MHRA to Regulate E-Cigarettes as Medicines

  • June 19, 2013

Beginning in 2016, e-cigarettes and other nicotine containing products (NCPs) will be regulated in the UK as medicines. This decision was based on research conducted by the Medicines and Healthcare Products Regulatory Agency (MHRA) over the past couple years that found, among other things, that “nicotine levels can vary considerably from the labeled content and the amount of nicotine per product can differ from batch to batch.”

It is estimated that 1.3 million people in Britain use e-cigarettes, many as a smoking-cessation method. MHRA hopes this change will “ensure that high-quality products can be made available to help support smokers to cut down their smoking and to quit.”

Manufacturers will be able to apply for licenses before 2016, in the meantime, however, it is likely e-cigarettes will remain on sale over the counter.

This decision comes at a time when e-cigarette manufacturers are anxiously awaiting a new rule from FDA that will include e-cigarettes among the group of already regulated tobacco products. FDA has stated its intent to issue this proposed rule and action is expected to be forthcoming.

Posted by Marla Scarola, Senior Consultant and Claire Robertson, Marketing Associate. For more information, please contact Marla at