Nicotine pouches no longer classified as medicinal products

Nicotine pouches intended for other than medicinal purposes are no longer classified as medicinal products, according to a new evaluation by the Finnish Medicines Agency Fimea.

Finnish Customs will adopt Fimea’s new evaluation immediately in preliminary investigations and in the import control of nicotine pouches, said an official press release.

“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”, said Hannu Sinkkonen, Director of Enforcement of Finnish Customs.

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

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