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Case: Vista-Life Pharma SA and Vista-Life Pharma Belgium SCRL v Laboratoires S.M.B. SA and Brussels Reps Pharma SRL. Referring court: Cour d’appel de Bruxelles (Belgium). CELEX: 62024CJ0721. ECLI: EU:C:2026:775. Language of the case: French. Subject: the concept of “health claim” (Article 2(2)(5)) for intake frequency and administration route, and the Article 14(2) conditions for reduction of disease risk claims.

Operative part: (1) Article 2(2)(5) of Regulation No 1924/2006 — statements relating to frequency of intake and/or method of administration of a food supplement fall within “health claim” where those practical matters are presented as linked to a beneficial effect on health or to the absence or reduction of an effect adverse to health. (2) Article 14(2) — does not require verbatim reproduction of the statutory wording, provided labelling, presentation or advertising informs the consumer of both points in a manner that is accurate, clear and easy to understand. (3) Article 14(2) — written advertising promoting a food supplement with a reduction of disease risk claim need not also contain that statement if it appears on the actual packaging of the supplement.
Diagram: when intake frequency and administration route become a health claim
Fig. 1. Article 2(2)(5): purely practical instructions ≠ health claim; link to a health effect (benefit or absence/reduction of an adverse effect) = health claim. C-721/24, operative point 1 and para 53.

1. Facts: Vista-D3, VistaSterol and HCP press advertising

Vista-Life markets, among others, the food supplements Vista-D3 and VistaSterol. Laboratoires S.M.B. and Brussels Reps Pharma — competitors in the pharmaceutical and parapharmaceutical sectors — challenged advertisements published in periodicals aimed at health professionals.

In February 2021, Vista-D3 ads linked a daily dose to “stable plasma levels”. In April 2021, a VistaSterol ad (plant sterols) used “the solution for controlling cholesterol” — the parties agreed this was a reduction of disease risk claim under Article 2(2)(6). From October to December 2022, further Vista-D3 ads suggested preventing an increase in mortality risk and included, inter alia, “daily better than single dose” and statements preferring sublingual over oral administration (faster absorption; avoiding first-pass hepatic effect and GI enzymatic degradation).

Packaging, leaflet and website for VistaSterol stated that high cholesterol is a risk factor for cardiovascular disease — but the advertising did not repeat the full Article 14(2) statement. The Brussels Business Court (French-speaking) upheld the injunction actions (judgments of 6 April 2022 and 5 April 2023). Vista-Life appealed; the Cour d’appel de Bruxelles joined the cases and made a reference for a preliminary ruling.

Primary source: facts and operative part from the CJEU judgment of 17 September 2026 in Case C-721/24 (CELEX 62024CJ0721; ECLI:EU:C:2026:775). No assessment of the Belgian Code of Economic Law merits — that remains for the referring court.

2. Three questions and the Q3 limit to written advertising

The Cour d’appel asked: (1) whether Article 2(2)(1) and (5) cover statements on frequency of intake and/or route of administration; (2) whether Article 14(2) requires verbatim reproduction of the statutory wording; (3) whether advertising with a disease-risk claim must include the Article 14(2) statement where it already appears on packaging, leaflet and/or website.

On the third question the Court reformulated the scope: the dispute concerned ads in HCP periodicals, so the answer is limited to written advertising. Digital, social and TV as such were not decided beyond those written-ad facts — the same limit as in the same-day companion judgment C-657/24 Kyberg (Article 10(2)).

Article 14(2) checklist after C-721/24: verbatim, both points, packaging vs written advertising
Fig. 2. Article 14(2) checklist: (1) verbatim not required; (2) both points mandatory; (3) labelling first; (4) C-721/24 + C-657/24 — no duty to repeat in written ads if the statement is on packaging. Warning: “cholesterol is a CVD risk factor” alone is insufficient (para ~72).

3. Holding 1: intake and administration route as health claims

Article 2(2)(1) defines “claim” broadly: any message suggesting or implying that a food has particular characteristics. The Court confirmed (following the AG, Opinion point 26) that “particular characteristics” are not limited to composition — they also cover the way the food is intended to be consumed where that is presented as relevant to the characteristics attributed to it. Statements such as “daily better than single dose” or “sublingual” can therefore attribute particular characteristics to a supplement.

Article 2(2)(5) defines a health claim as a claim stating, suggesting or implying a relationship between a food (or a constituent) and health. “Relationship” is broad (Green – Swan Pharmaceuticals C-299/12; Deutsches Weintor C-544/10): it covers improvement in health and the absence or reduction of adverse effects. Where frequency or route is presented as relevant to a beneficial effect or to avoiding an adverse effect — it falls within Article 2(2)(5).

Boundary (para 53): where statements are limited to purely practical information on how to consume the product, without any explicit or implicit reference to a health effect — they are not health claims. Operationally: “take 1 capsule daily” ≠ claim; “daily better than bolus for stable plasma levels / lower risk” = claim needing authorisation.

ElementEffect after C-721/24Source
Pure dosing instructionNot a health claimPara 53
Dose/route + health-effect linkHealth claim (Art. 2(2)(5))Operative point 1; paras 52, 57
VistaSterol “solution for controlling cholesterol”Parties: Art. 14 disease-risk claimParas 36–37
AuthorisationUnauthorised claims breach Art. 10(1)Art. 10; Novel Nutriology C-386/23

4. Holding 2: Article 14(2) — no verbatim duty, two points required

Article 14(2) requires that, for a reduction of disease risk claim, the labelling — or, if no such labelling exists, the presentation or advertising — also bears a statement indicating that the disease to which the claim refers has multiple risk factors and that altering one of those factors may or may not have a beneficial effect.

The Court held that the wording does not require verbatim reproduction of the words after “a statement indicating”. Elsewhere in Regulation 1924/2006 the legislature expressly mandates fixed wording (e.g. Article 4(2)(b); Annex). The aim of Article 14(2) — to clarify the scope of the claim and prevent a therapeutic reading (recital 28) — is met where the consumer receives both points accurately, clearly and understandably. Article 7(2) of Regulation 1169/2011 (fair information practices) confirms that standard; Regulation 1924/2006 must be read in the light of 1169/2011 after the repeal of Directive 2000/13.

Guidance on the facts (para 72, subject to verification by the referring court): the statement “high cholesterol is a risk factor in the development of cardiovascular disease” alone, next to “the solution for controlling cholesterol”, is not capable of conveying both required points to the average consumer in an accurate, clear and easy-to-understand manner. In particular, the second point (altering one factor may or may not help) and a clear message of multiplicity of risk factors are missing.

Operational for FBOs: do not mechanically paste the English statutory text — but ensure both elements are visible on packaging. “Cholesterol = CVD risk factor” alone is usually too thin. An Article 14 claim still needs authorisation (paragraph 1) — C-721/24 does not free unauthorised disease-risk claims.

5. Holding 3: no duty to repeat in written advertising

Article 14(2) uses “or” before “if no such labelling exists”: the statement must appear primarily on labelling; presentation and advertising apply only if labelling is absent. Labelling (Article 2(2)(j) of Regulation 1169/2011) covers words and particulars on packaging. Implementing Decision 2013/63 (Annex point 2.1) and Article 12 of Regulation 1169/2011 confirm: mandatory information must be available at the purchase decision; for prepacked food — directly on the package or attached label.

Where the required Article 14(2) statement is on the actual packaging of the supplement, written advertising with a disease-risk claim need not repeat it. The operative part anchors the exemption in packaging (actual packaging); the reasoning also notes leaflet as labelling on the facts — but operative point 3 is packaging-based.

Structurally the holding twins C-657/24 Kyberg (same day, Fifth Chamber): Article 10(2) — points (a)–(d) need not be repeated in written advertising if already on the labelling. C-721/24 transplants that place-hierarchy logic to Article 14(2). Substantive difference: Kyberg concerns information accompanying any health claim (Article 10(2)); Vista-Life concerns the mandatory disease-risk statement (Article 14(2)) and the threshold for dose/route as claims.

6. What the Court does not decide

  • Digital / social / TV as such — beyond written-advertising facts (reformulated Q3).
  • Whether specific Vista-D3 wording is authorised — a separate Article 10(1) / list issue; it was undisputed that the contested statements were not on the authorised lists.
  • Belgian Code of Economic Law / royal decree merits — remain for the Cour d’appel on the basis of the CJEU interpretation.
  • Whether VistaSterol’s exact packaging text meets Article 14(2) — the Court gave guidance (para 72), but verification is for the national court.

7. Operational checklist for supplement marketers

  1. Audit copy on dose, “daily vs bolus” schemes and route (sublingual, spray, etc.): if it suggests a health effect — treat as a health claim and check the Union lists.
  2. For Article 14: the claim must be authorised (paragraph 1); put both Article 14(2) points on packaging — clearly, not necessarily verbatim.
  3. Do not rely on “X is a risk factor for Y” alone — after para 72 that is usually insufficient.
  4. In press / written advertising — after C-721/24 — you need not repeat Article 14(2) if the full statement is on packaging; similarly C-657/24 for Article 10(2)(a)–(d).
  5. For generic advertising (not linked to a specific SKU with labelling) Decision 2013/63 still points to duties in presentation and advertising.
  6. Document: CELEX 62024CJ0721, 62024CJ0657, 32006R1924 Arts 2(2)(5) and 14(2), 32011R1169 Arts 7(2) and 12, 32013D0063.

Related pieces

Same day, same Chamber: C-657/24 Kyberg — Article 10(2), written advertising ≠ labelling. Claims hub: health claims on food supplements — EU law. Article 13(5) refusal: creatine → cognitive function (EU 2026/1118). Novel Nutriology C-386/23 (cited in C-721/24 on health protection and scientific assessment) concerns botanical claims.

Glossary

  • Article 2(2)(5) Reg. 1924/2006 — definition of health claim (food–health relationship).
  • Article 14(2) — mandatory statement for reduction of disease risk claims (multiple risk factors; altering one may or may not help).
  • Labelling — words, particulars, etc. relating to a food and placed on packaging, a document, a label… (Art. 2(2)(j) Reg. 1169/2011).
  • Decision 2013/63/EU — Article 10 guidelines; Annex point 2.1 distinguishes labelling (delivery) from advertising (promotion) — used by analogy for Article 14(2).

Conclusion

C-721/24 closes three practical disputes: (1) dose and route become health claims when sold with a health-effect link — pure instructions stay outside Article 2(2)(5); (2) Article 14(2) requires the substance of both points, not a magic quotation; “cholesterol = risk factor” alone usually fails; (3) for written advertising, full Article 14(2) on packaging removes the duty to repeat it in the ad — in tandem with C-657/24 (Article 10(2)). The judgment does not weaken claim authorisation or the duty to place a complete statement on the label. Belgian merits and non-written channels remain outside the operative part.

Educational material, not legal advice. Based on CJEU C-721/24 (CELEX 62024CJ0721; ECLI:EU:C:2026:775), Regulation 1924/2006 Arts 2(2)(5) and 14(2), Regulation 1169/2011 Arts 7(2) and 12, and Decision 2013/63/EU. Classification of a specific campaign depends on channel, claim wording and national enforcement law.

Primary sources

  1. CJEU judgment of 17 September 2026, C-721/24, Vista-Life Pharma — CELEX 62024CJ0721; ECLI:EU:C:2026:775. Language versions: PL, FR, DE.
  2. Regulation (EC) No 1924/2006 — Arts 2(2)(1), (5) and (6), 10, 14(1)–(2); CELEX 32006R1924.
  3. Regulation (EU) No 1169/2011 — Arts 2(2)(j), 7(2), 12; CELEX 32011R1169.
  4. Commission Implementing Decision 2013/63/EU — Annex point 2.1; CELEX 32013D0063.
  5. CJEU C-657/24, Kyberg Pharma (17 Sep 2026) — companion: Article 10(2), written advertising ≠ labelling; CELEX 62024CJ0657.
  6. CJEU C-386/23, Novel Nutriology (30 Apr 2025) — cited in C-721/24 on health protection and scientific assessment.