Fimea supports legislative reform concerning nicotine pouches

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4.4.2023

The Finnish Medicines Agency Fimea supports the legislative amendments concerning regulation of nicotine pouches in Finland. Nicotine pouches are dosage bags that contain nicotine but not the tobacco plant.

There are currently a large variety of nicotine products on the market, and according to Fimea's evaluation, they cannot all be classified as medicinal products under the Medicines Act solely on the basis of the effect of the nicotine they contain. National and EU pharmaceutical legislation and the case law of the European Union have been considered in the evaluation.

In Fimea's view, consumers use such products mainly as intoxicants similar to traditional snuff tobacco. "The regulation of nicotine pouches should be included in tobacco legislation," says Eija Pelkonen, Director General of Fimea. "The Ministry of Social Affairs and Health has already began preparations for the amendments to the law."

Effect and indication considered in classification

The Medicines Act has two definitions for medicinal products. One is based on the presentation of the product and the other on its effect. A substance or product is considered a medicinal product if it meets either or both of these definitions.

In its prior classification practice on nicotine pouches, Fimea has considered the products to meet the definition of medicinal product on the basis of the pharmacological influence of the nicotine they contain on the vital functions of humans. The classification practice has mainly been implemented in product assessment reports issued to Customs in connection with import control of nicotine dosage bags. The classification assessment is always made on a product-specific basis and based on effect and indication.

In its reassessment, Fimea has stated that nicotine pouches can no longer routinely be classified as medicinal products unless they are specifically marketed for a medicinal purpose or it can be proven in some other way that they are typically used like medicinal products.

Fimea's new assessment only applies to nicotine pouches typically used as intoxicants. The amendment will not apply to nicotine products that are intended to be used as medicinal products and that have been granted marketing authorisation as medicinal products.

Tobacco Act reform has begun

Nicotine pouches largely meet the definition of tobacco substitute as referred to in the Tobacco Act, i.e. they correspond to a tobacco product in their intended use but do not contain any tobacco plant. Therefore, in the future, the provisions on tobacco substitutes under the Tobacco Act will apply to these products where applicable. In addition, chemicals legislation will also apply to nicotine products in the future.

The Ministry of Social Affairs and Health has already started preparing the amendments to Tobacco Act. The preparation work is based on the proposal of the Tobacco and Nicotine Policy Development Working Group, according to which nicotine snuff should be regulated in the same way as traditional snuff. In practice, this would lead to the implementation of a sales prohibition and import restrictions.

Nicotine pouches are no longer classified as medicinal products (tulli.fi)

Proposal of the Tobacco and Nicotine Policy Development Working Group (in Finnish)