Food Supplement or Medicine? Manufacturer’s Intent Is the Deciding Factor

The text "reduces swelling and relieves pain" cannot be used for a food supplement. Food law prohibits making medical claims. This carries a fine of €525 or €1050. For years, the NVWA opts for a different legal basis. Under the Medicines Act, it imposes fines of up to twice €150,000. The District Court of Gelderland (in Dutch) reeled the NVWA back in.

 What exactly are these different bases? The FIC Regulation contains a ban on making medical claims for food. The Medicines Act stipulates that medical claims for medicines can only be made under a trade permit. This sounds logical: food products are governed by the FIC and medicines by the Medicines Act. However, the NVWA plays the leapfrog game by holding that food supplements with a medical claim are presented as medicines and should therefore also be assessed under the Medicines Act.

 The District Court puts a stop to this reasoning. Indeed, recent CJEU case law shows that you must first look at whether the product clearly meets the definition of a specific product category (such as a food or food supplement). If that is the case, product-specific legislation applies, not the legislation on medicines. 

One part of the definition of a food supplement is whether the product is intended to supplement the normal diet. According to the District Court, the manufacturer's intention is the deciding factor here. Did the manufacturer intend the product to be a food supplement? And is that expressed, for instance, in the mandatory statements on the label? Then the rules of the FIC Regulation are to be followed. Third-party statements, such as consumer reviews or suppliers' advertising texts with prohibited medical claims, are not relevant for determining the manufacturer's intention. 

Ebba Hoogenraad, Lisanne Steenbergen and Myrna Teeuw are representing the claimant in this case. They are also assisting a number of other parties in similar fundamental proceedings.