The European Parliament is set to vote on a batch of regulations on Wednesday that will treat electronic cigarettes like regular tobacco products.

Starting in 2016, advertisements for e cigs will be banned in all 28 nations of the European Union, just like tobacco ads. The packing must be childproof and have graphic health warning labels printed on them. Meanwhile, nicotine content will be limited to 20 milligrams per milliliter, same as tobacco cigarettes.

The European Union’s large scale e cigarette regulations could set a template for the rest of the world to follow. Many cities in the United States, such as Los Angeles, have taken it upon themselves to regulate electronic cigarettes which heat nicotine infused propylene gycol into vapor instead of waiting on the FDA’s decision.

The new e regulations are part of a larger anti smoking regulatory package, will which impose even more severe rules on tobacco cigarettes, including banning all kid friendly flavors and requiring 65 percent of packaging to feature graphic health warnings and photos of diseased lungs. But the restrictions are not as tough on e cigs as the parliament’s original proposal, which would have treated the product as medicine.

This is a victory, said Linda McAvan, the British Labour Party member of the European Parliament. The original proposal was stricter, and I would have voted for that, but the new law is anyway a huge step forward in tobacco control.”

Tobacco and e cigarette companies are of course unhappy about the measure. To Drago Azinovic, president of European operations for Phillip Morris International, the new regulation revamp represents a worrying departure from the E.U. s basic standards of proportionate, evidenced based policy making, which will further erode intellectual property rights and undermine the E.U. charter where these rights are protected.

While the new proposals do allow leeway for member states to classify e cigarettes as quit smoking products if they’d like, some members of the European parliament aren’t happy with the outcome.

This was a very bad agreement, says Martin Callanan, a British Conservative Party politician who believes e cigarettes could help people quit smoking. It s a massive loss for public health in Europe.

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 cigarettes or electronic nicotine
    delivery systems (ENDS), Statement, 9 July 2013