Electronic cigarettes: medical device or consumer product?

Legal status

Currently any nicotine containing product that claims or implies it can help users to give up smoking is deemed by the MHRA to be a medicinal product. The makers of e-cigarettes do not claim that their products help smoking cessation, but the MHRA seems determined to close what it sees as a regulatory loophole and hopes to reach a decision by next spring.

After a consultation launched in February 2010, the MHRA noted that “there remain clear gaps in knowledge regarding these products” and embarked on various strands of research to determine the nature, quality, and safety of nicotine containing products, the extent of their use, and the levels of nicotine that have an important physiological effect.

Crucially, the MHRA is also seeking to model “the potential impact of bringing these products into medicines regulation on public health outcomes.”

This has proved a keen concern, both among users of e-cigarettes and professionals from public health organisations, worried that any restriction in the availability of e-cigarettes could see users return to real cigarettes, adding to the toll of 80 000 lives lost prematurely each year through the use of tobacco products.

Just one comment from among the many hundreds of users who responded to the MHRA consultation, which attracted comments from 1200 individuals and organisations, summed up the consumer experience.

“I feel so much healthier now with no chest problems or shortness or breath,” wrote a 52 year old architect, who said he or she had smoked 30 cigarettes a day before taking up e-cigarettes a year ago, and had since cut back to one or none a day.

“Do not ban the product . . . This would lead to an increase in smoking of cigarettes and all the health and associated costs to the country.”2

Patterns of use

John Britton, director of the UK Centre for Tobacco Control Studies at the University of Nottingham, says that most people who use e-cigarettes do so “either as a temporary substitute to smoking tobacco or . . . as a long-term substitute and eventually quit.”

Without doubt, he says, such devices “have a huge amount to offer public health, potentially.” But at the same time “you want consumers and health professionals to be secure in the knowledge that what they are buying contains what it says it contains and meets acceptable standards of safety, quality and consistency.”

If e-cigarettes were regulated as medicinal products, each type would have to undergo evaluation by the MHRA for quality, safety, and efficacy. The MHRA, which insists it “does not want to see useful products removed from the market,” nevertheless recognises that this “will have an economic impact on importers of these products” and even that some companies could go out of business. However, regulation “could make such products more widely available,” it suggests; general sale legal status would mean e-cigarettes could be sold in general sale outlets, such as supermarkets, where they would be “supported by clear information for users and appropriate advertising.”

Industry resistance

For its part, an industry that has grown swiftly over the past few years is reluctant to see its products regulated as medicinal, and insists their safety is ensured by general product safety legislation.

“If the MHRA attempts to regulate e-cigarettes under a medicinal regime we will seek legal redress,” says Katherine Devlin, president of the Electronic Cigarette Industry Trade Association, which has 22 members, mainly from the UK.

Compliance with MHRA licensing, she says, “would cost so much per product and would necessitate a fundamental shift in how the products are put together and operate, which would restrict the current freedom of choice that consumers have.”

Regulation, however, seems likely. The MHRA says the e-cigarette is a medicinal product as defined by article 1 of European directive 2001/83/EC on the code relating to medicinal products for human use. Furthermore, said a spokesman, available data suggested that the quality or efficacy of e-cigarettes could not be guaranteed.

“The release of nicotine from the same electronic cigarette can vary over time, and the amount of nicotine per product might not be the same from batch to batch,” he said. In addition, “toxic elements may be included and unexpectedly high doses of nicotine could produce adverse effects, particularly in some vulnerable patient groups.”

The MHRA has quoted laboratory analysis by the Food and Drug Administration in the United States, in which “samples were found to contain carcinogens and toxic chemicals, against which general product safety legislation could not protect.”3

On the other hand, it recognises that harm reduction should be included as an indication for nicotine replacement therapy “since it has become widely accepted that there are no circumstances in which it is safer to smoke than to use NRT.”4

In America, where tobacco products cause over 400 000 premature deaths a year, the Food and Drug Administration has been obliged to take a different approach—and one that might encourage the UK industry’s resistance to the MHRA’s plans in the UK. Last year, after an initial attempt by the FDA to regulate e-cigarettes as medical devices was challenged by a manufacturer and met defeat in court, it announced that, in accordance with the decision by the US Court of Appeals, it was now planning to regulate them as a tobacco product.5