A possible route to ‘reduced risk’ status for e-cigs in the EU?

At present it appears that article 13 of the EU Tobacco Products Directive (TPD) has been interpreted by all but one of the European Union’s 28 member states-Cyprus-as banning all claims of health and physical benefits relating to e-cigarette products.

While certain claims that a product is beneficial may be possible, they would require a medical licence. But there may be scope for a “reduced risk” classification, according to an ECigIntelligence report which draws parallels with the US Food and Drug Administration (FDA)’s modified risk tobacco product application (MRTPA).

Since e-cigarette products are officially acknowledged by health organisations in some European countries to contain fewer toxins than regular tobacco products such as cigarettes, it could be argued that they can help reduce the effects of smoking on public health.

Promoting e-cigarettes as a reduced risk product would not affect their being categorised as a consumer/tobacco-related product, but the classification could change to that of a medicinal product if they are promoted as an aid to giving up smoking.

This is important because the categorisation of the product defines it, not only in regard to making claims on packaging or in advertising but also in regard to regulations such as tax, notification systems, product requirements, labelling and packaging restrictions, and advertising. A pathway to a reduced-risk classification would not require a medical licence to be obtained.

-ECigIntelligence staff

Image: Gerd Altmann

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