The researchers say the Directive contains unclear definitions of what a food supplement actually is; what is meant by a “normal diet” in the European Union bloc; as well as remaining ambiguous about the treatment of nutrients such as amino acids, fatty acids, fibre and herbal extracts and yet-to-be-confirmed dosage levels.
The result, they say, is a regulation that “turns out to be useless” and which, “fails to comply not only with the standards of good legislation but even basic legislative requirements.”
Writing in European Food and Feed Law, the University of Warsaw’s Professor Malgorzata Korzycka-Iwanow (Head of Department of Food Law) and Monika Zboralska (doctorate researcher) concluded the FSD’s attempt to ring-fence food supplements was producing a counter effect.
“…remarkable difficulties associated with qualifying a product as a food supplement, especially against a medicinal product is seen as an impediment of free movement of goods within the EU.”
FSD interpretation in the European Court of Justice (ECJ)
The FSD’s deficiencies have led to a situation where, in the author’s view, the ECJ has been called into the breach, with many cases revolving around the nebulous notion of just what a food supplement is.
In several rulings the ECJ has found a supplement can be classified by factors such as:
- its composition
- its pharmacological properties
- its manner of use
- its distribution
- its familiarity among consumers
- its risk of use
Korzycka-Iwanow and Zboralska noted, however, that a supplement and a medicinal product may contain the same substances albeit at different levels.
Similarly both a supplement and a medicinal product could possess pharmacological or therapeutic effects, but the ECJ had attempted to established a ‘threshold of significance’ to determine how to classify a product. That threshold being that medicinal products should prevent or treat disease as had been exemplified in a 2004 ECJ case about how to classify garlic supplements that saw Germany forced to treat them as supplements and not drugs as the government had sought.
ECJ rulings have also found that groups of products cannot be classified as medicines due to the presence of particular substances, vitamins or due to high dosage levels.
Other aggrieved parties have gone to the ECJ with questions about whether member states should be able to conceive their own maximum permitted limits for nutrients used in food supplements.
Relating the problem of transposing the FSD into member state legislatures, a process that remains incomplete across the EU, they wrote: “Many EU member states, including the Polish legislator, struggle with the problem of the transparency of the procedure of product classification, which should at the same time protect the safety of consumers.”