Electronic nicotine delivery systems (ENDS) are devices that allow a user to inhale nicotine without the need to burn nicotine. The most common type involve the electronic heating of a liquid containing nicotine, to produce a vapour which is inhaled by the user. In recent years there has been a tremendous growth in the number and type of these nicotine delivery systems.

Applications for regulatory approval

In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) has clarified that the “government will regulate electronic cigarettes and other nicotine containing products (NCPs) as medicines” and that the government “encourages applications for medicines licenses for nicotine-containing products (NCPs) already on the market”. It is thought that unlicensed products will be withdrawn at some point in the future. As part of the license application process, a supplier must assess the compliance and efficacy of the product, including a detailed risk assessment of all chemical components in the liquid formulation and a comprehensive evaluation of the potential extractables and leachables originating from all parts of the electronic nicotine delivery system.

The Food and Drug Administration (FDA), Center for Tobacco Products, is establishing a public docket in conjunction with the first public workshop to gather scientific information about ENDS in 2015.

Testing and support with submissions

With world-leading extractables and leachables expertise, Smithers is at the forefront of this new and developing industry. We can help you with: 

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