TOBACCO POLICY SPECIAL
ideally, on the road to quitting. But there’s no really safe alternative nicotine product designed to just replace cigarettes and for people to carry on using nicotine in a way that’s much less hazardous to them.”
She said it was “absurd” that the tobacco industry is developing new products, in- cluding lozenges and strips, with very little regulation except for the health warnings they must have, whereas pharmaceuti- cal companies have to go through a long- winded and very rigorous regulatory pro- cess to bring a medicine to the market to help people stop smoking. She said those processes were necessary and justifiable for medical drugs, but that some nicotine products should face a less burdensome regulatory process – more like that faced by tobacco products than a new drug or medical device.
Whether e-cigarettes should fall into that category is up for debate, Sandford said.
“E-cigarettes are a very interesting develop- ment. On the face of it, they would fit into that category of a ‘reduced harm’ product, because most of the harm from smoking comes from the smoke and combustion process and inhaling the smoke. With e- cigarettes, users get the nicotine from inhal- ing the heated vapour – there’s no combus- tion involved. Presently, it looks as though they are considerably safer than ordinary cigarettes. But at the moment they are un- regulated, so we’re still faced with questions – are there additional additives in there, for example? They haven’t been around long enough for longer-term studies to have been done to conclude whether they are truly a safe alternative to cigarettes.”
In ASH’s response to the MHRA’s review of nicotine regulation, it recommended that new nicotine containing products coming onto the market should be lightly regu- lated. Sandford said: “They should have basic safety testing, consumer information on their contents and use and safety meas- ures, ensuring children don’t get them – but should not be as tightly regulated as other medicines.”
A final MHRA decision is not expected until Spring 2013, but if e-cigarettes are proved as harmless as manufacturers claim, would they ever be prescribed by health profes- sionals for smokers seeking to quit?
“It’s possible, but too soon to say for sure,” Sandford said. “At the moment, stop smok- ing services advise patients to use estab- lished nicotine replacement products, or the two medicines available – Champix (Varenicline) and Zyban (Bupropion) –
warnings on cigarette packaging in mem- ber states – but a review of the directive, which has faced intensive tobacco industry lobbying and has been delayed until 2012, could change this.
that are clinically proven to be effective stop smoking aids. That’s what we’d ad- vise too. It’s far better to quit completely but there are these products available for smokers who are not ready to quit or don’t want to give up nicotine altogether.
“But with e-cigarettes, it’s a case of caveat emptor…we can’t advise you to use them because we don’t know yet whether they are fully safe.”
Some clinicians have raised fears that e- cigarettes, because of their apparent safety and potential for alternative flavours and so on, could attract new people to the act of smoking, and unintentionally make them more interested in trying tobacco products.
Sandford said ASH recognised that danger: “We would certainly want to see very tight controls on any marketing, just as there are controls on the marketing of medicines.”
E-cigarettes, because they contain no to- bacco, technically are not regulated under the current EU Tobacco Products Direc- tive, which controls labelling and health
In one ‘orientation note’ produced for the European Commission early in the debate, the Health & Consumer Protection Di- rectorate-General noted that e-cigarettes “have the potential of undermining the smoking cessation policies, since they keep the smoking addiction”.
Some e-cigarette manufacturers suggest them as cigarette replacements for smokers in situations where they are banned from smoking tobacco – in which case they are regulated by trading standards bodies and chemicals legislation. Others highlight them as smoking cessation tools – the amount of nicotine inhaled can be gradually reduced to zero as a smoker quits, for example – which defines them as a medical device, and thus subject to MHRA marketing authorisation, which has not yet been granted.
This confusing situation is replicated around the world – Singapore and Thai- land have banned them, for example, while the Danish Gov- ernment regulates them as a medicinal product, and different airlines have different policies on them too.
Amanda Sandford
TELL US WHAT YOU THINK
opinion@nationalhealthexecutive.com
national health executive Nov/Dec 11 | 25
Tithius Agurto
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