Legal framework in case of prohibited medical claim
No, in the case of a food, dietary supplement or cosmetic product one may not say that it helps with a disease. So no ‘helps against eczema’ in the case of a cream. Nor 'reduces pain with joint complaints ' in the case of glucosamine products.
But what if this is communicated? Until now the Netherlands Food and Consumer Product Safety Authority (NVWA) has always imposed a super high and double fine based on the Medicines Act (starting amount €150,000 per fine). That's pretty crazy, because why doesn't the NVWA opt for the 'normal' fine based on food law or the cosmetics law (fine €525 or €1050)? In fact, these also contain a ban on making medical claims, and these regulations are more specific and more recent.
Recently, we have been representing several clients in proceedings on this issue, with opposing judgments.
2023 brought good news. The Court of Justice has now said in the nasal spray case that if a product clearly meets the definition of a food (food supplement) - or medical device, or cosmetic product - in terms of its characteristics, the specific legislation applies. So no drug law fine for medical claims for food supplements that are intended by the manufacturer to be a food supplement and meet the legal definition. And no medicines law fine for cosmetics advertising that mention diseases.
This Court of Justice ruling is an important landmark and a great help in the proceedings before the appellate Council of State on this long-running legal question. There is light at the end of the tunnel.
Ebba Hoogenraad