Medicinal labelling rules to apply to e-cigarettes

02nd April 2014 - Fine Cut

The British government is changing the law to make any products containing nicotine licensed as medicinal, including e-cigarettes.

It will have significant implications for labelling and ensure that factors, such as the amount of nicotine within items, will be regulated.

Under the new Tobacco Products Directive proposed by the European Commission, regulation of all products containing nicotine will come into force.

The revised directive was officially adopted by the European Council in March 2014, following its formal approval by the European Parliament the previous month.

However, the UK government has determined the Medicines and Healthcare Products Regulatory Agency (MHRA) will regulate the market earlier in the UK, as the European Union (EU) rules look set to come into force in 2016.

Under the MHRA plans, e-cigarettes will be subject to tighter safety and quality controls, with the rules extending to packaging and labelling.

Labels on products will have to include information about potential hazards associated with them and details of the contents.

By regulating nicotine-containing items as medicines, the government aims to make them safer and more effective, and assist people in stopping smoking.

MHRA group manager of vigilance and risk management of medicines Jeremy Mean commented: "Some nicotine-containing products are already licensed and the government's decision to work towards medicines licensing for all these products is designed to deliver quality products that will support smokers to cut down and to quit."

A public consultation on the issue of nicotine-containing products in 2010 prompted the government's announcement, having found that the public health community supported medicinal licensing.

The EU Tobacco Products Directive covers the manufacture, presentation and sale of tobacco and related products, and is intended to improve health protection standards within Europe.

An estimated 1.3 million people in the UK use e-cigarettes, which are currently regulated as consumer products and subject to labelling rules as such.

MHRA research into nicotine-containing products found that levels of the stimulant can vary widely from what is stated on the label.

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