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The Belgian Joint Commission’s Chamber for Products for Human Use no longer considers oral nicotine pouches to qualify as medicinal products

Author
Carmeliet Tine
Tine Carmeliet

Associate

Brussels

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Lore Van Espen

Trainee

Brussels

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23 November 2021

In a new decision dated 24 September 2021, the Belgian Joint Commission's Chamber for Products for Human Use reversed its previous decision dated 27 November 2020, and now considers that oral nicotine pouches do not qualify as medicinal products (Dutch and French). 

On 27 November 2020, the Belgian Joint Commission's Chamber for Products for Human Use (Joint Commission), consisting of representatives from various governmental healthcare agencies, decided that nicotine pouches are considered medicinal products by function. 

Nicotine pouches are small pouches filled with a filler, nicotine, flavoring, and an alkalinizing agent. Users hold pouches in their mouths to absorb the nicotine and to experience the effects of nicotine. The Joint Commission deemed these pouches to constitute a risk to consumers due to the high dosage of nicotine and increased nicotine absorption due to the way in which the pouches are consumed.

Reversing its decision of 27 November 2020, the Joint Commission now decided on 24 September 2021 that that oral nicotine pouches no longer qualify as medicinal products by function. On the basis of additional information relating to the toxic effects of nicotine, the Joint Commission concluded that the normal 10 mg pouch dose does not cause any adverse effects in adults. This means that (in addition to other obligations applicable to medicinal products) a marketing authorisation is no longer required for the distribution of oral nicotine pouches on the Belgian market. Despite this requalification, the Joint Commission still recommends that manufacturers: 

  • limit the maximum dosage to 20mg of nicotine per pouch; 
  • determine a maximum number of pouches to be used per day, and state this on the package; 
  • do not sell or offer nicotine pouches to minors; and 
  • exclude any therapeutic claims on the products.
As the Joint Commission also sought the advice of the (i) Superior Health Council regarding the concentration of notice per pouch, and (ii) Federal Public Service Health, Food Chain Safety and Environment concerning the possible qualification of nicotine pouches as “similar products" as provided for in Article 1, 2°, d) of the Law of 24/01/1977 concerning the protection of the health of the users in terms of foodstuffs and other products, it may still make certain amendments to its decision in view of their opinions.

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