The government accepted the advice of the CHM and its expert group, which concluded that NCPs currently on the market do not meet appropriate standards of safety, quality and efficacy. Testing data confirm that nicotine levels can vary considerably from the labelled content and the amount of nicotine per product can differ from batch to batch. In terms of how well NCPs work, there can be widely differing amounts of nicotine from the same format with one form delivering what could be an effective therapeutic dose, another a 'placebo' dose. With regards to safety, toxic elements may be included at unexpectedly high doses which could produce adverse effects, particularly in vulnerable patient groups.
The consistent evidence from a variety of sources is that most electronic cigarettes use is to support stop smoking attempts or for partial replacement to reduce harm associated with smoking. This is comparable to other nicotine replacement products (eg gums, patches, inhalator), which are licensed as medicines. The current evidence is that electronic cigarettes have shown promise in helping smokers quit tobacco but the quality of existing NCPs is such that they cannot be recommended for use.
The public health priority of reducing the harms of smoking is not supported by the current regulatory framework, under the general product safety regulations. To manage the risk of poor and ineffective products and to maximise the potential for public health gain, NCPs should be regulated as medicines to ensure that:
- standards of quality, safety and efficacy are met
- monitoring safety in use, including over the long term, is provided for
- advertising of NCPs is controlled through medicines provisions
- and any emerging risks, eg of NCPs acting as a gateway to smoking tobacco, can be effectively managed.