Nicotine pouches are no longer classified as medicinal products

According to a new evaluation by the Finnish Medicines Agency Fimea, nicotine pouches intended for other than medicinal purposes are no longer classified as medicinal products. Finnish Customs will adopt Fimea’s new evaluation immediately in preliminary investigations and in the import control of nicotine pouches.

Fimea’s new evaluation of nicotine pouches has an impact on the customs control of imported goods. From now on, nicotine pouches intended for other than medicinal purposes are no longer classified as medicinal products.

“Customs is the implementing authority and we always follow the evaluations of the competent authority, which in this case is Fimea’s current guidelines on the classification of medicinal products. From now on, we will implement Fimea’s new evaluation both in the import control and in our preliminary investigations”, says Mr Hannu Sinkkonen, Director of Enforcement.

The new guidelines only apply to the import of nicotine pouches – the change does not affect the import regulations on snus

The new guidelines apply to the import of nicotine pouches starting from 4 April 2023. 

According to Fimea’s earlier guidelines, stronger nicotine pouches were treated as prescription drugs and could not be imported without a prescription. In accordance with the previous guidelines, Customs has detained or seized illegally imported nicotine pouches and started preliminary investigations as needed. 

Nicotine pouches are pouches that are placed in the oral cavity and that contain nicotine but no tobacco. The changes concerning the import of nicotine pouches do not affect the import regulations on snus.

The Ministry of Social Affairs and Health has already started preparing the amendments to the Tobacco Act. The preparation work is based on a proposal of the Tobacco and Nicotine Policy Development Working Group stating that nicotine pouches should be subject to the same legislation as traditional snus. Read more in the news published by Fimea and Valvira (in Finnish and Swedish).

As an implementing authority, Customs carries out import controls on goods in several different administrative sectors, meeting the needs of different competent authorities.

News bulletin published by Fimea (4 April 2023): Fimea supports legislative reform concerning nicotine pouches

News bulletin published by Valvira (4 April 2023, available in Finnish and Swedish only): Nikotiinipusseihin sovelletaan tupakkalakia