Medicinal product or foodstuff? – CJEU clarifies the priority rule for borderline products

The classification of borderline products at the intersection of medicinal product, foodstuff and medical device law is one of the most complex issues in European health law.

With itsjudgment of 4 September 2025in the caseC-451/24 (Kwizda Pharma)the Court of Justice of the European Union (EuGH) has clarified the scope of the priority rule in Article 2(2) of Directive 2001/83/EG. The judgment makes clear that the legal classification is not merely a technical matter but a centralquestion of market access and health protection.

Why thedelineation of product categoriesis so important

Whether a product is classified as a medicinal product, as a food for special medical purposes, as a dietary supplement or as a medical device determines theregulatory hurdles. For medicinal products, a strict approval procedure applies, coupled with high requirements for quality, safety and efficacy. Foods for special medical purposes or dietary supplements, by contrast, can be placed on the market with simple notification or labelling.

Precisely at these interfaces, so-called'borderline products'emerge, whose characteristics speak in favour of one category or another. For enterprises, this entails a considerable risk: if a product is notified as a foodstuff but later classified as a medicinal product, the consequence isdistribution bans, recalls and penalties. Conversely, products could wrongly fall within the medicinal product approval requirement, which delays market access and blocks investments.

The dispute in Austria: Kwizda Pharma v the Vienna Regional Authority

Kwizda Pharma GmbH placed four products on the market whose active ingredients were intended to prevent bacterial adhesion to the mucous membranes of the urinary tract. The products were recommended for urinary tract infections and were notified asfoods for special medical purposes.

The Vienna Regional Authority took a different view: it prohibited the marketing on the grounds that the products did not meet the requirements of food law. Rather, they werepresentation medicinal productssince their presentation and advertising gave the impression of a therapeutic product.

The Vienna Administrative Court upheld this view. However, the Austrian Administrative Court of Appeal initially overturned this decision and referred to the priority rule in Article 2(2) of Directive 2001/83/EG. According to this rule, medicinal product law takes precedence in cases of doubt. This raised the question of whether a food authority has the power at all to withdraw from the market products that a court considers to be medicinal products. This uncertainty led to the referral to the CJEU.

The key findings of the CJEU

The CJEU used the case to clarify the scope of the priority rule:

1. Priority rule only in genuine cases of doubt
   Article 2(2) of Directive 2001/83/EG applies exclusively when it is genuinely unclear whether a product is a medicinal product or falls under another regime – such as food law.
2. Clarity excludes priority
   If there is no doubt that a product is a medicinal product (e.g. a presentation medicinal product), only medicinal product law is applicable. Conversely, if a product clearly falls within the definition of other categories such as foodstuff or medical devices, medicinal product law does not apply.
3. Obligation of administrative cooperation
   The CJEU emphasises the principle of Union law ofgenuine cooperation(Article 4(3) TEU). National authorities must exchange information in order toavoid regulatory gaps and enforcement gaps. A food authority must not leave an unlawful product on the market simply because the medicinal product authority is formally responsible.
4. Protection of public health as a guiding principle
   The stringent requirements of medicinal product law serve primarily to protect health. This objective would be undermined if a product, despite being clearly classified as a medicinal product, could be distributed under the guise of a foodstuff.

Practical consequences for enterprises and other market operators

The judgment makes clear that thestrategic choice of product categorymust not be an instrument for enterprises to circumvent approval requirements. In particular, health-related advertising claims carry the risk of classification as a presentation medicinal product.

Enterprises should therefore:

• Carry out a sound legal reviewof the product characteristics, mode of action and presentation before market entry.
• Position borderline products with careand adapt advertising claims strictly to the regulatory framework.
• Seek dialogue with the authorities at an early stagein order to minimise the risks of recalls and distribution bans.
• Establish compliance processesthat take account of both food law and medicinal product law.

Conclusion and recommendation

The CJEU has reinforced the line: Medicinal product law is not a catch-all provision but a protection rule for cases of doubt.Once clarity exists as to the classification, only the relevant regime applies. For practice, this means: enterprises must thePresentation and marketing of their products must be designed with particular care. Even implicit healing promises are sufficient to bring a product under the stricter regime of pharmaceutical law.

Manufacturers, importers and dealers should conduct a legal early review by AVANTCORE Rechtsanwälte in Stuttgart for every product development, taking into account both functional mechanisms of action as well as presentation and marketing. Only in this way can regulatory pitfalls be avoided and market viability be secured in the long term.