Tobacco companies lobbied European lawmakers heavily to dilute the new rules, and some changes made at the last minute weakened an earlier proposal. But the guidelines still represent a big improvement from current European rules. Lawmakers will now negotiate the changes with national governments and the European Commission before final rules are approved next year.

European lawmakers voted to increase the size of the warning labels on cigarette packs to 65 percent of the front and back of packs, up from 40 percent now. By contrast, warning labels in the United States are small text boxes that appear on the sides. A 2009 law instructed the Food and Drug Administration to require graphic warning labels that covered half of the front and back of cigarette packs, but after losing a court case on a set of labels, the F.D.A. has not yet come up with replacements.

The European Parliament also voted to ban flavored cigarettes three years after the rules are finalized and menthol cigarettes after eight years. The 2009 American law banned flavored cigarettes but left a decision on menthol to the F.D.A., which has not yet proposed any regulations. Studies have shown that flavored cigarettes make smoking more appealing to kids and young people and make it harder for addicted smokers to quit.

The most controversial part of the European rules concerned electronic cigarettes, the battery powered devices that people use to inhale nicotine vapors. These devices are safer than conventional cigarettes because they do not contain carcinogens and other toxic substances from burning tobacco. But nicotine in any form is highly addictive and can be dangerous, especially to young people. Under pressure from the makers of e cigarettes, European lawmakers rejected a proposal to regulate those products as drug delivery devices. But they did vote to confine their sale to adults and applied the same marketing and advertising rules to these products that apply to conventional cigarettes a significant improvement.

Only 23 American states have banned the sale of e cigarettes to people younger than 18, according to the Campaign for Tobacco Free Kids. The F.D.A. has said it intends to regulate these devices as tobacco products, but after years of studying the issue, it has not done so.

More than 700,000 Europeans and more than 440,000 Americans die from smoking related illnesses every year. Lawmakers in Europe have taken some important steps United States regulators should do the same.

E-cigarettes: regulation – tobaccotactics

Cigarettes and valentines – wikipedia, the free encyclopedia

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

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. 2 However, a final decision will await the outcome of the EU Tobacco Products Directive Revision.

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

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. 3

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. 4 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 5 and the Council 6 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. 3

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. 7

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. 8 Other TobaccoTactics Resources

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


  1. Library of the European Parliament, Electronic Cigarettes, Library Briefing, 27 March 2013, accessed January 2013
  2. MRHA, Nicotine containing products, December 2013, accessed January 2014
  3. 3.0 3.1 Andy Coghlan, UK government to ban e cigarettes for under 18s, New Scientist Health, 30 January 2014, accessed January 2014
  4. European Commission,Commissioner Borg welcomes agreement on the revision of the Tobacco Products Directive, 18 December 2013, accessed December 2013
  5. 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
  6. Council of the European Union, release 3247th Council meeting Employment, Social Policy, Health and Consumer Affairs, 21 June 2013, accessed June 2013
  7. FDA, Regulation of e Cigarettes, no date, accessed January 2014
  8. WHO, Questions and answers on electronic cigarettes or electronic nicotine delivery systems (ENDS), Statement, 9 July 2013