Medical claims in food to be fined under FIC Regulation or Medicines Act?

Groundbreaking and justified. If a prohibited medical claim is made for a food supplement the NVWA is to base a fine on the Foodstuffs Act (starting amount €550). Until now the NVWA reasoned that a double fine could be imposed on the company based on the Medicines Act (starting amount per fine €150,000). In a thorough and convincing judgment the Court of Oost-Brabant rules out the Medicines Act in this case.

Sometimes you see advertisements for food supplements that claim to help reduce pain or to prevent a cold. Until now the NVWA reasoned very strictly: the mere fact that the food supplement advertises about a disease (medical claim) would cause that it is legally assessed as a medicine. In legal terms, this means that the foodstuff becomes a medicine via the presentation criterion. The consequence? Mega high fines without a warning in advance. This happened to Super Nature Products. For its food supplement Resveratrol the company had depicted a man wearing a mouth mask on its website and had used the word 'cold' for its product Echinacea. High drug fines followed.

Is that right? No, now says the District Court of Oost-Brabant (in Dutch). The answer lies in the European Medicines Directive, which explicitly states that if a product clearly falls under the definition of a food supplement, the Medicines Act does not apply. There is no doubt that these products are food supplements. Because the Medicines Act is therefore not applicable, the ‘submission criterion’ derived from this act does not come into play either. Moreover, the European FIC Regulation 1196/2011 was drawn up especially for foodstuffs, including food supplements, and is of a much more recent date. It provides for a ban on making medical claims. The court annuls the fine decision. So medical claims in foodstuffs are to be fined under the FIC Regulation.

This is a breakthrough and an answer to a discussion that has been going on for much longer. The Minister has appealed. Time will tell. You will be hearing from us.

This case was handled for Super Nature Products by Ebba Hoogenraad, Lisanne Steenbergen and Myrna Teeuw.