The recent announcement that the MHRA (Medicines and Healthcare products Regulatory Agency) has licensed VOKE, believed to be the world’s first cigarette-shaped nicotine inhaler, is welcome news and a wonderful example of life-improving innovation.
This product has the potential to deliver such significant health benefits to existing smokers to be worthy of registration as a medicinal product. This announcement and wider news coverage in the BBC, Telegraph and elsewhere helps to clarify what registration means to the wider public.
When it was announced in the summer of 2012 that e-cigarettes would be classed as medicines, the news was misreported by some as though regulators had already considered them to be safe and beneficial. This was an alarming and incorrect assumption.
E-cigarettes, as a new category of product, fall between the established regulatory controls for food, drugs, medical devices and tobacco in almost all countries. Without any regulation, users are at the mercy of whatever the producer includes and practices vary widely. In the worst cases, e-cigarettes have produced known carcinogens or to have exploded in use (Sources: TIME, BBC).
Introducing regulation as medicines does not mean the category as a whole is safe and beneficial. It means each product will be assessed according to stringent requirements. Eventually, only those that are safe, offer proven health benefits and are tightly quality-controlled will be legal and available in our markets.
VOKE, as a cigarette-replacement nicotine inhaler, is the first such product to be licensed in the UK as a medicinal product. We look forward to its launch, to the positive effect it will have on people’s lives and are delighted to have contributed to its innovation.