MEPs, under pressure from manufacturers and users of e cigarettes, had refused to accept an EU ban on refillable cartridges. But member states are concerned the cartridges are unsafe and had been demanding an EU ban. They are generally worried about the possibility of unknown long term health effects from these new products.

The issue of how to regulate e cigarettes had become so contentious that it threatened to derail the overall reform of EU tobacco rules (see box) in the final weeks of negotiations. Removing e cigarettes entirely from the proposal was being entertained as a solution.

That would have pleased e cigarette enthusiasts, who argue that the product has no place in the legislation because it contains no tobacco.

But a compromise was agreed yesterday which would permit the sale of refillable cartridges no larger than 2 millilitres, while empowering member states to ban specific types of cartridges where justified by safety concerns. If three member states were to adopt a ban on a specific cartridge, the European Commission could unilaterally impose an EU level ban, without approval by Parliament or member states. Manufacturers and users still fear that this could allow bans through the back door on all refillable e cigarettes.

Medicine debate

The conflict over whether e cigarettes should be regulated as general products, preferred by MEPs, or as medicines, preferred by member states, was also resolved with a compromise. EU law will regulate them as general products, but member states may classify them as pharmaceuticals if they wish. A manufacturer can also choose to have its e cigarette authorised as a pharmaceutical. E cigarettes will be limited to a maximum permitted nicotine concentration level per cigarette of 20 mg/ml, roughly equivalent to the amount of nicotine in one pack of regular cigarettes.

The full parliament is expected to vote on the deal in March, followed by a final rubber stamp from health ministers.

The new tobacco products directive

All characterising flavours will be banned, though the menthol flavour will be given a four year derogation until 2020.

Graphic pictorial health warnings covering 65% of the front and back of cigarette packs will be required. Member states can go further and ban branding if they wish.

An EU wide tracking and tracing system will be set up to combat illicit trade of tobacco products. Cross border internet sales will be banned.

European lawmakers reject tight restrictions on e-cigarettes –

Electronic cigarette buying guide – all you need to know to get started

European lawmakers endorsed a permissive approach to the sale and use of e cigarettes, although the products could not be sold legally to anyone younger than 18.

The Food and Drug Administration in the United States has said it wants to issue regulations on the nicotine delivery devices soon. Industry leaders and public health officials had expected them by the end of October but the regulations may be delayed because of the partial government shutdown that has emptied F.D.A. offices.

The electronic cigarette measure in Europe was widely watched because the use of e cigarettes, primarily by smokers seeking a way to kick the tobacco habit, has skyrocketed in Europe and the United States. Instead of smoke from burning tobacco, users ingest the nicotine in the form of vapors from a heated fluid an alternative to smoking commonly called vaping.

The advent of vaping has removed some of the stigma of tobacco use, and in some cases people can use e cigarettes in places where smoking tobacco is prohibited. The European Union legislation, however, does not address the issue of where vaping is permitted, leaving that to national and local jurisdictions.

Some Wall Street analysts predict that sales of the battery powered devices could surpass those of cigarettes within a decade. But the products and their use have quickly outrun any regulations on either side of the Atlantic. Some people hope this new technology will become a widely used alternative to tobacco. While their health effects are not fully understood, e cigarettes are generally considered less harmful than smoking.

E cigarette companies, supported by growing legions of e cigarette users, had lobbied hard against medicinal regulation. They welcomed the European Parliament vote as a victory for good health and good sense.

This is a fantastic result for public health and the millions of smokers around Europe who are switching to e cigarettes, said Charles Hamshaw Thomas, corporate affairs director of Britain s biggest e cigarette brand by sales volume, E Lites. Common sense has prevailed.

But while exempting e cigarettes from an onerous and potentially costly certification process required for drugs, an amendment to the Tobacco Products Directive approved by parliamentarians imposes tight restrictions on advertising and sponsorship. In these areas, e cigarettes face the same restraints as regular cigarettes, including the ban on sales to young people.

As expected, the European Parliament also voted to approve measures adopted this year by European Union officials, banning conventional cigarettes with menthol flavoring and requiring cigarette packs to carry health warnings in pictures and text covering 65 percent of the packages, up from 40 percent. But Parliament voted to delay the menthol ban by five years. It will take effect in eight years instead of three.

Regulators in the United States must now grapple with two serious concerns public health officials have raised about e cigarettes. Scientists are not certain of the health impact of using e cigarettes or of inhaling secondhand vapor. Perhaps more pressing, it is not clear whether e cigarettes will revive an interest in smoking by celebrating a behavior that health officials have spent decades trying to demonize.

These products threaten to undo all that, said Matthew L. Myers, president of Campaign for Tobacco Free Kids, who wants the F.D.A. to issue tough guidelines for how e cigarettes can be marketed and sold. With such regulations, e cigarettes have potentially positive value, he said, but we ve already seen that, if left to their own, e cigarette manufacturers will reach out to our children, do everything to maximize sales, including re glamorizing smoking, and that s where we are today.