Wednesday, June 27, 2018

Are e-cigarettes tobacco products?

Nicotine and Tobacco Research: Should e-cigarettes should be classified as tobacco products? In 2014 the Food and Drug Administration (FDA) in the US concluded that they are (1), and we regularly receive submissions describing e-cigarettes as tobacco products. However, this judgement is the product of policy developments around the role of the FDA and their ability to provide regulative guidance and authority relating to a range of products. Products that contain nicotine derived from tobacco fall within a court-endorsed legal framework for FDA regulation. To date, Nicotine & Tobacco Research has not had an explicit policy on how e-cigarettes should be described.

However, describing e-cigarettes as tobacco products is a particularly US phenomenon. Some countries include e-cigarettes in tobacco product regulation, but others do not. This includes Canada, a near neighbour to the US, for example. In Europe, while some elements of e-cigarette regulation are contained within the EU Tobacco Products Directive, the devices themselves are not referred to as tobacco products. If all products containing nicotine derived from tobacco were labelled as “tobacco products” internationally, then nicotine replacement therapies would be classified as tobacco products, which they are clearly not. As a scientific journal, definitions matter, and a legal ruling in a single country is not a sound basis for determining whether a certain definition is valid.
Our preference is for the term “tobacco products” to be reserved for those products that are made from and contain tobacco (rather than contain constituents such as nicotine extracted from it). The term “nicotine-containing products” is more general, and can be applied to tobacco products but also non-tobacco products such as e-cigarettes and nicotine replacement therapies. However, even the term nicotine-containing products does not apply to cases where aerosol-producing devices are used with liquids that do not contain nicotine – in this case distinguishing between vaping devices and liquids (which may or may contain nicotine) could be helpful. Another common description is electronic nicotine-delivery systems (ENDS), but again this is potentially problematic because not all devices are electronic (and again may deliver liquids that do not contain nicotine). A simpler approach would therefore be to refer to “cigarettes”, “e-cigarettes” and so on, without reference to broad categories. The exception would be cases where e-cigarettes are being referred to in a specific policy context (e.g., in relation to the FDA). The guiding principle is that the terminology used should be clear, unambiguous, and scientifically appropriate.
Some of our readers may disagree with this position, but it is motivated by a desire for clarity of expression that reflects our status as an international journal with contributions from many countries, each with their own legal and regulatory frameworks around tobacco and other nicotine-containing products. There is a great deal of ongoing debate about the potential relative harms and benefits of e-cigarettes (with heat-not-burn products likely to complicate the picture further), but we are fundamentally a scientific journal and should ensure that the terms we use a clear, unambiguous and valid.