The future legislation of Nicotine containing products (NCPs) including e cigarettes is part of ongoing discussion on the revision of Tobacco Products Directive (TPD).

EPHA Briefing on Regulatory options for Nicotine Containing Products (NCPs) in the EU

Annexes to the EPHA Briefing on Regulatory options for Nicotine Containing Products (NCPs) in the EU

In light of the available regulatory options for Nicotine Containing Products (NCPs), identified and presented in the EPHA Briefing, EPHA recommends the following principles of future EU wide NCP legislation, public health requirements of NCPs, and policy options for regulating NCPs

Principles of future EU wide NCP legislation

  • Public health needs to be the driving motivation of regulation of NCPs. All NCPs should demonstrate proven safety and quality
  • NCPs must not become a gateway product, especially for young people and must not re normalise smoking
  • NCPs should be regulated at EU level, in order to reduce existing health inequalities, and to provide greater legal certainty, in line with the EPHA European Charter for Health Equity
  • NCPs should be regulated in an appropriate manner in line with the precautionary principle.
  • Future NCP regulation should take into consideration the future and fast development of this market.
  • NCPs should facilitate access to social support networks through the provision of information. Tobacco cessation services (quit lines) are crucial to sustained and successful efforts to quit smoking. NCPs of high quality have significant potential to help smokers who are not otherwise ready or able to quit smoking.

Public Health requirements of NCPs

Regulation of NCPs, including e cigarettes, needs to protect public health by ensuring

  • product safety and quality,
  • control of advertising and sponsorship,
  • market surveillance and monitoring,
  • accesibility of NCPs for existing smokers

Policy options for regulating NCPs

  • Appropriate safety assessment should be a cornerstone of any future EU legislation.
  • The public health benefit of NCPs is that they may help smokers to quit smoking. In order to maintain the same standards for the same products, both the product safety aspects and the claimed effects of the given product should be taken into consideration by future regulation of NCPs.
  • Strict marketing limits similar to tobacco and medicine marketing rules are essential so that NCPs do not promote smoking behaviour either in a direct or indirect way.
  • Given the potential of products such as e cigarettes not containing nicotine to indirectly promote smoking and undermine smoking cessation policy, the European Commission should be empowered to adopt delegated acts to regulate these products appropriately.
  • Having no new regulation on NCPs, or maintaining long transitional periods which is equivalent to maintaining the status quo has the potential danger of market developments which do not provide a high level of public health protection to EU citizens, violating Article 168 of the Treaty on the Functioning of the European Union (TFEU). Therefore, the transition period before the application of the new NCP legislation, as well as the binding deadline for the European Commission to submit a report about the application of the future NCP legislation should be as short as possible, and the European Commission should be empowered to adopt delegated acts in other to be able to reflect public health risks emerging from the rapid market development.
  • Appropriate monitoring including surveys and data collection is necessary so that any future legislation should rely on the latest data and evidence. Particular attention should be given to the attitudes and preferences of children and young people in that regard.
  • Future regulations should include elements which ensure appropriate funding and resources for more research for both social and biomedical aspects of NCPs.
  • Flavourings have two dimensions On the one hand, some flavours are necessary to make NCPs intended for oral use palatable. On the other hand, additional flavours can make NCPs more attractive for both smokers and non smokers. NCPs should be allowed to contain the necessary flavours which are allowed in Nicotine Replacement Therapies (NRT) but should be subject to flavouring restrictions, as regards additional flavourings not necessary for the use.
  • An appropriate simplified authorisation procedure for NCPs merging the necessary elements of other legislations would be useful ensuring that NCPs comply with the principles and guidelines of Good Manufacturing Practice (GMP), Manufacturers present all ingredients of the products, including emissions and a Risk Management Plan for monitoring and recording any adverse reactions, similarly, NCPs should be subject to appropriate labelling and packaging rules
  • The future legal framework should ensure that accessibility to NCPs for existing smokers is not hindered while ensuring that they are unappealing and inaccessible to minors.

EPHA related articles

  • Joint press statement Mixed victory for tobacco control in European Parliament’s vote
  • Final countdown public health community calls on European Parliament to vote for a strong Tobacco Products Directive
  • Joint Open Letter to President of European Parliament Philip Morris lobbying activities on the Tobacco Products Directive
  • EPHA Calls for Strong Tobacco Products Directive (TPD) without further delay
  • Sign the ERS petition for a strong Tobacco Products Directive!
  • Global Initiative Don’t Touch the Spanish Tobacco Law
  • EPHA Open Letter to Spanish Prime Minister Smoking should be banned at “Eurovegas”
  • EPHA and Public Health NGOs call for an updated EU Tobacco Products Directive
  • EPHA position paper Revision of the Tobacco Products Directive
  • EPT Tobacco Directive (Revision) European Commission Proposal Revision of The Tobacco Products Directive (25 June 2013)

Eu vote on electronic cigarettes ‘makes no sense’ – telegraph

Marlboro ad man eric lawson dies of chronic lung disease

The vote was intended to make tobacco smoking less attractive to young people through mandatory warnings, minimum pack sizes, and rules on flavourings.

However, the revision of the EU ‘Tobacco Products Directive’ would classify most e cigarettes as a medicinal product, despite the fact that in the UK alone 25 percent of all attempts to kick the habit are made using e cigarettes, making them the most popular aid.

The European Commission had proposed that e cigarettes containing 4 milligrammes or more of nicotine must be classed as medicinal products but an EU parliamentary committee went further, voting to classify all e cigarettes as pharmaceuticals, regardless of the nicotine content.

Users of e cigarettes (known as vapers) have protested, arguing that through e cigarettes they were able to kick the tobacco habit.

They say classifying them as medical devices will mean they must undergo a costly and protracted authorisation processes before marketing. Their availability would be restricted to certain pharmacies.

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Producers of e cigarettes said the vote could push many out of business and reduce choice for e cigarette users.

Fraser Cropper, chief executive of e cigarette company Totally Wicked, said “It will result in many smaller and more innovative producers of e cigarettes going out of business. Medicines regulation creates a default prohibition and requirement for approval, leaving deadly tobacco cigarettes as the only easily marketed source of nicotine.”

Martin Callanan, Conservative MEP, proposed an amendment that would see e cigarettes authorised in a similar way to other nicotine products.

He said, “”The world has gone mad when tobacco is less regulated than products designed to end tobacco use. Thousands of people have given up smoking thanks to e cigarettes. For the EU to over regulate them is completely counter productive and hypocritical.

“This vote is not the end of this process and we will be working with vapers to make other MEPs see sense and support e cigarette producers and users.”

Policy toward the new technology widely varies across the EU. Some countries such as Denmark have banned them, while in others such as Britain they are freely available for sale with no restrictions.