The recent decision by the UK medicines and healthcare products regulatory agency (MHRA) to regulate electronic cigarettes as medicinal products is good news for manufacturers of real cigarettes and nicotine patches, but not so much for Britain’s growing number of e-cigarette users, now estimated to exceed one million. No one denies that e-cigarettes should meet basic standards of safety and quality, but there are enough consumer-protection laws in place already without forcing this patently non-medical product down the pharmaceutical route.
The MHRA’s justification for medicalising e-cigarettes is that most vapers (e-cigarette enthusiasts) use them to quit or reduce their smoking. ‘This’, the MHRA says, ‘is comparable to how nicotine replacement products (eg, gums, patches, inhalator), which are licensed as medicines, are used’. This is fallacious logic. Pharmaceutical nicotine products are licensed medicines because pharmaceutical companies needed them to be viewed as such before they could be marketed as cessation aids and prescribed by doctors. There is no other precedent for medicalising products that might help people to quit smoking, whether they contain nicotine (eg, snuff) or are merely substitutes for a habit (eg, chewing gum). Medical approval was a commercial necessity for the pharmaceutical industry, but it is neither necessary nor appropriate for e-cigarettes. No one would expect skimmed milk and Special K to be licensed as medicines just because the anti-obesity drug Alli went down that route, although all of them can be used to help people lose weight.
The justification for treating nicotine products as medicines has never been compelling. If they are medicines, what disease do they treat? Nicotine addiction, perhaps, but it is debatable whether nicotine addiction is a bona fide disease, and even if it is, how is taking more nicotine supposed to cure it? It cannot. The most that patches and gums can offer is a way for smokers to get out of the habit of smoking for a few weeks while they prepare to give up nicotine. This system of ‘nicotine replacement therapy’ (NRT) works for some people, but not many. A 2008 Cochrane Review found that 95-97 per cent of people who try to quit ‘cold turkey’ are smoking again within a year. The use of NRT only reduces this failure rate to around 92-95 per cent. This is better than nothing, but despite its widespread use as a state-subsidised treatment, it is unlikely that pharmaceutical nicotine will ever lead to mass abstinence.
The fledgling e-cigarette industry has no desire to move its tanks onto Big Pharma’s lawn. E-cigarettes are not marketed as medicinal products and, despite countless customers testifying that they stopped smoking after they started vaping, they are not advertised as smoking cessation aids. They are recreational nicotine products – superficially similar to cigarettes but without any tobacco and with a dramatically lower risk profile (no significant health risks have yet been associated with them). Some vapers may use them as a stepping stone towards total abstinence from nicotine, thereby acting as a ‘cure’ for nicotine addiction, but that is not their selling point. Most users see them as long-term substitutes for tobacco rather than as an opportunity to quit nicotine entirely.
If forced down the route of medical trials, a well-funded e-cigarette company could gather the empirical evidence to demonstrate their product’s efficacy as a smoking cessation aid and its relative safety as a consumer product. The question is how long that process would take and whether e-cigarette users would be pushed back on to tobacco in the meantime. As former ASH director Clive Bates has noted, if the regulatory obstacles can be overcome, the likely result will be that prices will rise, innovation will be stifled and the current, diverse crop of e-cigarettes will be replaced by ‘dull but perfectly safe medicalised products that no-one wants to use’. This dismal outcome is arguably the best-case scenario. The prohibitionists who are busy manufacturing myths about children using e-cigarettes as a ‘gateway’ to smoking may yet use medical regulation as a way of forcing a precautionary ban, as has happened in several other countries.
Important though it is, the immediate future of e-cigarettes is only one part of picture. The full implications of the MHRA’s decision – which will undoubtedly influence legislation in Brussels –go far beyond one product. While the media focused on the effect the decision will have on vapers, the MHRA addressed the broader question of ‘whether to bring nicotine containing products (NCPs) within the medicines licensing regime’. Its answer was that they should. The effect will be to automatically regulate all non-tobacco nicotine products as medicines, including those which have yet to be invented. The MHRA’s assurances about quality control and light-touch regulation have obscured the fact that an entire product category is on the verge of being taken over by the medical establishment and the pharmaceutical industry.
This is the continuation of a process that began with the 1868 Pharmacy Act (UK) and the 1915 Harrison Narcotics Tax Act (US) which restricted the sale of opium to chemists and doctors, after lobbying from the Pharmaceutical Society and the American Medical Association respectively. By 1920, the medical establishment had brought all narcotics under its authority on both sides of the Atlantic and paved the way for the war on drugs. In America this extended to alcohol, with doctors able to prescribe medicinal liquor during Prohibition (a privilege they greatly abused). British medics have never seized control of the drinks industry, but the MHRA ruling will give them authority over the other remaining outpost of chemically induced pleasure – nicotine.
This is an audacious move with profound implications for the years ahead. The conventional mass-produced cigarette is arguably a relic of the nineteenth century which will be gradually rendered obsolete by twenty-first century technology. Recreational nicotine use in a few years time will look radically different to that of the cigarette era. It is reasonable to expect e-cigarette technology to improve significantly if a competitive market is allowed to flourish. It is also likely that other safe, or vastly safer, nicotine products will emerge to compete with them.
All this could be jeopardised if the authoritarian and moralistic public health lobby becomes the judge, jury and executioner of the recreational nicotine industry. Their instinctive asceticism takes little account of the desire for pleasure that motivates nicotine users and their obsession with legislation and top-down behavioural control is irreconcilable with the spirit of free enterprise that created these revolutionary products in the first place.
The MHRA review gave the medical establishment an opportunity to increase their power and influence and they grabbed it. Their takeover of ‘nicotine-containing products’ will not create a monopoly so long as the tobacco industry remains their (only) rival in the nicotine market, but the health lobby makes no secret of its aim of destroying them and building a tobacco-free world. Thereafter, the long-term vision is to not only eradicate tobacco smoking, but to eliminate all recreational nicotine, turning a drug that has been used socially for thousands of years into a controlled substance over which the medical establishment has sole authority. Only occasionally is this aim made explicit, but the MHRA’s decision to medicalise the most promising innovations in the nicotine market while asserting its authority over all nicotine products that are developed in the future is an important step towards that goal.
Chris Snowdon is the author of The Art of Suppression: Pleasure, Panic and Prohibition Since 1800 (Buy this book from Amazon(UK)).