MHRA to regulate E Cigarettes

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that all nicotine replacement therapy products should be regulated

including electronic cigarettes. Consumers can currently buy electronic cigarettes freely without regulation, although the European Commission is currently revising the Tobacco Products Directive, which may result in the amount of nicotine in e-cigarettes being limited to just 4mg. Many smokers and ex-smokers who use e-cigarettes have claimed this would not be a sufficiently high nicotine level to control nicotine cravings and as a result many smokers may just give up trying to quit and revert to using tobacco products.

Regulating electronic cigarettes could be a two-edged sword if regulation results in changes in nicotine levels, limiting use of electronic cigarettes by imposing a time limit on how long they could be used for, or by making them more expensive. Currently smokers can self-regulate the amount of nicotine they inhale using different strengths of nicotine vapour in electronic cigarettes.

There has also recently been concern over whether the vapour itself poses a health risk, despite the fact that the low levels of chemicals found in nicotine vapour are in very small doses and also are used in popular cosmetic and technology applications, from baby wipes to refrigeration equipment.

The announcement from the MHRA on Wednesday (12/06/13) has generally been greeted favourably by doctors and health organisations and charities. Mike Knapton, associate medical director at The British Heart Foundation, said:

“The MHRA has rightly addressed the worrying dearth of regulation around nicotine-containing products and electronic cigarettes, an important step to ensuring their safety.

“Marketing of these products must now be closely monitored to ensure non-smokers and children don’t end up using them.
“We also need more research into the potential health implications of long-term nicotine use, and further evaluation by NICE as part of their nicotine harm reduction strategy.”

Some health experts have raised concerns about the risk of passive “vaping” (the term coined to describe those who use e-cigarettes) if nonsmokers inhale nicotine vapour when in close proximity to someone using an electronic cigarette. Currently young adults aged 16 can buy and use electronic cigarettes in some countries and this has caused concern that e-cigarettes might act as a gateway to smoking harmful tobacco products.

In the EU, Italy has imposed a ban on those under 18 buying electronic cigarettes until the end of October, to allow more research into whether the levels of nicotine stated on nicotine refill cartridges are accurate. However, it is generally thought that electronic cigarettes are less dangerous to health than tobacco products because using them does not involve ingesting carcinogenic smoke and tar from cigarettes.
However, once the MHRA imposes regulation on the electronic cigarette market, manufacturers will have to apply to the MHRA for a licence to manufacture them and further conditions and restrictions on use may be applied.

The decision brings electronic cigarettes into line with other nicotine replacement products (NRP), such as nicotine gum or patches. Electronic cigarettes have only very recently become a recommended smoking cessation aid for NHS use, as previously nicotine gum and patches were used in the NHS smoking cessation initiative used by GPs and pharmacies.
The regulation of electronic cigarettes is due to be introduced in 2016 and from then they will be classed as healthcare or medical products.
Currently around 1.3 million people use e-cigarettes and it is envisaged they will be made available as an over-the-counter health product once regulation begins.

It is also likely manufacturers will have to introduce more rigorous testing of their products, which could push the price up, meaning many vapers will begin stocking up on nicotine replacement refills and electronic cigarettes before regulation is introduced. Currently electronic cigarettes work out at roughly half the cost of smoking tobacco, with a £5 nicotine refill supplying the equivalent of 40 cigarettes, depending on individual use.

GPs will also be able to prescribe e-cigarettes as part of a smoking cessation programme and the MHRA said the purpose of regulation was to make e-cigarettes “safer and more effective”. Countries such as Norway and Brazil have already introduced regulation and in these countries e-cigarettes can only be bought in pharmacies. To date there have been no reported deaths linked to vaping since e-cigarettes came to market in 2004,and many ex-smokers claim that without electronic cigarettes, they would have been unable to kick the tobacco habit. The MHRA has pushed back the introduction of regulation to 2016 to enable e-cigarette manufacturers to apply for licences.