The German authorities consider the product as a food, and consequently as a non-approved novel food, and have issued several rapid alerts on the product.
There is disagreement among the EU Member States about whether nicotine pouches are a food or not. The product, however, does not fall under the Tobacco Products Directive, nor is it a medicinal product.
The German Risk Assessment Institute, BfR, has conducted a Health Risk Assessment of Nicotine Pouches.
The BfR expects health risks, in particular for the following vulnerable subpopulations:
- children, adolescents and non-smokers, as nicotine is addictive;
- pregnant and breastfeeding women, because of the effects of nicotine during pregnancy and because of the transfer of nicotine to breast milk; and
- people with cardiovascular diseases, as nicotine has strong cardiovascular effects.
The long-term effects of consuming nicotine pouches cannot be reliably assessed based on the limited amount of data available at the moment, and as a result sale of the products is to be discontinued on the German market.
For more information on nicotine or novel foods, please contact:
Helle Buchardt Boyd
hbb@dhigroup.com
Tel +45 4516 9097
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