The Department of Health says new controls on e-cigarettes to be introduced next month could make consumers turn to potentially dangerous black market products.
Its impact assessment (pdf) on EU rules to be enshrined in UK law also acknowledges that higher costs for e-cigarette manufactures could lead to price increases and reduction of choice for consumers, leading people to switch back to smoking, which public health experts regard as far more dangerous.
It recognises too that regulations might create new barriers for small- and medium-sized companies, a concern that comes as public health doctors warned of possible consequences from tobacco giants becoming more involved in making e-cigarettes.
The document says: “There is a risk that a black market will develop with potentially harmful e-cigarette products. due to consumers no longer having the same degree of choice in the legal market.”
The rules introduce for the first time minimum standards for the safety and quality of e-cigarettes and refill containers. Companies will have to give information on all their products to regulators. They are part of a broader package that also tightens rules on tobacco.
One e-cigarette company boss suggested the government was “grudgingly accepting” that the new controls could result in a “public health disaster”.
The government believes the health gain from stronger tobacco controls will bring a £13bn health gain across the UK over 10 years because there will be fewer smokers so the NHS will have to treat fewer people for diseases related to the habit.
But the changes could cost the UK e-cigarette industry £140m, it suggests. Much of the e-cigarette “hardware” is already produced in China and an increasing amount of e-liquid manufacture is said to be moving there too.
Ian Gregory, of campaign group Vapers for Britain, said: “In its assessment, the Department of Health has not been able to quantify any benefit from the massive regulation of e-cigarettes.”
The health department said: “By its nature an impact assessment is honest about risks, but these are far outweighed by the health benefits of the directive, which are worth more than £13bn to the UK.
“The best thing a smoker can do for their health is to quit smoking. We know that there are now over a million people who have completely replaced smoking with e-cigarettes and that the evidence indicates that they are significantly less harmful to health than smoking tobacco.
“We want to see a wide range of good quality e-cigarettes on the market including licensed products whose safety, quality and effectiveness are independently assured.”
The department says that, while there are measures in the directive that could both increase and decrease the illicit trade, overall the impact in this area is estimated to be zero. The evidence for increasing the illicit trade is also based on a report by the tobacco industry, and the report highlights this to be likely to be an overestimate.
The assessment of the new regulations, which result from the 2014 Tobacco Products Directive, came as doctors warned growing involvement of tobacco manufacturers in the e-cigarette market could jeopardise attempts by public health specialists to promote vaping as a safer alternative to smoking.
They expressed concerns that such companies might seek to rehabilitate what has become a “pariah industry” and therefore undermine tobacco control.
A report from the Royal College of Physicians (RCP) published on Thursday found e-cigarettes could play a valuable role in shifting smokers away from their “addictive and lethal” habit, a similar position to that taken last year by the English government’s Public Health England, which said e-cigarettes were about 95% less harmful than tobacco cigarettes.
Dame Sally Davies, the chief medical officer, said at the time however that e-cigarettes should only be used a means to help smokers quit.
The Nicotine Without Smoke report concluded that e-cigarettes were not a gateway to smoking, did not help normalise it and could act as a way out of the deadly habit. There are still nearly 9 million smokers in the UK, despite big falls in recent decades, while an estimated 2.6 million UK adults use e-cigarettes and as many as 1 million of those may have completely stopped smoking.
The RCP did not dismiss the possibility of harm from long-term use of e-cigarettes, but said it was likely to be substantially smaller than that from the carcinogens, carbon monoxide and other toxins that come with tobacco.
However, the report’s authors were worried by the involvement of tobacco giants such as British American Tobacco (BAT), Imperial Tobacco, Altria and Philip Morris International, including their taking over previously independent manufacturers and importers.
The industry’s recent programme of investment and acquisition in e-cigarettes might be recognition that the products, available in the UK for less than a decade, could be a threat to their “core business of selling tobacco”, the 200-page report found.
Manufacturers might use e-cigarettes to help expand tobacco markets or make nicotine products attractive to non-smokers, says the report, which is also summarised by its contributors in the BMJ medical journal.
There is “little likelihood that the industry sees e-cigarettes as a route out of the tobacco business”, the report added. It said it was highly likely, however, that tobacco manufacturers would exploit e-cigarettes to try to undermine the World Health Organisation’s framework convention of tobacco control, which is, among other measures, designed to protect nations’ public health policies from commercial and other vested interests of the tobacco industry.
Tobacco companies have long sought to “redress the challenge of a toxic reputation” by seeking to establish partnerships or common ground with public health researchers and advocates, the report said.
“There is no firewall between a ‘good’ tobacco industry that is marketing harm-reduction products in the UK and a ‘bad’ one that promotes smoking, or undermines tobacco control activities in low-and middle-income countries.”
It called however for “proportionate” regulation that does not undermine the development of products such as e-cigarettes that provide alternative sources of nicotine to tobacco.
The report said it remained to be seen whether the new EU rules would help or hinder the use of e-cigarettes in the battle against smoking. Some measures should help raise standards, the authors say in their BMJ article, but limits on nicotine content might diminish e-cigarettes’ effectiveness as smoking substitutes while health warnings might discourage their use.
These requirements would not apply to products licensed as medicines, but there are fears that smaller manufacturers will be discouraged by the high costs and delays that the process involves.
“Achieving the right balance of regulation for e-cigarettes is not easy: too much regulation can stifle innovation and reduce choice for smokers, while too little leaves smokers exposed to products that are ineffective, unduly hazardous, or both.”
John Britton, professor of epidemiology at the Centre for Tobacco and Alcohol Studies, one of the authors, said the report “lays to rest almost all the concerns over these products, and concludes that with sensible regulation, electronic cigarettes have the potential to make a major contribution towards preventing the premature death, disease and social inequalities in health that smoking currently causes in the UK”.
Smokers should be reassured e-cigarettes could “help them quit all tobacco use for ever”.
The RCP president, Jane Dacre, also said she believed that “with careful management and proportionate regulation, harm reduction provides an opportunity to improve the lives of millions of people”. It is “an opportunity that, with care, we should take”, she said.
The Tobacco Manufacturers Association said tobacco and e-cigarettes would co-exist. “Consumers’ requirements are evolving and so is the e-cigarette market”, said Giles Roca, its director general.
“The fact that tobacco manufacturers are now involved in this industry is good news. Tobacco manufacturers possess considerable expertise, resources and capacity for research that allows them to contribute substantially to the scientific and regulatory debate and the overall development of the e-cigarette industry.”
BAT said: “Accusations that we are using e-cigarettes to enhance tobacco sales are entirely untrue … We are explicit in our vapour product marketing principles that sales of e-cigarettes – all of which feature non-tobacco brands – should not promote our cigarette products.
“Our involvement in this category offers an opportunity for a ‘win, win, win’: a win for society as the public health impact of smoking is lessened, a win for consumers as we commercialise a range of quality innovative products for them to choose from, and a win for our shareholders over the long term,” the company said.
- This article was amended on 28 April 2016. An earlier version incorrectly attributed a quote to Dan Marchant, the director of Vape Club.
