The European market is increasingly confronted with products whose nature lies at the boundary between medicinal products, food supplements, and foods for special medical purposes, thereby creating significant regulatory uncertainty for both businesses and national authorities. In this context, the judgment of the Court of Justice of the European Union in Case C‑451/24 of 4 September 2025[1] (hereinafter the “Judgment”) is of fundamental importance, as it clarifies the boundaries between individual product categories and confirms the key principles governing their classification, in particular the significance of product presentation, cooperation between authorities, and the limits of the rule of precedence pursuant to Article 2 (2) of Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use[2] (hereinafter the “Directive”).
Background of the dispute and legal issues
The Judgment addresses the boundaries between medicinal products and other categories of regulated products, in particular foods for special medical purposes and food supplements. The dispute arose in connection with products containing substances that prevent bacteria from adhering to the mucosa of the urinary tract, which were recommended for the prevention and treatment of urinary tract infections. These products were initially placed on the market as foods for special medical purposes, however, the Austrian national authorities subsequently reclassified them as medicinal products. The key legal question was whether, in such circumstances, Article 2 (2) of the Directive, the so‑called rule of precedence, applies, pursuant to which, in cases of doubt, the regulatory framework applicable to medicinal products should take precedence over other regulatory regimes.
The rule of precedence and its application
The Court of Justice of the European Union expressly held that the rule of precedence applies only where there is genuine uncertainty as to whether a product that meets the definition of a medicinal product may simultaneously fall within another category of regulated products. Where it is clear that a product does not satisfy the definition of a medicinal product and cannot be classified as such, the rule of precedence does not apply.
The Judgment reiterates that a product may be classified as a medicinal product in two alternative ways: by function or by presentation. Classification by function is based on the existence of a pharmacological, immunological, or metabolic effect, whereas classification by presentation depends on the manner in which the product is communicated to the consumer, namely whether it is presented as a means of preventing, treating, or modifying physiological functions. This dual approach is of particular relevance for so‑called “borderline products”, i.e. products situated at the interface between foods for special medical purposes, food supplements, and medicinal products. An accurate assessment of the role of product presentation is crucial, as even subtle claims relating to health effects may be interpreted as indications of a therapeutic effect, thereby triggering the application of the more stringent medicinal products regulatory regime.
Cooperation between national authorities and the protection of public health
The Court of Justice of the European Union further emphasized the necessity of close cooperation between national authorities responsible for the regulation of medicinal products and those supervising other product categories, such as foods. Such cooperation is indispensable for the effective protection of public health and for minimizing legal uncertainty. Jurisdictional disputes between authorities must not jeopardize consumer safety. Where a product is classified as a medicinal product, it must fall within the competence of the authority responsible for medicinal products, which is required to ensure compliance with all relevant obligations, including marketing authorization, safety and efficacy controls, and supervision of its placing on the market.
Implications of the judgment for businesses manufacturing regulated products
The Judgment has significant implications, in particular for manufacturers and distributors of products situated at the boundary between different regulatory categories. The legal classification of a product must not be based solely on the manufacturer’s declaration, but rather on the product’s actual characteristics, effects, and manner of presentation. Businesses must be prepared for the possibility that products with therapeutic effects, or products presented as having such effects, may be subject to the stricter regulatory regime applicable to medicinal products, even if they were originally intended to be marketed as foods for special medical purposes or food supplements.
Products with potential biological or physiological effects should therefore be subjected at an early stage to both legal and regulatory analysis. Marketing claims must be formulated with particular caution to avoid presenting a product as a medicinal product unless it has been duly authorized as such. Consistency in relation to composition, declared effects, and marketing claims is also essential, as even an implied therapeutic effect may fundamentally alter the legal classification of a product. Comprehensive internal documentation is of key importance in the event of disputes and for demonstrating that a product falls within the appropriate regulatory category. Manufacturers are therefore advised to consider consulting experts in the regulation of medicinal products and foods to minimize the risk of sales bans or reclassification under a more stringent regulatory regime.
Practical recommendations for businesses
Businesses whose product portfolios include medicinal products, food supplements, or foods for special medical purposes are advised to implement a systematic product classification process and, for each product, to carefully assess its actual function and effects, particularly where it lies at the boundary between a food for special medical purposes and a medicinal product. For borderline products, a risk analysis of potential reclassification should be carried out, and consideration should be given at an early stage to whether it may be appropriate to subject the product directly to the medicinal products regime, or alternatively to modify its composition or consumer communication. Technical documentation, strict control of marketing claims, and internal compliance processes ensuring conformity with EU directives and regulations are essential. Businesses should maintain proactive communication with the relevant supervisory authorities, regularly assess regulatory risks across their product portfolios, and continuously train their teams to prevent ambiguous product presentation and to strengthen legal certainty.
Concluding remarks
The Judgment confirms the importance of the rule of precedence while simultaneously providing a clear delineation of its scope of application. It highlights that “borderline products” straddling the line between medicinal products and other categories require thorough legal assessment and a cautious regulatory approach. For businesses operating in the pharmaceutical, food, and food supplement sectors, the Judgment serves as a signal to ensure rigorous compliance, prudent marketing practices, and close cooperation with national supervisory authorities. The Judgment thus not only clarifies the legal framework but also establishes concrete standards for business practice in the placing of products on the European Union market, emphasizing the need for a carefully considered strategy in product classification and presentation.
Should you have any questions regarding borderline products, please do not hesitate to contact us.
[1] https://eur-lex.europa.eu/legal-content/CS/TXT/PDF/?uri=CELEX:62024CJ0451
[2] https://eur-lex.europa.eu/legal-content/CS/TXT/?uri=CELEX:02001L0083-20250101
Mgr. Jakub Málek, managing partner – malek@plegal.cz
Mgr. Kateřina Musilová, junior lawyer – musilova@plegal.cz
Tereza Hrudková, legal assistant – hrudkova@plegal.cz
18. 12. 2025