The eu’s tobacco promotion directive

Yet the MHRA itself has been at the forefront of pushing for greater regulation. In June 2013, MHRA confirmed plans to regulate e cigarettes as medicines in a way that, from its own analysis, threatens thousands of lives. This is despite the fact that the Commission on Human Medicines (CHM), which the MHRA offers as authority for its e cigarettes policy, equates 34 per cent annual growth in e cigarette usage to saving 2,000 smokers lives. Every year of growth at these rates will save more.

This push for medicinal regulation also flies in the face of public opinion. In 2011, the MHRA consulted the public on the issue. The overwhelming majority 78 per cent of respondents opposed medicinal regulation but the MHRA proceeded with the policy anyway. As a result, the UK has backed the TPD. As for our elected representatives, they were never consulted. Anna Soubry, the minister of health responsible for this area, simply voted to back the plan without referring to parliament. Soubry then squirmed as MPs on the European Scrutiny Committee asked her to justify her decision afterwards, a session which only revealed Soubry’s ignorance of the directive she had voted for. (Soubry has now been shuffled off to the Ministry of Defence.)

How has this mad policy been justified? The phrases ‘insufficient evidence’ and ‘requires further research’ appear throughout the MHRA/CHM material. Despite strong indications that e cigarettes are far less harmful than the tobacco variety, there isn t enough proof that they are completely harmless and insufficient evidence that they are effective in reducing smoking. Medicinal regulation s mantra is establishing quality, safety and efficacy. Through twisted logic, MHRA concludes that doubts about evidence and efficacy can only be resolved through testing, control and monitoring as medicines.

A single strand of the MHRA/CHM argument is reasonable. Testing a few e cigarettes, they found variances between advertised and actual nicotine content one sample had trace toxins. Medical practitioners cannot recommend a product as a substitute for smoking or an aid to quitting unless they know it s safe. Yes, the MHRA should regulate devices provided by doctors. But these observations by no means demand that all e cigarettes should require medicine level regulation.

Far better to regulate e cigarettes as consumer products and to encourage the development of voluntary testing and labelling schemes as already done by the Electronic Cigarette Industry Trade Association (ECITA).

There are some rational voices in the European Parliament who want to overturn this aspect of the TPD. Conservatives and Liberal Democrats sought a balanced compromise on the directive products marketed as medicinal would be regulated as such other e cigarettes would need warning labels, a ban on under age sales and specific quality standards. This compromise was out voted by the Socialist Group in the Parliament s Health Committee, backed by the UK Department of Health briefings for MHRA s ‘regulate everything as medicine’ stance.

Martin Callanan MEP, leader of the European Conservatives & Reformists group, and a prime mover for sensible regulation explains ‘It would be the greatest folly to classify e cigarettes as medicinal products. This would limit their availability when a lethal alternative (tobacco) remains available in every corner shop. Treating all e cigarettes as medicinal products would raise costs, reduce product diversity, slow down innovation, inhibit creativity and make the products less appealing to the very people we hope will switch to them.’

MHRA regulators are well meaning but have tunnel vision their business is medicinal approval and, not surprisingly, that s their answer to the question of e cigarettes. If we continue down this path, the tunnel comes out in a place where I can t get the products that keep me off cigarettes. Years of experience with governments preaching ‘just say no’ show that endless lectures do not work. Deprived of e cigarettes, a million people in the UK may return to smoking regular cigarettes.

Well, at least each pack sold will shove another 4 in tax to the government’s much strained coffers. Frankly, I hope they choke on it.

Craig Arnall is an accountant and management consultant living in London.

Not all electronic cigarettes comply with eu directives — authority —

A number of electronic cigarettes found on the market do not comply with the essential health and safety requirements of the European directives under which such products fall, or are being claimed to fall, the Technical Regulations Division within the Malta Competition and Consumer Affairs Authority said.

It said in a statement that all electronic cigarettes should have the CE mark.

Moreover, products which either claim to assist the user to stop smoking and/or have other health claims and/or have a nicotine content of 10mg per ml or more fall under the Medical Devices Regulations.

Electronic cigarettes and their use must also comply with the provisions of legislation on tobacco products, even if they do not contain any nicotine, the division said.

It advised consumers that inhaling vapours could not in any way be considered healthy.

«It is evident from research carried out by the authority that a number of people are importing these cigarettes personally over the internet and are then selling them to consumers, or even to some retail outlets, on a one to one basis.

«The Technical Regulations Division reminds such economic operators that they are and remain personally responsible for the products they are placing on the market and that they may be liable for legal action should the products not conform to all applicable requirements.»

The division said that consumers who wished to report any unsafe product could do so directly on the authority s website, tel 2395 2000.