Intended for healthcare professionals


Why Britain needs a nicotine regulation authority

BMJ 2001; 322 doi: (Published 05 May 2001) Cite this as: BMJ 2001;322:1077
  1. John Britton, professor of epidemiology,
  2. Ann McNeill, independent consultant in public health
  1. Division of Respiratory Medicine, City Hospital, Nottingham NG5 1PB
  2. 78 Kenwood Drive, Beckenham, Kent BR3 6QZ

    To bring consistency and regulation to tobacco and alternative nicotine products

    In the United Kingdom, as in most developed countries, strict laws apply to the production and supply of goods and services to the public. An important function of this legislation is to protect consumers from damage caused by the products they buy, and in many cases this protection extends to levels of risk that are, at an individual level, extremely small. It is therefore an anomaly that cigarettes, which if used as intended kill half of all regular consumers,1 enjoy remarkable freedom from consumer protection legislation.

    Cigarettes are not a food, so are not regulated by the Food Standards Agency, and not medicines, so are not regulated by the Medicines Control Agency. They are a consumer product but are exempt from the Consumer Protection Act 1987 and General Product Safety Regulations 1994. Thus the most dangerous product on general sale in the UK is subject to the least regulatory control.

    Cigarettes kill because they produce nicotine, which is addictive, and tar and other combustion products, which are toxic. Most smokers smoke to relieve or avoid the unpleasant symptoms of nicotine withdrawal2 and in the process are exposed to harmful components of tobacco smoke. Since pure nicotine at the doses obtained from cigarettes appears to be relatively free from major adverse effects,2 nicotine addiction itself is not the central problem: it is the use of tobacco combustion products. The tobacco industry has long realised the importance of nicotine addiction to the use of their products and has refined and developed cigarettes to optimise nicotine delivery3 but has done little to reduce smokers' exposure to toxic tobacco products. That the cigarette companies have failed a moral duty to meet the requirement that the Consumer Protection Act imposes on other manufacturers to minimise the safety hazard of their products is evident for all to see. For successive governments to endorse this behaviour by maintaining their exemption from basic consumer protection law is a neglect of social responsibility.

    In June 2000 the House of Commons Health Committee concluded, “Current regulation applying to tobacco products is entirely inadequate.”4 The committee recommended the establishment of a tobacco regulatory authority to bring the activities of cigarette manufacturers under statutory control,4 particularly in relation to marketing, advertising, sponsorship, packaging, labelling, health claims, brand stretching, harm reduction, product development, and the use of additives. As steps towards more effective regulation of the tobacco industry, these are essential and welcome proposals, but controls on cigarette manufacturers are only part of the legislative change required.

    To meet the needs of the estimated 13 million current smokers in Britain,5 many of whom will never overcome their nicotine addiction, we also need legislation that explicitly encourages the development of alternative products that can deliver uncontaminated nicotine at a dose and rate comparable with cigarettes and in a way that is commercially and socially acceptable. If instead of nearly 13 million addicted smokers we have 13 million addicted to clean nicotine devices, so be it: the result could be six million lives saved. Achieving this, while maintaining reasonable safeguards for consumers and society, is not feasible within current legislation on the development, marketing, and distribution of new nicotine products. We need a single regulatory authority to take responsibility for all nicotine products and establish a regulatory balance that favours clean nicotine delivery devices over cigarettes and other tobacco combustion products.

    In 1998 the government promised to “tackle smoking”5 and deserves credit for banning tobacco advertising and promotion, increasing tobacco tax, and introducing smoking cessation services into the NHS. However, these are measures that act predominantly on the demand side of the tobacco market. Tackling smoking related disease also requires effective controls on the safety of the tobacco product supplied, and here the government seems reluctant to act.6 Current government policy on tobacco regulation appears to be to defer to the European Commission,6 and although a European directive currently being negotiated7 includes some of the measures recommended by the Commons health committee,4 the more comprehensive nicotine legislation we need is not on the agenda at European level, not least because eight member states are tobacco producers.

    The UK government has an immediate obligation to existing smokers in Britain, most of whom are among the most disadvantaged members of society, and to the hundreds of thousands who will start smoking before any European legislation materialises. These people deserve protection against the activities of the tobacco industry and some safer solutions to their nicotine addiction. Britain needs to regulate tobacco and alternative nicotine products consistently, radically, and creatively, and needs to do so now.


    JB has been reimbursed by GlaxoSmithKline for attending international conferences in respiratory medicine and is participating in a clinical trial funded by Pharmacia and Upjohn. Both companies manufacture nicotine replacement products. AM was formerly involved in the Pharmacia and Upjohn trial. She also participates in the WHO partnership project to reduce tobacco dependence, which is funded by pharmaceutical companies who make products to treat tobacco dependence.


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