The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) this week clarified that nicotine-containing products (NCPs) such as electronic cigarettes will soon be regulated as medicines. The agency states that the move will help to make the products safer and "more effective."
E-cigarettes are personal vaporizers that take a liquid solution that contains nicotine and heat it into a vapor to simulate smoking. The process allows smokers to ingest nicotine through their lungs via water vapor, rather than through tobacco smoke. The devices are, compared to cigarettes, very new, and few studies have been published on possible side effects of their use. As such, the burgeoning e-cigarette industry is currently unregulated in much of the world. The MHRAs announcement means the devices will join other NCPs, such as nicotine gum, patches, and mouth sprays.
The MHRA said in a statement that it believes making e-cigarettes "safe and effective" could help smokers cut down or quit real tobacco, potentially saving some of the estimated 80,000 smokers who die in England each year.
"Reducing the harms of smoking to smokers and those around them is a key Government health priority," said Jeremy Mean, MHRA group manager of Vigilance and Risk Management of Medicines. "Our research has shown that existing electronic cigarettes and other nicotine containing products on the market are not good enough to meet this public health priority.
“Some NCPs 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.
“The decision announced today provides a framework that will enable good quality products to be widely available. It’s not about banning products that some people find useful, it’s about making sure that smokers have an effective alternative that they can rely on to meet their needs."
The MHRA made its decision following a public consultation on e-cigarette regulation, which it says revealed "widespread support for medicines regulation from the public health community." The U.K. government expects the European Commission to adopt new legislation on NCPs in 2014, and for the requirement for medicine licenses to begin in 2016. The MHRA is encouraging current e-cigarette manufacturers to apply for a medicine license.
The agency emphasized that a major part of its decision came down to ensuring that e-cigarette quality and reliability. The possible marketing of the devices to children was also a concern, as there is currently no ban on doing so.
“Smokers are harmed by the deadly tar and toxins in tobacco smoke, not the nicotine," said Dame Sally Davies, Chief Medical Officer for England. “While it’s best to quit completely, I realise that not every smoker can and it is much better to get nicotine from safer sources such as nicotine replacement therapy.
“More and more people are using e-cigarettes, so it’s only right these products are properly regulated to be safe and work effectively.”