Foodstuff or not? A closer look at the legal status of kratom

Legislation and Regulation: What is a Foodstuff?

The legal framework regarding novel foods is laid down in:

1. General Food Law (Regulation (EC) No 178/2002) ('GFL'), specifically Article 2, which sets out the definition of foodstuff (or food product). The definition stipulates, among other things, that the following are not included: medicinal products within the meaning of the Medicinal Products Directive (sub d) and narcotic drugs or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs of 1961 and the United Nations Convention on Psychotropic Substances of 1971 (sub g);
2. Regulation (EU) 2015/2283 on novel foods, amending Regulation (EU) No 1169/2011 and repealing Regulation (EC) No 258/97 ('Novel Foods Regulation'), specifically Article 3 (definitions) and Article 6 (the Union list of authorised novel foods), and the Dutch Commodities Act Decree on Novel Foods and Genetically Modified Foodstuffs.

Controls upon entry are carried out pursuant to Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products ('Official Controls Regulation').

The Case: Kratom Refused upon Entry

On 24 June 2025, the CBb issued a judgment (ECLI:NL:CBB:2025:340) concerning a shipment of ‘Mitragyna speciosa dried leaves powder’ (also known as ‘kratom’) that was refused and detained upon entry into the Netherlands. Kratom is derived from a deciduous tree – the Mitragyna speciosa – which grows in Southeast Asia. The primary active substance is mitragynine, an alkaloid. Kratom has a stimulating effect and, at a higher dose, a sedative effect. It is also sometimes used as a recreational drug. The question at issue was whether kratom was correctly classified as a foodstuff.

The Dispute: Foodstuff?

The Netherlands Food and Consumer Product Safety Authority (NVWA) had detained a shipment of 1,100 kg of kratom and refused its entry into the EU. The reason given was that, according to the NVWA, kratom is classified as a foodstuff within the meaning of Article 2 GFL and this foodstuff did not comply with the legal rules for introducing it into the EU. Based on Regulation (EU) 2015/2283, kratom may not be present in foodstuffs.

The Appellant argued that the detention was incorrect because it is a psychotropic substance and therefore cannot be classified as a foodstuff. Furthermore, the air waybill stated that it was not for human consumption. The producer's documents (including the material safety data sheet) qualified the product as a textile dye. The Appellant had been selling the product as a dye for eleven years, and Customs had classified the shipment of kratom as a medicinal product.

The objection and the appeal were declared unfounded. The court ruled that kratom was not a medicinal product and was not included on the list referred to by the exception in Article 2, sub g GFL. According to the court, kratom was rightly classified as a novel food.

The CBb's Judgment

It was undisputed that the court had correctly ruled that kratom could be classified as a foodstuff, unless it was to be held that it fell under one of the exceptions listed in the definition of foodstuff in Article 2 GFL. In the appeal, the only remaining dispute was whether kratom fell under exception (g) of the GFL.

The CBb holds that kratom is not listed as a narcotic drug or psychotropic substance in the United Nations Single Convention on Narcotic Drugs of 1961 or the United Nations Convention on Psychotropic Substances of 1971. According to the CBb, this means that the foodstuff exception does not apply to kratom. The fact that kratom is comparable to substances included in these UN Conventions does not mean that kratom also falls under the exception in Article 2, sub g GFL. The CBb stated that the clear text of this provision offers no basis whatsoever for such an interpretation. The CBb also pointed out that a substance is considered a foodstuff not only if it is "intended" for human consumption, but also if it can reasonably be expected to be consumed by humans.

Conclusion

This judgment emphasizes that the qualification as a foodstuff depends not only on the importer's intent but also on the objective expectation of human consumption. Therefore, for companies that import substances with an alternative purpose (such as dyes), it is important to be alert to how these products can be legally classified.

Furthermore, as this judgment shows, it does not matter whether the product in question had been traded as a dye for years (in this case, eleven years), that the documents (material safety data sheet and air waybill) indicated it was not intended for human consumption, or that Customs had classified the shipments as a medicinal product.

About Ploum’s International Trade, Customs and Food and Commodities Practice Team

The specialists in our International Trade, Customs and Food and Commodities Practice team will gladly advise you on the legislation and regulation, as well as the required legal steps, for importing, selling, or developing (novel) foodstuffs. Our years of experience, particularly in the Food and Commodities practice, enable us to serve you quickly and effectively. If you have questions about this topic or other issues concerning International Trade, Customs, or Food Safety and Legislation, please contact one of our team members or contact Mirjam Louws directly (m.louws@ploum.nl).