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 smoking cessation. This paper examines areas where public health considerations suggest changes should be made to the current indications and characteristics for NRT products. It is argued that the current regulatory framework restricts access to NRT without adequately considering that the likely consequence is continued dependent use of a far more harmful and widely available version of the same drug: tobacco. The paper argues that minors, pregnant smokers and smokers with cardiovascular disease (CVD) be allowed to use NRT. NRT use for smoking reduction, to support temporary abstinence, for long-term use should also be enabled and NRT products should be made as widely available as cigarettes. This paper also recommends that regulators encourage the development of less harmful forms of nicotine delivery devices to compete with cigarettes. Although this paper is written largely with reference to the UK medicines regulatory framework, these issues also apply to many other countries.