Tobacco product directive revision would protect cigarette sales

If the European Commission’s revisions to the tobacco products directive are adopted, traditional cigarette sales will be protected from competition by electronic cigarettes.

Professor Michael Siegel, of Boston University’s School of Public Health, said in a blog relayed by the TMA that according to a draft copy of the revisions obtained by the author and historian, Christopher Snowdon, ‘nicotine-containing products [with] a nicotine level exceeding 2 mg, a nicotine concentration exceeding 4 mg per ml, or whose intended use results in a mean maximum peak plasma concentration exceeding 4 mg per ml, may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy’.

Siegel said that such a revision would prevent smokers from having access to electronic cigarettes because most of these devices contain more than 2 mg of nicotine.

Companies wishing to market products with more than 2 mg of nicotine would be required to conduct a long series of clinical trials, which would cost tens of millions of dollars and an average of eight years to complete.

Siegel questioned what the purpose of this aspect of the directive was, and said the effect would be to protect cigarette sales in Europe at the expense of public health.