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Regulating e-cigarettes – medical devices, or the consumer products to finally break tobacco’s harmful monopoly?

The increasing popularity and availability of e-cigarettes (otherwise known as Electronic Nicotine Delivery Systems, or ENDS) in many countries has prompted fierce debate among public health professionals, with some expressing concerns that lack of safety information for the devices could result in unforeseen damage to public health if they are not appropriately regulated. Others argue that e-cigarettes provide a safer and appealing alternative to smoking, and their increasing usage – likely to be accompanied by a reduction in the number of smoked – could be stalled if excessive restrictions are placed on their sale and manufacture.

Today [Tuesday 23 July], leading smoking cessation experts present contrasting perspectives on e-cigarettes in two Comments published in The Lancet Respiratory Medicine.

In the Comment ‘Regulatory challenges for refined ’, Dr , of the Department of Pulmonary and Critical Care at Georgetown University Medical Center in the US, outlines the “paradoxical” situation whereby e-cigarettes do not come under the US Food and Drug Administration’s ban on marketing of non-pharmaceutical for human consumption.

With safety data and accurate product information on e-cigarettes currently scarce or non-existent, Dr Cobb points out that, “Without oversight or consumer safety regulations, the manufacturers of ENDS produce products that are more widely available, much cheaper, and might contain more nicotine and contaminants than competitor products manufactured by pharmaceutical companies. Meanwhile, sales of and profit projections for ENDS continue to increase rapidly, and big tobacco companies are following with their own products.”

Pointing out that bringing e-cigarettes under the same medical regulation structure as nicotine patches and nicotine replacement products would increase their costs, without making either product more widely available, Dr Cobb argues that the regulatory playing field needs to be “reset”, adding that “A fixation on a single refined nicotine delivery mechanism (‘electronic cigarettes’) is a distraction born of commercial interests; the question should be what regulatory system will get safe and effective refined nicotine products into the hands of more smokers and promote elimination of the most lethal combusted products?”

In another Comment, Should e-cigarettes be regulated as a medicinal device?, Professor Peter Hajek, Director of the Tobacco Dependence Research Unit at the Wolfson Institute of Preventive Medicine, Queen Mary University of London, UK, argues that proposals to regulate e-cigarettes as – currently under consideration by the EU, and already planned by the UK in 2016 – could jeopardise enormous potential benefits to public health by drastically reducing the appeal of e-cigarettes.

According to , “Compared with hypothetical risks that seem unlikely in view of current knowledge about e-cigarettes, we know the product e-cigarettes are replacing is seriously dangerous. If any new risks emerge, then appropriately tighter regulation can be implemented.”

Placing e-cigarettes under the same regulation as medical devices now is likely to lead to increased costs and less product innovation, which Professor Hajek argues could ultimately lead to a winning situation for the tobacco industry. He concludes that, “Since e-cigarettes are a recreational consumer product that are competing with much more dangerous cigarettes, which are not regulated as medicines, mandatory medicinal regulation is not required for public safety and can harm public health by restricting the competition of e-cigarettes with cigarettes in the marketplace. Excessive regulation of e-cigarettes would protect the market monopoly of cigarettes and have the potential consequences of disease in and death of millions of smokers who were prevented from moving on to the next generation of e-cigarettes.”

“For the first time in the history of the tobacco control movement, a realistic possibility is emerging that the tobacco problem might get resolved, and that this could happen with minimal or no government involvement or expenditure. Regulators of medicines should hold their fire.”


Regulatory challenges for refined nicotine products

Should e-cigarettes be regulated as a medicinal device?

The Lancet