In a comment piece published today in The Lancet Respiratory Medicine, Professor Peter Hajek, director of the Tobacco Dependence Research Unit at Barts and The London School of Medicine and Dentistry, Queen Mary, calls for medicines regulators to “hold their fire”.
In June the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced that e-cigarettes are to be classed as “medicines” under new proposals to tighten up the regulation of nicotine-containing products.
Professor Hajek says: “Compared with hypothetical risks that seem unlikely in view of current knowledge about e-cigarettes, we know that the product e-cigarettes are replacing is seriously dangerous. If any new risks emerge, then appropriately tighter regulation can be implemented.”
E-cigarettes are designed to deliver nicotine without the toxins which are present in tobacco smoke.
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 adds: “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 ability of e-cigarettes to compete 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.”
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Hajek et al. Should e-cigarettes be regulated as a medicinal device? Published today in The Lancet Respiratory Medicine