Nicotine pouches are no longer considered to be a medicinal product

date: 24/09/2021

In its new advice the Joint Commission states that nicotine pouches are no longer considered to be a medicinal product. When used normally, the usual doses (around 10 mg) do not pose a risk of poisoning. However, there are some recommendations for manufacturers. These concern the nicotine yield and the maximum daily dose, the use by children and therapeutic claims.

In the past, the Joint Commission has issued an opinion on the use of nicotine pouches. These are small bags (filled with nicotine, fillers, flavourings and alkaline substances) that are kept in the mouth. Based on the then available knowledge, the Commission held the opinion that it was a medicinal product based on its effects. Meanwhile, the Commission has received additional information allowing for a reconsideration of the opinion.

New advice with recommendations for manufacturers
The new opinion (available in Dutch or French) states that, in principle, nicotine pouches cannot be considered as medicinal products. The reason for this is that the information provided shows that the usual doses (around 10 mg) in adults do not cause any adverse effects. The intoxication risk was one of the main arguments to consider the product as a medicinal product, but this argument is no longer valid.

It remains, however, a nicotine-based product, a potentially toxic substance. It is therefore recommended that manufacturers limit the quantity of nicotine. Based on the available data, and analogous with what the Tobacco Directive prescribes for e-cigarettes, the rule of thumb is that a pouch should contain no more than 20 mg. In addition, it is recommended to determine a maximum number of pouches a day, and to have this maximum use mentioned on the packaging.

The situation is different for children. Their lower body weight rapidly increases the risk of side effects. Such products should therefore not be sold or offered to minors, and should be difficult for children to open.

Finally, these products may not bear therapeutic claims. Claims like 'Helps to quit smoking' would make the products medicinal products, even if the claim is only mentioned on a website and not on the packaging.

Next steps
The Joint Commission also wonders whether the product is not a 'similar product' (like tobacco) as stated in the law of 24 January 1977 and has therefore submitted its opinion to the competent service of the FPS Health, Food Chain Safety and Environment.

Moreover, the Commission has previously requested an opinion from the Superior Health Council, which is currently pending. This opinion might enable the Commission to further adjust its position.



Last updated on 24/09/2021