Dosage instructions as health claims? – Advocate General's conclusions in Case C-721/24 clarify requirements for advertising dietary supplements

The Advocate General's conclusions of 29 January 2026 clarify the distinction between neutral dosage instructions and health claims requiring authorisation.

Legal framework: health claims, risk reduction claims and labelling

The Advocate General's conclusions in Case C-721/24 address central questions of European food law, in particular Regulation (EC) No 1924/2006 on nutrition and health claims (so-called Health Claims Regulation – HCVO). At the centre is the distinction between mere instructions for use and health claims, as well as the scope of obligations regarding statements concerning the reduction of disease risk pursuant to Article 14 HCVO.

The HCVO pursues the objective of a high level of consumer protection whilst ensuring fair competition conditions in the internal market. According to Article 10 (1) HCVO, health claims are in principle prohibited unless they are authorised and included in the positive list. For risk reduction claims within the meaning of Article 14 HCVO, additional requirements apply, in particular the obligation to include an explanatory statement that the disease in question has multiple risk factors and that the modification of a single factor may have no effect.

Of considerable practical importance is also the concept of labelling, which according to the Food Information Regulation (LMIV) must be interpreted broadly and can encompass all product-related information. In times of increasing online distribution, the question in particular arises whether a product website is to be classified as labelling or as advertising.

It should be explicitly emphasised that these are the Advocate General's conclusions of 29 January 2026. These are not binding on the Court of Justice of the European Union (EuGH). The Court of Justice frequently follows the Advocate General's conclusions, but is not legally bound by them and may reach a different assessment in its later judgment.

Background to proceedings C-721/24

The request for a preliminary ruling from the Court of Appeal Brussels is based on a competition law dispute between manufacturers of dietary supplements. The advertising claims objected to included

• "Stable plasma levels"
• "Prevents an increase in mortality risk"
• "Daily better than bolus"
• "Excellent absorption"
• "Solution for cholesterol level control".

The claimant saw in these statements impermissible health claims and breaches of Article 10 and Article 14 HCVO. The national court referred several questions to the Court of Justice of the European Union (EuGH) regarding the interpretation of the terms "claim" and "health claim" as well as the scope of the warning obligation pursuant to Article 14 (2) HCVO.

Broad interpretation of the term "health claim"

The Advocate General emphasises the functional and broad interpretation of the term health claim. What is decisive is not merely the wording, but the overall impression on the average informed, attentive and discerning consumer.

Particularly relevant in practice is the statement that references to frequency of intake or to method of administration can also constitute a health claim if they are presented as evidence of a health benefit. If, for example, sublingual administration is linked with "stable plasma levels" or "improved absorption", the statement leaves the sphere of neutral dosage instructions and becomes a regulated health claim.

Pure instructions for use such as "one tablet daily" or "take with water" remain permissible, provided they do not suggest an implicit or explicit health benefit. It is always decisive whether the presentation establishes or suggests a link between the product and health.

No obligation to reproduce the warning literally

With regard to the requirements of Article 14 (2) HCVO, the Advocate General clarifies that a literal reproduction of the regulatory text is not required. The provision does not require a specific wording, but only the substantive communication of two key statements: the multicausality of the disease and the uncertainty regarding the effect of the change in a single risk factor.

An appropriate, comprehensible and complete reproduction suffices. Again, what is decisive is the perspective of the average consumer and the clear qualification of any quasi-therapeutic impression.

Warning not necessarily required to be repeated in every advertisement

Of considerable importance for practice is the interpretation of the obligation to place the warning. The Advocate General deduces from the wording of Article 14 (2) HCVO that repetition of the warning in every single advertising measure is not in principle required if proper labelling is in place.

He devotes particular attention to the digital environment. Depending on its function, a website can be classified as advertising or as part of labelling. If it serves distance selling and provides the mandatory pre-contractual information, it can be regarded functionally as a labelling-substitute document. In such cases, a clear and easily findable reference may also suffice, provided the consumer perceives the warning before making a purchasing decision.

Practical assessment and recommendation for action

The Advocate General's conclusions make clear that the threshold for classifying a statement as a health claim remains low. Companies in the field of dietary supplements, pharmaceutical advertising{ "

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