Last week, the European Parliament voted on a draft for the Tobacco Products Directive (TPD) and declined to accept the European Commission's proposal to regulate electronic cigarettes ("e-cigarettes") as medicines. The majority of Members of European Parliament ("MEPs") supported using a mixture of tobacco regulation (e.g., controls on promotion) and medicines-style regulation (e.g., reporting of adverse reactions) for all nicotine products (including medicines), and applying medicines regulation to products that make medicinal claims.
However, just prior to the Parliament's decision the United Kingdom ("UK") Medicines and Healthcare Products Regulatory Agency ("MHRA") had announced that the UK government would regulate e-cigarettes and other nicotine-containing products ("NCPs") as medicines. After the vote the MHRA stated that it still believed that medicinal regulation of NCPs is in the best interests of the public health, and they will continue to encourage companies voluntarily to seek a medicinal license for their NCPs. Comparable nicotine replacement products (e.g. gums, patches, inhalator), for example, are licensed as medicines.
Earlier the Commission on Human Medicines ("CHM") working group on NCPs had concluded that the NCPs currently on the market do not meet appropriate standards of safety, quality, and efficacy. Their study found that nicotine levels can vary considerably from the labeled content, and the amount of nicotine per product can differ from batch to batch. Regarding e-cigarettes, which deliver nicotine via a cartridge, there is also no data concerning the manufacture of the cartridge or device to suggest consistent nicotine doses across multiple cartridges or multiple devices. Additionally, the cartridges may contain potentially toxic elements at unexpectedly high doses, which could produce adverse effects, particularly in vulnerable patient groups.