Why are some healthcare professionals concerned about the use of e cigarettes?

E cigarettes have been the subject of intense debate in the media across Europe as some healthcare professionals are concerned about the promotion and use of the products.

The concerns include

Products are regulated differently E cigarettes are currently regulated differently across Europe. This means that there are no restrictions on the chemicals that can be added to the cartridges. This also means that they are not subject to strict quality control, and products may be labelled the same but have different amounts of chemicals and nicotine in them.

Continuing addictive behaviour As e cigarettes look and feel like a cigarette, users are not encouraged to change their behaviour. Their addiction to the physical and emotional elements of smoking continues.

Visibility for others who have quit There are no restrictions on e cigarettes being used in offices and other public places where normal smoking is banned. Smoke free legislation, which bans smoking in public places, has contributed to a change in the perception of smoking, de normalising it and making it seem abnormal and unacceptable. Some experts believe that visibility to people smoking e cigarettes could make smoking seem acceptable and could tempt people who have quit, or are trying to quit, to slip back into the habit.

Children s exposure to smoking Children who are growing up in areas where smoke free legislation has been common since their childhood are exposed to smoking behaviour when they see e cigarette users. Some experts feel this will undo the steps made by smoke free legislation in changing the perceptions of smoking. They are concerned that the behaviour of smoking, whether the product is an e cigarette or a tobacco cigarette, is once more being promoted to children and young people.

Lack of evidence A key concern for healthcare professionals at the moment is a lack of evidence on the potential harm to the user. Although the products are thought to be less harmful than smoking normal cigarettes, the devices contain various chemicals and long term studies on the health effects of the products have not yet been carried out. More research is needed on the harm caused by the mist, vapour, flavours and additives delivering nicotine.

The European Lung Foundation and the European Respiratory Society have responded to the uncertainty around the products and will conduct research to find out the short and long term effects of the products.

Have eu plans to regulate e-cigarettes as medicinal products gone up in smoke? – lexology

Ex-marlboro man dies from smoking-related disease – businessweek

The European Parliament rejected Commission proposals under the Tobacco Products Directive (“TPD”) to regulate e cigarettes as medicinal products in October 2013, but what does this mean in practice for the regulation of e cigarettes across the 28 EU Member States?

At present e cigarettes are regulated in a variety of ways across the various Member States across nine members states (including the UK) there are no specific rules relating to e cigarettes only existing consumer product safety legislation currently applies. In another eleven Member States (including Germany and the Netherlands), e cigarettes are considered medicinal products which subjects the products to stricter regulation. At the extreme, currently e cigarettes are prohibited in Greece unless specifically approved by the Health Ministry.

Under the original Commission proposal for the TPD, rules applying to e cigarettes would have been harmonized and e cigarettes would have been treated as medicinal products resulting in stricter regulation and a more costly approval process across the entire EU. Approvals for medicinal products cost on average f200,000 to secure. Regulating e cigarettes as medicinal products would also have limited sales points to pharmacies. The European Parliament rejected this proposal on in October 2013 and has now reached a compromise with the Council which will see the majority of e cigarettes regulated as consumer products.

While this should help to clarify the current regulatory uncertainty, the debate is far from over.

Although the full text of the compromise is not yet publicly available it is understood that the compromise sets mandatory safety and quality requirements, for example on nicotine content, ingredients and devices, as well as refill mechanisms. The new rules also make health warnings and information leaflets obligatory and introduce notification requirements for manufacturers and importers of e cigarettes, stricter rules on advertising and monitoring on market developments.

In relation to refillable e cigarettes the compromise contains a safeguard clause which could result in refillable e cigarettes being banned in the EU in the future.

The new rules are due to enter into force in 2016 (subject to adoption of the TPD in the course of 2014) and as such it is important that all manufacturers, exporters and importers of these products familiarize themselves with these new rules and begin considering securing any approvals that are necessary to ensure a smooth transition and continued access to the EU market.