The UK's National Institute for Clinical Excellence (NICE) has formally supported a policy of tobacco harm reduction. This has been seen in some quarters as good news for users of e-cigarettes. I'm not so sure. It is possible that e-cigarettes could be approved and regulated, but it is also possible that they might be banned for good.
A public consultation has been launched which emphasises the dubious findings of the FDA:
We know from work done by the Food and Drug Administration (FDA) in the United States that laboratory analyses of e-cigarette samples were found to contain carcinogens and toxic chemicals, against which general product safety legislation could not protect.
Will e-cigarettes go the way of snus? It's too early to say. For now, the government's objective is to get them off the market. The consultation ends in May and NICE favours doing this within 21 days of a decision being made. Once taken off the market it could be years, if ever, before they return. In the meantime it will be back on the cigarettes for Britain's vapers. Some harm reduction strategy that would be.
The consultation reads:
In order to ensure there is no risk to public health from unlicensed products on the market that have not been assessed for safety, quality and efficacy and in the light of the developing extent of their use and familiarity we are consulting to elicit views on whether and how to bring all products containing nicotine into regulation.
Option 1 – Whether products containing nicotine should be considered by the Agency to be medicinal products by function and, if so, whether all unlicensed NCPs should be removed from the market within 21 days. Currently, MHRA operates a strict practice regarding the period of notice operators are allowed to comply with under the Marketing Authorisation Regulations following the classification of a product as medicinal. Given that these Regulations do not make explicit provisions for a staged withdrawal from the market of an unlicensed medicinal product, immediate cessation of the sale or supply is usually required by the Agency, with written confirmation of the same within 21 days.
Option 2 – Whether products containing nicotine should be considered by the Agency to be medicinal products by function and, if so, whether a notice should be issued to manufacturers that all marketing must cease by a certain date e.g. June 2011. After this date enforcement action would be taken against manufacturers not holding an MA for any such product on the market. This would effectively allow manufacturers a year from the end of public consultation to produce relevant evidence to support an application for an MA, submit it to the MHRA for approval and get the newly licensed products on to the market.
Option 3 – Do nothing and allow these unregulated products containing nicotine that have not been assessed for safety, quality and efficacy to remain on the market.
The MHRA’s preferred option is option 1, which is in line with current practice.
