigarettes in enclosed public spaces. In early April 2014, the Welsh Health Minister, Professor Mark Drakeford revealed that he was considering a ban amid concerns the products could re normalise the use of conventional cigarettes. He said there were also concerns that the spread of e cigarettes could undermine the ban on tobacco smoking in enclosed public spaces, making it more difficult to enforce. The proposal is part of a new set of ideas for public health legislation. 3

UK Regulation

In the summer of 2013, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK decided that e cigarettes should be regulated as medicines from 2016. This regulation would require manufacturers to present data on the quality of their products, how they deliver nicotine to the body and how they compare with nicotine replacement products like patches and gums. 4 However, a final decision will await the outcome of the EU Tobacco Products Directive Revision.

The UK government announced plans to ban sales of e cigarettes to under 18s. The new regulation could come into force within a year of the announcement in January 2014. 5

  • More information on the policy decision process can be found on the Nicotine containing products page on the MHRA’s website.

EU Tobacco Products Directive Revision

On 18 December 2013, after years of delay, a political agreement was reached on the text for a revised Tobacco Products Directive (TPD) between the European Commission, Parliament and the Council. 6 This compromise text now has to be approved at a plenary session of the Parliament (expected in February or March 2014) and again by the Council. Once this has occured, Member States will have two years to implement the new rules at national level. Although the European Commission 7 and the Council 8 proposed to regulate e cigarettes as a medicine, this approach was rejected by the Parliament in October 2013. In December 2013, a compromise agreement was reached between the three EU institutions which should see e cigarettes regulated for the first time at EU Level. The compromise agreement provides for two ways of placing e cigarettes on the market

  • as a medicine, if companies choose to make a claim that e cigarettes help smokers quit smoking
  • as a consumer product (if companies do not make any health claims) subject to certain safeguards, including
  • a limit on nicotine strength of 20mg/ml
  • quality and purity standards
  • the same advertising bans as for cigarettes
  • a size limit and safety mechanisms for e liquid bottles and refillable cigarettes.

This agreement will also allow the UK Government, to introduce extra safeguards for instance on age limits and flavourings in e cigarettes.

FDA Regulation in the USA

Only e cigarettes that are marketed for therapeutic purposes are currently regulated by the FDA Center for Drug Evaluation and Research (CDER) at the national level. Furthermore, 26 US States have banned sales to minors on the basis that smoking e cigarettes, or vaping, might tempt them to try smoking. 5

The process of developing new policies is a long and complicated one, but the FDA is expected to introduce regulations on e cigarettes in early 2014. Until then, the position of the FDA is a cautious one. The agency s website warns that as long as e cigarettes have not been fully studied, consumers do not know the following

  • the potential risks of e cigarettes when used as intended,
  • how much nicotine or other potentially harmful chemicals are being inhaled during use, or
  • if there are any benefits associated with using these products.

Additionally, it is not known if e cigarettes may lead young people to try other tobacco products, including conventional cigarettes, which cause disease and lead to premature death. 9

WHO s Position on e Cigarettes

In July 2013, the World Health Organization (WHO) issued a statement on e cigarettes and advised that consumers should not use e cigarettes until they are deemed safe. It said the potential risks “remain undetermined” and that the contents of the vapour emissions had not been thoroughly studied.

Contrary to what some marketers of the e cigarette imply in their advertisements, WHO does not consider it to be a legitimate therapy for smokers trying to quit. Furthermore, the efficacy of e cigarettes for helping people to quit smoking has not been scientifically demonstrated. According to WHO, they are

often touted as tobacco replacements, smoking alternatives or smoking cessation aids. But we know that for smoking cessation products to be most effectively and safely used, they need to be used according to instructions developed for each product through scientific testing.

The WHO concluded it was best to stay away from electronic nicotine delivery systems (ENDS), as they call them

Until such time as a given ENDS is deemed safe and effective and of acceptable quality by a competent national regulatory body, consumers should be strongly advised not to use any of these products, including electronic cigarettes. 10 Other TobaccoTactics Resources

  • E cigarettes
  • E cigarettes Marketing
  • E cigarettes At The Pharmacy
  • E cigarettes Lobbying
  • Harm Reduction
  • Product Innovation

Notes

  1. Library of the European Parliament, Electronic Cigarettes, Library Briefing, 27 March 2013, accessed January 2013
  2. Kevin Hughes, The rise of the e cigarette, 3 April 2014, accessed April 2014
  3. Ronan Hegarty, Wales weighs e cig ban in public places and minimum unit pricing, The Grocer, 2 April 2014, accessed April 2014
  4. MRHA, Nicotine containing products, December 2013, accessed January 2014
  5. 5.0 5.1 Andy Coghlan, UK government to ban e cigarettes for under 18s, New Scientist Health, 30 January 2014, accessed January 2014
  6. European Commission,Commissioner Borg welcomes agreement on the revision of the Tobacco Products Directive, 18 December 2013, accessed December 2013
  7. European Commission, Proposal for a Directive of the Revision of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products, 19 December 2012, accessed December 2012
  8. Council of the European Union, release 3247th Council meeting Employment, Social Policy, Health and Consumer Affairs, 21 June 2013, accessed June 2013
  9. FDA, Regulation of e Cigarettes, no date, accessed January 2014
  10. WHO, Questions and answers on electronic cigarett
    es or electronic nicotine delivery systems (ENDS), Statement, 9 July 2013

Science ‘wrong’ in eu’s proposed e-cigarette law – health – 23 january 2014 – new scientist

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Fifteen prominent scientists who have investigated the health consequences of electronic cigarettes have accused European Union regulators of misinterpreting their results. The scientists say the EU aim is to draft an unjustifiably burdensome new law to regulate e cigarettes.

Their argument is made in a letter to the EU’s health commissioner Tonio Borg. The scientists state that if the newly amended Tobacco Products Directive becomes law as it stands which could happen as soon as April it will severely limit the scope for smokers of real cigarettes to give up or cut down by switching to e cigarettes, which contain nicotine but not the tobacco that contains tar and thousands of other substances harmful to health.

“If wisely regulated, e cigarettes have the potential to make cigarettes obsolete and save millions of lives worldwide,” the signatories say in the letter, which was also sent to members of the European Parliament, European Commission and the Council of Ministers the three bodies that will decide the fate of the directive. “Excessive regulation, on the contrary, will perpetuate the existing levels of smoking related disease, death and health care costs,” it continues, pointing out that smoking currently kills 700,000 Europeans each year.

The British Medical Association told New Scientist that longer trials are needed to learn more about the long term effects of e cigarettes. “Better regulation of e cigarettes is essential,” a spokesperson says. “Studies have shown that they are unreliable in the levels of nicotine they provide and there’s a lack of evidence regarding their safety.”

Ethical imperative

The signatories of the letter say regulation must be built on robust science. The cited errors relate to the strength of nicotine solutions allowed, the doses needed to match the nicotine “hit” from real cigarettes, an overstatement of the known dangers from nicotine and unwarranted assumptions that e cigarettes will become “gateway products”, tempting non smokers and young people to try real cigarettes.

As it stands, say the scientists, the draft would unnecessarily restrict nicotine content in the liquids that are vapourised in e cigarettes to deliver the drug to users when they suck on the devices.

Currently, the draft would restrict content to 20 milligrams of nicotine per millilitre of fluid, on the grounds that this matches the dose from a real cigarette over the same period of smoking. An estimated 20 to 30 per cent of e cigarette users prefer higher doses than this, and so could potentially return to smoking real cigarettes unless stronger e cigarettes are allowed, warn the researchers.

Outdated, overestimated

One of the signatories, Konstantinos Farsalinos of the University Hospital in Gasthuisberg in Leuven, Belgium, says his own research on e cigarettes was used to reach this figure, but that it has been misinterpreted. His work shows that 20 milligrams is less than half of what is required to match the output from a real cigarette, equivalent to roughly 50 milligrams per millilitre.

Much of the misinterpretation of results comes from outdated information and overestimation of the toxicity of nicotine, say the researchers.

The EU’s current assumption that 60 milligrams of nicotine is lethal is incorrect, they say, and dates from self experiments reported in a pharmacology textbook published in 1856. “This is not the case, and people have ingested doses 60 times higher, which only led to nausea and vomiting,” says the scientists’ letter. “Poisoning from tobacco, nicotine replacement medications or e cigarette liquid is extremely rare, and there is no risk of overdosing through inhalation,” they say.

Deep breath

Another gripe with the current draft of the Tobacco Products Directive is its insistence that electronic cigarettes deliver nicotine doses “consistently”. This is nonsensical, they say, because “vapers” the users of e cigarettes dictate for themselves how much nicotine they breathe in.

Research shows, for example, that individual users of the same electronic cigarette differ in nicotine intake by as much as 20 fold because they inhale different amounts at different rates.

The scientists also take issue with wording in the directive implying that there is strong evidence that e cigarettes lead to nicotine addiction and in turn the smoking of real cigarettes. “Existing data do not suggest that electronic cigarettes are having any such effects,” they go on to say that the evidence suggests the use of e cigarettes helps smokers of all ages reduce or give up smoking.

Dog’s breakfast

Supporters of e cigarettes argue that they could help smokers avoid disease and premature death. Proponents are lobbying either for further amendments to the draft directive to ease the restrictions, or for the e cigarettes component of the directive to be removed altogether and re drafted as an independent regulation.

“Otherwise, we’ll end up with a dog’s breakfast that will set the direction of e cigarette legislation for decades,” says Clive Bates, former director of UK public health charity Action on Smoking and Health (ASH), and a prominent campaigner for harm reduction through e cigarettes.

But time to amend the directive is limited because it will be read in the European Parliament in March. If passed, it could be rubber stamped into law by the Council of Ministers a month later.

The EU’s Environment, Public Health and Food Safety committee met 22 January in Brussels, Belgium, to consider the latest draft.

“My main issue with the directive is that it is unbalanced in its treatment of e cigarettes compared to tobacco products,” says signatory Chris Bullen of the University of Auckland in New Zealand. Last year Bullen headed a trial demonstrating that e cigarettes are at least as effective as nicotine patches in helping people quit smoking or cut down. “Proportionate regulation is what’s needed, sufficient to give consumers confidence in the quality, reliability and safety of e cigarettes,” he says.