Dutch court: assess medicine or supplement case by case7 juli 2016
PRESS RELEASE, Amersfoort (NL), 7th of July 2016
Melatonin supplements cannot be considered medicines by only looking at the dosage. The national authority must take into account all characteristics of the product, when determining it as a food supplement or a medicine. This needs to be done on a case-by-case basis, according to the judgement in a Dutch court case.
The ruling sets a precedent
The case was started by NPN, the Dutch trade association for food supplements. Many people use melatonin supplements when having a jetlag or to fall asleep faster. Saskia Geurts, director of NPN, stresses the importance of this judgement that confirms principles already set in EU case law. “This ruling sets a precedent for assessment of other categories of products sold as food supplements and protects the assortment of food supplements”.
Assessment per individual product
The judge made clear that it needs to be demonstrated on an individual basis that the product can be considered as medicine. It is not possible to classify a whole range of food supplements as medicines based on the dosage of an ingredient alone.
According to the court a certain product can only be qualified as a medicine after taking into account all characteristics of the product. The composition, the product form, but also among others, the manner in which the product is used, the familiarity of the product to consumers and the risks which use of the product may pose, need to be examined. Enforcement needs to execute the assessment in a transparent and verifiable manner. The court indicates that an individual product with a pharmacological function can still be categorized as food supplement, by stating: “A pharmacological function of a dosage of a certain ingredient does not preclude that in an individual assessment of all characteristics, a product with this dosage should not be categorized as medicine.”
Relevant for other food supplements
The principle of determining individual products taking into account all characteristics set in EU case law in 2009, is also important for other supplements such as vitamin D and glucosamine. And it is also applicable in the recent vitamin B12 case in Italy, where authorities ponder reclassification of high-dose vitamin B12 products as a medicine. Saskia Geurts: “The Dutch ruling learns us once again that authorities need to look further than only the dosage of an ingredient. The manner in which the product is used and familiarity to the consumers are, among others, very important characteristics.”
Future of melatonin products
In the Netherlands enforcement policy on melatonin is not confirmed yet. It is clear that the authority cannot assess a product as a drug only by assessing a single feature, in this case the dosage of melatonin. Because enforcement needs to act on a product basis, companies regained their legal opportunity for defending their products. They need to demonstrate that a product, when determined as medicinal by function, has significant characteristics of a food supplement that categorizes the product as food supplement.
NPN is the Dutch Trade Association for food supplements, such as vitamins, minerals and herbal preparations. NPN represents companies throughout the entire chain, from raw material suppliers to distributors.
For more information: Saskia Geurts, NPN • +31 33 245 60 01