The U.K. will require all nicotine-containing products including electronic cigarettes to be licensed as medicines by 2016, a regulatory agency said.
The Medicines and Healthcare products Regulatory Agency will oversee the products in an effort to provide safe and effective options for people trying to quit or cut down on smoking, the agency said in a statement today. Electronic cigarettes, which mimic the look and feel of traditional versions, are currently regulated as consumer products in the U.K., the MHRA said.
The European Commission has said it expects new region-wide legislation to be adopted next year that will take effect in the U.K. in 2016. The MHRA will require manufacturers to present data on the quality of their products, on how they deliver nicotine to the body and on how they compare with existing nicotine-replacement products, said Jeremy Mean, an official in the agency unit in charge of vigilance risk management of medicines.
Research commissioned by the MHRA has shown that “nicotine levels can be considerably different from the level stated on the label,” Mean told reporters at a briefing in London today. “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 products won’t be assessed for how effective they are in helping people quit, Mean said.
Electronic cigarettes made by companies such as Lorillard Inc. (LO) and Vapor Corp. (VPCO) have been facing increasing scrutiny around the world. Use of the products in public spaces such as restaurants should be forbidden, French researchers wrote last month in a government-commissioned report. Electronic cigarettes have been banned in Brazil, Norway and Singapore, according to Cancer Research UK.
Sales of the products may double in the U.S. this year to $1 billion, according to an analysis by Bloomberg Industries. In the last two months, tobacco companies including Altria Group Inc. (MO), Reynolds American Inc. (RAI) and British American Tobacco Plc (BATS) have discussed plans to enter the electronic cigarette market.
The U.K. decision will benefit the large tobacco companies in the short term by stemming the flow of electronic cigarettes, which compete with traditional tobacco products, said Chris Wickham, a tobacco industry analyst at Oriel Securities in London.
“In the longer run, it makes it more difficult for those wishing to get into that market themselves, hoping for a landgrab via their traditional distribution platforms,” Wickham said.
The U.K.’s health-cost agency, the National Institute for Health and Care Excellence, last week recommended licensed nicotine-containing products to help people cut down on smoking, which it said was the first such public health guidance in the world.
The primary components of electronic cigarette cartridges and vapor are propylene glycol, glycerine and nicotine. Smokers are harmed by the deadly tar and toxins in tobacco smoke, not the nicotine, said MHRA Chief Medical Officer Sally Davies in today’s statement.
“Nicotine is the principal addictive constituent in tobacco, but not the cause of the harms associated with tobacco use,” said Marcus Munafo, professor of biological psychology at the University of Bristol. “If people could be encouraged to use cleaner nicotine products rather than tobacco, there would be substantial health benefits.”
Still, there has been little research into how safe electronic cigarettes are, according to Cancer Research UK. Anecdotally, aspiration pneumonia and second-degree burns from a cigarette exploding in a consumer’s mouth have been reported, MHRA said.
Researchers at the University of Athens said electronic cigarettes cause damage to the lungs, as shown in a study they presented in September at the European Respiratory Society annual meeting in Vienna.
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