Regulation of nicotine replacement therapies (NRT): a critique of current practice

Nicotine replacement therapy (NRT) describes a group of products delivering nicotine that are licensed for the relief of withdrawal as an aid to smoki ng cessation. This paper examines areas where public health considerations suggest changes should be made to the current indications and characteristi cs for NRT products. It is argued that the current regulatory framework res tricts access to NRT without adequately considering that the likely consequ ence is continued dependent use of a far more harmful and widely available version of the same drug: tobacco. The paper argues that minors, pregnant s mokers and smokers with cardiovascular disease (CVD) be allowed to use NRT. NRT use for smoking reduction, to support temporary abstinence, for long-t erm use should also be enabled and NRT products should be made as widely av ailable as cigarettes. This paper also recommends that regulators encourage the development of less harmful forms of nicotine delivery devices to comp ete with cigarettes. Although this paper is written largely with reference to the UK medicines regulatory framework, these issues also apply to many o ther countries.