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Europe decides not to regulate e-cigarettes as medicines

Electronic cigarettes will not have to be regulated as medicines in the EU following a vote by Members of the European Parliament yesterday (8 October 2013).

EU flag (Thorsten/dreamstime.com)

E-cigarettes will be subject to tighter regulation in the EU, but won’t be treated as medicines

The EU Parliament has passed a draft law that will mean only electronic cigarettes that make curative or preventive health claims will be regulated as medicines. Products that make no claims will be subject to much tighter regulation than they are currently. They will not be allowed to contain more than 30mg/ml nicotine, they will have to carry health warnings and must not be sold to anyone under the age of 18 years. Restrictions on advertising that apply to the tobacco industry will also be applied to electronic cigarettes.

Earlier this year, the Medicines and Healthcare products Regulatory Agency made the decision to regulate electronic cigarettes as medicines in the UK from 2016 (PJ 2013;290:691). The MHRA told PJ Online that the UK Government continues to believe that regulation of nicotine containing products, including electronic cigarettes, as medicines is the best way to deliver a benefit to public health. The MHRA also said it supported the European Commission’s Tobacco Products Directive.

“We will need to wait and consider what the latest vote means. We will be continuing to encourage companies voluntarily to seek a licence for their products so that they can be seen to meet appropriate standards of safety, quality and efficacy.”

However, the MHRA added that the EU legislative process is not complete. The decision by the MEPs will have to be negotiated with the Council of Ministers, which will have to approve the new law before it comes into force.

The Directive aims to make tobacco products less attractive to young people and will also ban the use of flavours, such as menthol, in cigarettes. Additionally, all cigarette packs will have to carry health warnings that cover 65 per cent of their surface.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11128319

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